Federal Minister of Health Karl Lauterbach’s plan to convert the electronic patient file (ePA) to an opt-out principle has faced a setback. The plan also involved giving doctors and scientists broad access to the digital archive, including doctor’s letters, reports, and prescribed medication. However, the majority of Germans want their consent to be taken before providing access to their sensitive health data.
A representative survey by the Ipsos Institute, published on Thursday, revealed that 58% of Germans believe doctors should only have access to their electronic patient registers if they have given their express consent. Only 18.8% want automatic access for researchers, while 47.8% pushed for general approval, and 25.8% favored an opt-in for each specific research project.
The situation is similar in France and Spain. However, in Estonia, 25% more citizens are in favor of their health data being released automatically for research purposes.
Many experts debate whether an opt-out is sufficient to ensure privacy in the healthcare sector. Former Federal Data Protection Commissioner Peter Schaar recently pointed out that the instrument of consent is not effective. “In view of constant reports of hacks and leaks of confidential patient files, every citizen must be able to decide for themselves whether they want an electronic patient file and which treatments should be listed there,” counters MEP Patrick Breyer (Pirate Party).
The Green Group, which Breyer has joined, has submitted numerous amendments to the EU Commission’s proposal for a European Health Data Space (EHDS) to the EU Parliament. The amendments demand sufficient safeguards to ensure a high level of data protection and security, including the option for citizens to opt-out of all or selected healthcare professionals registering their EHRs in a centralized system. In principle, the release of health data for research purposes should only be possible with explicit consent.
