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Leveraging IHE profiles
and the upcoming
IHE conformity assessment in
ehealth projects
IHE-Europe
EU-Affairs and IHE Services Committees
1
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
2
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
3
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
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
implementation on various
applications/systems to be interconnected
5
Use of IHE Profiles in eHealth Projects
Selecting Profiles for Interoperability Specification
Key health systems
objectives
Profiles for Use Case A
Content & Terms
Business
Use case A
Profiles
Standards
• Patient summary
• Lab Report
• Imaging Info Exchange
• ECG Report
• ...
Services
• Patient Demographics
• X Document sharing
• Health Provider
Directory
• ...
Security and Privacy
IHTSDO
• Consent management
• Audit Trail
•...
Interoperability
Testing
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
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
Use of IHE Profiles in eHealth Projects
Selecting Profiles for Interoperability Specification
Key health systems
objectives
Profiles for Use Case A
Content & Terms
Business
Use case A
Profiles
Standards
• Patient summary
• Lab Report
• Imaging Info Exchange
• ECG Report
• ...
Services
• Patient Demographics
• X Document sharing
• Health Provider
Directory
• ...
Security and Privacy
IHTSDO
• Consent management
• Audit Trail
•...
Interoperability
Testing
Use of IHE Profiles in eHealth Projects
Selecting Profiles for Interoperability Specification
Key health systems
objectives
Project
Interoperability
Specification
Technical
Use case 1
Technical
Use case 2
Combination / Glue
Business Use case A
Technical
Use case 3
IHE
Profile for
Content
IHE Profile
Sharing Doc
Services
IHE
Profile for
Security
Custom
Profile for
Terms
IHE Profile
Patient Id
Mgt
IHE
Profile for
Privacy
Profiles
IHE Profile
for
Content
Custom
Profile for
Terms
IHE Profile
Sharing Doc
Services
IHE Profile
Patient Id
Mgt
IHE Profile
for
Security
IHE Profile
for
Privacy
Use of IHE Profiles in eHealth Projects
Two Examples of Technical Use Case/Profiles
Key health systems
objectives
Project
Interoperability
Specification
Technical
Use case 1
Technical
Use case 2
Combination / Glue
Business Use case A
Technical
Use case 3
IHE
Profile for
Content
IHE Profile
Sharing Doc
Services
IHE
Profile for
Security
Custom
Profile for
Terms
IHE Profile
Patient Id
Mgt
IHE
Profile for
Privacy
Profiles
IHE Profile
for
Content
Custom
Profile for
Terms
IHE Profile
Sharing Doc
Services
IHE Profile
Patient Id
Mgt
IHE Profile
for
Security
IHE Profile
for
Privacy
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
12
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
13
Concepts of IHE Conformity Assessment
IHE International
Conformity Assessment Scheme Holder
Common Test Tools and Plans
International Conformity Assessment Oversight
Testing Report
Accreditation
Body
Conformity Assessment/Testing
by an AccreditedLaboratory
Accredits to
operate per
ISO17025
Application
Testing Report
Vendor
Product Testing
Report
Elements shown above may be deployed in various ways
14
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 projectspecific interoperability specification).
15
IHE Accredited Testing and Connectathon
Confomity Asessment, a value-add to Connectathon, not a replacement:
Dimensions
Participants
Specific Product version
IHE Connectathon
IHE Profile Conformity
Assessment
Vendors & Open Source
Vendors & Open Source
No
Yes
(IHE allows for vendor self-attestation
through Integration Statement)
Trial Implementation and Final text
Only Selected Final Text Profiles
Yes
No
None – Only to pass preConnectathon tests
Vendor has successfully passed
profile tests at an IHE Connectathon
Commitment to commercial
availability
No – Pre-product testing OK
Yes
Guarantee Interoperability of
tested products
No – Reasonable expectation
No – But Clearer expectation for
specific product version
Monitored by volunteers
Monitored by professional
staff
Testing Profiles
Collaborative and Learning
Pre-requisite
Staffing of oversight/jury
16
IHE Conformity Assessment for who ?
1.
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).
2.
The care delivery organization with simple
interoperability projects (e.g. connecting devices to
a Clinical System). Only a few profiles to be
combined.
3.
Vendors that want to avoid the overhead of retesting
in each project at the profile level.
17
IHE’s contribution to ehealth projects
eHealth Project
Interoperability
Specifcations
Profiles
Projectathon
Project IS Conformity
Assessment
Product
Product
IHE Conformity
Assessment
Add
extensions
IHE Connectathon
Standards
Enhancing testing rigor and reducing costs
and risks on an on-going basis
IHE
Gazelle Test
Platform
18
IHE’s contribution to ehealth projects
(Another View)
Specifications
Conformity
Assessment
Interoperability
Testing
eHealth Interoperability
Project specifications
IS Conformity
Assessment
Projectathon
IHE
Profiles
IHE
Gazelle TestBed
IHE Conformity
Assessment
Connectathon
Standards
Products
19
Providers and Vendors
Working Together to Deliver
Interoperable Health Information Systems
in the Enterprise
and Across Care Settings
http://www.ihe.net
20
21