Healthcare industry fears mount over this week's vote on tougher EU data protection rules
Just ahead of a crucial European Parliament vote this week on new data protection rules, an industry-led coalition of organisations claiming to represent "citizens' interests" on Monday underlined the risks to healthcare and health research that it sees in some of the proposals.
As part of a major overhaul of 19-year-old data protection laws, the EU is aiming to give people control over their personal data and to tighten safeguards for data transfers to non-EU countries. MEPs will debate the proposal on Tuesday, and vote on Wednesday.
The text of the new rules could jeopardise innovation in large disease databases, personalised medicine, medical imaging, e-health, mobile health, human genome decoding, disease prediction, biobanks, and biomarkers, said the Healthcare Coalition on Data Protection in a statement.
These "rely on the collection, analysis, and sharing of health data to better understand diseases and treat them as part of an efficient and effective healthcare system".
The grouping, which includes the European Federation of Pharmaceutical Industries and Associations, other associations representing the medical devices, radiology, e-health and hospital sectors, as well as academics, said it is "supporting citizens' interests in the benefits of data driven healthcare in a secure environment".
It argued that access to and sharing of data is crucial for the healthcare delivery and quality. "Not only is data fundamental to responding to patients' needs, but it also helps in defining public health policy development and improving patient care", it said.
Elements in the proposed rules "will restrict the sharing of health data, create legal uncertainty and increase compliance costs if they remain unchanged", said the coalition.
MEPs have "not found the right balance" and have "failed to appreciate the benefits of properly-regulated data-sharing". The text they are proposing "would make much valuable research involving personal data at worst impossible and at best unworkable."
In particular, the new rules should recognise that safeguards to protect data subjects "are already in place", and should "avoid additional, potentially disproportionate or contradictory requirements."
The coalition wants exemptions for processing data for healthcare and research to be clarified and reinforced, with a clear legal basis.
It also wants explicit recognition that identifiable and pseudonymised (disguised identity) data - which face a ban on transmission - are essential to the delivery of healthcare and health research.
It should be possible for pseudonymised personal data for health or research to be transferred between EU countries and beyond, to countries with safeguards in place to prevent re-identification.
"Research increasingly builds upon international cooperation, such as in large-scale trials that may need several thousands of records", said the coalition.
There must also be "an unambiguous exemption from consent for the processing of personal data for health and research purposes where appropriate safeguards are in place", the coalition added.
The secondary use of health data for research should be permitted where this is not incompatible with the purpose data were collected for, and where appropriate safeguards protect the interests of data subjects.
In the context of a debate that has focused largely on allowing individuals to delete personal information they have put onto social networks, the coalition is looking for exemptions to this 'right to be forgotten' in relation to health.
"Deleting data may run counter to individual treatment and patient safety, as well as to the validity of research", it argued.
There should also be a similar exemption in relation to health data that would prevent individuals exercising the right to rectification.
Separately, Denis Horgan, director of the European Union Alliance for Personalised Medicine, told APM on Monday that his members had similar concerns over the vote.
"Health research is already regulated by a robust framework", he said. "It is crucial that the regulation takes account of these safeguards and procedures", so that the legal environment "promotes the interests of data subjects while providing EU citizens with better healthcare resulting from advances made by the health sciences."
He added an economic consideration. "The EU must remain a viable and globally competitive location for health research to capitalise on economic benefits of research that include more efficient healthcare systems and healthier citizens and the promotion of innovation and growth".
The Wellcome Trust has also said "health and scientific research will be severely threatened" by the proposed changes. Its statement is supported by around 50 scientific organisations in the healthcare sphere.