In September 2020 European Commission President Ursula von der Leyen announced a new legislative proposal to create a ‘European health data space’. Eighteen months later, the Commission published a draft regulation setting up a health data space.
According to the Commission, the European health data space will:
- Promote safe exchange of patients’ data (including when they travel abroad) and citizens’ control over their health data;
- support research on treatments, medicines and medical devices;
- encourage access to and use of health data for research
- support digital health services; and
- clarify the safety and liability of artificial intelligence in health.
Of course, we welcome legislation that helps to provide better access to health data for citizens, especially citizens with disabilities who may encounter accessibility barriers when trying to access their health records. We were therefore pleased to see that there is reference to the European Accessibility Act in the proposed regulation.
Better access to health data but concerns over consent
However, there are other aspects of the proposed regulation that are causing concern, in particular the way the Commission proposes to give access to patients’ health data to researchers, innovators, public institutions, and industry. This is known as ‘secondary use’ of health data.
The problem is that the Commission proposes to force doctors to hand over their patients’ health data to digital health authorities without the explicit consent of these patients. This would severely compromise trust between patients and their doctor. It would also undermine doctor-patient confidentiality, as well as the reasonable privacy expectations all EU citizens have when they speak to their doctor.
Concerns about privacy and data protection
Organisations of doctors and patients, as well as public institutions, have raised concerns about the implications of forcing doctors to hand over health data without their patients’ consent.
As well as potentially damaging trust between a patient and their doctor, there are many reasons why this proposal could create significant risks for patients with disabilities, not least because anonymization of personal health data can never be guaranteed.
We are also concerned about the range of data that would be considered ‘health data’ under the proposed regulation, as this goes far beyond health data used to treat patients and could include information about their lifestyle, health insurance status, professional status, education, income or even behaviour.
What are we doing about this?
We know that some patients will be happy to give access to their health data for secondary use, but others will not. We believe that all patients should be able to make an informed decision about how their personal health data will be used.
Together with other EU organisations we have therefore been advocating for patients to be in control of who has access to their data. We also co-signed an open letter to EU legislators urging Members of the European Parliament (MEPs) and ministers to uphold the rights of patients in the European health data space.
The draft regulation is still being discussed in the European Parliament and in Council. We asked MEPs directly involved in negotiations to protect patients with disabilities and we will continue to work with other organisations to ensure that our concerns are taken into account.