The EU plan to harmonise electronic health data promises to make life easier for start-ups, but barriers to success still remain

Proposals to build a European Health Data Space (EHDS) have received a warm welcome from digital health start-ups, which are frustrated by obstacles to scaling-up within Europe. If the plan succeeds in harmonising electronic health data between EU member states, it will already have done these entrepreneurs a huge favour.

“Harmonising Europe-wide processes for sharing and accessing health data is the cornerstone for digital health start-up innovation,” said Benedikt Blomeyer, EU policy director at Allied for Startups, a Brussels lobby group that has taken a close interest in the proposals. “The EHDS has the opportunity to become the runway for start-ups to scale-up in the EU once, not 27 times.”

But gaps and uncertainties in the proposals may yet put a dent in the innovation gains foreseen by the Commission. For example, who will make reluctant healthcare providers release their data? And who will pay the costs of setting the data free?

The headline aim of the EHDS is to make electronic health data more accessible across the EU. This will give patients full control over their health records, so that they can get better healthcare at home and abroad. It will also create a framework for the secondary use of electronic health data, under strict security and privacy conditions.

Standards for data interoperability and security will become mandatory. Companies and researchers who want to use electronic health data will need a permit from one of the new health data access bodies, to be set up in each EU state. Access will only be granted if the requested data is used for specific purposes, in closed, secure environments and without revealing the identity of the individual it refers to.

The national health data access bodies will be connected to a decentralised EU infrastructure for secondary use, called HealthData@EU, which will be set up to support cross-border projects. Innovators from outside the EU will also be able to access this European data for secondary use, under the same conditions.

The Commission expects the total economic benefit of the EHDS to top €11 billion over 10 years, evenly split between primary and secondary uses of health data. It thinks researchers and innovators in digital health, medical devices and medicinal products will benefit to the tune of €3.4 billion.

No standards, no scale-up

Belgian start-up Andaman7 is a good example of how hard it is for health data start-ups to scale-up in Europe. It has developed a smartphone app that helps patients collect and manage their health records, for free and without selling their data to third parties. This free service is subsidised by the other half of the business, which offers pharmaceutical, biotech and medtech companies a tool for managing clinical trials and enrolling patients, including handling issues such as consent, treatment adherence and anonymisation.

“So we are not using patient data, we are selling access to patients and an easy way to collect data from them, and only if they agree,” said co-founder and CEO Vincent Keunen.

As it stands, Europe has not proved a very welcoming environment. “The lack of health data standards has been a huge barrier,” Keunen said. “We are based in Belgium, and we are very interested in the Belgian and European market, but only one hospital and one private lab here are compatible with our system. But in the US, we are already compatible with 85% of all US hospitals, just by implementing FHIR [the Fast Healthcare Interoperability Resources standard].”

But standards alone are not enough to create the data-rich environment the EHDS aspires to be. Hospitals and other healthcare providers need to be persuaded to release the data. “There is still a lot of resistance from the medical sector, sometimes for good reasons, sometimes not, and I hope that the regulation will push that back, because it is really slowing down development, and therefore improvements to care and research,” said Keunen.

The American experience is instructive. “In the US, it happened almost in two waves. First, imposing the standards on everyone, then imposing fines if the data is not available in line with those standards. So Europe has a chance to do that faster, learning from the US experience.”

Money also has to flow

For Philip Taillieu, CEO and co-founder of Cascador Health, also based in Belgium, the EHDS is exactly the kind of regulation the health data scene needs. “It provides us with a framework that gives us some certainty about what we will be able to do in the future, and what we won’t be able to do.”

Cascador is right in the middle of the health data economy, acting as an intermediary between hospitals and other healthcare providers which have data, and companies and researchers who want to use it. Founded in 2021, it raised €3.4 million in March this year with a view to further validating its data platform and continuing European expansion.

While the EHDS will make accessing health data easier for everyone, it will not put Cascador out of business. Quite the contrary. “Much of the complexity in unlocking medical data is linked to governance, and making sure that, as a healthcare provider or a pharmaceutical company, you are doing it the right way, and protecting the rights of individual patients or the interests of the hospital,” Taillieu says. “Our software platform does exactly that. We clear data so that it can be transferred to third parties, so this legislation is an opportunity for us.”

But he also sees gaps in the proposals. “Sharing data is a very noble objective, but it costs money. The data needs to be prepared to be shared, it needs to be uniform and harmonised, it needs to be put on IT systems.” Healthcare providers certainly don’t have spare resources to do this. “You could argue that those who benefit from using the data should pay for it, but as far as I know this is not really addressed in the legislation,” Taillieu said.

Then there is a worrying vagueness in what the data interoperability standard will look like, and what the data exchange platform HealthData@EU will actually do, when it becomes operational in 2025, at the earliest. “Both risks can lead to paralysis of healthcare providers when it comes to data sharing in the years to come, as they wait for more transparency on interoperability and the platform,” said Taillieu. “So, instead of promoting data sharing, the EHDS could put a brake on data sharing in the near future. This something that should certainly be avoided.”

A pan-EU standard

It is also possible, however, that the EHDS will have a broader impact than foreseen. German start-up Semalytix, for example, will probably not be covered by the new regulation, but it is keen to embrace the data standards it will lay down. The company was created in 2015 by researchers working on natural language processing at the Centre for Cognitive Interaction Technology (CITEC) at Bielefeld University. Currently with around 50 employees, it is developing systems that analyse patient experience in order to better understand the perceived value of treatments.

Its raw material is text, from discussions in patient forums, to peer reviewed journal papers and clinical trial reports. Natural language processing tailored to medical terminology makes this information comprehensible to an artificial intelligence system, which then looks for patterns. “We try to identify significant gaps in treatments that are available and put a value on a new solution in a particular niche or patient cohort,” said cofounder and CEO Janik Jaskolski. “So, if patients say ‘this is what bothers me’, we can quickly go on to ask: is this something new, have the patients got it right, and has this been researched?”

While this information is about patients, it is not healthcare data, generated from a clinical setting. The General Data Protection Regulation must be observed, but in practice Semalytix recognises that this is not ordinary personal data, Jaskolski said. "We already go much further than what GDPR already requires of us to protect identities, such as anonymisation, removal of personal information, and any other information that is not specifically required to quantify patient needs."

But GDPR is also subject to local interpretation, which creates uncertainties for the company. This is where the EHDS could help. "Common health data regulations have the potential to alleviate this uncertainty. If EHDS removes residual vagueness of GDPR in healthcare, we end up with one EU-wide guideline, and our clients know what to expect from us, then everything becomes much easier. So I expect that the EHDS is a very good thing for us"

And further down the line, Semalytix expects to integrate its patient experience data with electronic health records, again looking for useful connections. Health records, for example, might show a particular group of patients tending to stop taking a drug, which could be connected with information from other sources on negative experiences. “It’s just a correlation, but it could be enough to start research through questionnaires, interviews and so on, and then you might be on to something,” said Jaskolski.

Elsewhere in the Ecosystem...

• The European Investment Bank is putting up to €20 million into a co-investment facility with Sabadell Venture Capital to support early-stage Spanish start-ups affected by COVID-19. The EIB has invested heavily in pandemic recovery initiatives, but this focus on start-ups is unusual. It says early-stage, innovation-driven Spanish businesses are having trouble accessing equity because of the pandemic, hampering their growth. Sabadell will match the EIB contribution, creating a total fund of €40 million. All sectors will be covered, with a strong emphasis on tech companies.
• Buried in the European Parliament’s report on artificial intelligence, agreed last week, is a damning review of the European Digital Innovation Hubs (EDIHs), part of the Digital Europe programme. These could play an important role in building up an AI ecosystem based on university-industry clusters, the report says, but criteria for their designation are too vague. As a result, EDIHs across Europe differ in their capabilities and development, and the interplay with other EU digital hubs remains unclear. More coordination, more effort, and an overall cluster of decentralised AI hubs is required.
• Berlin-based digital health company Fosanis has raised more than €10 million to extend Mika, an AI-driven platform that helps cancer patients cope with the challenges of the disease and treatment process. It was developed together with the University of Leipzig Medical Centre and Charité Berlin. The funding will help Fosanis enter the UK healthcare market, and build new partnerships with cancer research centres. The investment round was led by the Debiopharm Innovation Fund.

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