1. Certification - one of the means to our Goal
Kees Smedema
Chairman COCIR Healthcare IT Committee
Philips Medical Systems

2. “Quality” Goals Healthcare Authorities: Care Providers Patients
Promote use of good quality eHealth solutions
Provide comfort to the care providers and the patients
Make sure that promised benefits are realized
Care Providers
Trust quality and functionality of eHealth solutions
Patients
Safety, quality of care, privacy
Vendors
Trust by Care Providers in products and solutions
Improving market and market access
COCIR/HINE Industry Session
Kees Smedema, 9 Oct 2006, 2

3. Quality Assurance: at which Level?
Dutch Switchpoint example:
National
Switch
Point
Care Provider
Care Provider
Enterprise IT
Enterprise IT
GP summary
GP summary
COCIR/HINE Industry Session
Kees Smedema, 9 Oct 2006, 3

4. Requirements before connecting to Dutch Switchpoint
Application (functional) Requirements
Features
Includes security, accuracy, recent
Interoperability/Connectivity requirement
Connectivity and message exchange with Switch point
Implementation (quality) Requirements
Security, authorization, availability, up-time, performance/response time, scalability, accuracy
Management/Maintenance Requirements
Management of connectivity, security, availability, actuality
Test node is provided
Pilot, no certification yet
COCIR/HINE Industry Session
Kees Smedema, 9 Oct 2006, 4

5. Questions
Can we devise certification/quality schemes without having a clear idea about the context?
Compare HIPAA: regulation for Institution, not for a product
What Quality aspect are we talking about?
Functionality
Connectivity and interoperability
Installation, Maintenance, operational use
What is the best way to guarantee quality?
3rd party certification?
Self certification, supported by a formal test process
Provision of (open source) certified test scripts
How can we make this process efficient and effective?
Incentives to vendors and 3rd party
Added value by involving users
COCIR/HINE Industry Session
Kees Smedema, 9 Oct 2006, 5

6. Interoperability/Connectivity Experience
DICOM
Available commercial DICOM test tools
Cross-vendor testing
During shows (RSNA,.. )
Within vendor labs
Enormous market pressure to produce good products
Very close community: you know who to call from “the other vendor”
IHE
Connect-a-thon and demo’s, public test-tools
“integration statements” published by vendors
Vendor community much wider
COCIR/HINE Industry Session
Kees Smedema, 9 Oct 2006, 6

7. IHE, testing and certification, some ideas
Implement test scripts (open source) together with the technical specifications
Formal review process for the test tools
Connect-a-thon: make distinction between prototypes and products
Independent “jury” at Connect-a-thon
Do self-certification with the approved test-scripts
Introduce light-weight problem reporting process with feedback loop to specifications and test tools.
COCIR/HINE Industry Session
Kees Smedema, 9 Oct 2006, 7

8. Concluding
There are many ways to assure quality of eHealth implementations
E.g. by providing “certified” tests
Provide incentives and additional value when 3rd party certification is done for certain aspects
E.g. testing by experienced users
Independent bodies can be divorced from reality and their added value maybe very small or negative compared to the additional cost (cost-feedback loop!)
Realize that products and interoperability specs are embedded in a context
Requiring other ways of quality assurance
COCIR/HINE Industry Session
Kees Smedema, 9 Oct 2006, 8