Lauterbach plan: patient data for industry – partly without right of objection

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Deutschland Lauterbach plan

Patient data for industry – partly without right of objection

Source: Amin Akhtar/WELT; Luis Alvarez/Getty imagesMontage: infographic WORLD

According to the Minister of Health’s plan, data from the electronic patient file should also be made available to the research industry – for example to prevent pharmaceutical companies from moving away. In some cases, patients cannot object. Two lawsuits are already pending.

NAfter a long standstill, Federal Health Minister Karl Lauterbach (SPD) wants to decisively advance digitization in the healthcare system with two laws. On Thursday in Berlin he outlined the cornerstones of the planned draft legislation.

This should be the case by the end of 2024 electronic patient record set up for all those with statutory health insurance and at the beginning of the year the e-prescription will become a “binding standard”. It is also planned that in the future more patient data will be collected, linked and made available to research and the research-based industry. Among other things, this is intended to prevent pharmaceutical companies such as Biontech migrate to other countries.

Lauterbach wants to accelerate e-patient files and e-prescriptions

Federal Health Minister Karl Lauterbach wants to significantly accelerate the sluggish spread of digital applications for patients. Germany’s healthcare system is decades behind in digitization.

But in addition to plenty of praise for the ambitious Minister’s plans serious concerns and criticism are raised. On the one hand, these relate to the “opt-out” regulation for electronic patient files, which had been discussed long beforehand.

This provides for the data of each patient to be automatically saved on the card, provided that the patient does not actively object beforehand. “The citizens must not be deprived of control over their medical information,” warns Eugen Brysch, head of the Patient Protection Foundation. “Because silence does not mean consent.” The Federal Data Protection Commissioner Ulrich Kelber had previously expressed concerns about the objection solution.

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Federal Health Minister Karl Lauterbach (SPD)

Pressure on Minister of Health

In addition, some quarters have complained that the research industry – such as pharmaceutical companies – will in future be allowed to use patient data for their own purposes. Companies can apply to the research data center of the Federal Institute for Drugs and Medical Devices for use.

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“The fact that sensitive health data should also be passed on to industry without the patient’s active consent massively jeopardizes trust in the electronic patient file and the health system,” complains Kathrin Vogler, spokeswoman for health policy for the left-wing parliamentary group in the Bundestag.

Data that may be stored for up to 30 years

Another aspect of the legislative plans is particularly piquant: In addition to the data from the electronic patient file, the use of which citizens can object to, other health data are apparently also to be made available for the research industry – but without the citizens being able to veto beforehand.

This refers to the billing data of the statutory health insurance companies, which have been stored centrally in the research data center since October last year. This includes extensive data from all 73 million people with statutory health insurance, such as their medical diagnoses, operations and medication. The data is pseudonymised and must be deleted after 30 years at the latest.

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The introduction of this controversial database goes back to a law by Lauterbach Predecessor Jens Spahn (CDU) from 2019 back. In this respect, it is surprising that Lauterbach does not use the current legislative process to adapt the regulation and give citizens more say. The topic is also sensitive because two corresponding lawsuits are currently being heard at the Berlin and Frankfurt social courts.

The Society for Freedom Rights is suing along with Constanze Kurz, spokeswoman for the Chaos Computer Club, and another anonymous plaintiff who suffers from a rare blood disorder. Above all, they criticize inadequate data security standards and the lack of a right to object.

In the urgent procedure, they were right in early summer: the respective health insurance companies are initially no longer allowed to pass on the corresponding health data. The result of the main proceedings is still open.

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“It is incomprehensible why one can object to the patient’s file, but not when passing on one’s own health insurance data,” says Bijan Moini, lawyer and process coordinator at the Society for Freedom Rights. The sensitivity of the data is almost identical. “Insurance data collected for up to 30 years allows many extremely sensitive conclusions to be drawn about the respective person,” says Moini. Lauterbach should use the current law to introduce a right of objection here as well.

Karl Broich, President of the Federal Institute for Drugs and Medical Devices, says WELT: “In the future, the health research data center will be one of the key success factors for the safe supply of patients with new, effective therapy options.” However, data protection and the chance of new medical therapy options should not be played off against each other. Therefore, “extensive security concepts” are currently being developed for all aspects of identification protection, data protection and data security.

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