The Council of the EU has adopted a new law that will make it easier to exchange and access health data at EU level, paving the way for it to come into force.
The
European Health Data Space (EHDS) regulation aims to improve individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for research and innovation purposes for the benefit of European patients. It provides for a
health-specific data environment that will ensure cross-border access to digital health services and products within the EU.
Easier access to health data for individuals
Under the new rules, 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.
Greater research potential
The EHDS will also provide researchers and policy-makers with access to specific kinds of anonymised, secure health data, enabling them to tap into the vast potential provided by the EU’s health data to inform scientific research, develop better treatments, and improve patient care.
Ensuring interoperability
Currently, the level of digitalisation of health data in the EU varies from one member state to another, making it more difficult to share data across member-state borders. The new 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.
Next steps
The regulation will now be formally signed by the Council and the European Parliament. It will enter into force 20 days after publication in the EU’s Official Journal.
EFPIA response
“EFPIA welcomes the adoption of the European Health Data Space (EHDS) by the Council of the EU, marking a significant step forward in leveraging health data to advance research, innovation, and healthcare delivery across the EU.
In a changing world, with new challenges and the European Union increasingly focused on competitiveness and prosperity, the successful implementation of this transformative initiative is paramount.
EHDS holds significant potential for pharma R&I activities within the EU. This can be exploited further through the clarification of key EHDS provisions such as opt out, sharing of data containing trade secrets, broadly defined categories of data in scope and rules for international transfer of data.
EFPIA is committed to collaborating with the EU institutions, Member States, and other stakeholders during the implementation process. This will help us to realise the EHDS's vision of a unified and well balanced health data ecosystem that benefits patients, researchers, and healthcare providers alike.”
