The European Health Data Space (EHDS) will be a home for the data of patients across Europe. A draft of the regulation, which was leaked last week, said the system would promote the transfer of data across borders, supporting both delivery of care and research and innovation. A communication accompanying the draft proposal stated that digital transformation of healthcare was essential, “to support long-term competitiveness and innovation within the EU’s medical industry, and to help the EU recover from the pandemic.”

Patient groups have been watching these developments keenly. “In the long term, patients can expect that the European Health Data Space will improve their quality of life by driving improvements in the quality of care they receive in the EU Member States,” said Petra Wilson, senior advisor, European Health Policy & EU Affairs, HIMSS. “Shorter term … patients can expect to be able to have much better access to and control of health data that concerns them.”

For the rare diseases community in particular, the sharing of data at a population level holds promise. “The logic of Europe of doing anything in health is blindingly obvious for rare diseases,” said Tamsin Rose, a senior fellow for health at the Friends of Europe.

A potential generator for scientific innovation

This pooling of data is likely to benefit patients with rare conditions, some of which occur so infrequently they are called syndromes without a name, or SWANs. “For rare diseases obviously you want the absolute maximum amount of data flowing, and you also want the maximum of access by researchers,” Rose explained.

Friends of Europe recently published a report about the potential of the EHDS to revolutionise care for rare diseases, arguing that not only could rare disease patients benefit from the EHDS; they could also offer lessons from their experience. European Reference Networks (ERNS) were set up in 2017 to facilitate the sharing of information about these rare conditions; but inadequate funding meant they sometimes struggled to reach their potential, Rose said.

The cost of creating clean, robust and comparable data is often under-estimated, Rose said. With the ERNs, “There wasn’t enough being allocated to data, and data services, data management, data collection, data architecture – I think that’s key.”

Complexity of cross-border care

Indeed, harmonising data collection across Europe’s many diverse healthcare systems will require investment from member states, Wilson observed. The EHDS’ biggest challenge, “is to achieve its ambitious target of implementing a fully integrated and interoperable electronic health record system across the EU within a year of the regulation entering into force.”

In addition, the system will have to balance ethical questions about privacy and patient consent with the need to give researchers access to data and encourage scientific investigation. One difference between rare disease patients and other citizens is in their willingness to share data that might accelerate research and innovation— “to go further and faster than the general population,” said Rose. There is a concern within the rare disease community that their interests may be lost, or diluted, within a bigger system.

But Rose said that the community is optimistic. “They’re desperate for this to work and to work well, for the most ambitious forms of sharing to develop.”

“For rare diseases it’s like finding a needle in a haystack. You’ve got to create the haystack to be able to find where the needle is.”