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


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“


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


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.“


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


http://ec.europa.eu/digital-agenda/en/news/ehealth-interoperability-framework-study

http://ec.europa.eu/digital-agenda/en/news/ehealth-interoperability-framework-study

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


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.


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


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).”


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


Hosting the IHE Connectathon Vienna 2009

90 companies Accompanying workshop "Sharing

Clinical Documents and Integrating Workflow“

www.ihe.net



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


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


• Systems and software engineering

• Systems and software Quality Requirements and Evaluation

(SQuaRE)• System and software quality models

ISO 25010 (2011) (früher ISO 9126):


• Konzentration auf Interoperabilität• Vieles andere wird nicht getestet und als gegeben vorausgesetzt

ISO 25010 (2011) (früher ISO 9126): Modellelemente


• 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


• 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


• 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


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


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]


mailto:[email protected]






http://www.healthy-interoperability.at/


http://www.projectsolutions.at/

project solutions technikum wien elga testen? stefan sauermann flytieto, wien, 1. oktober 2013

Documents

shortliffe slide

motto ehealth

tested ehealth products

ihe europe

assessment framework

european moves

data exchange

member ihe