The Commission has published an open public consultation on the European Health Data Space, which is an important component of the European Health Union. It aims to make the most of digital health to provide high quality healthcare and reduce inequalities. It will promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policy and law making. The right of individuals to control their own personal health data will be an essential element of the European health data space. The consultation will remain open until July 26, 2021.
Citizens, stakeholders and organizations are invited to participate in the consultation. National public health, digital health and data protection authorities, existing data authorization bodies, healthcare professionals and providers, health insurers, organizations representing patients and civil society active in digital health, academia and research institutions, ethics committees, trade unions, as well as the digital, pharmaceutical and medical device industries may have a particular interest in contributing.
This public consultation focuses on:
- access to and use of health data for health care delivery, research and innovation, and policy and regulatory purposes;
- the promotion of a genuine single market for digital health services and products, including innovative ones.
The rationale for such a consultation is to facilitate better access to and exchange of health data, crucial to ensure greater accessibility, availability and affordability of healthcare, stimulate innovation in health and care to improve treatment and outcomes, and encourage innovative solutions that make use of digital technologies, including artificial intelligence (AI).
Context
The creation of a European health data space is one of the key priorities of this Commission in the field of health. The purpose of the European health data space is to promote the exchange of health data and to support research on new preventive strategies, as well as on treatments, medicines, medical devices and outcomes.
In its Communication “A European Data Strategy”, the Commission announced its intention to deliver concrete results in the area of health data and to exploit the possibilities offered by advances in digital technologies. The collection, access, storage, use and reuse of data in healthcare pose specific challenges that need to be addressed. This requires a regulatory framework that better serves the interests and rights of individuals, especially with regard to the processing of sensitive personal health data.
In this context, the Commission adopted its proposed Data Governance Act (2020), which sets out the conditions for access to data and contains provisions to build trust in voluntary data sharing.
More information
Roadmap- the European health data space
European health and care space
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