100 days before launch of the e-patient file 3.0: Confidence with restrictions

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Karl Lauterbach is late for the presentation of the electronic patient file (ePA) at lunchtime, but the project should not suffer this fate under any circumstances. "After 20 years of preparation, there are now only 100 days until the electronic patient file finally arrives," says the Federal Minister of Health. A campaign on social media, in the press, on the radio and with an Infomobile is now being used to raise awareness of the opportunities.

There is no fundamental criticism of the ePA, says Lauterbach. Findings, doctor's letters and similar documentation were missing during treatment, which could lead to duplicate examinations, incomplete diagnoses and fatal interactions. Based on a "well-done study" according to Lauterbach, Barmer assumes that "up to 65,000" deaths could be avoided as a result.

Not everything will work from January

"Not everything will work on the first day of implementation," Lauterbach warned against exaggerated expectations. Functions will be activated gradually. Initially, the introduction is to begin in two test regions in January. "It's about whether the new architecture actually works with the practice management systems in the way we thought it would," explained Lauterbach. At present, he has no indication that this could be otherwise.

"The introduction and operation are a highly complex undertaking," emphasized Florian Fuhrmann, CEO of Gematik, the future digital agency for healthcare. The revised architecture should be more stable and more powerful than the current ePA, which those with statutory health insurance have to apply for. Insured persons will have to object to the "ePA for all" from 2025 if they do not want it. Although positive, the president of the GP association, Markus Beier, nevertheless emphasizes that the "nationwide roll-out" of the ePA will take place in the middle of the phase of the year when there are the most infections.

"Short PDF phase" desired

In contrast to the launch of previous government healthcare projects – such as the e-prescription or the electronic certificate of incapacity for work –, he warned that the launch of the electronic patient file should be stable for everyone. Among other things, he also called for better searchability of the content stored on them: "The PDF phase must be fairly short." Doctors would also have to keep their own patient records anyway.

Data protection and data security "most important concerns"

"Data protection and data security were our most important concerns at every stage of the introduction," says Lauterbach. "The confidential computing environment is particularly secure in terms of security." However, when asked, the Minister of Health admits that he did not agree with former Federal Data Protection Commissioner and SPD party colleague Ulrich Kelber more than once on the ePA due to data protection issues.

Lowering the security level is a breach of the GDPR

Kelber sent a warning to the health insurance companies in May: if they lowered the security level in certain cases, this would be a breach of the General Data Protection Regulation. An argument that Doris Pfeiffer, Chairwoman of the Association of Health Insurance Funds, does not accept: The statutory requirements of the federal government would be followed by the health insurance funds: "Mr. Kelber had announced that he would not allow this. That is something where you have to ask the question, what is the legal reality now?" Pfeiffer had understood "that the new Federal Data Protection Commissioner might deal with the issue somewhat differently."

Data protection must not prevent the use of data

Karl Lauterbach emphasizes that it is appropriate to discuss the matter intensively: "It doesn't help anyone if data protection works in such a way that the data cannot be used." To his knowledge, there are no longer any fundamental objections from the BSI or BfDI, otherwise the ePA would not have been introduced. "The ePA is and remains voluntary," says Doris Pfeiffer from the National Association of Statutory Health Insurance Funds.

However, implementation in the practice management software is likely to remain decisive for acceptance by the medical profession. Lauterbach has announced that anyone who does not adhere to the guidelines of Gematik, which is to be expanded into a digital agency, must expect to lose their license. To this end, Gematik will be expanded to become the digital agency of the Ministry of Health.

(olb)