On 15 March 2024, the Council of the EU announced that it and the European Parliament reached a provisional agreement on a new law making it easier to exchange and access health data at EU level. The agreement will now need to be endorsed by both the Council and the Parliament.
The proposed regulation for a European Health Data Space (EHDS) aims to improve individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for public interest, policy support, and scientific research purposes. It provides for a health-specific data environment that will help foster a single market for digital health services and products.
Currently, cross-border access to health data varies across the EU. Here are some examples of the aims of the new rules. For example, it would become possible for a Spanish tourist to pick up a prescription in a German pharmacy, or for doctors to access the health information of a Belgian patient undergoing treatment in Italy.
"After months of hard work and dedication, we [now] have a deal that will strongly support patient care and scientific research in the EU. The new law [...] 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.
Key elements of the provisional agreement
The provisional agreement reached on 15 March 2024 between the Council and the Parliament amends the Commission’s original proposal in a number of key areas. They include the following five:
- opt-out: member states can allow patients to opt-out on the use of their health data being accessed, whether by a healthcare professional (primary use) or for further use (secondary use, always under strict conditions), except for purposes of public interest, policy making, statistics and research purposes in the public interest
- restricted information: if patients choose to restrict information, healthcare professionals will only be able to access restricted health data in situations of vital interest
- sensitive data: member states may put in place stricter measures governing access to certain kinds of sensitive data, such as genetic data, for research purposes
- trusted data holders: in order to reduce the administrative burden, member states may establish trusted data holders that can securely process requests for access to health data
- clinically significant findings: if researchers inform a health data access body (HDAB) about findings that may impact the health of a patient whose data was used in the scientific research, the HDAB may inform the trusted data holder who has to inform the patient or the relevant treating health professional about these findings.
Next steps
The provisional agreement will now have to be endorsed by the Council and the Parliament. It will then be formally adopted by both institutions after legal-linguistic revision. The regulation will enter into force 20 days after publication in the EU’s Official Journal. The text of the regulation itself includes a wide variety of dates over an eventual two-year to 10 year timeline when actions, and evaluations of the regulation's results, will need to be undertaken.
Read more: