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IHE Conformity AssessmentThe European Perspectives
Alexander BerlerIHE Services Director
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
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