Application for the Conformity Assessment Testing Session

Transcription

1 Application for the Conformity Assessment Testing Session IHE Europe Webinar on Conformity Assessment March 11 th, 2016 Charles Parisot, Anne-Gaëlle Bergé

2 Agenda Organization Tested profiles Rules and commitments Fees Questions 2

3 Organization (1) 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 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 3

4 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

5 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 5 Vendors applying for IHE Conformity Assessment shall select specific actors for one or more of the listed profiles for their SUT

6 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). 6

7 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 ( 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 7

8 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 8

9 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

10 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 10

11 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. The Test Report will be issued once the vendor pays the Conformity Assessment fees 11

12 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 LAW: PIX: Patient Encounter Consumer Patient Encounter Supplier Patient Demographic Consumer Patient Demographic Supplier Laboratory Automation Workflow Analyzer Analyzer Manager 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 12 Vendors applying for IHE Conformity Assessment shall select specific actors for one or more of the listed profiles for their SUT

13 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. Rijnmondnet 13

14 Thank you for your attention! Questions? March 2016 Charles Parisot, Anne-Gaëlle Bergé