Published on 01.03.2023 01.03.2023

TEHDAS study: Member states to harmonise national legislation to enable the secondary use of health data

Differing interpretations of the data protection regulation hinder the use of health data at the expense of health research, policymaking and innovation. TEHDAS has developed recommendations for member states to develop legislation on the secondary use of health data.

The recent report of the joint action Towards the European Health Data Space (TEHDAS) urges EU member states to harmonise national provisions on data protection and consider abolishing national derogations on the General Data Protection Regulation (GDPR). The report also provides recommendations on drafting national legislation on the secondary use of health data that can expedite the realisation of the European health data space (EHDS) when it enters into force.

Currently, countries have national legislation or rules on the use of health data for secondary purposes in addition to the GDPR. The GDPR provides a harmonised approach to data protection across the EU, but it allows member states to adopt national legislation which causes a lack of harmonisation. TEHDAS has previously concluded that the main obstacle for the cross-border use of health data for research, innovation and policymaking is differing interpretations of the law.

The report presents nine recommendations for the member states on planning and implementing national legislation to regulate the secondary use of health data to complement the European health data space. They include choosing public interest as the legal basis for collecting health data, addressing security by design to avoid problems in practice when using data, and ensuring proper financial and human resources for processing data access applications and preparing data for its users.

There are also aspects of national laws that are specifically relevant to consider concerning the cross-border sharing of health data, for instance data security legislation prohibiting the transfer of data out of the country. Member states should consider harmonising such regulation.

Furthermore, a general recommendation for facilitating cross-border sharing of health data would be necessary to avoid divergent national regulations, since this is one of the main reasons that the full potential of sharing data cross-border has not yet been realised.

Because the negotiations on the EHDS proposal are ongoing, TEHDAS hopes that the member states can benefit from the recommendations as they plan their national legislation on the secondary use of health data. This could smooth the transition to European health data space.

The report is based on a study conducted in six European countries.

The report has been approved by the project steering group. The European Commission gives final approval to all joint action’s deliverables.