A European regulation governing access to, exchange of, and reuse of health data across the European Union.
The EEDS aims to create a single market for data that serves citizens, professionals, and researchers, while ensuring enhanced protection of personal data.

The Promise to Citizens

• Easy access to one’s health data, anywhere in Europe
• Greater control over how their data is used
• Greater transparency: citizens know how their data is used

 The sale of their data is prohibited. 

Two regulated uses

Primary use: Continuity of care, medical records shared among Member States Secondary

use: Reuse of existing data for research, innovation, and public policy development 

Who is affected?
 

All stakeholders in digital health: healthcare facilities, software developers, manufacturers of connected medical devices, researchers, innovators, and more. Health software and apps will be subject to a self-certification system.
 

For innovators

Are
you developing a solution that uses health data?
Depending on your activity, you may be: A data

holder: subject to an obligation to securely share data and eligible

for financial compensation A data user: granted access for regulated purposes (research, monitoring, innovation, training, …)


Two years to prepare: stay informed and keep up with regulatory

changes Support: the Digital Health Agency and the Health Data Platform assist stakeholders in achieving compliance  

Key takeaways:
 

The EEDS is a common European framework for innovating with health data in an ethical, secure, and sovereign manner.