Conformity Assessment - Yasunari Shiokawa Senior Healthcare Information Technologist - IHE
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Conformity Assessment
Yasunari Shiokawa
Senior Healthcare Information Technologist
IHE-International Conformity Assessment Coordination Committee
IHE-Japan Director, Radiology Technical Committee Chair
Toshiba Medical Systems Corporation
1
Agenda
1. Introduce IHE Japan.
2. What is Conformity Assessment？
3. IHE Japan Activity with CA tools.
2
Introduce IHE Japan
• IHE-Japan Organization
– Established: 2001, Incorporated: 2007
– President: Yutaka Ando, Vice-presidents: Michio Kimura, Minoru Hosoba
• Overall number of members
– 60 Healthcare Professional Associations
– 99 Healthcare IT and Consulting Companies
• IHE-J Membership model
– Fees based on membership ranks.
( S: \500,000- / year, A: \100,000-, B: \5,000- )
• Activity situation
– Until 2014, Government had offered IHE-J to create a Connectathon test
environment for healthcare system interoperability in Japan.
– We continued Connectathon and developed small jobs to the government.
– We are now making efforts to develop new business activities.
3
Introduce IHE Japan
• Japan Connectathon 2016
– Term: Sep. 13 TUE – Sep. 17 SAT 2016
– Place： Tokyo Metropolitan Trading Center Asakusa-kan, Asakusa, Tokyo
– Participants: 48 companies 81 systems including supportive participation
(2014; 44 companies 88 systems, 2015: 47 companies 79 systems )
– Testing Domains & Profiles:
• RAD (SWF.b, ARI, CPI, ED, KIN, MAMMO, PDI, IRWF, REM, XDS-I.b,
XCA-I)
• LAB (LAW, LBL, LDA, LPOCT, LTW(GIR), LTW-MB)
• CARD (CATH, ECG, ECHO, ED-CARD, IVI)
• END (EWF)
• PCD (ACM, DEC, POVQ)
• RO (BRTO2)
• ITI (ATNA, CT, PAM, PDQ, PDQ V3, PIX V3, XDS.b, XCA)
– Monitors: 56 monitors including 8 voluntaries from medical facilities.
4
IHE World Summit 2017
What is Conformity Assessment?
5
World Connectathons
China
over 100?
Japan
About 45
EU
Korea
about 90 about 10 NA
about 70
Australia
about 10?
Vendor’s participation
6
Japan Connectathon
7
NA / EU Connectathons
8
Connectathon Goal
Connectathon is:
A Testing place for IHE products from regional vendors.
Regional management with regional monitoring rules
( and with National Extensions in Japan )
Monitors are human (no mechanical checking)
Gold Star tables of regions opened on IHE website
have no relation with each other
IHE does not deliver any Connectathon
certification. Each vendor publishes an
Integration Statement.
9
Start Conformity Assessment Oct. 1st 2015 - US, EU and JP made a basic agreement to start the Conformity Assessment program.
Conformity Assessment
What is IHE Conformity Assessment(CA) ?
IHE delivers an official report of CA test for vendor’s products.
Based on ISO/IEC 17025 standard.
Certified Test Labo manages and runs CA testing for
vendors.
CA test tool checks vendor product accurately.
IHE Int’l provides CA mark for passing product and
publishes the information on the IHE CA website.
CA mark valid globally.
IHE grants the CA mark based on
comprehensive compliance assessment.
11CA Committee members
★ : Co-Chair
IHE-EU (Test Labo : Kereval company )
★Lapo Bertini - ITA, Charles Parisot - FRA
Held the first CA test in 2015 inside the Connectahon place for a trial event.
CA Tool development team is in France.
IHE-USA (Test Labo : ICSA-Lab )
★Amit Trivedi, Joyce Sensmeier, John Donnelly, Chris Carr
Launching HIMSS CON/CERT and RSNA Image Share certification.
IHE-Japan ( still NO test Labo )
Yasunari Shiokawa, Michio Kimura
Launching test environment on behalf of government since 2014
Others
Sequoia Project : Didi Davis IHE-UK : Neil Robinson
12CA definition http://ihe.net/Conformity-Assessment/ 13
CA testing Profiles
• Consistent Time (CT)
• Audit Trail and Node Authentication (ATNA)
• Cross Enterprise User Assertion (XUA)
• Cross-Enterprise Document Sharing (XDS.b)
• Cross-Enterprise Document Sharing for Imaging (XDS-I.b)
• Patient Identification Cross-referencing (PIX)
• Patient Identification Cross-referencing HL7v3 (PIXV3)
• Patient Demographics Query (PDQ)
• Patient Demographics Query HL7v3 (PDQV3)
• Cross-Community Access (XCA)
• Cross-Community Access for Imaging (XCA-I)
• Cross-Community Patient Discovery (XCPD)
• Patient Administration Management (PAM)
• Laboratory Analytical Workflow (LAW)
• Device Enterprise Communication (DEC)
• Point-of-Care Infusion Verification (PIV)
http://wiki.ihe.net/index.php/Conformity_Assessment_Committee 14CA testing Report https://conformity.ihe.net/summary-reports 15
HIE certifications based on CA
https://www.rsna.org/Image_Share.aspx
http://www.himssinnovationcenter.org/concert-himss
16IHE World Summit 2017
IHE Japan Activity with CA Tools
17Problem on HIE in Japan
Vendor B
Vendor A Spec
Charge Calculation
System Spec
EHR system
！
Radiology Domain System
！
！
Cardio Domain System
Laboratory Domain System
・・・ Vendor C
Spec 18Government plan based on IHE http://www.mhlw.go.jp/file/05-Shingikai-12601000-Seisakutoukatsukan-Sanjikanshitsu_Shakaihoshoutantou/0000091465.pdf 19
HIE Specs in Japan
Ministry of Health, Labour and Welfare
Creating cross regional HIE infrastructure Proj.
2013 FY;
FEB. 2014; Ver. 1.0, Publishing Technical
Specification Document
2014 FY;
AUG. 2014; Ver. 1.1, as revising for comments
by HELICS organization.
MAR. 2015; Ver. 2.0, as the final version of
2014FY business work.
• Add XCA-I
• Add audit log specification for
XDS-I.b, XCA and XCA-I
Implementing test env. for HIE infrastructure Proj.
2016 FY;
NOV. 2016; Ver. 3.0, as additional profiles for
exchanging patient IDs
• Add XDR, XCPD
http://www.ihe-j.org/file2/docs/IHE-J_ITI_DocumentV3.0.pdf 202016: Implemented Testing Env.
Sep Oct Nov Dec Jan Feb Mar
Planning
Learn & Install 2016 EU Education Program
▼
Preparing CA of 2016 EU
Evaluate CA
Update 2017 CA CA2017 release
▼
CA test event
Documentation
Reporting
Plan Result
IHE-Services supported us on those phases.
21Emulators Procure CA
Interconnectability Validation Tools
Transactions module using
XDS Doc Consumer XDS Registry
XDS Doc Source XDS Repository IHE Services
help
XDS Repository XDS Doc Source
XDS Registry XDS Doc Consumer
XCA Responding GW XCA Initiating GW
XCA Initiating GW XCA Responding GW Display
PIXV3 PIX Manager PIXV3 PID Source of test
PIXV3 PIX Consumer PIXV3 PIX Consumer result
PIXV3 PID Source PIXV3 PIX Manager
Interoperability
Contents Upload function
Test Target
Contents Validation Tools
Contents Upload Monitor
HL7V2.5 For HL7V2.5
Standard CDAr2 For CDAr2
Contents Procure Art
Storage DICOM Image Décor and
For DICOM
Part10 File(?) Object
Checker
IHE-J develops
GUI GUI
environment on
Test Target Community Test Environment CA testing tools.2016: Implemented Testing Env.
• Oct. 20 - 24 2016 at KEREVAL, Rennes
– Participated in education programs on CA tools for implementing.
• Eric P. and KEREVAL development team provided us with 3 days educational
program on CAsC tools: installation, use of tools, editing of settings and
configuration.
• Mr. Seki, IHE-J ITI Technical staff, was the main student as technical personnel and
Salt Shiokawa, as the manager and translator, was a lazy student this time!
• We also received the 2016 CA tool
module packaged by Eric.
• After that, we implemented test tools
well and got to start using them for
trial evaluation.
• IHE-Services provided us with great
technical support and the tools were
quite accurate, so that we had very
few questions.
23Future test environment
Test Tool
Test Labo Japan
ISO/IEC 17025
AA CA Tool
Product
ProductThank you for your listening!
ご清聴ありがとうございました。
Very happy to answer your questions!
25You can also read
