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HomeStudy supporting the impact assessment of policy options for an EU initiative on a European health data space
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This study provides evidence to support the realisation of a European Health Data Space (EHDS) for primary and secondary use of health data. Evidence was collected from existing sources and new research undertaken to inform the analysis of the impacts. This included desk research, a public consultation of stakeholders, findings from related studies conducted recently by the EU Commission in preparation of this IA, and interviews with Member States’ representatives. The evidence was brought together and used to assess the impacts of the options identified using the dimensions of effectiveness, efficiency, and coherence, as compared to the baseline. The analysis suggests that the preferred option for EHDS is Option B (B+ for primary use). This option introduces the regulatory framework for a system of joint decision-making at European level on requirements for interoperability, security and other related aspects of use of health data, affecting Member States and market operators in the Single Market, supported by national implementation. It strengthens the rights of individuals to access and control their health data and establishes an EU framework for re-use of health data. The governance relies on national bodies brought at EU level in expert groups that would implement and enforce nationally EU-level mandatory requirements.
- Pubblicato:
- Servizio autore: Directorate-General for Health and Food Safety (Commissione europea) , ICF S.A , NTT DATA , RAND Europe , Timelex
- Temi: Politica della sanità , Tecnologia dell'informazione e telecomunicazioni
- Argomento: application of EU law , decision-making , e-Health , EU initiative , health policy , impact study , medical data , report , single market , systems interconnection
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| ISSN | ISBN 978-92-76-52135-8 | DOI 10.0000/320027 | Numero di catalogo EW-06-22-203-EN-N |
- Released on EU publications website:
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