The European Health Data Space – what you need to know
 

On 3 May 2022, the European Commission presented its proposal for the
European Health Data Space
[https://ec.europa.eu/health/ehealth-digital-health-and-care/european-health-data-space_en]
(EHDS), a milestone for easier and more secure rules, structures, and
processes across EU Member States to access and share health data
across borders.

Building on legislation such as the GDPR, the proposed Data Governance
Act
[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020PC0767], draft
Data Act
[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2022%3A68%3AFIN] and
the NIS Directive
[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32016L1148],
the EHDS aims at addressing the complexity of present European rules
on data sharing in the health sector, unveiled during the COVID-19
pandemic, and foster health digital services across Europe.

To do so, this health specific European ecosystem comprises rules,
common standards, and practices, as well as infrastructures and a
governance framework for two data purposes.

On the one hand, the EHDS should empower individuals through increased
digital access to and control of their electronic personal health
data, nationally and cross-borders. Furthermore, it supports
citizens’ free movement, fostering a genuine single market for
electronic health record systems, relevant medical devices and high
risk artificial intelligence (AI) systems (primary use of data
[https://ec.europa.eu/health/ehealth-digital-health-and-care/electronic-cross-border-health-services_en]).

On the other hand, the EHDS shall provide a consistent, trustworthy
and efficient set-up for the use of health data for research,
innovation, policy-making and regulatory activities (secondary use of
data [https://tehdas.eu/]).

The proposal for the EHDS is accompanied by a Communication from the
Commission
[https://ec.europa.eu/health/publications/communication-commission-european-health-data-space-harnessing-power-health-data-people-patients-and_en],
resulting from an impact assessment
[https://ec.europa.eu/health/publications/impact-assessment-european-health-data-space_en] and
an open public consultation
[https://ec.europa.eu/health/consultations/digital-health-data-and-services-european-health-data-space_en].
The proposal put forward by the European Commission will now be
discussed by the Council and the European Parliament.

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Publication Date/Time
2022-06-08T08:30:00+00:00
The European Commission launched one of the central building blocks of
a strong European Health Union