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Unravelling the wild west in data-driven healthcare?

Data is the crude oil of the 21st century, or the new gold as others say. Does that make the European Health Data Space the new wild, wild west? Let’s dive into this and see if this undertaking is worth pursuing. But at first, a little personal note about studying abroad and seeking medical advice.

Imagine this: You are studying in the European Union while encountering a little medical hiccup. Nothing too severe, but nerve wracking, nonetheless. I have been there and done that multiple times in different European countries over the course of the last few years, as I pursued my trinational master’s degree in Upper Silesia in Poland. I suffered from chest ache due to a silly sports accident (ouch). So, off to the hospital I went for a medical check-up. A place, where I faced a few uncertainties, such as language barrier (Polish) and the unknown specificity of the healthcare system (form of payment, health questionnaires etc.).

Now picture this: Your personal health data, like known allergies, previous prescriptions and diagnosis, history of x-rays taken and so on and so forth – all being accessible for the local medical personnel. This would make things more comfortable for you and the medical staff, wouldn’t it? It certainly would have in my case; I tell you that!

From a patient perspective this primary use of data could be one of the key perks of the European Health Data Space (EHDS) which should promote the safe exchange of patients’ data. On top of that, this will lead to positive outcomes in the secondary use of data, such as enhanced research support, better health policymaking, and flawless digital health services. Additionally, the EHDS plans to regulate the use of artificial intelligence (AI) in the health sector, so that AI-based solutions will help upgrade our healthcare systems towards more sustainability – while helping to address the patients’ unmet needs. Therefore, the EHDS seeks to clarify the safety and liability of AI in health.

Right now, most European member states are at least in the process of adopting their electronic patient health records (German equivalent: elektronische Patientenakte (ePA)) where physicians can find information such as the patients’ allergies, current medication, and previous illnesses. Most EU countries do not give file inspection rights to European patients yet. Next to accessibility, also the question of interoperability of data sets becomes imminent, which is an important aspect for all parts of research and innovation in the medical field. After all, if you have access to the data, you want to use the data and work with that data, so that other people can also interpret your work and the information you provided… and improve the health care for everyone.

Are these amounts of “data” tameable? It depends…

As we know, healthcare is still a member state competence. And due to the fragmented (data-)landscape in the European Union the data – once accessible – may be of divergent quality and complexity, which makes everything even more complicated, especially for your average small medium sized companies (SME). The good news is, that the platform for cross-border exchange of patient data under the EHDS is planned to go operational in 15 Member States by the end of this year. By 2023 24 EU member states (except for Austria, Bulgaria, and Denmark) will be equipped for cross-border patient data sharing (Poland included, hooray!).

Creating an EHDS is an enormous challenge, no doubt. We need a safe area where data is securely stored, accessible, interoperable and of sufficient quality, so it becomes usable for health and research purposes. All of that embedded in a balanced regulatory framework that is in line with our strong European privacy rules for personal data will avoid the wild west in data-driven healthcare.

Overall, the European Commission has a difficult task to master: On one hand the Commission must pay extra attention to master the fine tune between the provision of access to health data to foster innovation for key industries such as the pharmaceutical industry, while on the other hand ensuring digital health data safety for millions of Europeans.

The deadline for the consultation on the European Health Data Space has ended on 26th July 2021. We consolidated and sent the appropriate feedback. Get in touch if you would like to have a chat about it!

Contact: Carl Philipp Gierlich, (BPI office Brussels)