Members' Research Service By / September 16, 2022

European health data space [EU Legislation in Progress]

Digital health refers to the use of digital technologies and information and communications technology (ICT) by individuals and healthcare systems for health purposes.

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Written by Clément Evroux (2nd edition, updated on 11.12.2023).

The COVID-19 pandemic shone a light on the growing importance of digital health technologies, both to enable remote medical care and to facilitate the health response by international, national and local authorities. At the same time, personal health data have been key for containment measures such as the EU digital COVID certificate.

The Commission’s May 2022 proposal for a regulation on a European health data space aims to improve individuals’ access to and control of their electronic personal data (primary use), while facilitating data re-use for the good of society across the EU (secondary use). The proposal establishes a set of rules, infrastructure and governance mechanisms to promote the primary and secondary use of electronic health data, while ensuring data protection and strengthening cybersecurity. The Commission expects the initiative to have a broad socio-economic impact, from improving individuals’ health conditions to facilitating uptake of evidence-based policy-making. Its success is thought to depend on broader conditions such as EU-wide connectivity, social trust and digital skills.

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Parliament’s Committees on Civil Liberties, Justice and Home Affairs (LIBE) and Environment, Public Health and Food Safety (ENVI) adopted their joint report on 28 November 2023. The Council adopted its general approach on 6 December 2023. Parliament is expected to vote

Versions

Proposal for a regulation of the European Parliament and of the Council establishing the Union Health Data Space
Committee responsible:Civil Liberties, Justice and Home Affairs (LIBE) and Environment, Public Health and Food Safety (ENVI)COM(2022) 0197
3.5.2022
Rapporteur:Tomislav Sokol (EPP, Germany); Annalisa Tardino (ID, Italy)2022/0140(COD)
Shadow rapporteurs:Javier Zarzalejos (EPP, Spain); Sara Cerdas (S&D, Portugal); Petar Vitanov (S&D, Bulgaria); Susana Solís Pérez (Renew, Spain); Lucia Ďuriš Nicholsonová (Renew, Slovakia); Patrick Breyer (Greens/EFA, Germany); Tilly Metz (Greens/EFA, Luxembourg); Elisabetta De Blasis (ECR, Italy); Beata Kempa (ECR, Poland); Joanna Kopcińska (ECR, Poland); Konstantinos Arvanitis (The Left, Greece); Kateřina Konečná (The Left, Czechia)Ordinary legislative procedure (COD) (Parliament and Council on equal footing – formerly ‘co-decision’)
Next steps expected: First-reading vote in plenary
timeline-10 steps-voted in plenary

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