The newly-launched European Health Data Space, one of the central building blocks of the European Health Union and a milestone in EU’s digital transformation, aims to:
- improve healthcare delivery across the EU, by empowering people to control their health data in their home country or in other EU countries;
- offer a consistent, secure, trustworthy and efficient framework for the use of health data. Under strict conditions, researchers, innovators, public institutions or industry will have access to large amounts of high-quality health data, crucial to developing life-saving treatments, vaccines or medical devices;
- foster a genuine single market for digital health services and products;
- fulfilling unmet medical needs;
- supporting a competitive and innovative European pharmaceutical industry;
- enhancing resilience through diversified supply chains, environmental sustainability, and crisis preparedness promoting high standards for medical products globally.
Trust is a fundamental enabler for the success of the European Health Data Space. The European Health Data Space will provide a trustworthy setting for secure access to and processing of a wide range of health data. It builds further on the General Data Protection Regulation (GDPR), proposed Data Governance Act, draft Data Act and Network and Information Systems Directive.
As horizontal frameworks, they provide rules that also apply to the health sector. However, more specific rules are developed in the European Health Data Space Regulation, taken into account the sensitivity of health data.
The proposal for the European Health Data Regulation is accompanied by a Communication from the Commission. It is the result of a process that included an impact assessment and an open public consultation.