Pharmaceutical and health groups say opt-out could undermine use of data for research
Drug companies and other industry and health groups have raised concerns about what they say are changes to plans for a proposed European Health Data Space, to enable people to opt out of sharing their data for purposes including research.
In 2022, the European Commission put forward a proposal to create the EHDS to make it easier for people to control their health data and for such data to be used for secondary purposes including research, innovation and policymaking.
But according to organisations including the European Federation of Pharmaceutical Industries and Associations, EU policymakers have been discussing plans for an opt-out mechanism, whereby citizens could prevent their data from being used for secondary purposes.
Efpia and 31 other organisations including disease associations and research infrastructures released a statement on 6 June expressing concerns about the new plans.
Risk of bias
“Any form of opt-in or-opt out mechanism would introduce the real risk that data bias will form part of the EHDS from its inception and thus undermine its principal value for secondary-use research purposes,” the statement said.
It added that it is “fundamental” to the success of the EHDS—which is intended to be comprised of rules, common practices, infrastructures and a governance framework—that multiple and complete data sets be included.
The data should be representative of European citizens and their demographic, ethnic or socio-economic backgrounds, the statement said.
According to the groups, there is a “substantial risk” that use of the EHDS for research purposes will be undermined because there are challenges in including certain populations, including ethnic and deprived groups, in health datasets.
They added that many healthy citizens have little interest in providing health information.
Next-best solutions
While the groups expressed their support of the original EHDS proposal, without an opt-out clause, they said that if opt-out plans do go ahead, a full impact assessment of the mechanism should be carried out as soon as possible to understand its implications and to inform implementation.
Such an opt-out should have “a limited but well-defined, consistent and transparent scope”, and should be routinely monitored, the organisations said.