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JOS DUMORTIER 

Timelex

Ensure that the processing of health data in the use cases complies with the provisions of the GDPR and applicable national data protection and health legislation, also considering the announced Guidelines of the EDPB in this field and the legal and ethical rules applicable to clinical investigations.

To follow up the impact on the project of ongoing legislative initiatives at the European level, in particular the announced proposals for a European Health Data Space (EHDS) Regulation and for a EU Data Act, the proposed AI Regulation and the proposed Data Governance Act.

To study the legal and ethical aspects of providing via AI-based information support systems, health-related recommendations
to health care professionals and/or directly to patients, considering applicable legal regimes such as the medical device regulation.

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Funded by the EU

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.

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