1. IHE-Europe EU-Affairs and IHE Services Committees
Leveraging IHE profiles and the upcoming IHE conformity assessment in ehealth projects
IHE-Europe
EU-Affairs and IHE Services Committees

2. strategic overview and practical principles
Bring the most recent developments in IHE to achieve interoperability within various eHealth projects such as :
Hospital and Hospital groups
Regional health information exchange platforms
National ehealth programs
Todays focus is to address the critical question of establishing the necessary overall interoperability governance process to solve technical and semantic interoperability
Note: The legal and organizational policies that ensure information exchange participants operate with trust and clinical relevance are critical but not within the scope of this presentation

3. For an effective Interoperability Governance
How should organize the processes in an eHealth program to deliver effective interoperability ?
Address and focus on my ehealth program objectives
Allows the best use (and reuse) of IHE profiles
Sets the role and structure for an Interoperability Specification that bridges the gap between my use cases and IHE profiles
Assesses conformity of implementations to IHE profiles and my Interoperability Specifications
Establish a project specific testing platform to drive production level interoperability.
Can the IHE International Conformity Assessment program to be launched in April at the Luxemburg Connectathon help

4. The journey has two major parts
From an ehealth program objectives to the delivery of robust project specific Interoperability Specifications
From the project specific Interoperability Specifications to interoperable implementations on various applications/systems to be interconnected

5. The journey has two major parts
From an ehealth program objectives to the delivery of robust project specific Interoperability Specifications
From the project specific Interoperability Specifications to interoperable implementation on various applications/systems to be interconnected

6. Key health systems objectives Interop-erability Testing
Use of IHE Profiles in eHealth Projects Selecting Profiles for Interoperability Specification
Key health systems objectives
Content & Terms
Security and Privacy
Services
Patient summary
Lab Report
Imaging Info Exchange
ECG Report
. . .
Patient Demographics
X Document sharing
Health Provider Directory
Consent management
Audit Trail
Profiles for Use Case A
Business Use case A
Interop-erability Testing
Profiles
Standards
IHTSDO

7. The IHE Global Standards Adoption Process
First Step: Select and Document a Business Use case Document the interoperability needed to support
Second Step: Meet the interoperability requirements of the business use case by specification in an interoperability specification of:
a combination of a suitable set of profiles
remaining gaps by project specific custom elements
 How is this done ? 7 7

8. Use Case: Sharing Patient Summaries
Business Use Case (simplified):
A Patient Summary Service allows creation and access to a standardized set of basic medical data that includes the most important clinical facts required to ensure safe and secure healthcare. This data is intended to aid health professionals in providing better coordinated care as well as unscheduled care.
A medical summary consisting of general information and clinical patient data (e.g. allergies, current medical problems, implants, or major surgical procedures, current prescribed medications.
This service should ensure:
That health professionals access information either from specific encounter or review and aggregate information across time
Attribution , consistency and accountability by the professionals
Patient’s control over access to shared information 8 8

9. Key health systems objectives Interop-erability Testing
Use of IHE Profiles in eHealth Projects Selecting Profiles for Interoperability Specification
Key health systems objectives
Content & Terms
Security and Privacy
Services
Patient summary
Lab Report
Imaging Info Exchange
ECG Report
. . .
Patient Demographics
X Document sharing
Health Provider Directory
Consent management
Audit Trail
Profiles for Use Case A
Business Use case A
Interop-erability Testing
Profiles
Standards
IHTSDO

10. Key health systems objectives
Use of IHE Profiles in eHealth Projects Selecting Profiles for Interoperability Specification
Key health systems objectives
Project Interoperability Specification
Combination / Glue
IHE Profile for
Content
Custom Profile for
Terms
IHE Profile
Sharing Doc Services
Security
Privacy
Patient Id Mgt
Business Use case A
Technical Use case 1
IHE Profile for
Content
Custom Profile for
Terms
Technical Use case 2
IHE Profile
Sharing Doc Services
Patient Id Mgt
Technical Use case 3
IHE Profile for
Security
Privacy
Profiles

11. Key health systems objectives
Use of IHE Profiles in eHealth Projects Two Examples of Technical Use Case/Profiles
Key health systems objectives
Project Interoperability Specification
Combination / Glue
IHE Profile for
Content
Custom Profile for
Terms
IHE Profile
Sharing Doc Services
Security
Privacy
Patient Id Mgt
Business Use case A
Technical Use case 1
IHE Profile for
Content
Custom Profile for
Terms
Technical Use case 2
IHE Profile
Sharing Doc Services
Patient Id Mgt
Technical Use case 3
IHE Profile for
Security
Privacy
Profiles

12. The journey has two major parts
From an ehealth program objectives to the delivery of robust project specific Interoperability Specifications
From the project specific Interoperability Specifications to interoperable implementation on various applications/systems to be interconnected

13. What is meant by Conformity Assessment?
Test Report provided by a trusted neutral organization that guarantees that an IHE profile implementation in a commercial products is positively tested against an IHE test plan/test tools
Specific version of a specific product (re-testing may be needed for every major version). Does not imply that retesting is needed for each product/version (e.g. using same software).
The process and rigor of “Conformity Assessment” to be defined in terms of a “conformity assessment scheme” (process, test plan and test tools) to ensure world-wide equivalence.
Expects a vendor to pass appropriate Connectathon tests as a prerequisite for seeking profile/actor accredited testing

14. Concepts of IHE Conformity Assessment
IHE International Conformity Assessment Scheme Holder
Common Test Tools and Plans
International Conformity Assessment Oversight
Testing Report
Conformity Assessment/Testing by an AccreditedLaboratory
Accreditation Body
Accredits to operate per
ISO17025
Testing Report
Application
Vendor
Product Testing Report
Elements shown above may be deployed in various ways

15. Elements of an IHE Conformity Assessment Scheme
A single international scheme with delegation of accreditation operation testing at the national/regional level.
Allows IHE National/Regional Deployment Committee to deliver a internationally recognized testing report based on transparency
Testing of National extensions/combination of IHE Profiles is to be addressed as a subsequent testing step (“projectathon” or ehealth project-specific interoperability specification).

16. IHE Accredited Testing and Connectathon
Confomity Asessment, a value-add to Connectathon, not a replacement:
Dimensions
IHE Connectathon
IHE Profile Conformity Assessment
Participants
Vendors & Open Source
Specific Product version
No (IHE allows for vendor self-attestation through Integration Statement)
Yes
Testing Profiles
Trial Implementation and Final text
Only Selected Final Text Profiles
Collaborative and Learning No
Pre-requisite
None – Only to pass pre-Connectathon tests
Vendor has successfully passed profile tests at an IHE Connectathon
Commitment to commercial availability
No – Pre-product testing OK
Guarantee Interoperability of tested products
No – Reasonable expectation
No – But Clearer expectation for specific product version
Staffing of oversight/jury
Monitored by volunteers
Monitored by professional staff

17. IHE Conformity Assessment for who ?
The larger eHealth Projects (national, regional, hospital network) that want to engage a broad number of vendors to supply products with IHE profile conformance. Use IHE Conformity Assessment as an entry criteria into procurement and project level lab testing (Projectathon).
The care delivery organization with simple interoperability projects (e.g. connecting devices to a Clinical System). Only a few profiles to be combined.
Vendors that want to avoid the overhead of retesting in each project at the profile level.

18. IHE’s contribution to ehealth projects
Projectathon
Project IS Conformity Assessment
Interoperability Specifcations
Product
IHE Conformity Assessment
Profiles
Add extensions
Product
IHE Connectathon
Standards
IHE
Gazelle Test Platform
Enhancing testing rigor and reducing costs and risks on an on-going basis

19. IHE’s contribution to ehealth projects (Another View)
Conformity
Assessment
Interoperability Testing
Projectathon
Connectathon
Specifications
eHealth
Project
Interoperability
specifications
IHE Gazelle TestBed
IS Conformity
Assessment
IHE
Profiles
IHE Conformity
Assessment
Standards
Products

20. Working Together to Deliver Interoperable Health Information Systems
Providers and Vendors
Working Together to Deliver
Interoperable Health Information Systems
in the Enterprise
and Across Care Settings