EUCOPE Resources / News - September 20, 2022

?️Sounds of Science Episode 8 on the European Health Data Space (EHDS)

Sounds of Science Podcast – Episode 8

Ensuring a Robust European Health Data Space (EHDS)

On 3 May 2022, the European Commission published the proposal for a regulation introducing the European Health Data Space (or EHDS).

The proposal aims to enable better exchange and access to different types of health data (such as genomics data, data from patient registries, electronic health records, etc.).

And what does it want? Well, It intends to create a common space where natural persons can easily control their data which should enable individuals to gain better digital access to their personal health data and support free movement. This is commonly referred to as the primary use of data.

It also allows for the secondary use of data, meaning that the EHDS makes it possible for researchers, innovators and policymakers to use electronic health data of Europeans in a trusted and secure way.

EUCOPE welcomes the proposal on the European Health Data Space. It also recognises the importance of EU-level data collection standards and the promotion of data interoperability and exchange protocols. However, such a domain-specific common data space is expected to face challenges.

To help us address these challenges and propose some options for a fit-for-purpose regulatory framework, we’re joined by:

  • Julie Chauvet, Director EU Public Affairs at Novartis
  • Paul Michaloux, EU Associate Director at HANBURY STRATEGY
  • Dan Whitehead, Senior Counsel at HOGAN LOVELLS

This episode is hosted by Leander Vranken, Digital Health Policy Officer at EUCOPE.

You can listen to Episode 8 and all other Sounds of Science episodes using the links below:

Episode Highlights

Dan Whitehead, Senior Counsel at HOGAN LOVELLS

“The fundamental problem is likely to be the Member States’ local implementing laws may place stricter restrictions on the sharing of health data than those that are envisaged under the EHDS and in practice. This could result in a conflict of law situation and acts as a barrier to incentivizing data holders.”

‘‘The main body of the EHDS regulation should set out how the GDPR requirements will apply to data users, data holders and health data access bodies in practice.’’

Paul Michaloux, EU Associate Director at HANBURY STRATEGY

“We need to really assess if this regulatory framework is clear and harmonized as it will be key to ensure timely access treatments for patients accelerating the development of personalized therapies.”

“The ability for companies to work with a single health data access body to process the parent request would minimize the complexity of data sharing.”

Julie Chauvet, Director EU Public Affairs at NOVARTIS

‘’We are convinced that the use of real world evidence (RWE) gathered from patients’ health records can lead to better standards of care or provide more useful information for the development of new treatments’’

“In order to construct longitudinal data sets, particularly in complex diseases, it is important that access to identifiable electronic health records and data are preserved in order to promote the generation of high quality real world data for research purposes.”

“We firmly believe that research partners need to be able to share confidential commercial information in a secured manner over the course of the R&D process”

If your company would like to put forward a topic for us to discuss or to participate in a future episode, please reach out to our producer, Dante Di Iulio.