EU health data space to boost novel life-saving treatments

The revolutionary EU health data space has been hailed as the dawn of a new era for medical devices, but its proper implementation presents the sector with challenges on regulatory aspects and confidentiality of business information.

Presented last May and currently discussed by EU lawmakers, the Commission’s proposal on a European Health Data Space (EHDS) addresses the limited use of digital health data in the EU due to different standards among member states or limited interoperability of this data.

The ambition of the EU executive is to introduce a new governance framework for health data with cross-border interoperability requirements and a pan-European infrastructure.

“This space is not about imposing a one-size-fits-all,” said EU Health Commissioner Stella Kyriakides in the European Parliament at the end of February, addressing some concerns from stakeholders.

“It is not about creating a centralised European database,” she continued. “What we are doing is introducing common standards that allow member states to digitalise the way that works best for them”.

According to Kyriakides, this is going to boost the development of novel life-saving treatments, medical devices and next-generation medicines, as well as facilitate the uptake of personalised medicine and artificial intelligence.

The impact on the health sector of such a revolution may vary as some fields, like medical devices, are already collecting and using health data – for instance, from diagnostic imaging or cardiac electrical monitoring.

In February, the EU association of medical devices manufacturers (MedTech Europe) released a position paper as a contribution to the ongoing discussion among lawmakers on the dossier – one of the last health files that could be concluded before the end of the legislative mandate in 2024.

“We see it really as a new era, a pivotal moment. It will shape the future of how we use data and data sharing and has a lot of potential to really unlock the benefits of data, especially for patients,” Alexander Olbrecths, director for digital health at MedTech Europe, told EURACTIV.

Sitting on a ‘goldmine’
The EHDS is expected to produce significant savings as, for instance, EU countries spend €1.4 billion on medical images annually, and 10% of this is unnecessary.

But the Commission’s real goal is to unleash the health data economy by fostering the development of new digital health services and products. Once the same standards and specifications are available in all member states, creating an EU-wide market for electronic health records could be possible.

“A vast amount of health data is generated every second as you speak, yet its potential is globally under-explored,” said Commission vice-president Margaritis Schinas at the end of February.

According to Schinas, the EHDS brings the unique opportunity to turn the wealth of health data across Europe into knowledge with a clear aim to prevent better, diagnose and treat diseases.

“Europe can no longer afford to sit on a goldmine but not able to buy it,” he added.

Medical devices and diagnostic companies, in particular, are among those sitting on that goldmine.

For instance, the connectivity of medical devices can provide information on the measurement of body functions, such as the heart rate or the body temperature, as well as on the performance of the specific devices in different therapies.

“We are already producing high amounts of data and are already connected with a lot of it so we have that expertise to offer and we want to help build this EHDS,” commented MetTech Europes’s Olbrecths.

The Internet of Medical Things (IoMT) is not restricted to purely health data as it is also enriched by information on the status of the medical device itself like the battery level. This data could help software developers design new applications or health service providers conceive new products.

“It’s a positive spiral that we’re creating here because a lot is already in place, and that’s why it is so important,” continued Olbrecths.

Challenges ahead
The sector of medical devices has been recently shaken by another ‘revolution’ – the revamping of the two-decade-old regulatory framework for registering these products.

The new rules entered into force in 2017, and into application in May 2021 and required that all medical devices produced in Europe had to be re-certified.

However, not enough notified bodies were created to assess the conformity to the new rules posing the risk of a potential shortage of these products. The solution found at the end was a longer transition period to adapt to new rules proposed by the Commission and agreed upon by both MEPs and EU ministers.

According to Olbrechts, the new regulatory framework for medical devices is already a comprehensive set of rules and requirements for our technologies. “If you start adding requirements, the interplay with them has to be as well considered,” he said.

“If we want to unlock the EHDS success, this needs to come in an agile manner, with all the legislations that are integrated and aligned with each other,” he said, mentioning also interaction with national legislation, to avoid unnecessary confusion, possible duplications and further fragmentation.

The other concern for the medical devices sector is about the protection of intellectual property (IP) rights and trade secrets in the so-called ‘secondary use’, namely data created and registered for health services or activities that can be used for purposes other than the reason for which they were initially collected.

The current EHDS proposal obliges data holders to disclose their data for secondary use to data users established in the EU, even if these data entail IP rights or trade secrets.

For Olbrechts, it is important to “ensure the necessary sharing of data is the intention, but at the same time, this should be built upon existing legislation governing trade secrets and IP rights, which are there with a good reason to protect innovation and trade”

Getting adequate safeguards for IP rights and trade secrets “will serve as an incentive for collaboration and making this system work, for all stakeholders,” he concluded. EurActiv