Having drilled the first bolts of its ambitious EU health agenda, the European Commission is now called to the challenging task of creating a trustworthy, patient-centred European health data space.
Expectations are high for this cornerstone of health digitalisation that will seek to make good use of healthcare data for research and innovation, but also for policymaking and regulatory purposes.
In 2021, the Commission is planning a legislative initiative that will be part of the European Health Union, which is intended to reshape the way health is dealt with in the EU.
Investments in the European health data space will be supported by the newly established EU4Health programme, as well as common data spaces and digital health-related innovation under the Horizon Europe and the Digital Europe programmes.
A peek at this new data ambition was included in the recently unveiled pharmaceutical strategy that included a strong push for digitalisation, and artificial intelligence, which the Commission considers key to improving prevention and diagnosis as well as for the discovery and development of new medicines.
One important way of doing this is by ensuring access to health data through an “interlinked system that gives access to comparable and interoperable health data from across the EU,” the pharmaceutical strategy says, pointing to the upcoming legislative proposal on a European health data space.
“The idea is to strengthen interoperability to strengthen portability,” said Ioana-Maria Gligor from the Commission’s Directorate-general on Health (DG SANTE) at a recent EURACTIV event.
She added that for citizens and patients this will mean, for instance, they can bring their data when moving from one healthcare provider to another without doing the same test over and over again just because the data is not available to another healthcare provider in electronic format.
Gligor added that the Commission is working on four main pillars of this much-awaited European health data space, namely on governance, legislation, infrastructure and capacity building for member states.
A ‘house’ for health data
For Maltese socialist MEP Alex Agius Saliba, raising awareness about data sharing in the healthcare sector is a priority since the COVID-19 crisis has shown a lack of unity and coordination among European health systems, which also shed light on the benefits of better sharing and use of health data.
“The time has come for a European health data space to enable health data exchanges, strengthen also cooperation across member states and promote research and innovation in this area,” he said.
“I don’t see the European health data space as a closed infrastructure but rather as a house,” said Nick Schneider, head of the division on data use at the German federal ministry of health.
As a common space, a house offers different rooms for different circumstances, he continued. “So, there’s going to be a room for patient access to data, a room for healthcare professionals on how to exchange data, as well as for other stakeholders and policymakers.”
But the key challenge is balancing the needs of these different users and actors in the system, including healthcare providers, researchers, private companies, and policymakers, while simultaneously protecting citizens’ data.
The GDPR has provided a legal framework for processing health data, including across borders. However, with health being a national competence, there remain many different national rules that make health data sharing across EU borders challenging.
Secondary use of data
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.
But this raises the thorny issue of secondary use of health data, meaning the way data created and registered for health services or activities can be used for purposes other than the reason for which they were originally collected.
Last week, Alphabet’s Google won EU antitrust approval on Thursday (17 December) for its $2.1 billion bid for Fitbit, the US company leader in the manufacture of wearable devices such as smartwatches and fitness trackers, after agreeing on restrictions on how it will use customers’ health-related data.
Specifically, Google had to assure the EU merger authority that all health data collected by Fitbit are not used to target ads to EU users.
The Commission has launched a joint action that will begin next year on sharing best practice looking at the governance models on the secondary use of health data.
In Finland, the company Findata promotes secondary use of health and social data operating within the national institute for health and welfare, but as a separate entity,
The main task of Findata is to collect and coordinate data received from different registers and provide services related to data utilisation and knowledge.
The Commission wants to engage with stakeholders to develop codes of conduct for secondary health data use, a process that it is encouraged by the ‘All Policies for a Healthy Europe’ coalition to facilitate greater trust in increased health data sharing.
[Edited by Benjamin Fox]