| Author (Corporate) | European Commission: DG Health and Food Safety |
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| Series Details | COM (2022) 197 |
| Publication Date | 04/05/2022 |
| Content Type | Policy-making |
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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. |
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| Source Link | https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2022:197:FIN |
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| Subject Categories | Health |
| Subject Tags | Digitalisation, Public Health |
| Keywords | Data Hosting | Storage, e-Health, Health Services | Healthcare |
| International Organisations | European Union [EU] |
