IHE Conformity Assessment
The European Perspectives
Alexander Berler
IHE 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 Catalogue
1. Connectathons
and Projectathons
2. Gazelle Test Bed
and Tools
4. Virtual
Connectathons
5. Consulting / IoP
Specifications
9. Conformity
Assessment/Report
8. Interoperability
Showcases
3. Training
6. Tailored Test
Tools
7. Tailored Test
Plans
Luxembourg 2015
~300
Participants
75
Companies
230+
30+
50+
2400+
90+
engineers from
participating
organizations
committee
members
monitors
tests
performed
systems
Bochum 2016
~370
~310
30+
55
3000
114
Participants
engineers from
participating
organizations
committee
members
monitors
tests
performed
systems
83
Companies
Connectathon key figures
Gazelle Test Framework
Specifications/Standards
Validators
System A
Conformance
checks
Conformance
checks
System B
Interoperability
testing
Vendor A
Vendor B
Simulators
 Test management tool oriented toward interoperability and
conformance testing.
 Suite of conformance testing tools.
 Suite of simulators tools.
Use
Cases
GITB
Shared and Global eBusiness
Interoperability Test Bed Infrastructure
Use Cases
include, but
are not
limited to: Public Procurement Healthcare
Test Registry and
Repository (TRR)
aims at managing, archiving
and sharing
distributed Testing
Resources, like test
artifacts und test cases
Test Bed Architecture
aims at reusability, modularity and portability of test artefacts
and -beds, and enables
their coordination
Manufacturing /
Automotive
More
Open Source Test Bed
Implementation
Open source
software and
running demo
of the interoperable Test
Bed as well as sample
Testing Artefacts
GITB Testing Framework and Methodology
A shared test platform: Connectathon, Conformity, and ehealth Projects
eHealth Projects
Interoperability
Specifications
Projectathon
Project Conformity
Assessment
Product
Test Report
Profiles
Product
IHE Conformity
Assessment
IHE Connectathon
Standards
Enhancing testing rigor and reducing
costs and risks on an on-going basis
Add
project
extensions
IHE
Gazelle Test
Platform
ΙΗΕ Conformity
Assessment Scheme
History
14 years of experience
A unique business: TEST
Software Testing Lab
Values
Independence
Impartiality
Excellence
44 People
Our accreditations
Test Laboratory accredited for ISO 17025
LABORATOIRE CTA KEREVAL
ACCRÉDITATION
N° 1-2347
PORTÉE DISPONIBLE SUR
WWW.COFRAC.FR
Training provider
 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 retesting 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
Interoperability
Architecture
• ePrescription
• Patient Summary
•
•
•
•
•….
EHRs
HIS
LIS
…
Standards
• ΙΗΕ
• Continua
•…
Use Cases
User Needs
Integration
Profiles
•
•
•
•
•
HL7 CDA
HL7 FHIR
DICOM
W3C
…
Testing
•
•
•
•
Actors
Transactions
semantics
…
Interoperability
Specifications
• ΙΗΕ Gazelle
• Connectathon
• Simulators Validators
• Conformity
assessment
• ISO 17025
• ISO 17065
Certification
Interoperability Framework
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)
Decision 2015 / 1302 - 28 July 2015
XCPD
XCF
XCA
XDR
XDM
XDS.b
CT
ATNA
PIX
PDQ
PAM
BPPC
SVS
XUA
PRE
DIS
XPHR
MS
XD LAB
SWF
PIR
XDS-I.b
SWF.b
LTW
LCSD
LAW
XD-SD
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_199_R_0011
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?
Conformity of IHE-Profiles
with:
•
Conformity
Assessment
of IHEProfiles
Light extensions (incl.
metadata, forced fields, add
fields)
17025 Right to extend test methods and to test
Conformity of IHE-Profiles
with:
•
•
extensions (incl metadata,
forced, add fields)
Modifications (make optional,
not use required, )
A best practice: Switzerland intends to built its
certification program over IHE CAS
Testing of
National
Profiles
Thank you!
Questions ?
www.ihe-Europe.net