Application for the Conformity
Assessment Testing Session
March 11th, 2016
Charles Parisot, Anne-Gaëlle Bergé
Agenda
2
Organization
Tested profiles
Rules and commitments
Fees
Organization (1)
3
The test session will be conducted according to
the
IHE Conformity Assessment Scheme
IHE-CAS-1
IHE-CAS-2
The test sessions will be conducted in Europe*
by KEREVAL HealthLab, an
ISO/CEI 17025
accredited testing laboratory
, under supervision of
its qualified resources : testing team and test
session manager
* ICSA Labs in the USA will also offer IHE-CA testing sessions for a subset of the profiles
Organization (2)
Limited Production testing:
Limited number of seats (one per new actor/profile)
Starts in March 2016
Production testing:
Open to everybody for the 15 profiles
Starts in May 2016
In both cases:
On-line testing with KEREVAL
Requires Internet access, webcam, screen sharing
through WebEx
Tested profiles
New for production testing in May 2016 (
limited Production in
March 2016
)
XCA: Cross-Community Document Access
XCPD: Cross-Community Patient Discovery
XDS-I.b: Cross-Enterprise Document Sharing for Imaging
XCA-I: Cross-Community Document Access for Imaging
PAM: Patient Administration Management
LAW: Laboratory Automation Workflow
PIX: Patient Identification Cross-referencing (HL7V2)
DEC: Device Enterprise Communication
PIV: Point-of-Care Infusion Verification
For production testing since May 2015:
PIXV3: Patient Identification Cross-referencing (HL7V2)
XDS.b: Cross-Enterprise Document Sharing
PDQ: Patient Demographics Query (HL7V2)
PDQV3: Patient Demographics Query (HL7V3)
ATNA: Audit Trail and Node Authentication
CT: Consistent Time
Vendors applying for IHE
Conformity Assessment
shall select specific
actors for one or more
of the listed profiles for
their SUT 5
Rules and commitments
for Systems Under Test (SUT)
Be a marketed released commercial product
The version and integrity of the SUT is not allowed to change, at any time, during the test session
The product commercial name and version shall be disclosed to the test laboratory. The capacity to attest its version shall be
offered when requested.
The vendor shall have passed the IHE Connectathon Tests for the profile/actors targeted for conformity assessment (during any
Connectathon in the previous two years, including the one held in Bochum for Production testing).
Rules and commitments
for Conformity Assessment Report
(1/2)
The Testing Laboratory is in charge of:
Publishing the Conformity Assessment Report on the IHE International Web Site (http://conformity.ihe.net)
Sending the report to the company: In a .pdf format
to an identified Single Point Of Contact
The Test Report will be provided as soon as all the
elements of the test session are completed
Rules and commitments
for Conformity Assessment Report
(2/2)
The Conformity Assessment Report issued is valid for
two years
If a product is updated with a new released version:
The previous version Conformity Assessment Report will not be valid
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
Rules and commitments
for
SUT operators
Selected by the company submitting the SUT
Use their unique login that permits personal identification in the testing management system during the testing session.
They shall not share their login
Level of skills:
Knowledge and experience of the use of the SUT >= 1 year
Knowledge and experience in tested IHE profiles >= 1 year
Participation to a Test session (e.g. Connectathon) as SUT operator >= 1 time
Participation to webinar offered by Kereval for SUT operators
During the Conformity Test Session, SUT operators are required To prepare their SUT (registration, identification, configuration preparation…)
To execute the test steps required by the test scripts.
To follow the directions of the test session manager 9
Preparation
Kick off meetings will be organized in advanced of the
session
System under test shall be able to display its
commercial version at any point of time during the
testing
SUT operator shall provide KEREVAL Health Lab with
the IP used for testing (access to the testing environment
is restricted)
SUT operator shall ensure that he/she is able to
connect to Webex, to share his/her screen and to
connect an external webcam
Fees
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.
11
The Test Report will be issued once the vendor pays the Conformity Assessment fees
Profile/Actors Pairs
for Limited Production Testing by Kereval
XCA: Cross-Community Document Access Initiaing Gateway
Responding Gateway
XCPD: Cross-Community Patient Dscovery Initiaing Gateway
Responding Gateway
PAM: Patient Administration
Management
Patient Encounter ConsumerPatient Encounter Supplier Patient Demographic Consumer Patient Demographic Supplier
LAW: Laboratory Automation Workflow Analyzer
Analyzer Manager
PIX: Patient Identification Cross-referencing (HL7V2) Patient Identifier Cross-referencing Manager
Patient Identifier Consumer
For Vendors interested in limited production testing the following profiles is also offered by other testing labs. Contact Alexander Berler.
XDS-I.b: Cross-Enterprise Document Sharing for Imaging
XCA-I: Cross-Community Document Access for Imaging
DEC: Device Enterprise Communication
PIV: Point-of-Care Infusion Verification
Vendors applying for IHE
Conformity Assessment
shall select specific
actors for one or more
of the listed profiles for
their SUT
To apply
•
Fill
the
application
form
(sent
on
demand
by
IHE
‐
Europe)
•
Send
to
Alexander
Berler
(Director
IHE
Services)
•
For
Limited
Production
Testing:
Deadline
is
March
18
th
•
For
Testing
before
the
summer,
recommend
to
apply
before
April
22
nd
,
week
after
the
European
Connectathon in
Bochum.
Thank you for your attention!
Questions?
March 2016
Charles Parisot, Anne-Gaëlle Bergé
