A conversation with Inge Franki - “Sharing health data must become more common, without taking control away from the patient”

Many people have already heard the term “European Health Data Space” but it may not always be entirely clear on what it entails. What is the EHDS, and what will be the most visible benefit for a Belgian patient once the system is fully operational?

“The European Health Data Space, or EHDS, sets out European rules to make it easier and safer to share health data. This happens at two levels. The first is direct patient care. At present, data is not always exchanged smoothly between doctors or hospitals. Anyone seeking a second opinion elsewhere may find that a doctor does not have access to previous test results. The EHDS is designed to ensure that relevant information is more readily available, so that tests, such as scans, do not have to be repeated unnecessarily.

This also applies across national borders. Consider, for example, someone who needs medical assistance whilst on holiday in France. If a significant allergy is recorded in their medical records, the treating doctor must be able to access that information. The use of electronic prescriptions across borders will also become easier.

The second level concerns the reuse of health data for research and policymaking. Clear conditions apply here: data is anonymised or pseudonymised (names are replaced by a code) and analyses are carried out in a secure environment. Data is therefore not simply released. Moreover, the patient retains control. In Belgium, you can already deny certain healthcare providers access to your records. We are also providing an option whereby patients can indicate that they do not wish to share their health data for reuse in research."

The EHDS is intended to make health data more readily available for research. What potential medical breakthroughs or improvements are currently being held back because the data is too fragmented?

“Rare diseases are a clear example. If there are only a few patients with a particular condition in a single country, it is difficult to conduct in-depth research based on such a small group. By securely pooling data from different European countries, researchers can study larger groups and gain a better understanding of such conditions.

A second example is new, often expensive treatments, such as gene therapies. In such cases, it is important to know what they mean for patients in the longer term. Does their quality of life improve? And how do the results compare with those of existing treatments? If data from larger patient groups become more accessible for research, these questions can be investigated more effectively. Naturally, this must always be done within the applicable regulations.

This collaboration can only work if patients retain control. With regard to the second use of data for research, we are working on a system whereby patients can use a so-called “opt-out” mechanism to indicate that they do not wish their data to be shared, even when that data is anonymised or pseudonymised. The EHDS must therefore make data more readily available, but within clear rules and with respect for the patient’s choices.”

Belgium has strong research institutions, hospitals and a significant biopharmaceutical sector. What role can they play in maximising the potential of the EHDS?

“It is important for all these parties not to view the EHDS solely as an obligation to share data. It also offers the opportunity, under the laid-down conditions, to request access to data available elsewhere. This can make research more efficient: institutions do not have to repeat the same preparatory work or conduct the same studies over and over again.

I understand that companies and research institutions want to protect their data. There are safeguards in place for intellectual property and other exceptions. But there is also a principle of reciprocity: those who share data can also request data for their own research. If we strike the right balance, universities, hospitals and companies can together make the most of the available knowledge.”

What concrete progress has been made with regard to the EHDS after one year? And how does Belgium compare with other countries in Europe in this regard?

“Belgium took early action on a number of points. With the Health Data Agency, we already have a central agency that will play a role in the request for and access to health data for reuse. In several other European countries, discussions are still ongoing as to which body will take on that role.

In addition, we already have a metadata catalogue. This does not contain the health data itself, but descriptions of available datasets. This allows researchers to identify which data are relevant to their research and then submit a request to use them. We are now working hard to include more data holders and descriptions in that catalogue. Work is also continuing the secure analysis environment.

That does not mean that everything has already been sorted out. Discussions are still ongoing with other European countries regarding certain aspects, such as the precise role of ethics committees. But as far as the establishment of a central agency and the technical preparations are concerned, I believe Belgium is among the frontrunners.”

If you look five years ahead, how will we be able to tell that the EHDS has truly been a success?

“Five years is an ambitious timeframe for such a major change. There will undoubtedly still be teething problems during the roll-out. After all, we are not only changing rules and infrastructure, but also the way we handle health data. In doing so, data protection and existing privacy rules must continue to be respected.

For me, the EHDS will be a success when the secure sharing of data has become standard practice: when healthcare providers have access to the information they need, researchers can utilise results and data more efficiently, and citizens understand what happens to their data and remain involved in the process. Perhaps we will not quite be there in five years’ time. But that is certainly the direction we must work towards.”