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Brussels’ penchant for bureaucracy could trip up its ambitious plan to transform the sharing of the bloc’s highly valuable health data.
No one would fault the Commission’s ambition for the European Health Data Space: to save lives by making it easier to share patient information across the bloc and for this data to be used to develop new treatments. But, as the Commission prepares to present its strategy on May 3, there are concerns that the extensive legislative proposal could overcentralize decision-making in Brussels and impose a heavy compliance burden on countries.
Broadly, the proposal has two threads: governing how health data can be shared between countries for direct patient care and then using this data to inform research and policymaking.
It’s not entirely new. In fact, a version of the health data space already exists, with several EU countries sharing health data since 2019. During this time, a community of national experts has emerged who have worked to convince policymakers, hospital managers, GPs and government officials that implementing painstaking legislative and technical changes will ultimately benefit patients. A pilot project to test the centralized sharing of health data for research and policymaking is also in the works.
POLITICAL spoke to people working on these projects in several countries. While hopeful that the Commission’s legislative proposal would be beneficial, they expressed fears that Brussels would impose a one-size-fits-all bureaucracy that could make their work harder rather than easier.
The concern is that member 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.
“I understand the Commission’s motivation… they want the rollout to be faster,” said Jiráková. “But I think they kind of are failing to understand what it takes inside member states to make sure that everybody’s behind you.”
The European Health Data Space plan, first announced in September 2019, was originally meant to land in late 2021, but has faced a series of delays. Now, the Commission finally appears ready to present the proposal.
In the background, the EU has been working for years on enabling the exchange of health data across borders. The awkwardly named [email protected] has been live in several EU countries for three years already, enabling the exchange of e-prescriptions and patient summaries between two countries.
Practically, it means that a doctor treating a Portuguese patient who presents in an emergency room in Prague can access the patient’s basic health information. Also, an Estonian patient stuck in Helsinki in a COVID-19 lockdown would be able to obtain their prescription medication at a local pharmacy.
As for the use of health data for research, a new pilot will soon be launched to connect national infrastructure, research agencies and data platforms in a system that would be made available for research purposes.
But the Commission believes that previous voluntary efforts have left the effectiveness and efficiency of the data sharing “rather limited.” The fact that only a handful of countries have taken part is “resulting in [a] fragmented landscape and uneven access to and portability of health data, “the Commission argued in a leaked text obtained last month by POLITIC.
The solution, according to the Commission, is to lay down specific rules, rights and obligations around accessing and exchanging health data across borders “with a governance structure ensuring coordination of specific responsible bodies at EU level.”
The Commission did not respond to a request for comment.
There’s no arguing it’s taken a long time and that only the digital front-runners are on board. But that’s because it’s been a monumental task.
In the Czech Republic, for example, there is no central storage of patient summaries. That means that before a patient’s file can be shared with a neighboring country, each and every health care facility needs to be connected to a central system. And that process is complex and labor-intensive.
Even when data is centralized, as in Finland, the process can be difficult. The Nordic country is already sharing e-prescriptions, and now hopes to start sharing patient summaries in 2023 and receiving them in 2024. What’s made sharing patient summaries harder is the ever-present problem of interoperability. With some of the coding systems in Finland being very different to those used elsewhere in Europe, they need to be mapped onto one another – a process that takes time.
The fear is that, to comply with the new legislation coming from Brussels, countries will need to do extensive work to ensure that it is fully applied in their national context – further straining already stretched staff.
The Commission has set a 2025 deadline for most countries to be up and running with [email protected] That same year, the system for the reuse of health data should be piloted and operational. With countries like Germany still struggling to roll out e-prescriptions, that target looks ambitious.
Aurora Ursula Joala, adviser on e-services development and innovation policy at the Estonian Ministry of Social Affairs, acknowledges that the speed at which digital COVID certificates were implemented shows that, if a country is really motivated, “everything is possible.” But she is also a realist – “in Europe sometimes things take a bit more time.”
Aside from the technical challenges, what’s been most important is convincing the numerous players – politicians, doctors, hospital administrators and IT technicians – to get on board.
In Estonia, the world’s most advanced country for digital health, such services have been in development since the turn of the century. The impetus behind the success of this work, said Joala, is that “the political will has always been there.”
It’s a similar story in Finland. “When it comes to politicians, I think that they have been a driving force along with our government officials,” said Kimmo Rissanen, lead product owner at Kanta Services, the entity that manages Finland’s digital health care services. “They have been very positive from the beginning. And that’s probably why we are kind of pioneers. ”
The first two years of [email protected] in the Czech Republic were what Jiráková called “internal marketing.” This involved extensive explaining to politicians, lawyers, and hospital officials about the benefits and how it will work. Only now, with decision-makers on board can “we can concentrate on the technical, semantic and organizational side of things.”
Among the early adopters, a community of sorts has formed. Rules may be amended if a country can’t comply, exceptions are granted and support is readily available. That’s not to say Brussels is removed from the process, but rather that what’s driving the success or failure of the project is the expertise developed in member countries.
While Rissanen agreed that legislation from the Commission may be needed, “it’s another thing what the legislation says must be done.”
“There is a lot of expertise in all European countries, and it’s not only in Brussels,” he said. “We need to work together. It’s not Brussels alone that makes this thing work. “
Pieter Haeck contributed reporting.
This article is part of POLITICIAN Pro
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