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The European Institute for Innovation through Health Data

i~HD

The European Institute for Innovation through Health Data (i~HD) has been formed as one of the key sustainable entities arising from the Electronic Health Records for Clinical Research (EHR4CR) and SemanticHealthNet projects, in collaboration with several other European projects and initiatives supported by the European Commission.

Lobbying Activity

Response to A European Health Data Space

2 Feb 2021

Digital Health Society & the European Institute for Innovation Through Health Data Calls to Action on Health Data Ecosystems This contribution summarises the outcomes of two recent multi-stakeholder consultations to examine the acceptance criteria for societal trust in the use of health data and a recipe for trustworthy digital health: standards, architecture and value. The Round Tables were developed and convened by DHS and i~HD neutrally and independently from the event sponsors, Johnson & Johnson and Microsoft. Each meeting was attended by around 27 online participants from EU institutions, national governments, industry, academia, hospital management, healthcare professionals, regulators and patient representatives. DG Sante and Connect officials contributed to both events. The recommendations and calls to action arising from these events were presented to large online audience at the Digital Health Society Summit in November 2020 and discussed by a multi-stakeholder panel. The recommendations, the calls to action and round table summaries are documented in the accompanying uploaded report. The recommendations cover the following key themes. Raise the digital, literacy & skills of all stakeholders Citizens, health professionals, researchers and decision makers all need higher levels of health data literacy. Member States, healthcare funders and research sponsors all need to invest more in educational programmes and their delivery, ensuring equity of access to literacy services. Generate and value trustworthy Real World Evidence All of those connected with building, operating and making use of health data infrastructures must ensure staff understand the nature, strengths and limitations of real world data, how to analyse it appropriately to generate trustworthy insights and how to appraise the quality of the data they are using. Accelerate interoperability across Europe and globally Member States should embrace an alignment of standards adoption with other countries, such as on the EEHRxF, and reflect those as strong interoperability demands within national and regional procurement policy and specifications. Healthcare providers should demand, from their EHR suppliers, explicit and independently verified interoperability against prescribed standards through procurement specifications and renewal contracts. Demonstrate benefits to society from data access, use and reuse Data Permit Authorities and data sharing intermediaries should make transparent the purposes and kinds of organisation they will support to use health data, what terms and conditions they will require for use, and publish regularly their access decision and benefits emerging from data use. Adopt a risk stratification approach When applying the GDPR to research data use, a risk stratification approach should be adopted, and guidance developed, so that proportionate protection measures are applied and data uses are appropriately enabled. Build a trustworthy framework for data access and use Data Permit Authorities should promote the development and adoption of multi-stakeholder Compacts/codes of conduct regarding responsible data use and re-use, transparency, accountability and communication. All public and private stakeholder should support the adoption of these Compacts and of standards for how data access requests are formulated and transparently reported on. Adopt a transformational approach to health data All stakeholders should support and promote treating repositories of pooled anonymised health data as a societal good. Investments should promote the uptake of federated data models to facilitate interoperability, connectivity and FAIR data access while upholding GDPR compliance. The full reports explain the rationale for these recommendations and express the expected opportunities and acceptance concerns of the different stakeholders which includes public and private data sources, data users and data subjects.
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Response to European Electronic Health Record (EHR) Exchange Format

17 Dec 2018

I would urge the EC to avoid making a hasty nomination of any one standard or a few standards based on lobby interests. First take on board that much work has been undertaken on EHR interoperability standards, especially by CEN, such as EN13606 (EHRcom), EN13940 (Contsys), EN12967 (HISA )and the forthcoming IPS embodied in prEN17269. The EC roadmap should carefully consider the correct positioning of FHIR and SNOMED CT, which should be part of but not the whole standards solution. There is a need for clear guidance about how these standards should best be adapted for combined use. I would request that the EC roadmap does not see the solution as a silver bullet task of picking the winning standards that will become adopted across Europe simply because the EC has chosen them. Please consider carefully why it has proved difficult to get existing good standards adopted, over many years and despite many large scale Member State investments. Most importantly the EC should review the results of some of its own CSA projects that have investigated barriers and success factors to the scale up of interoperability, and develop a strategy to address these as part of its roadmap. Please especially review the results of FP7 SemanticHealthNet, and the final recommendations from Horizon 2020 projects: Trillium Bridge, eStandards, Assess CT and VALUeHEALTH. These recommendations strongly advise multi-stakeholder engagement in standards profiling, including patients. Pleases also align with the value of interoperability for research, taking on board IMI project results such as EHR4CR, EMIF. There are many European experts who can help you work on this!
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