Status Report IHE-Europe Certification Workgroup

1
Status Report IHE-Europe Certification Workgroup

• Cor Loef, convener IHE-EU Certification Group

2
eHealth Solutions Quality Goals

• Healthcare Authorities
• 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

3
Quality Assurance at which Level?
Dutch Switch point example
National Switch Point
Care Provider
Care Provider
Enterprise IT
Enterprise IT
GP summary
GP summary
4
Requirements before connecting to Dutch Switch
point

• Application (functional) Requirements
• Features
• Includes security, accuracy
• 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

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

6
Interoperability/Connectivity Experience

• DICOM
• Available commercial and public 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 demos, public test-tools
• integration statements published by vendors
• Vendor community much wider
• Web Technology consortia approach

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Concluding

• There are many ways to assure quality of eHealth
  implementations
• E.g. by providing certified tests, jury
  inspections, self-certification, etc.
• Realize that products and interoperability specs
  are embedded in a context
• Requiring specific ways of quality assurance

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IHE, testing and certification, improvement
ideas (1)

• 1Introduce light-weight vendor-neutral field
  problem reporting process with feedback loop to
  IHE TF specifications and test tools.
• 2Connect-a-thon make distinction between
  prototypes and products.
• 3Independent healthcare provider jury at
  Connect-a-thon. Have ISO certification of IHE
  Connectathon process. Contact recognized testing
  bodies and invite them to Connectathon.
• 4Introduction of test specifications in the IHE
  Technical Framework and Integration Profile
  development process.
• 5Formal review process by healthcare providers
  for the test specifications.

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IHE, testing and certification, improvement
ideas (2)

• 6Improve the IHE test tools, by means of an
  Open Source development.
• 7Perform self-certification by vendors with the
  approved test specifications and tools.
• 7b Validation of the tools by third party ?
  
• 8Vendors Marketing/Sales staff should know
  about and promote IHE quality testing process,
  based on easy to use tool given to them with
  technical stuff.
• 9List the features of the actors in IHE
  profiles, to facilitate the use of building
  blocks in National Healthcare IT Infrastructure
  projects, hospitals and others healthcare
  organizations
• 10 general glossary
• 11 process of maintenance of fixes to TF , CP
  process

10
2 the result table with only products and
impact to the CAT organization 3 select third
party ?
Feedback
10
11
1
Connect-a-thon
Implementation
8
Needs standards
Technical Framework
Tools for Connect-a-thon
2
5
6
9
3
4
7b
Feedback
4 document of test plan/profile.actor 5
Validation of the document 6 Gazelle 7b
validation of Gazelle by ISO (?)
10 general glossary List of profiles,
actors,standards 11 definition of the
maintenance process
1 reporting from user organizations to users
cochairs, consolidation of the reports (to be
defined) 8 education sessions to users and
vendors 9 easy to use documents
11
1

• Definition of an diagnostic report to give to
  user organizations to evaluate the quality of the
  integration
• Process study
• Evaluation of the IHE workflow
• Differences ?
• Terminology
• Selected Profiles
• Actors, companies, transactions
• Others transactions
• Process of site test
• WHO
• Delay
• parameters
• Test plan (from IHE ?)
• Problem met
• Others concerns