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The General Data Protection Regulation (GDPR) recognises data concerning health as a special category of data and provides a definition for health data for data protection purposes. Though the innovative principles introduced by the GDPR (privacy by design or the prohibition of discriminatory profiling) remain relevant and applicable to health data as well, specific safeguards for personal health data and for a definitive interpretation of the rules that allows an effective and comprehensive protection of such data have now been addressed by the GDPR. Processes that foster innovation and better quality healthcare, such as clinical trials or mobile health, need robust data protection safeguards in order to maintain the trust and confidence of individuals in the rules designed to protect their data.

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28
Aug
2024

EDPS formal comments on the draft Implementing Regulation laying down procedural rules for the cooperation with EMA as regards the joint clinical assessment and joint scientific consultation

EDPS formal comments on the draft Implementing Regulation laying down procedural rules for the cooperation with EMA as regards the joint clinical assessment and joint scientific consultation

Available languages: English
5
Jul
2024

EDPS Formal comments for the application of Regulation(EU) 2021/2282 of the EP and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups

EDPS Formal comments on the draft Commission Implementing Regulation laying down rules for the application of Regulation(EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups.

4
Apr
2024

EDPS Formal comments on Draft Implementing Regulation for Health Technology Assessment under Regulation (EU) 2021/2282

EDPS Formal comments on the draft Commission Implementing Regulation laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments

Available languages: English
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