Proposal for a Regulation on the European Health Data Space

Author (Corporate)
Series Details COM (2022) 197
Publication Date 04/05/2022
Content Type

Summary:

Legislative initiative adopted by the European Commission on 3 May 2022, aimed at setting up a European Health Data Space (EHDS).

Further information:

Natural persons currently have difficulties in exercising their rights over their electronic health data, including accessing and transmitting it nationally and cross-borders. This is despite the provisions of Regulation (EU) 2016/679, where such rights are safeguarded. The uneven implementation and interpretation of the General Data Protection Regulation (GDPR) across the European Union (EU) created legal uncertainties, resulting in barriers to secondary use of electronic health data. Directive 2011/24/EU holds the first references to eHealth in EU legislation. However, the relevant provisions of this Directive are voluntary in nature. The COVID-19 (coronavirus) pandemic showed the relevance of such data for the development of policy in response to health emergencies. It also highlighted the need to ensure timely access to personal electronic health data for health threats preparedness and response, as well as for treatment, research, innovation, patient safety, regulatory purposes, policy-making, statistical purposes or personalised medicine.

The European Strategy for Data proposed the establishment of domain-specific common European data space. This initiative on establishment of the EHDS is the first proposal of such domain-specific common European data spaces. It aims to address health-specific challenges to electronic health data access and sharing, and it is seen as one of the main building blocks of the European Health Union. The EHDS allows for the creation of a common space where natural persons can control their electronic health data. It also makes it possible for researchers, innovators and policy-makers to use this electronic health data in a trusted and secure way that preserves privacy.

The draft law was tabled by the European Commission on 3 May 2022, and it was supported by a Communication providing the reasoning behind it.

Source Link https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2022:197:FIN
Related Links
Commentary and Analysis
Politico, 03/05/2022: 5 things to know about the EU’s health data space https://www.politico.eu/article/5-things-to-know-about-the-eus-health-data-space/
Digital Europe: News, 03/05/2022: The European Health Data Space: an ambitious framework for health data, but more clarity is needed on how it will work https://www.digitaleurope.org/news/the-european-health-data-space-an-ambitious-framework-for-health-data-but-more-clarity-is-needed-on-how-it-will-work/

News
Bloomberg, 03/05/2022: EU Ready to Spend €2.5 billion on Hub for Health-Care Data https://www.bloomberg.com/news/articles/2022-05-03/eu-ready-to-spend-2-6-billion-on-hub-for-healthcare-data
Euronews, 03/05/2022: Brussels wants to create EU health data space to streamline access https://www.euronews.com/my-europe/2022/05/03/brussels-wants-to-create-eu-health-data-space-to-streamline-access
Reuters, 03/05/2022: EU plans to cut unneeded medical tests with data health plan https://www.reuters.com/business/healthcare-pharmaceuticals/eu-plans-cut-unneeded-medical-tests-with-data-health-plan-2022-05-03/

Official
EUR-LEX: SWD(2022)130: Staff Working Document accompanying the Proposal - Subsidiarity Grid https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2022:130:FIN
EUR-LEX: SWD(2022)131: Staff Working Document accompanying the Proposal - Impact Assessment Report https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2022:131:FIN
EUR-LEX: SWD(2022)132: Staff Working Document accompanying the Proposal - Executive Summary of the Impact Assessment Report https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2022:132:FIN
European Commission: Public Health: European Health Data Space https://ec.europa.eu/health/ehealth-digital-health-and-care/european-health-data-space_en
European Commission: Press Release, 03/05/2022: European Health Union: A European Health Data Space for people and science https://ec.europa.eu/commission/presscorner/detail/en/ip_22_2711
European Commission: Questions and answers - EU Health: European Health Data Space (EHDS) (3 May 2022) https://ec.europa.eu/commission/presscorner/detail/en/qanda_22_2712
European Commission: Remarks by Vice-President Margaritis Schinas at the press conference on the European Health Data Space (3 May 2022) https://ec.europa.eu/commission/presscorner/detail/en/speech_22_2788
European Commission: Remarks by Commissioner Stella Kyriakides at the press conference on the European Health Data Space (3 May 2022) https://ec.europa.eu/commission/presscorner/detail/en/speech_22_2790

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