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Tarbijakaitse ja Tehnilise Järelevalve Amet · 9. märts 2020
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9. märts 2020
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1 Juhtimine, asjaajamine, arhiivitöö korraldus, suhtekorraldus 2020 - ...
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1-9 Kirjavahetus isikute-, asutuste ja organisatsioonidega
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1-9/2020
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13. märts 2020

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  • 📎A European Strategy for Data.pdf748 KB
  • 📎E-kiri.pdf671 KB
  • 📎On Artificial Intelligence - A European approach to excellence and trust.pdf940 KB
  • 📎Shaping Europe's digital future.pdf660 KB

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EUROPEAN COMMISSION Brussels, 19.2.2020 COM(2020) 66 final COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS A European strategy for data EN EN A European strategy for data 1. Introduction Over the last few years, digital technologies have transformed the economy and society, affecting all sectors of activity and the daily lives of all Europeans. Data is at the centre of this transformation and more is to come. Data-driven innovation will bring enormous benefits for citizens, for example through improved personalised medicine, new mobility and through its contribution to the European Green Deal. In a society where individuals will generate ever- increasing amounts of data, the way in which the data are collected and used must place the interests of the individual first, in accordance with European values, fundamental rights and rules. Citizens will trust and embrace data-driven innovations only if they are confident that any personal data sharing in the EU will be subject to full compliance with the EU’s strict data protection rules. At the same time, the increasing volume of non-personal industrial data and public data in Europe, combined with technological change in how the data is stored and processed, will constitute a potential source of growth and innovation that should be tapped. Citizens should be empowered to make better decisions based on insights gleaned from non- personal data. And that data should be available to all – whether public or private, big or small, start-up or giant. This will help society to get the most out of innovation and competition and ensure that everyone benefits from a digital dividend. This digital Europe should reflect the best of Europe - open, fair, diverse, democratic, and confident. The EU can become a leading role model for a society empowered by data to make better decisions – in business and the public sector. To fulfil this ambition, the EU can build on a strong legal framework – in terms of data protection, fundamental rights, safety and cyber- security – and its internal market with competitive companies of all sizes and varied industrial base. If the EU is to acquire a leading role in the data economy, it has to act now and tackle, in a concerted manner, issues ranging from connectivity to processing and storage of data, computing power and cybersecurity. Moreover, it will have to improve its governance structures for handling data and to increase its pools of quality data available for use and re- use. Ultimately, Europe aims to capture the benefits of better use of data, including greater productivity and competitive markets, but also improvements in health and well-being, environment, transparent governance and convenient public services. The measures laid out in this paper contribute to a comprehensive approach to the data economy that aim to increase the use of, and demand for, data and data-enabled products and services throughout the Single Market. This Communication outlines a strategy for policy measures and investments to enable the data economy for the coming five years. This data strategy is presented at the same time as the Commission’s Communication on “Shaping Europe’s digital future” and a White Paper on 1 artificial intelligence that indicates how the Commission will support and promote the development and uptake of artificial intelligence across the EU. On the basis of this strategy, the Commission launches a comprehensive consultation on the specific measures that could be taken to keep the EU at the forefront of the data-agile economy, while respecting and promoting the fundamental values that are the foundation of European societies. 2. What is at stake? Growing data volumes and technological change The volume of data produced in the world is growing rapidly, from 33 zettabytes in 2018 to an expected 175 zettabytes in 20251. Each new wave of data represents major opportunities for the EU to become a world leader in this area. Furthermore, the way in which data is stored and processed will change dramatically over the coming 5 years. Today 80% of the processing and analysis of data takes place in data centres and centralised computing facilities, and 20% in smart connected objects, such as cars, home appliances or manufacturing robots, and in computing facilities close to the user (‘edge computing’). By 2025 these proportions are likely to be inverted2. Aside from the economic and sustainability advantages that this development presents, it opens up additional opportunities for businesses to develop tools for data producers to increase control over their own data. The importance of data for the economy and society Data will reshape the way we produce, consume and live. Benefits will be felt in every single aspect of our lives, ranging from more conscious energy consumption and product, material and food traceability, to healthier lives and better health-care. Personalised medicine will better respond to the patients’ needs by enabling doctors to take data-enabled decisions. This will make it possible to tailor the right therapeutic strategy to the needs of the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention. Data is the lifeblood of economic development: it is the basis for many new products and services, driving productivity and resource efficiency gains across all sectors of the economy, allowing for more personalised products and services and enabling better policy making and upgrading government services. It is an essential resource for start-ups and small and medium-sized enterprises (SMEs) in developing products and services. The availability of data is essential for training artificial intelligence systems, with products and services rapidly 1 IDC, 2018. 2 Gartner, 2017. 2 moving from pattern recognition and insight generation to more sophisticated forecasting techniques and, thus, better decisions. Data will also fuel the wide implementation of transformative practices such as the use of digital twins in manufacturing. Digital twins create a virtual replica of a physical product, process or system. The replica can for example predict when a machine will fail, based on data analysis, which allows to increase productivity through predictive maintenance. Moreover, making more data available and improving the way in which data is used is essential for tackling societal, climate and environment-related challenges, contributing to healthier, more prosperous and more sustainable societies. It will for example lead to better policies to achieve the objectives of the European Green Deal. At the same time, the current environmental footprint of the ICT sector is estimated to be between 5 to 9% of the world’s total electricity use and more than 2% of all emissions, a large part of which is due to data centres, cloud services and connectivity. The EU’s digital strategy ‘Shaping Europe’s digital future’ proposes green transformation measures for the ICT sector. The EU has everything to play for in the data economy of the future Currently, a small number of Big Tech firms hold a large part of the world’s data. This could reduce the incentives for data-driven businesses to emerge, grow and innovate in the EU today, but numerous opportunities lie ahead. A large part of the data of the future will come from industrial and professional applications, areas of public interest or internet-of-things applications in everyday life, areas where the EU is strong. Opportunities will also arise from technological change, with new perspectives for European business in areas such as cloud at the edge, from digital solutions for safety critical applications, and also from quantum computing. These trends indicate that the winners of today will not necessarily be the winners of tomorrow. But the sources of competitiveness for the next decades in the data economy are determined now. This is why the EU should act now . The EU has the potential to be successful in the data-agile economy. It has the technology, the know-how and a highly skilled workforce. However, competitors such as China and the US are already innovating quickly and projecting their concepts of data access and use across the globe. In the US, the organisation of the data space is left to the private sector, with considerable concentration effects. China has a combination of government surveillance with a strong control of Big Tech companies over massive amounts of data without sufficient safeguards for individuals. In order to release Europe’s potential we have to find our European way, balancing the flow and wide use of data, while preserving high privacy, security, safety and ethical standards. 3 What has been done so far? The Commission has already taken a number of steps since 2014. With the General Data Protection Regulation (GDPR)3, the EU created a solid framework for digital trust. The upcoming review of the GDPR may provide further useful elements in this regard. Other initiatives that have fostered the development ofthe data economy are the Regulation on the free flow of non-personal data (FFD)4, the Cybersecurity Act (CSA)5, and the Open Data Directive6. The Commission had also engaged in digital diplomacy recognising 13 countries as providing adequate level of protection for personal data. Sector-specific legislation on data access has also been adopted in some fields to address identified market failures, such as automotive7, payment service providers8, smart metering information9, electricity network data10, or intelligent transport systems11. The Digital Content Directive12 contributed to empowering individuals by introducing contractual rights when digital services are supplied to consumers who provide access to their data. 3. The vision The Commission’s vision stems from European values and fundamental rights and the conviction that the human being is and should remain at the centre. The Commission is convinced that businesses and the public sector in the EU can be empowered through the use of data to make better decisions. It is all the more compelling to seize the opportunity presented by data for social and economic good, as data – unlike most economic resources – can be replicated at close to zero cost and its use by one person or organisation does not prevent the simultaneous use by another person or organisation. That potential should be put to work to address the needs of individuals and thus create value for the economy and society. To release this potential, there is a need to ensure better access to data and its responsible usage. The EU should create an attractive policy environment so that, by 2030, the EU’s share of the data economy – data stored, processed and put to valuable use in Europe - at least corresponds to its economic weight, not by fiat but by choice. The aim is to create a single European data space – a genuine single market for data, open to data from across the world – where personal as well as non-personal data, including sensitive business data, are secure and businesses also 3 Regulation (EU) 2016/679. 4 Regulation (EU) 2018/1807. 5 Regulation (EU) 2019/881. 6 Directive (EU) 2019/1024. 7 Regulation 715/2007 as amended by Regulation 595/2009. 8 Payment Service Directive Directive 2015/2366. 9 Directive 2019/944 for electricity, Directive 2009/73/EC for gas meters. 10 Commission Regulation (EU) 2017/1485, Commission Regulation (EU) 2015/703. 11 Directive 2010/40/EU. 12 Directive (EU) 2019/770. 4 have easy access to an almost infinite amount of high-quality industrial data, boosting growth and creating value, while minimising the human carbon and environmental footprint. It should be a space where EU law can be enforced effectively, and where all data-driven products and services comply with the relevant norms of the EU’s single market. To this end, the EU should combine fit-for-purpose legislation and governance to ensure availability of data, with investments in standards, tools and infrastructures as well as competences for handling data. This favourable context, promoting incentives and choice, will lead to more data being stored and processed in the EU. The European data space will give businesses in the EU the possibility to build on the scale of the Single market. Common European rules and efficient enforcement mechanisms should ensure that: - data can flow within the EU and across sectors; - European rules and values, in particular personal data protection, consumer protection legislation and competition law, are fully respected; - the rules for access to and use of data are fair, practical and clear, and there are clear and trustworthy data governance mechanisms in place;there is an open, but assertive approach to international data flows, based on European values. The steps listed here to enable access to data need to be complemented with a broader industrial strategy for the data-agile economy. Data spaces should foster an ecosystem (of companies, civil society and individuals) creating new products and services based on more accessible data. Public policy can increase demand for data-enabled offerings, both by increasing the public sector’s own ability to employ data for decision-making and public services and by updating regulation and sectoral policies to reflect the opportunities provided by data and ensure that they do not maintain disincentives for productive data use. The functioning of the European data space will depend on the capacity of the EU to invest in next-generation technologies and infrastructures as well as in digital competences like data literacy. This in turn will increase Europe’s technological sovereignty in key enabling technologies and infrastructures for the data economy. The infrastructures should support the creation of European data pools enabling Big Data analytics and machine learning, in a manner compliant with data protection legislation and competition law, allowing the emergence of data-driven ecosystems. These pools may be organised in a centralised or a distributed way13. The organisations contributing data would get a return in the form of increased access to data of other contributors, analytical results from the data pool, services such as predictive maintenance services, or licence fees. 13 In the latter case the data are not moved to a central place in order to analyse them together with other data assets. The analytical tools come to the data, not the other way around. This makes it easier to keep the data secure and to ensure control over who accesses what data for what purposes. 5 While data is essential for all sectors of the economy and society, each domain has its own specificities and not all sectors are moving at the same speed. Therefore, cross-sectoral actions towards a European data space need to be accompanied by the development of sectoral data spaces in strategic areas such as manufacturing, agriculture, health, and mobility. 4. The problems Several issues are holding the EU back from realising its potential in the data economy. Fragmentation between Member States is a major risk for the vision of a common European data space and for the further development of a genuine single market for data. A number of Member States have started with adaptations of their legal framework, such as on use of privately-held data by government authorities14, data processing for scientific research purposes15, or adaptations to competition law16. Others are only starting to explore how to handle the issues at stake. The emerging differences underline the importance of common action in order to leverage the scale of the internal market. Progress will need to be made together on the following issues: Availability of data: The value of data lies in its use and re-use. Currently there is not enough data available for innovative re-use, including for the development of artificial intelligence. The issues can be grouped according to who is the data holder and who is the data user, but also depend on the nature of data involved (i.e. personal data, non-personal data, or mixed data-sets combining the two17). Several of the issues concern the availability of data for the public good. Data for the public good: Data is created by society and can serve to combat emergencies, such as floods and wildfires, to ensure that people can live longer and healthier lives, to improve public services, and to tackle environmental degradation and climate change, and, where necessary and proportionate, to ensure more efficient fight against crime. Data generated by the public sector as well as the value created should be available for the common good by ensuring, including through preferential access, that these data are used by researchers, other public institutions, SMEs or start-ups. Data from the private sector can also make a significant contribution as 14 For example the French ‘LOI n° 2016-1321 du 7 octobre 2016 pour une République numérique’, allowing the public sector to access certain (private sector) data of general interest or the Finnish Forest Act obliging forest owners to share information related to the management of the forest with the public sector. 15 For example the Finnish law on secondary use of health and social data, creating a data permit authority. 16 Discussions on adapting the competition rules to make them better equipped for the data economy are for example ongoing in Germany. See also the report for the Commission on ‘Competition policy for the digital era’. 17 For adding legal certainty, the European Commission issued practical guidance for businesses on how to process mixed datasets in May 2019; see COM(2019)250 https://ec.europa.eu/digital-single- market/en/news/practical-guidance-businesses-how-process-mixed-datasets 6 public goods. The use of aggregated and anonymised social media data can for example be an effective way of complementing the reports of general practitioners in case of an epidemic. - Use of public sector information by business (government-to-business – G2B – data sharing). Opening up government-held information is a long-standing EU policy18. This data has been produced with public money and should therefore benefit society. The recently revised Open Data Directive19 as well as other sector-specific legislation ensures that the public sector makes more of the data it produces easily available for use 20, in particular by SMEs but also for civil society, and the scientific community, in the framework of independent public policy evaluations. However, governments can do more. High-value datasets are often not available under the same conditions across the EU to the detriment of the use of the data by SMEs that cannot afford this fragmentation. At the same time, sensitive data (e.g. health data) in public databases is often not made available for research purposes, in the absence of capacity or mechanisms that allow specific research actions to be taken in a manner compliant with personal data protection rules. - Sharing and use of privately-held data by other companies (business-to-business – B2B – data-sharing). In spite of the economic potential, data sharing between companies has not taken off at sufficient scale. This is due to a lack of economic incentives (including the fear of losing a competitive edge), lack of trust between economic operators that the data will be used in line with contractual agreements, imbalances in negotiating power, the fear of misappropriation of the data by third parties, and a lack of legal clarity on who can do what with the data (for example for co-created data, in particular IoT data). - Use of privately-held data by government authorities (business-to-government – B2G – data sharing). There is currently not enough private sector data available for use by the public sector to improve evidence-driven policy-making21 and public services such as mobility management or enhancing the scope and timeliness of official statistics22, and hence their relevance in the context of new societal developments. The recommendations of an Expert Group23 created by the Commission, include the creation of national structures for B2G data sharing, the development of appropriate incentives to create a 18 Since the adoption of Directive 2003/98/EC on the re-use of public sector information. 19 Directive (EU) 2019/1024, repealing Directive 2003/98/EC as revised by Directive 2013/37/EU. 20 The European open data portal contains examples of a range of companies from across the EU that have benefited from open data, and some of them would not exist without the data availability. https://www.europeandataportal.eu/en/using-data/use-cases. 21 For example in new areas such as platform work. 22 The scope of the work on B2G does not include the use of data for law enforcement purposes. Any action in this area should comply with data protection and privacy legislation. 23 see here: https://ec.europa.eu/digital-single-market/news-redirect/666643. 7 data-sharing culture, and the suggestion to explore an EU regulatory framework to govern the public sector’s re-use for the public interest of privately-held data.. - Sharing of data between public authorities is equally important. It can make a considerable contribution to improving policy making and public services, but also to reduce the administrative burden on companies operating in the Single Market (‘once only’ principle). Imbalances in market power: Beside the high concentration in the provision of cloud services and data infrastructures, there are also market imbalances in relation to access to and use of data, for example when it comes to access to data by SMEs. A case in point comes from large online platforms, where a small number of players may accumulate large amounts of data, gathering important insights and competitive advantages from the richness and variety of the data they hold. This can affect, in turn, the contestability of markets in specific cases – not only the market for such platform services, but also the various specific markets for goods and services served by the platform, in particular if the platform is itself active on such related markets. The high degree of market power resulting from the ‘data advantage’ can enable large players to set the rules on the platform and unilaterally impose conditions for access and use of data or, indeed, allow leveraging of such ‘power advantage’ when developing new services and expanding towards new markets. Imbalances may also arise in other situations, such as with regard to access to co-generated IoT data from industrial and consumer devices. Data interoperability and quality: Data interoperability and quality, as well as their structure, authenticity and integrity are key for the exploitation of the data value, especially in the context of AI deployment. Data producers and users have identified significant interoperability issues which impede the combination of data from different sources within sectors, and even more so between sectors. The application of standard and shared compatible formats and protocols for gathering and processing data from different sources in a coherent and interoperable manner across sectors and vertical markets should be encouraged through the rolling plan for ICT standardisation24 and (as regards public services) a strengthened European Interoperability Framework.25 Data governance: There have been calls to further reinforce the governance of data use in society and the economy.26 For these data spaces to become operational, organisational approaches and structures (both public and private) are needed that enable data-driven innovation on the basis of the existing legal framework. 24 https://ec.europa.eu/digital-single-market/en/news/rolling-plan-ict-standardisation. 25 https://ec.europa.eu/isa2/eif_en; see: COM(2017)134 final. 26 E.g. in a recent series of workshops undertaken by the Commission on the concept of ‘common European data spaces’ https://ec.europa.eu/digital-single-market/en/news/report-european-commissions-workshops-common- european-data-spaces. 8 Data infrastructures and technologies: The digital transformation of the EU economy depends on the availability and uptake of secure, energy-efficient, affordable and high-quality data processing capacities, such as those offered by cloud infrastructures and services, both in data centres and at the edge. In this perspective, the EU needs to reduce its technological dependencies in these strategic infrastructures, at the centre of the data economy. However problems persist on both the supply and demand side of cloud. On the supply side: - EU-based cloud providers have only a small share of the cloud market, which makes the EU highly dependent on external providers, vulnerable to external data threats and subject to a loss of investment potential for the European digital industry in the data processing market; - Service providers operating in the EU may also be subject to legislation of third countries, which presents the risk that data of EU citizens and businesses are accessed by third country jurisdictions that are in contradiction with the EU’s data protection framework. In particular, concerns have been voiced about several Chinese laws related to cybersecurity and national intelligence. - While third country legislations like the U.S. CLOUD Act are based on public policy reasons such as law enforcement access to data for criminal investigations, the application of foreign jurisdictions’ legislation raises legitimate concerns for European businesses, citizens and public authorities over legal uncertainty and compliance with applicable EU law, such as data protection rules. The EU is acting to mitigate such concerns through mutually beneficial international cooperation, such as the proposed EU-U.S. Agreement to facilitate cross border access to electronic evidence, alleviating the risk of conflict of laws and establishing clear safeguards for the data of EU citizens and companies. The EU is also working at the multilateral level, including in the context of the Council of Europe, to develop common rules on access to electronic evidence, based on a high level of protection of fundamental and procedural rights. - There is uncertainty about compliance of cloud service providers with important EU rules and standards, for example on data protection. - Micro-enterprises and SMEs suffer economic detriment because of contract-related problems, e.g. non-conformity with the contract or unfair contract terms.27 On the demand side: - There is a low cloud uptake in Europe (1 company in 4, only 1 in 5 for SMEs 28). Significant divergences in cloud uptake exist between Member States (from below 10% to up to 65% of businesses using cloud); 27 Study on the economic detriment from unfair and unbalanced cloud computing contract terms. 28 https://ec.europa.eu/eurostat/statistics-explained/index.php/Cloud_computing_- _statistics_on_the_use_by_enterprises. 9 - Specifically, cloud uptake in the European public sector is low. This may lead to less efficient digital public services, not only because of the clear potential to cut IT costs by cloud adoption, but also because governments need the scalability of cloud computing to deploy technologies like Artificial Intelligence. - There is frequently insufficient visibility on the market of smaller, often European, providers of innovative cloud services. - European businesses often experience problems with multi-cloud interoperability, in particular data portability. Empowering individuals to exercise their rights: Individuals value the high level of protection granted by the GDPR and ePrivacy legislation. However, they suffer from the absence of technical tools and standards that make the exercise of their rights simple and not overly burdensome. The potential of Article 20 of the GDPR to enable novel data flows and foster competition is recognised in reports for the Commission and Member State governments29, not limited to the EU30. Yet, as a result of its design to enable switching of service providers rather than enabling data reuse in digital ecosystems the right has practical limitations. Since increasingly large amounts of data are generated by consumers when they use IoT devices and digital services, consumers may be faced with risks of discrimination, unfair practices and ‘lock-in’ effects. Considerations of consumer and innovation empowerment underlie the provisions on data access and reuse of the Payment Services Directive In response to this, there are calls to give individuals the tools and means to decide at a granular level what is done with their data (by the MyData movement and others) 31. This promises significant benefits to individuals, including to their health and wellness, better personal finances, reduced environmental footprint, hassle-free access to public and private services and greater oversight and transparency over their personal data. Those tools and means include consent management tools, personal information management apps, including fully decentralised solutions building on blockchain, as well as personal data cooperatives or trusts acting as novel neutral intermediaries in the personal data economy32. Currently such tools are still in their infancy, although they have significant potential and need a supportive environment. Skills and data literacy: Currently, big data and analytics are top of the list of critical skills shortages. In 2017, there were approximately 496 000 unfilled positions in the area of big data 29 Cf. e.g. Cremer/deMontjoye/Schweitzer, Competition policy for the digital era; Furman, Unlocking digital competition, report for the UK government; German Datenethikkommission. 30 See introduction of a new Consumer Data Right in Australia, https://www.accc.gov.au/focus-areas/consumer- data-right-cdr-0 and the consultation in on data portability in Singapore. 31 https://mydata.org/; https://www.decodeproject.eu/; https://solid.mit.edu/, https://radicalxchange.org/ 32 See report of German Datenethikkommission, p. 133 and Staff Working Document, p. 8. 10 and analytics in the EU2733. Moreover, general data literacy in the workforce and across the population is relatively low and participation gaps exist (for example by elderly people). If it is not addressed, the shortage in data experts and the lack of data literacy will affect the EU’s capacity to master the challenges of the data economy and society. Cybersecurity: In the area of cybersecurity Europe has developed an already comprehensive framework to support Member States, businesses and citizens to tackle cybersecurity threats and attacks, and Europe will continue to develop and improve its mechanisms to protect its data and the services building on it. The safe and widespread use of data-fuelled products and services will also depend on the highest cybersecurity standards. The EU Cybersecurity Certification Framework and the EU Agency for Cybersecurity (ENISA)34 are expected to play an important role towards that endeavour. However, the new data paradigm where less data will be stored in data centres, and more data will be spread in a pervasive way closer to the user ‘at the edge’, brings new challenges for cybersecurity. It will be essential to preserve data security when data are being exchanged. Ensuring the continuity of access controls (i.e. how security attributes of data are managed and respected) across data value chains will be a key, but demanding, pre-requisite to foster data sharing and ensure trust among the different actors of European data ecosystems. New decentralised digital technologies such as blockchain offer a further possibility for both individuals and companies to manage data flows and usage, based on individual free choice and self-determination. Such technologies will make dynamic data portability in real time possible for individuals and companies, along with various compensation models. 5. The strategy This European data strategy serves to realise the vision for a genuine single market for data and tackles the problems identified through policy measures and funding, building on what has already been achieved in the last few years. Each of the new legislative measures will be prepared and assessed in full compliance with the Better Regulation principles. The actions are based on four pillars: 33 IDC 2019. 34 Regulation (EU) 2019/881 – European Cybersecurity Act. 11 A. A cross-sectoral governance framework for data access and use Cross-sectoral (or horizontal) measures for data access and use should create the necessary over-arching framework for the data-agile economy, thereby avoiding harmful fragmentation of the internal market through inconsistent actions between sectors and between the Member States. Such measures should nonetheless take into account the specificities of individual sectors and of the Member States. The Commission’s approach to regulation is to create frameworks that shape the context, allowing lively, dynamic and vivid ecosystems to develop. Because it is difficult to fully comprehend all elements of this transformation towards a data-agile economy, the Commission deliberately abstains from overly detailed, heavy-handed ex ante regulation, and will prefer an agile approach to governance that favours experimentation (such as regulatory sandboxes), iteration, and differentiation. In line with this principle, a first priority for operationalising the vision is to put in place an enabling legislative framework for the governance of common European data spaces (Q4 2020). Such governance structures should support decisions on what data can be used in which situations, facilitate cross-border data use, and prioritise interoperability requirements and standards within and across sectors, while taking into account the need for sectoral authorities to specify sectoral requirements. The framework will reinforce the necessary structures in the Member States and at EU level to facilitate the use of data for innovative business ideas, both at sector- or domain-specific level and from a cross-sector perspective. It will build on recent initiatives in the Member States35 and in individual sectors to address one or more of the following issues: - strengthen the governance mechanisms at EU level and in the Member States relevant for cross-sector data use and for data use in the common sectoral data spaces, involving both private and public players. This could include a mechanism to prioritise standardisation activities36 and to work towards a more harmonised description and overview of datasets, data objects and identifiers to foster data interoperability (i.e. their usability at a technical level37) between sectors and, where relevant, within sectors38. This can be done in line with the principles on Findability, Accessibility, Interoperability and Reusability (FAIR) of data taking into account the developments and decisions of sector-specific authorities; 35 Finnish Health and Social Data Permit Authority (https://www.findata.fi/en/), French Health Data Hub (https://www.health-data-hub.fr/), German Forschungsdatenzentrum (https://www.forschungsdatenzentrum.de/en). 36 The idea is not to create a body that develops new standards, but rather to be able to prioritise between existing and future standards to be developed. 37 See also the FAIR data principles: https://www.force11.org/group/fairgroup/fairprinciples. 38 For instance, the 2017 Tallinn Ministerial Declaration on e-Government calls on governments to “increase the findability, quality and technical accessibility of data in key base registers.” 12 - facilitate decisions on which data can be used, how and by whom for scientific research purposes in a manner compliant with the GDPR. This is particularly relevant for publicly- held databases with sensitive data not covered by the Open Data Directive; - make it easier for individuals to allow the use of the data they generate for the public good, if they wish to do so (‘data altruism’), in compliance with the GDPR. Secondly, the Commission will work on making more high-quality public sector data available for re-use, in particular in view of its potential for SMEs. In order to open up key public sector reference data sets for innovation, it shall start the procedure for the adoption of an Implementing act on high-value data sets (Q1 2021) under the Open Data Directive, making these data sets available across the EU for free, in machine-readable format and through standardised Application Programming Interfaces (APIs). The Commission will look into mechanisms to take into account the particular needs of SMEs. It will also assist the Member States to ensure a timely and accurate transposition of the new rules of the Open Data Directive by 17 July 2021. Third, the Commission will explore the need for legislative action on issues that affect relations between actors in the data-agile economy to provide incentives for horizontal data sharing across sectors (complementing data sharing within sectors as described in the appendix)). One or more of the following issues could be taken forward in a Data Act (2021): - Foster business-to-government data sharing for the public interest also in the light of the recommendations included in the report of the Expert Group on Business-to-Government Data Sharing). - support business-to-business data sharing, in particular addressing issues related to usage rights for co-generated data (such as IoT data in industrial settings), typically laid down in private contracts. The Commission will also seek to identify and address any undue existing hurdles hindering data sharing and to clarify rules for the responsible use of data (such as legal liability). The general principle shall be to facilitate voluntary data sharing. - only where specific circumstances so dictate39, access to data should be made compulsory, where appropriate under fair, transparent, reasonable, proportionate and/or non- discriminatory conditions40. - evaluating the IPR framework with a view to further enhance data access and use (including a possible revision of the Database Directive41 and a possible clarification of the application of the Trade Secrets Protection Directive42 as an enabling framework). 39 A data access right should only be sector-specific and only given if a market failure in this sector is identified/can be foreseen, which competition law cannot solve. The scope of a data access right should take into account legitimate interests of the data holder and needs to respect the legal framework. 40 Variations of this principle apply in particular with respect to certain motor vehicle repair and maintenance information to be made accessible under Regulation 715/2007 as well as for information resulting from testing of chemicals on vertebrate animals under Regulation 1907/2006 (REACH). 41 Directive 96/9/EC. 13 Furthermore, the Commission will assess what measures are necessary to establish data pools for data analysis and machine learning. The Commission will provide more guidance to stakeholders on the compliance of data sharing and pooling arrangements with EU competition law by means of an update of the Horizontal Co-operation Guidelines43. The Commission is also prepared to provide additional individual project-related guidance on the compatibility with EU competition rules, if needed. In the exercise of its merger control powers, the Commission will look closely at the possible effects on competition of large-scale data accumulation through acquisitions and at the utility of data-access or data-sharing remedies to resolve any concerns. In its ongoing review of a number of State Aid guidelines, the Commission will examine the relationship between public support to undertakings (e.g. for digital transformation) and the minimisation of competition distortions through data-sharing requirements for beneficiaries. The review of the current self-regulatory approach for cloud provider switching44 could lead to further action, depending on the progress made by market players. The Commission will also consider jurisdictional issues related to data. These issues create uncertainty for businesses which may face conflicting rules. The EU should not compromise on its principles: all companies which sell goods or provide services related to the data-agile economy in the EU must respect EU legislation and this should not be compromised by jurisdictional claims from outside the EU. The Commission will consider measures that facilitate the use of data in products and services and increase demand for data-enabled services. Sectoral reviews should identify regulatory and non-regulatory obstacles to the use of data and data-enabled offerings. Increased availability and standardisation of data should also facilitate real-time and cross-border compliance, leading to reductions in administrative burdens and barriers to the Single Market. Furthermore, governments can also foster demand through increased use of data-analytics and automated services in public services and decision making. The accumulation of vast amounts of data by Big Tech companies, the role of data in creating or reinforcing imbalances in bargaining power and the way these companies use and share the data across sectors is being analysed by the Observatory of the Online Platforms Economy. The issue will not be addressed as part of the Data Act, but under the broader fact-finding around the high degree of market power of certain platforms and also in the context of the Commission’s work on the Digital Services Act package. On the basis of this fact-finding, the Commission will consider how best to address more systemic issues related to platforms and data, including by ex ante regulation if appropriate, to ensure that markets stay open and fair. 42 Directive (EU) 2016/943. 43 2011/C 11/01. 44 https://swipo.eu/ The approach is based on the Free flow of data regulation, Regulation (EU) 2018/1807. 14 Leading by example The Commission will strive for excellence in the way it organises its own data, uses the data for better policy making, and makes the data it produces and funds available to others, including through the EU Open Data Portal45. The EU will continue to make data resulting from its research and deployment programmes available in line with the principle ‘as open as possible, as closed as necessary’, and will continue to facilitate discovery, sharing of, access to and reuse of data and services by researchers through the European Open Science Cloud (EOSC)46. The EU will also contribute data and infrastructure from the Copernicus earth observation programme to underpinning the European data spaces where relevant. At the same time, enhancing the Copernicus ecosystem through the application of European digital technological solutions will offer new innovation opportunities to the data spaces constituency, both public and private. The EU will seek to make increased use of data and data analytics in its internal processes and as an input to Commission decision-making and reviews of existing policy Key actions - Propose a legislative framework for the governance of common European data spaces, Q4 2020 - Adopt an implementing act on high-value data-sets, Q1 2021 - Propose, as appropriate, a Data Act, 2021 - Analysis of the importance of data in the digital economy (e.g. through the Observatory of the Online Platform Economy), and review of the existing policy framework in the context of the Digital Services Act package (Q4 2020). B. Enablers: Investments in data and strengthening Europe’s capabilities and infrastructures for hosting, processing and using data, interoperability Europe’s data strategy relies on a thriving ecosystem of private actors to create economic and societal value from data. Start-ups and scale-ups will play a key role in developing and growing disruptive new business models that fully take advantage of the data revolution. Europe should offer an environment that supports data-driven innovation and stimulates demand for products and services that rely on data as an important factor of production. 45 https://data.europa.eu/euodp/en/data/. 46 https://ec.europa.eu/research/openscience/index.cfm?pg=open-science-cloud. See also COM (2016) 178 final and SWD(2018)83. 15 Making rapid progress on data-driven innovation in strategic areas requires investments, both from the private and public sectors. The Commission will use its convening power as well as EU funding programmes to strengthen Europe’s technological sovereignty for the data-agile economy. This will be done through standard setting, tool development, best practices collection on how to deal with personal data (especially around pseudonymization) as well as build-out of next-generation infrastructures for data processing. Where relevant, the investments will be co-ordinated with relevant authorities in Member States and paired, in line with state aid rules, with national and regional funding and with investments through the structural and investment funds. In the period 2021-2027, the Commission will invest in a High Impact Project on European data spaces and federated cloud infrastructures.. The project will fund infrastructures, data-sharing tools, architectures and governance mechanisms for thriving data-sharing and Artificial Intelligence ecosystems. It will be based on the European federation (i.e. interconnection) of energy-efficient and trustworthy edge and cloud infrastructures (Infrastructure-as-a-Service, Platform-as-a-Service and Software-as-a- Service services). It will address the specific needs of industries in the EU, including hybrid cloud deployment models that allow data processing at the edge with no latency (cloud-to- edge). This project will involve and benefit the European ecosystem of data-intensive companies, and will support European companies and the public sector in their digital transformation. For this project to be credible as a pan-European initiative, it needs an adequate level of investment. The Member States and industry are expected to co-invest with the Commission in the project, which could arrive at a total funding in the order of €4-6 billion, of which the Commission could aim at financing €2 billion, drawing upon different spending programmes, subject to an agreement on the next Multiannual Financial Framework. This Project needs to be seen in the context of a wider set of strategic EU investments in new technologies that the Commission will present in March 2020 as part of its industrial strategy. They concern in particular funding for edge computing, high-performance computing/quantum computing, cyber-security, low-power processors and 6G networks. These investments are essential for the EU’s data infrastructure of the future, to equip Europe with the right infrastructures, computing power, encryption capacity and cybersecurity tools to process data. High Impact Project: developing common European data spaces and interconnecting cloud infrastructures Concretely, the Commission intends to fund the establishment of EU-wide common, interoperable data spaces in strategic sectors. Such spaces aim at overcoming legal and technical barriers to data sharing across organisations, by combining the necessary tools and infrastructures and addressing issues of trust, for example by way of common rules developed 16 for the space. The spaces will include: (i) the deployment of data-sharing tools and platforms; (ii) the creation of data governance frameworks; (iii) improving the availability, quality and interoperability of data – both in domain-specific settings and across sectors. Funding will also support authorities in the Member States in making high value data sets available for re- use in the different common data spaces. The support for data spaces will also cover data processing and computing capacities that comply with essential requirements in terms of environmental performance, security, data protection, interoperability and scalability. With focus on the areas where EU level support has clear added value, investments may also cover the interconnection of existing computing capacities at national47 and European level, including High Performace Computing capacities48, and will -where needed- bring together the capacity of data processing resources. The aim is to help common data and world class cloud infrastructures for the public good to emerge, enabling secure data storage and processing for the public sector and research institutions. Similar positive effects are expected from the interconnection with the European Open Science Cloud (EOSC) and the Data and Information Access Services (DIAS) cloud-based platform that provides access to services based on the Copernicus earth observation data. The private sector, including notably SMEs, also needs data and cloud infrastructures and services that provide the essential features of security, sustainability, interoperability and scalability. This is essential for European businesses to benefit from a complete value chain of data generation, processing, access and re-use49. The investment track will bring together private actors with public support to develop common platforms offering access to a large diversity of cloud services for secure data storage and sharing as well as applications ranging from artificial intelligence to simulation, modelling, digital twins and high performance computing (HPC) resources. The platform will cover all the layers of data and computing infrastructure and services and will seize the opportunities offered by latest developments such as edge computing, the deployment of 5G and the uptake of Internet of Things across industrial sectors. It will also help develop a dynamic ecosystem for a data- and cloud-based supply industry in Europe across the value chain. The cloud federation component of the High Impact Project will foster the gradual rebalancing between centralised data infrastructure in the cloud and highly distributed and smart data processing at the edge. Such a project should therefore interconnect emerging edge computing capacities from the start. Over time, the project should furthermore enable access to top-end high-performance computers and its integration with mainstream data processing 47 Such as the French “Cloud de Confiance” initiative or the Polish Common State IT Infrastructure Programme (WIIP) 48 Notably the capacities supported under the EuroHPC initiative. 49 For example as expressed by the industry support to the German Gaia-X project. 17 services. This will provide a seamless computing continuum to maximize the growth and exploitation of common European data spaces for public, industrial and scientific applications. In this context, the Commission will foster synergies between the work on European cloud federation and Member States’ initiatives such as Gaia-X50. This is necessary to avoid multiplication of fragmented cloud federation and data-sharing initiatives, as the success of such an initiative would depend on pan-European participation and capacity to scale. For this reason, the Commission will facilitate Memoranda of Understanding with Member States by Q3 2020, starting with those having existing cloud federation and data-sharing initiatives. Enabling access to competitive, secure and fair European cloud services In order to protect the rights and interests of EU companies and citizens, the Commission, with the support of the relevant authorities of the Member States, will pay particular attention to the adherence of cloud service providers operating on the EU market to EU rules (e.g. General Data Protection Regulation, Free Flow of non-personal Data Regulation and the Cybersecurity Act) and, where relevant, their envisaged implementation through self- and co- regulatory mechanisms and technological means to increase trust, such as security by design and automated compliance. Currently, no comprehensive overview of these EU rules and self- /co-regulatory schemes is available for cloud providers and users. In this context, the Commission will bring together by Q2 2022 a coherent framework around the different applicable rules (including self-regulation) for cloud services, in the form of a ‘cloud rulebook’. In a first instance, the cloud rulebook will offer a compendium of existing cloud codes of conduct and certification on security, energy efficiency, quality of service, data protection and data portability. In the area of energy efficiency earlier action will be considered. In coherence with the cloud rulebook, the Commission will facilitate the development of common European standards and requirements for the public procurement of data processing services. This will enable the EU’s public sector at European, national, regional and local level to also become a driver of new EU data processing capacities, rather than just a beneficiary of such European infrastructures51. To fully leverage this potential, additional work should be done to connect demand-side organisations in the private and public sector to the new and innovative offering of tailored data processing services, specifically at Platform-as-a-Service and Software-as-a-Service 50 An initiative to stimulate cloud federation from the German perspective, presented by the German government on 29 October 2019. The purpose of the project is to cater for European standards and reference architectures to create EU-based ‘virtual hyperscale providers’. 51 Examples of similar public procurement programmes in this area can be drawn from third countries, e.g. the American ‘FedRAMP’ government procurement program. It provides a standardised approach to security assessment, authorisation, and continuous monitoring for cloud products and services across federal agencies. 18 levels. The set-up of a cloud services marketplace for EU users from the private and public sector will be facilitated by the Commission by Q4 2022. The marketplace will put potential users (in particular the public sector and SMEs) in the position to select cloud processing, software and platform service offerings that comply with a number of requirements in areas like data protection, security, data portability, energy efficiency and market practice. Participation in the marketplace for service providers will be made conditional on the use of transparent and fair contract conditions, which the current market does not always provide, specifically to micro-enterprises and SME users52. The marketplace can facilitate public sector procurement of alternative solutions, and take-up by the public sector can support the marketplace due to its significant aggregate demand. While a number of Member States are already developing similar marketplace initiatives at national level, the advantage of an EU-level cloud services marketplace is two-fold: first, it can resolve the current problem of market asymmetry between hyperscale global actors that often offer integrated solutions containing applications also provided by smaller (EU) players. Second, it can generate clarity about the compliance of cloud services with relevant rules. This will ensure a better match between the EU offer and demand stemming notably from public administrations, services of general public interest and SMEs. Support progress on data technologies The Horizon Europe programme will continue to support technologies that are crucial for the next stages of the data economy, such as privacy preserving technologies and technologies underpinning industrial and personal data spaces. Several Horizon Europe candidate partnerships, such as the partnership for Artificial intelligence, data and robotics and the European Open Science Cloud partnership, that are in preparation can help steer the investments in this area. Key actions - Invest in a High Impact project on European data spaces, encompassing data sharing architectures (including standards for data sharing, best practices, tools) and governance mechanisms, as well as the European federation of energy-efficient and trustworthy cloud infrastructures and related services, with a view to facilitating combined investments of €4-6 billion, of which the Commission could aim at investing €2 billion. First implementation phase foreseen for 2022; - Sign Memoranda of Understanding with Member States on cloud federation, Q3 2020; 52 See: ‘Study on the economic detriment to SMEs arising from unfair and unbalanced cloud computing contracts’, https://ec.europa.eu/info/sites/info/files/dg_just_cloud_computing_final_report_web_final.pdf. 19 - Launch a European cloud services marketplace, integrating the full stack of cloud service offering, Q4 2022; - Create an EU (self-)regulatory cloud rulebook, Q2 2022. C. Competences: Empowering individuals, investing in skills and in SMEs Empowering individuals with respect to their data Individuals should be further supported in enforcing their rights with regard to the use of the data they generate. They can be empowered to be in control of their data through tools and means to decide at a granular level about what is done with their data (‘personal data spaces’). This could be supported by enhancing the portability right for individuals under Article 20 of the GDPR, giving them more control over who can access and use machine-generated data, for example through stricter requirements on interfaces for real-time data access and making machine-readable formats compulsory for data from certain products and services, e.g. data coming from smart home appliances or wearables. In addition, rules for providers of personal data apps or novel data intermediaries such as providers of personal data spaces could be considered, guaranteeing their role as a neutral broker53. These issues can be further explored in the context of the Data Act mentioned above. The Digital Europe programme will also support the development and roll-out of ‘personal data spaces’. Investments in skills and general data literacy The funding dedicated to skills under the Digital Europe programme will contribute to narrowing the gap in terms of big data and analytics capacities. The programme will make funding available to expand the digital talent pool with in the order of 250 000 people who will be able to deploy the latest technologies in businesses throughout the EU. Given the importance of data in the digital economy, many of these are likely to be related to data. Overall, by 2025, the EU and the Member States should have halved the current gap of 1 million digital specialists, including by putting a focus on increasing the participation of women. The idea of a network of data stewards from across data-intensive organisations (both businesses and the public sector), put forward by the expert group on Business-to- Government data sharing, will be further explored. In terms of general data literacy, the Reinforced Skills agenda will set out a pathway showing how EU and Member State action can increase the proportion of the EU population with basic digital skills, from the current 57% to 65% by 2025. 53 Secure and universally usable digital identities are also crucial to enabling individuals’ access to and control over their data. 20 Big data and learning analytics offer new opportunities to capture, analyse and use data to improve education and training. The updated Digital Education Action Plan will reinforce better access to and use of data as one of its key priorities, in order to make education and training institutions fit for the digital age and equip them with the capabilities needed for making better decisions and improving skills and competences. Dedicated capacity building for SMEs The forthcoming European SME strategy will define measures to build capacity for SMEs and start-ups. Data is an important asset in this context, since starting or scaling a company based on data is not very capital intensive. SMEs and start-ups often require legal and regulatory advice to fully capture the many opportunities ahead from data-based business models. The Horizon Europe and Digital Europe programmes as well as the structural and investment funds will create opportunities for SMEs in the data economy, to have better access to data and to develop new services and applications based on data, inter alia through incubation schemes. Key action - Explore enhancing the portability right for individuals under Article 20 of the GDPR giving them more control over who can access and use machine-generated data (possibly as part of the Data Act in 2021). D. Common European data spaces in strategic sectors and domains of public interest In complement to the horizontal framework, as well as to the funding and the actions on skills and empowerment of individuals under A, B and C54, the Commission will promote the development of common European data spaces in strategic economic sectors and domains of public interest. These sectors or domains are those where the use of data will have systemic impact on the entire ecosystem, but also on citizens. This should lead to the availability of large pools of data in these sectors and domains, combined with the technical tools and infrastructures necessary to use and exchange data, as well as appropriate governance mechanisms. While not having a one-size-fits-all approach, common governance concepts and models can be replicated in the different sectors. The horizontal framework will – where appropriate – be complemented by sectoral legislation for data access and use, and mechanisms for ensuring interoperability. Differences between the sectors will depend on the maturity of the discussions on and problems identified with data availability in the sector. A further relevant factor is the degree of public interest and involvement in a given sector, which may be higher in areas such as health and lower in areas such as manufacturing. The potential cross-sector use of data between sectors also needs to be 54 The list of sectoral data spaces is not exhaustive and can be extended. 21 taken into account. The data spaces will be developed in full compliance with data protection rules and according to the highest available cyber-security standards. Data spaces need to be complemented by policies that stimulate the use of data and demand for services enriched with data. Work on sectoral data spaces will be complemented by sectoral measures across the data value chain. Building on the ongoing experience with the research community with the European Open Science Cloud, the Commission will also support the establishment of the following nine common European data spaces:  A Common European industrial (manufacturing) data space, to support the competitiveness and performance of the EU’s industry, allowing to capture the potential value of use of non-personal data in manufacturing (estimated at € 1,5 trillion by 2027).  A Common European Green Deal data space, to use the major potential of data in support of the Green Deal priority actions on climate change, circular economy, zero- pollution, biodiversity, deforestation and compliance assurance. The “GreenData4All” and ‘Destination Earth’ (digital twin of the Earth) initiatives will cover concrete actions.  A Common European mobility data space, to position Europe at the forefront of the development of an intelligent transport system, including connected cars as well as other modes of transport. Such data space will facilitate access, pooling and sharing of data from existing and future transport and mobility databases.  A Common European health data space, which is essential for advances in preventing, detecting and curing diseases as well as for informed, evidence-based decisions to improve the accessibility, effectiveness and sustainability of the healthcare systems.  A Common European financial data space, to stimulate, through enhanced data sharing, innovation, market transparency, sustainable finance, as well as access to finance for European businesses and a more integrated market.  A Common European energy data space, to promote a stronger availability and cross-sector sharing of data, in a customer-centric, secure and trustworthy manner, as this would facilitate innovative solutions and support the decarbonisation of the energy system.  A Common European agriculture data space, to enhance the sustainability performance and competitiveness of the agricultural sector through the processing and analysis of production and other data, allowing for precise and tailored application of production approaches at farm level.  Common European data spaces for public administration, to improve transparency and accountability of public spending and spending quality, fighting corruption, both 22 at EU and national level, and to address law enforcement needs and support the effective application of EU law and enable innovative ‘gov tech’, ‘reg tech’ and ‘legal tech’ applications supporting practitioners as well as other services of public interest  A Common European skills data space, to reduce the skills mismatches between the education and training system on the one hand and the labour market needs on the other. The annex presents in more detail each of the sector- and domain-specific common European data spaces, with background on the sector-specific policies and legislation underpinning the creation of such spaces in the different sectors and domains, and proposing sector-specific actions that are tangible, sizable, focused on data, and accompanied by a clear and realistic timeline. The Commission may consider launching, in a sequential way, additional common European data spaces in other sectors. 6. An open, but proactive international approach The vision of a common European data space implies an open, but assertive approach to international data flows, based on European values. Today’s European companies operate in a connected environment that goes beyond the EU’s borders, so that international data flows are indispensable for their competitiveness. Building upon the strength of the Single Market’s regulatory environment, the EU has a strong interest in leading and supporting international cooperation with regard to data, shaping global standards and creating an environment in which economic and technological development can thrive, in full compliance with EU law. At the same time, European companies operating in some third countries are increasingly faced with unjustified barriers and digital restrictions. The EU will continue to address these unjustified obstacles to data flows in bilateral discussions and international fora – including the World Trade Organisation – while promoting and protecting European data processing rules and standards, in full compliance with EU legislation. The Commission will be particularly vigilant to protect and assert the rights, obligations and interests of Europeans and companies, in particular as regards data protection, security and fair and trustworthy market practices. The Commission is convinced that international cooperation must be based on an approach that promotes the EU’s fundamental values, including protection of privacy. The EU must ensure, therefore, that any access to EU citizen’s personal data and European commercially sensitive data is in compliance with its values and legislative framework. In that context, transfers and sharing of data between trusted countries should be promoted. As regards personal data, international transfers are done via adequacy decisions and other existing transfer tools which guarantee that the protection travels with the data no matter where the data is. Additionally, and without prejudice to the EU’s framework for the protection of personal data, free and safe flow of data should be ensured with third countries, 23 subject to exceptions and restrictions for public security, public order and other legitimate public policy objectives of the European Union, in line with international obligations. This would allow the EU to have an open but assertive international data approach based on its values and strategic interests. The Commission will continue to improve its capacity to analyse the EU’s strategic interest with regard to further facilitating international data flows. To this end, the Commission will create a European analytical framework for measuring data flows (Q4 2021). This should be a durable framework that provides the tools to conduct a continuous analysis of data flows and the economic development of the EU’s data processing sector, including a robust methodology, economic valuation and data flows collection mechanisms. It will serve to better understand patterns of data flows and centres of gravity, both within the EU and between the EU and the rest of the world, and can be a basis for adequate policy responses by the Commission, if necessary. It should also help to drive adequate investments to overcome possible infrastructure gaps preventing data flows. The Commission will therefore seek in due course cooperation with relevant financial and international organisations on the data flow measurement framework (e.g. EIB, EBRD, OECD, IMF). The EU should take advantage of its effective data regulatory and policy framework to attract the storage and processing of data from other countries and regions, and to increase the high- value-added innovation that arises from these data spaces. Companies from around the world will be welcome to avail of the European data space, subject to compliance with applicable standards, including those developed relative to data sharing. The The Connecting Europe Facility (CEF 2) programme as well as t the new external instruments, the Neighbourhood, Development and International Cooperation Instrument and the Instrument for Pre-accession Assistance, will support the connectivity of third countries with Europe, which will in turn increase the attractivness of data interchange between the EU and the relevant partner countries. In parallel, the EU will also actively promote its standards and its values with its partners around the world55. It will work in multilateral fora to fight abuses such as the disproportionate access of governments to data, for example access to personal data that is not in line with the EU’s data protection rules. In order to promote the European model around the world, the EU will work with trusted partners sharing the same standards and values, to support others who wish to give their citizens greater control over their data, in line with values they share with Europe. For instance, the EU will support Africa in creating an African data economy for the benefit of its citizens and businesses. 55 Following examples such as the adoption of rules modelled on the GDPR by Brazil and Kenya. 24 Key action Create a framework to measure data flows and estimate their economic value within Europe, as well as between Europe and the rest of the world, Q4 2021. 7. Conclusion This Communication puts forward a European data strategy whose ambition is to enable the EU to become the most attractive, most secure and most dynamic data-agile economy in the world – empowering Europe with data to improve decisions and better the lives of all of its citizens. It enumerates a number of policy measures and investments needed to achieve this goal. The stakes are high, since the EU’s technological future depends on whether it manages to harness its strengths and seize the opportunities offered by the ever-increasing production and use of data. A European way for handling data will ensure that more data becomes available for addressing societal challenges and for use in the economy, while respecting and promoting our European shared values. In order to secure its digital future, the EU has to seize its window of opportunity in the data economy. 25 APPENDIX to the Communication ‘A European strategy for data’ Common European data spaces in in strategic sectors and domains of public interest The Communication ‘A European strategy for data’ announces the creation of sector- and domain-specific data spaces. This document gives additional background on the sector-specific policies and legislation underpinning the creation of such spaces in the different sectors and domains. 1. Common European industrial (manufacturing) data space Europe has a strong industrial base, and manufacturing in particular is an area where the generation of and use of data can make a significant difference to the performance and competitiveness of European industry. A 2018 study estimated the potential value of use of non-personal data in manufacturing at € 1,5 trillion by 202756. In order to unleash this potential, the Commission will:  Address issues related to the usage rights on co-generated industrial data (IoT data created in industrial settings), as part of a wider Data Act (Q4 2021).  Gather key players from the manufacturing sector to agree – in a manner compliant with competition rules as well as principles of fair contracts – the conditions under which they would be ready to share their data and how to further boost data generation, notably via smart connected products (Q2 2020 onwards). Where data generated by individuals are concerned, their interests should be fully taken into account in such a process and compliance with data protection rules must be ensured. 2. Common European Green Deal data space Europe’s Green Deal has set out the ambitious goal for Europe to become the world's first climate-neutral continent by 2050. The Commission’s Communication clearly underlines the importance of data for achieving this goal. A European green data space can exploit the major potential of data in support of the Green Deal priority actions on climate change, circular economy, zero-pollution, biodiversity, deforestation and compliance assurance. In this context the Commission will:  Initiate a ‘GreenData4All’ initiative. This consists in evaluating and possibly reviewing the Directive establishing an Infrastructure for Spatial Information in the EU (INSPIRE), together with the Access to Environment Information Directive (Q4 2021 or Q1 2022). It will modernise the regime in line with technological and innovation opportunities, making it easier for EU public authorities, businesses and citizens to support the transition to a greener and carbon-neutral economy, and reducing administrative burden. 56 Deloitte 2018. 26  Roll out re-usable data-services on a large scale to assist in collecting, sharing, processing and analysing large volumes of data relevant for assuring compliance with environmental legislation and rules related to the priority actions set in the Green Deal.(Q4 2021)  Establish a common European data space for smart circular applications making available the most relevant data for enabling circular value creation along supply chains. A particular focus will be concentrated at the outset on the sectors targeted by the Circular Economy Action Plan, such as the built environment, packaging, textiles, electronics, ICT and plastics. Digital ‘product passports’ will be developed, that will provide information on a product’s origin, durability, composition, reuse, repair and dismantling possibilities, and end-of-life handling. Development of architecture and governance (2020), sectoral data strategies (2021), adoption of a sustainable product policy with product passport (2021) and resource mapping and waste shipments tracking (2021).  Initiate a pilot for early implementation of the data strategy in the context of the ‘zero pollution ambition’ to harvest the potential of an already data-rich policy domain with data on chemicals, air, water and soil emission, hazardous substances in consumer products, etc. which is underexploited and where early results can benefit consumers and the Planet directly (Q4 2021).  Launch the ‘Destination Earth’ initiative The ‘Destination Earth’ initiative will bring together European scientific and industrial excellence to develop a very high precision digital model of the Earth. This ground- breaking initiative will offer a digital modelling platform to visualize, monitor and forecast natural and human activity on the planet in support of sustainable development thus supporting Europe’s efforts for a better environment as set out in the Green Deal. The digital twin of the Earth will be constructed progressively, starting in 2021. 3. Common European mobility data space Transport and mobility are at the forefront of the debate on data sharing, an area where the EU has many assets. This concerns the automotive sector, where connected cars critically depend on data, as well as other transport modes. Digitisation and data in all modes of transport and in logistics will be an essential component of further work on the ‘European Transport System’ and in particular in the upcoming ‘Smart and Sustainable Transport Strategy’ (Q4 2020). This will include actions in all transport sectors as well as for cross- modal data sharing logistics and passengers ecosystems. Automotive Today, modern vehicles generate around 25 gigabytes of data every hour and autonomous cars will generate terabytes of data that can be used for innovative mobility-related services and for repair and maintenance services. Innovation in this area requires that car data are shared, in a secure and well-framed way, in line with competition rules amongst many different economic players. The access to in-vehicle data is regulated since 2007 in the EU 27 vehicle approval legislation57 to ensure fair access to certain car data by independent repairers. This legislation is now being updated to take into account the increasing use of connectivity (3G-4G, so-called remote diagnostics)58, that the rights and interests of the car-owners generating the data are respected and compliance with data protection rules is ensured. The full transport system Passenger transport activity is projected to grow by 35% during 2015-2050. Freight traffic for inland modes is expected to grow faster than for passenger at 53% by 205059. Digitalisation and data play an increasing role in supporting transport sustainability. Several legislative frameworks already contain data-sharing obligations, which establishes a list of datasets (including datasets concerning public transport). Moreover, the Digital Transport and Logistics Forum is working on a concept of ‘federated platforms’ to define what needs to be done at the EU level to facilitate data-sharing/re-use by connecting different public and private platforms. Furthermore, networks of national access points to make data available exist in the Member States where the data are made available with a view to serving road safety, traffic and multi-modal travel information services, with data generated by the public and the private sector. Wide availability and use of data in public transport systems has the potential to make them more efficient, green and customer friendly. Data use to improve transport systems is also a central feature of smart cities. The Commission will:  Review the current EU type approval legislation for motor vehicles (currently focused on wireless data sharing for repair and maintenance), to open it up to more car data based services (Q1 2021). The review will inter alia look at how data is made accessible by the car manufacturer, what procedures are necessary to obtain it in full compliance with data protection rules and the role and rights of the car owner.  Review the Directive on harmonised river information services60 and the Directive on Intelligent Transport Systems61, including its delegated regulations to further contribute to data availability, reuse and interoperability (both in 2021) and establish a stronger coordination mechanism to federate the National Access Points established under the ITS Directive through a EU wide CEF Programme Support Action (2020).  Amend the proposal for a Regulation on the Single European Sky62 to include new provisions on data availability and market access of data service providers in order to promote the digitalisation and automation of air traffic management (2020). This will improve safety, efficiency and capacity in air traffic. 57 Regulation (EC) 715/2007. 58 As required by Article 61 of Regulation (EU) 2018/858. 59 In-depth analysis in support of Commission Communication COM(2018) 773 ‘A Clean Planet for all: A European long-term strategic vision for a prosperous, modern, competitive and climate neutral economy’. 60 Directive 2005/44/EC. 61 Directive 2010/40/EU. 62 COM(2013) 410 final. 28  Review the regulatory framework for interoperable data-sharing in rail transport in 2022.  Establish common data sets as foreseen in the Regulation on Maritime Single Window63 and, subject to its final adoption, in the Regulation on electronic freight transport information regulations64 (the first such act to be adopted by Q3 2021 and Q4 2022 respectively) to facilitate digital exchange and data reuse between businesses and administration. 4. Common European health data space The current regulatory and research models rely on access to health data, including individual level data from patients. Strengthening and extending the use and re-use of health data is critical for innovation in the healthcare sector. It also helps healthcare authorities to take evidence-based decisions to improve the accessibility, effectiveness and sustainability of the healthcare systems. It also contributes to the competitiveness of the EU’s industry. Better access to health data can significantly support the work of regulatory bodies in the healthcare system, the assessment of medical products and demonstration of their safety and efficacy. Citizens have the right in particular to access and control their personal health data and to request their portability, but implementation of this right is fragmented. Working towards making sure that every citizen has secure access to their Electronic Health Record (EHR) and can ensure the portability of his/her data – within and across borders – will improve access to and quality of care, cost effectiveness of care delivery and contribute to the modernisation of health systems. Citizens also need to be reassured that, once they have given consent for their data to be shared, the healthcare systems uses such data in an ethical manner and ensure that the given consent can be withdrawn at any time. Health is an area where the EU can benefit from the data revolution, increasing the quality of healthcare, while decreasing costs. Progress will often depend on the willingness of Member States and healthcare providers to join forces and find ways to use and combine data, in a manner compliant with the GDPR, under which health data merit specific protection. While the GDPR has created a level playing field for the use of health personal data, fragmentation remains within and between Member States and the governance models for accessing data are diverse. The landscape of digital health services remains fragmented, especially when provided cross-border. The Commission will:  Develop sector-specific legislative or non-legislative measures for the European health data space, complementing the horizontal framework of the common data space. Take measures to strengthen citizens’ access to health data and portability of these data and 63 Regulation (EU) 2019/1239. 64 The negotiations with the co-legislators are concluded, adoption is foreseen mid-2020. 29 tackle barriers to cross-border provision of digital health services and products. Facilitate the establishment, in accordance with Article 40 of the GDPR, of a Code of Conduct for processing of personal data in health sector. These actions will build upon an ongoing mapping of the use of personal health data in Member States and the results of the Joint Action in the context of the Health programme (2020-2023)65.  Deploy the data infrastructures, tools and computing capacity for the European health data space, more specifically support the development of national electronic health records (EHRs) and interoperability of health data through the application of the Electronic Health Record Exchange Format. Scale up cross-border exchange of health data; link and use, through secure, federated repositories, specific kinds of health information, such as EHRs, genomic information (for at least 10 million people by 2025), and digital health images, in compliance with the GDPR. Enable the exchange of electronic patient summaries and ePrescriptions between 22 Member States participating in the eHealth Digital Service Infrastructure (eHDSI) by 2022; start cross-border electronic exchanges through eHDSI of medical images, laboratory results and discharge reports and enhance the virtual consultation model and registries of European Reference Networks; support big data projects promoted by the network of regulators. These actions will support prevention, diagnosis and treatment (in particular for cancer, rare diseases and common and complex diseases), research and innovation, policy-making and regulatory activities of Member States in the area of public health. 5. Common European financial data space In the financial sector, EU legislation requires financial institutions to disclose a significant amount of data products, transactions and financial results. Moreover, the revised Payment Services Directive marks an important step towards open banking, where innovative payment services can be offered to consumers and businesses on the basis of the access to their bank account data. Going forward, enhancing data sharing would contribute to stimulating innovation as well as achieving other important policy objectives at EU level. The Commission will set out concrete initiatives on this in its upcoming Digital Finance Strategy in Q3 2020 along the following considerations:  The Commission will further facilitate access to public disclosures of financial data or supervisory reporting data, currently mandated by law, for example by promoting the use of common pro-competitive technical standards. This would facilitate more efficient processing of such publicly accessible data to the benefit of a number of other policies of public interest, such as enhancing access to finance for European businesses through more integrated capital markets, improving market transparency and supporting sustainable finance in the EU. 65 https://ec.europa.eu/health/funding/programme_en. 30  On the basis of recent market developments on open finance, the Commission will continue to ensure full implementation of the revised Payment Services Directive and explore additional steps and initiatives building on this approach. 6. Common European energy data space In the energy sector, several Directives establish customer access to and portability of their meter and energy consumption data on a transparent, non-discriminatory basis and in compliance with data protection law. The specific governance frameworks are to be defined at the national level. Legislation also introduced data-sharing obligations for electricity network operators. Regarding cybersecurity, work is ongoing to address energy-specific challenges, notably: real-time requirements, cascading effects and the mix of legacy technologies with smart/state-of-the-art technology . The availability and cross-sector sharing of data, in a secure and trustworthy manner can facilitate innovative solutions and support the decarbonisation of the energy system. The Commission will address these issues as part of the smart sector integration strategy to be adopted in the second quarter of this year as announced in the Communication on the European Green Deal. The Commission will:  Adopt implementing act(s)66 setting out the interoperability requirements and non- discriminatory and transparent procedures for access to data, building on existing national practices on the basis of the Electricity Directive 2019/944 (2021/2022).  Consider actions for improving the interoperability in smart buildings and products, with a view to improve their energy efficiency, optimise local consumption and broaden the integration of renewable energy sources (Q4 2020). 7. Common European agricultural data space Data is one key element to enhance the sustainability performance and competitiveness of the agricultural sector. Processing and analysing production data, especially in combination with other data on the supply chain and other types of data, such as earth observation or meteorological data, allows for precise and tailored application of production approaches at farm level. A code of conduct for sharing of agricultural data by contractual agreement was developed in 2018 by EU stakeholders, involving – among others – the farming as well as the machinery sector. A common data space for agricultural data based on existing approaches towards data sharing could lead to a neutral platform for sharing and pooling agricultural data, including both private and public data. This could support the emergence of an innovative data-driven ecosystem based on fair contractual relations as well as strengthen the capacities for monitoring and implementing common policies and reducing administrative burden for 66 Article 24 Directive (EU) 2019/944. 31 government and beneficiaries. In 2019, Member States have joined forces and signed a declaration of cooperation ‘A smart and sustainable digital future for European agriculture and rural areas’67, which recognises the potential of digital technologies for the agricultural sector and rural areas and supports the setting up of data spaces. The Commission will:  Take stock with Member States and stakeholder organisations of experiences gained with the stakeholder code of conduct on agricultural data sharing by contractual agreement, also on the basis of the current market for digital farm solutions and their requirements in terms of data availability and use (Q3/Q4 2020).  Take stock of agricultural data spaces in current use, including funded under the Horizon 2020 programme, with stakeholders and Member State organisations and take decision on an EU approach (Q4 2020/Q1 2021). 8. Common European data spaces for public administrations Public administrations are big producers and also users of data in different areas. The data spaces for public administrations will reflect this. Actions in this areas will focus on law and public procurement data and other areas of public interest such as data use for improving law enforcement in the EU in line with EU law, including the principle of proportionality and data protection rules. Public procurement data are essential to improve transparency and accountability of public spending, fighting corruption and improving spending quality. Public procurement data is spread over several systems in the Member States, made available in different formats and is not easily possible to use for policy purposes in real-time. In many cases, the data quality needs to be improved. Similarly, seamless access to and easy reuse of EU and Member State legislation, jurisprudence as well as information on e-justice services is critical not only for the effective application of EU law but also enables innovative ‘legal tech’ applications supporting practitioners (judges, public officials, corporate counsel and lawyers in private practice). The Commission will:  Elaborate a data initiative for public procurement data covering both the EU dimension (EU datasets, such as TED68) and the national ones (Q4 2020). It will be complemented by a procurement data governance framework (Q2 2021);  Issue guidance on common standards as well as interoperable frameworks for legal information69 held at European and national level, in close cooperation with Member States (Q1 2021); 67 The declaration has been signed by 25 Member States. For further information on the declaration, see https://ec.europa.eu/digital-single-market/en/news/eu-member-states-join-forces-digitalisation-european- agriculture-and-rural-areas. 68 Tenders Electronic Daily. 32  work with Member States to ensure that data sources related to the implementation of the EU budget are Findable, Accessible, Interoperable and Reusable (FAIR). 9. Common European skills data space The skills of its people are Europe’s strongest asset. In a global race for talent, the European education and training systems and labour markets need to quickly adapt to new and emerging skills needs. This requires high-quality data on qualifications, learning opportunities, jobs and the skill sets of people. Over the past years, the Commission has put in place a range of open standards, reference frameworks and semantic assets to increase data quality and interoperability70. As announced in the Digital Education Action Plan71, the Commission also developed the Europass Digital Credentials framework to issue credentials to learners in a secure and interoperable digital format. The Commission will:  Support Member States in the development of digital credential transformation plans and in the preparation of re-usable data-sets of qualifications and learning opportunities (2020-2022);  Establish a governance model for the on-going management of the Europass Digital Credentials Framework in close cooperation with Member States and key stakeholders (by 2022). 10. European Open Science Cloud In addition to the creation of nine Common European data spaces, work will continue on the European Open Science Cloud, which provides seamless access and reliable re-use of research data to European researchers, innovators, companies and citizens through a trusted and open distributed data environment and related services. The European Open Science Cloud is therefore the basis for a science, research and innovation data space that will bring together data resulting from research and deployment programmes and will be connected and fully articulated with the sectoral data spaces. The Commission will:  Deploy European Open Science Cloud operations to serve EU researchers by 2025; Steer the underpinning development of a stakeholder-driven EOSC governance structures, possibly in connection with the launch of the corresponding EOSC European partnership by end 2020; 69 E.g. on the use of the ELI and ECLI identifiers and on publishing law online with an official translation in order to support the further use of machine translation. 70 E.g. Europass Learning Model; European Qualifications Framework for lifelong learning (EQF); European Skills, Competences, Qualifications and Occupations (ESCO), Digital Competence Framework (DigComp). 71 COM(2018)22 final. 33  In the medium term, open up, connect and articulate EOSC beyond the research communities, with the wider public sector and the private sector from 2024 onwards. 34 Saatja: Teele Tohver <[email protected]> Saadetud: 06.03.2020 17:33 Adressaat: Lembi Tasane <[email protected]> Teema: FW: Euroopa Komisjoni digipakett - palume teie arvamust, tähtaeg 13. märts Manused: Shaping Europe's digital future.pdf; A European Strategy for Data.pdf; On Artificial Intelligence - A European approach to excellence and trust.pdf Lembi palun rega ja suuna mulle. Tänud! From: Kristina Vaksmaa-Tammaru <[email protected]> Sent: Thursday, February 27, 2020 4:17 PM To: Teele Tohver <[email protected]> Subject: FW: Euroopa Komisjoni digipakett - palume teie arvamust, tähtaeg 13. märts Hei, Teele! Ma saadan selle pöördumise sinule edasi. Kui see puudutab teisi meie majast, palun saada edasi. Tervitades Kristina From: TTJA <[email protected]> Sent: Thursday, February 27, 2020 1:38 PM To: Kristina Vaksmaa-Tammaru <[email protected]> Subject: FW: Euroopa Komisjoni digipakett - palume teie arvamust, tähtaeg 13. märts Kuhu ja mis sarja registeerime? From: Kadi Avingo <[email protected]> Sent: Thursday, February 27, 2020 1:13 PM To: TTJA <[email protected]> Subject: Euroopa Komisjoni digipakett - palume teie arvamust, tähtaeg 13. märts Tere! 19. veebruaril avalikustas Euroopa Komisjon digipaketi „Digiajastu nõudmistele vastav Euroopa“, mis koosneb digistrateegiast, andmestrateegiast ja tehisintellekti valgest raamatust (manuses, märksõnad sisu kohta all). MKMi eestvedamisel hakatakse koostama Eesti seisukohti paketi kohta. Selleks palume ka teie arvamust hiljemalt 13. märtsiks. 1. Digistrateegia „Shaping Europe’s digital future“  üldine ülevaade Euroopa Komisjoni tulevikuplaanidest, sh tulevastest eelnõudest, tegevuskavadest, strateegiatest, investeeringute fookusest, ELi globaalne roll digivaldkonnas. 2. Andmestrateegia „A European strategy for data“  eesmärgiks on tekitada Euroopas ühtne andmeruum (a single European data space) ehk tõeline ühtne turg nii isiku- kui mitteisikuandmete jaoks;  horisontaalne valdkondadeülene haldusraamistik andmete kasutamise ja ligipääsu tagamiseks (reeglid, standardid), sh kõrgväärtusega andmete kättesaadavuse parandamine ja võimaliku Data Act’i välja töötamine, mis mh käsitleks ettevõtjate ja valitsusasutuste (B2G) ning ettevõtjatevahelist (B2B) andmete jagamist;  omavahel ühendatud pilvetaristu loomine, reeglid pilveteenustele Euroopas;  valdkondlikud andmeruumid (töötlev tööstus, Green Deal, transport/liikuvus, tervishoid, rahandus, energeetika, põllumajandus, avalik haldus (riigihanked, õiguskaitse), oskused, teadus);  rahvusvaheline suund, andmevood kolmandate riikidega. 3. Tehisintellekti valge raamat „On Artificial Intelligence – A European approach to excellence and trust“  Ecosystem of excellence: tehisintellekti arengute toetamine, investeeringud, tehnoloogia testimisvõimalused, VKE-de toetamine, oskused, avaliku ja erasektori partnerluste loomine;  Ecosystem of trust (tehisintellekti jaoks reguleeriva raamistiku loomine): põhiõigused, ohutus ja vastutuse küsimused, mh ettepanek liigitada teatud tehisintellekti rakendused kõrge riskiga rakendusteks, millele oleks vaja kaaluda täiendava EL tasandi regulatsiooni loomist, rakendustele mis ei ole kõrge riskiga kaalutakse vabatahtlikku märgistamist. Koos eelpoolmainitud dokumentidega avalikustati ka komisjoni aruanne „Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics“ ja kõrgetasemelise B2G Data Sharing ekspertgrupi aruanne (ülevaade ja link raportile kättesaadav siit). Küsimuste korral palun pöörduge minu poole. Heade soovidega Kadi Avingo EL ja rahvusvahelise koostöö osakonna nõunik Tel: 625 6491 | Mob: 526 8648 Majandus- ja Kommunikatsiooniministeerium www.mkm.ee | Suur-Ameerika 1, Tallinn 10122 EUROPEAN COMMISSION Brussels, 19.2.2020 COM(2020) 65 final WHITE PAPER On Artificial Intelligence - A European approach to excellence and trust EN EN White Paper on Artificial Intelligence A European approach to excellence and trust Artificial Intelligence is developing fast. It will change our lives by improving healthcare (e.g. making diagnosis more precise, enabling better prevention of diseases), increasing the efficiency of farming, contributing to climate change mitigation and adaptation, improving the efficiency of production systems through predictive maintenance, increasing the security of Europeans, and in many other ways that we can only begin to imagine. At the same time, Artificial Intelligence (AI) entails a number of potential risks, such as opaque decision-making, gender-based or other kinds of discrimination, intrusion in our private lives or being used for criminal purposes. Against a background of fierce global competition, a solid European approach is needed, building on the European strategy for AI presented in April 20181. To address the opportunities and challenges of AI, the EU must act as one and define its own way, based on European values, to promote the development and deployment of AI. The Commission is committed to enabling scientific breakthrough, to preserving the EU’s technological leadership and to ensuring that new technologies are at the service of all Europeans – improving their lives while respecting their rights. Commission President Ursula von der Leyen announced in her political Guidelines2 a coordinated European approach on the human and ethical implications of AI as well as a reflection on the better use of big data for innovation. Thus, the Commission supports a regulatory and investment oriented approach with the twin objective of promoting the uptake of AI and of addressing the risks associated with certain uses of this new technology. The purpose of this White Paper is to set out policy options on how to achieve these objectives. It does not address +the development and use of AI for military purposes.The Commission invites Member States, other European institutions, and all stakeholders, including industry, social partners, civil society organisations, researchers, the public in general and any interested party, to react to the options below and to contribute to the Commission’s future decision-making in this domain. 1. INTRODUCTION As digital technology becomes an ever more central part of every aspect of people’s lives, people should be able to trust it. Trustworthiness is also a prerequisite for its uptake. This is a chance for Europe, given its strong attachment to values and the rule of law as well as its proven capacity to build safe, reliable and sophisticated products and services from aeronautics to energy, automotive and medical equipment. Europe’s current and future sustainable economic growth and societal wellbeing increasingly draws on value created by data. AI is one of the most important applications of the data economy. Today most data are related to consumers and are stored and processed on central cloud-based infrastructure. By contrast a large share of tomorrow’s far more abundant data will come from industry, business and the public sector, and will be stored on a variety of systems, notably on computing devices working at the edge of the network. This opens up new opportunities for Europe, which has a strong position in 1 AI for Europe, COM/2018/237 final 2 https://ec.europa.eu/commission/sites/beta-political/files/political-guidelines-next-commission_en.pdf. 1 digitised industry and business-to-business applications, but a relatively weak position in consumer platforms. Simply put, AI is a collection of technologies that combine data, algorithms and computing power. Advances in computing and the increasing availability of data are therefore key drivers of the current upsurge of AI. Europe can combine its technological and industrial strengths with a high-quality digital infrastructure and a regulatory framework based on its fundamental values to become a global leader in innovation in the data economy and its applications as set out in the European data strategy3. On that basis, it can develop an AI ecosystem that brings the benefits of the technology to the whole of European society and economy:  for citizens to reap new benefits for example improved health care, fewer breakdowns of household machinery, safer and cleaner transport systems, better public services;  for business development, for example a new generation of products and services in areas where Europe is particularly strong (machinery, transport, cybersecurity, farming, the green and circular economy, healthcare and high-value added sectors like fashion and tourism); and  for services of public interest, for example by reducing the costs of providing services (transport, education, energy and waste management), by improving the sustainability of products4 and by equipping law enforcement authorities with appropriate tools to ensure the security of citizens5, with proper safeguards to respect their rights and freedoms. Given the major impact that AI can have on our society and the need to build trust, it is vital that European AI is grounded in our values and fundamental rights such as human dignity and privacy protection. Furthermore, the impact of AI systems should be considered not only from an individual perspective, but also from the perspective of society as a whole. The use of AI systems can have a significant role in achieving the Sustainable Development Goals, and in supporting the democratic process and social rights. With its recent proposals on the European Green Deal6, Europe is leading the way in tackling climate and environmental-related challenges. Digital technologies such as AI are a critical enabler for attaining the goals of the Green Deal. Given the increasing importance of AI, the environmental impact of AI systems needs to be duly considered throughout their lifecycle and across the entire supply chain, e.g. as regards resource usage for the training of algorithms and the storage of data. A common European approach to AI is necessary to reach sufficient scale and avoid the fragmentation of the single market. The introduction of national initiatives risks to endanger legal certainty, to weaken citizens’ trust and to prevent the emergence of a dynamic European industry. This White Paper presents policy options to enable a trustworthy and secure development of AI in Europe, in full respect of the values and rights of EU citizens. The main building blocks of this White Paper are: 3 COM(2020) 66 final. 4 AI and digitalisation in general are critical enablers of Europe’s Green deal ambitions. However, the current environmental footprint of the ICT sector is estimated at more than 2% of all global emissions. The European digital strategy accompanying this White Paper proposes green transformation measures for digital. 5 AI tools can provide an opportunity for better protecting EU citizens from crime and acts of terrorism. Such tools could, for example, help identify online terrorist propaganda, discover suspicious transactions in the sales of dangerous products, identify dangerous hidden objects or illicit substances or products, offer assistance to citizens in emergencies and help guide first responders. 6 COM(2019) 640 final. 2  The policy framework setting out measures to align efforts at European, national and regional level. In partnership between the private and the public sector, the aim of the framework is to mobilise resources to achieve an ‘ecosystem of excellence’ along the entire value chain, starting in research and innovation, and to create the right incentives to accelerate the adoption of solutions based on AI, including by small and medium-sized enterprises (SMEs).  The key elements of a future regulatory framework for AI in Europe that will create a unique ‘ecosystem of trust’. To do so, it must ensure compliance with EU rules, including the rules protecting fundamental rights and consumers’ rights, in particular for AI systems operated in the EU that pose a high risk7. Building an ecosystem of trust is a policy objective in itself, and should give citizens the confidence to take up AI applications and give companies and public organisations the legal certainty to innovate using AI. The Commission strongly supports a human-centric approach based on the Communication on Building Trust in Human-Centric AI8 and will also take into account the input obtained during the piloting phase of the Ethics Guidelines prepared by the High-Level Expert Group on AI. The European strategy for data, which accompanies this White Paper, aims to enable Europe to become the most attractive, secure and dynamic data-agile economy in the world – empowering Europe with data to improve decisions and better the lives of all its citizens. The strategy sets out a number of policy measures, including mobilising private and public investments, needed to achieve this goal. Finally, the implications of AI, Internet of Things and other digital technologies for safety and liability legislation are analysed in the Commission Report accompanying this White Paper. 2. CAPITALISING ON STRENGTHS IN INDUSTRIAL AND PROFESSIONAL MARKETS Europe is well placed to benefit from the potential of AI, not only as a user but also as a creator and a producer of this technology. It has excellent research centres, innovative start-ups, a world-leading position in robotics and competitive manufacturing and services sectors, from automotive to healthcare, energy, financial services and agriculture. Europe has developed a strong computing infrastructure (e.g. high-performance computers), essential to the functioning of AI. Europe also holds large volumes of public and industrial data, the potential of which is currently under-used. It has well- recognised industrial strengths in safe and secure digital systems with low-power consumption that are essential for the further development of AI. Harnessing the capacity of the EU to invest in next generation technologies and infrastructures, as well as in digital competences like data literacy, will increase Europe’s technological sovereignty in key enabling technologies and infrastructures for the data economy. The infrastructures should support the creation of European data pools enabling trustworthy AI, e.g. AI based on European values and rules. Europe should leverage its strengths to expand its position in the ecosystems and along the value chain, from certain hardware manufacturing sectors to software all the way to services. This is already happening to an extent. Europe produces more than a quarter of all industrial and professional service robots (e.g. for precision farming, security, health, logistics.), and plays an important role in developing and using software applications for companies and organisations (business-to-business applications such as Enterprise Resource Planning, design and engineering software) as well as applications to support e-government and the "intelligent enterprise". 7 Although further arrangements may need to be put in place to prevent and counter misuse of AI for criminal purposes, this is outside the scope of this white paper. 8 COM(2019) 168. 3 Europe leads the way in deploying AI in manufacturing. Over half of the top manufacturers implement at least one instance of AI in manufacturing operations9. One reason for Europe’s strong position in terms of research is the EU funding programme that has proven instrumental in pooling action, avoiding duplications, and leveraging public and private investments in the Member States. Over the past three years, EU funding for research and innovation for AI has risen to €1.5 billion, i.e. a 70% increase compared to the previous period. However, investment in research and innovation in Europe is still a fraction of the public and private investment in other regions of the world. Some €3.2 billion were invested in AI in Europe in 2016, compared to around €12.1 billion in North America and €6.5 billion in Asia10. In response, Europe needs to increase its investment levels significantly. The Coordinated plan on AI11 developed with Member States is proving to be a good starting point in building closer cooperation on AI in Europe and in creating synergies to maximise investment in the AI value chain. 3. SEIZING THE OPPORTUNITIES AHEAD: THE NEXT DATA WAVE Although Europe currently is in a weaker position in consumer applications and on online platforms, which results in a competitive disadvantage in data access, major shifts in the value and re-use of data across sectors are underway. The volume of data produced in the world is growing rapidly, from 33 zettabytes in 2018 to an expected 175 zettabytes in 2025 12 . Each new wave of data brings opportunities for Europe to position itself in the data-agile economy and to become a world leader in this area. Furthermore, the way in which data are stored and processed will change dramatically over the coming five years. Today 80% of data processing and analysis that takes place in the cloud occurs in data centres and centralised computing facilities, and 20% in smart connected objects, such as cars, home appliances or manufacturing robots, and in computing facilities close to the user (“edge computing”). By 2025 these proportions are set to change markedly13. Europe is a global leader in low-power electronics which is key for the next generation of specialised processors for AI. This market is currently dominated by non-EU players. This could change with the help of initiatives such as the European Processor Initiative, which focuses on developing low-power computing systems for both edge and next generation high-performance computing, and the work of the Key Digital Technology Joint Undertaking, proposed to start in 2021. Europe also leads in neuromorphic solutions14 that are ideally suited to automating industrial processes (industry 4.0) and transport modes. They can improve energy efficiency by several orders of magnitude. Recent advances in quantum computing will generate exponential increases in processing capacity15. Europe can be at the forefront of this technology thanks to its academic strengths in quantum computing, as well as European industry’s strong position in quantum simulators and programming environments for quantum computing. European initiatives that aim to increase the availability of quantum testing and experimentation facilities will help apply these new quantum solutions to a number of industrial and academic sectors. 9 Followed by Japan (30%) and the US (28%). Source: CapGemini (2019). 10 10 imperatives for Europe in the age of AI and automation, McKinsey (2017). 11 COM(2018) 795. 12 IDC (2019). 13 Gartner (2017). 14 Neuromorphic solutions means any very large-scale system of integrated circuits that mimic neuro-biological architectures present in the nervous system. 15 Quantum computers will have the capacity to process in less than seconds many fold larger data sets than today’s highest performance computers allowing for the development of new AI applications across sectors. 4 In parallel, Europe will continue to lead progress in the algorithmic foundations of AI, building on its own scientific excellence. There is a need to build bridges between disciplines that currently work separately, such as machine learning and deep learning (characterised by limited interpretability, the need for a large volume of data to train the models and learn through correlations) and symbolic approaches (where rules are created through human intervention). Combining symbolic reasoning with deep neural networks may help us improve explainability of AI outcomes. 4. AN ECOSYSTEM OF EXCELLENCE To build an ecosystem of excellence that can support the development and uptake of AI across the EU economy and public administration, there is a need to step up action at multiple levels. A. WORKING WITH MEMBER STATES Delivering on its strategy on AI adopted in April 2018,16 in December 2018 the Commission presented a Coordinated Plan - prepared together with the Member States - to foster the development and use of AI in Europe17. This plan proposes some 70 joint actions for closer and more efficient cooperation between Member States, and the Commission in key areas, such as research, investment, market uptake, skills and talent, data and international cooperation. The plan is scheduled to run until 2027, with regular monitoring and review. The aim is to maximise the impact of investment in research, innovation and deployment, assess national AI strategies and build on and extend the Coordinated Plan on AI with Member States:  Action 1: The Commission, taking into account the results of the public consultation on the White Paper, will propose to the Member States a revision of the Coordinated Plan to be adopted by end 2020 EU-level funding in AI should attract and pool investment in areas where the action required goes beyond what any single Member State can achieve. The objective is to attract over €20 billion18 of total investment in the EU per year in AI over the next decade. To stimulate private and public investment, the EU will make available resources from the Digital Europe Programme, Horizon Europe as well as from the European Structural and Investment Funds to address the needs of less- developed regions as well as rural areas. The Coordinated Plan could also address societal and environmental well-being as a key principle for AI. AI systems promise to help tackling the most pressing concerns, including climate change and environmental degradation. It is also important that this happens in an environmentally friendly manner. AI can and should itself critically examine resource usage and energy consumption and be trained to make choices that are positive for the environment. The Commission will consider options to encourage and promote AI solutions that do this together with the Member States. B. FOCUSING THE EFFORTS OF THE RESEARCH AND INNOVATION COMMUNITY 16 Artificial Intelligence for Europe, COM(2018) 237. 17 Coordinated Plan on Artificial Intelligence, COM(2018) 795. 18 COM(2018) 237. 5 Europe cannot afford to maintain the current fragmented landscape of centres of competence with none reaching the scale necessary to compete with the leading institutes globally. It is imperative to create more synergies and networks between the multiple European research centres on AI and to align their efforts to improve excellence, retain and attract the best researchers and develop the best technology. Europe needs a lighthouse centre of research, innovation and expertise that would coordinate these efforts and be a world reference of excellence in AI and that can attract investments and the best talents in the field. The centres and the networks should concentrate in sectors where Europe has the potential to become a global champion such as industry, health, transport, finance, agrifood value chains, energy/environment, forestry, earth observation and space. In all these domains, the race for global leadership is ongoing, and Europe offers significant potential, knowledge and expertise 19 . Equally important is to create testing and experimentation sites to support the development and subsequent deployment of novel AI applications.  Action 2: the Commission will facilitate the creation of excellence and testing centres that can combine European, national and private investments, possibly including a new legal instrument. The Commission has proposed an ambitious and dedicated amount to support world reference testing centres in Europe under the Digital Europe Programme and complemented where appropriate by research and innovation actions of Horizon Europe as part of the Multiannual Financial Framework for 2021 to 2027. C. SKILLS The European approach to AI will need to be underpinned by a strong focus on skills to fill competence shortages.20 The Commission will soon present a reinforcement of the Skills Agenda, which aims to ensure that everyone in Europe can benefit from the green and digital transformations of the EU economy. Initiatives could also include the support of sectoral regulators to enhance their AI skills in order to effectively and efficiently implement relevant rules. The updated Digital Education Action Plan will help make better use of data and AI-based technologies such as learning and predictive analytics with the aim to improve education and training systems and make them fit for the digital age. The Plan will also increase awareness of AI at all levels of education in order to prepare citizens for informed decisions that will be increasingly affected by AI. Developing the skills necessary to work in AI and upskilling the workforce to become fit for the AI- led transformation will be a priority of the revised Coordinated Plan on AI to be developed with Member States. This could include transforming the assessment list of the ethical guidelines into an indicative “curriculum” for developers of AI that will be made available as a resource for training institutions. Particular efforts should be undertaken to increase the number of women trained and employed in this area. In addition, a lighthouse centre of research and innovation for AI in Europe would attract talent from all over the world due to the possibilities it could offer. It would also develop and spread excellence in skills that take root and grow across Europe. 19 The future European Defence Fund and Permanent Structured Cooperation (PESCO) will also provide opportunities for research and development in AI. These projects should be synchronized with the wider EU civilian programmes devoted to AI. 20 https://ec.europa.eu/jrc/en/publication/academic-offer-and-demand-advanced-profiles-eu 6  Action 3: Establish and support through the advanced skills pillar of the Digital Europe Programme networks of leading universities and higher education institutes to attract the best professors and scientists and offer world-leading masters programmes in AI. Beyond upskilling, workers and employers are directly affected by the design and use of AI systems in the workplace. The involvement of social partners will be a crucial factor in ensuring a human-centred approach to AI at work. D. FOCUS ON SMES It will also be important to ensure that SMEs can access and use AI. To this end, the Digital Innovation Hubs 21 and the AI-on-demand platform 22 should be strengthened further and foster collaboration between SMEs. The Digital Europe Programme will be instrumental in achieving this. While all Digital Innovation Hubs should provide support to SMEs to understand and adopt AI, it will be important that at least one innovation hub per Member State has a high degree of specialisation in AI. SMEs and start-ups will need access to finance in order to adapt their processes or to innovate using AI. Building on the forthcoming pilot investment fund of €100 million in AI and blockchain, the Commission plans to further scale up access to finance in AI under InvestEU 23 . AI is explicitly mentioned among the eligible areas for the use of the InvestEU guarantee.  Action 4: the Commission will work with Member States to ensure that at least one digital innovation hub per Member State has a high degree of specialisation on AI. Digital Innovation Hubs can be supported under the Digital Europe Programme.  The Commission and the European Investment Fund will launch a pilot scheme of €100 million in Q1 2020 to provide equity financing for innovative developments in AI. Subject to final agreement on the MFF, the Commission’s intention is to scale it up significantly from 2021 through InvestEU. E. PARTNERSHIP WITH THE PRIVATE SECTOR It is also essential to make sure that the private sector is fully involved in setting the research and innovation agenda and provides the necessary level of co-investment. This requires setting up a broad- based public private partnership, and securing the commitment of the top management of companies.  Action 5: In the context of Horizon Europe, the Commission will set up a new public private partnership in AI, data and robotics to combine efforts, ensure coordination of research and innovation in AI, collaborate with other public-private partnerships in Horizon Europe and work together with the testing facilities and the Digital Innovation Hubs mentioned above. 21 ec.europe.eu/digital-single-market/en/news/digital-innovation-hubs-helping-companies-across-economy-make-most- digital-opportunities. 22 www.Ai4eu.eu. 23 Europe.eu/investeu. 7 F. PROMOTING THE ADOPTION OF AI BY THE PUBLIC SECTOR It is essential that public administrations, hospitals, utility and transport services, financial supervisors, and other areas of public interest rapidly begin to deploy products and services that rely on AI in their activities. A specific focus will be in the areas of healthcare and transport where technology is mature for large-scale deployment.  Action 6: The Commission will initiate open and transparent sector dialogues giving priority to healthcare, rural administrations and public service operators in order to present an action plan to facilitate development, experimentation and adoption. The sector dialogues will be used to prepare a specific ‘Adopt AI programme’ that will support public procurement of AI systems, and help to transform public procurement processes themselves. G. SECURING ACCESS TO DATA AND COMPUTING INFRASTRUCTURES The areas for action set out in this White Paper are complementary to the plan presented in parallel under the European data strategy. Improving access to and the management of data is fundamental. Without data, the development of AI and other digital applications is not possible. The enormous volume of new data yet to be generated constitutes an opportunity for Europe to position itself at the forefront of the data and AI transformation. Promoting responsible data management practices and compliance of data with the FAIR principles will contribute to build trust and ensure re-usability of data24. Equally important is investment in key computing technologies and infrastructures. The Commission has proposed more than €4 billion under the Digital Europe Programme to support high-performance and quantum computing, including edge computing and AI, data and cloud infrastructure. The European data strategy develops these priorities further. H. INTERNATIONAL ASPECTS Europe is well positioned to exercise global leadership in building alliances around shared values and promoting the ethical use of AI. The EU's work on AI has already influenced international discussions. When developing its ethical guidelines, the High-Level Expert Group involved a number of non-EU organisations and several governmental observers. In parallel, the EU was closely involved in developing the OECD’s ethical principles for AI25. The G20 subsequently endorsed these principles in its June 2019 Ministerial Statement on Trade and Digital Economy. In parallel, the EU recognises that important work on AI is ingoing in other multilateral fora, including the Council of Europe, the United Nations Educational Scientific and Cultural Organization (UNESCO), the Organisation for Economic Co-operation and Development’s (OECD), the World Trade Organisation and the International Telecommunications Union (ITU). At the UN, the EU is involved in the follow-up of the report of the High-Level Panel on Digital Cooperation, including its recommendation on AI. The EU will continue to cooperate with like-minded countries, but also with global players, on AI, based on an approach based on EU rules and values (e.g. supporting upward regulatory convergence, accessing key resources including data, creating a level playing field). The Commission will closely monitor the policies of third countries that limit data flows and will address undue restrictions in 24 Findable, Accessible, Interoperable and Reusable as stated in the Final Report and Action Plan from the Commission Expert Group on FAIR data, 2018, https://ec.europa.eu/info/sites/info/files/turning_fair_into_reality_1.pdf. 25 https://www.oecd.org/going-digital/ai/principles/ 8 bilateral trade negotiations and through action in the context of the World Trade Organization. The Commission is convinced that international cooperation on AI matters must be based on an approach that promotes the respect of fundamental rights, including human dignity, pluralism, inclusion, non- discrimination and protection of privacy and personal data26 and it will strive to export its values across the world27. It is also clear that the responsible development and use of AI can be a driving force to achieve the Sustainable Development Goals and advance the 2030 Agenda. 5. AN ECOSYSTEM OF TRUST: REGULATORY FRAMEWORK FOR AI As with any new technology, the use of AI brings both opportunities and risks. Citizens fear being left powerless in defending their rights and safety when facing the information asymmetries of algorithmic decision-making, and companies are concerned by legal uncertainty. While AI can help protect citizens' security and enable them to enjoy their fundamental rights, citizens also worry that AI can have unintended effects or even be used for malicious purposes. These concerns need to be addressed. Moreover, in addition to a lack of investment and skills, lack of trust is a main factor holding back a broader uptake of AI. That is why the Commission set out an AI strategy28 on 25 April 2018 addressing the socioeconomic aspects in parallel with an increase in investment in research, innovation and AI-capacity across the EU. It agreed a Coordinated Plan29 with the Member States to align strategies. The Commission also established a High-Level Expert Group that published Guidelines on trustworthy AI in April 201930. The Commission published a Communication31 welcoming the seven key requirements identified in the Guidelines of the High-Level Expert Group:  Human agency and oversight,  Technical robustness and safety,  Privacy and data governance,  Transparency,  Diversity, non-discrimination and fairness,  Societal and environmental wellbeing, and  Accountability. In addition, the Guidelines contain an assessment list for practical use by companies. During the second half of 2019, over 350 organisations have tested this assessment list and sent feedback. The High-Level Group is in the process of revising its guidelines in light of this feedback and will finalise this work by June 2020. A key result of the feedback process is that while a number of the requirements are already reflected in existing legal or regulatory regimes, those regarding transparency, traceability and human oversight are not specifically covered under current legislation in many economic sectors. On top of this set of non-binding Guidelines of the High-Level Expert Group, and in line with the President’s political guidelines, a clear European regulatory framework would build trust among 26 Under the Partnership Instrument, the Commission will finance a €2.5 million project that will facilitate cooperation with like-minded partners, in order to promote the EU AI ethical guidelines and to adopt common principles and operational conclusions. 27 President Von der Leyen, A Union that strives for more – My agenda for Europe, page 17. 28 COM(2018) 237. 29 COM(2018) 795. 30 https://ec.europa.eu/futurium/en/ai-alliance-consultation/guidelines#Top 31 COM(2019) 168. 9 consumers and businesses in AI, and therefore speed up the uptake of the technology. Such a regulatory framework should be consistent with other actions to promote Europe’s innovation capacity and competitiveness in this field. In addition, it must ensure socially, environmentally and economically optimal outcomes and compliance with EU legislation, principles and values. This is particularly relevant in areas where citizens’ rights may be most directly affected, for example in the case of AI applications for law enforcement and the judiciary. Developers and deployers of AI are already subject to European legislation on fundamental rights (e.g. data protection, privacy, non-discrimination), consumer protection, and product safety and liability rules. Consumers expect the same level of safety and respect of their rights whether or not a product or a system relies on AI. However, some specific features of AI (e.g. opacity) can make the application and enforcement of this legislation more difficult. For this reason, there is a need to examine whether current legislation is able to address the risks of AI and can be effectively enforced, whether adaptations of the legislation are needed, or whether new legislation is needed. Given how fast AI is evolving, the regulatory framework must leave room to cater for further developments. Any changes should be limited to clearly identified problems for which feasible solutions exist. Member States are pointing at the current absence of a common European framework. The German Data Ethics Commission has called for a five-level risk-based system of regulation that would go from no regulation for the most innocuous AI systems to a complete ban for the most dangerous ones. Denmark has just launched the prototype of a Data Ethics Seal. Malta has introduced a voluntary certification system for AI. If the EU fails to provide an EU-wide approach, there is a real risk of fragmentation in the internal market, which would undermine the objectives of trust, legal certainty and market uptake. A solid European regulatory framework for trustworthy AI will protect all European citizens and help create a frictionless internal market for the further development and uptake of AI as well as strengthening Europe’s industrial basis in AI. A. PROBLEM DEFINITION While AI can do much good, including by making products and processes safer, it can also do harm. This harm might be both material (safety and health of individuals, including loss of life, damage to property) and immaterial (loss of privacy, limitations to the right of freedom of expression, human dignity, discrimination for instance in access to employment), and can relate to a wide variety of risks. A regulatory framework should concentrate on how to minimise the various risks of potential harm, in particular the most significant ones. The main risks related to the use of AI concern the application of rules designed to protect fundamental rights (including personal data and privacy protection and non-discrimination), as well as safety32 and liability-related issues. Risks for fundamental rights, including personal data and privacy protection and non- discrimination 32 This includes issues of cybersecurity, issues associated with AI applications in critical infrastructures, or malicious use of AI. 10 The use of AI can affect the values on which the EU is founded and lead to breaches of fundamental rights33, including the rights to freedom of expression, freedom of assembly, human dignity, non- discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, as applicable in certain domains, protection of personal data and private life, 34 or the right to an effective judicial remedy and a fair trial, as well as consumer protection. These risks might result from flaws in the overall design of AI systems (including as regards human oversight) or from the use of data without correcting possible bias (e.g. the system is trained using only or mainly data from men leading to suboptimal results in relation to women). AI can perform many functions that previously could only be done by humans. As a result, citizens and legal entities will increasingly be subject to actions and decisions taken by or with the assistance of AI systems, which may sometimes be difficult to understand and to effectively challenge where necessary. Moreover, AI increases the possibilities to track and analyse the daily habits of people. For example, there is a potential risk that AI may be used, in breach of EU data protection and other rules, by state authorities or other entities for mass surveillance and by employers to observe how their employees behave. By analysing large amounts of data and identifying links among them, AI may also be used to retrace and de-anonymise data about persons, creating new personal data protection risks even in respect to datasets that per se do not include personal data. AI is also used by online intermediaries to prioritise information for their users and to perform content moderation. The processed data, the way applications are designed and the scope for human intervention can affect the rights to free expression, personal data protection, privacy, and political freedoms. Certain AI algorithms, when exploited for predicting criminal recidivism, can display gender and racial bias, demonstrating different recidivism prediction probability for women vs men or for nationals vs foreigners. Source: Tolan S., Miron M., Gomez E. and Castillo C. "Why Machine Learning May Lead to Unfairness: Evidence from Risk Assessment for Juvenile Justice in Catalonia", Best Paper Award, International Conference on AI and Law, 2019 Certain AI programmes for facial analysis display gender and racial bias, demonstrating low errors for determining the gender of lighter-skinned men but high errors in determining gender for darker-skinned women. Source: Joy Buolamwini, Timnit Gebru; Proceedings of the 1st Conference on Fairness, Accountability and Transparency, PMLR 81:77-91, 2018. Bias and discrimination are inherent risks of any societal or economic activity. Human decision- making is not immune to mistakes and biases. However, the same bias when present in AI could have a much larger effect, affecting and discriminating many people without the social control mechanisms that govern human behaviour35. This can also happen when the AI system ‘learns’ while in operation. 33 Council of Europe research shows that a large number of fundamental rights could be impacted from the use of AI, https://rm.coe.int/algorithms-and-human-rights-en-rev/16807956b5. 34 The General Data Protection Regulation and the ePrivacy Directive (new ePrivacy Regulation under negotiation) address these risks but there might be a need to examine whether AI systems pose additional risks. The Commission will be monitoring and assessing the application of the GDPR on a continuous basis. 35 The Commission’s Advisory Committee on Equal Opportunities for Women and Men is currently preparing an “Opinion on Artificial Intelligence” analysing inter alia the impacts of Artificial Intelligence on gender equality which is expected to be adopted by the Committee in early 2020. The EU Gender Equality Strategy 2020-2024 also addresses the link between AI on gender equality; The European Network of Equality Bodies (Equinet) will publish a report (by Robin 11 In such cases, where the outcome could not have been prevented or anticipated at the design phase, the risks will not stem from a flaw in the original design of the system but rather from the practical impacts of the correlations or patterns that the system identifies in a large dataset. The specific characteristics of many AI technologies, including opacity (‘black box-effect’), complexity, unpredictability and partially autonomous behaviour, may make it hard to verify compliance with, and may hamper the effective enforcement of, rules of existing EU law meant to protect fundamental rights. Enforcement authorities and affected persons might lack the means to verify how a given decision made with the involvement of AI was taken and, therefore, whether the relevant rules were respected. Individuals and legal entities may face difficulties with effective access to justice in situations where such decisions may negatively affect them. Risks for safety and the effective functioning of the liability regime AI technologies may present new safety risks for users when they are embedded in products and services. For example, as result of a flaw in the object recognition technology, an autonomous car can wrongly identify an object on the road and cause an accident involving injuries and material damage. As with the risks to fundamental rights, these risks can be caused by flaws in the design of the AI technology, be related to problems with the availability and quality of data or to other problems stemming from machine learning. While some of these risks are not limited to products and services that rely on AI , the use of AI may increase or aggravate the risks. A lack of clear safety provisions tackling these risks may, in addition to risks for the individuals concerned, create legal uncertainty for businesses that are marketing their products involving AI in the EU. Market surveillance and enforcement authorities may find themselves in a situation where they are unclear as to whether they can intervene, because they may not be empowered to act and/or don’t have the appropriate technical capabilities for inspecting systems 36 . Legal uncertainty may therefore reduce overall levels of safety and undermine the competitiveness of European companies. If the safety risks materialise, the lack of clear requirements and the characteristics of AI technologies mentioned above make it difficult to trace back potentially problematic decisions made with the involvement of AI systems. This in turn may make it difficult for persons having suffered harm to obtain compensation under the current EU and national liability legislation.37 Allen and Dee Masters) on “Regulating AI: the new role for Equality Bodies – Meeting the new challenges to equality and non-discrimination from increased digitalisation and the use of AI”, expected early 2020. 36 An example may be the smart watch for children. This product may cause no direct harm to the child wearing it, but lacking a minimum level of security, it can be easily used as a tool to have access to the child. Market surveillance authorities may find it difficult to intervene in cases where the risk is not linked to the product as such. 37 The implications of AI, Internet of Things and other digital technologies for safety and liability legislation are analysed in the Commission Report accompanying this White Paper. 12 Under the Product Liability Directive, a manufacturer is liable for damage caused by a defective product. However, in the case of an AI based system such as autonomous cars, it may be difficult to prove that there is a defect in the product, the damage that has occurred and the causal link between the two. In addition, there is some uncertainty about how and to what extent the Product Liability Directive applies in the case of certain types of defects, for example if these result from weaknesses in the cybersecurity of the product. Thus, the difficulty of tracing back potentially problematic decisions taken by AI systems and referred to above in relation to fundamental rights applies equally to safety and liability-related issues. Persons having suffered harm may not have effective access to the evidence that is necessary to build a case in court, for instance, and may have less effective redress possibilities compared to situations where the damage is caused by traditional technologies. These risks will increase as the use of AI becomes more widespread. B. POSSIBLE ADJUSTMENTS TO EXISTING EU LEGISLATIVE FRAMEWORK RELATING TO AI An extensive body of existing EU product safety and liability legislation38, including sector-specific rules, further complemented by national legislation, is relevant and potentially applicable to a number of emerging AI applications. As regards the protection of fundamental rights and consumer rights, the EU legislative framework includes legislation such as the Race Equality Directive 39 , the Directive on equal treatment in employment and occupation40, the Directives on equal treatment between men and women in relation to employment and access to goods and services41, a number of consumer protection rules42, as well as rules on personal data protection and privacy, notably the General Data Protection Regulation and other sectorial legislation covering personal data protection, such as the Data Protection Law Enforcement Directive43. In addition, as from 2025, the rules on accessibility requirements for goods and services, set out in the European Accessibility Act will apply44. In addition, fundamental rights need to be respected when implementing other EU legislation, including in the field of financial services, migration or responsibility of online intermediaries. While the EU legislation remains in principle fully applicable irrespective of the involvement of AI, it is important to assess whether it can be enforced adequately to address the risks that AI systems create, or whether adjustments are needed to specific legal instruments. 38 The EU legal framework for product safety consists of the General Product Safety Directive (Directive 2001/95/EC), as a safety net, and a number of sector-specific rules covering different categories of products ranging from machines, planes and cars to toys and medical devices aiming to provide a high level of health and safety. Product liability law is complemented by different systems of civil liability for damages caused by products or services. 39 Directive 2000/43/EC. 40 Directive 2000/78/EC. 41 Directive 2004/113/EC; Directive 2006/54/EC. 42 Such as the Unfair Commercial Practices Directive (Directive 2005/29/EC) and the Consumer Rights Directive (Directive 2011/83/EC). 43 Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data. 44 Directive (EU) 2019/882 on the accessibility requirements for products and services. 13 For example, economic actors remain fully responsible for the compliance of AI to existing rules that protects consumers, any algorithmic exploitation of consumer behaviour in violation of existing rules shall be not permitted and violations shall be accordingly punished. The Commission is of the opinion that the legislative framework could be improved to address the following risks and situations:  Effective application and enforcement of existing EU and national legislation: the key characteristics of AI create challenges for ensuring the proper application and enforcement of EU and national legislation. The lack of transparency (opaqueness of AI) makes it difficult to identify and prove possible breaches of laws, including legal provisions that protect fundamental rights, attribute liability and meet the conditions to claim compensation. Therefore, in order to ensure an effective application and enforcement, it may be necessary to adjust or clarify existing legislation in certain areas, for example on liability as further detailed in the Report, which accompanies this White Paper.  Limitations of scope of existing EU legislation: an essential focus of EU product safety legislation is on the placing of products on the market. While in EU product safety legislation software, when is part of the final product, must comply with the relevant product safety rules, it is an open question whether stand-alone software is covered by EU product safety legislation, outside some sectors with explicit rules45. General EU safety legislation currently in force applies to products and not to services, and therefore in principle not to services based on AI technology either (e.g. health services, financial services, transport services).  Changing functionality of AI systems: the integration of software, including AI, into products can modify the functioning of such products and systems during their lifecycle. This is particularly true for systems that require frequent software updates or which rely on machine learning. These features can give rise to new risks that were not present when the system was placed on the market. These risks are not adequately addressed in the existing legislation which predominantly focuses on safety risks present at the time of placing on the market.  Uncertainty as regards the allocation of responsibilities between different economic operators in the supply chain: in general, EU legislation on product safety allocates the responsibility to the producer of the product placed on the market, including all components e.g. AI systems. But the rules can for example become unclear if AI is added after the product is placed on the market by a party that is not the producer. In addition, EU product liability legislation provides for liability of producers and leaves national liability rules to govern liability of others in the supply chain.  Changes to the concept of safety: the use of AI in products and services can give rise to risks that EU legislation currently does not explicitly address. These risks may be linked to cyber threats, personal security risks (linked for example to new applications of AI such as to home appliances), risks that result from loss of connectivity, etc. These risks may be present at the time of placing products on the market or arise as a result of software updates or self-learning when the product is being used. The EU should make full use of the tools at its disposal to 45 For instance software intended by the manufacturer to be used for medical purposes is considered a medical device under the Medical Device Regulation (Regulation (EU) 2017/745). 14 enhance its evidence base on potential risks linked to AI applications, including using the experience of the EU Cybersecurity Agency (ENISA) for assessing the AI threat landscape. As indicated earlier, several Member States are already exploring options for national legislation to address the challenges created by AI. This raises the risk that the single market may be fragmented. Divergent national rules are likely to create obstacles for companies that want to sell and operate AI systems in the single market. Ensuring a common approach at EU level would enable European companies to benefit from smooth access to the single market and support their competitiveness on global markets. Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics The Report, which accompanies this White Paper, analyses the relevant legal framework. It identifies uncertainties as to the application of this framework with respect to the specific risks posed by AI systems and other digital technologies. It concludes that the current product safety legislation already supports an extended concept of safety protecting against all kind of risks arising from the product according to its use. However, provisions explicitly covering new risks presented by the emerging digital technologies could be introduced to provide more legal certainty.  The autonomous behaviour of certain AI systems during its life cycle may entail important product changes having an impact on safety, which may require a new risk assessment. In addition, human oversight from the product design and throughout the lifecycle of the AI products and systems may be needed as a safeguard.  Explicit obligations for producers could be considered also in respect of mental safety risks of users when appropriate (ex. collaboration with humanoid robots).  Union product safety legislation could provide for specific requirements addressing the risks to safety of faulty data at the design stage as well as mechanisms to ensure that quality of data is maintained throughout the use of the AI products and systems.  The opacity of systems based on algorithms could be addressed through transparency requirements.  Existing rules may need to be adapted and clarified in the case of a stand-alone software placed as it is on the market or downloaded into a product after its placing on the market, when having an impact on safety.  Given the increasing complexity of supply chains as regards new technologies, provisions specifically requesting cooperation between the economic operators in the supply chain and the users could provide legal certainty. The characteristics of emerging digital technologies like AI, the IoT and robotics may challenge aspects of the liability frameworks and could reduce their effectiveness. Some of these characteristics could make it hard to trace the damage back to a person, which would be necessary for a fault-based claim in accordance with most national rules. This could significantly increase the costs for victims and means that liability claims against others than producers may be difficult to make or prove.  Persons having suffered harm caused with the involvement of AI systems need to enjoy the same level of protection as persons having suffered harm caused by other technologies, whilst technological innovation should be allowed to continue to develop.  All options to ensure this objective should be carefully assessed, including possible amendments to the Product Liability Directive and possible further targeted harmonisation of national liability rules. For example, the Commission is seeking views whether and to what extent it may be needed to mitigate the consequences of complexity by adapting the burden of proof required by national liability rules for damage caused by the operation of AI applications. 15 From the discussion above, the Commission concludes that – in addition to the possible adjustments to existing legislation – a new legislation specifically on AI may be needed in order to make the EU legal framework fit for the current and anticipated technological and commercial developments. C. SCOPE OF A FUTURE EU REGULATORY FRAMEWORK A key issue for the future specific regulatory framework on AI intelligence is to determine the scope of its application. The working assumption is that the regulatory framework would apply to products and services relying on AI. AI should therefore be clearly defined for the purposes of this White Paper, as well as any possible future policy-making initiative. In its Communication on AI for Europe the Commission provided a first definition of AI 46 . This definition was further refined by the High Level Expert Group47. In any new legal instrument, the definition of AI will need to be sufficiently flexible to accommodate technical progress while being precise enough to provide the necessary legal certainty. For the purposes of this White Paper, as In autonomous driving for example, the algorithm uses, in well as of any possible future discussions real time, the data from the car (speed, engine on policy initiatives, it seems important to consumption, shock-absorbers, etc..) and from the sensors clarify the main elements that compose scanning the whole environment of the car (road, signs, AI, which are “data” and “algorithms”. AI other vehicles, pedestrians etc..) to derive which direction, can be integrated in hardware. In case of acceleration and speed the car should take to reach a certain machine learning techniques, which destination. Based on the data observed, the algorithm constitute a subset of AI, algorithms are adapts to the situation of the road and to the outside trained to infer certain patterns based on a conditions, including other drivers’ behaviour, to derive the set of data in order to determine the actions most comfortable and safest drive. needed to achieve a given goal. Algorithms may continue to learn when in use. While AI-based products can act autonomously by perceiving their environment and without following a pre-determined set of instructions, their behaviour is largely defined and constrained by its developers. Humans determine and programme the goals, which an AI system should optimise for. The EU has a strict legal framework in place to ensure inter alia consumer protection, to address unfair commercial practices and to protect personal data and privacy. In addition, the acquis contains specific rules for certain sectors (e.g. healthcare, transport). These existing provisions of EU law will continue to apply in relation to AI, although certain updates to that framework may be necessary to reflect the digital transformation and the use of AI (see section B). As a consequence, those aspects that are 46 COM(2018) 237 final, p. 1: “Artificial intelligence (AI) refers to systems that display intelligent behaviour by analysing their environment and taking actions – with some degree of autonomy – to achieve specific goals. AI-based systems can be purely software-based, acting in the virtual world (e.g. voice assistants, image analysis software, search engines, speech and face recognition systems) or AI can be embedded in hardware devices (e.g. advanced robots, autonomous cars, drones or Internet of Things applications).” 47 High Level Expert Group, A definition of AI, p. 8: “Artificial intelligence (AI) systems are software (and possibly also hardware) systems designed by humans that, given a complex goal, act in the physical or digital dimension by perceiving their environment through data acquisition, interpreting the collected structured or unstructured data, reasoning on the knowledge, or processing the information, derived from this data and deciding the best action(s) to take to achieve the given goal. AI systems can either use symbolic rules or learn a numeric model, and they can also adapt their behaviour by analysing how the environment is affected by their previous actions.” 16 already addressed by existing horizontal or sectoral legislation (e.g. on medical devices48, in transport systems) will continue to be governed by this legislation. As a matter of principle, the new regulatory framework for AI should be effective to achieve its objectives while not being excessively prescriptive so that it could create a disproportionate burden, especially for SMEs. To strike this balance, the Commission is of the view that it should follow a risk- based approach. A risk-based approach is important to help ensure that the regulatory intervention is proportionate. However, it requires clear criteria to differentiate between the different AI applications, in particular in relation to the question whether or not they are ‘high-risk’49. The determination of what is a high-risk AI application should be clear and easily understandable and applicable for all parties concerned. Nevertheless even if an AI application is not qualified as high-risk, it remains entirely subject to already existing EU-rules. The Commission is of the opinion that a given AI application should generally be considered high-risk in light of what is at stake, considering whether both the sector and the intended use involve significant risks, in particular from the viewpoint of protection of safety, consumer rights and fundamental rights. More specifically, an AI application should be considered high-risk where it meets the following two cumulative criteria:  First, the AI application is employed in a sector where, given the characteristics of the activities typically undertaken, significant risks can be expected to occur. This first criterion ensures that the regulatory intervention is targeted on the areas where, generally speaking, risks are deemed most likely to occur. The sectors covered should be specifically and exhaustively listed in the new regulatory framework. For instance, healthcare; transport; energy and parts of the public sector.50 The list should be periodically reviewed and amended where necessary in function of relevant developments in practice;  Second, the AI application in the sector in question is, in addition, used in such a manner that significant risks are likely to arise. This second criterion reflects the acknowledgment that not every use of AI in the selected sectors necessarily involves significant risks. For example, whilst healthcare generally may well be a relevant sector, a flaw in the appointment scheduling system in a hospital will normally not pose risks of such significance as to justify legislative intervention. The assessment of the level of risk of a given use could be based on the impact on the affected parties. For instance, uses of AI applications that produce legal or similarly significant effects for the rights of an individual or a company; that pose risk of injury, death or significant material or immaterial damage; that produce effects that cannot reasonably be avoided by individuals or legal entities. The application of the two cumulative criteria would ensure that the scope of the regulatory framework is targeted and provides legal certainty. The mandatory requirements contained in the new regulatory framework on AI (see section D below) would in principle apply only to those applications identified as high-risk in accordance with these two cumulative criteria. 48 For example, there are different safety considerations and legal implications concerning AI systems that provide specialized medical information to physicians, AI systems providing medical information directly to the patient and AI systems performing medical tasks themselves directly on a patient. The Commission is examining these safety and liability challenges that are distinct to healthcare. 49 EU legislation may categorise “risks” differently to what is described here, depending on the area, such as for example, product safety 50 The public sector could include areas like asylum, migration, border controls and judiciary, social security and employment services. 17 Notwithstanding the foregoing, there may also be exceptional instances where, due to the risks at stake, the use of AI applications for certain purposes is to be considered as high-risk as such – that is, irrespective of the sector concerned and where the below requirements would still apply. 51 As an illustration, one could think in particular of the following:  In light of its significance for individuals and of the EU acquis addressing employment equality, the use of AI applications for recruitment processes as well as in situations impacting workers’ rights would always be considered “high-risk” and therefore the below requirements would at all times apply. Further specific applications affecting consumer rights could be considered.  the use of AI applications for the purposes of remote biometric identification 52 and other intrusive surveillance technologies, would always be considered “high-risk” and therefore the below requirements would at all times apply. D. TYPES OF REQUIREMENTS When designing the future regulatory framework for AI, it will be necessary to decide on the types of mandatory legal requirements to be imposed on the relevant actors. These requirements may be further specified through standards. As noted in section C above and in addition to already existing legislation, those requirements would apply to high-risk AI applications only, thus ensuring that any regulatory intervention is focused and proportionate. Taking into account the guidelines of the High Level Expert Group and what has been set out in the foregoing, the requirements for high-risk AI applications could consist of the following key features, which are discussed in further detail in the subsections below:  training data;  data and record-keeping;  information to be provided;  robustness and accuracy;  human oversight;  specific requirements for certain particular AI applications, such as those used for purposes of remote biometric identification. To ensure legal certainty, these requirements will be further specified to provide a clear benchmark for all the actors who need to comply with them. a) Training data It is more important than ever to promote, strengthen and defend the EU’s values and rules, and in particular the rights that citizens derive from EU law. These efforts undoubtedly also extend to the high-risk AI applications marketed and used in the EU under consideration here. 51 It is important to highlight that other pieces of EU legislation may also apply. For example, when incorporated into a consumer product, the General Product Safety Directive may apply to the safety of AI applications. 52 Remote biometric identification should be distinguished from biometric authentication (the latter is a security process that relies on the unique biological characteristics of an individual to verify that he/she is who he/she says he/she is). Remote biometric identification is when the identities of multiple persons are established with the help of biometric identifiers (fingerprints, facial image, iris, vascular patterns, etc.) at a distance, in a public space and in a continuous or ongoing manner by checking them against data stored in a database. 18 As discussed earlier, without data, there is no AI. The functioning of many AI systems, and the actions and decisions to which they may lead, very much depend on the data set on which the systems have been trained. The necessary measures should therefore be taken to ensure that, where it comes to the data used to train AI systems, the EU’s values and rules are respected, specifically in relation to safety and existing legislative rules for the protection of fundamental rights. The following requirements relating to the data set used to train AI systems could be envisaged:  Requirements aimed at providing reasonable assurances that the subsequent use of the products or services that the AI system enables is safe, in that it meets the standards set in the applicable EU safety rules (existing as well as possible complementary ones). For instance, requirements ensuring that AI systems are trained on data sets that are sufficiently broad and cover all relevant scenarios needed to avoid dangerous situations.  Requirements to take reasonable measures aimed at ensuring that such subsequent use of AI systems does not lead to outcomes entailing prohibited discrimination. These requirements could entail in particular obligations to use data sets that are sufficiently representative, especially to ensure that all relevant dimensions of gender, ethnicity and other possible grounds of prohibited discrimination are appropriately reflected in those data sets;  Requirements aimed at ensuring that privacy and personal data are adequately protected during the use of AI-enabled products and services. For issues falling within their respective scope, the General Data Protection Regulation and the Law Enforcement Directive regulate these matters. b) Keeping of records and data Taking into account elements such as the complexity and opacity of many AI systems and the related difficulties that may exist to effectively verify compliance with and enforce the applicable rules, requirements are called for regarding the keeping of records in relation to the programming of the algorithm, the data used to train high-risk AI systems, and, in certain cases, the keeping of the data themselves. These requirements essentially allow potentially problematic actions or decisions by AI systems to be traced back and verified. This should not only facilitate supervision and enforcement; it may also increase the incentives for the economic operators concerned to take account at an early stage of the need to respect those rules. To this aim, the regulatory framework could prescribe that the following should be kept:  accurate records regarding the data set used to train and test the AI systems, including a description of the main characteristics and how the data set was selected;  in certain justified cases, the data sets themselves;  documentation on the programming53 and training methodologies, processes and techniques used to build, test and validate the AI systems, including where relevant in respect of safety and avoiding bias that could lead to prohibited discrimination. The records, documentation and, where relevant, data sets would need to be retained during a limited, reasonable time period to ensure effective enforcement of the relevant legislation. Measures should be 53 For instance, documentation on the algorithm including what the model shall optimise for, which weights are designed to certain parameters at the outset etc. 19 taken to ensure that they are made available upon request, in particular for testing or inspection by competent authorities. Where necessary, arrangements should be made to ensure that confidential information, such as trade secrets, is protected. c) Information provision Transparency is required also beyond the record-keeping requirements discussed in point c) above. In order to achieve the objectives pursued – in particular promoting the responsible use of AI, building trust and facilitating redress where needed – it is important that adequate information is provided in a proactive manner about the use of high-risk AI systems. Accordingly, the following requirements could be considered:  Ensuring clear information to be provided as to the AI system’s capabilities and limitations, in particular the purpose for which the systems are intended, the conditions under which they can be expected to function as intended and the expected level of accuracy in achieving the specified purpose. This information is important especially for deployers of the systems, but it may also be relevant to competent authorities and affected parties.  Separately, citizens should be clearly informed when they are interacting with an AI system and not a human being. Whilst EU data protection legislation already contain certain rules of this kind 54 , additional requirements may be called for to achieve the abovementioned objectives. If so, unnecessary burdens should be avoided. Therefore, no such information needs to be provided, for instance, in situations where it is immediately obvious to citizens that they are interacting with AI systems. It is furthermore important that the information provided is objective, concise and easily understandable. The manner in which the information is to be provided should be tailored to the particular context. d) Robustness and accuracy AI systems – and certainly high-risk AI applications – must be technically robust and accurate in order to be trustworthy. That means that such systems need to be developed in a responsible manner and with an ex-ante due and proper consideration of the risks that they may generate. Their development and functioning must be such to ensure that AI systems behave reliably as intended. All reasonable measures should be taken to minimise the risk of harm being caused. Accordingly, the following elements could be considered:  Requirements ensuring that the AI systems are robust and accurate, or at least correctly reflect their level of accuracy, during all life cycle phases;  Requirements ensuring that outcomes are reproducible;  Requirements ensuring that AI systems can adequately deal with errors or inconsistencies during all life cycle phases. 54 In particular, pursuant to Art. 13(2)(f) GDPR, controllers must, at the time when the personal data are obtained, provide the data subjects with further information necessary to ensure fair and transparent processing about the existence of automated decision-making and certain additional information. 20  Requirements ensuring that AI systems are resilient against both overt attacks and more subtle attempts to manipulate data or algorithms themselves, and that mitigating measures are taken in such cases. e) Human oversight Human oversight helps ensuring that an AI system does not undermine human autonomy or cause other adverse effects. The objective of trustworthy, ethical and human-centric AI can only be achieved by ensuring an appropriate involvement by human beings in relation to high-risk AI applications. Even though the AI applications considered in this White paper for a specific legal regime are all considered high-risk, the appropriate type and degree of human oversight may vary from one case to another. It shall depend in particular on the intended use of the systems and the effects that the use could have for affected citizens and legal entities. It shall also be without prejudice to the legal rights established by the GDPR when the AI system processes personal data. For instance, human oversight could have the following, non-exhaustive, manifestations:  the output of the AI system does not become effective unless it has been previously reviewed and validated by a human (e.g. the rejection of an application for social security benefits may be taken by a human only);  the output of the AI system becomes immediately effective, but human intervention is ensured afterwards (e.g. the rejection of an application for a credit card may be processed by an AI system, but human review must be possible afterwards);  monitoring of the AI system while in operation and the ability to intervene in real time and deactivate (e.g. a stop button or procedure is available in a driverless car when a human determines that car operation is not safe);  in the design phase, by imposing operational constraints on the AI system (e.g. a driverless car shall stop operating in certain conditions of low visibility when sensors may become less reliable or shall maintain a certain distance in any given condition from the preceding vehicle). f) Specific requirements for remote biometric identification The gathering and use of biometric data55 for remote identification56 purposes, for instance through deployment of facial recognition in public places, carries specific risks for fundamental rights57. The 55 Biometric data is defined as “personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique authentification or identification of that natural person, such as facial images or dactyloscopic [fingerprint] data.” (Law Enforcement Directive, Art. 3 (13); GDPR, Art. 4 (14); Regulation (EU) 2018/1725, Art. 3 (18). 56 In connection to facial recognition, identification means that the template of a person’s facial image is compared to many other templates stored in a database to find out if his or her image is stored there. Authentication (or verification) on the other hand is often referred to as one-to-one matching. It enables the comparison of two biometric templates, usually assumed to belong to the same individual. Two biometric templates are compared to determine if the person shown on the two images is the same person. Such a procedure is, for example, used at Automated Border Control (ABC) gates used for border checks at airports. 57 For example on people’s dignity. Relatedly, the rights to respect for private life and protection of personal data are at the core of fundamental rights concerns when using facial recognition technology. There is also a potential impact on non- discrimination and rights of special groups, such as children, older persons and persons with disabilities. Moreover, freedom of expression, association and assembly must not be undermined by the use of the technology. See: Facial recognition technology: fundamental rights considerations in the context of law enforcement, https://fra.europa.eu/en/publication/2019/facial-recognition. 21 fundamental rights implications of using remote biometric identification AI systems can vary considerably depending on the purpose, context and scope of the use. EU data protection rules prohibit in principle the processing of biometric data for the purpose of uniquely identifying a natural person, except under specific conditions 58 . Specifically, under the GDPR, such processing can only take place on a limited number of grounds, the main one being for reasons of substantial public interest. In that case, the processing must take place on the basis of EU or national law, subject to the requirements of proportionality, respect for the essence of the right to data protection and appropriate safeguards. Under the Law Enforcement Directive, there must be a strict necessity for such processing, in principle an authorisation by EU or national law as well as appropriate safeguards. As any processing of biometric data for the purpose of uniquely identifying a natural person would relate to an exception to a prohibition laid down in EU law, it would be subject to the Charter of Fundamental Rights of the EU. It follows that, in accordance with the current EU data protection rules and the Charter of Fundamental Rights, AI can only be used for remote biometric identification purposes where such use is duly justified, proportionate and subject to adequate safeguards. In order to address possible societal concerns relating to the use of AI for such purposes in public places, and to avoid fragmentation in the internal market, the Commission will launch a broad European debate on the specific circumstances, if any, which might justify such use, and on common safeguards. E. ADDRESSEES In relation to the addressees of the legal requirements that would apply in relation to the high-risk AI applications referred to above, there are two main issues to be considered. First, there is the question how obligations are to be distributed among the economic operators involved. Many actors are involved in the lifecycle of an AI system. These include the developer, the deployer (the person who uses an AI-equipped product or service) and potentially others (producer, distributor or importer, service provider, professional or private user). It is the Commission’s view that, in a future regulatory framework, each obligation should be addressed to the actor(s) who is (are) best placed to address any potential risks. For example, while the developers of AI may be best placed to address risks arising from the development phase, their ability to control risks during the use phase may be more limited. In that case, the deployer should be subject to the relevant obligation. This is without prejudice to the question whether, for the purpose of liability to end-users or other parties suffering harm and ensuring effective access to justice, which party should be liable for any damage caused. Under EU product liability law, liability for defective products is attributed to the producer, without prejudice to national laws which may also allow recovery from other parties. Second, there is the question about the geographic scope of the legislative intervention. In the view of the Commission, it is paramount that the requirements are applicable to all relevant economic operators providing AI-enabled products or services in the EU, regardless of whether they are established in the EU or not. Otherwise, the objectives of the legislative intervention, mentioned earlier, could not fully be achieved. 58 Article 9 GDPR, Article 10 Law Enforcement Directive. See also Article 10 Regulation (EU) 2018/1725 (applicable to the EU institutions and bodies). 22 F. COMPLIANCE AND ENFORCEMENT In order to ensure that AI is trustworthy, secure and in respect of European values and rules, the applicable legal requirements need to be complied with in practice and be effectively enforced both by competent national and European authorities and by affected parties. Competent authorities should be in a position to investigate individual cases, but also to assess the impact on society. In view of the high risk that certain AI applications pose for citizens and our society (see section A above), the Commission considers at this stage that an objective, prior conformity assessment would be necessary to verify and ensure that certain of the above mentioned mandatory requirements applicable to high-risk applications (see section D above) are complied with. The prior conformity assessment could include procedures for testing, inspection or certification59. It could include checks of the algorithms and of the data sets used in the development phase. The conformity assessments for high-risk AI applications should be part of the conformity assessment mechanisms that already exist for a large number of products being placed on the EU’s internal market. Where no such existing mechanisms can be relied on, similar mechanisms may need to be established, drawing on best practice and possible input of stakeholders and European standards organisations. Any such new mechanism should be proportionate and non-discriminatory and use transparent and objective criteria in compliance with international obligations. When designing and implementing a system relying on prior conformity assessments, particular account should be taken of the following:  Not all requirements outlined above may be suitable to be verified through a prior conformity assessment. For instance, the requirement about information to be provided generally does not lend itself well for verification through such an assessment.  Particular account should be taken of the possibility that certain AI systems evolve and learn from experience, which may require repeated assessments over the life-time of the AI systems in question.  The need to verify the data used for training and the relevant programming and training methodologies, processes and techniques used to build, test and validate AI systems.  In case the conformity assessment shows that an AI system does not meet the requirements for example relating to the data used to train it, the identified shortcomings will need to be remedied, for instance by re-training the system in the EU in such a way as to ensure that all applicable requirements are met. The conformity assessments would be mandatory for all economic operators addressed by the requirements, regardless of their place of establishment60. In order to limit the burden on SMEs, some support structure might be envisaged including through the Digital Innovation Hubs. In addition, standards as well as dedicated online tools could facilitate compliance. 59 The system would be based on conformity assessment procedures in the EU, see Decision 768/2008/EC or on Regulation (EU) 2019/881 (Cybersecurity Act), taking into account the specificities of AI. See the Blue Guide on the Implementation of EU product rules, 2014. 60 As regards the relevant governance structure, including the bodies designated to carry out the conformity assessments, see section H below. 23 Any prior conformity assessment should be without prejudice to monitoring compliance and ex post enforcement by competent national authorities. That holds true in respect of high-risk AI applications, but also in respect of other AI applications subject to legal requirements, although the high-risk nature of the applications at issue may be reason for the competent national authorities to give particular attention to the former. Ex-post controls should be enabled by adequate documentation of the relevant AI application (see section E above) and, where appropriate, a possibility for third parties such as competent authorities to test such applications. This may be especially important where risks to fundamental rights arise, which are context dependent. Such monitoring of compliance should be part of a continuous market surveillance scheme. Governance-related aspects are further discussed in section H below. Moreover, both for high- risk AI applications and for other AI applications, effective judicial redress for parties negatively affected by AI systems should be ensured. Issues related to liability are further discussed in the Report on the safety and liability framework accompanying this White Paper. G. VOLUNTARY LABELLING FOR NO-HIGH RISK AI APPLICATIONS For AI applications that do not qualify as ‘high-risk’ (see section C above) and that are therefore not subject to the mandatory requirements discussed above (see sections D, E and F above), an option would be, in addition to applicable legislation, to establish a voluntary labelling scheme. Under the scheme, interested economic operators that are not covered by the mandatory requirements could decide to make themselves subject, on a voluntary basis, either to those requirements or to a specific set of similar requirements especially established for the purposes of the voluntary scheme. The economic operators concerned would then be awarded a quality label for their AI applications. The voluntary label would allow the economic operators concerned to signal that their AI-enabled products and services are trustworthy. It would allow users to easily recognise that the products and services in question are in compliance with certain objective and standardised EU-wide benchmarks, going beyond the normally applicable legal obligations. This would help enhance the trust of users in AI systems and promote the overall uptake of the technology. This option would entail the creation of a new legal instrument that sets out the voluntary labelling framework for developers and/or deployers of AI systems that are not be considered as high-risk. While participation in the labelling scheme would be voluntary, once the developer or the deployer opted to use the label, the requirements would be binding. The combination of ex ante and ex post enforcement would need to ensure that all requirements are complied with. H. GOVERNANCE A European governance structure on AI in the form of a framework for cooperation of national competent authorities is necessary to avoid fragmentation of responsibilities, increase capacity in Member States, and make sure that Europe equips itself progressively with the capacity needed for testing and certification of AI-enabled products and services. In this context, it would be beneficial to support competent national authorities to enable them to fulfil their mandate where AI is used. A European governance structure could have a variety of tasks, as a forum for a regular exchange of information and best practice, identifying emerging trends, advising on standardisation activity as well as on certification. It should also play a key role in facilitating the implementation of the legal framework, such as through issuing guidance, opinions and expertise. To that effect, it should rely on a network of national authorities, as well as sectorial networks and regulatory authorities, at national and EU level. Moreover, a committee of experts could provide assistance to the Commission. 24 The governance structure should guarantee maximum stakeholders participation. Stakeholders – consumer organisation and social partners, businesses, researchers, and civil society organisations – should be consulted on the implementation and the further development of the framework. Given already existing structures such as in finance, pharmaceuticals, aviation, medical devices, consumer protection, data protection, the proposed governance structure should not duplicate existing functions. It should instead establish close links with other EU and national competent authorities in the various sectors to complement existing expertise and help existing authorities in monitoring and the oversight of the activities of economic operators involving AI systems and AI-enabled products and services. Finally, if this option is pursued, the carrying out of conformity assessments could be entrusted to notified bodies designated by Member States. Testing centres should enable the independent audit and assessment of AI-systems in accordance with the requirements outlined above. Independent assessment will increase trust and ensures objectivity. It could also facilitate the work of relevant competent authorities. The EU enjoys excellent testing and assessment centres and should develop its capacity also in the area of AI. Economic operators established in third countries wanting to enter the internal market could either make use of designated bodies established in the EU or, subject to mutual recognition agreements with third countries, have recourse to third-country bodies designated to carry out such assessment. The governance structure relating to AI and the possible conformity assessments at issue here would leave the powers and responsibilities under existing EU law of the relevant competent authorities in specific sectors or on specific issues (finance, pharmaceuticals, aviation, medical devices, consumer protection, data protection, etc.) unaffected. 6. CONCLUSION AI is a strategic technology that offers many benefits for citizens, companies and society as a whole, provided it is human-centric, ethical, sustainable and respects fundamental rights and values. AI offers important efficiency and productivity gains that can strengthen the competitiveness of European industry and improve the wellbeing of citizens. It can also contribute to finding solutions to some of the most pressing societal challenges, including the fight against climate change and environmental degradation, the challenges linked to sustainability and demographic changes, and the protection of our democracies and, where necessary and proportionate, the fight against crime. For Europe to seize fully the opportunities that AI offers, it must develop and reinforce the necessary industrial and technological capacities. As set out in the accompanying European strategy for data, this also requires measures that will enable the EU to become a global hub for data. The European approach for AI aims to promote Europe’s innovation capacity in the area of AI while supporting the development and uptake of ethical and trustworthy AI across the EU economy. AI should work for people and be a force for good in society. With this White Paper and the accompanying Report on the safety and liability framework, the Commission launches a broad consultation of Member States civil society, industry and academics, of concrete proposals for a European approach to AI. These include both policy means to boost investments in research and innovation, enhance the development of skills and support the uptake of AI by SMEs, and proposals for key elements of a future regulatory framework. This consultation will 25 allow a comprehensive dialogue with all concerned parties that will inform the next steps of the Commission. The Commission invites for comments on the proposals set out in the White Paper through an open public consultation available at https://ec.europa.eu/info/consultations_en. The consultation is open for comments until 19 May 2020. It is standard practice for the Commission to publish submissions received in response to a public consultation. However, it is possible to request that submissions, or parts thereof, remain confidential. Should this be the case, please indicate clearly on the front page of your submission that it should not be made public and also send a non-confidential version of your submission to the Commission for publication. 26 EUROPEAN COMMISSION Brussels, 19.2.2020 COM(2020) 67 final COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Shaping Europe's digital future EN EN Shaping Europe’s digital future 1. Introduction Digital technologies are profoundly changing our daily life, our way of working and doing business, and the way people travel, communicate and relate with each other. Digital communication, social media interaction, e-commerce, and digital enterprises are steadily transforming our world. They are generating an ever-increasing amount of data, which, if pooled and used, can lead to a completely new means and levels of value creation. It is a transformation as fundamental as that caused by the industrial revolution. In her political guidelines, Commission President von der Leyen stressed the need for Europe to lead the transition to a healthy planet and a new digital world. This twin challenge of a green and digital transformation has to go hand-in-hand. It requires, as set out in the European Green Deal, an immediate change of direction towards more sustainable solutions which are resource-efficient, circular and climate-neutral. It requires that every citizen, every employee, every business person has a fair chance, wherever they live, to reap the benefits of our increasingly digitised society. Digital solutions such as communications systems, artificial intelligence or quantum technologies can enrich our lives in many ways. But the benefits arising from digital technologies do not come without risks and costs. Citizens no longer feel in control over what happens with their personal data and are increasingly overloaded by artificial solicitations of their attention. And malicious cyberactivity may threaten our personal well-being or disrupt our critical infrastructures and wider security interests. This substantive societal transformation calls for a profound reflection at all levels of society as to how Europe can best meet, and continue to meet, these risks and challenges. It will require a huge effort, but Europe undoubtedly has the means to bring about this better digital future for everyone. 2. Our vision and goals The Commission wants a European society powered by digital solutions that are strongly rooted in our common values, and that enrich the lives of all of us: people must have the opportunity to develop personally, to choose freely and safely, to engage in society, regardless of their age, gender or professional background. Businesses need a framework that allows them to start up, scale up, pool and use data, to innovate and compete or cooperate on fair 1 terms. And Europe needs to have a choice and pursue the digital transformation in its own way. European technological sovereignty starts from ensuring the integrity and resilience of our data infrastructure, networks and communications. It requires creating the right conditions for Europe to develop and deploy its own key capacities, thereby reducing our dependency on other parts of the globe for the most crucial technologies. Europe’s ability to define its own rules and values in the digital age will be reinforced by such capacities. European technological sovereignty is not defined against anyone else, but by focusing on the needs of Europeans and of the European social model. The EU will remain open to anyone willing to play by European rules and meet European standards, regardless of where they are based. Citizens should be empowered to make better decisions based on insights gleaned from non- personal data. And that data should be available to all – whether public or private, big or small, start-up or giant. This will help society to get the most out of innovation and competition and ensure that everyone benefits from a digital dividend. This digital Europe should reflect the best of Europe - open, fair, diverse, democratic, and confident For the next five years, the Commission will focus on three key objectives to ensure that digital solutions help Europe to pursue its own way towards a digital transformation that works for the benefit of people through respecting our values. It will also put Europe in a position to be a trendsetter in the global debate.  Technology that works for people: Development, deployment and uptake of technology that makes a real difference to people’s daily lives. A strong and competitive economy that masters and shapes technology in a way that respects European values.  A fair and competitive economy: A frictionless single market, where companies of all sizes and in any sector can compete on equal terms, and can develop, market and use digital technologies, products and services at a scale that boosts their productivity and global competitiveness, and consumers can be confident that their rights are respected.  An open, democratic and sustainable society: A trustworthy environment in which citizens are empowered in how they act and interact, and of the data they provide both online and offline. A European way to digital transformation which enhances our democratic values, respects our fundamental rights, and contributes to a sustainable, climate-neutral and resource-efficient economy. 2 For Europe to truly influence the way in which digital solutions are developed and used on a global scale, it needs to be a strong, independent and purposeful digital player in its own right. In order to achieve this, a clear framework that promotes trustworthy, digitally enabled interactions across society, for people as well as for businesses, is needed. Without this focus on trustworthiness, the vital process of digital transformation cannot succeed. Creating a Europe fit for the digital age is a complex puzzle with many interconnected pieces; as with any puzzle, the whole picture cannot be seen without putting all the pieces together. The following sections will describe how the Commission intends to complete this puzzle and turn its vision into reality. A. Technology that works for people Europe has a long and successful history of technology and creativity. Europe is strongest when it acts together and joins forces between the EU and its Member States; involving regions and municipalities, academia, civil society, financial institutions, businesses and social enterprises. Europe needs to pool its investments in research and innovation, to share experiences, and to cooperate across countries. Recent agreements to work together in areas such as supercomputing and micro-electronics have shown that collaboration can be highly 3 effective. Similar initiatives on key areas of the next wave of innovative technologies will follow. Promoting the digital transformation of public administrations throughout Europe is also crucial in this regard. Europe must invest more in the strategic capacities that allow us to develop and use digital solutions at scale and to strive for interoperability in key digital infrastructures, such as extensive 5G (and future 6G) networks and deep tech.1 To take just one example: connectivity is the most fundamental building block of the digital transformation. It is what enables data to flow, people to collaborate wherever they are, and to connect more objects to the Internet, transforming manufacturing, mobility and logistic chains. Gigabit connectivity2, powered with secure fibre and 5G infrastructures, is vital if we are to tap into Europe’s digital growth potential. To this end, adequate investments at EU, national and regional levels are necessary to achieve the EU 2025 connectivity objectives.,3 The new EU Multiannual Financial Framework will contribute to these objectives. The aim is to achieve more and better strategic capacity where it matters – through targeted funding programmes4, and making use of the InvestEU guarantee and of structural and rural development funds5. This public funding has to be used to leverage private investment, because only together can we plug the investment gaps. The Capital Markets Union will facilitate the access of innovative and high-tech companies to market-based financing across the whole EU. We therefore need to ensure there is a broad array of private and public equity available to finance digital innovation. Europe needs to invest in connectivity, deep tech and human capital, as well as in smart energy and transport infrastructures. For digital infrastructure and networks alone, the EU has an investment gap of EUR 65 billion per year.6 Implementing reforms and stepping up investments in Research and Development and technological deployment could yield 14% of cumulative additional GDP growth by 2030. Acting quickly (for example by stepping up investments and adopting measures by 2022 rather than by 2025) would bring an additional 1 Supercomputing, quantum technologies, blockchain and secure, pan-European cloud capacities 2 Commission Communication “Connectivity for a Competitive Digital Single Market - Towards a European Gigabit Society”, COM/2016/0587 final. 3 These objectives require for all European households, rural or urban, an internet connectivity of at least "100 Mbps, upgradable to Gigabit speed". This reflects the Commission’s expectation that, as the decade progresses, households will increasingly need 1 Gbps. This is in line with the Commission’s observation of exponentially growing network capacity demands and the need to ensure sustainable investments into networks capable of offering symmetric (i.e. upload and download) Gigabit speeds to cater for the European data economy beyond 2025. All main socio-economic drivers, such as schools, hospitals, businesses should already benefit from Gigabit connectivity with equally fast upload and download speeds at the latest by 2025. 4 The Digital Europe Programme (DEP), Connecting Europe Facility (CEF 2), Horizon Europe, the Space Programme. 5 ERDF, EARDF. 6 Restoring EU competitiveness, EIB 2016. The EIB Investment Report 2019/20, Accelerating Europe’s Transformation, confirms the large-scale public investment needed to support infrastructure digitalisation. 4 3.2% increase in GDP and positive job creation by 2030.7 This is a socio-economic boost that Europe cannot afford to miss. Investing in innovation is only part of the issue, however. A true digital transformation has to start from European citizens and businesses trusting that their applications and products are secure. The more interconnected we are, the more we are vulnerable to malicious cyber activity. To tackle this growing threat, we need to work together at every stage: setting consistent rules for companies and stronger mechanisms for proactive information-sharing; ensuring operational cooperation between Member States, and between the EU and Member States; building synergies between civilian cyber resilience and the law enforcement and defence dimensions of cybersecurity8; ensuring that law enforcement and judicial authorities can work effectively by developing new tools to use against cybercriminals; and last but by no means least, it means raising the awareness of EU citizens on cybersecurity9. Feeling safe and secure is not just a question of cybersecurity. Citizens need to be able to trust the technology itself, as well as the way in which it is used. This is particularly important when it comes to the issue of artificial intelligence. In this respect, the European Commission is presenting a White Paper on creating ecosystems of excellence and trust in the field of AI, based on European values. Improving education and skills is a key part of the overall vision for digital transformation in Europe. European companies need digitally savvy employees to thrive in the global technology-driven marketplace. In turn, workers need digital competences to succeed in an increasingly digitalised and fast changing labour market10. More women can and must have rewarding careers in tech, and European tech needs to benefit from women’s skills and competences. The need for digital skills goes well beyond the jobs market, however. As digital technologies permeate our professional and private lives, having at least basic digital literacy and skills has become a precondition for participating effectively in today's society. As more processes are automated, digitisation will lead to changes beyond the tech sector. Numerous occupations will be entirely transformed. The digital transition must be fair and just and encourage women to fully take part. Social partners have a crucial role to play in this context. At the same time, promoting innovation and technological diffusion are a prerequisite 7 Shaping the digital transformation, Study conducted for the European Commission, McKinsey Global Institute (to be published in Q2 2020). 8 The recently published EU toolbox for 5G security constitutes an important milestone as it puts in place a set of robust and comprehensive measures for an EU coordinated approach to secure 5G networks. 9 Enhancing cybersecurity will make a key contribution towards building a genuine and effective Security Union. 10 Over 90% of jobs already require at least basic digital skills, yet 43% of European citizens and over a third of the EU labour force lack them. 5 for a good quality of life, employment opportunities and to close existing participation gaps, notably in rural and remote areas suffering from population ageing and decline. New challenges are also emerging as regards working conditions. The growing number of online platforms has created new opportunities for people to earn income, enter or remain in the labour market. At the same time, it has raised new questions as regards legal protections for people who do not have a worker status yet who share some of the vulnerabilities of workers. The Commission will therefore propose an enhanced framework for platform workers. 6 Key actions - White Paper on Artificial Intelligence setting out options for a legislative framework for trustworthy AI (adopted together with this Communication), with a follow-up on safety, liability, fundamental rights and data (Q4 2020). - Building and deploying cutting-edge joint digital capacities in the areas of AI, cyber, super- and quantum computing, quantum communication and blockchain. European Strategies on Quantum and blockchain (Q2 2020) as well as a revised EuroHPC Regulation11 on supercomputing. - Accelerating investments in Europe’s Gigabit connectivity, through a revision of the Broadband Cost Reduction Directive12, an updated Action Plan on 5G and 6G, a new Radio Spectrum Policy Programme (2021). 5G corridors for connected and automated mobility, including railway corridors, will be rolled out (2021-2030) (2021-2023). - A European cybersecurity strategy, including the establishment of a joint Cybersecurity Unit, a Review of the Security of Network and Information Systems (NIS) Directive13 and giving a push to the single market for cybersecurity. - A Digital Education Action Plan to boost digital literacy and competences at all levels of education (Q2 2020). - A reinforced Skills Agenda to strengthen digital skills throughout society and a reinforced Youth Guarantee to put a strong focus on digital skills in early career transitions (Q2 2020). - Initiative to improve labour conditions of platform workers (2021). - A reinforced EU governments interoperability strategy to ensure coordination and common standards for secure and borderless public sector data flows and services. (2021) B. A fair and competitive economy In an ever-shrinking world where technology is gaining in importance, Europe needs to continue to act and decide independently and reduce over-reliance on digital solutions created elsewhere. For the development of many products and services, data needs to be widely and easily available, easily accessible, and simple to use and process. Data has become a key factor of production, and the value it creates has to be shared back with the entire society participating in providing the data. This is why we need to build a genuine European single market for data - a European data space based on European rules and values. 11 Council Regulation (EU) 2018/1488 of 28 September 2018. 12 Directive 2014/61/EU of the European Parliament and of the Council of 15 May 2014. 13 Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016. 7 Many European companies – and SMEs in particular – have been slow at taking up digital solutions, and therefore have not benefitted from them and missed opportunities to scale up. The Commission will seek to address this issue with a new EU Industrial Strategy that will set out actions to facilitate the transition towards a more digital, clean, circular and globally competitive EU industry. It will also include a strategy for SMEs, a vital part of the European economy, often hampered by lack of available skills, access to finance and markets. To start up and grow in Europe, SMEs need a frictionless single market, unhampered by diverging local or national regulations that increase administrative burdens for smaller companies in particular. They need clear and proportionate rules that are effectively and uniformly enforced across the EU, providing them with an immensely powerful home market from which to launch themselves on the world stage. In the digital age, ensuring a level playing field for businesses, big and small, is more important than ever. This suggests that rules applying offline – from competition and single market rules, consumer protection, to intellectual property, taxation and workers’ rights – should also apply online. Consumers need to be able to trust digital products and service just as much as they would any other. There is a need to pay attention to the most vulnerable consumers and to ensure the enforcement of safety laws, also in relation to goods originating from third countries. Some platforms have acquired significant scale, which effectively allows them to act as private gatekeepers to markets, customers and information. We must ensure that the systemic role of certain online platforms and the market power they acquire will not put in danger the fairness and openness of our markets. With specific respect to EU competition law, its foundations are as relevant for digital as for traditional industries. EU competition law serves Europe well by contributing to a level playing field where markets serve consumers. At the same time, it is important that the competition rules remain fit for a world that is changing fast, is increasingly digital and must become greener. With this in mind, the Commission is currently reflecting on the effectiveness of the way in which the current rules are applied, for example in relation to anti- trust remedies, and also conducting an evaluation and review of the rules themselves to ensure that they meet today’s digital and green challenges. Reviews are already underway of the rules governing horizontal and vertical agreements and of the market definition notice, as is a “fitness” check of various state aid guidelines. Among the key issues for Europe’s digital future are data access, pooling and sharing, and the balance between online and offline commerce. The review of the market definition notice will also take account of new digital business models - such as “free” services that users access while providing their data – and their implications for competitive constraints. The ongoing fitness check of the Commission’s 2014 Important Projects of Common European Interest (IPCEI) Communication is designed to assess whether an update is necessary to further clarify the 8 conditions under which major Member State-led projects in key, strategic sectors for the digital and green future of Europe can proceed effectively. The Commission is also planning to launch a sector inquiry with a strong focus on these new and emerging markets that are shaping our economy and society. However, competition policy alone cannot address all the systemic problems that may arise in the platform economy. Based on the single market logic, additional rules may be needed to ensure contestability, fairness and innovation and the possibility of market entry, as well as public interests that go beyond competition or economic considerations. Ensuring fairness in the digital economy is a major challenge. In the borderless digital world, a handful of companies with the largest market share get the bulk of the profits on the value that is created in a data-based economy. Those profits are often not taxed where they are generated as a result of outdated corporate tax rules, distorting competition. This is why the Commission will look to address the tax challenges arising from the digitisation of the economy. 9 Key actions - A European Data Strategy to make Europe a global leader in the data-agile economy (February 2020), announcing a legislative framework for data governance (Q4 2020) and a possible Data Act (2021). - Ongoing evaluation and review of the fitness of EU competition rules for the digital age (2020-2023), and launch of a sector inquiry (2020). - The Commission will further explore, in the context of the Digital Services Act package, ex ante rules to ensure that markets characterised by large platforms with significant network effects acting as gate-keepers, remain fair and contestable for innovators, businesses, and new market entrants. (Q4 2020). - - Propose an Industrial Strategy Package putting forward a range of actions to facilitate the transformation towards clean, circular, digital and globally competitive EU industries, including SMEs and the reinforcement of single market rules. - Create a framework to enable convenient, competitive and secure Digital Finance, including legislative proposals on crypto assets, and on digital operational and cyber resilience in the financial sector and a strategy towards an integrated EU payments market that supports pan- European digital payment services and solutions (Q3 2020); - Communication on Business Taxation for the 21st century, taking into account the progress made in the context of the Organisation for Economic Co-operation and Development (OECD) to address the tax challenges arising from the digitisation of the economy. - Delivering a new Consumer Agenda, which will empower consumers to make informed choices and play an active role in the digital transformation (Q4 2020). C. An open, democratic and sustainable society People are entitled to technology that they can trust. What is illegal offline must also be illegal online. While we cannot predict the future of digital technology, European values and ethical rules and social and environmental norms must apply also in the digital space. In recent years, Europe has led the way towards an open, fair, inclusive and people-centric internet with its standard-setting General Data Protection Regulation and its rules for platform-to-business cooperation. In order to protect European democracies and the values underpinning them, the Commission will continue to develop and implement innovative and proportionate rules for a trustworthy digital society. Such a digital society should be fully inclusive, fair and accessible for all. 10 In this context, it is essential that the rules applicable to digital services across the EU are strengthened and modernised, clarifying the roles and responsibilities of online platforms. The sale of illicit, dangerous or counterfeit goods, and dissemination of illegal content must be tackled as effectively online as it is offline. Trust in the online world also means helping consumers take greater control of and responsibility for their own data and identity. Clearer rules on the transparency, behaviour and accountability of those who act as gatekeepers to information and data flows are needed, as is effective enforcement of existing rules. People should also be able to control their online identity, when authentication is needed to access certain online services. A universally accepted public electronic identity (eID) is necessary for consumers to have access to their data and securely use the products and services they want without having to use unrelated platforms to do so and unnecessarily sharing personal data with them. Europeans can also benefit from use of data to improve public as well as private decision-making. In a world where much of the public debate and political advertising has moved online, we must also be prepared to act to forcefully defend our democracies. Citizens want meaningful answers to attempted manipulations of the information space, often in the form of targeted and coordinated disinformation campaigns. Europe needs greater transparency on the ways in which information is shared and managed on the internet. Trustworthy quality media is key for democracy as well as for cultural diversity. With these in mind, the Commission will present a European Democracy Action Plan and a specific action plan for the media and audiovisual sector. The digital component will also be key in reaching the ambitions of the European Green Deal14 and the Sustainable Development Goals15. As powerful enablers for the sustainability transition, digital solutions can advance the circular economy, support the decarbonisation of all sectors and reduce the environmental and social footprint of products placed on the EU market. For example, key sectors such as precision agriculture, transport and energy can benefit immensely from digital solutions in pursuing the ambitious sustainability objectives of the European Green Deal. Digital solutions, and data in particular, will also enable a fully integrated life-cycle approach, from design through sourcing of energy, raw materials and other inputs to final products until the end-of-life stage. For example, by tracking when and where electricity is most needed, we can increase energy efficiency and use fewer fossil fuels. 14 The European Green Deal, COM(2019) 640 final, 11 Dec. 2019: https://ec.europa.eu/info/sites/info/files/european-green-deal-communication_en.pdf 15 The Sustainable Development Goals (SDG) are a collection of 17 global goals designed to be a “blueprint to achieve a better and more sustainable future for all”. They were set by the UN General Assembly, as part of UN resolution 70/1, in 2015: https://www.un.org/sustainabledevelopment/sustainable-development-goals/. 11 Yet it is also clear that the ICT sector also needs to undergo its own green transformation. The environmental footprint of the sector is significant, estimated at 5-9% of the world's total electricity use and more than 2% of all emissions.16 Data centres and telecommunications will need to become more energy efficient, reuse waste energy, and use more renewable energy sources. They can and should become climate neutral by 2030. How ICT equipment is designed, bought, consumed and recycled also matters. Beyond the energy efficiency requirements of Ecodesign, ICT equipment must become fully circular - designed to last longer, to be properly maintained, to contain recycled material and to be easily dismantled and recycled. The power of data is essential also in the health sector. Digitised health records, gathered in a European health data space, can lead to better treatment for major chronic conditions, including cancer and rare diseases, but also to equal access to high quality health services for all citizens. Key actions - New and revised rules to deepen the Internal Market for Digital Services, by increasing and harmonising the responsibilities of online platforms and information service providers and reinforce the oversight over platforms’ content policies in the EU. (Q4 2020, as part of the Digital Services Act package). - Revision of eIDAS Regulation to improve its effectiveness, extend its benefits to the private sector and promote trusted digital identities for all Europeans (Q4 2020) - - Media and audiovisual Action Plan to support digital transformation and competitiveness of the audiovisual and media sector, to stimulate access to quality content and media pluralism (Q4 2020) - European Democracy Action Plan to improve the resilience of our democratic systems, support media pluralism and address the threats of external intervention in European elections (Q4 2020) - Destination Earth, initiative to develop a high precision digital model of Earth (a “Digital Twin of the Earth”) that would improve Europe’s environmental prediction and crisis management capabilities (Timing: from 2021). - A circular electronics initiative, mobilising existing and new instruments in line with the policy framework for sustainable products of the forthcoming circular economy action plan, 16 World Energy Forum: https://www.enerdata.net/publications/executive-briefing/expected-world-energy- consumption-increase-from-digitalization.html. 12 to ensure that devices are designed for durability, maintenance, dismantling, reuse and recycling and including a right to repair or upgrade to extend the lifecycle of electronic devices and to avoid premature obsolescence (2021). - Initiatives to achieve climate-neutral, highly energy-efficient and sustainable data centres by no later than 2030 and transparency measures for telecoms operators on their environmental footprint. - The promotion of electronic health records based on a common European exchange format to give European citizens secure access to and exchange of health data across the EU . A European health data space to improve safe and secure accessibility of health data allowing for targeted and faster research, diagnosis and treatment ( from 2022). 3. The international dimension – Europe as a global player The European model has proved to be an inspiration for many other partners around the world as they seek to address policy challenges, and this should be no different when it comes to digital. In geopolitical terms, the EU should leverage its regulatory power, reinforced industrial and technological capabilities, diplomatic strengths and external financial instruments to advance the European approach and shape global interactions. This includes the work done under association and trade agreements, as well as agreements reached in international bodies such the United Nations, the OECD, ISO and the G20, with the support of EU Member States. A strong digital presence in the EU’s enlargement, neighbourhood and development policy will enable growth and drive sustainable development, including the uptake of green ICT in partner countries and regions, in accordance with Europe’s commitment to the 2030 Agenda for Sustainable Development. The conclusions of the EU-African Union Digital Economy Task Force will underpin the support for the digital transformation in Africa, including the creation of a single African Digital Market as funding becomes available under the EU’s new Multiannual Financial Framework. Many countries around the world have aligned their own legislation with the EU’s strong data protection regime. Mirroring this success, the EU should actively promote its model of a safe and open global Internet. In terms of standards, our trading partners have joined the EU-led process that successfully set global standards for 5G and the Internet of Things. Europe must now lead in the adoption and standardisation process of the new generation of technology: blockchain, supercomputing, quantum technologies, algorithms and tools to allow data sharing and data usage.17 17 For example, the use of the EU eInvoicing standard in Australia, New Zealand and Singapore, has been a success, acting as a trade facilitator for EU businesses and is being considered for use at international level. 13 As regards trade and investment, the Commission will continue to address unjustified restrictions for European companies in third countries, such as data localisation requirements, and pursue ambitious goals in terms of market access, respect of intellectual property, research and development and standardisation programmes. The ongoing discussions about building a trustworthy data alliance with like-minded partners who share our values and high standards could enhance data flows and the pool of available high-quality data. The European Union is and will remain the most open region for trade and investment in the world, provided that anyone who comes to do business here accepts and respects our rules. The Commission will use all instruments at its disposal to ensure that everyone respects EU legislation and international rules to maintain a level playing field in the digital sector. It will also propose new rules where necessary, such as the ongoing work to develop a legal instrument to deal with the distortive effects of foreign subsidies in the internal market. A Global Digital Cooperation Strategy will put forward a European approach to the digital transformation that builds on our long and successful history of technology, innovation and ingenuity, vested in European values, including openness, and will project them onto the international stage and engage with our partners. It will also reflect the EU's work in Africa and elsewhere with respect to the Sustainable Development Goals, "Digital4Development" and capacity building. Europe is at the forefront in addressing manipulative interference in its information space and has developed important approaches and instruments. It will continue to work closely with its international partners, such as the G7, to find common approaches with a view to developing international norms and standards. Key actions - A Global Digital Cooperation Strategy (2021). - A White Paper on an instrument on foreign subsidies (Q2 2020). - A Digital for Development Hub that will build and consolidate a whole-of-EU approach promoting EU values and mobilising EU member states and EU industry, Civil Society Organisations (CSOs), financial institutions, expertise and technologies in digitisation. - A strategy for standardisation, which will allow for the deployment of interoperable technologies respecting Europe’s rules, and promote Europe’s approach and interests on the global stage (Q3 2020). - Mapping of opportunities and action plan to promote the European approach in bilateral relations and multilateral fora (Q2 2020). 14 4. Conclusion Digital technologies, as advanced as they may be, are just a tool. They cannot solve all of our problems. Yet they are making things possible which were unthinkable a generation ago. The success of Europe’s digital strategy will be measured in how well we are able to put these tools to work in delivering public goods to European citizens. The data-agile economy and its enormous transformative potential will affect all of us and Europe stands ready to make full use of the advantages it will bring. Yet for this digital transformation to be fully successful, we will need to create the right frameworks to ensure trustworthy technology and to give businesses the confidence, competences and means to digitalise. Coordination of efforts between the EU, Member States, regions, civil society and the private sector is key to achieving this and strengthening European digital leadership. Europe can own this digital transformation and set the global standards when it comes to technological development. More importantly still, it can do so while ensuring the inclusion and respect of every single human being. The digital transformation can only work if it works for all and not for only a few. It will be a truly European project – a digital society based on European values and European rules - that can truly inspire the rest of the world. 15
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