'Use the EHDS as a driver of transformation'

We are going the present and future shortages by doing things just a little more efficiently. We will really have to organize healthcare differently. The EHDS is the big driver for this, thinks Vincent van den Berg, supplier chairman at IHE Netherlands.

On Jan. 21, the European Health Data Space, EHDS for short, was adopted in Europe. Twenty days later, the law will take effect. This European regulation, which takes precedence over national legislation, leans on three pillars.

The first is primary use of healthcare data: making it easier for both patients and providers to access health data. Among other things, patients will soon have the right to download their own health data, set access restrictions and add information themselves. In six years, the following categories of information that should meet these requirements: patient summary, electronic prescription of medication, electronic dispensing of medication, medical images and image reports, discharge letters and medical test results.

The second pillar is the secondary use of healthcare data. The EHDS mandates that parties generating or processing health data must make such data available under certain conditions if it serves the public interest, such as for scientific research.

The third pillar is regulation of the healthcare ICT market. All suppliers who supply software on the European market will soon have to comply with the same rules when it comes to (product) safety, security and interoperability. This should make it easier for suppliers to sell their products in multiple countries, creating an open European market that functions better and thus has a downward effect on prices.

ICT suppliers

"Right now, nothing is changing for patients, healthcare providers and researchers. But these are the three parties that will benefit most from the European regulation. It is the ICT suppliers who have to get to work to adapt their software," says Vincent van den Berg, supplier chairman at IHE Netherlands.

IHE, which stands for Integrating the Healthcare Enterprise, is an international nonprofit organization that brings together healthcare organizations, software vendors and governments. Its goal: to reach agreements on how medical data can be securely exchanged digitally. In that capacity, IHE has an important voice in the development of the EHDS, says Van den Berg. "We ensure that it becomes easier for software vendors to develop software that uses open standards. And that it becomes easier for healthcare organizations to implement that software in such a way that data exchange becomes possible in a standardized way."

Significance for the Netherlands

The Netherlands still has some work to do to get ready for the arrival of the EHDS, says Wim de Koning, co-director at IHE Netherlands. "You unfortunately see that within the Wegiz there is still often a choice for self-made interfaces and no use of open international standards."

Open international standards

"The EHDS is going to require the use of open international standards. So many Wegiz interfaces will have to be recreated for the EHDS. Fortunately, that realization is starting to sink in a bit and we are seeing a cautious movement to make Wegiz interfaces 'EHDS ready.' For image availability, this is already the case. For the other exchanges, that could be done via the Twinn TA Pull route."

Data availability

Despite this amount of work, the EHDS offers opportunities for the Netherlands, thinks Gaby Wildenbos, strategic advisor at Nictiz and in that capacity an important interlocutor for IHE Netherlands. " Data availability will improve for both healthcare professionals and patients. And the administrative burden goes down because you don't have to type over data that has already been recorded somewhere as often. Citizens' control over their own health data increases and, last but not least, there will be a level playing field for suppliers of applications that capture health data."

Interoperability

But it also offers opportunities because the EHDS hangs like an umbrella over all Dutch policy agreements and legislation, such as Wegiz and IZA. "Even though there are differences, for example between the BgZ MSZ and the European patient summary, the direction we are going in is the same. We are pulling the Dutch situation towards the European one, although this will sometimes be quite exciting because the timelines do not quite overlap. But either way, the EHDS is going to provide an acceleration in our country when it comes to interoperability." The European EHR exchange format (EEHRxF) is one of the catalysts.

Making headway with AI

Itte Overing, a lawyer at ICTRecht who specializes in health law, gets very excited when she thinks of the possibilities that will arise when secondary use of data finally gets off to a good start. "Then there will be an acceleration of digital health. The goal of the EHDS is to keep data flowing. If you implement this in the right way, you can change the whole model on which we deliver care now. Then you can redesign care. This is high time, because the current model is 120 years old and is reaching its limits."

Large data sets

Among other things, there are great opportunities to use AI to conduct research into such things as the origins of diseases and better treatments. "The promise is that researchers will soon finally have access to the large data sets they need to train their algorithms. As a lawyer, I'm very excited about that. There is a fear among some health care providers that medical confidentiality is being completely overhauled. And yes, there will be a revision. A revision better suited to the current times. But no, that does not mean that privacy is no longer an issue. Because 'Europe' has actually been looking for a way that, on the one hand, provides sufficient space for healthcare innovation, and on the other hand, protects patient privacy. In my view, the EHDS has succeeded well in this."

Medical confidentiality

Indeed, medical confidentiality has until now been a major showstopper for AI. This prevents data collected by one healthcare provider from being shared with another party who wants to conduct scientific research or improve treatment methods based on that data. The patient must specifically consent to this (opt-in), which far from all patients do. As a result, datasets on certain patient populations often do not form a good cross-section of all patients, with all the consequences this has for the outcomes of scientific research.

The EHDS is subject to an opt-out: if patients do nothing, the datasets described in the EHDS may be shared with other healthcare providers for primary use or with a Health Data Access Body (HDAB) for secondary use. The secondary use will always be done based on anonymized (or if that is not possible pseudonymized) data. Moreover, the Netherlands has requested and received an exception for the human genome. Because those data are so sensitive, this is subject to an opt-in.

Ethical and security boundaries

Like Itte Overing, her professional colleague Arthur van der Wees, founder and director of Arthur's Legal, is also enthusiastic about the EHDS. "The regulation seizes the opportunities of digitization, but within ethical and security boundaries. In the past, unjustified excuses have often been used not to share data, but you are allowed much more than we have agreed on together in the Netherlands; also within the AVG."

The EHDS builds on agreements already made in other European laws and regulations, such as the AVG, but also the AI Act, the Data Governance Act and the Data Act. Van der Wees: "All these new laws and regulations from Europe can feel like a tsunami of new rules coming at us. But it is rather a tsunami to regain and rebuild trust."

"Europe is taking back control, with the goal of giving European citizens and organizations control over their own data. Think of data that smart watches and other devices now capture about you unasked. But also with the goal of finally using data to do good for society."

More efficient and effective

Vincent van den Berg summarizes, "We need to start seeing data as an asset. If we agree again who records what data where and where all that data can be reused, the healthcare chain as a whole can work more efficiently and effectively. Opportunities abound. Let's seize them together."

During the Care & ICT Exhibition, IHE Netherlands and HL7 Netherlands will jointly provide a presentation entitled: Fit for the EHDS on FHIR. Now that the EHDS has been adopted, data availability at EU level becomes a reality by requiring all source systems to support the same dataset. How do we make this work on a European scale as well as in the Netherlands? Come to the session of Robert Stegwee, director at HL7 Netherlands, and Vincent van den Berg, director at IHE Netherlands.