How should health data be defined and used across Europe?

Platformable will be responding to the current Towards the European Health Data Space public consultation. This public consultation covers:

• Proposed standards for how to describe health data 
• Proposed technical specifications for how this health data should be catalogued so it is discoverable
• Proposed processes for how an organisation can apply for access to use health data
• Proposed guidelines for how users who have been granted access to use health data can use a secure environment platform to analyse the data.

At Platformable, our goal is to support open digital ecosystems. For digital health across Europe, we believe this means building on European-based public digital infratsructure, using open data standards and data models, providing resources for interoperability, ensuring regular engagement with patient organisations and the public about the value and risks of health data sharing, and creating a level playing field that offers opportunities for all types of organisations to make use of health data responsibly and ethically.

Often, the voice of digital health tech startups, smaller research teams, and community organisations working with health data is not heard because you do not have time to respond to these consultations. We would like to support you to share your thoughts and we will prepare a group response. You will be offered a copy of the draft when it is prepared and you can decide whether to add your name to it.

The public consultation is due on 28 February 2025. We will be submitting our response around 25 February.

Process

• Book a time with us
• You can share with us (at a high level) how you might use health data in future
• Based on this, we will highlight areas of the consultation documents that might impact on your plans
• We will get your opinions on key principles and ideal scenarios for how health data can be shared responsibly and ethically
• In early February, we will share an open document so you can see our progress as we go along and can provide additional comments if you wish

This is an independent activity of Platformable and we have no conflicts of interest to declare.

Even if you do not want to contribute, but are curious about the potential future impacts of these documents on your business, book a time and we can share our analysis with you.

Background/Context

The European Union Data Act came into force in January 2024, but many of its requirements become applicable from September 2025. Overall, the Data Act mostly focuses on data sharing in the Internet of Things context, although data sharing in general (especially through the design of model contracts between businesses and between business and government) is also covered. Interoperability is addressed by establishing the idea of European Data Spaces. A data space is like an ecosystem of stakeholders that agree on common standards, interoperability specifications and data-sharing approaches within a given sector. To date, the formation of these has been fairly patchy. The collaborative work of Catena-X for the automotive industry seems quite advanced, while work by the Agricultural Data Space is fairly lacklustre, and the Finance Data Space last met in October 2024 and is struggling to even have a clear presence.

The European Health Data Space, on the other hand, has taken a truly collaborative approach. Through funding to the Finnish agency Sitra, a Towards the European Health Data Space initiative (TEHDAS2) was established to identify interoperability issues that would need to be solved for a shared data ecosystem to operate across Europe. Previous work by this group (under the initial TEHDAS) identified regulatory fragmentation challenges and so on. Current work has now progressed to the point that they have developed a metadata model for health data so that data can be catalogued across European borders, aiding data discoverability and use. Thinking through the user journey for describing data discovery on a catalogue/portal, requesting access and using in a secure environment, TEHDAS 2 has documented four guidelines for each stage of this data journey.

How to participate

For healthtech startups, pharmaceutical and medical device companies, biotech, and other innovators looking to make use of health data in future for analysis, research and product design, this consultation is essential for market entry and ecosystem participation. You need to check that the way TEHDAS is proposing that data be described, made discoverable, accessed and analysed does not create barriers for your future strategy and roadmap and that larger, incumbent stakeholders are not priveleged over new innovators.

For patient representative groups, community based health organisations and community advocates, ensuring appropriate safeguards are in place in the TEHDAS2 proposed guidelines and that the beneficial outcomes from the use of population and community health data are shared by all society are important considerations.

All up the documents total almost 150 pages of pre-reading materials. We can help you understand the key issues and implications of the guidelines for your organisation and mission. Please book a time with us to discuss what you would need from a European Health Data Space that enables the fair, equitable, responsible and ethical use of health data for your benefit as well as for society, local economies and the environment.

We will be sharing our draft response openly and invite other organisations and businesses to join us. Please revisit this blog post for links to our draft response in early February.