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New draft regulation on health data by the EU Commission – what you need to know

This week, the European Commission will publish a draft regulation on a subject important to us all—health. In this blog, I look at some of the changes included in the proposal.


Markus Kalliola

Project Director, Health data 2030


European integration is advancing at different speeds. There is steady long-term progress, but also rapid developments in leaps and bounds. In the economy, the euro single currency and the introduction of the IBAN payment standard made such a leap visible to us all. An analogous example would be the removal of roaming charges in the telecoms market. In health policy, nothing similar has happened so far, at least not to any significant extent.

This week, however, the European Commission will publish a legislative proposal titled the European health data space, which aims to bring about a major change in the way health data is handled and thus concerns us all.

I agree that health data space has an odd ring to it, even though I have spent over a year coordinating the joint TEHDAS project of 25 European countries and in support of the draft regulation. Despite its name, the proposed legislation will consist of very everyday matters. Well, this isn’t entirely true. It consists of many things that are not evident in daily life, but also everyday things.

These are the five things you should know about the Commission’s draft regulation:

  1. Better healthcare when you travel
    When you travel south in the summer and get food poisoning from a carelessly washed salad, you’re likely to end up seeing a doctor who doesn’t speak Finnish. The health data space means that the doctor can look at your Finnish medical records in his or her own language and give you better treatment that factors in your past medical conditions or medications.
  2. Medication from pharmacies in any EU country with an electronic prescription
    “I swear I put them in here.” Except you didn’t. You left your vital prescription medication at home after hastily departing on a long-awaited business trip. No worries. The European health data space allows you to get the prescription issued in your home country for use in pharmacies in other EU countries.
  3. Data helps develop healthcare
    Uber revolutionised the taxi industry, Airbnb the travel industry and courier services our food culture. We haven’t seen a similar transformation in healthcare. One reason has been the difficulty of making use of health data. Nowadays, innovation is largely driven by data, but health data lies unused in information systems.

    The health data space will create common rules for EU countries on how health data can be used for both scientific research and innovation. So it may be that in the future the health app on your phone, your prescription medication, or the vaccine you took was developed using the health data space.
  4. Jobs and growth
    Europe’s well-functioning and efficient internal market is the engine of growth, ensuring growth and jobs also here in Finland. The European health data space will strengthen the interoperability of information systems and applications in healthcare especially. This means that systemic differences between countries will decrease and the same software will be easier to sell throughout Europe. For Finnish companies, this development will open up a wider market and, as a pioneer of digitalisation, we can expect a significant share of the total market.
  5. Standards for the quality of health data
    The increase in the amount and availability of health data are key elements in all the issues mentioned so far. For health data to be used for innovations that benefit us all, it must be of high quality. For instance, to develop artificial intelligence apps and training algorithms we need top quality data. The European health data space defines standards for data quality. This in turn will make data of higher quality for the health professionals, researchers and companies that use it.

And there is much more to come. Despite all its possibilities, the passage of the Commission’s draft legislation is not a foregone conclusion. I won’t go into the key points of controversy here, but there is a debate going on in Europe right now about such fundamental questions as which article of the EU Treaty the forthcoming legislation is based on. The executive power of the EU in this matter can be directly derived from this, in addition to how far the harmonisation of health data use can be defined. I broached this topic in The European Files.

You can follow the discussion on the future of EU health policy in English by subscribing to the TEHDAS newsletter or the Reilun datatalouden uutiskirje in Finnish. It’s also worth following @tehdas on Twitter. And you can come and meet Sitra’s experts at the HIMSS Europe event in Helsinki in June. See you there!

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