IHE Conformity AssessmentThe European Perspectives

Alexander BerlerIHE Services Director

alexander.berler@ihe-europe.net

IHE-Services• Formally created in 2012 • Built upon a long experience in interoperability

testing management and experience with epSOS.• IHE-Services has the goal to offer professional

services to support IHE Members as well as national/regional authorities, local projects or any other organisations deploying IHE profiles for their ehealth projects

IHE Services Catalogue1. Connectathonsand Projectathons

5. Consulting / IoPSpecifications

3. Training

9. Conformity Assessment/Report

4. Virtual Connectathons 6. Tailored Test

Tools

7. Tailored Test Plans

2. Gazelle Test Bed and Tools

8. Interoperability Showcases

IHE Service & Project Lifecycle

Functional Requirements

IoPArchitecture

& Specs

Procurement & Implementation

In House Testing

Pre Production

Testing

Production

Strategy & Roadmap

Consultancy Services Actors, Transactions

Consultancy ServicesTraining Services

Consultancy ServicesTraining ServicesTailored Test PlansVirtual ConnectathonsGazelle

Virtual ConnectathonsTraining ServicesTailored Test PlansTailored Test ToolsGazelle

Tailored Test PlansTailored Test ToolsConnectathonsVirtual ConnectathonsGazelle

Interoperability ShowcasesIHE CAS

© IHE-Europe Copyright

Connectathon key figures

~300Participants

75Companies

230+engineers from

participating organizations

30+committee members

50+monitors

2400+tests

performed

90+systems

~370Participants

83Companies

~310engineers from

participating organizations

30+committee members

55monitors

3000tests

performed

114systems

Luxembourg 2015

Bochum 2016

Gazelle Test Framework

Test management tool oriented toward interoperability and conformance testing.

Suite of conformance testing tools. Suite of simulators tools.

Specifications/Standards

System A

Vendor ASystem B

Vendor B

Conformance checks

Interoperabilitytesting

Conformance checks

Validators

Simulators

aims at reus-ability, modul-arity and port-ability of test artefacts and -beds, and enables their coordination

Open source software and running demoof the interoperable Test Bed as well as sample Testing Artefacts

aims at manag-ing, archiving and sharing distributed Testing Resources, like test artifacts und test cases

Use Cases include, but are not limited to:

GITB Testing Framework and Methodology

Test Registry andRepository (TRR) Test Bed Architecture Open Source Test Bed

Implementation

HealthcarePublic Procurement Manufacturing / Automotive

Use

C

ases

GITBShared and Global eBusiness

Interoperability Test Bed Infrastructure

More

Projectathon

IHE Connectathon

A shared test platform: Connectathon, Conformity, and ehealth Projects

Enhancing testing rigor and reducing costs and risks on an on-going basis

Standards

Profiles

Interoperability Specifications

Project Conformity Assessment

IHE Conformity Assessment

eHealth Projects

Add project extensions

Product

Product

IHEGazelle Test

Platform

Test Report

ΙΗΕ Conformity Assessment Scheme

Software Testing LabHistory14 years of experienceA unique business: TEST

ValuesIndependenceImpartialityExcellence

Our accreditations

LABORATOIRE CTA KEREVALACCRÉDITATIONN° 1-2347PORTÉE DISPONIBLE SURWWW.COFRAC.FR

Test Laboratory accredited for ISO 17025 Training provider

People44

One of the two testing labs accredited (17025) to realize Conformity Assessment Testing sessions according to IHE profiles

Management of the Conformity Assessment Testing session in Luxembourg (2015)

Management of online Conformity Assessment Testing session

Rules and commitments for Systems Under Test (SUT)Be a marketed released (or about to be released) commercial

product The vendor shall have passed in the previous 2 years the IHE

Connectathon for the profile/actors to be conformity assessed.The Test Report, valid for two years, will be provided as soon as

all the elements of the test session are completed If a product is updated with a new released version:

The vendor may request an extension of the scope of the report to the testing laboratory. The testing laboratory, upon the analysis of the information communicated by the vendor, will decide if some re-testing is required or not.

An additional Conformity Assessment report is issued The Testing Laboratory is in charge of: Publishing the Conformity Assessment Report on the IHE

International Web Site (http://conformity.ihe.net) Providing the report to the company

FeesIHE-Europe has established with Kereval a

cost-recovery only fee. For 1 system under test (SUT) and for up to 4

profile/actor pairs : 5500 €Note: the CT/Time Client profile/actor pair is tested for free

Additional profile/actor pairs for the same system (SUT) may be tested for 1000 € each.

14

Interoperability Framework

• ePrescription• Patient Summary•….

Use CasesUser Needs

• EHRs• HIS• LIS• …

Interoperability Architecture • ΙΗΕ

• Continua• …

Integration Profiles

• HL7 CDA• HL7 FHIR• DICOM• W3C• …

Standards

• Actors• Transactions• semantics• …

Interoperability Specifications

• ΙΗΕ Gazelle• Connectathon• Simulators -

Validators

Testing• Conformity

assessment• ISO 17025• ISO 17065

Certification

ehealth EIF• eHealth European Interoperablity

Framework described use cases and selected IHE profiles and standards

• Antilope refined the eHealth EIF with tools for – Guidelines for implementation of the use cases– Interoperability Quality Manual– Set of testing tools– Quality label and certification process

• Endorsement by the eHealth Network

27 IHE Profiles included under EU regulation 1025/2012 (EU MSP)

XCPD

XDR

CT

PDQ

XCF

XDM

ATNA

PAM

SVS

DIS

XD LAB

XDS-I.b

XUA

XPHR

SWF

SWF.b

XCA

XDS.b

PIX

BPPC

PRE

MS

PIR

LTW

LCSD LAW XD-SD

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_199_R_0011

Decision 2015 / 1302 - 28 July 2015

EU and IHE profiles• Commission Decision 2015/1302, published on 31 July 2015, identifies

27 IHE Integration profiles for referencing in public procurement• These IHE profiles have the potential to increase interoperability of

eHealth services and applications to the benefit of patients and medical community

• The 27 IHE profiles should therefore be identified as ICT technical specifications eligible for referencing in public procurement

The IHE profiles identified by the European Commission are already included in the IHE CAS

H2020: Call for Proposal• Call on EU eHealth Interoperability Conformity

assessment on February 2016• Challenge: Establishment of a sustainable

European Conformance Assessment Scheme associated with the maintenance of the eEIF, fostering a wider eHealth Interoperability uptake for the entire European market

Future CAS for Europe?

A best practice: Switzerland intends to built its certification program over IHE CAS

Conformity Assessment

of IHE-Profiles

Conformity of IHE-Profiles with:

• extensions (incl metadata, forced, add fields)

• Modifications (make optional, not use required, )

Testing of National Profiles

Conformity of IHE-Profiles with:

• Light extensions (incl. metadata, forced fields, add fields)

17025 Right to extend test methods and to test

Thank you!Questions ?

www.ihe-Europe.net