Ensuring a robust European Health Data Space (EHDS): Working to create a fit-for-purpose regulatory framework

EUCOPE's Sounds of Science

EUCOPE

Science, Life Sciences

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🗓️ 19 September 2022

⏱️ 23 minutes

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Summary

SOUNDS OF SCIENCE - EPISODE 8

On 3 May 2022, the European Commission published the proposal for a regulation introducing the European Health Data Space (EHDS). The proposal aims to enable better exchange and access to different types of health data (think about 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 discuss these challenges and what it will take to deliver on the ambitious promise of the EHDS, we have three of our members as guest today:

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

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For more information about our work on the European Health Data Space (EHDS) or how to join our Digital Health Working Group, simply visit our website or send an email to [email protected].

Transcript

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0:00.0	Hello everybody and welcome to Sounds of Science, a series of podcast hosted by
0:08.0	Yuko, a European trade body representing small and mid-sized companies active in health technologies.
0:13.8	My name is Leandro Franke and I'm the policy officer for digital health here at Yukobe.
0:18.5	Before moving forward, we'd like to kindly ask you to click on the
0:21.3	subscribe button for a podcast and follow us on Twitter and LinkedIn to stay up to date on all
0:27.0	of the latest news and initiatives within the world of European Life Sciences.
0:35.8	So, on the 3rd of May 2022, the European Commission published the proposal for a regulation
0:44.6	introducing the European Health Data Space, or EHDS.
0:48.7	It intends to create a common space where citizens can easily control their data, which
0:53.6	should enable them to gain better
0:55.4	digital access to their personal health data and support free movement. This is commonly
1:00.4	referred to as the primary use of data. It also allows for the secondary use of data, meaning
1:06.5	that the EHDS makes it possible for researchers, innovators and policymakers to use electronic health
1:12.5	data of Europeans in a trusted and secure way. While we welcome this proposal, it is expected
1:18.7	to face some challenges. To discuss these challenges and what it will take to deliver on the
1:23.2	ambitions promise of the EHDS, our guest today include Dan Whitehead, Senior Associate at Hogan Novels,
1:30.3	Paul Mikalou, EU Associate Director at Hanbury Strategy, and Julie Chauver, Director EU Public Affairs at Novartis.
1:38.3	Welcome everybody. So let's jump right in. Dan, our health data and privacy is protected under the GDPR,
1:46.8	which stands for the general data protection regulation. The health data space is going to involve
1:53.8	the processing and large quantities of data, which are of, well, highly sensitive nature.
2:00.6	The EHDS proposal might not be fully consistent
2:03.6	with GDPR rules and this could trigger a risk of legal uncertainties for individuals.
	...

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