Project Solutions Technikum Wien ELGA Testen? Stefan Sauermann FlyTieto, Wien, 1. Oktober 2013.
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Transcript of Project Solutions Technikum Wien ELGA Testen? Stefan Sauermann FlyTieto, Wien, 1. Oktober 2013.
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
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
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
Time axis, EU, Austria, Technikum
2003-05 06 07 08 09 10 11 12 13
e-health Focus Group
e-health Action Plan
eHealth Initiative
Health reform
ELGA project company
Projects, theses, papers, … Healthy IO Project Focus eHealth
IHE Austria
eHealth Interoperability
FW (eH EIF)
Health reform
AntilopeHITCH
HITCH: Healthcare Interoperability Testing and Conformance Harmonisation
www.projectsolutions.at © 2013
Reference Projects
National, Regional
and Local Projects
Market, Industry,Small and Medium-sized
Enterprises (SMEs)
HITCH Roadmapissues and solutionsfor interoperability
Effective In
terop
erability
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
Req
uir
emen
ts
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/
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 2011http://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-interoper
ability-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
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 efficiencyeHealth 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
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
EXPERIENCE
EXPERIENCE
Connectathons /PlugFests
IHE / Continua Certified
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
www.projectsolutions.at
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
Reference Projects
www.projectsolutions.at
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
Reference Projects
• 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
ELGA CDA Import/Export Test und Zertifizierung
www.projectsolutions.at
• Systems and software engineering
• Systems and software Quality Requirements and Evaluation
(SQuaRE)• System and software quality models
ISO 25010 (2011) (früher ISO 9126):
www.projectsolutions.at
• Konzentration auf Interoperabilität• Vieles andere wird nicht getestet und als gegeben vorausgesetzt
ISO 25010 (2011) (früher ISO 9126): Modellelemente
www.projectsolutions.at
• Functionality– 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.
Wie war es früher: ISO 9126
www.projectsolutions.at
• Chapter 7: „Test documentation content topics to be addressed “
– Plans
IEEE 829 (2008)Standard for Software and System Test Documentation
• Chapter 7: „Test documentation content topics to be addressed “
– Reporting
IEEE 829 (2008)Standard for Software and System Test Documentation
Documents and Roles
• 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
Zeitplan
www.projectsolutions.at
• 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
Vorschläge für die Zukunft
www.projectsolutions.at
IHE Product Certification, concepts
Antilope concepts for EU
www.antilope-project.euwww.projectsolutions.at
Antilope Project Validation WorkshopIn 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
Save the date: Antilope Workshop 2014, WIen
www.projectsolutions.at
Kontakt
ProjektleitungFH-Prof. DI Dr. Stefan [email protected]
FH-Prof. Dipl.-Ing. Alexander [email protected]
ProjektkoordinationMathias Forjan, [email protected]
EntwicklerMatthias Frohner, [email protected]
DI (FH) Birgit Pohn, [email protected]
Philipp Urbauer, [email protected]
www.healthy-interoperability.at
GeschäftsführungMag. Gabriele Kö[email protected]
www.projectsolutions.at