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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