EHDS: Spanish presidency seeks additional tweaks on health record systems

The Spanish presidency of the EU Council wants an opt-out option for the primary use of health data in emergency situations and two mandatory ‘harmonised components’ for health record systems (EHRs) in the EU’s health data regulation, according to a position paper obtained by Euractiv.

The European Health Data Space (EHDS), presented by the Commission in May 2022, aims to regulate the transmission and sharing of health data and unleash its full potential for all stakeholders – from patients and healthcare professionals to policymakers and researchers.

Currently, the file is in the hands of the EU lawmakers – the European Parliament and the Council of Ministers – who are currently preparing their amendments to the Commission’s proposal before entering into interinstitutional talks to approve the new rules.

The Council already advanced on the dossier under both the Czech and Spanish presidencies, covering the general provisions and ‘primary’ use of health data and ‘secondary’ use of data.

The primary use of data focuses on data use for citizens and healthcare professionals at the national and EU levels, and on fostering a genuine single market for EHRs, relevant medical devices, and high-risk AI systems.

The secondary use of data is there to provide a consistent, trustworthy and efficient data pool for research, innovation, policy-making, and regulatory activities.

On the last day of October, the Spanish Presidency made additional adjustments to the primary use of health data in the Presidency’s third compromise proposal. Among the provisions, the Presidency opt-out option is being introduced for the primary use of health data. This means that patients who don’t want their data to be accessed and used by healthcare professionals could decide to stay out of the system. 

The Commission in the proposal acknowledged that people who don’t want to share some parts of their personal electronic health data “should be supported”. 

However, this is not the case in emergency situations, as an emergency override was proposed to protect vital interests, meaning that in life-threatening situations the data could be accessed by healthcare professionals. 

The presidency added to the proposal that EU countries may provide for a full opt-out without an emergency override, both for cross-border access and inside that member state, by establishing the rules and specific safeguards.

They also outlined a further opt-out option to object access and/or exchange their personal electronic health data registered in an Electronic Health Record (EHR) system within the country and cross-border. Again, the responsibility of creating rules and specific safeguards falls on member states. 

For the Parliament, the question of limiting access to certain sensitive data for healthcare professionals was one of the main discussion points on primary use. 

Patients do not want to give access to all of their data to healthcare professionals and Parliament is to support this, Croatian MEP Tomislav Sokol (EPP), the rapporteur of the file, said on Thursday (16 November) during the European Cancer Summit panel session on digital health.

“For instance, if they have some kind of mental health issue or similar, they can decide like that [not to give access]. This is what was defined. Some things were made more precise and I think these [Parliament’s] provisions are pretty good,” he said. 

As for the information on those that accessed the health data, the Presidency specified the Commission’s proposal, bullet-pointing that patients shall have the right to know the healthcare provider who accessed the personal electronic health data, the date and time of access and which data was accessed. 

The European electronic health record exchange format

As European electronic health record systems and the digitalisation landscape in the EU at large are fragmented, the Commission proposed an exchange format to form the basis for specifications related to the registration and exchange of electronic health data.

The Presidency wants to see this format split into two profiles: one for national use and one for cross-border use. As for the national use, the profile should include the technical specifications for the ‘European interoperability component for EHR systems’, as well as harmonised technical specifications for the ‘European logging component for EHR systems’ defined through implementing acts. Both components are defined as ‘discrete software’, without which manufacturers cannot place their EHR systems on the market. 

The conformance assessment in the Presidency’s position remains that it should be done by means of self-certification, “given the low risk of these components and the wide scope of the definition of EHR systems”. 

This opposes the Parliament’s position, which is in favour of a third-party assessment mechanism. “The majority of the Parliament decided to have better control of the safety of these systems is to have the third party certification of these systems,” said Sokol. 

In the Presidency’s file, the Commission is mandated to develop a ‘European digital testing environment’ to support the assessment of harmonised components of EHR systems. 

The Parliament’s position is to be voted in the committee on 28 November, with the vote in the plenary foreseen for December. Initially, the final vote in the plenary was expected to take place in November, but there were delays, according to Sokol, due to “a lot of the technical work that had to be done on on all of these details, detailed provisions of the regulation”. 

He hopes to reach a political agreement before the end of the mandate, adding that “it won’t be easy”.

“We should put the pressure on both the political groups in parliament and also the member states to put the focus on this so that we are able to finish this before the mandate of this Parliament and the Commission expires,” Sokol concluded.

Luca Bertuzzi contributed to the reporting.

[Edited by Nathalie Weatherald]

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