Civil society coalition urges EU to put the interests of patients and citizens at the heart of the European Health Data Space

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Statement

Written by:

Written by: Irene Schipper

Written by: David Ollivier de Leth

Published on: 27 February 2024

Seventeen civil society organisations, including patient organisations and trade unions, call upon EU member states and the European Parliament to ensure a number of safeguards regarding the use of patient data and digital health infrastructures are included in the final design of the European Health Data Space (EHDS).

While the signatories welcome the intention of the EHDS to promote health data and patient record sharing within the frame of direct medical treatment of patients (primary use), it is essential to include strong and meaningful safeguards regarding the use of health data for secondary purposes, such as research and product development by companies, and policy-making by governments.

Although the EHDS aims to improve EU citizens’ access to personal health information, patients in fact risk losing control over the sharing of their own medical data due to the absence of a consent requirement. Moreover, with the EHDS proposal, the EU is rolling out the red carpet for Big Tech companies such as Amazon, Google, and Microsoft, by offering them an unprecedented opportunity to use EU citizens’ health data to expand their already problematic monopolistic market power into the health sector.

The undersigned organisations therefore urgently call upon EU negotiators to ensure the following points regarding the use of the patient data and digital health infrastructures are included in the final design of the EHDS:

• The right for patients across the EU to at least opt-out from the use of their health data for primary and secondary purposes.
• The requirement for companies to charge fair prices and ensure widespread accessibility of the products and services that were developed using EU citizens’ health data, so that EU citizens and health systems actually benefit from the data they provide.
• The inclusion of the voice of EU citizens in the decisions on who is granted access to their health data and under what conditions. Health Data Access Bodies must be governed in a transparent, democratic, and independent manner. Industry representatives who may have an interest in accessing patient data for secondary use should not be allowed to partake in the governance of these data access bodies.
• Governments and market regulators must act against the growing monopolistic market positions of Big Tech companies. Governments and national health systems should invest in public and transparent digital health infrastructures.

See also our article about this topic in Social Europe(opens in new window) .