European Health Data Space progresses with landmark agreement between the European Parliament and Council

After much speculation, the Council of the EU and the European Parliament have reached a preliminary agreement on the European Health Data Space legislation.

Proposed by the European Commission (EC) in May 2022, the European Health Data Space (EHDS) aims to create a framework to promote health-data exchange in the EU, setting out the requirements, infrastructure and governance for the primary and secondary use of electronic health record (EHR) data. In addition to enabling European citizens to access, manage and share their data, EHDS will also enable sharing of a wide range of health-related data for public interest, policy support, and scientific research. As discussed during the plenary session at ISPOR Europe 2023, EHDS is expected to have a major impact on real-world evidence (RWE), making it easier to collect, analyze and use real-world data (RWD).

The new deal agreeing on the new law reached between the Council of the EU and the European Parliament is one step closer to EHDS being a reality in Europe.

“After months of hard work and dedication, we have a deal that will strongly support patient care and scientific research in the EU. The new law agreed on today will allow patients to access their health data wherever they are in the EU, while also providing scientific research for important reasons of public interest with a wealth of secure data that will greatly benefit the development of health policies.” Frank Vandenbroucke, Belgian Deputy Prime-Minister and Minister of Social Affairs and Public Health

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Key provisions of the EHDS agreement

EHDS is being developed to address the challenges of fragmented health data across the EU. It aims to create a standardized and secure system for the primary and secondary use of EHR data while prioritizing patient control and building upon the General Data Protection Regulation (GDPR) right to data access and portability. Primary use refers to the direct use EHR data, including patient summaries, electronic prescriptions, medical imagery, and laboratory results, by healthcare providers and associated services to deliver patient care. Secondary use involves the aggregation and analysis of this anonymized data, including clinical trials, pathogens, health claims and reimbursements, genetic data and public health registry information for research, development, and regulatory purposes.

One of the main goals of EHDS is to provide a framework for seamless interoperability to support data exchange between healthcare providers within countries and across borders. All EHR systems will be required to follow the specifications of the European EHR exchange format, based on the MyHealth@EU platform.

During the agreement between the Council and the Parliament, several amendments to the EC’s original proposal were made to strengthen how data is used and accessed. One of the key modifications centers on citizens being able to ‘opt-out’ on the use of their health data being accessed for primary or secondary use, “except for purposes of public interest, policy making, statistics and research purposes in the public interest.” Citizens can also choose to restrict access to specific parts of their data, with healthcare professionals only able to access this restricted information in critical situations. The amendments also allow member states to have the flexibility to implement stricter controls for accessing particularly sensitive data, like genetic information, used in research. To streamline the process, the EHDS allows for the establishment of ‘trusted data holders’ to securely manage requests for accessing health data. The EHDS also incorporates a mechanism for handling clinically significant findings that might impact the health of a patient. If researchers discover something relevant to a patient’s health, they can inform health data access bodies (HDABs) who in turn inform the trusted data holder and the patient themselves.

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Next steps for EHDS

With the new EHDS agreement, the next step will be for both the Council and Parliament to officially endorse the agreement. As noted by Markus Kalliola of the Finnish Innovation Fund Sitra in his recent interview with The Evidence Base, implementation of EHDS by the individual member states will not be easy.

“Once the regulation is agreed and published in the official journal, the implementation period by member states will begin. Each member state will have their homework to do to adopt or amend their national legislation to ensure that it complies with the requirements of the EHDS regulation. Even the most digitally advanced member states will have a lot of work to do to fulfil the requirements from the regulation.”

Building on the groundwork laid by its predecessor, TEHDAS (Joint Action Towards the European Health Data Space), the proposed TEHDAS2 project will aim to support the EC to develop practical tools for implementation of the legislation. This will include details of creating guidelines for member states for sharing health data and technical specifications to ensure smooth data exchange across different systems.