The European Commission is set to propose a new governance framework for health data with cross-border interoperability requirements and pan-European infrastructure in the first sector-specific legislation of its kind, according to a draft seen by EURACTIV.
The proposed EU Health Data Space is seen as “the fuel that drives the European Health Union forward”, a reference to the plan launched in the aftermath of the COVID pandemic to reshape the way health care is handled through the block.
It is also the first sector-specific legislation intended to build on the Data Governance Act and the Data Act, respectively horizontal data governance legislation and a recently presented EU law on data governance. data sharing.
The main objectives of the regulation are to make the health sector more efficient and to advance scientific research in the field of telehealth, and to “liberate the health data economy”, by promoting the development of new services and digital health products.
Rights of individuals to “main” use
For the Commission, individuals should have the right to access a minimum set of “primary” health data, including vaccination, electronic prescriptions, images, lab results, discharge reports, etc. – using a free access service.
The Commission hopes that this standardization can strengthen patients’ right to control their health data in electronic format.
These new rules will also affect markets for existing products such as electronic health records, medical software and wellness apps.
Individuals will also have the right to restrict access to such data or to share it with third parties free of charge. The European Digital Identity Framework, a proposal to establish a compatible online identification system across the EU, will enable cross-border functionality.
“Secondary use” for personalized drugs
The legislative proposals include provisions on the thorny issue of the re-use of health data for so-called ‘secondary use’, i.e. data created and stored for health services or activities which can be used purposes other than the reason for which they were originally collected.
For regulation, secondary use includes health records, social data, administrative data, genetic and genomic data, public records, clinical studies, research questionnaires, and biomedical data such as biobanks.
For the Commission, the use of secondary data for better research and policy-making can significantly boost the innovative field of personalized medicines.
Secondary Usage Data is in raw form and additional information obtained by processing the data in the context of healthcare services.
The list of authorized uses includes informing regulatory decisions and supporting public authorities in carrying out their tasks, as well as in education, scientific research, development of innovative solutions for the public interest and training. of algorithms with medical applications.
Conversely, certain purposes are explicitly prohibited, such as informing of decisions against persons having legal effects, including insurance premiums, commercial advertising and the sale of data to third parties.
The draft regulations also include provisions to implement “data altruism” in the healthcare sector, a concept introduced in the Data Governance Act to give legal status to entities that process personal data. for reasons of public interest, for example medical research.
A whole new governance of health data
The Commission should establish a formal expert group, the European Digital and Health Data Committee, to ensure cooperation between competent authorities, in particular the relationship between primary and secondary use of electronic health data.
Two expert subgroups of the Council will address health data for health care delivery and the application of health data for research, innovation, policy development and regulation.
These bodies will manage secondary data access requests, minimizing the amount of data shared and anonymizing or aggregating data where appropriate.
The committee will support and advise the Commission on the development of guidelines and requirements for labelling, certification and data quality.
Interoperability and international transfers
Another crucial area is the interoperability of health data across borders, with the establishment of a dedicated digital infrastructure to exchange health data between healthcare providers within countries.
Interoperability with electronic health record systems could reduce unnecessary or duplicate testing since healthcare professionals can easily access patients’ medical histories, resulting in substantial cost savings for patients and the healthcare system.
The health data space echoes the provisions of the IT law, in particular introducing limits to the international transfers of non-personal health data.
Compulsory certification system and health data infrastructure
The draft proposal outlines specific requirements for Electronic Health Record (EHR) systems, the software used to store and share health records. The appendix includes a set of requirements, including interoperability and security, and describes the technical specifications that these systems should meet.
In terms of interoperability, EHR systems must ensure compatibility with European infrastructure and the ability to share health data with other healthcare professionals and entities. These requirements would be operationalized through existing technical standards or common specifications identified by the European Commission.
The EU executive will also propose a common infrastructure called [email protected] to facilitate cross-border exchange of electronic health data between national contact points designated by member states.
Funding: EU4Health, Horizon, Recovery Plans
The new EU4Health program and digital health-related funding under the Horizon Europe and Digital Europe programs will support investments in the European health data space.
In particular, the EU4Health program will support the [email protected] platform and the pilot project to develop the EU’s new decentralized infrastructure for secondary data use from 2022.
Part of the funding will also come from NextGenerationEU, as 22 Member States have already planned a total of €12 billion of investments contributing to digital health in their recovery plans.
[Edited by Zoran Radosavljevic]