1. The eHealth platform: current situation and future perspectives Leuven.Inc Frank Robben General manager of the eHealth platform Quai de Willebroeck 38 B-1000 Brussels E-mail: Frank.Robben@ehealth.fgov.be Website eHealth platform https://www.ehealth.fgov.be Personal website: www.frankrobben.be 13/05/2014

2. Some evolutions in health care more chronic care instead of merely acute care remote care (monitoring, assistance, consultation, diagnosis, operation,...), and home care multidisciplinary, transmural and integrated care patient-oriented care and patient empowerment rapidly evolving knowledge => need for reliable and coordinated management and access to knowledge threat of excessively time-consuming administrative processes thorough support of health care policy and research requires thorough, integrated and anonymised information cross-border mobility need for cost control 2 13/05/2014

3. These evolutions require... collaboration between all actors in health care efficient and safe electronic communication between all actors in health care high-quality electronic patient files, across specialties care pathways optimised administrative processes technical and semantic interoperability guarantees concerning – information security – privacy protection – respect for the professional secrecy of health care providers 13/05/2014 3

4. Overall objectives of the eHealth platform how? – through a well-organised, mutual electronic service and information exchange between all actors in health care – by providing the necessary guarantees with regard to information security, privacy protection and professional secrecy what? – optimisation of health care quality and continuity – optimisation of patient safety – simplification of administrative burden for all actors in health care – thorough support of health care policy and research 13/05/2014 4

5. eHealth platform In practice The patient consults his doctor Administrative advantages Possibility to register therapeutic relationships and informed consent 5 13/05/2014

6. Medical advantages eHealth platform In practice Laboratory results Look up medical history through the SumEHR Medication schedule Online advice and guidelines Electronic medical referral form Electronic prescriptions 6 13/05/2014

7. Adminis- trative advantages eHealth platform In practice Tarification, billing Create and send certificates Update SumEHR, medication schedule,... Send a report to the GMF owner Registrations 7 13/05/2014

8. Basic services eHealth platform Network Basic architecture 13/05/2014 Patients, health care providers and health care institutions VASVASVAS Suppliers Users Overall objectives of the eHealth platform Overall objectives of the eHealth platform Health portal Health portal AVS Software health care institution Software health care institution AVS MyCareNet AVS Software health care provider Software health care provider AVS Site NIHDI Site NIHDI AVS VASVASVAS 8

9. 10 missions 1.development of a vision and a strategy with regard to eHealth 2.organisation of collaboration between other government agencies charged with coordinating electronic services 3.acting as a key driver for the necessary changes in order to carry out the vision and strategy with regard to eHealth 4.establishing the functional and technical norms, standards and specifications and the basic ICT architecture 5.registration of software for management of electronic patient files 13/05/2014 9

10. 10 missions 6.creation, development and management of a cooperative platform for safe electronic data exchange with the corresponding basic services 7.to agree on task division and quality standards with regard to information storage, and to verify whether these standards are complied with 8.as an independent trusted third party (TTP), being in charge of the coding and anonymisation of personal health data for the benefit of specific agencies, as established by law, in order to support scientific research and policy 9.promoting and coordinating the development of programs and projects 10.managing and coordinating the ICT aspects of data exchange within the framework of electronic patient files and electronic medical prescriptions 13/05/2014 10

11. 10 basic services 13/05/2014 1.integrated user and access management 2.orchestration of electronic subprocesses 3.portal environment (https://www.ehealth.fgov.be)https://www.ehealth.fgov.be 4.logging management 5.system for end-to-end encryption 6.personal electronic mailbox for each health care provider (eHealthBox) 7.timestamping 8.coding and anonymisation 9.consultation of the National Register and of the Crossroads Bank Registers 10.reference directory (metahub) 11

12. 6.1.integrated user and access management: makes it possible to guarantee that only authorised health care providers/ health care institutions have access to personal data to which they are authorised to have access access rules are defined by, among other things, the law and authorisations issued by the Health Section of the Sectoral Committee (established within the Privacy Commission) each application defines its own access rules when a user authenticates his identity (using the electronic identity card or token), the generic verification model of the tool is set in motion: it consults the rules established for the application, verifies if the user does indeed meet these rules and accordingly grants or restricts access to the application 10 basic services 13/05/2014 12

13. Integrated user and access management 13 13/05/2014

14. 6.2.orchestration of electronic subprocesses: allows for the flexible and harmonious integration of the different processes that are linked to the implementation of several basic services into one, single application 6.3.portal environment: a web window offering a variety of online services to health care actors in order to help them provide the best possible health care; the portal environment provides all useful information on the services that are offered by the eHealth platform, its tasks, its standards, etc. It contains, among other things, the documents users need to configure the right settings in order for them to have access to the available online services 10 basic services 13/05/2014 14

15. 6.4.logging management: management of a register of access to the information management system: all read, write and delete accesses are registered and have probative value in case of a complaint 6.5.system for end-to-end encryption: transfer of complete and unmodified data from one point to another by making them indecipherable (encryption), provided that these data have not been decrypted with a key Two methods: In the case of a known recipient: use of an asymmetric encryption system (2 keys) In the case of an unknown recipient: use of symmetric encryption (the information is encrypted and stored outside the eHealth platform; the decryption key can only be obtained through the eHealth platform) 10 basic services 13/05/2014 15

16. Encryption for a known recipient eHealth platform Health care actor person or entity Internet Identification certificate Identification certificate Web service Register key Connector or other software to generate key pair Sends public key Stores private key in a secure way Public keys repository 1 2 2 Authenticates sender Stores public key 3 4 16 13/05/2014

17. Identification certificate Encryption for a known recipient Internet eHealth platform Public keys repository Authenticates sender Sends public key 2.2. 3 Message originator Identification certificate Asks for public key Encrypts message 4 1 Message recipient Decrypts message 5 Stored private key Identification certificate Web service Ask public key Send message Any protocol 17 13/05/2014

18. Encryption for an unknown recipient User 2 Recipient User 1 Originator Key Management / Depot Messages Depot 1 asks for key 2 sends key Symmetric key Encrypted with public key of user 1 3 sends encrypted message Message encrypted with symmetric key Encrypted with public key of Message depot Message encrypted with symmetric key 4 justifies right to obtain key 4 justifies right to obtain message Symmetric key Encrypted with public key of user 2 5 receives key 5 receives message Message encrypted with symmetric key Encrypted with public key of User 2 18 13/05/2014

19. 6.6.timestamping: makes it possible to assign a time and date, accurate to the second, to a health care document and thereby makes it possible to permanently ensure the validity of its content by appending an eHealth signature 6.7.coding and anonymisation: makes it possible to hide the identity of individuals behind a code, so that the useful data of these individuals can be used without infringing on their privacy + makes data anonymisation possible by replacing patients’ detailed characteristics with generalised characteristics. These encoded or anonymised data preserve their usefulness, but without allowing the direct or indirect identification of the person 10 basic services 13/05/2014 19

20. Trusted Third Party (TTP) Use Case : A university wants to study the impact of a medical treatment on patients by crossing medical informations from multiple sources (hospitals, cancer registry, insurance, …)  Most of these medical information is confidential and highly sensitive  Warranty must be provided that privacy, professional secrecy and patient rights are not violated when medical data are communicated 13/05/2014 20

21. Trusted Third Party (TTP) Solution : eHealth platform assumes the role of « trusted third party » (go-between organization) between instances identified by the law eHealth, by coding patient ID’s such as SSIN (Social Security Inscription Number), ensures that a patient cannot be identified directly or indirectly and thus that privacy, medical secret and patient rights are well respected this role is executed under the supervision of a Sectoral Committee 13/05/2014 21

22. In practice eHealth platform doesn’t perform consolidation or small cell risk analysis > this role must be assigned to a Data Manager 13/05/2014 22 By this way only eHealth platform can relate patientID’s with the code and separation between data sources and researchers is guaranteed reidentification of a patient can thus only be performed via eHealth platform medical data (=MD) must normally be encrypted by the source > by this way eHealth platform has only access to the patientID n most cases, this process can be automated by using the eHealthBox Researcher

23. Useful links all information concerning eHealth platform TTP service is available at the eHealth portal https://www.ehealth.fgov.be/fr/support/services-de-base/codage-et-anonymisationhttps://www.ehealth.fgov.be/fr/support/services-de-base/codage-et-anonymisation (FR) https://www.ehealth.fgov.be/nl/support/basisdiensten/codering-en-anonimiseringhttps://www.ehealth.fgov.be/nl/support/basisdiensten/codering-en-anonimisering (NL) information requests can be submitted by mail at the address: TTP@ehealth.fgov.be 13/05/2014 23

24. Application of timestamping: electronic prescriptions in hospitals Prescription A 1 Hashcode A 2 Prescription B Hashcode B Timestamp bag Electronic timestamping 4 Electronic signature 5 Archive 6 6 3 24 13/05/2014

25. 6.8.consultation of the National Register and Crossroads Bank Registers: authorised health care actors access the National Register and the Crossroads Bank Registers under strict conditions 6.9.eHealthBox: a secured electronic mailbox for the exchange of medical data 6.10.reference directory: indicates which types of data are stored, by which health care actors and for which patients, with the consent of said patients 10 basic services 13/05/2014 25

26. Value-added services 65 value-added services in production > 40 value-added services under study examples of value-added services: registration in and consultation of – cancer registry – registry of hip and knee prostheses (Orthopride) – registries of care provided for heart implants (Qermid) – shared electronic arthritis file, including electronic processes for the reimbursement of anti-TNF medication (Safe) 13/05/2014 26

27. Value-added services PROCARE RX allows radiologists to upload and send anonymous X-rays and information to experts for review or a second opinion management of on-call GP and dentist shifts (Medega) reports on MUG interventions electronic communication to the owner of a global medical file (GMF) of the reports drawn up by on-call GPs Resident Assessment Instrument (BelRAI) electronic consultation of patients' health insurance coverage by nurses 13/05/2014 27

28. Value-added services SARAI care portal of the Antwerp Hospital Network ('Ziekenhuisnetwerk Antwerpen'-ZNA) in support of – collaboration between GPs, specialists and health care teams within the NIHDI health care programs (diabetes and renal insufficiency) – the contribution of GPs to the multidisciplinary oncology consultation electronic forwarding of third party invoices by nurses (nurse groups) to health insurance funds quality indicator for hospitals (QI dataserver) registration of the emergency services data of 2 participating hospitals electronic medical card for people without documents (eCarmed) 13/05/2014 28

29. Value-added services platform for data exchange between the Flemish Agency for Care and Health and the services recognised by the Agency (VESTA) support of the electronic care prescription in 108 hospitals (77 % of hospitals) consultation of living wills regarding euthanasia electronic registration and consultation of the medical evaluation of disabled people in the FPS Social Security information system (Medic-e) online registration system for private facilities within the sector of special youth care in Flanders electronic birth registration – eBirth 13/05/2014 29

30. Cornerstone: Multidisciplinary data sharing 1.data transmission – snapshot of the data – sender chooses recipient – sender is responsible for sending the data only to recipients who are entitled to have access to these data 2.data sharing – evolutive data – the source does not know in advance who will consult the data (e.g. on-call GP) – necessity of clarifying which people are entitled to have access to the data 13/05/2014 30

31. Data transfer: eHealthBox: sending of messages to "actors in health care" – based on national Register number NIHDI number CBE number – through web application or integrated into the medical file – with (or without) encryption based on eHealth certificates/ eHealth keys – other functionalities receipt, publication and reading confirmation reply & forward check multiple mailboxes priority level auto delete – an average of 1.6 million messages sent per month to the eHealthBox (multiple recipients) – an average of 2.4 million messages downloaded per month through the eHealthBox 13/05/2014 31

32. Multidisciplinary data sharing 1.data from hospitals – sharing of documents between hospitals and doctors – “hubs and metahub system” 2.extramural data – sharing of structured data between first-line health care providers and other extramural health care providers – “extramural vaults” 3.coupled and interoperable – standards – informed consent – therapeutic relationship/ health care relationship 13/05/2014 32

33. Hubs & Metahub system: Creation of the "hubs" 5 hubs 3 technical implementations 98 % of Belgian hospitals (have signed the 2012 protocol) 13/05/2014 33

34. Hub-metahub: currently 34 13/05/2014

35. Hub-metahub: in future A C B 1: Where can we find data? 3. Retrieve data from hub A 3: Retrieve data from hub C 4: All data available 2: In hub A and C 35 13/05/2014

36. Extramural data 1/2 supporting the development of data exchange platforms for all sorts of extramural health care providers (GPs, dentists, pharmacists, physiotherapists, home nurses, dietitians, psychologists,...) – in cooperation with Communities (first-line health care conference in Flanders, the Intermed initiative in Wallonia) – for the disclosure of data via the hub/metahub system between local information systems of extramural health care providers and between these systems and the information systems of health care/welfare organizations – for the interaction with extramural vaults awaiting development – by reusing the basic services of the eHealth platform and by making use of several achievements of the developed data sharing platform between hospitals and GPs/doctors 13/05/2014 36

37. Extramural data 2/2 A C B Inter- Med 37 13/05/2014

38. Data sharing Each actor keeps their own file up to date However, they can decide to share parts of the file with other actors Examples: medication schedule SUMEHR parameters journal … 38 13/05/2014

39. Access for health care providers having a "health care relationship" depending on their role No access for IT administrators, hoster,.. eHealth platform authorities without the active cooperation of the owner of the 2 nd key Vault Governance Archiving Management Vault data Authentication...Authorisation Data quality Encryption Decryption Authentication Vault connector Treshold decryptie Trusted 3rd party 2 1.1. Vault core 39 13/05/2014

40. Informed consent & therapeutic relationship content of informed consent – for registration in the reference directory (as required by the eHealth law) – for the electronic exchange of health data between health care providers within the framework of patient health care, as long as the following conditions are met: approval by the Sectoral Committee therapeutic relationship required only relevant data the patient decides, in consultation with the health care provider, which data will be shared health care providers may be excluded by name possibility of a posteriori verification of the granted access consent may be revoked at any given time 13/05/2014 40

41. registration of informed consent – patient is informed about the system – specific procedure approved by the Board of Directors and the Sectoral Committee – consent can be registered through eHealth consent either by the concerned person themselves or by a doctor, a pharmacist, a hospital or a health insurance fund – https://www.ehealth.fgov.be/fr/prestataires-de-soins/services-en- ligne/ehealthconsent therapeutic relationship – only health care providers who have a therapeutic relationship with the patient (1) can access the information they need to perform their task (2) (1) proof of therapeutic relationship determines which patient the health care provider has access to (2) role determines which type of data the health care provider has access to Informed consent & therapeutic relationship 41 13/05/2014

42. eHealthConsent 42 13/05/2014

43. eHealthConsent 43 13/05/2014

44. eHealthConsent 13/05/2014 44

45. eHealthConsent 13/05/2014 45

46. Health care computerization Plan 2013-2018 / Overview at the end of 2012, organization of a Round table regarding the development of health care computerisation participation of about 300 people from the sector tangible, 5-year action plan for eHealth established – Roadmap the action plan is based on 5 pillars: – to develop data exchange by health care providers on the basis of a joint architecture – to increase patient awareness of eHealth – to develop a reference terminology – to achieve administrative simplification and efficiency – to implement a flexible and transparent governance structure in which all competent authorities and stakeholders are involved this action plan constitutes a clear framework for 20 concrete and measurable objectives for the next five years 13/05/2014 46

47. Roadmap 2013-2018 (www.rtreh.be) each owner of a GMF manages an electronic file regarding the concerned patient, updates the relevant data in a SumEHR and shares them through Vitalink/Intermed each hospital has a structured electronic patient file hospital documents are shared and generalised through the hub/metahub system intramural and extramural laboratory results and reports of medical imaging are shared through the hub/metahub system or through Vitalink/Intermed 13/05/2014 47

48. Roadmap 2013-2018 (www.rtreh.be) data concerning delivered medicines and medication schedules are shared electronically – shared pharmaceutical file as an authentic source for delivered medicines – Vitalink and Intermed as authentic sources for medication schedules electronic medicine prescriptions in the ambulatory sector are generalised and extended to other prescriptions (physiotherapy, nursing, laboratory research, medical imaging) for each health care profession, minimum content of an electronic patient file is defined 13/05/2014 48

49. Roadmap 2013-2018 (www.rtreh.be) generalised usage of the eHealthBox traceability of medical devices elaboration of a national terminology policy extension of the hub/metahub system to psychiatric hospitals and rest homes evolution of BelRAI as an evaluation tool social debate on whether or not access rights to patient data should be modularised patients organise access to their data adaptation of regulation and financing as incentives for ICT usage 13/05/2014 49

50. Roadmap 2013-2018 (www.rtreh.be) inclusion of eHealth in the training of health care providers implementation of MyCarenet services (electronic billing of third-party payers, electronic consultation of insurability, electronic exchange between hospitals and health insurance funds in the event of hospitalisation,...) inventory and consolidation of registers action plan for further administrative simplification monitoring and execution of the action plan 13/05/2014 50

51. THANK YOU ! Any q uestions ? Frank.Robben@ehealth.fgov.be @FrRobben https://www.ehealth.fgov.be http://www.ksz.fgov.be/ http://www.frankrobben.be 13/05/2014