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

2. 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, ..

3. 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

4. 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“

5. 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

6. 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,

7. 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.“

8. 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, …

9. 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
© 2013

10. HITCH: Roadmap for Europe
HITCH Healthcare Interoperability Testing and Conformance Harmonisation, WP6: D6.4 Final Report including consolidated Roadmap and recommendations, Version July

11. 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
Part 2, 3, 4: “Vision on eHealth EIF”, “Assessment framework” „First proposal technical layer“
IHE, Continua, epSOS were studied as pilots

12. 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/ , Version 1.2, 14/02/2013

13. 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/ , Version 1.2, 14/02/2013

14. 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/ , Version 1.2, 14/02/2013

15. 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/ , Version 1.2, 14/02/2013

16. 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

17. 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/ Version 1.2, 14/02/2013

18. 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 ).”

19. 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

20. 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

21. Hosting the IHE Connectathon Vienna 2009
90 companies
Accompanying workshop "Sharing Clinical Documents and Integrating Workflow“

22. 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

23. 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:

24. 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

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

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

27. 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.

28. 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

29. 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

30. Documents and Roles

31. Zeitplan Testdokumentation liegt in Rohfassung vor
Review Workhop
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

32. 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

33. IHE Product Certification, concepts

34. Antilope concepts for EU

35. 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

36. Kontakt Geschäftsführung Projektleitung
FH-Prof. DI Dr. Stefan Sauermann
FH-Prof. Dipl.-Ing. Alexander Mense
Projektkoordination
Mathias Forjan, MSc
Entwickler
Matthias Frohner, MSc
DI (FH) Birgit Pohn, MSc
Philipp Urbauer, MSc
Geschäftsführung
Mag. Gabriele Költringer