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(BRUSSELS) – The European Parliament and EU Council reached provisional agreement Friday on a new law making it easier to exchange and access health data at EU level.
The proposed European Health Data Space (EHDS) aims to improve individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for public interest, policy support, and scientific research purposes.
Currently, cross-border access to health data varies across the EU. Under the new rules, a Spanish tourist would be able to pick up a prescription in a German pharmacy, or doctors could access the health information of a Belgian patient undergoing treatment in Italy.
Individuals will have faster and easier access to electronic health data, regardless of whether they are in their home country or another member state. They will also have greater control over how that data is used. EU countries will be required to set up a digital health authority to implement the new provisions.
Researchers will have access to specific secure health data, enabling them to tap into EU health data to inform scientific research in the public interest.
The proposed regulation requires all electronic health record (EHR) systems to comply with the specifications of the European electronic health record exchange format, ensuring that they are interoperable at EU level.
Key elements of the provisional agreement
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
The agreement will now need to be endorsed by both the Council and the Parliament.The regulation will enter into force 20 days after publication in the EU’s Official Journal.
Proposal for a Regulation to set up the European Health Data Space
