German Federal Minister of Health Karl Lauterbach is looking to implement big plans for further digitization of the healthcare system. His plan is to start “catching up both in everyday care and in research.” He envisions the expansion of electronic medical records, electronic prescriptions, and telemedicine. The German Federal Cabinet recently passed two pieces of draft legislation: the Digital Act and the Act on the Use of Health Data.

Electronic Medical Records

The electronic patient file (ePA) is at the heart of the Digital Act. According to the act, a file will be set up for every insured person by the start of 2025. The opt-out rule will apply: every insured person who does not wish to use the ePA will have to reject the creation of his or her file. Otherwise, it will be automatically created for him or her. The draft legislation states that “the objective is the comprehensive and, as far as possible, automated filling of the ePA with data structured specifically to support healthcare.”

Electronic Prescriptions

Together with the ePA, patients with insurance will automatically be issued a digital overview of their medication. This overview should prevent any drug interactions.

Electronic prescriptions will also be developed further. According to the draft legislation, as of January 1, 2024, there will be “a compulsory standard in pharmaceutical provision.” For practicing physicians, the electronic prescription may represent the biggest change. Unlike with the ePA, there is no way to reject the update with the electronic prescription, since it “essentially completely replaces the previous paper prescription,” explains the Federal Ministry of Health (BMG). However, insured patients can decline the automatic transfer of medication information from the electronic prescription service to the ePA.

Social Security Funds

Digital healthcare apps (DiGA, “apps on prescription”) will be used more widely, for example, in complicated applications such as telemonitoring.

Previously, only as medical devices in risk classes I or IIa were classified as DiGA. The Cabinet now also wants medical devices in risk class IIb to be classified as DiGA. Above all, DiGA should become more affordable, according to the government. “The pricing for the DiGA should be more strictly based on success criteria and therefore be even more useful for adjusting the offering. A more transparent quality competition will be established,” says the draft legislation.

Regulations regarding cybersecurity and interoperability are also being added.

The funds for implementing the Act — overall, more than €2.1 billion for the period from 2024 to 2028 — are not coming from the Cabinet’s coffers but rather from social security.

Health Data Use

The second piece of draft legislation being introduced by the Federal Cabinet concerns the use of health data. “For example, billing data offers a broad overview of paths through the different health sectors and an insight into various diseases,” according to the draft legislation.

It goes on to outline the problem by stating that health data are collected at many points in Germany, but they are not available for research “and other purposes that serve the greater good.” This is because in Germany, various provisions from the European Union, the federal states, and German federal law make access to health data very difficult. In addition, data protection officers and supervisory authorities have contradictory interpretations of the law. Much of the data cannot therefore be used “outside of the healthcare context,” the legislation states.

This situation should now change. In the future and as decided by the Cabinet, an independent body shall coordinate the independent use of health data. “In this respect, data from a range of data sources will first be combined together. The access point should function as a central contact point for those using the data,” the BMG explained.

“Patients should be able to trust that their health data are being used securely everywhere to improve their healthcare,” said Lauterbach. “And scientists should be sure that they are getting the best prerequisite in Germany for their research.”

Insurance Companies Balk

Health insurance companies are endorsing Lauterbach’s proposed legislation as an “urgently required switch to a digital healthcare system,” as reported in a statement by Doris Pfeiffer, chair of the National Association of Statutory Health Insurance Funds. She particularly welcomed the opt-out rule for the ePA.

However, Pfeiffer is demanding another year before its implementation. “For the ePA to be accepted with all of its advantages, the Statutory Health Insurance Funds need time to prepare, inform, and educate their policyholders. So that no unrealistic expectations are set, the introduction of ‘ePA for all’ should take place by July 1, 2025,” said Pfeiffer.

Silence and Consent

Eugen Brysch, chair of the German Foundation for Patient Safety, has a different outlook on the topic. Among other things, he is critical of the opt-out rule. In Brysch’s view, silence does not equate to consent. “The federal government is removing any concern with the Digital Acts.” Without needing to do so, this step may fuel skepticism among the population about electronic patient files, even though their introduction is important for patients.

“Medical data may also not be forwarded to research without consent. Additionally, people without access to the internet are completely left behind,” said Brysch.

This article was translated from the Medscape German Edition.


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