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 (1st edition).

The COVID-19 pandemic has 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-19 certificate.

The European Commission’s 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 societal good across the EU (secondary use). Grounded in the EU data strategy, which mentions health as one of the nine European common data spaces, it cuts across several other EU policy priorities, such as the health union and the digital single market.

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The proposal establishes a set of rules, infrastructure and governance mechanisms to promote both primary and secondary uses of electronic health data, while ensuring data protection and strengthening cybersecurity.

The Commission expects the initiative to have a broad socio-economic impact, ranging from improving people’s health, to facilitating the uptake of evidence-based policy-making. Its success is thought to depend not only on the capacity to implement the legal basis effectively, but also on broader conditions such as EU-wide connectivity, social trust and digital skills.

The legislative procedure is in its early stages. A European Parliament rapporteur has not yet been appointed.

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)COM(2022) 0197
3.5.2022
Rapporteur:2022/0140(COD)
Shadow rapporteurs:Ordinary legislative procedure (COD) (Parliament and Council on equal footing – formerly ‘co-decision’)
Next steps expected: Publication of draft report

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