MEPs want more safeguards in the European health data space

MEPs want to ensure the EU’s plan for setting up a secure infrastructure for sharing health data across the bloc is trusted and robust, as they draft an opinion on the proposed regulation.

The European Commission proposed the plan for setting up a European health data space (EHDS) last May and it’s been making its way through the Brussels policy mill since, with the hopes to have it done before the current Parliament ends its term next year.

The ambition is to give researchers from academe and industry access to large amounts of high quality health data, to enable discovery and development of drugs, vaccines and medical devices, and to inform healthcare delivery and improve the resilience of Europe’ healthcare systems

Officials hope this will lead to better health outcomes and boost the bloc’s global standing in health innovation.

Today, Europe’s healthcare sector generates vast amounts of data but only a fraction of it is accessible for secondary analysis, with strict privacy rules and fragmented implementation making it hard to share anonymised patient data and impeding critical health research. The new framework aims to enable cross-border sharing while ensuring privacy.

Under the Commission’s proposal, researchers, companies and institutions will require a permit from a health data access body, to be set up in all member states. Access will only be granted to use de-identified data for approved research projects, which will be carried out in closed, secure environments.

The health data access bodies will be connected to a new decentralised EU infrastructure for secondary use, which will be set up to support cross-border projects.

“It’s important for us to reinforce the secondary use of data, how we are going to use them, given the importance they are going to have in research into new treatments for patients and at the end of the day for the competitiveness of European industry,” said Susana Solís Pérez, MEP in Parliament’s liberal Renew group. “We’re looking at one of the most important reports in the area of health we are going to have in this Parliament.”

The Parliament industry, research and energy committee (ITRE) supports the proposal but wants to prop it up with more robust data protections than in the original proposal. This, the MEPs hope, will ensure trust in the platform, enabling wider use.

“I believe that a prudent implementation of [the General Data Protection Regulation] is necessary to avoid unnecessary restrictions for health research and data sharing,” said the committee’s rapporteur for the file, Cristian Bușoi, in today’s debate on the draft opinion.

His fellow MEPs in the ITRE committee tabled their amendments to the draft committee opinion this afternoon, with many looking to ensure better data protection provisions. “We need to reflect how we generate a space where the patients are confident their data is being handled correctly,” said centre-right MEP Angelika Niebler.

Andreas Glück, a surgeon and Renew group MEP, noted the EHDS should provide a variety of health-related data for researchers, including geodata, environmental data, and factors that are relevant to health, such as employment status.

The Greens meanwhile want to make sure the new health data space advances Europe’s open science ambitions. “As the data will be publicly collected, the public needs to also benefit from the research activities carried out, and we should also make sure that research communities and universities are included in the approach,” said MEP Ville Niinistö.

The file is also being debated in the Parliament’s committee on the environment, public health and food safety as well as the home affairs committee.