5 things to know about the EU health data space – POLITICO


The European Commission on Tuesday presented its much-awaited health data space, aimed at radically reshaping access to medical data and its use in research and policy.

The legislative proposal will not only change the way patients, doctors, researchers and decision makers access and use health data; the plan is also hoped to result in billions in economic gains. The EU says it will add up to €11 billion over the next 10 years, with half coming from improving data exchange in healthcare itself and the other half from the use of health data in research and policy.

The health data space is the EU’s first sectoral regulation under its 2020 data strategy, but it was the coronavirus pandemic that made it clear 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 mobilized €810 million in funding to build the necessary infrastructure. But more than funding, the plan’s success will hinge on people’s willingness to share their most intimate data — at a time when technology like COVID passes was met with suspicion. We explain everything you need to know about the proposal.

1. Harness the power of block data

The EU is sitting on a potential gold mine. The bloc has treasure troves of health data that could aid in the development of new treatments, lead to better patient care, save doctors and patients countless hours, and help health systems work better.

But to achieve this, data cannot sit and gather dust in paper filing cabinets. It must be organized in such a way that it can be accessed across the bloc, can be easily shared and understood in all 27 member countries, and can be accessed securely by external researchers and organizations.

The situation varies considerably from block to block. In Estonia, a doctor may even struggle to remember how to write a prescription on paper, but in Germany it takes more than 10 years to set up an electronic health record.

2. Simplified cross-border healthcare

The settlement aims to allow a Spanish patient traveling to Italy on vacation to access a prescription at a local pharmacy, or an emergency doctor in France to access basic health information for a Finnish patient. The infrastructure for this already exists in the form of [email protected], but the proposal would see that expanded to include things like lab results and MRI scans. There would also be mandatory interoperability and security requirements. 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, duplicate medical imaging procedures becoming a thing of the past.

However, there are already concerns about increased 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 Regional Authority for Vysočina Region in the Czech Republic and co-chair of the Member States’ eHealth expert. Group.

3. Putting data at the service of research and policy

Health technology companies have criticized Europe’s fragmented digital health market, which prevents them from rapidly deploying their data-driven devices or services or leveraging data to improve them. “Due to different standards and limited interoperability, digital health service providers … face additional barriers and costs when entering the market in other member states,” the senior official said. of the Commission.

To avoid this, the EU aims to put in place a new legal framework. New health data access bodies in EU member countries will assess data access requests and grant permissions for specific purposes. The use of this data for the purposes of commercial advertising, the design of harmful products or the increase of an insurance premium is prohibited.

4. 2025 is a landmark date

Parliament and Council will now examine the plans. The Commission is optimistic that the first results will start to appear in 2025, in particular for the exchange of data in the field of health itself, the [email protected] program. “For the [email protected], we are already working with the Member States. We have pilot projects underway. While we currently have two thirds of the Member States on board, by 2025 we should already have all Member States on board,” said the senior Commission official.

A new European Digital and Health Data Committee will also be set up, chaired by the Commission and composed of digital health authorities and health data access bodies as well as observers. But DIGITALEUROPE chief executive Cecilia Bonefeld-Dahl warns that it is crucial that the board also includes patient organisations, researchers, industry and healthcare professionals, “otherwise there will never be trust necessary”. 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 ensuring that the public has confidence in the security of their data is another. “Citizens must be confident that their health data is properly protected,” reads the text. This raises the question of how the plans work with EU data protection rules, the General Data Protection Regulation.

The GDPR opened the door for individuals to control their health data, but it was not enough, admits the text: “Today, individuals face challenges in exercising their right to control their data. of health…despite the relevant rules provided by the GDPR.”

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

The EU claims to have strong ‘safeguards’ in place – health data access bodies only grant permits for specific purposes, and data processing can only take place in ‘secure’ environments “.

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