eHealth in support of high quality care for rare disease patients in Europe

1. eHealth in support of high quality carefor rare disease patients in Europe Frank Robben General Manager eHealth platform Sint-Pieterssteenweg 375 B-1040 Brussels E-mail: Frank.Robben@ehealth.fgov.be eHealth platform website: https://www.ehealth.fgov.be Personal website: www.law.kuleuven.be/icri/frobben

2. Formulation of the challenge • due to some characteristics of rare diseases • limited number of patients within a single country • scarcity of expertise within a single country • cooperation and knowledge sharing between centres of expertise and dissemination of expertise towards health care providers is necessary for appropriate and timely diagnosis and high quality care for rare disease patients • this implies the need for • specific disease information networks • registries and databases • for epidemiological and research purposes • if useful, in support of multidisciplinary, transmural (and even transborder) health care provision to concrete patients

3. Some ICT-related critical success factors • technical interoperability • semantic interoperability (only 250 of about 5.000 to 8.000 rare diseases have a code in ICD10 !) • common business processes • good balance between • efficient and effective information exchange and management • information security, privacy protection and respect for professional secrecy • common patient identifiers in case of multidisciplinary, transmural or longitudinal treatment • trust of health care providers and patients in the preservation of the necessary autonomy and the security of the system

4. Inspiration from Belgian eHealth platform ? • overall objective • how? • through a well-organised, mutual electronic service and information exchange between all healthcare actors • with the necessary guarantees in the area of information security, privacy protection and professional secrecy • what? • optimization of healthcare quality and continuity • optimization of patient safety • simplification of administrative formalities for all healthcare actors • reliable support of healthcare policy and research

5. Inspiration from Belgian eHealth platform ? • vision and strategy • no central storage of personal healthcare data, except, in a coded way, in registries and databases for epidemiological and research purposes • safe electronic data exchange between all actors in healthcare • if the patient wishes so, gradual referencing to places where his/ her personal health data are available, without being able to deduce from those references any intrinsic information about health • unrestricted application of law concerning privacy protection, professional secrecy, patient rights and the exercise of medicine • the platform is managed by the representatives of the various healthcare actors in order to create trust • respect for the therapeutic liberty of healthcare providers

6. Inspiration from Belgian eHealth platform ? • vision and strategy • special attention to information security and privacy protection • end-to-end encryption of exchanged personal health data • very thorough preventive access control • personal health data can only be exchanged through the eHealth platform with permission provided legally, by an independent Sectoral Committee of the Privacy Commission or by an informed consent of the patient • logging of electronic services performed (who, what, about whom, when – not exchanged personal health data !) • information security policies and advisors • safe operation of the eHealth platform is controlled by an independent Sectoral Committee of the Privacy Commission • the eHealth platform does not perform studies itself and provides no intrinsic policy support in the area of healthcare, so as to avoid possible conflicts of interest

7. Architecture Belgian eHealth platform Health Portal VAS VAS VAS VAS Patients, healthcare providers and institutions Care provider software Healthcare institution software VAS VAS VAS VAS RIZIV-INAMI site eHealth platformPortal MyCareNet VAS VAS VAS VAS VAS VAS VAS VAS VAS VAS VAS VAS Users Basic services eHealth platform Network ADS ADS ADS ADS ADS ADS Suppliers

8. Architecture Belgian eHealth platform value-added service (VAS) a service made available to patients and / or its healthcare providers the provider of a value-added service can for this purpose use the basic services offered by the eHealth platform basic service a service developed and made available by the eHealth platform, which can be used by the provider of a value-added service in developing and offering that value-added service authentic data source (ADS) a database containing reliable information that can be accessed via the eHealth-platform the database manager is responsible for the availability and (organisation of) the quality of the information made available

9. Task division Belgian eHealth platform • 9 multifunctional basic services are provided free of charge by the eHealth platform • the development and maintenance of the value-added services and of the authentic data sources is the primary responsibility of other actors • the eHealth platform acts as the developer or hosting platform for certain value-added services or authentic data sources not containing personal health data concerning patients • the choice was made to work as much as possible based on open standards or, at least, open specifications in order to prevent dependence on one or a limited number of suppliers

10. Basic services Belgian eHealth platform • fully operational • coordination of electronic processes • web portal (https://www.ehealth.fgov.be) • integrated user and access management • logging management • system for end-to-end encryption • for communication of data to a recipient known at the time of the encryption • for communication of data to a recipient not known at the time of the encryption • personal electronic mailbox for each healthcare supplier with basic features • electronic time stamping • coding and anonymizing

11. Basic services Belgian eHealth platform • operational by the end of 2010 • reference directory (“metahub”) • operational by the second quarter of 2011 • personal electronic mailbox for each healthcare supplier with extended features

12. Coordination of electronic processes Clients Application Application Application Exposed services eHealth Service Bus (ESB) Orchestration Orchestration Application Integration & Monitoring Consulted services Application Application Application Providers

13. User and access management

14. Encryption eHealth platform Healthcare actor Person or entity Internet 3 1 Connector or other software to generate key pair Authenticates sender 4 2 Identification certificate Identification certificate Stores public key Sends public key Web service Register key 2 Public keys repository Stores private key in a secure way

15. Encryption eHealth platform Message originator Internet Web service Ask public key 1 Identification certificate Identification certificate 2 Asks for public key Authenticates sender Send message Any protocol 3 4 Sends public key Encrypts message Identification certificate Public keys repository Message recipient Stored private key 5 Decrypts message

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

17. Coding and anonymizing

18. Coding and anonymizing

19. Conclusion • the necessary electronic information exchange of personal health between health care providers in several European countries with regard to rare diseases could be facilitated by a (virtual) paneuropean ICT platform, acting as a trusted third party and offering basic services for • business process orchestration • end-to-end encryption of exchanged personal health information • user and access management • coding and anonymization of health information for epidemiological or research purposes • governance of the platform could be done representa-tives of national eHealth platforms or Ministries for Public Health

20. Conclusion • registries or databases containing personal health information should be managed outside the platform by representatives of health care providers and patients • agreements have to be made concerning • technical interoperability • semantic interoperability • common patient identifier if needed • if useful, scripts containing specific expertise with regard to rare diseases could be developed and applied to standardized electronic (summary) patient records

21. Read more • Belgian eHealth platform portal (https://www.ehealth.fgov.be) contains detailed functional and technical documentation on • the basic architecture • the 9 multifunctional basic services provided by the eHealth platform • the value-added services that use these basic services • those authentic sources already available • the norms, standards and specifications • all electronic messages • own website (http://www.law.kuleuven.be/icri/frobben) contains all slides used in presentations

22. Th@nk you !Questions?