The proposed EU Labeling and Certification Framework for e-health interoperability across Europe Tassos TAGARIS, Executive Director HL7 Hellas based on a presentation by Jos Devlies, EuroRec, Belgium and Ib Johanson, MedCom, DK
Presentation Outline HL7 International & Interoperability in HC HL7 Hellas Conformance Testing & Certification Antilope Thematic Network Proposed Quality label and Certification Functional Model Conclusions 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 2
What is HL7? Health Level Seven (HL7) is an ANSI accredited Standards Developing Organization (SDO), and develops the HL7 standard for Interoperability in Healthcare domain HL7 is an ISO certified standard (v2.7 & v3) It is an Open Standard accepted by the majority of healthcare solution suppliers Allows for data exchange between applications of different suppliers flexibility on solutions to be selected and adopted Is adopted by Governments as part of their strategic policy related to ICT in Healthcare But is not enough to solve the interoperability problems of the healthcare domain! 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 3
HL7 International Non Profit >2200 members >500 vendors members Involves ~ 90% of the biggest healthcare solution vendors worldwide Affiliations in >30 countries. www.hl7.org www.hl7.org.gr (HL7 Hellas) 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 4
HL7 International 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 5
HL7 Standards timeline 2013: HL7 makes standards available under free license 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 6
HL7 mission Ensure interoperability between information systems in order to achieve: Best treatment and health prevention Integration of procedures in healthcare Improvement and quality assurance of medical data Knowledge exchange between all involved stakeholders 4 interoperability methods Messaging interface (HL7 v2.x) Interfaces through web services (SOA web-services) (HL7 v3) XML Structured file exchange (HL7 CDA R2) Data exchange focusing on mobile apps (Web Methods REST JSON) (HL7 FHIR) 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 7
HL7 Hellas Founded 2003 (HL7 Hellas - International Affiliate) 29 Members EHR Vendors and Healthcare Solution Providers, Universities Research Institutes, Medical Associations, Individual Citizens (Engineers, Doctors, ) State Hospitals, IDIKA SA Ministry of Health 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 8
HL7 Hellas - Objectives Educate the healthcare community and promote the use of the interoperability standards in HC Analyse the needs and the gaps in the domain of electronic communication and information exchange in healthcare Transfer the local needs and Greek particularities to the HL7 standard Develop and sustain Special Interest Groups (SIG, task forces) and actively participate in HL7 International committees Align and promote the international actions of the HL7 Participate and organize dissemination events (conferences, workshops etc.) New! Conformance Testing & Certification 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 9
Antilope Thematic network Create, validate and disseminate a common approach for testing and certification of ehealth solutions and services in Europe To promote use of standards for e- Health interoperability in EU To foster their adoption across EU Call: CIP-ICT-PSP-2012-6 Grant agreement for: Competitiveness and Innovation Programme Thematic Network Project acronym: Antilope Grant agreement no.: 325077 Start: 01 February 2013 End: 31 January 2015 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 10
The need for interoperability Interoperability of ehealth systems should never be taken as given Quality and efficiency of care are prerequisites for affordable care. Quality is never granted for free and needs to be proven. Efficiency requires sharing and reuse of clinical data Interoperable services are standards based data exchange services with defined content. 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 11
Antilope Background, purpose, outcome Digital Agenda and ehealth action plan 2012-2020 European Projects: 2008-2013 EpSOS: specifications of the cross border exchange of medical data 2009-2012 EHR-Q TN : Quality Labelling and Certification of EHR systems 2010-2011 HITCH (Healthcare Interoperability testing and Conformance Harmonisation): ehealth Interoperability roadmap 2012 eeif: ehealth Interoperability Framework 2013-2015 Antilope: Thematic Network 30/09/2014 3η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 12
Antilope, Background, purpose, outcome HITCH: 1. There is a need for a widely accepted quality guide for interoperability testing based on existing quality standards. 2. An organized collaboration is needed to reduce the fragmentation and lack of maturity in interoperability test tools and test plans in specific areas. 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 13
Antilope, Background, purpose, outcome Antilope: a thematic network: Develop documentation and educational materials related to existing standards and profiles for ehealth interoperability mentioned in the eeif report and: Drive adaption and improve the standard development process Define QA testing guidelines for interoperability Propose a labelling and certification process (EU level and national level) 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 14
The ANTILOPE partnership Consortium of organisations and experts involved in: standards development and project specifications interoperability testing quality labelling and certification processes organisations representing users, industry and health authorities Partners from eeif framework project. 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 15
Antilope Core and Expert Partners 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 16
Antilope Validation Partners Denmark, Norway, Sweden Finland, Iceland, Estonia, Lithuania, Latvia Poland, Czech Republic, Slovakia, Hungary Ireland, United Kingdom Belgium, The Netherlands, Luxemburg France, Switzerland, Germany, Austria Slovenia, Croatia, Serbia, Bosnia, FYE Macedonia, Montenegro Italy, Malta Portugal, Spain Romania, Bulgaria, Greece, Cyprus, Turkey 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 17
WP7: Project Management WP6: Communication Input / output in Antilope WP1: ehealth Interoperability Framework WP2: Testing Guidelines & Quality Manual for IOP Testing WP3: Testing Tools WP4: Labelling and Certification Process WP5: Validation, Scalability to EIP and Adoption 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 18
Antilope, Background, purpose, outcome 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 19
Functions A certification or quality label process requires: A Certification/Label Scheme Owner: a party that sets the Certification or a quality label program or system; A label/certification Body: a party that issues the quality label or certificate on the basis of the conformity assessment performed by a conformity assessment body; A Conformity Assessment Body: a party that assesses the conformity of products, services and/or suppliers (often called a testing laboratory) 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 20
Quality label and Certification Functional Model 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 21
The Quality Label and Certification processes 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 22
Antilope, Background, purpose, outcome Main benefits: For Healthcare providers A harmonized European market for the ehealth solutions Better integration between solutions Ability to exchange electronically medical data between Regions and Nations For Industry One recognized quality label or certification process in Europe Avoid duplication between the national and regional testing processes Factor and mutualize specifications elements and corresponding testing tools develop a unified market in Europe 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 23
Conclusion Sum Up Interoperability of ehealth systems should never be taken as given Quality and efficiency of care are prerequisites for affordable care. Quality is never granted for free and needs to be proven. Efficiency requires sharing and reuse of clinical data ANTILOPE designs a European quality label or certification process that supports ehealth interoperability in Europe and shall operate in harmony with country specific quality label or certification processes. good opportunity for the industry to market their products in Europe within one recognized testing process, avoiding duplicate testing and inconsistencies among different testing processes HL7 Hellas coordinates region 5 (Romania, Bulgaria, Greece, Cyprus, Turkey) in ANTILOPE HL7 Hellas can be one of the major links between the Greek Healthcare community and the International Interoperability SDOs 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 24
http://www.antilope-project.eu/ www.hl7.org.gr Tassos Tagaris Thank you for being with us
Interoperability (one definition) The ability of two or more systems or components to exchange information and to use the information that has been exchanged Source: Institute of Electrical and Electronics Engineers. IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries. New York, NY: 1990. 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 34
Antilope, Background, purpose, outcome Outcome Common approach for testing and certification through recommendations for reaching interoperability, based on: 1. Use cases 2. Quality manual Quality process 3. Selected tools 4. Certification and labelling 5. Educational material 6. Input from Regional summits 30/09/2014 3 η συνάντηση οικοσυστήματος ηλεκτρονικής υγείας 35