Vastutava töötleja luba

EESTI BIOEETIKA JA INIMUURINGUTE NÕUKOGU OTSUS 22. märtsil 2021 nr 1.1-12/186 Nõukogu koosseisus: Esimees: Liina Vahter – Tallinna Ülikool Aseesimees: Aime Keis – Tartu Ülikooli inimuuringute eetika komitee Teadussekretär: Aive Pevkur – Tallinna Tehnikaülikool Liikmed: Kristi Rüütel – Tervise Arengu Instituudi inimuuringute eetikakomitee Meego Remmel – Eesti Kirikute Nõukogu Agne Velthut-Meikas – Tallinna Tehnikaülikool Merike Sisask – Tallinna Ülikool Ingeri Luik-Tamme – TGS Baltic Advokaadibüroo Kristjan Kask – Tallinna Ülikool Pärt Peterson – Tartu Ülikool Kärt Salumaa-Lepik – Tallinna Tehnikaülikool Arutas 9. veebruaril 2021. a vastutava uurija Peeter Ross, Tallinna Tehnikaülikooli professori uuringu „Universaalse andmemudeli ja raviteekondade järjepidevuse standardi väljatöötamine lähtudes rahvusvahelistest uue põlvkonna terviseinfosüsteemide standarditest“ taotlust. Projekti põhieesmärgid tulenevad otseselt Health Sense projektis kokkulepitud eesmärkidest, mis on täpselt välja toodud projektilepingu lisas 1. Kitsamad uuringu eesmärgid on: 1. töötada välja ja piloteerida Uue Põlvkonna Eesti Tervise Infosüsteemi (UPTIS) jaoks uus e- tervise andmemudel, mis oleks universaalne ning ülekantav teistele suure-mahulistele digitaalsetele tervise infosüsteemidele; 2. töötada välja raviteekondade järjepidevuse standard, et tagada UPTIS-e semantiline koosvõime; 3. luua terminoloogia andmebaasi struktuur ning esitleda seda tervishoiutöötajatele. Taotletava projekti raames uuritakse soole ja vere mikrobioomi muutusi põletikuliste soolehaiguste (haavandiline koliit ja Crohni tõbi) patsientidel ning võrreldakse neid kontrollgrupiga, kes on valitud Eesti geenivaramu geenidoonorite seast. Uuringu põhieesmärgiks on leida uusi mikrobioomi põhiseid biomarkereid, mis võimaldaksid efektiivsemalt kaardistada kõrge haigusriskiga isikud ning hinnata, kas indiviidi unikaalne mikrobioomi koosseis mõjutab põletikuliste soolehaiguste puhul määratud bioloogilise ravi kulgu. Uuringu valim: kuni 10 000 patsiendi andmed. Andmeandja: Tervise Infosüsteem. Uuringu taotluse menetlusest taandasid ennast Maarja Kirss, Andmekaitse Inspektsioonist ning Maie Bachmann, Tallinna Tehnikaülikoolist. Otsus: anda luba uuringu läbiviimiseks. Uuringu läbi viimise lõpptähtaeg on 31. jaanuar 2023. Otsuse lahutamatud lisad on vastutava uurija Peeter Ross poolt 19. jaanuaril 2021 allkirjastatud uuringu taotlus koos selle lisadega ning 22. veebruaril 2021 allkirjastatud täiendatud taotlus koos vastustega nõukogu esitatud lisaküsimustele. /allkirjastatud digitaalselt/ Liina Vahter Eesti bioeetika ja inimuuringute nõukogu esimees  UURINGU EETILISE HINDAMISE TAOTLUS EESTI BIOEETIKA JA INIMUURINGUTE NÕUKOGULE 1. Uuringu nimetus (ingliskeelsete taotluse puhul tuleb uuringu nimetus ära tuua ka eesti keeles) Norra finatsmehhanismist kaasrahastatava programmi “Green ICT” projekti „Health Sense“ raames läbiviidav uuring: “ Universaalse andm e mudeli ja raviteekon dade järjepidevuse standard i väljatöötamine l ähtudes rahvusvahelistest uue põlvkonna terviseinfosüsteemide standarditest ” . 2. Uuringu põhieesmärk kuni 450 tähemärki (0,25 lk) (ingliskeelsete taotluse puhul tuleb uuringu põhieesmärk ära tuua ka eesti keeles) Projekti põhi eesmärgid tulenevad otseselt Health Sense projektis kokkulepitud eesmärkidest , mis on täpselt välja toodud projektilepingus ( Lisa 1 „ Output 1.5 “ ) . Kitsamad uuringu eesmärgid on: t öötada välja ja piloteerida Uue P õlvkonna Eesti Tervise Infosüsteemi (UPTIS) jaoks uus e-tervise andmemudel , mis oleks universaalne ning ülekantav teistele suure-mahulistele digitaalsetele tervise infosüsteemidele ; t öötada välja r aviteekondade järjepidevuse standard, et tagada UPTIS-e semantiline koos võime ; l uua terminoloogia andmebaasi struktuur ning esitleda seda tervishoiutöötajatele. 3. Vastutava ( d ) uurija (d) ning tema (nende) kontaktandmed Eesnimi: Peeter Perekonnanimi: Ross Ametikoht: professor, E-meditsiini keskuse juh ataja (Lisa 2 – vastutava uurija CV ) Organisatsioon: Tallinna Tehnikaülikool Telefon: +372 5635 3460 e-post: p eeter. r [email protected] Skype: peeterross 4. Uuringu läbiviijad (lisada juurde vajalik arv ridu) Eesnimi: Janek Perekonnanimi: Metsallik Ametikoht: e-tervise ekspert Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Igor Perekonnanimi: Bossenko Ametikoht: doktorant-nooremteadur Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Kristian Perekonnanimi: Kankainen Ametikoht: doktorant-nooremteadur Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Gunnar Perekonnanimi: Piho Ametikoht: dotsent, programmijuht Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Toomas Perekonnanimi: Klementi Ametikoht: doktorant-nooremteadur Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Madis Perekonnanimi: Tiik Ametikoht: vanemlektor Organisatsioon: Tallinna Tehnikaülikool 5. Uuringu finantseerimine Finantseerimise allika d Norra finantsmehhanismist (2014-2021) kaas rahastatav programm i „Green ICT“ projekt „Health Sense“ Uuringu ü ldmaksumus (summa) 121 382, 5 € Uuritavale kompensatsiooni maksmine (jah, ei, põhjendus ja summa) Ei Uuritavate kindlustus (jah, ei, kindlustaja ja võimalusel kindlustaja poliis) Ei 6. Uuringu läbiviimise aeg (algus ja lõpp kuu ja aasta täpsusega) 01.02.2021 - 31.01.2023 7. Teave sama uuringu projekti varasema või samaaegse hindamise kohta (sh teistes riikides) Sama uuringu projekt pole varasemalt hinnatud ega samaaegsel hindamisel (sh teistes riikides). 8. Lühiülevaade siiani samal teemal tehtud uuringutest (kuni 900 tähemärki, 0,5 lk) Varasemalt samal teemal tehtud uuringu te hulka võib lugeda nii rahvusvahelisi kliiniliste andmemudelite ga seotud kui ka Eesti tervise infosüsteemi (TIS) andmekvaliteeti hindavaid uuringu i d. Näiteks Austria OntoHealth projektis seoti kliinilised andmed tegevustega diabeedi raviteekonnal , ent erinevalt käesolevast projektis t , ei seotud selle raames modelleeritud formaalset mudelit ravi järjepidevuse standardiga ISO13940 ( 1) . Samuti on tehtud uuringuid, mis keskenduvad detailsetele kliinilistele mudelitele – tehnoloogiavabadele, kontseptuaalsetele andmemudelitele, mis seovad informatsiooni ja äri perspektiive. Detailsed kliinilised mudelid seovad nii andmete infot (näiteks HL7 või ope n EHR), konteksti ( ISO13940 ) kui ka termi noloogiat (näiteks S NOMED-CT ) (2 ,3 ) . TIS-i andmete kvaliteeti hindavatest uuringutest on selgunud, et kui gi osa andmetest kogutakse struktureeritud kujul vastavalt ettenähtud standardile, on suur hulk andmetest esitatud vabateksti na või mitte nõutavas vormis (4) . Muuhulgas on hinnatud näiteks hambaravi andmete olemasolu TIS-s, võrreldud TIS-i ja Tervise Arengu Instituudi andmeid päevaravi- ja haiglaravi osutamisel ning hinnatud TIS-i andmete kvaliteeti ja kasutatavust ooteaegade analüüsimiseks (5,6,7). 9. Planeeritava uuringu põhjendus ning uurimisküsimused ja/või hüpoteesid (kuni 1800 tähemärki, 1 lk) Alates 2008. aastast on TIS -i andmete kogumisel kasutatud HL7 CDA andmevahetus e standar dit. TIS- s on d efineeritud 17 dokumenti, millest enamik on XML-formaadis . Samasid fakte (andmeelemente) on kogutud erinevatesse dokumentidesse ja erineva l viis i l , alustades vabatekstist kuni struktureeritud andmeelementideni välja . H etkel ei täida TIS- i kogutud andmed oma kogu potentsiaali - nende analüüsimine on töömahukas ja sekundaarne kasutamine tervishoiutöötajatele aeganõudev . TIS-i ja teiste andmekogude vahelist koosvõimet takistab ühtse terminoloogia puudumine. Hetke olukord ei vasta kaasaegsetele ootustele, mis eeldavad tervise infosüsteemilt tõenduspõhiseid otsustustugesid, tehisintellekti võimalus te kasutamist ning intuitiivsust. Hüpotees 1: D okumendipõhine andmeedastus ja andmete hoiustamine TIS-s ei võimalda kogutud andmeid kõigi l huvitatud osapoolte l ( kaasa arvatud tervishoiutöötaja d) efektiivse l t , maksimaalselt kasutada. Uus, faktipõhine andmemudel , võimalda b sisestada üht fakti ainult korra , kuid kasutada korduvalt erinevatel eesmärkidel ja erinevate osapoolte poolt . Hüpotees 2 : Hetkel ei toeta TIS raviteekondade järjepidevuse kontseptsiooni. Uue andmemudeli defineer imine võimaldab kirjeldada uu ed protsessid, milles iga eriala/haigusseisundi jaoks on kindlaksmääratud minimaalne andmekoosseis, mis võimaldab omakorda t õendusp õhiste ots ust e tegemist ja defineeritud tervise kokkuvõt ete loomist. Hüpotees 3 : Praegu ei toim u TIS- i ja teiste Eesti andmekogude (näiteks Eesti Haigekassa, Tervise Arengu Instituudi) ning teenuste (kaugmonitooringu seadmete andmed jne) vahel ootustele vastavat andmevahetust. Terminoloogia andmebaasi struktuuri loomine võimaldab tulevikus erinevate andmekogude ja teenuste koostoimimist. 10. Uurimismetoodika (kuni 1800 tähemärki, 1 lk) Andmemudeli loomiseks võrreldakse kolme raviteekonna puhul (insult, vähk, diabeet) hetkel TIS- i kogutavaid andmeid tegelike andmevajaduste vas tu erinevate osapoolte vaatest (tervishoiutöötaja, teadlane, tervishoiuorganisatsiooni juht, patsient, rahastaja, regulaator/poliitik) . Analüüsitavate andmete kogum defineeritakse eelmainitud haiguste puhul vastavalt WHO poolt 2018. aastal välja antud tervise indikaatorite nimekirjale ( TIS-i päringusse kaasa mise kriteeriumid ja täpne andmete koosseis - Lisa 3 ). Reaalsete TIS päringute põhjal analüüsitakse andmete o lemasolu, vastavust, ja ajakohasust tänases olukorras, et luua võrdlusbaas mu u datuste mõju hindamiseks. T egeliku andmevajaduse hindamiseks analüüsitakse varasemalt Eestis vastavate raviteekondade projektides (näiteks Eesti Haigekassa Insuldi juhtprojekt ) valminud sisendit ning tehakse vajadusel täiendavaid ekspertintervjuusid erinevate raviteekonna osapooltega. Uue andmemudeli loomisel lähtutakse HL7 CDA asemel HL7 FHIR andmevahetuse standardist ning raviteekonna järjepidevuse arendamisel ContSys/ISO13 940 standardist. Terminoloogia andmebaasi struktuuri loomiseks lähtutakse rahvusvaheliselt tunnustatud taksonoomiatest ja standarditest: RHK-10, LOINC, SNOMED-CT, HL7, ISO, openEHR. 11. Uuritavate valim ja värbamise viisi kirjeldus. U uritavate informeerimise ja nõusoleku vormid, ankeetide, küsitluste ja testide vormid esitada taotluse lisadena . Valimi suurus ja kontrollgruppide olemasolu Valimiks on tervise infosüsteemist päritavad patsiendi andmed vastavalt Lisa 3 päringutele vahemikus 1. jaanuar – 31. detsember 2019. Kes värbab uuritavaid ja kuidas/kus/kelle poolt võetakse informeeritud nõusolek? (kui on asjakohane) Pole asjakohane . Uuritavate värbamist ei toimu. Andmebaasi päringutes kasutatakse ainult pseudonümiseeritud ja hägustatud andmeid. Kuidas ja kelle hulgast toimub uuritavate valik? Millised on uuritavate kaasamise või väljajätmise kriteeriumid? Uuritavate valik toimub vastavalt Lisa 3 päringutele Eesti tervise infosüsteemist (TIS) . Sekkumiste liik (füüsiline, vaimne või andmed, sh eriliiki isikuandmed) Sekkumine põhineb TIS -i tervise andmete analüüsil. Koormus uuritavale (kontaktivõtmise viisid, visiitide arv, u uringute tüüp ja arv, kutsete saatmise kordus jms) Pole asjakohane . 12. Uuringu eetiliste aspektide analüüs (3600 tähemärki, kuni 2 lk ) . Kõik uuringud, mille objektiks on inimesed, peavad olema läbi viidud, arvestades eetilisi nõudeid, eelkõige autonoomia austamise, hea teg emise ja kahju vältimise ning õigluse printsiipe. ( https://www.coe.int/en/web/bioethics/guide-for-research-ethics-committees-members ). vt ka https://www.etag.ee/wp-content/uploads/2020/01/Eetika_Tabel_EST_2020.pdf 12 a Inimesed Abik üsimus ed Ei Jah Kas uurimisobjektiks on inimesed ? Ei Kas uurimisobjektiks on haavatavad isikud või isikute grupid? Ei Kas uurimisobjektiks on isikud, kes ei saa ise anda teadlikku nõusolekut uuringus osalemiseks (sh piiratud teovõimega isikud)? Ei Kas uurimisobjektiks o n alaealised? Ei Kas uurimisobjektiks on patsiendid? Ei Kas uurimistöös kogutakse inimestelt bioloogilisi proove? Kas inimestelt võetud bioloogiliisi proove kavatsetakse eksportida kolmandasse riiki ( https://www.aki.ee/et/teenused-poordumisvormid/andmete-edastamine-valisriiki ) või importida neid teisest riigist Eestisse? Ei 12 b Isikuandmed Ei Jah Kas uurimistöö käigus kogutakse või analüüsitakse isikuandmeid , sh eriliiki isikuandmeid ? Uuringu käigus analüüsitakse TIS -s olevaid terviseandmeid (täpne andmete koosseis Lisa 3 ) . Töödeldavad andmed on asjakohased, sest ainult TIS-is olevate andmete analüüsimise põhjal saame anda hinnangu siiani kogutud andmete kvaliteedi kohta ja pakkuda välja uue andmemudeli. Andmesubjektid pole uuringu läbiviijale tuvastatavad. Kogu andmete töötlus (pseudonümiseerimine ja hägustamine) toimub andmehaldaja (TEHIK) poolt ning pseudonümiseeeritud andmete vastavustabelit isikukoodile uurijale ei edastata. Pseudonümiseerimisv õtit hoitakse TEHIK infosüsteemide haldusosakonnas analoogiliselt sertifikaatidega. Uurija saab krüpteeritult ainult pseudonümiseeritud ning hägustatud andmed. Kas uurimistöö hõlmab üksikisiku süsteemset jälgimist, tema andmeprofiili kogumist või töödeldakse suures ulatuses eriliiki ja/või tundlikke andmeid või kasutatakse (sekkuvaid) andmete töötlemise meetodeid varjatud viisil (nt elulemuse uuringud, jälgimine, järelevalve, audio ja video salvestamine, geo- positsioneerimine jne) või mistahes andmete töötlemise protsessi, mis võib kahjustab uuritavate õigusi ning vabadust? Ei Kas uurimistöös analüüsitakse eelnevalt kogutud isikuandmeid? Uurimistöös analüüsitakse eelnevalt kogutud isikuandmeid, mis pärinevad TIS - st. Uurija analüüsib vaid eelnevalt pseudonümiseeritud ja hägustatud andmeid ega saa ligipääsu pseudonümiseerimisv õtmele ehk uurijal pole võimalust isikute tuvastamiseks. Töötlemiseks on valitud vaid kindlad, WHO 2018. aasta tervise indikaatorite st t ulenevad andmed , mille analüüsimine on vajalik projekti eesmärkide täitmiseks . Täpne andmete koosseis - Lisa 3 . Kas uurimistöös analüüsitakse avalikult kättesaadavaid andmeid? Ei Kas kavatsetakse edastada isikuandmeid või võimaldada neile juurdepääs kolmandas t riiki dest ( https://www.aki.ee/et/teenused-poordumisvormid/andmete-edastamine-valisriiki )? Ei Kas uurimistöö lõppetes toimub isikuandmete hävitamine/ anonüümimine? Pärast uuringu lõppu ning projekti eesmärkide täitmist, hiljemalt 31.01.2023: hävitatakse TalTech-le edastatud andmed TalTech Arvutusklastrist ; kustuta takse TEHIK -s isikukood-pseudonüüm vastav ustabe l, pseudonümiseerimisvõti . 12 c Teised eetilised küsimused Kas uurimistöö läbiviimine võib kaasa tuua eelpool kirjeldamata eetilisi riske? Kuna tegemist on andmete kvaliteeti uuriva projektiga, kus ei muudeta patsiendi diagnostika või raviga seotud tegevusi, siis täiend avaid eelpool kirjeldamata eetilisi riske p ole. 13. Täita, kui uuring põhineb andmekogu ja/või andmeallika andmetel. Andmekogu ja/või andmeallika nimetus Eesti t ervise i nfosüsteem (TIS) Isikuandmete töötlemise eesmärk Projekti “Health Sense” raames läbiviidava uuringu “Universaalse andmemudeli ja raviteekondade järjepidevuse standardi väljatöötamine lähtudes rahvusvahelistest uue põlvkonna terviseinfosüsteemide standarditest” eesmärkide täitmine Andmekoosseis ja periood, mille kohta andmed kogutakse L isa 3 14. Isikuandmete kaitse meetmete kirjeldus, sealhulgas andmete hoidmise, säilitamise, turvalisuse ja kustutamise kohta , sh andmete ja/või koodivõtme kustutamise kuupäev (kuni 1800 tähemärki , 1 lk). Kirjeldada ja põhjendada uuringu vajaduseks kogutud andmete säilitamist ja tähtaega . A ndmeid säilitatakse TalTech Arvutusklastris uuringu eesmärkide täitmiseks uuringu lõpuni (31.01.2023). Kirjeldada isikuandmete pseudonüümimise protsessi ja vahend eid . TEHIK edas t ab uurijale pseudonümiseeritud ja hägustatud andmed. Pseudonüümimise l kaotatakse andmetest isikukood, isiku nimed , dokumendinumbrid ning asendatakse isikukohase pseudonüümimiskoodiga . Hägustamisel muudetakse isikut kaudselt tuvastada võimaldavate andmete (aadress, sünniaeg harvikhaigused ja –ravimid) täpsust. Aadress hägustatakse asula tasemele , s ünniaeg sünniaasta tasemele. Harvikhaiguste ja -ravimite kood asendatakse koodiga „<?>“ ja nimetus sõnaga “<harvikhaigus>“ või “<harvikravim>” . Kui andmevalimi moodustamise käigus leitakse veel isikule viitavaid andmeelemente , kasutatakase samuti hägustamist. Kas toimub isikuandmete transporti mine ning kirjeldada, kuidas on tagatud andmete turvalisus. TEHIK krüpteerib andmevalimi salajase parooliga , mis krüpteeritakse DigiDoc abil TalTech vastutava uurija isikukoodile ning koostab andmete väljastusprotokolli . K rüpteeritud parool ja väljastusprotokoll saadetakse vastutava uurija e-mailile. TEHIK säilitab isikukood-pseudonüüm vastavustabeli järgnevateks andmeväljastusteks kuni 31.01.2023. Seda v astavustabelit uurijale ei edastata. Krüpteeritud terviseandmed edastatakse SFTP kaudu TalTech Arvutusklastrisse , kasutades SFTP ühenduse jaoks uuri jate antud I P-aadressi, kasutajanime ja parooli. Kirjeldada, kuidas on andmed kaitstud loata või ebaseadusliku töötlemise eest. Uuringu ajal hoitakse andmeid TalTech Arvutusklastris ning pole selle raames kättesaadavad kõrvalistele isikutele. Tundlike andmete puhul kasutatakse täiendavaid turvameetmeid - andmete krüpteerimist ja protsesside pidevat monitooringut. Kõik meeskonnaliikmed on allkirjastanud konfidentsiaalsuslepingu ja informeeritud andmetele kohanduvatest andmekaitse nõuetest . Iga uurija saab ligi ainult andmet e le , mis konkreetselt tema tööks vajalik ud on. Kõik uurijad ei pääse ligi kõikidele andmetele. Andmete täpse koosseisu otsustab projekti juht , kaasates selleks asutuste vastutavaid esindajaid ning serverite administraatoreid TalTech Arvutusklastris . Kinnitan, et kõik uuringu läbiviijad on teadlikud projekti läbiviimisega kaasnevatest eetilistest ja isiku an dmete kaitsega kaasnevatest nõuetest. Vastutava uurija allkiri / digiallkiri / Taotluse esitamise k uupäev 19.01.2021 Ta o tluse EBIN ID (täidab hindaja) Lisadokumentide loetelu: L isa 1. Health Sense projekti leping Lisa 2. Vastutava uurija CV L isa 3 . Andmekoosseis Viited: Schweitzer, Marco & Alexander Hoerbst. 2017. An Approach for the Support of Semantic Workflows in Electronic Health Records. Studies in Health Technology and Informatics 235. 501–505 ISO/TS 13972:2015, https://www.iso.org/standard/62416.html Bernal, Juan G., Diego M. Lopez & Bernd Blobel. 2012. Architectural approach for semantic EHR systems development based on Detailed Clinical Models. Studies in Health Technology and Informatics 177. 164–169 “Feasibility study for the development of digital decision support systems for personalised medicine,” Tallinn University of Technology, Tallinn, 2015. Accessed: Sep. 13, 2020. [Online]. Available: https://www.sm.ee/sites/default/files/content-editors/eesmargid_ja_tegevused/Personaalmeditsiin/feasibility_study_for_the_development_of_digital_decision_support_systems_for_personalised_medicine.pdf H. Liivlaid, “Dental Care Data in the Health Information System,” National Institute for Health Development, Tallinn, 2019. Accessed: Sep. 11, 2020. [Online]. Available: https://intra.tai.ee//images/prints/documents/155800344725_Dental_Care_Data_in_the_HIS.pdf V. Kirpu and N. Eigo, “Comparison between the number of inpatient care and day care discharges on the basis of the data from Health Information System and National Institute for Health Development,” National Institute for Health Development, Tallinn, 2019. Accessed: Sep. 11, 2020. [Online]. Available: https://intra.tai.ee//images/prints/documents/155626766941_Comparison_of_inpatient_and_day_care_discharges_in_HIS_and_NIHD_data.pdf A.-L. Raid, “The Quality and Usability of Data in Estonian Health Information System for Analysing Waiting Times,” Unpublished Master’s Thesis, Tallinn University of Technology, Tallinn, 2017 EE-INNOVATION – Norwegian FM Programme Agreement Norwegian Financial Mechanism 2014-2021 PROGRAMME AGREEMENT between The Norwegian Ministry of Foreign Affairs and The Estonian State Shared Service Center (SSSC), hereinafter referred to as the “National Focal Point”, representing Estonia, hereinafter referred to as the “Beneficiary State” together hereinafter referred to as the “Parties” for the financing of the Programme “Competitiveness” hereinafter referred to as the “Programme” 1  EE-INNOVATION – Norwegian FM Programme Agreement Chapter 1 Article 1.4 Scope, Legal Framework, and Definitions Annexes and hierarchy of documents Article 1.1 1. Annexes attached hereto form an integral part of Scope this programme agreement. Any reference to this programme agreement includes a reference to its This programme agreement between the Norwegian annexes unless otherwise stated or clear from the Ministry of Foreign Affairs (hereinafter referred to context. as the NMFA) and the National Focal Point lays down the rights and obligations of the Parties 2. The provisions of the annexes shall be interpreted regarding the implementation of the Programme and in a manner consistent with this programme the financial contribution from the Norwegian agreement. Should the meaning of any provision of Financial Mechanism 2014-2021 to the Programme. the said annexes, so interpreted, remain inconsistent with this programme agreement, the provisions of the annexes shall prevail, provided that these Article 1.2 provisions are compatible with the Regulation. Legal Framework 3. Commitments, statements and guarantees, explicit 1. This programme agreement shall be read in as well as implicit, made in the preparation of the conjunction with the following documents which, programme are binding for the National Focal Point together with this programme agreement, constitute and the Programme Operator unless otherwise the legal framework of the Norwegian Financial explicitly stipulated in the annexes to this Mechanism 2014-2021: programme agreement. (a) Agreement between the Kingdom of Norway and the European Union on the Norwegian Financial Chapter 2 Mechanism 2014-2021 (hereinafter referred to as the The Programme Agreement);(b) the Regulation on the implementation of the Norwegian Financial Article 2.1 Mechanism 2014-2021 (hereinafter referred to as the Co-operation “Regulation”) issued by Norway in accordance with 1. The Parties shall take all appropriate and Article 10(5) of the Agreement; necessary measures to ensure fulfilment of the (c) the Memorandum of Understanding on the obligations and objectives arising out of this Implementation of the Norwegian Financial programme agreement. Mechanism 2014-2021 (hereinafter referred to as the 2. The Parties agree to provide all information “MoU”), entered into between Norway and the necessary for the good functioning of this Beneficiary State; and programme agreement and to apply the principles of (d) any guidelines adopted by the NMFA in implementation as set out in the Regulation. accordance with the Regulation. 3. The Parties shall promptly inform each other of 2. In case of an inconsistency between this any circumstances that interfere or threaten to programme agreement and the Regulation, the interfere with the successful implementation of the Regulation shall prevail. Programme. 3. The legal framework is binding for the Parties. An 4. In executing this programme agreement the act or omission by a Party to this programme Parties declare to counteract corrupt practices. agreement that is incompatible with the legal Further, they declare not to accept, either directly or framework constitutes a breach of this programme indirectly, any kind of offer, gift, payments or agreement by that Party. benefits which would or could be construed as illegal or corrupt practice. The Parties shall immediately inform each other of any indication of Article 1.3 corruption or misuse of resources related to this Definitions programme agreement. Terms used and institutions and documents referred to in this programme agreement shall be understood Article 2.2 in accordance with the Regulation, in particular Main responsibilities of the Parties Article 1.6 thereof, and the legal framework referred to in Article 1.2 of this programme agreement. 1. The National Focal Point is responsible and accountable for the overall management of the Norwegian Financial Mechanism 2014-2021 in the Beneficiary State and for the full and correct 2  EE-INNOVATION – Norwegian FM Programme Agreement implementation of this programme agreement. In agreement shall be interpreted in conjunction with particular, the National Focal Point undertakes to: the agreement regulating that support. (a) comply with its obligations stipulated in the 3. The financial plan annexed to this programme Regulation and this programme agreement; agreement shall: (b) ensure that the Certifying Authority, the Audit (a) contain a breakdown between the Programme’s Authority, the Irregularities Authority and the budget headings; Programme Operator properly perform the tasks (b) indicate the agreed advance payment, if any. assigned to them in the Regulation, this programme agreement and the programme implementation 4. The management cost of the Programme Operator agreement; shall not exceed the amount specified in this programme agreement. (c) take all necessary steps to ensure that the Programme Operator is fully committed and able to implement and manage the Programme; Article 2.5 (d) take the necessary measures to remedy Special conditions and programme specific rules irregularities in the implementation of the Programme and ensure that the Programme Operator 1. This programme agreement shall list any takes appropriate measures to remedy irregularities conditions set by the NMFA with reference to in Projects within the Programme, including paragraph 2 of Article 6.3 of the Regulation. The measures to recover misspent funds; National Focal Point shall ensure compliance with these conditions and take the necessary steps to (e) make all the necessary and appropriate ensure their fulfilment. arrangements in order to strengthen or change the way the Programme is managed. 2. The National Focal Point shall ensure compliance with any other programme specific rules laid down 2. The NMFA shall, subject to the rules stipulated in in this programme agreement. the legal framework referred to in Article 1.2 of this programme agreement, make available to the Beneficiary State a financial contribution Article 2.6 (hereinafter referred to as “the programme grant”) to Programme implementation agreement be used exclusively to finance the eligible cost of the Programme. With reference to Article 6.8 of the Regulation and without prejudice to paragraph 2 thereof, the National Focal Point shall, before any payment is Article 2.3 made to the Programme, sign a programme Objective and outcomes of the Programme implementation agreement with the Programme Operator. The National Focal Point shall notify the 1. This programme agreement sets out the objective, NMFA of such signing. outcome(s), outputs, indicators and targets for the Programme. 2. The National Focal Point shall ensure that the Article 2.7 Programme Operator implements and completes the Reporting Programme in accordance with the objective, The National Focal Point shall ensure that the outcome(s), outputs, indicators and targets set for Programme Operator provides financial reports, the Programme. annual programme reports and a final programme report in accordance with Chapter 9 and Articles 6.11 and 6.12 of the Regulation as well as statistical reporting in accordance with guidelines adopted by the NMFA. Article 2.4 Programme grant Article 2.8 External monitoring 1. The maximum amount of the programme grant, the programme grant rate, and the estimated eligible The external monitoring and audit referred to in cost of the Programme shall be as specified in this Articles 11.1, 11.2, 11.3 and 11.4 of the Regulation programme agreement. shall not in any way relieve the National Focal Point or the Programme Operator of their obligations 2. In case the Programme is also supported by the under the legal framework regarding monitoring of EEA Financial Mechanism, this programme 3  EE-INNOVATION – Norwegian FM Programme Agreement the Programme and/or its projects, financial control Telephone: +32 (0)2 286 1701 and audit. Telefax (general): +32 (0)2 211 1889 E-mail: [email protected] 3. Changes of or corrections to the contact Article 2.9 information referred to in this article shall be given Modification of the Programme in writing without undue delay by the Parties to this 1. Unless otherwise explicitly stipulated in this programme agreement. programme agreement, any modification of the Programme is subject to prior approval by the NMFA. Article 2.12 Representations and Warranties 2. Programme specific exceptions from paragraph 1, if any, are set in the annexes to this programme 1. This programme agreement and the awarding of agreement. the programme grant is based on information provided by, through, or on behalf of the National 3. Expenditures incurred in breach of this article are Focal Point to the NMFA prior to the signing of this not eligible. programme agreement. 4. Should there be a doubt as to whether the 2. The National Focal Point represents and warrants proposed modifications require approval by the that the information provided by, through, or on NMFA, the National Focal Point shall consult the behalf of the National Focal Point, in connection NMFA before such modifications take effect. with the implementation or conclusion of this 5. Requests for modifications shall be submitted and programme agreement are authentic, accurate and assessed in accordance with Article 6.9 of the complete. Regulation. Chapter 3 Article 2.10 Projects Communication Article 3.1 1. All communication to the NMFA regarding this Selection of projects and award of grants programme agreement shall take place in English and be directed to the Financial Mechanism Office 1. The National Focal Point shall ensure that the (hereinafter referred to as the FMO), which Programme Operator selects projects in accordance represents the NMFA towards the National Focal with Chapter 7 of the Regulation and this Point and the Programme Operator in relation to the programme agreement. implementation of the Programme. 2. Eligibility of project promoters and project 2. To the extent that original documents are not partners is stipulated in Article 7.2 of the Regulation available in the English language, the documents and, in accordance with paragraph 4 thereof, subject shall be accompanied by full and accurate only to the limitations stipulated in this programme translations into English. The National Focal Point agreement. shall bear the responsibility for the accuracy of the 3. Pre-defined projects shall be outlined in this translation that it provides and the possible programme agreement. consequences that might arise from any inaccurate translations. 4. The National Focal Point shall take proactive steps to ensure that the Programme Operator complies fully with Article 7.5 of the Regulation. Article 2.11 Contact information Article 3.2 1. The contact information of the Programme Project contract Operator is as specified in this programme agreement. 1. For each approved project a project contract shall be concluded between the Programme Operator and 2. The contact information for the NMFA and the the Project Promoter. Financial Mechanism Office are: 2. In cases where a project contract cannot, due to Financial Mechanism Office provisions in the national legislation, be made Att: Director between the Programme Operator and the Project EFTA Secretariat Promoter, the Beneficiary State may instead issue a Rue Joseph II, 12-16 legislative or administrative act of similar effect and 1000 Brussels content. 4  EE-INNOVATION – Norwegian FM Programme Agreement 3. The content and form or the project contract shall Regulation and fall within the categories and fulfil comply with Article 7.6 of the Regulation. the conditions of direct eligible expenditure set in Article 8.3 of the Regulation, the conditions 4. The National Focal Point shall ensure that the regarding the use of standard scales of unit costs set obligations of the Project Promoter under the project in Article 8.4 of the Regulation as well as indirect contract are valid and enforceable under the costs in accordance with Article 8.5 of the applicable law of the Beneficiary State. Regulation. 4. The first date of eligibility of expenditures in Article 3.3 projects shall be set in the project contract in Project partners and partnership agreements accordance with Article 8.13 of the Regulation. The first date of eligibility of any pre-defined projects 1. A project may be implemented in a partnership shall be no earlier than the date on which the between the Project Promoter and project partners as National Focal Point notifies the NMFA of a defined in paragraph 1(w) of Article 1.6 of the positive appraisal of the pre-defined projects by the Regulation. If a project is implemented in such a Programme Operator in accordance with paragraph partnership, the Project Promoter shall sign a 3 of Article 6.5 of the Regulation. partnership agreement with the project partners with the content and in the form stipulated in Article 7.7 5. The maximum eligible costs of the categories of the Regulation. referred to in paragraph 1 are set in this programme agreement. Programme specific rules on the 2. The partnership agreement shall be in English if eligibility of expenditure set in this programme one of the parties to the agreement is an entity from agreement shall be complied with. Norway. 3. The eligibility of expenditures incurred by a project partner is subject to the same limitations as Article 4.2 would apply if the expenditures were incurred by the Proof of expenditure Project Promoter. Costs incurred by Programme Operators, Project 4. The creation and implementation of the Promoters and project partners shall be supported by relationship between the Project Promoter and the documentary evidence as required in Article 8.12 of project partner shall comply with the applicable the Regulation. national and European Union law on public procurement as well as Article 8.15 of the Regulation. Article 4.3 Payments 5. The National Focal Point shall ensure that the Programme Operator verifies that the partnership 1. Payments to the Programme shall be made when agreement complies with this article. A draft all relevant conditions for payments stipulated in partnership agreement or letter of intent shall be this programme agreement and the Regulation have submitted to the Programme Operator before the been fulfilled. signing of the project contract. 2. Payments to the Programme shall take the form of an advance payment, interim payments and payment of the final balance and shall be made in accordance Chapter 4 with Articles 9.2, 9.3 and 9.4 of the Regulation. Finance 3. Payments of the project grant to the Project Article 4.1 Promoters may take the form of advance payments, Eligible expenditures interim payments and payments of the final balance. 1. Subject to Article 8.7 of the Regulation, eligible The level of advance payments and their off-set expenditures of this Programme are: mechanism is set in this programme agreement. (a) management costs of the Programme Operator in 4. The National Focal Point shall ensure that accordance with the detailed budget in the financial payments are transferred in accordance with plan; paragraph 2 of Article 9.1 of the Regulation. (b) payments to projects within this Programme in 5. Chapter 9 of the Regulation shall apply to all accordance with the Regulation, this programme aspects related to payments, including currency agreement and the project contract. exchange rules and handling of interests on bank accounts. 2. Eligible expenditures of projects are those actually incurred by the Project Promoter or project partners, meet the criteria set in Article 8.2 of the 5  EE-INNOVATION – Norwegian FM Programme Agreement Article 4.4 have the financial capacity to continue with the Transparency and availability of documents implementation of the Programme; or The National Focal Point shall ensure an audit trail (e) the Programme Operator has, in the opinion of for financial contributions from the Norwegian the NMFA, been engaged in corruption, fraud or Financial Mechanism 2014-2021 to the Programme similar activities or has not taken the appropriate in accordance with Article 9.8 of the Regulation. measures to detect or prevent such activities or, if they have occurred, nullify their effects. 2. This programme agreement can be terminated by Article 4.5 mutual agreement between the Parties. Irregularities, suspension and reimbursements 3. Termination does not affect the right of the Parties The NMFA has the right to make use of the remedies to make use of the dispute settlement mechanism provided in the Regulation, in particular Chapter 13 referred to in Article 5.1 or the right of the NMFA thereof. The National Focal Point has a duty to take to make use of the remedies provided in Chapter 13 all necessary measures to ensure that the provisions of the Regulation. in Chapter 12 and 13 of the Regulation regarding irregularities, suspension of payments, financial corrections and reimbursement are complied with. Article 5.3 Chapter 5 Waiver of responsibility Final provisions 1. Any appraisal of the Programme undertaken Article 5.1 before or after its approval by the NMFA, does not Dispute settlement in any way diminish the responsibility of the National Focal Point and the Programme Operator 1. The Parties waive their rights to bring any dispute to verify and confirm the correctness of the related to the programme agreement before any documents and information forming the basis of the national or international court, and agree to settle programme agreement. such a dispute in an amicable manner. 2. Nothing contained in the programme agreement 2. If a demand for reimbursement to the NMFA is shall be construed as imposing upon the NMFA or not complied with by the Beneficiary State, or a the FMO any responsibility of any kind for the dispute related to a demand for reimbursement arises supervision, execution, completion, or operation of that cannot be solved in accordance with paragraph the Programme or its projects. 1, the Parties may bring the dispute before Oslo Tingrett. 3. The NMFA does not assume any risk or responsibility whatsoever for any damages, injuries, or other possible adverse effects caused by the Article 5.2 Programme or its projects including, but not limited Termination to inconsistencies in the planning of the Programme or its projects, other project(s) that might affect it or 1. The NMFA may, after consultation with the that it might affect, or public discontent. It is the full National Focal Point, terminate this programme and sole responsibility of the National Focal Point agreement if: and the Programme Operator to satisfactorily (a) a general suspension decision according to address such issues. Article 13.6 of the Regulation or a decision to 4. Neither the National Focal Point, the Programme suspend payments according to paragraph 1(h) of Operator, entities involved in the implementation of Article 13.1 of the Regulation has not been lifted projects, nor any other party shall have recourse to within 6 months of such a decision; the NMFA for further financial support or assistance (b) a suspension of payments according to Article to the Programme in whatsoever form over and 13.1 of the Regulation, other than under paragraph above what has been provided for in the programme 1(h), has not been lifted within one year of such a agreement. decision; 5. Neither the European Free Trade Association, its (c) a request for reimbursement according to Article Secretariat, including the FMO, its officials or 13.2 of the Regulation has not been complied with employees, nor the NMFA, its officials or within one year from such a decision; employees, can be held liable for any damages or injuries of whatever nature sustained by the National (d) the Programme Operator becomes bankrupt, is Focal Point or the Beneficiary State, the Programme deemed to be insolvent, or declares that it does not Operator, Project Promoters or any other third 6  EE-INNOVATION – Norwegian FM Programme Agreement person, in connection, be it direct or indirect, with Article 5.4 this programme agreement. Entry into force and duration 6. Nothing in this programme agreement shall be 1. This programme agreement shall enter into force construed as a waiver of diplomatic immunities and on the date of the last signature of the Parties. privileges awarded to the European Free Trade 2. This programme agreement shall remain in force Association, its assets, officials or employees. until five years have elapsed after the date of the acceptance of the final programme report. ******** This programme agreement is drawn up in two originals in the English language. For the Donors For the National Focal Point Signed in Tallinn, Estonia on 26/04/2018 Signed in Tallinn, Estonia on 26/04/2018 ...................................................................... ...................................................................... Audun Halvorsen Jaak Aab State Secretary, Norwegian Ministry of Minister of Public Administration, Ministry of Finance Foreign Affairs of the Republic of Estonia 7  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Annex I to the Programme Agreement Programme Operators and Partners Ministry of Economic Affairs and Programme Operator: Communications Donor Programme Partner: Innovation Norway (IN) IPO: - Other Programme Partner(s): - Programme Increased value creation and sustainable growth Objective Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting Estimated annual CO2 Energy Annual Annually emissions reductions (tons of N/A audits, 0 N/A 25,000 number (APR) CO2 equivalent per year)1 energy bills Increased Estimated annual growth in Business Annually competitiveness turnover of supported N/A Percentage N/A N/A 5% report (APR) of Estonian enterprises2 companies Estimated annual growth in Business Annually within focus net operational profit of N/A Percentage N/A N/A 5% PA01 Outcome 1 report (APR) areas Green supported enterprises3 Industry Estimated annual decrease of Innovation, ICT Energy energy consumption of Annually and Welfare N/A Percentage audits, 0% N/A 5% supported enterprises (in (APR) Technology energy bills MWh)4 Attendance Number of Annually N/A Number sheets/ 0 N/A 10 products/services/processes (APR) registrations 1 CO2 emissions reductions will be verified by project promoter by performing independent audit or using other reliable method. 2 Definition of “turnover”: Enterprise’s net revenue for a fiscal year (after deduction of VAT, trade reductions and other indirect taxes). 3 Definition of “profit”: Difference between operating income and operating expenses. 4 Decrease of energy consumption will be verified by project promoter by performing independent energy audit or using other reliable method.  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting tested in the Open Cyber Range security platform5 Number of new products/services/processes Project Annually applied (new-to-the- N/A Number promoters 0 N/A 20 (APR) enterprise) (disaggregated by records sector) Copy of Number of registered application Annually applications for Intellectual N/A Number for 0 N/A 5 (APR) Property Protection registering IPR Semi- annually Employment Number of jobs created6 Gender, Age Number (APR and 0 N/A 100 contracts September IFR) Number of new Project products/services/processes Annually N/A Number promoters 0 N/A 25 developed (disaggregated by (APR) records sector)7 Enterprises Number of large enterprises Semi- Financing Output 1.1 supported to supported in SGS to prepare N/A Number annually 0 N/A 15 decisions develop or apply projects for main call8 (APR and 5 OCR is a virtual environment that is used for cybersecurity training and cyber technology development. Enterprises can test their products, services or processes against cyber threats in virtual testing environment to guarantee the real life security of products, services and processes. 6 The definition of a job created will follow the definition set out in the Core indicators guidance document: “All jobs (positions) supported or generated during programme implementation, irrespective of the duration and as a direct result of the EEA and Norway Grants support. Data on the job positions where the salary is not supported by the grants and the position is likely to continue after grant support has ended, i.e. the number of permanent jobs created – which will be a subset of the total number – may also be kept and reported if needed. 7 Definition of “developed”: Projects where the main activities are user driven R&D, i.e. validation or demonstration of technologies in relevant (industrial) environment, prototypes demonstrated in operational environment, system completed and qualified. With other words Technology Readiness Level (TRL) 5-8 (EU Commission’s scale used to describe the maturity of a technology). These types of projects will typically be cooperation between an enterprise and a research institution or similar. 8 Definition of “large enterprise”: The enterprise is considered large when it is characterized by at least one of the three elements mentioned above: employ more than 250 persons, has annual turnover which exceeds EUR 50 million, and/or an annual balance sheet total exceeding EUR 43 million.  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting innovative green September products, IFR) services and Semi- processes Number of large enterprises annually supported to apply new Financing N/A Number (APR and 0 N/A 5 green decisions September products/services/processes IFR) Semi- Number of SMEs supported annually Financing in SGS to prepare projects N/A Number (APR and 0 N/A 30 decisions for main call September IFR) Semi- Number of SMEs supported annually to apply new green Financing N/A Number (APR and 0 N/A 15 products/services/processes decisions September (new-to-the-enterprise)9 IFR) Semi- Number of SMEs supported annually Financing to develop new green N/A Number (APR and 0 N/A 5 decisions products/services/processes September IFR) Semi- Number of large enterprises annually supported to develop new Financing N/A Number (APR and 0 N/A 2 green decisions September products/services/processes IFR) Enterprises Semi- supported to Number of SMEs supported annually Financing Output 1.2 develop in SGS to prepare projects N/A Number (APR and 0 N/A 25 decisions innovative ICT for main call September products, IFR) 9 Definition of “SME-s”: SMEs are enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million.  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting services and Semi- processes Number of SMEs supported annually Financing to develop ICT products, N/A Number (APR and 0 N/A 8 decisions services and processes10 September IFR) Semi- Number of large enterprises annually Financing supported in SGS to prepare N/A Number (APR and 0 N/A 6 decisions projects for main call September IFR) Semi- Number of large enterprises annually supported to develop ICT Financing N/A Number (APR and 0 N/A 5 products, services and decisions September processes IFR) Semi- Number of large enterprises annually Financing supported in SGS to prepare N/A Number (APR and 0 N/A 2 decisions projects for main call September IFR) Copies of Enterprises contracts supported to signed with Semi- develop Project Number of enterprises annually Output 1.3 innovative Promoters; supported in SGS to prepare N/A Number (APR and 0 N/A 8 welfare products, Project projects for main call September services and Promoters’ IFR) processes reports, partnership agreements Number of SMEs supported Semi- to develop new welfare Financing N/A Number annually 0 N/A 5 technology decisions (APR and products/services/processes 10  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting September IFR) Semi- Number of SMEs supported Attendance annually to test new N/A Number sheets/ (APR and 0 N/A 15 products/services/processes registrations September Open Cyber in the Open Cyber Range IFR) Output 1.4 Range (OCR) is Semi- operational Attendance annually Number of professional staff Gender, Roma Number sheets/ (APR and 0 N/A 100 trained registrations September IFR) Data collection, and Semi- publishing environment To be annually architecture and data specified N/A Binary (APR and No 2019 Yes analysis environment with PDP September architecture developed and promoter IFR) published Semi- To be Data collection and annually specified publishing procedures/tools N/A Binary (APR and No 2019 Yes with PDP Health Sense in place and documented September promoter data IFR) management Semi- Output 1.5 To be platform Data analysis annually specified developed and procedures/tools in place and N/A Binary (APR and No 2019 Yes with PDP operating documented September promoter IFR) Semi- Number of data To be annually mining/Artificial Intelligence specified N/A Number (APR and 0 N/A 3 pilot projects successfully with PDP September finished promoter IFR) Semi- Number of professional staff Attendance Gender, Roma Number annually 0 N/A 10 trained sheets (APR and  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting September IFR) Level of satisfaction with the Survey Annually State type Scale 1-7 6.8611 2020 4.512 partnership results (APR) Level of trust between cooperating entities in Survey Annually State type Scale 1-7 6.6713 2020 4.514 Beneficiary States and results (APR) Donor States Enhanced Share of donor business collaboration partnerships which continue Survey Annually between N/A Percentage N/A N/A 50 %15 after project implementation results (APR) beneficiary and Bilateral Outcome period donor state entities involved Copy of in the Number of jointly registered application Bilateral Annually programme applications for Intellectual Donor State Number for 0 N/A 3 (APR) Property Protection registering IPR Share of cooperating organisations that apply the Survey Annually State type Percentage N/A N/A 5016 knowledge acquired from results (APR) bilateral partnership Semi- Bilateral Number of projects annually Financing Bilateral Output 1 partnerships involving cooperation with a Donor State Number (APR and 0 N/A 45 decisions supported donor project partner September IFR) 11 Survey carried out on behalf of the FMO 12 Target is ≥4.5, and an increase on the baseline value 13 Survey carried out on behalf of the FMO 14 Target is ≥4.5, and an increase on the baseline value 15 Target is minimum 50% 16 Target is minimum 50 %  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting Semi- Donor State, annually Number of staff from donor Attendance Gender, Type of Number (APR and 0 N/A 5 states in exchanges sheets exchange September IFR)  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Conditions General 1) The National Focal Point shall ensure that the Programme Operator, prior to signing a project contract for pre-defined project no. 1 “Open Cyber Range (OCR)” and no. 2 “Health Sense”, carries out an external and independent appraisal of the project, in order to verify its quality and contribution to the objectives of the Programme as well as compliance with EU and national legislation. Pre-eligibility 1) No costs shall be eligible under pre-defined project no. 1 “Open Cyber Range (OCR)” and no. 2 “Health Sense” before the detailed descriptions and budgets for these pre-defined projects have been submitted to and approved by the NMFA. Pre-payment 1) The Programme Operator shall submit the summary description of the procedure for the selection of projects to the NMFA for approval, prior to the publication of the small grant scheme and call for proposals foreseen under this programme. The programme agreement shall be amended accordingly. 2) The Programme Operator shall submit a communication plan for the programme to the NMFA for approval, prior to the publication of the small grant scheme and call for proposals foreseen under this programme. Pre-completion Not applicable Post-completion Not applicable Eligibility of costs - period First date Final date Eligibility of costs 10/05/2017 31/12/2024 Grant rate and co-financing Programme eligible expenditure (€) € 27,058,824 Programme grant rate (%) 85.00 % Maximum amount of Programme grant - EEA Financial Mechanism (€) - Maximum amount of Programme grant - Norwegian Financial Mechanism (€) € 23,000,000 Maximum amount of Programme grant - Total (€) € 23,000,000  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Norway Programme Programme co- Programme eligible Advance PA Budget Heading Total grant Grants grant rate financing expenditure payment Programme PA01 € 1,723,000 € 1,723,000 85.00 % € 304,059 € 2,027,059 n/a management Outcome 1 (Norway € PA01 € 21,277,000 85.00 % € 3,754,765 € 25,031,765 n/a Grants) 21,277,000 € Total € 23,000,000 85.00 % € 4,058,824 € 27,058,824 €0 23,000,000 Retention of management costs Retention of management costs - percentage of the management costs 10.00 % Retention of management costs - planned Euro value € 202,706  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II Competitiveness Operational rules (Annex II) 1. Programme summary This Annex sets out the operational rules for the programme. The programme agreement is based on the MoU, the concept note and comments made by the NMFA. Commitments, statements and guarantees, explicit as well as implicit, made in the concept note, are binding for the National Focal Point and the Programme Operator unless otherwise explicitly stipulated in the annexes to this programme agreement. The Programme Operator is the Ministry of Economic Affairs and Communications of Estonia. Certain tasks of the Programme Operator may be delegated to the Enterprise Estonia (EE), however this does not in any way reduce or restrict the responsibility of the Programme Operator. Innovation Norway (IN) shall act as Donor Programme Partner. The programme shall support the outcomes “Increased competitiveness of Estonian companies within focus areas Green Industry Innovation, ICT and Welfare Technology,” by way of one open call for proposals, one small grant scheme (SGS), and two pre-defined projects. The programme has three focus areas, Green Industry Innovation, ICT, and Welfare Technology. ICT can be a horizontal element across Green Industry Innovation and Welfare technology. The Programme targets 50% of funds to be allocated into Green Industry Innovation (through ICT- related projects) and ensures that minimum 75% of the funding goes to SMEs. 2. Eligibility 2.1 Eligible applicants: The rules on eligibility of applicants are set in Article 7.2 of the Regulation. In accordance with Article 7.2.4, the following entities shall be eligible: - For the open call and the small grant scheme, eligible applicants are companies registered in the Estonian Commercial Register, with no more than 25% public ownership. Eligible project partners are legal entities established in Estonia or in Norway. 2.2 Special rules on eligibility of costs: Costs are eligible in accordance with chapter 8 of the Regulation. 3. Bilateral relations 3.1 Bilateral relations The Programme shall contribute to strengthening bilateral relations between Estonia and Norway. The Programme shall as appropriate facilitate donor partnership projects by carrying out, inter alia, match-making events and activities in conjunction with launching calls for proposals, as well as by encouraging donor partnership projects in call texts. The further use of the funds for bilateral relations allocated to the programme shall be agreed in the Cooperation Committee. 4. Selection of projects and financial parameters 4.1 Open calls and availability of funds (including number of calls, duration of calls, and estimated size): Indicative Minimum/Maximum grant Outcome Modality Total available amount timing applied for 17  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II Increased Call for 2020 €18,871,549 competitiveness of proposals Estonian companies Green Industry Innovation: within focus areas Green Industry (Green Industry Innovation: €200,000 – €700,000 Innovation, ICT and €12,515,882) Welfare Technology ICT: (ICT: €1,930,667) €200,000 – €700,000 (Welfare Technology: €4,425,000) Welfare Technology: €200,000 – €1,250,000 Small Grant 2018 €828,451 €10,000 – €20,000 Scheme In case of unallocated funds following the call for proposals, an additional call for proposals may be launched. 4.2 Selection procedures: The project evaluation and award of grants shall be in accordance with Article 7.4 of the Regulation. The Programme Operator shall be responsible for the project evaluation and the award of grants. Small grant scheme: The small grant scheme will be administered by Enterprise Estonia. Enterprise Estonia shall review the applications received for compliance with the administrative and eligibility criteria. 18  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II Each application that meets the administrative and eligibility criteria shall be reviewed by two impartial experts appointed by Enterprise Estonia. The experts shall separately score the applications from 0-4, according to the selection criteria published with the call for proposals. For the purpose of ranking the applications, the average of the scores awarded by the experts shall be used. Applications receiving an average score of less than 2.50, or if the average score within one criterion is less than 2.00, shall be rejected. If the evaluation results with one expert scoring the application above and the other expert scoring the application below the thresholds, a third expert shall be commissioned by the Enterprise Estonia to score the application independently. In such cases, the average score of the two closest scores shall be used for the ranking of applications. A ranked list of the projects recommended for funding shall be prepared for the management board of Enterprise Estonia, which shall make the decision on which projects shall be supported. Open call for proposals: Enterprise Estonia shall review the applications received for compliance with the administrative and eligibility criteria. Each application that meets the administrative and eligibility criteria shall be reviewed by two impartial experts appointed by Enterprise Estonia. The experts shall separately score the applications from 0-4, according to the selection criteria published with the call for proposals. For the purpose of ranking the applications, the average of the scores awarded by the experts shall be used. Applications receiving an average score of less than 2.50, or if the average score within one criterion is less than 2.00, shall be rejected. If the evaluation results with one expert scoring the application above and the other expert scoring the application below the thresholds, a third expert shall be commissioned by the Enterprise Estonia to score the application independently. In such cases, the average score of the two closest scores shall be used for the ranking of applications. A ranked list of the projects recommended for funding shall be prepared for the Selection Committee’s decision. The Selection Committee shall be chaired by the Programme Operator and consist of representatives from the Programme Operator, Enterprise Estonia and the Donor Programme Partner. Additionally, a representative nominated by the Ministry of Social Affairs shall be part of the Selection Committee as a voting member when selecting projects to be funded under Welfare Technology. Additional representatives possessing the relevant expertise may also be invited to the meetings of the Selection Committee. The Selection Committee shall by consensus make its decision on which projects shall be funded. If consensus cannot be reached, the Programme Operator shall, as Chair of the Selection Committee, make the final decision on which projects shall be funded. The final ranking list of the projects to be funded shall be prepared for the management board of Enterprise Estonia, which shall formalise the decision of the Selection Committee. In justified cases, Enterprise Estonia may return the ranking list to the Selection Committee for renewed assessment prior to formalising the decision. 4.3 Project grant rate: Grants from the programme may be up to 75% of total eligible expenditure of the project. The grant rates for the pre-defined projects are set in section 5.1. The project grant rate shall in all cases be set at a level that complies with the State Aid rules in force and takes into account any and all other forms of public support granted to projects. Any remaining costs of the project shall be provided by the Project Promoter. 5. Additional mechanisms within the Programme 5.1 Pre-defined projects There will be two pre-defined projects implemented under the Programme: 19  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II 1) "Open Cyber Range (OCR)" Project Promoter: Estonian Ministry of Defence Donor project partner(s): Norwegian University for Science and Technology (NTNU) Other project partner(s): Tallinn University of Technology Total maximum eligible costs: € 3,331,765 Project grant rate: 100.00 % Maximum project grant amount: € 3,331,765 The project contributes to the programme outcome 1: “Increased competitiveness of Estonian companies within focus areas Green Industry Innovation, ICT and Welfare Technology”. Open Cyber Range is a virtual environment that is used for cybersecurity training and cybertechnology development. It provides tools that help strengthen the stability, security and performance of cyberinfrastructures and IT systems leading to secure and trustworthy products and well-educated personnel. The main objectives of this project are to create a platform for companies to develop, test and validate their innovative products, create a launch pad for new products to emerge to the market, promote security thinking in private sector and educate better workforce for the private companies. The project will create an environment for companies to test, experiment and validate newly developed products to meet the growing need for enhanced cybersecurity. Activities will include: creating a platform for (new) cybersecurity companies to develop, test and validate innovative products;  create a launch pad for new products to emerge to the market;  promote security thinking in private sector and  educate better workforce for the private companies. The platform will include tools and products that are not part of standard cloud service (automation tools, simulations, red and blue team tools, situational awareness, hybrid systems etc.). The SMEs that develop and test the products in OCR will be provided with a fast setup of testing and validation environment, reduced initial cost for the environment, and also support from academia and government, mentors and test-clients from other SMEs. 2) "Health Sense" Project Promoter: Ministry of Social Affairs - Estonia Donor project partner(s): Norwegian Directorate of Health (HDIR) Norwegian University for Science and Technology (NTNU) Other project partner(s): Health and Welfare Information Systems Center Tallinn University of Technology Tartu University Software Technology and Applications Competence Centre Total maximum eligible costs: € 2,000,000 Project grant rate: 100.00 % Maximum project grant amount: € 2,000,000 20  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II The project contributes to the programme Outcome 1: “Increased competitiveness of Estonian companies within focus areas Green Industry Innovation, ICT and Welfare Technology”. The aim of the project is to raise the availability of health and lifecycle data in order to enhance the creation of new products, services and solutions by the private sector, novel interventions by the public sector and relevant scientific knowledge by the R&D communities in order to raise life expectancy and prolong healthy life years of people. This will be done by developing a secure data storage, integration, access and analysis toolkit in order to provide large, complex and detailed sets of health and lifecycle data for the public sector, private sector and R&D institutions. Health Sense will be a virtual environment collecting health, health cycle and lifestyle data for research and service development purposes. In addition, it will provide a toolbox that enables the creation of data analysis-based solutions for prolonging a healthy human life. As the data handled in the environment is sensitive, the tools for safe collection, storage, access and processing of data are an essential part of the provided toolbox. All activities and outcomes of the project will be in line with the European General Data Protection Regulation (GDPR). 5.2 Financial Instruments Not applicable. 6. Programme Management 6.1 Payment flows The Programme Operator shall ensure that payments to projects are made in a timely manner. Payments of the project grant shall take the form of interim payments and a final payment. The interim payments shall be paid after the approval of project interim reports and final payments after the approval of project final report. The interim payments shall be paid within 1 month after the approval of project interim reports. Upon approval of the final project report a final balance payment, if applicable, shall be made within 1 month. The approval of project interim and final reports shall take place within 2 months from the submission of the required information. The periodicity of reporting periods, and deadlines for reporting will be further detailed in the description of the Programme Operator’s management and control systems. In case of euro-denominated contracts with entities from Donor States or with intergovernmental organizations, the Programme Operator shall transfer the amounts in euro. 6.2 Verification of payment claims The Programme Operator verifies that the expenditures declared by the project promoters have actually been incurred and complies with the Regulation, the Programme Agreement as well as applicable national and European Union law and that the financial contribution is used exclusively for the purpose of the programme and its projects and according to the Programme Agreement. Payments to projects are made on the basis of approved payment claims. Payment claim, submitted as integral part of the interim and final project reports, will be reviewed by the Programme Operator. Verification and approval of the payment claim will be based on information on incurred costs, financial status and project's progress described in reports, and on additional information to be submitted together with reports, if required by the Programme Operator. In line with point i) of Article 5.6.2 of the Regulation incurred expenditure reported shall be subject to administrative verifications before the report is approved. Verifications to be carried out shall cover 21  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II administrative, financial, technical and physical aspects of projects, as appropriate and be in accordance with the principle of proportionality. Additionally, in line with point ii) of Article 5.6.2 of the Regulation on–the-spot verifications of projects, which may be carried out on a sample basis, shall be carried out. The verification of costs will be based on sample methods taking into account results of the project implementation risk analysis. After approval of the payment claim the disbursement of the grant to the project promoter is made. The detailed procedure for verification of payment claims, periodicity of reporting periods, and deadlines for reporting will further be outlined in the description of the programme rules of procedure and Programme Operator’s management and control systems. 6.3 Monitoring and reporting The Programme Operator shall monitor, record and report on progress towards the programme’s outcomes in accordance with the provisions contained in the legal framework. The Programme Operator shall ensure that suitable and sufficient monitoring and reporting arrangements are made with the project promoters in order to enable the Programme Operator and the NFP to meet its obligations to the donors. When reporting on progress achieved in Annual and Final Programme Reports, the Programme Operator shall disaggregate results achieved as appropriate and in accordance with instructions and templates received from the FMO. 6.4 Programme administrative structures The programme is operated by the Estonian Ministry of Economic Affairs and Communications. Enterprise Estonia will act as the implementing agency and will be involved in the selection process as well as take on tasks related to verification of payments, payments to project promoters, monitoring of the projects and preparing the interim financial reports to be submitted to the Certifying Authority by the Programme Operator. Monitoring of financial management and budgeting will be followed by general state budget rules. The organisational structure of the Programme Operator shall ensure independence and functional separation of the division responsible for verification of incurred expenditure and approval of payments from other divisions responsible for the implementation of the programme. 7. Communication The Programme Operator shall comply with Article 3.3 of the Regulation, the Information and Communication Requirements in Annex 3 of the Regulation and the Communication plan for the programme. 8. Miscellaneous Not applicable. 22  CURRICULUM VITAE Isikuandmed Ees- ja perekonnanimi Peeter Ross Sünniaeg ja -koht 21.12.1966, Tallinn, Eesti Kontaktandmed Aadress Köömne 28-2, 10617 Tallinn, Eesti Telefon +372 56 353 460 E-mail [email protected] Peeter Ross on Tallinna Tehnikaülikooli (TTÜ) Tervisetehnoloogiate instituudi professor ja E-meditsiini keskuse juhataja. Peeter töötab ka Ida-Tallinna Keskhaiglas radioloogina ning on Maailmapanga, Saksa Arengupanga (KfW) ja Aasia Arengupanga e-tervise konsultant. Samuti on ta meditsiini infotehnoloogiaga tegeleva osaühingu SMIS International asutaja ja tegevjuht ning menetlusradioloogia õppevahendeid tootva ettevõtte SafeToAct OÜ asutaja. Professor Ross on varem töötanud Ida-Tallinna Keskhaigla juhatuse liikmena ning olnud Eesti Haigekassa ja Eesti E-Tervise Sihtasutuse nõukogu liige. Oma töös ja teadustegevuses on ta aktiivselt osalenud radioloogia, telemeditsiini ja tervishoiutehnoloogiate arendamisel ning e-tervise alases õppetöös. TTÜ-s on Peeter Ross olnud tervishoiutehnoloogia rahvusvahelise magistriõppekava üks loojaid ning juhendab ligi 10 aastat selle valdkonna magistritöid ja on tervishoiutehnoloogia lektor. Dr Ross on olnud teleradioloogia aluspanijaid Eestis, on olnud üks Eesti tervise infosüsteemi arendajaid ja tööle rakendajaid ning samuti osalenud arvukates rahvusvahelistes telemeditsiini ja e-tervise projektides (InterregPACS, Baltic eHealth, R-Bay, epSOS, Regional Telemedicine Forum, SUSTAINS, Momentum, eMedic, PrimCareIT). Professor Ross on olnud konsultant mitmete riikide e-tervise platvormide arendamisel (näit. Suurbritannia, Rootsi, Soome, Qatar, Bulgaaria, Moldaavia, Mongoolia, Leedu, Gruusia, Aserbaidžaan, Armeenia, Kirgiisia, Usbekistan, Saudi Araabia jt.). Ta on Eesti Radioloogia Ühingu endine president (2004-2010), Euroopa Radioloogia Ühingu ja Soome e-tervise ja Telemeditsiini Ühingu liige. Hariduskäik Õppeasutus (nimetus lõpetamise ajal) Lõpetamise aeg Haridus (eriala/kraad) Tallinna Tehnikaülikool 2011 Matemaatika- ja loodusteaduskond; Mehaanikateaduskond / PhD Healthcare engineering Tartu Ülikool 1996 Radioloogia ja onkoloogia osakond, Tartu Ülikool / Radioloog Tartu Riiklik Ülikool 1991 Arstiteaduskond / Arst Keeleoskus (alg-, kesk- või kõrgtase) Keel Tase Eesti Emakeel Inglise Kõrgtase Soome Kõrgtase Vene Kesktase Täiendusõpe Täiendusõppe nimetus Õppimise aeg Täiendusõppe läbiviija nimetus Visiting scolar 5-6/2013 Stanfordi Ülikool, California, USA European Health Leadership Program 1/2005 INSEAD, Prantsusmaa Course of Radiologic Pathology 2/1996-4/1996 Armed Forces Institute of Pathology, Washington DC, USA Residentuuri kursus 10/1995-12/1995 Radioloogia osakond, Oulu University, Soome Teenistuskäik Töötamise aeg Tööandja Ametikoht Alates 2010 Tallinna Tehnikaülikool Professor (alates 2015), vanemteadur, keskuse juhataja Alates 2013 Maailmapank Konsultant Alates 2019 Aasia Arengupank Konsultant Alates 2008 SMIS International OÜ Omanik, tegevjuht Alates 1996 Tallinna Keskhaigla / Ida-Tallinna Keskhaigla Radioloog 2006-2016 Tehnomeedikum, Tallinna Tehnikaülikool Nõukogu liige 2010-2016 Eesti E-Tervise Sihtasutus E-tervise ekspert 2004-2010 Ida-Tallinna Keskhaigla Juhatuse liige – arendusjuht 2005-2010 Eesti E-Tervise Sihtasutus Nõukogu liige 2002-2008 Eesti Haigekassa Nõukogu liige 2002-2004 Ida-Tallinna Keskhaigla Diagnostikakliiniku juhataja 1994-1996 Radioloogia ja onkoloogia osakond, Tartu Ülikool Resident 1992-1994 Meremeeste haigla Intern 1991 Helsingi Ülikooli sisehaiguste osakond Intern Õppetegevus Perearstide digitaalse kirjaoskuse suurendamise koolitus . Sihtgrupp : Perearstid . Koolituse periood : 2020-2022 Targa tellija koolitus - IT arenduste tellimise koolitus tervishoiuvaldkonna töötajatele . Sihtgrupp : Perearstid . Koolituse periood : 2019 SA Põhja-Eesti Regionaalhaigla „ Regionaalhaigla juhtide arendusprogramm “ . Sihtgrupp : Keskastme juhid . Koolituse periood : 2018-2019 IT- alane koolitus tervishoiu valdkonna töötajatele ja valdkondlike tarkavara rakenduse loojatele . Sihtgrupp : Tervishoiutöötajad /IT- arendajad . Koolituse periood : 2016-20 TTÜ Tervishoiutehnoloogia magistriprogramm . Sihtgrupp : Magistriüliõpilased . Koolituse periood : 2009-2020 Teadustegevus Elektroonsete tervishoiuteenuste kasutusele võtmise mõju tervishoius toimivatele diagnostika - ja raviprotsessidele Teadustöö põhisuunad. Jagatud töövoo rakendamist mõjutavate tegurite ja protsesside uurimine . Digitaalsete kliiniliste andmebaaside kasutamine haiguste varajase diagnoosimise algoritmide välja töötamiseks . Telemeditsiini rakenduste välja töötamine ja mõju hindamine . Meditsiinitekstide kui meditsiini allkeele uurimine . Publikatsioonid Sogomonjan , M.; Kerikmäe , T.; Ööpik , P.; Ross, P. (2019). A Report on the Survey. Attitudes of Estonian Healthcare Professionals to Internet-delivered Cognitive Behavioural Therapy. Cogent Psychology, 7 [forthcoming]. Koppel, T.; Ross, P.; Vilcane , I. (2018). Shielding static magnetic fields from Magnetic Resonance Imaging units by ferromagnetic material. EMBEC & NBC 2017: Joint Conference of the European Medical and Biological Engineering Conference (EMBEC) / Nordic-Baltic Conference on Biomedical Engineering and Medical Physics (NBC); Tampere, Finland; June 2017. Ed. Eskola , H; Vaisanen , O; Viik , J; Hyttinen , J. Springer-Verlag Singapore, 743−746. Metsallik , Janek ; Ross, Peeter ; Draheim , Dirk; Piho , Gunnar (2018). Ten years of the e-Health system in Estonia. MMHS : Proceedings of the 3rd International Workshop on (Meta)Modelling for Healthcare Systems Bergen, Norway, June 13th, 2018. Ed. Rutle , Adrian; Lamo , Yngve ; MacCaull , Wendy; Iovino, Ludovico. Aachen: RWTH Aachen University, 6−15. (CEUR Workshop Proceedings; 2336). Metsallik , Janek ; Ross, Peeter (2018). Das eHealth-System in Estland – Estonian Nation-wide Health Information System. Experience since 2008. Trill, Roland. Praxisbuch eHealth: Von der Idee zur Umsetzung (266−284). Stuttgart: Kohlhammer . Ross, Peeter (2018). Importance of data quality in nation-wide e-health system for personalized medicine decision support applications. Eesti Arst , 97 (Lisa 1): 7th Baltic Atherosclerosis Society Congress; Tallinn, Estonia; April 6-7, 2018. OÜ Celsius Healthcare, 31. Es s én , A; Isabella Scandurra , I; Gerrits , R; Humphrey, G; Johansen, MA; Kiergegaard , P; Koskinen, J; Liaw , S-T; Odeh, S; Ross, P; Ancker , JS. Patient access to electronic health records: Differences across ten countries. Health Policy and Technology (2017), https://doi.org/10.1016/j.hlpt.2017.11.003 Ross, P. E-Health Innovations in Estonia CARDIOLOGY Volume: 131, Supplement: 1. Pages: 14-14 , Meeting Abstract: O-17. Published: JUN 2015 Valdre , E.; Ross, P.; Tsepelina , K.; Veskis , K.; Vaino , T.; Kaalep , H.-J. (2014). Corpus-based analysis of abbreviations and abbreviating in Estonian radiology reports (In Estonian – Radioloogiauuringute vastuste lühendite ja lühendamise korpuslingvistiline analüüs ). Eesti Arst , 93(9), 502 - 512. Parv L, Kruus P, Mõtte K, Ross P. An evaluation of e-prescribing at a national level. Inform Health Soc Care, Early Online: 1–18, 2014. Informa UK Ltd. ISSN: 1753-8157 print / 1753-8165 online DOI: 10.3109/17538157.2014.948170 Ristolainen A, Ross P, Gavšin J, Semjonov E, Kruusmaa M. Economically affordable anatomical kidney phantom with calyxes for puncture and drainage training in interventional urology and radiology Acta Radiologica Short Reports June 2014 3: 2047981614534231, first published on June 13, 2014 doi:10.1177/2047981614534231 Ranschaert E, Bosmans J, Ross P, Dugar N, Schillebeeckx J, Mildenberger P, Ratib O. ESR white paper on teleradiology: an update from the teleradiology subgroup. Insights into Imaging 01/2014; DOI:10.1007/s13244-013-0307-z Lin L, Ross P, Kruusmaa M. Ultrasound image segmentation by Bhattacharyya distance with Rayleigh distribution. In Signal Processing: Algorithms, Architectures, Arrangements, and Applications (SPA), 2013, pp. 149-153. IEEE, 2013. de Lusignan S , Ross P , HYPERLINK "http://europepmc.org/search?page=1&query=AUTH:%22Seroussi+B%22" \h Seroussi B . A comparison of approaches to providing patients access to summary care records across old and new Europe: an exploration of facilitators and barriers to implementation. Studies in Health Technology and Informatics [2013, 192:397-401] Ross P, Mill R. Digital data sharing profiles in Healthcare ( HYPERLINK \h Digitaalsete dokumentide jagamise standardprofiilid tervishoius ). (2013). Eesti Arst 2013; 92(9):516–523 Ross P. Web-based access to personal health data : an overview of the usage of patient portals (In Estonian - Veebipõhine ligipääs isiklikele terviseandmetele: patsiendiportaalide kasutamise ülevaade ). Eesti Arst 2013; 92(3):145–151 Hunt A , Ristolainen A , Ross P , Opik R , Krumme A , Kruusmaa M . Low cost anatomically realistic renal biopsy phantoms for interventional radiology trainees. Eur J Radiol . 2013 Apr;82(4):594-600. doi : 10.1016/j.ejrad.2012.12.020. Epub 2013 Feb 8. Marko-Varga, G.; Végvári , Á.; Rezeli , M.; Prikk, K.; Ross , P.; Dahlbäck , M.; Edula , G.; Sepper , R.; Fehniger , T. (2012). Understanding Drug Uptake and Binding within Targeted Disease Micro-Environments in Patients : A New Tool for Translational Medicine . Clinical and Translational Medicine , 1( May ), 9 pp . Ross P. Regionaalse telemeditsiini foorum : Euroopa parimate telemeditsiiniteenuste analüüs ja näited (In Estonian). Eesti Arst 2012; 91(7):340–341 Parv L, Saluse J, Aaviksoo A, Tiik M, Sepper R, Ross P. Economic impact of a nationwide interoperable e- Health system using the PENG evaluation tool. Stud Health Technol Inform. 2012;180:876 -80. PMID: 22874318 Fehniger , T.E.; Végvári , A.; Rezeli , M.; Prikk, K; Ross , P.; Dahlbäck , M.; Edula , G.; Sepper , R.; Marko-Varga, G. (2011). Direct Demonstration of Tissue Uptake of an Inhaled Drug : Proof -of- Principle Study Using Matrix -Assisted Laser Desorption Ionization Mass Spectrometry Imaging. Anal Chem . 2011 Nov 1;83(21):8329-36. doi : 10.1021/ac2014349. Epub 2011 Oct 7. Sepper , R.; Ross , P.; Tiik, M. (2011). Nationwide health data management system : a novel approach for integrating biomarker measurements with comprehensive health records in large populations studies . Journal of Proteome Research , 10, 97 - 100. Lin Li, Peeter Ross, Maarja Kruusmaa , and Xiaosong Zheng. 2011. A comparative study of ultrasound image segmentation algorithms for segmenting kidney tumors. In Proceedings of the 4th International Symposium on Applied Sciences in Biomedical and Communication Technologies (ISABEL '11). ACM, New York, NY, USA , , Article 126 , 5 pages. DOI=10.1145/2093698.2093824 http://doi.acm.org/10.1145/2093698.2093824 Reilent , E.; Kuusik, A.; Lõõbas , I.; Ross , P. (2011). Improving the data compatibility of PHR and telecare solutions . In: 5th European Conference of the International Federation for Medical and Biological Engineering 14 - 18 September 2011, Budapest, Hungary : ( Eds .) Jobbágy , Á.. Springer , 2011, (IFMBE Proceedings ; 37), 925 - 928. Reilent , E.; Lõõbas , I.; Kuusik, A.; Parve, M.; Ross , P. (2011). Extendable Data Model for Universal Health Records . AMA-IEEE Medical Technology Conference , Boston, 16-18 October 2011. , 2011. [in press] Ross P, Pohjonen H. Images crossing borders : image and workflow sharing on multiple levels . Insights into Imaging, 2010, Vol 2, No 2 , 141-148 Tiik M, Ross P. Patient opportunities in the Estonian Electronic Health Record System . Stud Health Technol Inform. 2010;156:171 -7. Ross P, Sepper R, Pohjonen H. Cross-border teleradiology – experience from two international teleradiology projects. European Journal of Radiology 73 (2010) 20–25 Saluse J, Aaviksoo A, Ross P, Tiik M, Parv L, Sepper R, Pohjonen H, Jakovlev Ü, Enni K. Eesti terviseinfosüsteemi majandusmõju/puhastulu hindamine. TOF-DIGIMÕJU projekti lõpparuanne (Assessing the Net Benefits of the Estonian Electronic Health Record System). Eesti Arst 2010; 89(10):659−696 Teleradioloogia hetkeseis ja võimalused (In Estonian). Ross , P. (2008). Eesti Arst, 87, 731 - 732. Ross , P. (2008). Activities of the Estonian Society of Radiology . Eesti Arst, 87, 700 - 702. Comprehensive view of a medical case is provided for the professionals and patients by seamless integration of electronic health data and images . Ross , P.; Parve, M.; Luumann, T.; Siinmaa, P.; Valdre , E. (2008). Eesti Arst: Baltic Conference of Radiology 2008, Tartu 24.10.2008., 2008, (10), 720. Pohjonen , H.; Ross , P.; Blickman , J-H. (2008). Extending the radiological workplace across the borders . Gao , X. H.; Muller , H.; Loomes, M.; Comley , R.; Luo , S. ( Eds .). Medical Imaging and Informatics : 2nd International Conference , MIMI 2007, Beijing, China , August 14-16, 2007 Revised Selected Papers (12 - 17). Springer Pohjonen , H.; Ross , P.; Blickman , J.; Kamman , R. (2007). Pervasive access to images and data – The use of computing grids and mobile / wireless devices across healthcare enterprises . . IEEE Transactions on Information Technology in Biomedicine , 11, 81 - 86. Estonia leads the way in Baltic eHealth links. http://www.european-hospital.com/topics/article/995.html Andmekoosseis Päring 1 30-70 aasta vanused inimesed, kes on surnud mittenakkuslikesse haigustesse ajavahemikus 1. jaanuarist kuni 31. detsembrini 2019. aastal. RHK koodid: I00–I99, COO−C97, E10−E14 and J30−J98. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Enneaegne mittenakkuslikesse haigustesse suremus . Päring 2 Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud vereplasma glükoosisisaldus rohkem kui 7 mmol /l. Kõik normist kõrgemad glükoosisisalduse mõõtmiste väärtused. Sama valim, kellel on mõõdetud vere glük o hemoglobiini (Lühend B-HbA1c) sisaldust. Kõik glük o hemoglobiini mõõtmiste väärtused inimese lõikes aasta jooksul. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal diagnoositud diabeet, eraldi andmeveerus esmaselt diagnoositud diabeet. RHK koodid E10-E14. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): täiskasvanute kõrgenenud vere glükoosisisaldus / diabeet . Päring 3 Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud samal kuupäeval (± 1 nädal) kaal ja pikkus. Sama valim, kelle l on mõõdetud vööümbermõõt. Eraldi andmeveergudena kaal, pikkus, vööümbermõõt. Kõik aasta jooksul tehtud mõõtmised. Indikaator: Riskifaktorid (mittenakkuslikud haigused): Täiskasvanute ülekaalulisus ja rasvumin e . Päring 4. Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid füüsilise aktiivsuse kohta (näit. keskmise või kõrge intensiivsusega füüsiline koormus minutites ühes nädalas . Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Täiskasvanute ebapiisav füüsiline aktiivsus. Päring 5. Kõik inimesed alates 15. eluaastast, kelle kohta on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid tubakatoodete tarbimise kohta. Andmeveergudes sigarettide arv päevas ja suitsetatud aastate hulk. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Tubakatoodete tarbimine vanemate kui 15. aastaste hulgas. Päring 6. Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud kõrgenenud vererõhuväärtusi rahulolekus õlavarrelt ( s üstoolne vererõhk ≥ 140 mmHg ja diastoolne vererõhk ≥ 90 mmHg ). Kõik kõrgenenud vererõhuväärtused inimese kohta. Indikaator: Riskifaktorid (mittenakkuslikud haigused): Kõrgenenud vererõhk täiskasvanutel . Päring 7. Kõik inimesed, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal diagnoositud vähki. RHK koodid C00-C97. Eraldi ridadena vähi tüüp (RHK kood). Ainult patsiendid, kellel on antud ajavahemikus vähk diagnoositud esmakordselt. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Tervise staatus (haigestumus): Vähi esmashaigestumus tüübi järgi. Päring 8. Kõik inimesed alates 15. eluaastast, kelle kohta on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid alkoholi tarbimise kohta. Andmeveergudes aastas tarbitud alkoholi hulk liitrites (või alkoholiühikutes ehk 1 alkoholiühik on 10 g puhast alkoholi). Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Alkoholitoodete tarbimine vanemate kui 15. aastaste hulgas. Päring 9. Kõik naised vanuses 30-49 eluaastat, kes on 1. jaanuarist kuni 31. detsembrini 2019. aastal käinud emakakaelavähi sõeluuringul. Eraldi andmeveergudena vanus, elukoht (maakonna või valla/linna täpsusega). Kõik tervishoiuteenuse osutajad , kes on 1. jaanuarist kuni 31. detsembrini 2019. aastal läbi viinud emakakaelavähi sõeluuringuid. Ridades asutus, andmeveergudes sõeluuringul käinud naiste hulk. Indikaator: Teenusega kindlustamine (sõeluuringud ja ennetus): Emakakaelavähi sõeluuring . Päring 10 Juhuslikult valitud 90 patsienti vanuses 30-70 aastat, kellel on diagnoositud üks neist RHK10 koodiga I00–I99, C00−C97, E10−E14 kroonilisest haigusest (30 patsienti igast grupist). Patsiendi kõik andmed, mis on Tervise infosüsteemi saadetud ajavahemikus 1. jaanuarist kuni 31. detsembrini 2019. aastal. UURINGU EETILISE HINDAMISE TAOTLUS EESTI BIOEETIKA JA INIMUURINGUTE NÕUKOGULE 1. Uuringu nimetus (ingliskeelsete taotluse puhul tuleb uuringu nimetus ära tuua ka eesti keeles) Norra finatsmehhanismist kaasrahastatava programmi “Green ICT” projekti „Health Sense“ raames läbiviidav uuring: “ Universaalse andm e mudeli ja raviteekon dade järjepidevuse standard i väljatöötamine l ähtudes rahvusvahelistest uue põlvkonna terviseinfosüsteemide standarditest ” . 2. Uuringu põhieesmärk kuni 450 tähemärki (0,25 lk) (ingliskeelsete taotluse puhul tuleb uuringu põhieesmärk ära tuua ka eesti keeles) Projekti põhi eesmärgid tulenevad otseselt Health Sense projektis kokkulepitud eesmärkidest , mis on täpselt välja toodud projektilepingus ( Lisa 1 „ Output 1.5 “ ) . Kitsamad uuringu eesmärgid on: t öötada välja ja piloteerida Uue P õlvkonna Eesti Tervise Infosüsteemi (UPTIS) jaoks uus e-tervise andmemudel , mis oleks universaalne ning ülekantav teistele suure-mahulistele digitaalsetele tervise infosüsteemidele ; t öötada välja r aviteekondade järjepidevuse standard, et tagada UPTIS-e semantiline koos võime ; l uua terminoloogia andmebaasi struktuur ning esitleda seda tervishoiutöötajatele. 3. Vastutava ( d ) uurija (d) ning tema (nende) kontaktandmed Eesnimi: Peeter Perekonnanimi: Ross Ametikoht: professor, E-meditsiini keskuse juh ataja (Lisa 2 – vastutava uurija CV ) Organisatsioon: Tallinna Tehnikaülikool Telefon: +372 5635 3460 e-post: p eeter. r [email protected] Skype: peeterross 4. Uuringu läbiviijad (lisada juurde vajalik arv ridu) Eesnimi: Janek Perekonnanimi: Metsallik Ametikoht: e-tervise ekspert Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Igor Perekonnanimi: Bossenko Ametikoht: doktorant-nooremteadur Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Kristian Perekonnanimi: Kankainen Ametikoht: doktorant-nooremteadur Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Gunnar Perekonnanimi: Piho Ametikoht: dotsent, programmijuht Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Toomas Perekonnanimi: Klementi Ametikoht: doktorant-nooremteadur Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Madis Perekonnanimi: Tiik Ametikoht: vanemlektor Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Maarja-Liis Perekonnanimi: Elland Ametikoht: e-tervise analüütik Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Maarja Perekonnanimi: Kuslapuu Ametikoht: projekti assistent Organisatsioon: Tallinna Tehnikaülikool 5. Uuringu finantseerimine Finantseerimise allika d Norra finantsmehhanismist (2014-2021) kaas rahastatav programm i „Green ICT“ projekt „Health Sense“ Uuringu ü ldmaksumus (summa) 121 382, 5 € Uuritavale kompensatsiooni maksmine (jah, ei, põhjendus ja summa) Ei Uuritavate kindlustus (jah, ei, kindlustaja ja võimalusel kindlustaja poliis) Ei 6. Uuringu läbiviimise aeg (algus ja lõpp kuu ja aasta täpsusega) M ärts 2021 – jaanuar 2023 7. Teave sama uuringu projekti varasema või samaaegse hindamise kohta (sh teistes riikides) Sama uuringu projekt pole varasemalt hinnatud ega samaaegsel hindamisel (sh teistes riikides). 8. Lühiülevaade siiani samal teemal tehtud uuringutest (kuni 900 tähemärki, 0,5 lk) Varasemalt samal teemal tehtud uuringu te hulka võib lugeda nii rahvusvahelisi kliiniliste andmemudelite ga seotud kui ka Eesti tervise infosüsteemi (TIS) andmekvaliteeti hindavaid uuringu i d. Näiteks Austria OntoHealth projektis seoti kliinilised andmed tegevustega diabeedi raviteekonnal , ent erinevalt käesolevast projektis t , ei seotud selle raames modelleeritud formaalset mudelit ravi järjepidevuse standardiga ISO13940 ( 1) . Samuti on tehtud uuringuid, mis keskenduvad detailsetele kliinilistele mudelitele – tehnoloogiavabadele, kontseptuaalsetele andmemudelitele, mis seovad informatsiooni ja äri perspektiive. Detailsed kliinilised mudelid seovad nii andmete infot (näiteks HL7 või ope n EHR), konteksti ( ISO13940 ) kui ka termi noloogiat (näiteks S NOMED-CT ) (2 ,3 ) . TIS-i andmete kvaliteeti hindavatest uuringutest on selgunud, et kui gi osa andmetest kogutakse struktureeritud kujul vastavalt ettenähtud standardile, on suur hulk andmetest esitatud vabateksti na või mitte nõutavas vormis (4) . Muuhulgas on hinnatud näiteks hambaravi andmete olemasolu TIS-s, võrreldud TIS-i ja Tervise Arengu Instituudi andmeid päevaravi- ja haiglaravi osutamisel ning hinnatud TIS-i andmete kvaliteeti ja kasutatavust ooteaegade analüüsimiseks (5,6,7). 9. Planeeritava uuringu põhjendus ning uurimisküsimused ja/või hüpoteesid (kuni 1800 tähemärki, 1 lk) Alates 2008. aastast on TIS -i andmete kogumisel kasutatud HL7 CDA andmevahetus e standar dit. TIS- s on d efineeritud 17 dokumenti, millest enamik on XML-formaadis . Samasid fakte (andmeelemente) on kogutud erinevatesse dokumentidesse ja erineva l viis i l , alustades vabatekstist kuni struktureeritud andmeelementideni välja . H etkel ei täida TIS- i kogutud andmed oma kogu potentsiaali - nende analüüsimine on töömahukas ja sekundaarne kasutamine tervishoiutöötajatele aeganõudev . TIS-i ja teiste andmekogude vahelist koosvõimet takistab ühtse terminoloogia puudumine. Hetke olukord ei vasta kaasaegsetele ootustele, mis eeldavad tervise infosüsteemilt tõenduspõhiseid otsustustugesid, tehisintellekti võimalus te kasutamist ning intuitiivsust. Hüpotees 1: D okumendipõhine andmeedastus ja andmete hoiustamine TIS-s ei võimalda kogutud andmeid kõigi l huvitatud osapoolte l ( kaasa arvatud tervishoiutöötaja d) efektiivse l t , maksimaalselt kasutada. Uus, faktipõhine andmemudel , võimalda b sisestada üht fakti ainult korra , kuid kasutada korduvalt erinevatel eesmärkidel ja erinevate osapoolte poolt . Hüpotees 2 : Hetkel ei toeta TIS raviteekondade järjepidevuse kontseptsiooni. Uue andmemudeli defineer imine võimaldab kirjeldada uu ed protsessid, milles iga eriala/haigusseisundi jaoks on kindlaksmääratud minimaalne andmekoosseis, mis võimaldab omakorda t õendusp õhiste ots ust e tegemist ja defineeritud tervise kokkuvõt ete loomist. Hüpotees 3 : Praegu ei toim u TIS- i ja teiste Eesti andmekogude (näiteks Eesti Haigekassa, Tervise Arengu Instituudi) ning teenuste (kaugmonitooringu seadmete andmed jne) vahel ootustele vastavat andmevahetust. Terminoloogia andmebaasi struktuuri loomine võimaldab tulevikus erinevate andmekogude ja teenuste koostoimimist. 10. Uurimismetoodika (kuni 1800 tähemärki, 1 lk) Uuringu eesmärgi täitmiseks ehk uue põlvkonna tervise infosüsteemi jaoks uue andmemudeli, raviteekonna järjepidevuse standardi ja ühtse terminoloogia loomiseks tuleb esmalt hinnata, milliseid andmeid, kuidas ja kas hetkel TIS-i kogutakse. Antud infot kogutakse kolme raviteekonna näitel: insult, diabeet ja vähk. Hindamaks andmete kogumit, mida hetkel nendel raviteekondadel üldse kogutakse, päritakse I00–I99, COO−C97, E10−E14 haigusgrupi puhul juhuslikkuse alusel 90 inimese (30 inimest igas diagnoosigrupis) kõik 2019. aastal TIS-i saadetud andmed (Lisa 3, andmepäring 10). Lisaks sellele on valitud analüüsimiseks WHO poolt 2018. aastal välja antud tervise indikaatorite nimekirjast 9 indikaatorit, mille välja arvutamise võimalust praeguses süsteemis hindame (pidades indikaatorite jaoks vajalike andmete olemasolu TIS-s andmete kogumise kvaliteedinäitajaks) ning mis mõjutavad otseselt või kaudselt kas insuldi, vähi või diabeedi raviteekonda. Otseselt raviteekonda puudutavad indikaatorid on vererõhu väärtus (Lisa 3, päring 6), veresuhkru väärtus ja diabeedi diagnoos (Lisa 3, päring 2) ning vähki esmahaigestumus (Lisa 3, päring 7). Uue põlvkonna tervise infosüsteemi jaoks uuenduste loomisel peame aga arvestama sellega, et kaasaegsed ootused tervishoiusüsteemile ei piirdu vaid haiguste ravimisega, vaid ka ennetusega. Seega peame hindama andmete olemasolu nende haiguste riskifaktorite kohta laiemalt kui ainult nendes diagnoosigruppides. Kui tuleviku infosüsteemis pole võimalik tuvastada kõrge haigestumise riskiga inimesi, võib ka ennetustegevus kannatada. WHO indikaatorite hulgast on valitud analüüsimiseks andmete olemasolu järgmiste insuldi, diabeedi ja vähi riskifaktorite ja ennetustegevuste kohta: suitsetamine (Lisa 3, päring 5), alkoholitarbimine (Lisa 3, päring 8), ülekaal ja rasvumine (Lisa 3, päring 3), ebapiisav füüsiline aktiivusus (Lisa 3, päring 4) ning emakakaelavähi sõeluuring (Lisa 3, päring 9). Hindamaks enneaegset suremust mittenakkuslikesse haigustesse, on WHO välja töötanud indikaatori, mis sisaldab suremust neljas haigusgrupis: I00–I99, COO−C97, E10−E14 ja J30−J98. H indamaks, kas antud indikaatorit on võimalik TIS-i andmete põhjal hetkel välja arvutada, päritakse lisaks insuldi, vähi ja diabeedi suremuse andmetele ka krooniliste kopsuhaiguste diagnoosiga patsientide suremuse andmeid (Lisa 3, päring 1). Seega, r eaalsete TIS päringute põhjal analüüsitakse andmete o lemasolu, vastavust ja ajakohasust tänases olukorras, et luua võrdlusbaas mu u datuste mõju hindamiseks. T egeliku andmevajaduse hindamiseks analüüsitakse ka varasemalt Eestis vastavate raviteekondade projektides (näiteks Eesti Haigekassa Insuldi juhtprojekt ) valminud sisendit ning tehakse vajadusel täiendavaid ekspertintervjuusid erinevate raviteekonna osapooltega. Uue andmemudeli loomisel lähtutakse HL7 CDA asemel HL7 FHIR andmevahetuse standardist ning raviteekonna järjepidevuse arendamisel ContSys/ISO13 940 standardist. Terminoloogia andmebaasi struktuuri loomiseks lähtutakse rahvusvaheliselt tunnustatud taksonoomiatest ja standarditest: RHK-10, LOINC, SNOMED-CT, HL7, ISO, openEHR. 11. Uuritavate valim ja värbamise viisi kirjeldus. U uritavate informeerimise ja nõusoleku vormid, ankeetide, küsitluste ja testide vormid esitada taotluse lisadena . Valimi suurus ja kontrollgruppide olemasolu Valimiks on tervise infosüsteemist päritavad patsiendi andmed vastavalt Lisa s 3 välja toodud kümnele päringule vahemikus 1. jaanuar – 31. detsember 2019. Valimi suurus on ette teada ühe päringu (päring 10) puhul, kus kaasatakse päringusse 90 patsiendi andmed. Ülejäänud 9 andmepäringu puhul , mi lle aluseks on WHO tervise indikaatorid, on valimite suurused varieeruvad. Kuna pol e teada, kas ja kuidas kõik antud indikaatorite andmeid TIS-s kajastuvad, pole lõplik valimi suurus määratav , kuid suurusjärguks võime arvestada ligikaudu 10 000. Kes värbab uuritavaid ja kuidas/kus/kelle poolt võetakse informeeritud nõusolek? (kui on asjakohane) Uuritavate värbamist ei toimu. Andmesubjekti nõusolekuta tema kohta käivate andmete töötlemine teda tuvastada võimaldaval kujul on võimalik ( Isikuandmete kaitse seaduse § 6 lg 3 lähtuvalt) , kuna (1) pärast tuvastamist võimaldavate andmete ( näiteks diagnoos) eemaldamist ei oleks andmetöötluse eesmärgid enam saavutatavad , siiski on andme d pseudonümiseeritud ning lisameetmena isiku kaudset tuvastamist võimaldavad andmed (näiteks harvikhaigused ja –ravimid) hägustatud; (2) uue põlvkonna tervise infosüsteemi loomiseks on piisav avalik huvi, Eestis on riiklikul tasandil algatatud süsteemi väljatöötamist ning töös on mitmeid süsteemi loomist toetavaid projekte ; (3) töödeldavate isikuandmete põhjal ei muu tu kuidagi andmesubjekti kohustuste maht ega kahjustata muul viisil ülemäära andmesubjekti õigusi. Kuidas ja kelle hulgast toimub uuritavate valik? Millised on uuritavate kaasamise või väljajätmise kriteeriumid? Uuritavate valik toimub vastavalt Lisa 3 päringutele Eesti tervise infosüsteemist (TIS) . Sekkumiste liik (füüsiline, vaimne või andmed, sh eriliiki isikuandmed) Sekkumine põhineb TIS -i tervise andmete analüüsil. Koormus uuritavale (kontaktivõtmise viisid, visiitide arv, u uringute tüüp ja arv, kutsete saatmise kordus jms) Pole asjakohane . 12. Uuringu eetiliste aspektide analüüs (3600 tähemärki, kuni 2 lk ) . Kõik uuringud, mille objektiks on inimesed, peavad olema läbi viidud, arvestades eetilisi nõudeid, eelkõige autonoomia austamise, hea teg emise ja kahju vältimise ning õigluse printsiipe. ( https://www.coe.int/en/web/bioethics/guide-for-research-ethics-committees-members ). vt ka https://www.etag.ee/wp-content/uploads/2020/01/Eetika_Tabel_EST_2020.pdf 12 a Inimesed Abik üsimus ed Ei Jah Kas uurimisobjektiks on inimesed ? Jah , uurimisobjektiks on inimesed . Tegemist on andmekogu andmetel põhineva retrospektiivse uuringuga, mis välistab uurimisobjektide mistahes lubamatu mõjutamise uuringus osalemiseks. Kas uurimisobjektiks on haavatavad isikud või isikute grupid? Jah. Uuringu käigus uuritakse ka alaealisi isikuid vanuses 15+ eluaastat ehk uuring hõlmab ka 15-17 aastaseid inimesi. Kuna tegemist on andmekogu andmetel põhineva retrospektiivse uuringuga, lapsevanemate nõusolekut alaealiste kaasamiseks ei küsita ning lähtutakse ka siin antud taotluse punkt 11 väljatoodust (andmete töötlemist puudutav Isikandmete kaitse seadus § 6 lg 3 selgitus). Kas uurimisobjektiks on isikud, kes ei saa ise anda teadlikku nõusolekut uuringus osalemiseks (sh piiratud teovõimega isikud)? Ei Kas uurimisobjektiks o n alaealised? Jah. Uuringu käigus uuritakse ka isikuid vanuses 15 + eluaastat ehk uuring hõlmab ka 15-17 aastaseid inimesi . Antud vanusegrup i andmeid kasutatakse kahe TIS-i andmepäringu teostamiseks (Lisa 3, päring 5 ja 8). Alaealiste andmed on kaasatud, kuna need on vajalikud WHO tervise i n d ikaatorite korrektseks arvutamiseks. Tagamaks, et tulemused oleksid hiljem rahvusvaheliselt ja tuleviku-uuringutega võrreldavad, pole indikaatorite kriteeriumite osas uuringu disainimisel muudatusi tehtud. Kuna tegemist on andmekogu andmetel põhineva retrospektiivse uuringuga, lapsevanemate nõusolekut alaealiste kaasamiseks ei küsita ning lähtutakse ka siin antud taotluse punkt 11 välja toodust ( andmete töötlemist puudutav Isikandmete kaitse seadus § 6 lg 3 selgitus). Kas uurimisobjektiks on patsiendid? Jah. Uurimisobjektiks on I00-I99, C00-C97, E10-E14, J30-J98 diagnoosi saanud inimesed. Uuringusse kaasamise ja väljajätmise kriteeriumid (näiteks vanus) on kirjeldatud Lisas 3. Kas uurimistöös kogutakse inimestelt bioloogilisi proove? Kas inimestelt võetud bioloogiliisi proove kavatsetakse eksportida kolmandasse riiki ( https://www.aki.ee/et/teenused-poordumisvormid/andmete-edastamine-valisriiki ) või importida neid teisest riigist Eestisse? Ei 12 b Isikuandmed Ei Jah Kas uurimistöö käigus kogutakse või analüüsitakse isikuandmeid , sh eriliiki isikuandmeid ? Uuringu käigus analüüsitakse TIS -s olevaid terviseandmeid (täpne andmete koosseis Lisa 3 ) . Töödeldavad andmed on asjakohased, sest ainult TIS-is olevate andmete analüüsimise põhjal saame anda hinnangu siiani kogutud andmete kvaliteedi kohta ja pakkuda välja uue andmemudeli. Andmesubjektid pole uuringu läbiviijale tuvastatavad. Kogu andmete töötlus (pseudonümiseerimine ja hägustamine) toimub andmehaldaja (TEHIK) poolt ning pseudonümiseeeritud andmete vastavustabelit isikukoodile uurijale ei edastata. Pseudonümiseerimisv õtit hoitakse TEHIK infosüsteemide haldusosakonnas analoogiliselt sertifikaatidega. Uurija saab krüpteeritult ainult pseudonümiseeritud ning hägustatud andmed. Kas uurimistöö hõlmab üksikisiku süsteemset jälgimist, tema andmeprofiili kogumist või töödeldakse suures ulatuses eriliiki ja/või tundlikke andmeid või kasutatakse (sekkuvaid) andmete töötlemise meetodeid varjatud viisil (nt elulemuse uuringud, jälgimine, järelevalve, audio ja video salvestamine, geo- positsioneerimine jne) või mistahes andmete töötlemise protsessi, mis võib kahjustab uuritavate õigusi ning vabadust? Ei Kas uurimistöös analüüsitakse eelnevalt kogutud isikuandmeid? Uurimistöös analüüsitakse eelnevalt kogutud isikuandmeid, mis pärinevad TIS - st. Uurija analüüsib vaid eelnevalt pseudonümiseeritud ja hägustatud andmeid ega saa ligipääsu pseudonümiseerimisv õtmele ehk uurijal pole võimalust isikute tuvastamiseks. Töötlemiseks on valitud vaid kindlad, WHO 2018. aasta tervise indikaatorite st t ulenevad andmed , mille analüüsimine on vajalik projekti eesmärkide täitmiseks . Täpne andmete koosseis - Lisa 3 . Kas uurimistöös analüüsitakse avalikult kättesaadavaid andmeid? Ei Kas kavatsetakse edastada isikuandmeid või võimaldada neile juurdepääs kolmandas t riiki dest ( https://www.aki.ee/et/teenused-poordumisvormid/andmete-edastamine-valisriiki )? Ei Kas uurimistöö lõppetes toimub isikuandmete hävitamine/ anonüümimine? Pärast uuringu lõppu ning projekti eesmärkide täitmist, hiljemalt 31.01.2023: hävitatakse TalTech-le edastatud andmed TalTech Arvutusklastrist; kustuta takse TEHIK -s isikukood-pseudonüüm vastav ustabe l, pseudonümiseerimisvõti . 12 c Teised eetilised küsimused Kas uurimistöö läbiviimine võib kaasa tuua eelpool kirjeldamata eetilisi riske? Kuna tegemist on andmete kvaliteeti uuriva projektiga, kus ei muudeta patsiendi diagnostika või raviga seotud tegevusi, siis täiend avaid eelpool kirjeldamata eetilisi riske p ole. 13. Täita, kui uuring põhineb andmekogu ja/või andmeallika andmetel. Andmekogu ja/või andmeallika nimetus Eesti t ervise i nfosüsteem (TIS) Isikuandmete töötlemise eesmärk Projekti “Health Sense” raames läbiviidava uuringu “Universaalse andmemudeli ja raviteekondade järjepidevuse standardi väljatöötamine lähtudes rahvusvahelistest uue põlvkonna terviseinfosüsteemide standarditest” eesmärkide täitmine Andmekoosseis ja periood, mille kohta andmed kogutakse L isa 3 14. Isikuandmete kaitse meetmete kirjeldus, sealhulgas andmete hoidmise, säilitamise, turvalisuse ja kustutamise kohta , sh andmete ja/või koodivõtme kustutamise kuupäev (kuni 1800 tähemärki , 1 lk). Kirjeldada ja põhjendada uuringu vajaduseks kogutud andmete säilitamist ja tähtaega . A ndmeid säilitatakse TalTech Arvutusklastris uuringu eesmärkide täitmiseks uuringu lõpuni (31.01.2023). Kirjeldada isikuandmete pseudonüümimise protsessi ja vahend eid . TEHIK edas t ab uurijale pseudonümiseeritud ja hägustatud andmed. Pseudonüümimise l kaotatakse andmetest isikukood, isiku nimed , dokumendinumbrid ning asendatakse isikukohase pseudonüümimiskoodiga . Hägustamisel muudetakse isikut kaudselt tuvastada võimaldavate andmete (aadress, sünniaeg harvikhaigused ja –ravimid) täpsust. Aadress hägustatakse asula tasemele , s ünniaeg sünniaasta tasemele. Harvikhaiguste ja -ravimite kood asendatakse koodiga „<?>“ ja nimetus sõnaga “<harvikhaigus>“ või “<harvikravim>” . Kui andmevalimi moodustamise käigus leitakse veel isikule viitavaid andmeelemente , kasutatakase samuti hägustamist. Kas toimub isikuandmete transporti mine ning kirjeldada, kuidas on tagatud andmete turvalisus. TEHIK krüpteerib andmevalimi salajase parooliga , mis krüpteeritakse DigiDoc abil TalTech vastutava uurija isikukoodile ning koostab andmete väljastusprotokolli . K rüpteeritud parool ja väljastusprotokoll saadetakse vastutava uurija e-mailile. TEHIK säilitab isikukood-pseudonüüm vastavustabeli järgnevateks andmeväljastusteks kuni 31.01.2023. Seda v astavustabelit uurijale ei edastata. Krüpteeritud terviseandmed edastatakse SFTP kaudu TalTech Arvutusklastrisse , kasutades SFTP ühenduse jaoks uuri jate antud I P-aadressi, kasutajanime ja parooli. Kirjeldada, kuidas on andmed kaitstud loata või ebaseadusliku töötlemise eest. Uuringu ajal hoitakse andmeid TalTech Arvutusklastris ning pole selle raames kättesaadavad kõrvalistele isikutele. Tundlike andmete puhul kasutatakse täiendavaid turvameetmeid - andmete krüpteerimist ja protsesside pidevat monitooringut. Kõik meeskonnaliikmed on allkirjastanud konfidentsiaalsuslepingu ja informeeritud andmetele kohanduvatest andmekaitse nõuetest . Iga uurija saab ligi ainult andmet e le , mis konkreetselt tema tööks vajalik ud on. Kõik uurijad ei pääse ligi kõikidele andmetele. Andmete täpse koosseisu otsustab projekti juht , kaasates selleks asutuste vastutavaid esindajaid ning serverite administraatoreid TalTech Arvutusklastris . Kinnitan, et kõik uuringu läbiviijad on teadlikud projekti läbiviimisega kaasnevatest eetilistest ja isiku an dmete kaitsega kaasnevatest nõuetest. Vastutava uurija allkiri / digiallkiri / Taotluse esitamise k uupäev 19.01.2021 Ta o tluse EBIN ID (täidab hindaja) Lisadokumentide loetelu: L isa 1. Health Sense projekti leping Lisa 2. Vastutava uurija CV L isa 3 . Andmekoosseis Viited: Schweitzer, Marco & Alexander Hoerbst. 2017. An Approach for the Support of Semantic Workflows in Electronic Health Records. Studies in Health Technology and Informatics 235. 501–505 ISO/TS 13972:2015, https://www.iso.org/standard/62416.html Bernal, Juan G., Diego M. Lopez & Bernd Blobel. 2012. Architectural approach for semantic EHR systems development based on Detailed Clinical Models. Studies in Health Technology and Informatics 177. 164–169 “Feasibility study for the development of digital decision support systems for personalised medicine,” Tallinn University of Technology, Tallinn, 2015. Accessed: Sep. 13, 2020. [Online]. Available: https://www.sm.ee/sites/default/files/content-editors/eesmargid_ja_tegevused/Personaalmeditsiin/feasibility_study_for_the_development_of_digital_decision_support_systems_for_personalised_medicine.pdf H. Liivlaid, “Dental Care Data in the Health Information System,” National Institute for Health Development, Tallinn, 2019. Accessed: Sep. 11, 2020. [Online]. Available: https://intra.tai.ee//images/prints/documents/155800344725_Dental_Care_Data_in_the_HIS.pdf V. Kirpu and N. Eigo, “Comparison between the number of inpatient care and day care discharges on the basis of the data from Health Information System and National Institute for Health Development,” National Institute for Health Development, Tallinn, 2019. Accessed: Sep. 11, 2020. [Online]. Available: https://intra.tai.ee//images/prints/documents/155626766941_Comparison_of_inpatient_and_day_care_discharges_in_HIS_and_NIHD_data.pdf A.-L. Raid, “The Quality and Usability of Data in Estonian Health Information System for Analysing Waiting Times,” Unpublished Master’s Thesis, Tallinn University of Technology, Tallinn, 2017 Kaaskiri Antud kaaskirjas on välja toodud selgitused Nõukogu esitatud küsimustele ning viidatud parandustele eetikataotluses uuringu „Universaalse andmemudeli ja raviteekondade järjepidevuse standardi väljatöötamine lähtudes rahvusvahelistest uue põlvkonna terviseinfosüsteemide standarditest“ kohta. Eetikataotluses on sisseviidud muudatused nende paremaks eristamiseks välja toodud sinist värvi tekstiga. Nõukogu on seisukohal, et uuringu uurimisobjektiks on inimesed (punkt 12a). Isikuandmete uuringu objektiks on inimesed, olenemata sellest, kas neilt küsitakse uuringus osalemiseks nõusolekut või ei küsita. Palume taotlust täiendada. T aotluse punkt 12a ja selle alajotused (inimesed, haavatavad inimgrupid, alaealised, patsiendid) on vastavalt täiendatud . Lisast 3 nähtub, et uuritakse alaealiste isikuandmeid. Palume taotlust täiendada (punkt 12a). Taotluse punkt 12a on vastavalt täiendatud : Jah. Uuringu käigus uuritakse ka isikuid vanuses 15+ eluaastat ehk uuring hõlmab ka 15-17 aastaseid inimesi. Antud vanusegrupi andmeid kasutatakse kahe TIS-i andmepäringu teostamiseks (Lisa 3, päring 5 ja 8). Alaealiste andmed on kaasatud, kuna need on vajalikud WHO tervise indikaatorite korrektseks arvutamiseks. Tagamaks, et tulemused oleksid hiljem rahvusvaheliselt ja tuleviku-uuringutega võrreldavad, pole indikaatorite kriteeriumite osas uuringu disainimisel muudatusi tehtud. Kuna tegemist on andmekogu andmetel põhineva retrospektiivse uuringuga, lapsevanemate nõusolekut alaealiste kaasamiseks ei küsita ning lähtutakse ka siin antud taotluse punkt 11 väljatoodust (andmete töötlemist puudutav Isikandmete kaitse seadus § 6 lg 3 selgitus). Isikuandmete kaitse seaduse § 6 lg 3 loetleb tingimused, mil on lubatud andmesubjekti nõusolekuta tema kohta käivate andmete töötlemine andmesubjekti tuvastamist võimaldaval kujul. Palume selgitada ja taotlust täiendada, mil viisil on viidatud sättes toodud nõuded täidetud. Taotluse punkt 11 on vastavalt täiendatud. Selgitus: Andmesubjekti nõusolekuta tema kohta käivate andmete töötlemine teda tuvastada võimaldaval kujul on võimalik (Isikuandmete kaitse seaduse § 6 lg 3 lähtuvalt), kuna (1) pärast tuvastamist võimaldavate andmete (näiteks diagnoos) eemaldamist ei oleks andmetöötluse eesmärgid enam saavutatavad, siiski on andmed pseudonümiseeritud ning lisameetmena isiku kaudset tuvastamist võimaldavad andmed (näiteks harvikhaigused ja –ravimid) hägustatud; (2) uue põlvkonna tervise infosüsteemi loomiseks on piisav avalik huvi, Eestis on riiklikul tasandil algatatud uue põlvkonna tervise info süsteemi arendamist ning töös on mitmeid süsteemi loomist toetavaid projekte; (3) töödeldavate isikuandmete põhjal ei muutu kuidagi andmesubjekti kohustuste maht ega kahjustata muul viisil ülemäära andmesubjekti õigus i. Uuringu läbiviimine ei saa alata 01.02.2021 (punkt 6). Isikuandmete töötlemist ei saa alustada varasemalt kui komitee on vastavat taotlust menetlenud. Palume taotlust parandada. Taotlus e punkt 6 on parandatud järgnevalt: Märts 2021 – jaanuar 2023 . Palume arvuliselt täpsustada eeldatavat valimi suurust (punkt 11). Taotluse punkt 11 on täpsustatud järgnevalt: Valimiks on tervise infosüsteemist päritavad patsiendi andmed vastavalt Lisas 3 välja toodud kümnele päringule vahemikus 1. jaanuar – 31. detsember 2019. Valimi suurus on ette teada ühe päringu (päring 10) puhul, kus kaasatakse päringusse 90 patsiendi andmed. Ülejäänud 9 andmepäringu puhul, mille aluseks on WHO tervise indikaatorid, on valimite suurused varieeruvad. Kuna pole teada, kas ja kuidas kõik antud indikaatorite andmeid TIS-s kajastuvad, pole lõplik valimi suurus määratav , kuid suurusjärguks võime arvestada ligikaudu 10 000. Taotluses kirjeldatakse (punkt 10) kolme haigusgrupikoodid (insult, vähk, diabeet). Taotluse lisas 3 sisalduvad nelja haigusgrupikoodid (I00–I99, COO−C97, E10−E14 ja J30−J98). Palume taotlust täiendada osas, mitu haigusgruppi uuringusse kaasatakse ja kirjeldatud vastuolu lahendada. Taotluse punkt 10 on täiendatud. Lisaselgitus on toodud ka kaaskirja küsimus nr 7 vastuses. Andmemudeli loomiseks võrreldakse kolme raviteekonna puhul (insult, vähk, diabeet) hetkel TIS-i kogutavaid andmeid tegelike andmevajaduste vastu erinevate osapoolte vaatest (tervishoiutöötaja, teadlane, tervishoiuorganisatsiooni juht, patsient, rahastaja, regulaator/poliitik). Analüüsitavate andmete kogum defineeritakse eelmainitud haiguste puhul vastavalt WHO poolt 2018. aastal välja antud tervise indikaatorite nimekirjale (Lisa 3). Lisas 3 on kolme mainitud haigusgrupi raviteekonnale toodud ära veel kaks indikaatorit: (1) Riskifaktorid (mittenakkuslikud haigused): Täiskasvanute ebapiisav füüsiline aktiivsus, (2) Riskifaktorid (mittenakkuslikud haigused): Tubakatoodete tarbimine vanemate kui 15. aastaste hulgas. Palume täpsustada, kuidas kahe viimase indikaatori alusel tehtav päring aitab kaasa eelpool mainitud raviteekonna andmemudeli loomisele, st uuringu eesmärgi täitmisele? Milliseid tunnuseid kasutatakse tubakatoodete tarvitamise ja madala füüsilise aktiivsusega isikute otsinguteks? Palume selgitada, kuidas on antud päring eesmärgipärane ja täidab samal ajal andmete minimaalsuse põhimõtet. Nõukogule jääb selgusetuks kahe indikaatori seos uuringu eesmärgiga. Taotluse punkt 10 on täiendatud. Selgitus: Uuringu eesmärgi täitmiseks ehk uue põlvkonna tervise infosüsteemi jaoks uue andmemudeli, raviteekonna järjepidevuse standardi ja ühtse terminoloogia loomiseks tuleb esmalt hinnata, milliseid andmeid, kuidas ja kas hetkel TIS-i kogutakse . Antud infot kogutakse kolme raviteekonna näitel: insult, diabeet ja vähk. Hindamaks andme te kogumit, mida hetkel nendel raviteekondadel üldse kogutakse , päritakse I00–I99, COO−C97, E10−E14 haigusgrupi puhul juhuslikkuse alusel 90 inimese (30 inimest igas diagnoosigrupis) kõik 2019. aastal TIS-i saadetud andmed (Lisa 3, andmepäring 10). Lisaks sellele on valitud analüüsimiseks WHO poolt 2018. aastal välja antud tervise indikaatorite nimekirjast 9 indikaatorit, mille välja arvutamise võimalust praeguses süsteemis hindame (pidades indikaatorite jaoks vajalike andmete olemasolu TIS-s andmete kogumise kvaliteedinäitajaks) ning mis mõjuta vad otseselt või kaudselt kas insuldi, vähi või diabeedi raviteekonda. Otseselt raviteekonda puudutavad indikaatorid on vererõhu väärtus (Lisa 3, päring 6 ), veresuhkru väärtus ja diabeedi diagnoos (Lisa 3, päring 2 ) ning vähki esmahaigestumus (Lisa 3, päring 7 ) . Uue põlvkonna tervise infosüsteemi jaoks uuenduste loomisel peame aga arvestama sellega, et kaasaegsed ootused tervishoiusüsteemile ei piirdu vaid haiguste ravimisega, vaid ka ennetusega. Seega peame hindama andmete olemasolu nende haiguste riskifaktorite kohta laiemalt kui ainult nendes diagnoosigruppides. Kui tuleviku infosüsteemis pole võimalik tuvastada kõrge haigestumise riskiga inimesi, võib ka ennetustegevus kannatada. WHO indikaatorite hulgast on valitud analüüsimiseks andmete olemasolu järgmiste insuldi, vähi ja diabeedi riskifaktorite ja ennetustegevuste kohta: suitsetamine (Lisa 3, päring 5 ), alkoholitarbimine (Lisa 3, päring 8 ), ülekaal ja rasvumine (Lisa 3, päring 3 ), ebapiisav füüsiline aktiivusus (Lisa 3, päring 4 ) ning emakakaelavähi sõeluuring (Lisa 3, päring 9 ). Hindamaks enneaegset suremust mittenakkuslikesse haigustesse, on WHO välja töötanud indikaatori, mi s sisaldab suremust neljas haigusgrupis: I00–I99, COO−C97, E10−E14 ja J30−J98 . Seega h indamaks, kas antud indikaatorit on võimalik TIS-i andmete põhjal hetkel välja arvutada, päritakse lisaks insuldi, vähi ja diabeedi suremuse andmetele ka krooniliste kopsuhaiguste diagnoosiga patsientide suremuse andmeid (Lisa 3, päring 1). Milliseid tunnuseid kasutatakse tubakatoodete tarvitamise ja madala füüsilise aktiivsusega isikute otsinguteks? Tunnused on välja toodud Lisa 3 andmepäring 4 ja 5. Selgitus: T ubakatoodete tarvitamise ja madala füüsilise aktiivsuse info kogumi ne ei toimu hetkel vastavalt kindlale standardile , puudub ühtne terminoloogia ning pole selge , kas ja millisel määral neid andmeid üldse kogutakse. Projekti eesmärki arvestades on oluline tulem ka see, kui antud andmepäring selles osas vastust ei anna, kuna sel juhul on näha, et selliseid andmeid WHO indikaatorite arvutamiseks nõutaval kujul hetkel ei koguta. Vastavalt WHO indikaatoritele kasutame tubakatoodete tarvitamise puhul tunnuseid: sigarettide arv päevas, suitsetatud aastate hulk. Madala füüsilise aktiivusega isikute leidmise tunnused on: keskmise intensiivsusega füüsiline koormus (minutit/nädalas) ning kõrge intensiivsusega füüsiline koormus (minutit/nädalas). Väljaspool Nõukogu esitatud küsimusi sooviksime lisada taotlusesse ka kaks uut uurimismeeskonna liiget. Taotluse punkt 4 on vastavalt täiendatud. Eesnimi: Maarja-Liis Perekonnanimi: Elland Ametikoht: e-tervise analüütik Organisatsioon: Tallinna Tehnikaülikool Eesnimi: Maarja Perekonnanimi: Kuslapuu Ametikoht: projekti assistent Organisatsioon: Tallinna Tehnikaülikool EE-INNOVATION – Norwegian FM Programme Agreement Norwegian Financial Mechanism 2014-2021 PROGRAMME AGREEMENT between The Norwegian Ministry of Foreign Affairs and The Estonian State Shared Service Center (SSSC), hereinafter referred to as the “National Focal Point”, representing Estonia, hereinafter referred to as the “Beneficiary State” together hereinafter referred to as the “Parties” for the financing of the Programme “Competitiveness” hereinafter referred to as the “Programme” 1  EE-INNOVATION – Norwegian FM Programme Agreement Chapter 1 Article 1.4 Scope, Legal Framework, and Definitions Annexes and hierarchy of documents Article 1.1 1. Annexes attached hereto form an integral part of Scope this programme agreement. Any reference to this programme agreement includes a reference to its This programme agreement between the Norwegian annexes unless otherwise stated or clear from the Ministry of Foreign Affairs (hereinafter referred to context. as the NMFA) and the National Focal Point lays down the rights and obligations of the Parties 2. The provisions of the annexes shall be interpreted regarding the implementation of the Programme and in a manner consistent with this programme the financial contribution from the Norwegian agreement. Should the meaning of any provision of Financial Mechanism 2014-2021 to the Programme. the said annexes, so interpreted, remain inconsistent with this programme agreement, the provisions of the annexes shall prevail, provided that these Article 1.2 provisions are compatible with the Regulation. Legal Framework 3. Commitments, statements and guarantees, explicit 1. This programme agreement shall be read in as well as implicit, made in the preparation of the conjunction with the following documents which, programme are binding for the National Focal Point together with this programme agreement, constitute and the Programme Operator unless otherwise the legal framework of the Norwegian Financial explicitly stipulated in the annexes to this Mechanism 2014-2021: programme agreement. (a) Agreement between the Kingdom of Norway and the European Union on the Norwegian Financial Chapter 2 Mechanism 2014-2021 (hereinafter referred to as the The Programme Agreement);(b) the Regulation on the implementation of the Norwegian Financial Article 2.1 Mechanism 2014-2021 (hereinafter referred to as the Co-operation “Regulation”) issued by Norway in accordance with 1. The Parties shall take all appropriate and Article 10(5) of the Agreement; necessary measures to ensure fulfilment of the (c) the Memorandum of Understanding on the obligations and objectives arising out of this Implementation of the Norwegian Financial programme agreement. Mechanism 2014-2021 (hereinafter referred to as the 2. The Parties agree to provide all information “MoU”), entered into between Norway and the necessary for the good functioning of this Beneficiary State; and programme agreement and to apply the principles of (d) any guidelines adopted by the NMFA in implementation as set out in the Regulation. accordance with the Regulation. 3. The Parties shall promptly inform each other of 2. In case of an inconsistency between this any circumstances that interfere or threaten to programme agreement and the Regulation, the interfere with the successful implementation of the Regulation shall prevail. Programme. 3. The legal framework is binding for the Parties. An 4. In executing this programme agreement the act or omission by a Party to this programme Parties declare to counteract corrupt practices. agreement that is incompatible with the legal Further, they declare not to accept, either directly or framework constitutes a breach of this programme indirectly, any kind of offer, gift, payments or agreement by that Party. benefits which would or could be construed as illegal or corrupt practice. The Parties shall immediately inform each other of any indication of Article 1.3 corruption or misuse of resources related to this Definitions programme agreement. Terms used and institutions and documents referred to in this programme agreement shall be understood Article 2.2 in accordance with the Regulation, in particular Main responsibilities of the Parties Article 1.6 thereof, and the legal framework referred to in Article 1.2 of this programme agreement. 1. The National Focal Point is responsible and accountable for the overall management of the Norwegian Financial Mechanism 2014-2021 in the Beneficiary State and for the full and correct 2  EE-INNOVATION – Norwegian FM Programme Agreement implementation of this programme agreement. In agreement shall be interpreted in conjunction with particular, the National Focal Point undertakes to: the agreement regulating that support. (a) comply with its obligations stipulated in the 3. The financial plan annexed to this programme Regulation and this programme agreement; agreement shall: (b) ensure that the Certifying Authority, the Audit (a) contain a breakdown between the Programme’s Authority, the Irregularities Authority and the budget headings; Programme Operator properly perform the tasks (b) indicate the agreed advance payment, if any. assigned to them in the Regulation, this programme agreement and the programme implementation 4. The management cost of the Programme Operator agreement; shall not exceed the amount specified in this programme agreement. (c) take all necessary steps to ensure that the Programme Operator is fully committed and able to implement and manage the Programme; Article 2.5 (d) take the necessary measures to remedy Special conditions and programme specific rules irregularities in the implementation of the Programme and ensure that the Programme Operator 1. This programme agreement shall list any takes appropriate measures to remedy irregularities conditions set by the NMFA with reference to in Projects within the Programme, including paragraph 2 of Article 6.3 of the Regulation. The measures to recover misspent funds; National Focal Point shall ensure compliance with these conditions and take the necessary steps to (e) make all the necessary and appropriate ensure their fulfilment. arrangements in order to strengthen or change the way the Programme is managed. 2. The National Focal Point shall ensure compliance with any other programme specific rules laid down 2. The NMFA shall, subject to the rules stipulated in in this programme agreement. the legal framework referred to in Article 1.2 of this programme agreement, make available to the Beneficiary State a financial contribution Article 2.6 (hereinafter referred to as “the programme grant”) to Programme implementation agreement be used exclusively to finance the eligible cost of the Programme. With reference to Article 6.8 of the Regulation and without prejudice to paragraph 2 thereof, the National Focal Point shall, before any payment is Article 2.3 made to the Programme, sign a programme Objective and outcomes of the Programme implementation agreement with the Programme Operator. The National Focal Point shall notify the 1. This programme agreement sets out the objective, NMFA of such signing. outcome(s), outputs, indicators and targets for the Programme. 2. The National Focal Point shall ensure that the Article 2.7 Programme Operator implements and completes the Reporting Programme in accordance with the objective, The National Focal Point shall ensure that the outcome(s), outputs, indicators and targets set for Programme Operator provides financial reports, the Programme. annual programme reports and a final programme report in accordance with Chapter 9 and Articles 6.11 and 6.12 of the Regulation as well as statistical reporting in accordance with guidelines adopted by the NMFA. Article 2.4 Programme grant Article 2.8 External monitoring 1. The maximum amount of the programme grant, the programme grant rate, and the estimated eligible The external monitoring and audit referred to in cost of the Programme shall be as specified in this Articles 11.1, 11.2, 11.3 and 11.4 of the Regulation programme agreement. shall not in any way relieve the National Focal Point or the Programme Operator of their obligations 2. In case the Programme is also supported by the under the legal framework regarding monitoring of EEA Financial Mechanism, this programme 3  EE-INNOVATION – Norwegian FM Programme Agreement the Programme and/or its projects, financial control Telephone: +32 (0)2 286 1701 and audit. Telefax (general): +32 (0)2 211 1889 E-mail: [email protected] 3. Changes of or corrections to the contact Article 2.9 information referred to in this article shall be given Modification of the Programme in writing without undue delay by the Parties to this 1. Unless otherwise explicitly stipulated in this programme agreement. programme agreement, any modification of the Programme is subject to prior approval by the NMFA. Article 2.12 Representations and Warranties 2. Programme specific exceptions from paragraph 1, if any, are set in the annexes to this programme 1. This programme agreement and the awarding of agreement. the programme grant is based on information provided by, through, or on behalf of the National 3. Expenditures incurred in breach of this article are Focal Point to the NMFA prior to the signing of this not eligible. programme agreement. 4. Should there be a doubt as to whether the 2. The National Focal Point represents and warrants proposed modifications require approval by the that the information provided by, through, or on NMFA, the National Focal Point shall consult the behalf of the National Focal Point, in connection NMFA before such modifications take effect. with the implementation or conclusion of this 5. Requests for modifications shall be submitted and programme agreement are authentic, accurate and assessed in accordance with Article 6.9 of the complete. Regulation. Chapter 3 Article 2.10 Projects Communication Article 3.1 1. All communication to the NMFA regarding this Selection of projects and award of grants programme agreement shall take place in English and be directed to the Financial Mechanism Office 1. The National Focal Point shall ensure that the (hereinafter referred to as the FMO), which Programme Operator selects projects in accordance represents the NMFA towards the National Focal with Chapter 7 of the Regulation and this Point and the Programme Operator in relation to the programme agreement. implementation of the Programme. 2. Eligibility of project promoters and project 2. To the extent that original documents are not partners is stipulated in Article 7.2 of the Regulation available in the English language, the documents and, in accordance with paragraph 4 thereof, subject shall be accompanied by full and accurate only to the limitations stipulated in this programme translations into English. The National Focal Point agreement. shall bear the responsibility for the accuracy of the 3. Pre-defined projects shall be outlined in this translation that it provides and the possible programme agreement. consequences that might arise from any inaccurate translations. 4. The National Focal Point shall take proactive steps to ensure that the Programme Operator complies fully with Article 7.5 of the Regulation. Article 2.11 Contact information Article 3.2 1. The contact information of the Programme Project contract Operator is as specified in this programme agreement. 1. For each approved project a project contract shall be concluded between the Programme Operator and 2. The contact information for the NMFA and the the Project Promoter. Financial Mechanism Office are: 2. In cases where a project contract cannot, due to Financial Mechanism Office provisions in the national legislation, be made Att: Director between the Programme Operator and the Project EFTA Secretariat Promoter, the Beneficiary State may instead issue a Rue Joseph II, 12-16 legislative or administrative act of similar effect and 1000 Brussels content. 4  EE-INNOVATION – Norwegian FM Programme Agreement 3. The content and form or the project contract shall Regulation and fall within the categories and fulfil comply with Article 7.6 of the Regulation. the conditions of direct eligible expenditure set in Article 8.3 of the Regulation, the conditions 4. The National Focal Point shall ensure that the regarding the use of standard scales of unit costs set obligations of the Project Promoter under the project in Article 8.4 of the Regulation as well as indirect contract are valid and enforceable under the costs in accordance with Article 8.5 of the applicable law of the Beneficiary State. Regulation. 4. The first date of eligibility of expenditures in Article 3.3 projects shall be set in the project contract in Project partners and partnership agreements accordance with Article 8.13 of the Regulation. The first date of eligibility of any pre-defined projects 1. A project may be implemented in a partnership shall be no earlier than the date on which the between the Project Promoter and project partners as National Focal Point notifies the NMFA of a defined in paragraph 1(w) of Article 1.6 of the positive appraisal of the pre-defined projects by the Regulation. If a project is implemented in such a Programme Operator in accordance with paragraph partnership, the Project Promoter shall sign a 3 of Article 6.5 of the Regulation. partnership agreement with the project partners with the content and in the form stipulated in Article 7.7 5. The maximum eligible costs of the categories of the Regulation. referred to in paragraph 1 are set in this programme agreement. Programme specific rules on the 2. The partnership agreement shall be in English if eligibility of expenditure set in this programme one of the parties to the agreement is an entity from agreement shall be complied with. Norway. 3. The eligibility of expenditures incurred by a project partner is subject to the same limitations as Article 4.2 would apply if the expenditures were incurred by the Proof of expenditure Project Promoter. Costs incurred by Programme Operators, Project 4. The creation and implementation of the Promoters and project partners shall be supported by relationship between the Project Promoter and the documentary evidence as required in Article 8.12 of project partner shall comply with the applicable the Regulation. national and European Union law on public procurement as well as Article 8.15 of the Regulation. Article 4.3 Payments 5. The National Focal Point shall ensure that the Programme Operator verifies that the partnership 1. Payments to the Programme shall be made when agreement complies with this article. A draft all relevant conditions for payments stipulated in partnership agreement or letter of intent shall be this programme agreement and the Regulation have submitted to the Programme Operator before the been fulfilled. signing of the project contract. 2. Payments to the Programme shall take the form of an advance payment, interim payments and payment of the final balance and shall be made in accordance Chapter 4 with Articles 9.2, 9.3 and 9.4 of the Regulation. Finance 3. Payments of the project grant to the Project Article 4.1 Promoters may take the form of advance payments, Eligible expenditures interim payments and payments of the final balance. 1. Subject to Article 8.7 of the Regulation, eligible The level of advance payments and their off-set expenditures of this Programme are: mechanism is set in this programme agreement. (a) management costs of the Programme Operator in 4. The National Focal Point shall ensure that accordance with the detailed budget in the financial payments are transferred in accordance with plan; paragraph 2 of Article 9.1 of the Regulation. (b) payments to projects within this Programme in 5. Chapter 9 of the Regulation shall apply to all accordance with the Regulation, this programme aspects related to payments, including currency agreement and the project contract. exchange rules and handling of interests on bank accounts. 2. Eligible expenditures of projects are those actually incurred by the Project Promoter or project partners, meet the criteria set in Article 8.2 of the 5  EE-INNOVATION – Norwegian FM Programme Agreement Article 4.4 have the financial capacity to continue with the Transparency and availability of documents implementation of the Programme; or The National Focal Point shall ensure an audit trail (e) the Programme Operator has, in the opinion of for financial contributions from the Norwegian the NMFA, been engaged in corruption, fraud or Financial Mechanism 2014-2021 to the Programme similar activities or has not taken the appropriate in accordance with Article 9.8 of the Regulation. measures to detect or prevent such activities or, if they have occurred, nullify their effects. 2. This programme agreement can be terminated by Article 4.5 mutual agreement between the Parties. Irregularities, suspension and reimbursements 3. Termination does not affect the right of the Parties The NMFA has the right to make use of the remedies to make use of the dispute settlement mechanism provided in the Regulation, in particular Chapter 13 referred to in Article 5.1 or the right of the NMFA thereof. The National Focal Point has a duty to take to make use of the remedies provided in Chapter 13 all necessary measures to ensure that the provisions of the Regulation. in Chapter 12 and 13 of the Regulation regarding irregularities, suspension of payments, financial corrections and reimbursement are complied with. Article 5.3 Chapter 5 Waiver of responsibility Final provisions 1. Any appraisal of the Programme undertaken Article 5.1 before or after its approval by the NMFA, does not Dispute settlement in any way diminish the responsibility of the National Focal Point and the Programme Operator 1. The Parties waive their rights to bring any dispute to verify and confirm the correctness of the related to the programme agreement before any documents and information forming the basis of the national or international court, and agree to settle programme agreement. such a dispute in an amicable manner. 2. Nothing contained in the programme agreement 2. If a demand for reimbursement to the NMFA is shall be construed as imposing upon the NMFA or not complied with by the Beneficiary State, or a the FMO any responsibility of any kind for the dispute related to a demand for reimbursement arises supervision, execution, completion, or operation of that cannot be solved in accordance with paragraph the Programme or its projects. 1, the Parties may bring the dispute before Oslo Tingrett. 3. The NMFA does not assume any risk or responsibility whatsoever for any damages, injuries, or other possible adverse effects caused by the Article 5.2 Programme or its projects including, but not limited Termination to inconsistencies in the planning of the Programme or its projects, other project(s) that might affect it or 1. The NMFA may, after consultation with the that it might affect, or public discontent. It is the full National Focal Point, terminate this programme and sole responsibility of the National Focal Point agreement if: and the Programme Operator to satisfactorily (a) a general suspension decision according to address such issues. Article 13.6 of the Regulation or a decision to 4. Neither the National Focal Point, the Programme suspend payments according to paragraph 1(h) of Operator, entities involved in the implementation of Article 13.1 of the Regulation has not been lifted projects, nor any other party shall have recourse to within 6 months of such a decision; the NMFA for further financial support or assistance (b) a suspension of payments according to Article to the Programme in whatsoever form over and 13.1 of the Regulation, other than under paragraph above what has been provided for in the programme 1(h), has not been lifted within one year of such a agreement. decision; 5. Neither the European Free Trade Association, its (c) a request for reimbursement according to Article Secretariat, including the FMO, its officials or 13.2 of the Regulation has not been complied with employees, nor the NMFA, its officials or within one year from such a decision; employees, can be held liable for any damages or injuries of whatever nature sustained by the National (d) the Programme Operator becomes bankrupt, is Focal Point or the Beneficiary State, the Programme deemed to be insolvent, or declares that it does not Operator, Project Promoters or any other third 6  EE-INNOVATION – Norwegian FM Programme Agreement person, in connection, be it direct or indirect, with Article 5.4 this programme agreement. Entry into force and duration 6. Nothing in this programme agreement shall be 1. This programme agreement shall enter into force construed as a waiver of diplomatic immunities and on the date of the last signature of the Parties. privileges awarded to the European Free Trade 2. This programme agreement shall remain in force Association, its assets, officials or employees. until five years have elapsed after the date of the acceptance of the final programme report. ******** This programme agreement is drawn up in two originals in the English language. For the Donors For the National Focal Point Signed in Tallinn, Estonia on 26/04/2018 Signed in Tallinn, Estonia on 26/04/2018 ...................................................................... ...................................................................... Audun Halvorsen Jaak Aab State Secretary, Norwegian Ministry of Minister of Public Administration, Ministry of Finance Foreign Affairs of the Republic of Estonia 7  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Annex I to the Programme Agreement Programme Operators and Partners Ministry of Economic Affairs and Programme Operator: Communications Donor Programme Partner: Innovation Norway (IN) IPO: - Other Programme Partner(s): - Programme Increased value creation and sustainable growth Objective Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting Estimated annual CO2 Energy Annual Annually emissions reductions (tons of N/A audits, 0 N/A 25,000 number (APR) CO2 equivalent per year)1 energy bills Increased Estimated annual growth in Business Annually competitiveness turnover of supported N/A Percentage N/A N/A 5% report (APR) of Estonian enterprises2 companies Estimated annual growth in Business Annually within focus net operational profit of N/A Percentage N/A N/A 5% PA01 Outcome 1 report (APR) areas Green supported enterprises3 Industry Estimated annual decrease of Innovation, ICT Energy energy consumption of Annually and Welfare N/A Percentage audits, 0% N/A 5% supported enterprises (in (APR) Technology energy bills MWh)4 Attendance Number of Annually N/A Number sheets/ 0 N/A 10 products/services/processes (APR) registrations 1 CO2 emissions reductions will be verified by project promoter by performing independent audit or using other reliable method. 2 Definition of “turnover”: Enterprise’s net revenue for a fiscal year (after deduction of VAT, trade reductions and other indirect taxes). 3 Definition of “profit”: Difference between operating income and operating expenses. 4 Decrease of energy consumption will be verified by project promoter by performing independent energy audit or using other reliable method.  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting tested in the Open Cyber Range security platform5 Number of new products/services/processes Project Annually applied (new-to-the- N/A Number promoters 0 N/A 20 (APR) enterprise) (disaggregated by records sector) Copy of Number of registered application Annually applications for Intellectual N/A Number for 0 N/A 5 (APR) Property Protection registering IPR Semi- annually Employment Number of jobs created6 Gender, Age Number (APR and 0 N/A 100 contracts September IFR) Number of new Project products/services/processes Annually N/A Number promoters 0 N/A 25 developed (disaggregated by (APR) records sector)7 Enterprises Number of large enterprises Semi- Financing Output 1.1 supported to supported in SGS to prepare N/A Number annually 0 N/A 15 decisions develop or apply projects for main call8 (APR and 5 OCR is a virtual environment that is used for cybersecurity training and cyber technology development. Enterprises can test their products, services or processes against cyber threats in virtual testing environment to guarantee the real life security of products, services and processes. 6 The definition of a job created will follow the definition set out in the Core indicators guidance document: “All jobs (positions) supported or generated during programme implementation, irrespective of the duration and as a direct result of the EEA and Norway Grants support. Data on the job positions where the salary is not supported by the grants and the position is likely to continue after grant support has ended, i.e. the number of permanent jobs created – which will be a subset of the total number – may also be kept and reported if needed. 7 Definition of “developed”: Projects where the main activities are user driven R&D, i.e. validation or demonstration of technologies in relevant (industrial) environment, prototypes demonstrated in operational environment, system completed and qualified. With other words Technology Readiness Level (TRL) 5-8 (EU Commission’s scale used to describe the maturity of a technology). These types of projects will typically be cooperation between an enterprise and a research institution or similar. 8 Definition of “large enterprise”: The enterprise is considered large when it is characterized by at least one of the three elements mentioned above: employ more than 250 persons, has annual turnover which exceeds EUR 50 million, and/or an annual balance sheet total exceeding EUR 43 million.  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting innovative green September products, IFR) services and Semi- processes Number of large enterprises annually supported to apply new Financing N/A Number (APR and 0 N/A 5 green decisions September products/services/processes IFR) Semi- Number of SMEs supported annually Financing in SGS to prepare projects N/A Number (APR and 0 N/A 30 decisions for main call September IFR) Semi- Number of SMEs supported annually to apply new green Financing N/A Number (APR and 0 N/A 15 products/services/processes decisions September (new-to-the-enterprise)9 IFR) Semi- Number of SMEs supported annually Financing to develop new green N/A Number (APR and 0 N/A 5 decisions products/services/processes September IFR) Semi- Number of large enterprises annually supported to develop new Financing N/A Number (APR and 0 N/A 2 green decisions September products/services/processes IFR) Enterprises Semi- supported to Number of SMEs supported annually Financing Output 1.2 develop in SGS to prepare projects N/A Number (APR and 0 N/A 25 decisions innovative ICT for main call September products, IFR) 9 Definition of “SME-s”: SMEs are enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million.  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting services and Semi- processes Number of SMEs supported annually Financing to develop ICT products, N/A Number (APR and 0 N/A 8 decisions services and processes10 September IFR) Semi- Number of large enterprises annually Financing supported in SGS to prepare N/A Number (APR and 0 N/A 6 decisions projects for main call September IFR) Semi- Number of large enterprises annually supported to develop ICT Financing N/A Number (APR and 0 N/A 5 products, services and decisions September processes IFR) Semi- Number of large enterprises annually Financing supported in SGS to prepare N/A Number (APR and 0 N/A 2 decisions projects for main call September IFR) Copies of Enterprises contracts supported to signed with Semi- develop Project Number of enterprises annually Output 1.3 innovative Promoters; supported in SGS to prepare N/A Number (APR and 0 N/A 8 welfare products, Project projects for main call September services and Promoters’ IFR) processes reports, partnership agreements Number of SMEs supported Semi- to develop new welfare Financing N/A Number annually 0 N/A 5 technology decisions (APR and products/services/processes 10  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting September IFR) Semi- Number of SMEs supported Attendance annually to test new N/A Number sheets/ (APR and 0 N/A 15 products/services/processes registrations September Open Cyber in the Open Cyber Range IFR) Output 1.4 Range (OCR) is Semi- operational Attendance annually Number of professional staff Gender, Roma Number sheets/ (APR and 0 N/A 100 trained registrations September IFR) Data collection, and Semi- publishing environment To be annually architecture and data specified N/A Binary (APR and No 2019 Yes analysis environment with PDP September architecture developed and promoter IFR) published Semi- To be Data collection and annually specified publishing procedures/tools N/A Binary (APR and No 2019 Yes with PDP Health Sense in place and documented September promoter data IFR) management Semi- Output 1.5 To be platform Data analysis annually specified developed and procedures/tools in place and N/A Binary (APR and No 2019 Yes with PDP operating documented September promoter IFR) Semi- Number of data To be annually mining/Artificial Intelligence specified N/A Number (APR and 0 N/A 3 pilot projects successfully with PDP September finished promoter IFR) Semi- Number of professional staff Attendance Gender, Roma Number annually 0 N/A 10 trained sheets (APR and  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting September IFR) Level of satisfaction with the Survey Annually State type Scale 1-7 6.8611 2020 4.512 partnership results (APR) Level of trust between cooperating entities in Survey Annually State type Scale 1-7 6.6713 2020 4.514 Beneficiary States and results (APR) Donor States Enhanced Share of donor business collaboration partnerships which continue Survey Annually between N/A Percentage N/A N/A 50 %15 after project implementation results (APR) beneficiary and Bilateral Outcome period donor state entities involved Copy of in the Number of jointly registered application Bilateral Annually programme applications for Intellectual Donor State Number for 0 N/A 3 (APR) Property Protection registering IPR Share of cooperating organisations that apply the Survey Annually State type Percentage N/A N/A 5016 knowledge acquired from results (APR) bilateral partnership Semi- Bilateral Number of projects annually Financing Bilateral Output 1 partnerships involving cooperation with a Donor State Number (APR and 0 N/A 45 decisions supported donor project partner September IFR) 11 Survey carried out on behalf of the FMO 12 Target is ≥4.5, and an increase on the baseline value 13 Survey carried out on behalf of the FMO 14 Target is ≥4.5, and an increase on the baseline value 15 Target is minimum 50% 16 Target is minimum 50 %  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Expected Frequency Unit of Source of Baseline Baseline Target PA Outcome/Output programme Indicator Disaggregation of measurement verification values year value results reporting Semi- Donor State, annually Number of staff from donor Attendance Gender, Type of Number (APR and 0 N/A 5 states in exchanges sheets exchange September IFR)  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Conditions General 1) The National Focal Point shall ensure that the Programme Operator, prior to signing a project contract for pre-defined project no. 1 “Open Cyber Range (OCR)” and no. 2 “Health Sense”, carries out an external and independent appraisal of the project, in order to verify its quality and contribution to the objectives of the Programme as well as compliance with EU and national legislation. Pre-eligibility 1) No costs shall be eligible under pre-defined project no. 1 “Open Cyber Range (OCR)” and no. 2 “Health Sense” before the detailed descriptions and budgets for these pre-defined projects have been submitted to and approved by the NMFA. Pre-payment 1) The Programme Operator shall submit the summary description of the procedure for the selection of projects to the NMFA for approval, prior to the publication of the small grant scheme and call for proposals foreseen under this programme. The programme agreement shall be amended accordingly. 2) The Programme Operator shall submit a communication plan for the programme to the NMFA for approval, prior to the publication of the small grant scheme and call for proposals foreseen under this programme. Pre-completion Not applicable Post-completion Not applicable Eligibility of costs - period First date Final date Eligibility of costs 10/05/2017 31/12/2024 Grant rate and co-financing Programme eligible expenditure (€) € 27,058,824 Programme grant rate (%) 85.00 % Maximum amount of Programme grant - EEA Financial Mechanism (€) - Maximum amount of Programme grant - Norwegian Financial Mechanism (€) € 23,000,000 Maximum amount of Programme grant - Total (€) € 23,000,000  EE-INNOVATION – Norwegian FM Programme Agreement - Annex I Norway Programme Programme co- Programme eligible Advance PA Budget Heading Total grant Grants grant rate financing expenditure payment Programme PA01 € 1,723,000 € 1,723,000 85.00 % € 304,059 € 2,027,059 n/a management Outcome 1 (Norway € PA01 € 21,277,000 85.00 % € 3,754,765 € 25,031,765 n/a Grants) 21,277,000 € Total € 23,000,000 85.00 % € 4,058,824 € 27,058,824 €0 23,000,000 Retention of management costs Retention of management costs - percentage of the management costs 10.00 % Retention of management costs - planned Euro value € 202,706  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II Competitiveness Operational rules (Annex II) 1. Programme summary This Annex sets out the operational rules for the programme. The programme agreement is based on the MoU, the concept note and comments made by the NMFA. Commitments, statements and guarantees, explicit as well as implicit, made in the concept note, are binding for the National Focal Point and the Programme Operator unless otherwise explicitly stipulated in the annexes to this programme agreement. The Programme Operator is the Ministry of Economic Affairs and Communications of Estonia. Certain tasks of the Programme Operator may be delegated to the Enterprise Estonia (EE), however this does not in any way reduce or restrict the responsibility of the Programme Operator. Innovation Norway (IN) shall act as Donor Programme Partner. The programme shall support the outcomes “Increased competitiveness of Estonian companies within focus areas Green Industry Innovation, ICT and Welfare Technology,” by way of one open call for proposals, one small grant scheme (SGS), and two pre-defined projects. The programme has three focus areas, Green Industry Innovation, ICT, and Welfare Technology. ICT can be a horizontal element across Green Industry Innovation and Welfare technology. The Programme targets 50% of funds to be allocated into Green Industry Innovation (through ICT- related projects) and ensures that minimum 75% of the funding goes to SMEs. 2. Eligibility 2.1 Eligible applicants: The rules on eligibility of applicants are set in Article 7.2 of the Regulation. In accordance with Article 7.2.4, the following entities shall be eligible: - For the open call and the small grant scheme, eligible applicants are companies registered in the Estonian Commercial Register, with no more than 25% public ownership. Eligible project partners are legal entities established in Estonia or in Norway. 2.2 Special rules on eligibility of costs: Costs are eligible in accordance with chapter 8 of the Regulation. 3. Bilateral relations 3.1 Bilateral relations The Programme shall contribute to strengthening bilateral relations between Estonia and Norway. The Programme shall as appropriate facilitate donor partnership projects by carrying out, inter alia, match-making events and activities in conjunction with launching calls for proposals, as well as by encouraging donor partnership projects in call texts. The further use of the funds for bilateral relations allocated to the programme shall be agreed in the Cooperation Committee. 4. Selection of projects and financial parameters 4.1 Open calls and availability of funds (including number of calls, duration of calls, and estimated size): Indicative Minimum/Maximum grant Outcome Modality Total available amount timing applied for 17  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II Increased Call for 2020 €18,871,549 competitiveness of proposals Estonian companies Green Industry Innovation: within focus areas Green Industry (Green Industry Innovation: €200,000 – €700,000 Innovation, ICT and €12,515,882) Welfare Technology ICT: (ICT: €1,930,667) €200,000 – €700,000 (Welfare Technology: €4,425,000) Welfare Technology: €200,000 – €1,250,000 Small Grant 2018 €828,451 €10,000 – €20,000 Scheme In case of unallocated funds following the call for proposals, an additional call for proposals may be launched. 4.2 Selection procedures: The project evaluation and award of grants shall be in accordance with Article 7.4 of the Regulation. The Programme Operator shall be responsible for the project evaluation and the award of grants. Small grant scheme: The small grant scheme will be administered by Enterprise Estonia. Enterprise Estonia shall review the applications received for compliance with the administrative and eligibility criteria. 18  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II Each application that meets the administrative and eligibility criteria shall be reviewed by two impartial experts appointed by Enterprise Estonia. The experts shall separately score the applications from 0-4, according to the selection criteria published with the call for proposals. For the purpose of ranking the applications, the average of the scores awarded by the experts shall be used. Applications receiving an average score of less than 2.50, or if the average score within one criterion is less than 2.00, shall be rejected. If the evaluation results with one expert scoring the application above and the other expert scoring the application below the thresholds, a third expert shall be commissioned by the Enterprise Estonia to score the application independently. In such cases, the average score of the two closest scores shall be used for the ranking of applications. A ranked list of the projects recommended for funding shall be prepared for the management board of Enterprise Estonia, which shall make the decision on which projects shall be supported. Open call for proposals: Enterprise Estonia shall review the applications received for compliance with the administrative and eligibility criteria. Each application that meets the administrative and eligibility criteria shall be reviewed by two impartial experts appointed by Enterprise Estonia. The experts shall separately score the applications from 0-4, according to the selection criteria published with the call for proposals. For the purpose of ranking the applications, the average of the scores awarded by the experts shall be used. Applications receiving an average score of less than 2.50, or if the average score within one criterion is less than 2.00, shall be rejected. If the evaluation results with one expert scoring the application above and the other expert scoring the application below the thresholds, a third expert shall be commissioned by the Enterprise Estonia to score the application independently. In such cases, the average score of the two closest scores shall be used for the ranking of applications. A ranked list of the projects recommended for funding shall be prepared for the Selection Committee’s decision. The Selection Committee shall be chaired by the Programme Operator and consist of representatives from the Programme Operator, Enterprise Estonia and the Donor Programme Partner. Additionally, a representative nominated by the Ministry of Social Affairs shall be part of the Selection Committee as a voting member when selecting projects to be funded under Welfare Technology. Additional representatives possessing the relevant expertise may also be invited to the meetings of the Selection Committee. The Selection Committee shall by consensus make its decision on which projects shall be funded. If consensus cannot be reached, the Programme Operator shall, as Chair of the Selection Committee, make the final decision on which projects shall be funded. The final ranking list of the projects to be funded shall be prepared for the management board of Enterprise Estonia, which shall formalise the decision of the Selection Committee. In justified cases, Enterprise Estonia may return the ranking list to the Selection Committee for renewed assessment prior to formalising the decision. 4.3 Project grant rate: Grants from the programme may be up to 75% of total eligible expenditure of the project. The grant rates for the pre-defined projects are set in section 5.1. The project grant rate shall in all cases be set at a level that complies with the State Aid rules in force and takes into account any and all other forms of public support granted to projects. Any remaining costs of the project shall be provided by the Project Promoter. 5. Additional mechanisms within the Programme 5.1 Pre-defined projects There will be two pre-defined projects implemented under the Programme: 19  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II 1) "Open Cyber Range (OCR)" Project Promoter: Estonian Ministry of Defence Donor project partner(s): Norwegian University for Science and Technology (NTNU) Other project partner(s): Tallinn University of Technology Total maximum eligible costs: € 3,331,765 Project grant rate: 100.00 % Maximum project grant amount: € 3,331,765 The project contributes to the programme outcome 1: “Increased competitiveness of Estonian companies within focus areas Green Industry Innovation, ICT and Welfare Technology”. Open Cyber Range is a virtual environment that is used for cybersecurity training and cybertechnology development. It provides tools that help strengthen the stability, security and performance of cyberinfrastructures and IT systems leading to secure and trustworthy products and well-educated personnel. The main objectives of this project are to create a platform for companies to develop, test and validate their innovative products, create a launch pad for new products to emerge to the market, promote security thinking in private sector and educate better workforce for the private companies. The project will create an environment for companies to test, experiment and validate newly developed products to meet the growing need for enhanced cybersecurity. Activities will include: creating a platform for (new) cybersecurity companies to develop, test and validate innovative products;  create a launch pad for new products to emerge to the market;  promote security thinking in private sector and  educate better workforce for the private companies. The platform will include tools and products that are not part of standard cloud service (automation tools, simulations, red and blue team tools, situational awareness, hybrid systems etc.). The SMEs that develop and test the products in OCR will be provided with a fast setup of testing and validation environment, reduced initial cost for the environment, and also support from academia and government, mentors and test-clients from other SMEs. 2) "Health Sense" Project Promoter: Ministry of Social Affairs - Estonia Donor project partner(s): Norwegian Directorate of Health (HDIR) Norwegian University for Science and Technology (NTNU) Other project partner(s): Health and Welfare Information Systems Center Tallinn University of Technology Tartu University Software Technology and Applications Competence Centre Total maximum eligible costs: € 2,000,000 Project grant rate: 100.00 % Maximum project grant amount: € 2,000,000 20  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II The project contributes to the programme Outcome 1: “Increased competitiveness of Estonian companies within focus areas Green Industry Innovation, ICT and Welfare Technology”. The aim of the project is to raise the availability of health and lifecycle data in order to enhance the creation of new products, services and solutions by the private sector, novel interventions by the public sector and relevant scientific knowledge by the R&D communities in order to raise life expectancy and prolong healthy life years of people. This will be done by developing a secure data storage, integration, access and analysis toolkit in order to provide large, complex and detailed sets of health and lifecycle data for the public sector, private sector and R&D institutions. Health Sense will be a virtual environment collecting health, health cycle and lifestyle data for research and service development purposes. In addition, it will provide a toolbox that enables the creation of data analysis-based solutions for prolonging a healthy human life. As the data handled in the environment is sensitive, the tools for safe collection, storage, access and processing of data are an essential part of the provided toolbox. All activities and outcomes of the project will be in line with the European General Data Protection Regulation (GDPR). 5.2 Financial Instruments Not applicable. 6. Programme Management 6.1 Payment flows The Programme Operator shall ensure that payments to projects are made in a timely manner. Payments of the project grant shall take the form of interim payments and a final payment. The interim payments shall be paid after the approval of project interim reports and final payments after the approval of project final report. The interim payments shall be paid within 1 month after the approval of project interim reports. Upon approval of the final project report a final balance payment, if applicable, shall be made within 1 month. The approval of project interim and final reports shall take place within 2 months from the submission of the required information. The periodicity of reporting periods, and deadlines for reporting will be further detailed in the description of the Programme Operator’s management and control systems. In case of euro-denominated contracts with entities from Donor States or with intergovernmental organizations, the Programme Operator shall transfer the amounts in euro. 6.2 Verification of payment claims The Programme Operator verifies that the expenditures declared by the project promoters have actually been incurred and complies with the Regulation, the Programme Agreement as well as applicable national and European Union law and that the financial contribution is used exclusively for the purpose of the programme and its projects and according to the Programme Agreement. Payments to projects are made on the basis of approved payment claims. Payment claim, submitted as integral part of the interim and final project reports, will be reviewed by the Programme Operator. Verification and approval of the payment claim will be based on information on incurred costs, financial status and project's progress described in reports, and on additional information to be submitted together with reports, if required by the Programme Operator. In line with point i) of Article 5.6.2 of the Regulation incurred expenditure reported shall be subject to administrative verifications before the report is approved. Verifications to be carried out shall cover 21  EE-INNOVATION – Norwegian FM Programme Agreement - Annex II administrative, financial, technical and physical aspects of projects, as appropriate and be in accordance with the principle of proportionality. Additionally, in line with point ii) of Article 5.6.2 of the Regulation on–the-spot verifications of projects, which may be carried out on a sample basis, shall be carried out. The verification of costs will be based on sample methods taking into account results of the project implementation risk analysis. After approval of the payment claim the disbursement of the grant to the project promoter is made. The detailed procedure for verification of payment claims, periodicity of reporting periods, and deadlines for reporting will further be outlined in the description of the programme rules of procedure and Programme Operator’s management and control systems. 6.3 Monitoring and reporting The Programme Operator shall monitor, record and report on progress towards the programme’s outcomes in accordance with the provisions contained in the legal framework. The Programme Operator shall ensure that suitable and sufficient monitoring and reporting arrangements are made with the project promoters in order to enable the Programme Operator and the NFP to meet its obligations to the donors. When reporting on progress achieved in Annual and Final Programme Reports, the Programme Operator shall disaggregate results achieved as appropriate and in accordance with instructions and templates received from the FMO. 6.4 Programme administrative structures The programme is operated by the Estonian Ministry of Economic Affairs and Communications. Enterprise Estonia will act as the implementing agency and will be involved in the selection process as well as take on tasks related to verification of payments, payments to project promoters, monitoring of the projects and preparing the interim financial reports to be submitted to the Certifying Authority by the Programme Operator. Monitoring of financial management and budgeting will be followed by general state budget rules. The organisational structure of the Programme Operator shall ensure independence and functional separation of the division responsible for verification of incurred expenditure and approval of payments from other divisions responsible for the implementation of the programme. 7. Communication The Programme Operator shall comply with Article 3.3 of the Regulation, the Information and Communication Requirements in Annex 3 of the Regulation and the Communication plan for the programme. 8. Miscellaneous Not applicable. 22  CURRICULUM VITAE Isikuandmed Ees- ja perekonnanimi Peeter Ross Sünniaeg ja -koht 21.12.1966, Tallinn, Eesti Kontaktandmed Aadress Köömne 28-2, 10617 Tallinn, Eesti Telefon +372 56 353 460 E-mail [email protected] Peeter Ross on Tallinna Tehnikaülikooli (TTÜ) Tervisetehnoloogiate instituudi professor ja E-meditsiini keskuse juhataja. Peeter töötab ka Ida-Tallinna Keskhaiglas radioloogina ning on Maailmapanga, Saksa Arengupanga (KfW) ja Aasia Arengupanga e-tervise konsultant. Samuti on ta meditsiini infotehnoloogiaga tegeleva osaühingu SMIS International asutaja ja tegevjuht ning menetlusradioloogia õppevahendeid tootva ettevõtte SafeToAct OÜ asutaja. Professor Ross on varem töötanud Ida-Tallinna Keskhaigla juhatuse liikmena ning olnud Eesti Haigekassa ja Eesti E-Tervise Sihtasutuse nõukogu liige. Oma töös ja teadustegevuses on ta aktiivselt osalenud radioloogia, telemeditsiini ja tervishoiutehnoloogiate arendamisel ning e-tervise alases õppetöös. TTÜ-s on Peeter Ross olnud tervishoiutehnoloogia rahvusvahelise magistriõppekava üks loojaid ning juhendab ligi 10 aastat selle valdkonna magistritöid ja on tervishoiutehnoloogia lektor. Dr Ross on olnud teleradioloogia aluspanijaid Eestis, on olnud üks Eesti tervise infosüsteemi arendajaid ja tööle rakendajaid ning samuti osalenud arvukates rahvusvahelistes telemeditsiini ja e-tervise projektides (InterregPACS, Baltic eHealth, R-Bay, epSOS, Regional Telemedicine Forum, SUSTAINS, Momentum, eMedic, PrimCareIT). Professor Ross on olnud konsultant mitmete riikide e-tervise platvormide arendamisel (näit. Suurbritannia, Rootsi, Soome, Qatar, Bulgaaria, Moldaavia, Mongoolia, Leedu, Gruusia, Aserbaidžaan, Armeenia, Kirgiisia, Usbekistan, Saudi Araabia jt.). Ta on Eesti Radioloogia Ühingu endine president (2004-2010), Euroopa Radioloogia Ühingu ja Soome e-tervise ja Telemeditsiini Ühingu liige. Hariduskäik Õppeasutus (nimetus lõpetamise ajal) Lõpetamise aeg Haridus (eriala/kraad) Tallinna Tehnikaülikool 2011 Matemaatika- ja loodusteaduskond; Mehaanikateaduskond / PhD Healthcare engineering Tartu Ülikool 1996 Radioloogia ja onkoloogia osakond, Tartu Ülikool / Radioloog Tartu Riiklik Ülikool 1991 Arstiteaduskond / Arst Keeleoskus (alg-, kesk- või kõrgtase) Keel Tase Eesti Emakeel Inglise Kõrgtase Soome Kõrgtase Vene Kesktase Täiendusõpe Täiendusõppe nimetus Õppimise aeg Täiendusõppe läbiviija nimetus Visiting scolar 5-6/2013 Stanfordi Ülikool, California, USA European Health Leadership Program 1/2005 INSEAD, Prantsusmaa Course of Radiologic Pathology 2/1996-4/1996 Armed Forces Institute of Pathology, Washington DC, USA Residentuuri kursus 10/1995-12/1995 Radioloogia osakond, Oulu University, Soome Teenistuskäik Töötamise aeg Tööandja Ametikoht Alates 2010 Tallinna Tehnikaülikool Professor (alates 2015), vanemteadur, keskuse juhataja Alates 2013 Maailmapank Konsultant Alates 2019 Aasia Arengupank Konsultant Alates 2008 SMIS International OÜ Omanik, tegevjuht Alates 1996 Tallinna Keskhaigla / Ida-Tallinna Keskhaigla Radioloog 2006-2016 Tehnomeedikum, Tallinna Tehnikaülikool Nõukogu liige 2010-2016 Eesti E-Tervise Sihtasutus E-tervise ekspert 2004-2010 Ida-Tallinna Keskhaigla Juhatuse liige – arendusjuht 2005-2010 Eesti E-Tervise Sihtasutus Nõukogu liige 2002-2008 Eesti Haigekassa Nõukogu liige 2002-2004 Ida-Tallinna Keskhaigla Diagnostikakliiniku juhataja 1994-1996 Radioloogia ja onkoloogia osakond, Tartu Ülikool Resident 1992-1994 Meremeeste haigla Intern 1991 Helsingi Ülikooli sisehaiguste osakond Intern Õppetegevus Perearstide digitaalse kirjaoskuse suurendamise koolitus . Sihtgrupp : Perearstid . Koolituse periood : 2020-2022 Targa tellija koolitus - IT arenduste tellimise koolitus tervishoiuvaldkonna töötajatele . Sihtgrupp : Perearstid . Koolituse periood : 2019 SA Põhja-Eesti Regionaalhaigla „ Regionaalhaigla juhtide arendusprogramm “ . Sihtgrupp : Keskastme juhid . Koolituse periood : 2018-2019 IT- alane koolitus tervishoiu valdkonna töötajatele ja valdkondlike tarkavara rakenduse loojatele . Sihtgrupp : Tervishoiutöötajad /IT- arendajad . Koolituse periood : 2016-20 TTÜ Tervishoiutehnoloogia magistriprogramm . Sihtgrupp : Magistriüliõpilased . Koolituse periood : 2009-2020 Teadustegevus Elektroonsete tervishoiuteenuste kasutusele võtmise mõju tervishoius toimivatele diagnostika - ja raviprotsessidele Teadustöö põhisuunad. Jagatud töövoo rakendamist mõjutavate tegurite ja protsesside uurimine . Digitaalsete kliiniliste andmebaaside kasutamine haiguste varajase diagnoosimise algoritmide välja töötamiseks . Telemeditsiini rakenduste välja töötamine ja mõju hindamine . Meditsiinitekstide kui meditsiini allkeele uurimine . Publikatsioonid Sogomonjan , M.; Kerikmäe , T.; Ööpik , P.; Ross, P. (2019). A Report on the Survey. Attitudes of Estonian Healthcare Professionals to Internet-delivered Cognitive Behavioural Therapy. Cogent Psychology, 7 [forthcoming]. Koppel, T.; Ross, P.; Vilcane , I. (2018). Shielding static magnetic fields from Magnetic Resonance Imaging units by ferromagnetic material. EMBEC & NBC 2017: Joint Conference of the European Medical and Biological Engineering Conference (EMBEC) / Nordic-Baltic Conference on Biomedical Engineering and Medical Physics (NBC); Tampere, Finland; June 2017. Ed. Eskola , H; Vaisanen , O; Viik , J; Hyttinen , J. Springer-Verlag Singapore, 743−746. Metsallik , Janek ; Ross, Peeter ; Draheim , Dirk; Piho , Gunnar (2018). Ten years of the e-Health system in Estonia. MMHS : Proceedings of the 3rd International Workshop on (Meta)Modelling for Healthcare Systems Bergen, Norway, June 13th, 2018. Ed. Rutle , Adrian; Lamo , Yngve ; MacCaull , Wendy; Iovino, Ludovico. Aachen: RWTH Aachen University, 6−15. (CEUR Workshop Proceedings; 2336). Metsallik , Janek ; Ross, Peeter (2018). Das eHealth-System in Estland – Estonian Nation-wide Health Information System. Experience since 2008. Trill, Roland. Praxisbuch eHealth: Von der Idee zur Umsetzung (266−284). Stuttgart: Kohlhammer . Ross, Peeter (2018). Importance of data quality in nation-wide e-health system for personalized medicine decision support applications. Eesti Arst , 97 (Lisa 1): 7th Baltic Atherosclerosis Society Congress; Tallinn, Estonia; April 6-7, 2018. OÜ Celsius Healthcare, 31. Es s én , A; Isabella Scandurra , I; Gerrits , R; Humphrey, G; Johansen, MA; Kiergegaard , P; Koskinen, J; Liaw , S-T; Odeh, S; Ross, P; Ancker , JS. Patient access to electronic health records: Differences across ten countries. Health Policy and Technology (2017), https://doi.org/10.1016/j.hlpt.2017.11.003 Ross, P. E-Health Innovations in Estonia CARDIOLOGY Volume: 131, Supplement: 1. Pages: 14-14 , Meeting Abstract: O-17. Published: JUN 2015 Valdre , E.; Ross, P.; Tsepelina , K.; Veskis , K.; Vaino , T.; Kaalep , H.-J. (2014). Corpus-based analysis of abbreviations and abbreviating in Estonian radiology reports (In Estonian – Radioloogiauuringute vastuste lühendite ja lühendamise korpuslingvistiline analüüs ). Eesti Arst , 93(9), 502 - 512. Parv L, Kruus P, Mõtte K, Ross P. An evaluation of e-prescribing at a national level. Inform Health Soc Care, Early Online: 1–18, 2014. Informa UK Ltd. ISSN: 1753-8157 print / 1753-8165 online DOI: 10.3109/17538157.2014.948170 Ristolainen A, Ross P, Gavšin J, Semjonov E, Kruusmaa M. Economically affordable anatomical kidney phantom with calyxes for puncture and drainage training in interventional urology and radiology Acta Radiologica Short Reports June 2014 3: 2047981614534231, first published on June 13, 2014 doi:10.1177/2047981614534231 Ranschaert E, Bosmans J, Ross P, Dugar N, Schillebeeckx J, Mildenberger P, Ratib O. ESR white paper on teleradiology: an update from the teleradiology subgroup. Insights into Imaging 01/2014; DOI:10.1007/s13244-013-0307-z Lin L, Ross P, Kruusmaa M. Ultrasound image segmentation by Bhattacharyya distance with Rayleigh distribution. In Signal Processing: Algorithms, Architectures, Arrangements, and Applications (SPA), 2013, pp. 149-153. IEEE, 2013. de Lusignan S , Ross P , HYPERLINK "http://europepmc.org/search?page=1&query=AUTH:%22Seroussi+B%22" \h Seroussi B . A comparison of approaches to providing patients access to summary care records across old and new Europe: an exploration of facilitators and barriers to implementation. Studies in Health Technology and Informatics [2013, 192:397-401] Ross P, Mill R. Digital data sharing profiles in Healthcare ( HYPERLINK \h Digitaalsete dokumentide jagamise standardprofiilid tervishoius ). (2013). Eesti Arst 2013; 92(9):516–523 Ross P. Web-based access to personal health data : an overview of the usage of patient portals (In Estonian - Veebipõhine ligipääs isiklikele terviseandmetele: patsiendiportaalide kasutamise ülevaade ). Eesti Arst 2013; 92(3):145–151 Hunt A , Ristolainen A , Ross P , Opik R , Krumme A , Kruusmaa M . Low cost anatomically realistic renal biopsy phantoms for interventional radiology trainees. Eur J Radiol . 2013 Apr;82(4):594-600. doi : 10.1016/j.ejrad.2012.12.020. Epub 2013 Feb 8. Marko-Varga, G.; Végvári , Á.; Rezeli , M.; Prikk, K.; Ross , P.; Dahlbäck , M.; Edula , G.; Sepper , R.; Fehniger , T. (2012). Understanding Drug Uptake and Binding within Targeted Disease Micro-Environments in Patients : A New Tool for Translational Medicine . Clinical and Translational Medicine , 1( May ), 9 pp . Ross P. Regionaalse telemeditsiini foorum : Euroopa parimate telemeditsiiniteenuste analüüs ja näited (In Estonian). Eesti Arst 2012; 91(7):340–341 Parv L, Saluse J, Aaviksoo A, Tiik M, Sepper R, Ross P. Economic impact of a nationwide interoperable e- Health system using the PENG evaluation tool. Stud Health Technol Inform. 2012;180:876 -80. PMID: 22874318 Fehniger , T.E.; Végvári , A.; Rezeli , M.; Prikk, K; Ross , P.; Dahlbäck , M.; Edula , G.; Sepper , R.; Marko-Varga, G. (2011). Direct Demonstration of Tissue Uptake of an Inhaled Drug : Proof -of- Principle Study Using Matrix -Assisted Laser Desorption Ionization Mass Spectrometry Imaging. Anal Chem . 2011 Nov 1;83(21):8329-36. doi : 10.1021/ac2014349. Epub 2011 Oct 7. Sepper , R.; Ross , P.; Tiik, M. (2011). Nationwide health data management system : a novel approach for integrating biomarker measurements with comprehensive health records in large populations studies . Journal of Proteome Research , 10, 97 - 100. Lin Li, Peeter Ross, Maarja Kruusmaa , and Xiaosong Zheng. 2011. A comparative study of ultrasound image segmentation algorithms for segmenting kidney tumors. In Proceedings of the 4th International Symposium on Applied Sciences in Biomedical and Communication Technologies (ISABEL '11). ACM, New York, NY, USA , , Article 126 , 5 pages. DOI=10.1145/2093698.2093824 http://doi.acm.org/10.1145/2093698.2093824 Reilent , E.; Kuusik, A.; Lõõbas , I.; Ross , P. (2011). Improving the data compatibility of PHR and telecare solutions . In: 5th European Conference of the International Federation for Medical and Biological Engineering 14 - 18 September 2011, Budapest, Hungary : ( Eds .) Jobbágy , Á.. Springer , 2011, (IFMBE Proceedings ; 37), 925 - 928. Reilent , E.; Lõõbas , I.; Kuusik, A.; Parve, M.; Ross , P. (2011). Extendable Data Model for Universal Health Records . AMA-IEEE Medical Technology Conference , Boston, 16-18 October 2011. , 2011. [in press] Ross P, Pohjonen H. Images crossing borders : image and workflow sharing on multiple levels . Insights into Imaging, 2010, Vol 2, No 2 , 141-148 Tiik M, Ross P. Patient opportunities in the Estonian Electronic Health Record System . Stud Health Technol Inform. 2010;156:171 -7. Ross P, Sepper R, Pohjonen H. Cross-border teleradiology – experience from two international teleradiology projects. European Journal of Radiology 73 (2010) 20–25 Saluse J, Aaviksoo A, Ross P, Tiik M, Parv L, Sepper R, Pohjonen H, Jakovlev Ü, Enni K. Eesti terviseinfosüsteemi majandusmõju/puhastulu hindamine. TOF-DIGIMÕJU projekti lõpparuanne (Assessing the Net Benefits of the Estonian Electronic Health Record System). Eesti Arst 2010; 89(10):659−696 Teleradioloogia hetkeseis ja võimalused (In Estonian). Ross , P. (2008). Eesti Arst, 87, 731 - 732. Ross , P. (2008). Activities of the Estonian Society of Radiology . Eesti Arst, 87, 700 - 702. Comprehensive view of a medical case is provided for the professionals and patients by seamless integration of electronic health data and images . Ross , P.; Parve, M.; Luumann, T.; Siinmaa, P.; Valdre , E. (2008). Eesti Arst: Baltic Conference of Radiology 2008, Tartu 24.10.2008., 2008, (10), 720. Pohjonen , H.; Ross , P.; Blickman , J-H. (2008). Extending the radiological workplace across the borders . Gao , X. H.; Muller , H.; Loomes, M.; Comley , R.; Luo , S. ( Eds .). Medical Imaging and Informatics : 2nd International Conference , MIMI 2007, Beijing, China , August 14-16, 2007 Revised Selected Papers (12 - 17). Springer Pohjonen , H.; Ross , P.; Blickman , J.; Kamman , R. (2007). Pervasive access to images and data – The use of computing grids and mobile / wireless devices across healthcare enterprises . . IEEE Transactions on Information Technology in Biomedicine , 11, 81 - 86. Estonia leads the way in Baltic eHealth links. http://www.european-hospital.com/topics/article/995.html Andmekoosseis Päring 1 30-70 aasta vanused inimesed, kes on surnud mittenakkuslikesse haigustesse ajavahemikus 1. jaanuarist kuni 31. detsembrini 2019. aastal. RHK koodid: I00–I99, COO−C97, E10−E14 ja J30−J98. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Enneaegne mittenakkuslikesse haigustesse suremus . Päring 2 Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud vereplasma glükoosisisaldus rohkem kui 7 mmol /l. Kõik normist kõrgemad glükoosisisalduse mõõtmiste väärtused. Sama valim, kellel on mõõdetud vere glük o hemoglobiini (Lühend B-HbA1c) sisaldust. Kõik glük o hemoglobiini mõõtmiste väärtused inimese lõikes aasta jooksul. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal diagnoositud diabeet, eraldi andmeveerus esmaselt diagnoositud diabeet. RHK koodid E10-E14. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): täiskasvanute kõrgenenud vere glükoosisisaldus / diabeet . Päring 3 Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud samal kuupäeval (± 1 nädal) kaal ja pikkus. Sama valim, kelle l on mõõdetud vööümbermõõt. Eraldi andmeveergudena kaal, pikkus, vööümbermõõt. Kõik aasta jooksul tehtud mõõtmised. Indikaator: Riskifaktorid (mittenakkuslikud haigused): Täiskasvanute ülekaalulisus ja rasvumin e . Päring 4. Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid füüsilise aktiivsuse kohta (näit. keskmise või kõrge intensiivsusega füüsiline koormus minutites ühes nädalas . Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Täiskasvanute ebapiisav füüsiline aktiivsus. Päring 5. Kõik inimesed alates 15. eluaastast, kelle kohta on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid tubakatoodete tarbimise kohta. Andmeveergudes sigarettide arv päevas ja suitsetatud aastate hulk. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Tubakatoodete tarbimine vanemate kui 15. aastaste hulgas. Päring 6. Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud kõrgenenud vererõhuväärtusi rahulolekus õlavarrelt ( s üstoolne vererõhk ≥ 140 mmHg ja diastoolne vererõhk ≥ 90 mmHg ). Kõik kõrgenenud vererõhuväärtused inimese kohta. Indikaator: Riskifaktorid (mittenakkuslikud haigused): Kõrgenenud vererõhk täiskasvanutel . Päring 7. Kõik inimesed, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal diagnoositud vähki. RHK koodid C00-C97. Eraldi ridadena vähi tüüp (RHK kood). Ainult patsiendid, kellel on antud ajavahemikus vähk diagnoositud esmakordselt. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Tervise staatus (haigestumus): Vähi esmashaigestumus tüübi järgi. Päring 8. Kõik inimesed alates 15. eluaastast, kelle kohta on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid alkoholi tarbimise kohta. Andmeveergudes aastas tarbitud alkoholi hulk liitrites (või alkoholiühikutes ehk 1 alkoholiühik on 10 g puhast alkoholi). Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Alkoholitoodete tarbimine vanemate kui 15. aastaste hulgas. Päring 9. Kõik naised vanuses 30-49 eluaastat, kes on 1. jaanuarist kuni 31. detsembrini 2019. aastal käinud emakakaelavähi sõeluuringul. Eraldi andmeveergudena vanus, elukoht (maakonna või valla/linna täpsusega). Kõik tervishoiuteenuse osutajad , kes on 1. jaanuarist kuni 31. detsembrini 2019. aastal läbi viinud emakakaelavähi sõeluuringuid. Ridades asutus, andmeveergudes sõeluuringul käinud naiste hulk. Indikaator: Teenusega kindlustamine (sõeluuringud ja ennetus): Emakakaelavähi sõeluuring . Päring 10 Juhuslikult valitud 90 patsienti vanuses 30-70 aastat, kellel on diagnoositud üks neist RHK10 koodiga I00–I99, C00−C97, E10−E14 kroonilisest haigusest (30 patsienti igast grupist). Patsiendi kõik andmed, mis on Tervise infosüsteemi saadetud ajavahemikus 1. jaanuarist kuni 31. detsembrini 2019. aastal. Peeter Ross Tallinna Tehnikaülikool Teie 24.03.2021 / [email protected] Meie 05.04.2021 nr 1.5-20/1085-2 Vastutava töötleja luba Lugupeetud Peeter Ross Teadusuuringu läbiviija on edastanud Sotsiaalministeeriumile taotluse andmete väljastamiseks tervise infosüsteemist. Andmeid vajatakse Norra finatsmehhanismist kaasrahastatava programmi „Green ICT“ projekti „Health Sense“ raames läbiviidava uuringu „Universaalse andmemudeli ja raviteekondade järjepidevuse standardi väljatöötamine lähtudes rahvusvahelistest uue põlvkonna terviseinfosüsteemide standarditest“ läbiviimiseks. Uurimistöö eesmärgiks on töötada välja ja piloteerida uue põlvkonna tervise infosüsteemi (upTIS) jaoks uus e-tervise andmemudel, mis oleks universaalne ning ülekantav teistele suuremahulistele digitaalsetele tervise infosüsteemidele. Samuti töötada välja raviteekondade järjepidevuse standard, et tagada upTIS-e semantiline koosvõime ning luua terminoloogia andmebaasi struktuur ning esitleda seda tervishoiutöötajatele. Tervise infosüsteemist soovitakse patsientide andmeid vastavalt lisas 3 välja toodud kümnele päringule vahemikus 1. jaanuar – 31. detsember 2019. Uuring lõpeb 31. jaanuaril 2023. Lähtuvalt isikuandmete kaitse seaduse § 6 lõigetest 3 ja 4 ning tuginedes Eesti Bioeetika ja Inimuuringute Nõukogu 22. märtsi 2021 otsusele nr 1.1-12/186, annab Sotsiaalministeerium nõusoleku taotluse lisas 3 toodud ja eelnevalt kirjeldatud ulatuses ja mahus pseudonüümitud ja hägustatud andmete väljastamiseks tervise infosüsteemist. Pseudonüümimisel kaotatakse andmetest isikukood, isiku nimed, dokumendinumbrid ning asendatakse isikukohase pseudonüümimiskoodiga. Andmed väljastatakse Tervise ja Heaolu Infosüsteemise Keskuse poolt turvalisel andmekandjal ja krüpteeritakse vastutava uurija Peeter Rossi nimele ning koostatakse andmete väljastusprotokoll. TEHIK säilitab isikukood-pseudonüüm vastavustabeli järgnevateks andmeväljastusteks (tuginedes lisale 3) kuni uuringu lõpuni 31. jaanuar 2023. Lugupidamisega (allkirjastatud digitaalselt) Marika Priske kantsler Lisa: 1. Taotlus tervise infosüsteemist andmete väljastamiseks 2. Eesti Bioeetika ja Inimuuringute Nõukogu 22. märtsi 2021 otsus nr 1.1-12/186 3. Lisa 3 - Andmekoosseis Lisaadressaadid: Tervise ja Heaolu Infosüsteemide Keskus Mai-Liis Kullama 6269 702 [email protected] Suur-Ameerika 1 / 10122 Tallinn / 626 9301 / [email protected] / www.sm.ee / registrikood 70001952 Andmekoosseis Päring 1 30-70 aasta vanused inimesed, kes on surnud mittenakkuslikesse haigustesse ajavahemikus 1. jaanuarist kuni 31. detsembrini 2019. aastal. RHK koodid: I00–I99, COO−C97, E10−E14 and J30−J98. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Enneaegne mittenakkuslikesse haigustesse suremus . Päring 2 Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud vereplasma glükoosisisaldus rohkem kui 7 mmol /l. Kõik normist kõrgemad glükoosisisalduse mõõtmiste väärtused. Sama valim, kellel on mõõdetud vere glük o hemoglobiini (Lühend B-HbA1c) sisaldust. Kõik glük o hemoglobiini mõõtmiste väärtused inimese lõikes aasta jooksul. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal diagnoositud diabeet, eraldi andmeveerus esmaselt diagnoositud diabeet. RHK koodid E10-E14. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): täiskasvanute kõrgenenud vere glükoosisisaldus / diabeet . Päring 3 Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud samal kuupäeval (± 1 nädal) kaal ja pikkus. Sama valim, kelle l on mõõdetud vööümbermõõt. Eraldi andmeveergudena kaal, pikkus, vööümbermõõt. Kõik aasta jooksul tehtud mõõtmised. Indikaator: Riskifaktorid (mittenakkuslikud haigused): Täiskasvanute ülekaalulisus ja rasvumin e . Päring 4. Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid füüsilise aktiivsuse kohta (näit. keskmise või kõrge intensiivsusega füüsiline koormus minutites ühes nädalas . Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Täiskasvanute ebapiisav füüsiline aktiivsus. Päring 5. Kõik inimesed alates 15. eluaastast, kelle kohta on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid tubakatoodete tarbimise kohta. Andmeveergudes sigarettide arv päevas ja suitsetatud aastate hulk. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Tubakatoodete tarbimine vanemate kui 15. aastaste hulgas. Päring 6. Kõik inimesed alates 18. eluaastast, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal mõõdetud kõrgenenud vererõhuväärtusi rahulolekus õlavarrelt ( s üstoolne vererõhk ≥ 140 mmHg ja diastoolne vererõhk ≥ 90 mmHg ). Kõik kõrgenenud vererõhuväärtused inimese kohta. Indikaator: Riskifaktorid (mittenakkuslikud haigused): Kõrgenenud vererõhk täiskasvanutel . Päring 7. Kõik inimesed, kellel on 1. jaanuarist kuni 31. detsembrini 2019. aastal diagnoositud vähki. RHK koodid C00-C97. Eraldi ridadena vähi tüüp (RHK kood). Ainult patsiendid, kellel on antud ajavahemikus vähk diagnoositud esmakordselt. Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Tervise staatus (haigestumus): Vähi esmashaigestumus tüübi järgi. Päring 8. Kõik inimesed alates 15. eluaastast, kelle kohta on 1. jaanuarist kuni 31. detsembrini 2019. aastal kogutud andmeid alkoholi tarbimise kohta. Andmeveergudes aastas tarbitud alkoholi hulk liitrites (või alkoholiühikutes ehk 1 alkoholiühik on 10 g puhast alkoholi). Eraldi andmeveergudena vanus, sugu, elukoht (maakonna või valla/linna täpsusega). Indikaator: Riskifaktorid (mittenakkuslikud haigused): Alkoholitoodete tarbimine vanemate kui 15. aastaste hulgas. Päring 9. Kõik naised vanuses 30-49 eluaastat, kes on 1. jaanuarist kuni 31. detsembrini 2019. aastal käinud emakakaelavähi sõeluuringul. Eraldi andmeveergudena vanus, elukoht (maakonna või valla/linna täpsusega). Kõik tervishoiuteenuse osutajad, kes on 1. jaanuarist kuni 31. detsembrini 2019. aastal läbi viinud emakakaelavähi sõeluuringuid. Ridades asutus, andmeveergudes sõeluuringul käinud naiste hulk. Indikaator: Teenusega kindlustamine (sõeluuringud ja ennetus): Emakakaelavähi sõeluuring . Päring 10 Juhuslikult valitud 90 patsienti vanuses 30-70 aastat, kellel on diagnoositud üks neist RHK10 koodiga I00–I99, C00−C97, E10−E14 kroonilisest haigusest (30 patsienti igast grupist). Patsiendi kõik andmed, mis on Tervise infosüsteemi saadetud ajavahemikus 1. jaanuarist kuni 31. detsembrini 2019. aastal.