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

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

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

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

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

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

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

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

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

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

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

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

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

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

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).

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

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.

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

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

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 http://www.ihe.net