EU governments gave the green light yesterday to the creation of an EU Health Data Space (EHDS) which would interconnect patient data across Europe. In the meantime, lawmakers have yesterday submitted amendments to give patients a right to object to the collection of their personal health data in the new Data Space, and to ensure that patients retain control over their health data.
Firstly, 70 MEPs from S&D, Renew, Greens and Left request the following should be added to the Regulation: “Member States may provide for natural persons to have the right to object to the registration of their personal health data in an EHR system.” “Compulsory electronic health records for every citizen that are accessible across Europe would entail irresponsible risks of data theft, hacking or leaks of the most personal treatment data. It would deprive patients of any control over the collection of their illnesses and disorders,” warns Breyer. “This is nothing less than the end of medical confidentiality. Have we learnt nothing from the international hacker attacks on hospitals and other health data? If every mental illness, addiction therapy, every potency weakness and all abortions are collected in a remotely accessible data space, worried patients risk being deterred from urgent medical treatment – this can make people ill and harm their families! In the European Parliament, I will fight to give patients a choice over the collection of their health data.”
Other amendments tabled yesterday by Breyer and other MEPs concern the plan that patients would need to actively object in future in order to prevent healthcare providers and industry from accessing their treatment records. “Citizens should at least be asked orally whether they wish to object to the lifting of medical confidentiality,” explains Breyer the amendments. “For many patients who have little time or limited language skills, and for the elderly, a complicated written or electronic procedure is too burdensome to give them a real choice. International standards such as the International Code of Medical Ethics of the World Medical Association or the Helsinki Declaration on the Ethical Principles of Medical Research have so far required that the patient’s consent be obtained before their medical data is disclosed. A public opinion poll we commissioned confirms that people expect to be asked for their consent before their health data is shared. Every website asks us for consent before setting a cookie, but we shouldn’t even be asked before our health records are shared? This doesn’t effectively keep patients in control of their data.”
The EU’s Health Data Space bill is intended to oblige doctors to enter a summary of each patient’s treatment into an interconnected system (Article 7). Exceptions or a right to object are not provided even for particularly sensitive diseases and therapies such as mental disorders, sexual diseases and disorders such as impotence or infertility, HIV or addiction therapies. Patients whould only be able to object to access to their electronic patient file by other healthcare providers or industry. How this right could be exercised would be up to every Member State. According to a survey by the European Consumer Organisation BEUC, 44% of citizens are concerned about the risk of theft of their health data; 40% of citizens fear unauthorised data access.
Next Tuesday, the plenary of the European Parliament is to vote on final amendments to their negotiating mandate. The first round of negotiations between the EU Council, EU Parliament and EU Commission is due to take place as early as next Thursday. The rapporteurs want to finalise the negotiations before the 2024 European elections.