Project Solutions Technikum Wien ► ELGA Testen? Stefan Sauermann FlyTieto, Wien, 1. Oktober 2013

Who am I? Electronics Engineer 15 yrs Med. University of Vienna, research Biosignal work Then standards, medical informatics Program director Biomedical Engineering Sciences (Master) Key Research eHealth, Department of Biomedical Engineering Chair ONK 238, founding member IHE AT, member HL7, ASSTeH, ProRec AT, .. www.projectsolutions.at

Motto Scaling: Assembling „more of the same“ eHealth is big and complicated Everything worthwhile in medicine must scale (A.Rector) Scaling: Assembling „more of the same“ „The same“ is defined in standards Avoid the „assembly desaster“ Test before you plug? Follow European / international initiatives Align to the standardisation efforts early www.projectsolutions.at

Agenda Preview: An Austrian pilot Next steps?? Visions?? Latest news on standards and certification in Europe HITCH, Antilope, eHealth Interoperability Framework, high level coordination Preview: An Austrian pilot UBIT in Austria: Certification of software products for import / export of ELGA CDA conformant medical reports Test cases, documentation, tools Next steps?? Visions?? Join the European moves Establish an open platform for an Austrian „Schema“ www.projectsolutions.at

Semantic Interoperability Semantic“ interoperability enables automated further processig of data without additional manual effort at the receiving system Succeed if you address ALL Legal, Organisational, Semantic and Technical issues www.projectsolutions.at

Requirements for moving “intelligent” IT into healthcare on a large scale The need to develop national and international biomedical-networking infrastructures that use existing and future technologies for communication, data exchange, and information retrieval. The need for credible international standards for communications, data, and knowledge exchange that will allow both commercial and academic developers of medical information systems to know what to do in order to assure the integration of their products with other developing systems Shortliffe E.H.: The adolescence of AI in Medicine: Will the field come of age in the 90s? Artificial Intell.Med. 5, 1993, 93-105.

One more Shortliffe slide: Requirements „I do believe that we must accept the impossibility of viewing the introduction of decision support tools as a grass-roots activity that emerges from the research lab, (….) and then grows by some kind of mass effect to encompass an entire medical community. (…) will be realized when the infrastructure for introducing computational tools in medicine has been put in place by visionary leaders, who understand the importance of networking, integration, shared access to patient data bases, and the use of standards for data-exchange, communications and knowledge-sharing.“ www.projectsolutions.at

Projects, theses, papers, … Time axis, EU, Austria, Technikum eHealth Interoperability FW (eH EIF) e-health Focus Group e-health Action Plan HITCH Antilope Health reform ELGA project company Health reform eHealth Initiative IHE Austria Focus eHealth Healthy IO Project Projects, theses, papers, … 2003-05 06 07 08 09 10 11 12 13

HITCH Roadmap issues and solutions for interoperability Reference Projects HITCH: Healthcare Interoperability Testing and Conformance Harmonisation National, Regional and Local Projects Market, Industry, Small and Medium-sized Enterprises (SMEs) HITCH Roadmap issues and solutions for interoperability Effective Interoperability EU Projects M403, epSOS, Calliope, EHR-QTN, Smart PHS SDOs HL7, DICOM CEN, CENELEC ETSI Health Organisations EAHP, ECR, IHE Europe, HOPE, ESR, EuroRec, EHO,UEPS, GPEU Outside Europe CCHIT Infoway IHE International Requirements Issues Solutions Tools And Pro- cesses EU funded project Interoperability Testing Quality Management System (QMS) Determination of Future Tools and Tool Roadmap Quality Labelling Strategy for Tested eHealth Products http://www.hitch-project.eu/ www.projectsolutions.at © 2013

HITCH: Roadmap for Europe HITCH Healthcare Interoperability Testing and Conformance Harmonisation, WP6: D6.4 Final Report including consolidated Roadmap and recommendations, Version 1.0 18 July 2011 http://www.hitch-project.eu

Recent European Developments in eHealth interoperability European Interoperability Framework, 2013 Intended for many domains eGovernment, eBusiness, eXxxx, … Study on applicability in eHealth, see the report http://ec.europa.eu/digital-agenda/en/news/ehealth-interoperability-framework-study Part 2, 3, 4: “Vision on eHealth EIF”, “Assessment framework” „First proposal technical layer“ IHE, Continua, epSOS were studied as pilots www.projectsolutions.at

Generic Europen Interoperability Framework (EIF): Structure eHealth EIF eHealth European Interoperability Framework European Commission – ISA Work Programme Vision on eHealth EIF. A study prepared for the European Commission, DG Connect. Specific contract N° 60 Framework contract N° DI/06691-00, Version 1.2, 14/02/2013

EIF: 12 Underlying Principles Grouped under three categories: Context for EU action on European public services Subsidiarity and proportionality Generic user needs and expectations User-centricity, Inclusion and accessibility, Security and privacy, Multilingualism, Administrative simplification, Transparency, Preservation of information Foundation for cooperation among public administrations Openness, Reusability, Technological neutrality and adaptability, Effectiveness and efficiency eHealth EIF eHealth European Interoperability Framework European Commission – ISA Work Programme Vision on eHealth EIF. A study prepared for the European Commission, DG Connect. Specific contract N° 60 Framework contract N° DI/06691-00, Version 1.2, 14/02/2013

EIF: Interoperability Agreements Providing European public services requires “cooperation among different public administrations at the various interoperability levels For each interoperability level, the organisations involved should formalise cooperation arrangements in interoperability agreements. These agreements should be drafted with sufficient detail to enhance cooperation between different eHealth stakeholders, while leaving each stakeholder maximum internal autonomy. Furthermore, interoperability agreements should be multilateral so as to avoid point-to-point connections eHealth EIF eHealth European Interoperability Framework European Commission – ISA Work Programme Vision on eHealth EIF. A study prepared for the European Commission, DG Connect. Specific contract N° 60 Framework contract N° DI/06691-00, Version 1.2, 14/02/2013

EIF: Governance Ensuring interoperability … is a continuous task, as interoperability is disrupted by changes to the environment, i.e., changes that occur to legislation, the needs of businesses or citizens, the organisation of public administrations, business processes or technologies. Interoperability governance “covers the ownership, definition, development, maintenance, monitoring, promoting and implementing of interoperability frameworks in the context of multiple organisations working together to provide (public) services. It is a high-level function providing leadership, organisational structures and processes to ensure that the interoperability frameworks sustain and extend the organisations’ strategies and objectives. eHealth EIF eHealth European Interoperability Framework European Commission – ISA Work Programme Vision on eHealth EIF. A study prepared for the European Commission, DG Connect. Specific contract N° 60 Framework contract N° DI/06691-00, Version 1.2, 14/02/2013

Criteria, derived from EIF, as used in the study Organisational criteria Type of organisation, openness, consensus, transparency, maintenance and intellectual property rights. Technical specification criteria Market acceptance, coherence, availability, relevance and effectiveness, neutrality and stability and quality www.projectsolutions.at

Recommendations to Continua In order to establish a “public comment process allowing all stakeholders to provide feedback on profiles”: “… we recommend that the profile development process should be based on a decision making process in which all interested actors can take part on equal terms” eHealth EIF eHealth European Interoperability Framework European Commission – ISA Work Programme First proposal technical layer. A study prepared for the European Commission DG Connect. Specific contract N° 60, Framework contract N° DI/06691-00 Version 1.2, 14/02/2013

Standards and Profiles in eH EIF “As defined in European legislation (Article 1, paragraph 6, of Directive 98/34/EC), a standard is a technical specification approved by a recognised standardization body for repeated or continuous application, with which compliance is not compulsory and which is one of the following: international, European, national.” “In the study, profile (term used by IHE) and guideline (term used by Continua) are technical specifications that identify “a consistent set of chosen options from a base standard or from a set of base standards, in order to provide a given function in a given environment” (ETSI standard ETS 300 406).” www.projectsolutions.at

EM 2012 Small regional football clubs National football clubs National football team Championships EM Connectathons / PlugFests IHE / Continua Certified E X P R I N C E X P R I N C

2012: Research focus eHealth @Technikum Wien 2 Key researchers 4 senior reserchers, all are Technikum Wien graduates Settled in a stable team within the Departments of „Information Engineering & Security“ and „Biomedical Engineering“ with a rich set of network of IT experts close by www.projectsolutions.at

Hosting the IHE Connectathon Vienna 2009 90 companies Accompanying workshop "Sharing Clinical Documents and Integrating Workflow“ www.ihe.net www.projectsolutions.at

Reference Projects Technikum Wien eHealth Team: PAN manager, Bluetooth HDP, WAN sender tested successfully! @ Continua Plugfest 2012 Berlin HIO AHD as Android App Against testtools and other vendors Enables data exchange via smartphone from device to server www.projectsolutions.at

Technikum Wien eHealth Team: IHE Integration Statement reached! Reference Projects Technikum Wien eHealth Team: IHE Integration Statement reached! @ IHE Europe Connectathon 2013 Istanbul Document Source and Document Consumer 23 Tests on 4 IHE Profiles Dokumented interoperability! Connectathon Results Database: http://http://connectathon-results.ihe.net www.projectsolutions.at

ELGA CDA Import/Export Test und Zertifizierung Kooperation UBIT – Project Solutions Technikum Wien Aufbau von Test und Zertifizierungsmethoden für den ELGA CDA konformen Import und Export von Befunden aus medizinischer Software Erstellung der Testunterlagen, Pilot, Beschluß, Start der Zertifizierung um Praxiserfahrung über alle Phasen zu erarbeiten Offen für breite Abstimmung in Österreich Anbindung an international laufende Aktivitäten www.projectsolutions.at

ISO 25010 (2011) (früher ISO 9126): Systems and software engineering Systems and software Quality Requirements and Evaluation (SQuaRE) System and software quality models www.projectsolutions.at

ISO 25010 (2011) (früher ISO 9126): Modellelemente Konzentration auf Interoperabilität Vieles andere wird nicht getestet und als gegeben vorausgesetzt www.projectsolutions.at

Wie war es früher: ISO 9126 Functionality Reliability Usability The capability of the software product to provide functions which meet stated and implied needs when the software is used under specified conditions. Reliability The capability of the software product to maintain a specified level of performance when used under specified conditions Usability The capability of the software product to be understood, learned, used and attractive to the user, when used under specified conditions. Efficiency The capability of the software product to provide appropriate performance, relative to the amount of resources used, under stated conditions. Maintainability The capability of the software product to be modified. Modifications may include corrections, improvements or adaptation of the software to changes in environment, and in requirements and functional specifications. Portability The capability of the software product to be transferred from one environment to another. www.projectsolutions.at

Standard for Software and System Test Documentation IEEE 829 (2008) Standard for Software and System Test Documentation Chapter 7: „Test documentation content topics to be addressed “ Plans

Standard for Software and System Test Documentation IEEE 829 (2008) Standard for Software and System Test Documentation Chapter 7: „Test documentation content topics to be addressed “ Reporting

Documents and Roles

Zeitplan Testdokumentation liegt in Rohfassung vor Review Workhop 7.10.2013 Überarbeitung bis Ende Oktober Pilottests Überarbeitung aufgrund der Beobachtungen Gemeinsamer Beschluß, Start der Umsetzung noch 2013 Parallel: Feasibility Studie zur Umsetzung der Tests mit Gazelle Ziel: Nahtlose Integration mit IHE Testaktivitäten Als Projektpartner enge Abstimmung im EU Projekt Antilope www.projectsolutions.at

Vorschläge für die Zukunft Wir Österreicher sind eHealth Musterschüler eCard, ELGA gelten international als Vorzeigeprojekte Das Land macht mit Es herrscht weitgehend gute Stimmung Das Spiel läuft, Gleichstand im Semifinale, der Ball liegt am Elfmeterpunkt Der Tormann fädelt gerade erst die Schuhbänder ein Trotzdem Achtung: Auch Messi hat schon mal verschossen Bauen wir zusammen die „Interoperability Governance“ auf Offen, transparent, nachhaltig International abgestimmt www.projectsolutions.at

IHE Product Certification, concepts

Antilope concepts for EU www.projectsolutions.at www.antilope-project.eu

Save the date: Antilope Workshop 2014, WIen Antilope Project Validation Workshop In co-operation with IHE Austria, parallel to the Vienna Connectathon 11. April 2014 Get first hand insight into European concepts for interoperability testing and certification Provide feedback and critique, bring in your view and your requirements www.projectsolutions.at

Kontakt Geschäftsführung Projektleitung FH-Prof. DI Dr. Stefan Sauermann stefan.sauermann@technikum-wien.at FH-Prof. Dipl.-Ing. Alexander Mense alexander.mense@technikum-wien.at Projektkoordination Mathias Forjan, MSc mathias.forjan@technikum-wien.at Entwickler Matthias Frohner, MSc matthias.frohner@technikum-wien.at DI (FH) Birgit Pohn, MSc birgit.pohn@technikum-wien.at Philipp Urbauer, MSc philipp.urbauer@technikum-wien.at www.healthy-interoperability.at Geschäftsführung Mag. Gabriele Költringer gabriele.koeltringer@technikum-wien.at www.projectsolutions.at