eHealth Standards and Profiles in Action for Europe and Beyond Vincent van Pelt Senior Advisor, Nictiz (NL) eHealth Forum October 26, 2016 eHealth Stakeholders Group 1

eStandards The ambition of eStandards is to strengthen Europe’s global voice and local impact Reinforcing the bridges across the Atlantic, and between member states Addressing the challenges around interoperability in a practical way. Expected results - more alignment and convergence Experiences from different countries New use cases (after Antilope) Guideline addressing how to work with: Competing or overlapping standards Clinical content in profiles for large-scale eHealth deployments

Interoperability – agreements on different levels Legal and regulatory Compatible legislation and regulations Policy Agreements between organisations Care Process Alignment of care processes Standards and Profiles, Certification Security, Privacy, Governance Information Datasets, coding, terminologies Applications Integration, formatting of information, UI IT Infrastructure Communication protocols, network, databases Antilope

Interoperability – cooperation of different stakeholders Strategic Tactical Operational Legal and regulatory Legislators, advisors CEOs Lawyers Policy Policy makers Care Managers Healthcare professionals Patients Care Process Information- analysts, terminologists Standards and Profiles, Certification Security, Privacy, Governance Business- and information architects Information Software developers Applications System- architects System maintanance System engineers IT Infrastructure Antilope

Use Cases and Realization Scenarios Use case - describes a process and its requirements a functional description of what needs to be done Realization scenario – provides a possible solution for the use case a technical solution for the use case (one use case can have multiple realization scenarios) Examples: medication, discharge letters, referrals, radiological studies, patient summary, involvement of the patient, telemonitoring, … #1: Increase the relevance of standards sets to professionals and patients, by linking the use cases for standards sets explicitly to professional clinical guidelines and having representatives of patient and professional organisations review these use cases. #2: Encourage the incorporation of mature and shared clinical information models in health guidelines and digital health applications, detached from the particular use case and formalism used. #3: Support and enable the flow and mixed use of health data across jurisdictions, health record systems, and personal devices (“break down the silos”) to promote safe and effective health management and secondary use of health data. #4: Provide clarity and guidance on the regulatory framework relating to information from personal health and wellness or Active and Assisted Living (AAL) services, when shared with (a team of) healthcare professionals.

Combining standards and profiles Care Processes Can be described as use cases that consist of process steps In these process steps, information has to be exchanged Information Information elements have to be defined.. ..and linked to terminologies Applications Information must be ‘packaged’ into communication standards Preferably using reusable information building blocks Profiles use MIBBs and only have to define cardinality and conformance IT Infrastructure And sent between ICT systems, networks and databases eStandards

eStandards – some key messages Look at all the interoperability levels, and work together in implementation projects. Start small, from clearly defined use cases. Use standardized templates for describing use cases and realization scenarios Do not reinvent the wheel, look for use cases that already have been worked out (Antilope, eStandards). Selection of standards and profiles depends on the use case (and on the domain) From one use case you can create different realization scenarios (using different standards and profiles) – then find out which scenario works best (using a template for comparing realization scenarios). Care Process #1: Increase the relevance of standards sets to professionals and patients, by linking the use cases for standards sets explicitly to professional clinical guidelines and having representatives of patient and professional organisations review these use cases. #2: Encourage the incorporation of mature and shared clinical information models in health guidelines and digital health applications, detached from the particular use case and formalism used. #3: Support and enable the flow and mixed use of health data across jurisdictions, health record systems, and personal devices (“break down the silos”) to promote safe and effective health management and secondary use of health data. #4: Provide clarity and guidance on the regulatory framework relating to information from personal health and wellness or Active and Assisted Living (AAL) services, when shared with (a team of) healthcare professionals.

eStandards – some key messages Information Use tools for the data definition, such as ART-DECOR. Once again, the wheel has already been invented – reuse work from others, literally or as inspiration. Make sure vendors can implement the standards by defining implementation guidelines Use what has already been done in the field Look for standards for push and pull traffic As international as possible Applications #1: Increase the relevance of standards sets to professionals and patients, by linking the use cases for standards sets explicitly to professional clinical guidelines and having representatives of patient and professional organisations review these use cases. #2: Encourage the incorporation of mature and shared clinical information models in health guidelines and digital health applications, detached from the particular use case and formalism used. #3: Support and enable the flow and mixed use of health data across jurisdictions, health record systems, and personal devices (“break down the silos”) to promote safe and effective health management and secondary use of health data. #4: Provide clarity and guidance on the regulatory framework relating to information from personal health and wellness or Active and Assisted Living (AAL) services, when shared with (a team of) healthcare professionals. IT Infrastructure

eStandards – some key messages Identify use cases from an end-user perspective, including glossary, scenario, actors, privacy requirements and variations. Select profiles and standards (e.g. IHE and Continua profiles) that support the use case. Refine data content, including document templates, metadata, master files, terminology. Write interoperability specifications (implementation guides) that describe the standards/profiles selected, the refined data content, and other project specific local needs. This specification enables implementation of the use case across the various IT systems and devices. Organise testing by preparing test cases and a test environment for implementers to demonstrate component interoperability and by organising cross-implementer connectivity testing. Educate end-users on interoperability: Develop communications materials to familiarise end-users on the benefits and impact of Interoperability. #1: Increase the relevance of standards sets to professionals and patients, by linking the use cases for standards sets explicitly to professional clinical guidelines and having representatives of patient and professional organisations review these use cases. #2: Encourage the incorporation of mature and shared clinical information models in health guidelines and digital health applications, detached from the particular use case and formalism used. #3: Support and enable the flow and mixed use of health data across jurisdictions, health record systems, and personal devices (“break down the silos”) to promote safe and effective health management and secondary use of health data. #4: Provide clarity and guidance on the regulatory framework relating to information from personal health and wellness or Active and Assisted Living (AAL) services, when shared with (a team of) healthcare professionals.

Templates for Use Case and Realization Scenario Title   Purpose Relevance Domain Scale Context Information Participants Functional process steps Title   Related Use Case Scenario context Actors Transactions Technical process steps Associated Profiles Possible issues Implementation examples #1: Increase the relevance of standards sets to professionals and patients, by linking the use cases for standards sets explicitly to professional clinical guidelines and having representatives of patient and professional organisations review these use cases. #2: Encourage the incorporation of mature and shared clinical information models in health guidelines and digital health applications, detached from the particular use case and formalism used. #3: Support and enable the flow and mixed use of health data across jurisdictions, health record systems, and personal devices (“break down the silos”) to promote safe and effective health management and secondary use of health data. #4: Provide clarity and guidance on the regulatory framework relating to information from personal health and wellness or Active and Assisted Living (AAL) services, when shared with (a team of) healthcare professionals.

ART-DECOR Dutch ‘clinical building blocks’ International projects #1: Increase the relevance of standards sets to professionals and patients, by linking the use cases for standards sets explicitly to professional clinical guidelines and having representatives of patient and professional organisations review these use cases. #2: Encourage the incorporation of mature and shared clinical information models in health guidelines and digital health applications, detached from the particular use case and formalism used. #3: Support and enable the flow and mixed use of health data across jurisdictions, health record systems, and personal devices (“break down the silos”) to promote safe and effective health management and secondary use of health data. #4: Provide clarity and guidance on the regulatory framework relating to information from personal health and wellness or Active and Assisted Living (AAL) services, when shared with (a team of) healthcare professionals.

Use Case Repository Realization Scenario #1: Increase the relevance of standards sets to professionals and patients, by linking the use cases for standards sets explicitly to professional clinical guidelines and having representatives of patient and professional organisations review these use cases. #2: Encourage the incorporation of mature and shared clinical information models in health guidelines and digital health applications, detached from the particular use case and formalism used. #3: Support and enable the flow and mixed use of health data across jurisdictions, health record systems, and personal devices (“break down the silos”) to promote safe and effective health management and secondary use of health data. #4: Provide clarity and guidance on the regulatory framework relating to information from personal health and wellness or Active and Assisted Living (AAL) services, when shared with (a team of) healthcare professionals.

Useful links eStandards Antilope ART-DECOR eHealth Network (eHN) International Dutch eHealth Network (eHN) Assets Guide to interoperability between XDS Affinity Domains Use Case Repository ART-DECOR SNOMED-CT LOINC HL7 FHIR IHE #1: Increase the relevance of standards sets to professionals and patients, by linking the use cases for standards sets explicitly to professional clinical guidelines and having representatives of patient and professional organisations review these use cases. #2: Encourage the incorporation of mature and shared clinical information models in health guidelines and digital health applications, detached from the particular use case and formalism used. #3: Support and enable the flow and mixed use of health data across jurisdictions, health record systems, and personal devices (“break down the silos”) to promote safe and effective health management and secondary use of health data. #4: Provide clarity and guidance on the regulatory framework relating to information from personal health and wellness or Active and Assisted Living (AAL) services, when shared with (a team of) healthcare professionals.