TEHDAS stakeholders support European health data space proposal – implementation the biggest hurdle
The Commission’s proposal on the European health data space will increase the cross-border secondary use of health data in the EU, if consistently implemented in member states, say European health data stakeholders.
TEHDAS, the joint action Towards the European Health Data Space, held an online debate, 9 May, focusing on the initial responses to the European health data space (EHDS) proposal presented a week earlier by the European Commission. The online event brought together 350 European health data stakeholders.
TEHDAS stakeholders expressed broad support for the European health data space in harnessing the benefits of such data. But there are reservations concerning the implementation of the regulation and ensuring the representativeness of the European health data space board.
There were speakers from the Biomedical Alliance in Europe, DIGITALEUROPE, the European Institute for Innovation through Health Data (i~HD), EURORDIS – Rare Diseases Europe, MedTech Europe, Standing Committee of European Doctors. The views of participants were polled via an online tool.
Unleashing data for everyone’s benefit
All speakers welcomed the proposal and its benefits to individuals, researchers and policymakers. The resulting legislation needs to establish a clear framework for member states without burdening health care provisioning.
“If the legislation is unclear, it may hinder rather than propel forward fast-paced real time data access necessary for improving the lives of citizens through research and public health”, said Associate Professor Jennifer Baker, Biomedical Alliance in Europe.
“Had real time data been available, the additional vulnerability that people living with obesity had towards Covid could have been identified sooner, enabling better outcomes.”
The Commission’s proposal aims to make data accessible, findable, reusable and interoperable.
“There has been a consistent problem with different registries not speaking with one another as well as they could and it’s holding back research. We have been calling for legally binding targets for health data interoperability”, said Richard Price, Head of Policy, European Cancer Organisation.
Also, the industry needs data to produce innovations. “Connected medical devices are increasingly used in the treatment of disease. For the industry, the ability to access data is critically important to develop new innovative solutions and treatments”, said Michael Strübin, Director Digital Health, MedTech Europe.
Digitising health data can increase cybersecurity risks. “The highest standards on data protection and security must always apply”, said Sara Roda, EU Senior Policy Adviser at Standing Committee of European Doctors.
Implementation the biggest challenge
TEHDAS stakeholders see the implementation of the EHDS as the biggest challenge (image 1) in the legislative process.
“We need to act much faster if we want the infrastructure for data sharing to be up and running in all member states by 2030”, said Thomas Hellebrand, Manager for Digital Transformation Policy at DIGITALEUROPE.
Many speakers stressed the importance of aligning EHDS with existing EU legislation and legislative proposals, such as the General Data Protection Regulation (GDPR), Artificial Intelligence Act and Data Governance Act. They voiced concerns that without clear guidelines EHDS implementation could lead to fragmented approach as has happened with the GDPR.
“Fragmentation is blocking important lifesaving research. There is an ethical duty to overcome such barriers”, stressed Thomas Hellebrand.
For patients living with a rare disease, the secondary use is highly important due to scarcity of data.
“At the moment, due to GDPR derogations, obstacles exist in sharing genetic data, for instance. We are looking forward to a more harmonised approach based on strong ethical standards”, said Jelena Malinina, Patient Data Director, EURORDIS – Rare Diseases Europe.
Currently, countries have national laws or rules on health and research data in addition to the GDPR. To further complicate the secondary use of health data, countries interpret the GDPR in differing ways.
“There is a need for enormous coordination on a practical level between different legislation pieces to avoid confusion”, said Jelena Malinina.
Representation in governance challenged
The TEHDAS stakeholders (image 2) expressed the need to clarify the role of the European health data space board. According to the proposal, each member state will nominate an organisation to the EHDS board. The proposal also mentions having observers on the board, but their role is unclear.
Speakers highlighted the need for ensuring the representativeness of the board to ensure transparency and trust.
The role of health data access bodies also raised comments. A level European playing field requires the access bodies’ decision-making to be consistent across Europe.
“The success of the access bodies, especially the single application principle across Europe, is going to depend on their decision-making. The regulation leaves open how and the bases of which they make these decisions”, said Dipak Kalra, President of the European Institute for Innovation through Health Data.
Proposal starting point for legislative process
The work will continue at the Council of the EU and the European Parliament.
“The EU digital Covid certificate was a testament to what Europe united can do. We managed together to show Europe can become a global leader in digital world”, said Ioana Gligor, Head of Unit at the Directorate General for Health and Food Safety at the European Commission.
Isabel Zablit from the French EU presidency thanked TEHDAS for organising the event so soon after the proposal was presented. “The proposal is about an ambition for Europe, most importantly for European citizens. This is a turning point for the health sector.”
“I found it very valuable to hear the stakeholders’ comments. I want to thank the participants. TEHDAS stands ready to support the member states and the MEPs in the legislative process”, said TEHDAS Coordinator Markus Kalliola from the Finnish Innovation Fund Sitra.
The discussion will continue at the TEHDAS Stakeholder forum on 14 June 2022 in Helsinki, Finland and online.