Electronic patient file 3.0: insured persons don't know what to expect

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There are many uncertainties regarding the new version of the electronic patient file (ePA 3.0) – not only with regard to the announced launch date, as the participants of the tenth general meeting of the independent medical profession in Berlin found. The ePA is not yet functional, but is to be delivered to 70 million patients. The term"dark green banana software", which is to mature in practices, is therefore quite apt.

Speakers at the event included the former Federal Commissioner for Data Protection and Freedom of Information, Prof. Ulrich Kelber, and the former head of the Institute for Quality and Efficiency in Healthcare (IQWiG), Prof. Jürgen Windeler. All participants criticized the changeover of the ePA to the opt-out solution.

Uncertainties regarding liability and data protection

However, very few insured persons are likely to be aware of what the electronic patient file could mean for them – as the Federal Ministry of Health is circulating contradictory information. Only a few health insurance companies are providing comprehensive information about version 3.0 of the ePA. The ePA will provide comprehensive access to data for those involved in the treatment process. Silke Lüder from the board of the Freie Ärzteschaft explained that pharmacies from which prescription drugs are purchased can basically view everything except the dental bonus booklet. At this year's ePA Summit, it became clear that mail-order pharmacies are also increasingly demanding access to patient files.

For doctors, on the other hand, further liability-related questions arise. Although the National Association of Statutory Health Insurance Physicians emphasized that doctors do not have to read all documents in the ePA, it is unclear what the final outcome will be in court. It also criticized the fact that the ban on confiscation and the right to refuse to testify for health data are not included in the Health Data Usage Act. Data protectionists had already criticized this at the end of 2023.

Independence of doctors

According to the Chairman of the Independent Medical Association, Wieland Dietrich, the duty of confidentiality is the "basis of an indispensable relationship of trust between doctor and patient". This requires "professional and, if possible, organizational independence of doctors". This independence is increasingly under threat. According to Lüder, the new regulations with the ePA 3.0 threaten medical confidentiality, "which has been the basis of the doctor-patient relationship for 2,500 years".

The Chairman of the Independent Medical Association, Wieland Dietrich, described it as a "fatal mistake" to suggest that doctors generate a benefit from patients' health data, which is necessary for financial reasons – at the expense of confidentiality. Incentive systems of this kind already exist in the German Social Security Code V, for example with the economic efficiency bonus that doctors receive for "economic inducement and provision of laboratory services".

The medical profession is becoming increasingly commercialized and guided by false incentives that could compromise independent action in the interests of patients, explained Dietrich. An amendment to Social Code V, which the head of the National Association of Statutory Health Insurance Physicians recently described as a rapidly growing tumor, was "not only overdue in this area", said Dietrich. "The telematics infrastructure continues to occupy and disrupt processes in many practices. It serves various commercial interests", and its costs would also rise to "gigantic heights".

Leap of faith

According to the latest statements by Health Minister Karl Lauterbach, Google, Meta and Co. will soon be allowed to train with health data. The fact that the data from electronic patient records will be available to Big Tech for AI training in the future is causing an uproar. For Windeler, the promised benefits of the eHR are overblown and there are no known health benefits to date. The risks and side effects of the ePA are also not being discussed. There are statements in circulation that cannot be substantiated or show that there is not a single concrete research project in relation to the ePA. He also quoted Matthias Mieves, eHealth spokesperson for the SPD: "The ePA works with a leap of faith. The added value only comes with the data."

Debate is taboo

"We want digitalization, but not like this," announced Christian Messer, head of MEDI Berlin-Brandenburg. They have been waiting a long time for "sensible digitalization in the healthcare sector". Initially, there will be no benefits with the ePA, "but considerable risks", said Messer. The legal situation means a paradigm shift in medical and healthcare treatment. "Silence becomes consent. That is new. Worse still, the debate about it is being made taboo. The greed for data and money is too great," said Messer. The Federal Ministry of Health is talking itself into a frenzy about the treasure trove of data to be collected.

"What does HIV, drug use and depression matter if you can earn more money with this data?" And whether it wouldn't matter if a woman with dual citizenship was arrested in Poland for having an abortion. "We must be interested in all of this, we must care," Messer warned.

Unnecessary double examinations as an argument?

Silke Lüder also criticized the promised benefits of electronic patient records and pointed out unanswered questions, such as liability. She explained that she has been working with digital patient records for decades and that only a few duplicate examinations could actually be avoided by using existing documents. In her opinion, it is often useful to look at the patient again with an open mind. According to Windeler, the reasons for duplicate examinations include the following:

• first examination is too old
• first examination is of inadequate quality (objective or subjective)
• financial reasons, wrong incentives
• count for further training
• Patient wants it (and other reasons)
• Initial examination is not available

Only the last point can be influenced by ePA data, according to Windeler.