A step closer to a common health data space in Europe!

The Council of the EU and the European Parliament achieved a provisional agreement on a new law aiming at facilitating access to and exchange of health data across the EU. Indeed, today, cross-border access to health data (such as prescriptions) still varies across the countries.

The provisional agreement reached today between the Council and the Parliament amends the Commission’s original proposal in a number of key areas, including:

• opt-out: member states can allow patients to opt-out on the use of their health data being accessed, whether by a healthcare professional (primary use) or for further use (secondary use, always under strict conditions), except for purposes of public interest, policy making, statistics and research purposes in the public interest

• restricted information: if patients choose to restrict information, healthcare professionals will only be able to access restricted health data in situations of vital interest

• sensitive data: member states may put in place stricter measures governing access to certain kinds of sensitive data, such as genetic data, for research purposes

• trusted data holders: in order to reduce the administrative burden, member states may establish trusted data holders that can securely process requests for access to health data

• clinically significant findings: if researchers inform health data access bodies (HDABs) about findings that may impact the health of a patient whose data was used in the scientific research, the HDAB may inform the trusted data holder who has to inform the patient or the relevant treating health professional about these findings

This agreement will enhance the availability and utilisation of health data and healthcare data in Europe with the objective to drive innovation and policy development.

Read more

https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en