This article is part of our special report Diabetes in the EU between awareness and access to care.
Diabetes patients will be among the beneficiaries of the much-awaited European health data space, according to policymakers and health stakeholders.
In the coming months, the European Commission will seek to create a trustworthy, patient-centred EU’s health data space – a cornerstone of the European Health Union plan to reshape the way health is dealt with across the EU.
Expectations are high for this upcoming legislative proposal which promises to unlock the potential of digitalisation in improving hospital systems and enabling patients to have access to better care.
Among the main beneficiaries could be people with diabetes, a disease which one in ten Europeans suffer from and is envisaged to affect 80 million Europeans by 2045 if proper measures to tackle it are not undertaken.
For the Croatian Christian-democrat MEP Tomislav Sokol, diabetes is one of the biggest public health problems and the EU could address via the European health data space.
“We are putting pressure on the Commission to come up with a concrete legislative proposal [on health data space],” he said at a recent event, adding that amendments in the European Parliament will improve the initiative by making the data space a reality for diabetes patients too.
At the same event, the health data space was put in correlation to diabetes registries by Andrzej Rys, deputy director-general at the Commission’s DG SANTE. “We believe in the ambition we really should bring digital health to the 21st century,” he said.
Digitalisation of registries
Despite the lack of proper competencies on health, the EU can still support the harmonisation of healthcare standards across the bloc and support member states in achieving their healthcare objectives.
“The use of data in the area of healthcare is one of those areas where the EU can – and I believe will – provide an added value,” said MEP Sokol.
With the health data space proposal, the EU executive will try to simplify the exchange of and access to health data for different use cases, including healthcare provisions, digital health services and research.
“This includes the quality of registries and electronic health records. We very strongly support accessible medical devices as well as the use of smartphones and other IoT devices,” said the Commission’s Rys.
For the Commission, electronic health records, strictly in line with the GDPR rules, will help improve access to quality care, achieve cost-effectiveness of care delivery and contribute to the modernisation of health systems.
National and even sub-national diabetes registries are used mainly for surveillance, clinical management or improving the quality of care and they could benefit from digital automatisation.
However, the proposal will raise the problematic issue of secondary use of health data, meaning the way data created and registered for health services or related activities can be used for purposes other than the reason for which they were originally collected.
“We would like to increase access and security of primary data but on other hand, we have also the secondary health data which we believe should be more accessible,” said Rys.
The re-use of health data as secondary data poses problems because of the fragmented digital infrastructure, but also because there is still uncertainty on artificial intelligence (AI) liability in health and there are limited provisions of data for training AI.
Cross-border health data portability and the possibility to enjoy the benefits of the health data space across all member states is another important topic that needs to be addressed by the Commission.
“The EU can do what it can to remove obstacles to this cross border use of data,” said MEP Sokol, mentioning the need for cross-border clinical trials and research as well as the use of European reference networks.
Automatisation and access
According to Rys, automatisation is another key area in increasing the quality and access to data.
Likewise, Robert Heine, executive medical director for diabetes at the pharmaceutical company Ely Lilly, said that health data need to be collected automatically in order to have the double benefit of giving patients access to data and reducing the burden on the healthcare system.
“I don’t think we can ask people to enter data manually anymore. This also should ensure a higher quality of data collection,” he said.
However, access to care and, in particular, lack of diagnosis and treatment remain the thorniest problems when it comes to diabetes, according to Bente Mikkelsen, director of WHO’s department for non-communicable disease.
“Globally, we know that 50% of people with type-2 diabetes who need insulin don’t get what they need. And this happens 100 years after the discovery of insulin,” she said.
[Edited by Benjamin Fox]