Sitra’s statement on the European Health Data Space
Precise regulation is needed to develop digital health data and services as well as the European Health Data Space. The European Health Data Space will facilitate data mobility while also strengthening Europe’s digital sovereignty and patients’ rights to cross-border healthcare.
Sitra has participated in the European Commission’s open public consultation and issued a statement on the European Health Data Space. The public consultation is structured in three sections:
- the use of health data for healthcare provision, research and innovation as well as policy-making and regulatory decision
- the development and use of digital health services and products
- the development and use of artificial intelligence systems in healthcare
Last year, the European Commission issued a Communication on the European Strategy for Data, which was followed up by the publication of the Data Governance Act proposal. The EU wants to create an internal market for data where data can move freely between countries and sectors and bring benefits for individuals, society and companies. To improve the exchange and use of health data, the Commission is drafting sector-specific legislation pertaining to access to data. The Commission is expected to present a legislative initiative on the European Health Data Space in the final quarter of 2021. The creation of the European Health Data Space is one of the European Commission’s political priorities for 2019–2025.
Sitra’s main observations
Sitra attaches importance to the Commission’s aim to facilitate the exchange of health data and access to health data by creating a harmonised internal market for the use of health data. More extensive use of health data will improve the quality and cost-effectiveness of health services and create opportunities for more personalised care. Data can also be used to foster innovation in the health sector, such as more effective medicines and health technologies that promote health and support treatment.
Due to the sensitive nature of health data, special safeguards are needed in data processing. Sitra welcomes the fact that the upcoming legislative proposal related to the European Health Data Space is based on the General Data Protection Regulation and the proposed Data Governance Act, which deals with cross-sectoral data sharing.
The adoption of artificial intelligence in healthcare requires continuous co-operation between healthcare professionals, developers and patients as well as the development of people’s competencies and skills, building trust and identifying risks and malfunctions. Transparency, safeguards and monitoring and control of artificial intelligence are important. It may not be possible to identify all the risks, and so the ethical challenges and codes related to the use of artificial intelligence will change over time.
Sitra’s statement can be read in full (in Finnish) in the document attached to this article and on the Commission’s website after the end of the consultation period.
Read Sitra’s statement to the European Commission in its entirety in Finnish – Digital health data and services – European Health Data Space (pdf).