Connect with us

Hi, what are you looking for?

Technology

5 things to know about the EU’s health data space

The European Commission on Tuesday presented its much-anticipated health data space, aiming to dramatically reshape access to medical data and its use in research and policy. 

The legislative proposal won’t only change how patients, doctors, researchers and policymakers access and use health data; it’s also hoped the plan will lead to billions in economic gains. The EU claims it will add up to €11 billion over the next 10 years, with half coming from improved data exchanges in health care itself, and the other half from the use of health data in research and policy. 

The health data space is the EU’s first sector-specific regulation under its 2020 data strategy, but it’s the coronavirus pandemic that has made clear just how important health data is. What emerged from the crisis was a vision for a European Health Union, with the data space forming the “backbone” of that health union, Health Commissioner Stella Kyriakides said on Tuesday. 

The EU has lined up €810 million in funding to build the necessary infrastructure. But more than funding, the success of the plan will depend on people’s willingness to share their most intimate data — at a time when technology like COVID passes was greeted with distrust. We take you through all you need to know about the proposal.

1. Harnessing the power of the bloc’s data

The EU is sitting on a potential goldmine. The bloc has troves of health data that could help in the development of new treatments, lead to better care of patients, save doctors and patients countless hours, and contribute to better-functioning health systems. 

But to achieve that, the data can’t sit gathering dust in paper binders. It needs to be organized in such a way that it is accessible across the bloc, can be easily shared and understood in all 27 member countries, and can be safely accessed by external researchers and organizations. 

The picture varies dramatically across the bloc. In Estonia, a doctor may have trouble even remembering how to write a paper-based prescription, but in Germany, it’s taken over 10 years just to implement an electronic health record.

2. Easier cross-border health care

The regulation aims to make it possible for a Spanish patient traveling to Italy on holiday to access a prescription in a local pharmacy, or for a doctor in an emergency room in France to access a Finnish patient’s basic health information. Infrastructure for this already exists in the form of [email protected], but the proposal would see this expanded to include things such as lab results and MRI scans. There would also be mandatory requirements on interoperability and security. Patients would have access to this health data “immediately, free of charge, [and] in an easily readable format,” said a senior Commission official. 

Kyriakides argued that this will save money in addition to lives, with, for example, duplicated medical imaging procedures becoming a thing of the past. 

However, already there are concerns about more EU control over this infrastructure. The fear is that countries could be stripped of their decision-making role, making them mere consumers of the service, said Klára Jiráková, IT project coordinator and lawyer at the Czech Republic’s Vysočina Region Regional Authority and co-chair of the eHealth Member State Expert Group.

3. Putting data to work for research and policy

Healthtech companies have slammed Europe’s fragmented digital health market — which impedes them from quickly rolling out their devices or data-driven services or tapping into data to improve them. “Due to different standards and limited interoperability, the providers of the digital health services … face barriers and additional costs when entering the market of other member states,” the senior Commission official said. 

To avoid this, the EU aims to put in place a new legal framework. New health data access bodies in the EU’s member countries will evaluate data access requests, and grant permits for specific purposes. The use of such data for commercial advertising, designing harmful products or increasing an insurance premium is prohibited. 

4. 2025 is a milestone date

The Parliament and Council will now look into the plans. The Commission is optimistic that the first results will start to show in 2025, especially for the exchange of data in health care itself, the [email protected] program. “For the [email protected], we’re already working with member states. We have pilot projects on the way. Whilst we have two-thirds of the member states on board at the moment, we should by 2025 already have all member states on board,” the senior Commission official said. 

A new European Digitial and Health Data board will also be set up, chaired by the Commission and consisting of digital health authorities and health data access bodies as well as observers. But DIGITALEUROPE’s Director General Cecilia Bonefeld-Dahl warns it’s crucial that the board also includes patient associations, researchers, industry and health care professionals, “or there will never be the trust needed.” On Tuesday, Kyriakides clarified that there would be patient representatives on the board.

5. Privacy and security will be key

Building the infrastructure is one thing, but getting the public to trust that their data is safe is another. “Citizens must be confident that their health data is adequately protected,” the text reads. It raises the question of how the plans work together with the EU’s data protection rules, the General Data Protection Regulation.

The GDPR opened the door for individuals to control their health data, but it wasn’t sufficient, the text admits: “Today, individuals face challenges in exercising their right to control their health data … despite the relevant rules laid down in the GDPR.”

The GDPR requires consent, which is not relevant and can even be cumbersome in some cases, like for research purposes. “A lot of data is anonymized or pseudonymized data. So, it’s not really directly relevant at that point to talk about individual consent,” the senior Commission official said. 

The EU claims to have put in place strong “guarantees” — health data access bodies grant permits only for specific purposes, and processing data only can happen in “secure” environments.

This article is part of POLITICO Pro

The one-stop-shop solution for policy professionals fusing the depth of POLITICO journalism with the power of technology


Exclusive, breaking scoops and insights


Customized policy intelligence platform


A high-level public affairs network

Click to comment

Leave a Reply

Your email address will not be published.

You May Also Like

Europe

Having settled in Brussels after three decades reporting about the broader Middle East, Hugh Pope is preparing for publication “The Keys to Democracy,” a...

Europe

Canada has targeted media tycoon Alexander Lebedev as part of a wave of fresh sanctions against Russian oligarchs, in a move that places greater...

Europe

Australian Labor Party leader Anthony Albanese will be the country’s new prime minister, following incumbent Scott Morrison’s failure to win enough seats for the...

Europe

Moldova’s defenses should be bolstered to help guard against Russian President Vladimir Putin’s vision for an expanded Russia in Eastern Europe, U.K. Foreign Secretary...

Europe

The G7 member countries agreed Friday to ramp up their capabilities to fight future pandemics. “This pandemic will not be the last. We have...

Europe

Press play to listen to this article The pivotal meeting in the global health calendar starts Sunday with representatives from health ministries around the...

Europe

Portuguese Prime Minister António Costa arrived in Kyiv on Saturday morning, where he will sit down with Ukrainian President Volodymyr Zelenskyy to talk about...

Europe

Polish officials are preparing a letter asking the European Commission to redraw its current coronavirus vaccine procurement agreements after an informal meeting of health...