Integration von Apps in das elektronische Patientendossier der Schweiz. Was ist denkbar?

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1 Integration von Apps in das elektronische Patientendossier der Schweiz. Was ist denkbar? Jahrestagung von HL7 und IHE Deutschland vom Oktober 2016 in Kassel Oliver Egger, ahdis gmbh

2 Agenda Elektronisches Patientendossier in der Schweiz Empfehlungen mhealth ehealth Suisse 2016 Lösungsansätze Fragen

3 founder ahdis gmbh visionary AG, docbox, Managing Partner, CIO visionary AG, docbox, Senior Software Engineer Ecofin Research & Consulting AG, Software Engineer SPEAG, Vice President, GL+VR-Member 2016 Dozent BFH Bern Medizininformatik, Interoperabilität HL7.ch Board Member Leader Technical Committee, member hl7 since 2009 Oliver Egger phone: oliver.egger@ahdis.ch IHE Suisse Deputy Technical Manager since 2016, member since 2015 Dipl. Inf. ETH, ETH Zürich, 1996 IHE XDS Advanced Training, 2015 Certified HL7 CDA Specialist, 2015 Certified Scrum Master, 2014 NDK ehealthcare, Nottwil, 2009 Born in 1971 in Doncaster (UK), married, 2 daughters, back country skiing and cooking enthusiast

4 2007 Strategie ehealth Schweiz 2008 heute: ehealth Suisse Elektronisches Patienten-Dossier Schweiz Standards und Architektur Aufbau und Vernetzung Rechtliche Grundlagen und Finanzierung Online-Dienste und Befähigung 2013 Entwurf Bundesgesetz (EPDG) 2015 Gesetz angenommen 2017 Gesetz in Kraft 2018 Einführung und Betrieb Quelle:

5 EPD Dezentrale Architektur Austauschformate / Metadaten / Dokumente Gemeinschaft Stammgemeinschaft Eine Stammgemeinschaft muss dem Patienten ermöglichen eigene Dokumente hochzuladen.

6 Electronic Patient Dossier (EPD) Overview IHE Integration Profiles with Swiss National Extensions Identity Provider User Authentication Provider X-Assertion Provider Authenticate User Get X-User Assertions other Assertion transcations Patient Portal CT CH:ATNA Time Client ATNA CH:ATNA Secure Node PIX CH:PIX PIX CH:PIX HPD CH:PIDD SVS XUA CH:XUA Document Audit CH:ATNA Patient Identifier Patient Identitiy Provider Information Valuset X-Service Consumer Cross-reference Source Consumer Consumer User XDS Consumer Document [ITI-45] [ITI-44] Consumer [ITI-18, 43] XDS Document Source [ITI-41] CH:PRQ Policy Manager i [ITI-1] Maintain Time ih [ITI-19] Node Authentication i [ITI-20] Record Audit Event i [ITI-45] PIX V3 Query i [ITI-44] Patient Identity Feed HL7 V3 i [ITI-58] Provider Information Query i [CH:PIDD] Provider Information Delta Download i [ITI-48] Retrieve Value Sets i [ITI-60] Retrieve Multiple Value Sets i [ITI-40] Provide X-User Assertion i [ITI-18] Registry Stored Query i [ITI-43] Retrieve Document Set i [ITI-41] Provide & Register Document Set i [CH:PRQ] Privacy Policy Query Health Professional Portal, Primary Systems CT CH:ATNA Time Client ATNA CH:ATNA Secure Node CH:PDQ CH:PIX CH:PIX SVS XUA CH:XUA PIX XDS XDS PDQ PIX HPD CH:PIDD CH:PRQ Patient Demographics Patient Identifier Patient Identitiy Provider Information Valuset X-Service Document Document Policy Manager Consumer Cross-reference Source Source, Consumer Consumer User Consumer Source Consumer [ITI-47] [ITI-45] [ITI-44] [ITI-18, 43] [ITI-41] i [ITI-1] ih [ITI-19] i [ITI-20] i [ITI-47] Patient Demographics Query HL7 V3 i [ITI-45] i [ITI-44] i [ITI-58] i [ITI-59] i [CH:PIDD] i [ITI-48] i [ITI-60] i [ITI-40] i [ITI-18] i [ITI-43] i [ITI-41] i [CH:PRQ] CT CH:ATNA Time Client ATNA CH:ATNA Secure Node i [ITI-1] ih [ITI-19] i [ITI-20] i [ITI-47] i [ITI-45] i [ITI-44] PDQ CH:PDQ PIX CH:PIX PIX CH:PIX Patient Demographics Patient Identifier Patient Identitiy Supplier MPI Cross-reference Source Manager i [ITI-44] i [ITI-58] i [ITI-59] i [ITI-48] i [CH:PIDD] i [ITI-60] i [ITI-40] i [CH:PRQ] i [ITI-43] HPD Provider CH:PIDD SVS Valuset XUA CH:XUA Policy CH:PPQ XDS Information Directory Repository X-Service Repository HPD Provider Info. CH:PIDD SVS Valuset Provider Authorization Decision Source, Consumer Consumer Consumer CH:ADR i [ITI-58] Provider Information Query i [ITI-59] Provider Information Feed i [CH:PIDD] Provider Information Delta Download i [ITI-48] Retrieve Value Sets i [ITI-60] Retrieve Multiple Value Sets i [CH:ADR] h [ITI-43] i [ITI-41] Document Repository i [ITI-42] Register Document Set i [CH:ADR] Authorization Decision Consumer CH:ADR XUA X-Service CH:XUA User i [CH:XADR] i [ITI-20] i [ITI-18] i [ITI-43] i [ITI-18] i [ITI-42] h [ITI-18] h [ITI-43] i [ITI-18] i [ITI-43] i [CH:ADR] i [ITI-43] Audit Record CH:ATNA i [CH:XADR] Authorization Decision XDS XDS XCA CH:XCPD, CH:ATNA XCA CH:XCPD, CH:ATNA CH:ADR Repository CH:ADR Document Document Responding Initiating Authorization Decision Registry Consumer Gateway GW ATNA XUA CH:XUA Gateway Provider ATNA Audit Repository Consumer X-Service User i [CH:ADR] Authorization Decision Request i [ITI-18] h [CH:ADR] h [CH:XADR] h [ITI-18] Audit Record CH:ATNA Repository Audit Repository h [ITI-20] XUA X-Service Provider CH:XUA i [ITI-40] Core Community Components ih [ITI-19] h [ITI-20] ATNA CH:ATNA Secure Node Community A as a XDS Affinity Domain Secondary Systems CT CH:ATNA Time Client i [ITI-1] IHE Integration Profiles i [ITI-1] Maintain Time i [ITI-58] Provider Information Query i [ITI-59] Provider Information Feed i [CH:PIDD] Provider Information Delta Download i [ITI-48] Retrieve Value Sets i [ITI-60] Retrieve Multiple Value Sets h [ITI-38] h [ITI-39] h [ITI-55] i [ITI-38] Cross Gateway Query i [ITI-39] Gross Gateway Retrieve i [ITI-55] Gross Gateway Patient Discovery h [CH:XADR] i [CH:XADR] Cross Community Authorization Decision Request IT Infrastructure Technical Framework Vol 12.0 (IHE ITI) XCA-(I) Cross-Community Access XCA (-Imaging) XCPD Cross-Community Patient Discovery XUA Cross Enterprise User Assertion HPD Healthcare Provider Directory XDS(-I).b Cross-Enterprise Document Sharing (-Imaging) PDQ / PIX Patient Demographics Query, Patient Identifier Cross-referencing ATNA/CT Audit Trail and Node Authentication, Consistent Time SVS Sharing Value Sets National Extensions CH:ATNA Swiss Requirements on ATNA, XDS.b and CT for Audit Trail Consumption CH:PIX Swiss Requirements on PIXv3 CH:PDQ Swiss Requirements on PDQv3 CH:PIDD Swiss Requirements on HPD for Replication CH:XCPD Swiss Requirements on XCPD for Cross-Community Patient Discovery CH:XUA Swiss Requirements on XUA for XDS, ADR and PPQ National Integration Profiles CH:ADR Authorization Decision Request CH:PPQ Patient Privacy Policy Query HPD HPD Healthcare Provider Directory CT Time Server UPI Unique Person Identification Service Government Services SVS CPI Community / Portal Index SVS MDI Metadata Index Service XCA CH:XCPD, CH:ATNA Initiating Gateway Communities B, C, D XCA CH:XCPD, CH:ATNA Responding Gateway CH:ADR Authorization Decision Consumer CH:ADR Authorization Decision Provider Legend IHE Profile CH:Profile Actor ehealth Connector support 10/2015 i [ITI-x] IHE Transaction i [CH:x] National Extension or Integration Profile not specified by IHE HL7 trademark owned by Health Level Seven International

7 Quelle:

8 mhealth und EPD? EPD ist dokumentenbasiert, mhealth Apps oft datenbasiert (Vitalzeichen, Sensormessungen). Datenschutzanforderung EPD und mhealth: Starkes Authentifizierungsverfahren (2-Faktor) in mhealth Apps? EPD: Externes Zugangsportal nur Lesezugriff auf andere Gemeinschaften oder Stammgemeinschaft. mhealth: Gültigkeit, Zuverlässigkeit der Daten (medizinische Fachperson oder Patient, Gerät)

9 ehealth Suisse mhealth Empfehlungen I in der Anhörung Der Begriff mhealth beschreibt Massnahmen der privaten und öffentlichen Gesundheitsversorgung, die durch Mobilgeräte wie Mobiltelefone, Patientenüberwachungsgeräte, persönliche digitale Assistenten (PDA) und andere drahtlos angebundene Geräte unterstützt werden. (FH St. Gallen 2015: 4). Quelle:

10 Transparenz Handlungsempfehlugen in Anhörung Juristische Gutachten Leitfaden zuhanden Hersteller Datenschutz und Sicherheit Beratung für Hersteller Kriterienkatalog für Apps Selbstdeklaration für App Empfehlungen Informationsangaben für den Umgang Interoperabilität Empfehlungen zu Standards Vergütung Vergütung durch die Obligatorische Krankenpflegeversicherung, Forschungsförderung sowie Anpassung Tarifierung Quelle:

11 Interoperabilität ehealth Suisse empfiehlt bei Bedarf technische und semantische Standards fu r die Kommunikation von mhealth-leistungen und Applikationen. Dabei stehen Standards im Vordergrund, die sich international etabliert haben (zum Beispiel Continua oder IHE PCD). In der Fussnote des Berichts finden sich auch die IHE MHD, PDQm (FHIR) und IHE IUA Profile die im Bereich mhealth Anwendung finden. Quelle:

12 Lösungsansätze App in EPD Stammgemeinschaft, Gemeinschaft Getrennte Lösung die Dokumente dem EPD zur Verfügung stellt (On Demand Dokumente) Externes Zugangsportal erweitert mit IHE Mobile Profilen (MHD, PDQm, PIXm), Austauschformate PHR Profile/FHIR Profile auf nationaler Ebene definieren für mhealth Apps

13 App in EPD Stammgemeinschaft, Gemeinschaft App in der EPD Stammgemeinschaft, Gemeinschaft App Muss keine Interoperabilitätsstandards befolgen, Einsatz, Entwicklung, Governance pro (Stamm-)Gemeinschaft. Einsatz möglich von IHE, Continua Profilen für medizinische Apps

14 Getrennte Lösung die Dokumente dem EPD zur Verfügung stellt (On Demand Dokumente) App Server App/Server Lösung separat Daten/Dokumente aus der App werden als On- Demand Dokumente der (Stamm-)gemeinschaft zur Verfügung gestellt. Schweiz: meineimpfungen.ch im Aufbau (WebApp) ELGA/Österreich: Architektur Draft für Einbindung medizinische Geräte mit IHE/Continua

15 IHE MHD, PDQm, PIXm Profile vor dem externen Zugangsportal CDA CH Austauschformate für Dokumente App IHE MHD App IHE MHD IHE MHD: FHIR Restful API auf eine XDS Umgebung IHE MHD Profil, PDQm, PIXm über Zugansportal oder (Stamm-)Gemeinschaft anbieten Vereinfachung des mobilen Zugriffes für Dokumente aus dem EPD Option: Dokumente als CDA-CH Austauschformate Kein Schreibzugriff auf das EPD via externes Zugangsportal

16 mhealth Apps basierend auf FHIR Profile / API App FHIR Profile / API FHIR Profile definieren basierend auf CDA-CH Austauschformaten Initiativen in Niederlande, Kanada, USA sowie Australien für FHIR Profile und API s Problematik Daten vs Dokumente FHIR API und EPD? In der Schweiz bis jetzt noch keine Aktivitäten bezüglich EPD aber erste Projekte mit FHIR basierten Apps laufen (z.b. mimoti/midata)

17 Feedback, Fragen

18 ahdis health data information systems - introduction contact ahdis gmbh bertastrasse zürich switzerland meet us: Impact hub zürich Sihlquai zürich switzerland oliver egger ahdis gmbh, zürich, switzerland, 7/3/16

19 Backupslides

20 Leaders in ehealth Interoperability Ahdis gmbh, zürich, switzerland, 27/11/2015 Working together towards interoperability for healthcare Sept 2016

21 About IHE and PCHA Integrating the Healthcare Enterprise (IHE) and Personal Connected Health Alliance (PCHA) are each focused on improving the ways health IT systems share information. IHE s primary domain is in clinical healthcare settings and their regional/national/crossborder exchanges while PCHA s primary domain is in home and remote health settings. IHE Profiles and PCHA s Continua Design Guidelines are both standard-based, open specifications for health information exchange: Where they overlap they are consistent, resulting in a mature and interoperable information ecosystem Together they ensure that device data whether captured by the patient or in a care delivery setting flows into electronic health records in the same format and coded content Together, both IHE and PCHA continually improve interoperability within their domains and oversee conformity testing and certification of products worldwide. Ahdis gmbh, zürich, switzerland, 27/11/2015

22 Where to deploy IHE Profiles and PCHA s Continua Guidelines Personal Health Device (Health, Medical and Fitness devices) Personal Health Gateway (Hub, phone, tablet, etc) Health Information Service Health & Fitness Service (Care Management Services) Ambulatory EMR Health Information Exchange Hospital Device Hospital Device Hospital Device Gateway Hospital EMR Hospital EMR (Nursing Station, Gateway) Ahdis gmbh, zürich, switzerland, 27/11/2015 Defined in IHE Profiles Defined in Continua Guidelines Defined & aligned in both Continua Guidelines & IHE Profiles

23 Architecture Draft from Austria This image by Stefan Sauermann. The architecture shown follows the personal views of the author alone. It is not final and subject to ongoing discussions in Austria and internationally. #

24 Architecture recommendations (summary) 1: PAN, TAN, LAN Interface - optional 2: WAN Interface - optional 3: HRN Interface - modified: Continua payload HL7 PHMR CDA: mandatory (adapt for AT regulatory req.) Different transport: IHE ITI-41 (XDS): mandatory (as in ELGA) 4: IHE XDS IHE ITI-18, ITI-43: mandatory (as in ELGA) IHE ITI-61 (On Demand Documents): optional This is the real clever, revolutionary bit!!! Basically this is Continua. We added more IHE XDS as data reaches EHRs. 1: We need to carefully look at market dynamics around this one 2: FHIR will be loved here, when stable!! #

25 mhealth needs ehealth or the other way round? ehealth Forum 2016, Athen, C. Parisot Quelle:

26 mhealth 250 Apps Ahdis gmbh, zürich, switzerland, 27/11/2015

27 ehealth 39 Apps Ahdis gmbh, zürich, switzerland, 27/11/2015

28 CDA Parser on ios, Android? ehealth Forum 2016, Athen, C. Parisot Quelle: