EU Health Data Access Proposal Should Not Include Opt-Out Model, Pharma Says

The European Commission is mulling the addition of an opt-out mechanism for patients under its European Health Data Space framework, but health and pharma industry stakeholders have warned that this could cause “scientific damage” and act as a barrier to research.

Opt-Out Opt-In
• Source: Shutterstock

A main aim of the European Commission’s proposed European Health Data Space (EHDS) is to enable the secondary use of anonymized, or pseudo-anonymized, patient health data for purposes such as scientific research and health policy development.

This initiative, which would be introduced under an EU-wide regulation, has been broadly welcomed by industry, academic groups and healthcare providers.

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