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By Enrique Santamaría Together with the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), the proposal for a Regulation on the European HealthData Space (EHDS) will most likely form the new regulatory and governance framework for the use of healthdata in the European Union.
In the context of health, let alone highly sophisticated cell signaling and microenvironment data, the web gets even more tangled. The HIPAA Problem The privatization of next-generation medicaltechnologies, especially in regenerative and precision medicine, further muddies the data-protection waters.
Additionally, it is yet to be determined how the new AI Act will synchronize with other legislative proposals like the European HealthData Space (EHDS) , and existing EU regulations such as the General Data Protection Regulation (GDPR) and the Medical Device Regulation (MDR).
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