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Semantic Interoperability. A complex and multi-level issue. This is more than a discussion about whether we should adopt SNOMED or not It is a difficult issue that will require a stepwise approach Because of the complexity itself Because of the costly change or replacement of legacy systems
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A complex and multi-level issue • This is more than a discussion about whether we should adopt SNOMED or not • It is a difficult issue that will require a stepwise approach • Because of the complexity itself • Because of the costly change or replacement of legacy systems • Because of ‘psycho-political’ issues • EU versus US • Best theoretical model versus actually used • Because of technical/scientific issues (ontology and information model discussions) • Therefore: “Think big, act small” • “Big” in time: foresee the future • “Big” in space: global universal • “Big” in scope: health care + life sciences • Mark the road and act consistently in the same direction but with small steps
Think big • The ultimate goal is defined in the ‘Semantic Web Stack’ designed by Tim Berners Lee, the inventor of the www • Ultimately we need to be able to share ‘proofs’ and ‘trust’ to fully be interoperable • Even if I understand the meaning of what you say, are you entitled to say this anyway ?
The scope • ‘Semantic’ & ‘Interoperability’ • Semantic= understand the meaning • Need to standardize both domain and clinical content of the information • The content: e.g. the clinical data itself: patient x has ‘hypertension’ terminologies, classification systems (ICD, SNOMED, IPCP, …) • The domain: e.g. hypertension is a ‘medical condition’ domain ontologies and reference models such as EN 13606 (OpenEHR) with archetypes, HL7 RIM with templates, CDA, CDISC • Interoperability= being able to collaborate • Need to standardize the communication itself (exchange models): HL7 V2.x, V3, CEN 13606, XDS • Need to standardize distributed and adaptable workflow: still a major challenge • Decision support: how can we share rules and guidelines ? no standard yet • Proof and trust: no standards yet • We are only at the beginning …
Challenges • No unified approach between US and EU, although both are on speaking terms • This is a blocking factor for development and implementation of concrete projects because of the international scale of some of the stakeholders (e.g. industry) • A lot of work to re-factor existing systems: need for resources from both industry and customers • Clinical care and Clinical Research are still silos (although this meeting proves that things are changing) • Still a lot of psychological – scientific – political discussion on the reference model (Open EHR versus HL7 RIM) • EU Member states are not aligned
Proposals for next steps (1/3) • We need to make clear statements on where we are heading to and what the current status is • Who is ‘we’ ? The EC, The industry, the customers, global initiatives like IHE, the member states • Need for a concrete roadmap with timeline: this helps industry and customers to plan ahead • Be realistic • the holy grail does not exist • Therefore: adopt the IHE model: bring industry + customers together • The ultimate validation comes from customers • IHE has proven that it can be done (profiles, XDS, …). Let’s take the same approach and put our semantic interoperability under this umbrella • Make EU – US consolidation a priority ! • Redesign our European approach, if necessary • Redesign the US approach, if necessary
Proposals for next steps (2/3) • Give incentives for semantic interoperability • Proposals for FP7 and FPx calls should take this into account • Instead of (only) giving funding for the development of European standards give incentives for efforts to consolidate global standards • Foster translational medicine initiatives (connect HC and LS) • The W3C HCLS Interest Group • For example the DebugIT project • Fund interoperability projects of the stakeholders • It is more than ‘just’ a technical implementation issue • Stakeholders are asked to invest in the ‘bigger’ picture. This requires vision, resources and courage
Proposals for next steps (3/3) • In the translational medicine domain • Involve drug agencies of the member states • Open and standardized access to be used for decision support systems • Standardize adverse event reporting in the clinical IT systems • Standardize results and outcome of clinical trials • let clinical IT systems have computer readable access to evidences • Support IHE initiatives for profiling ‘secondary use of clinical data’