In Germany, the digitization of the healthcare market is a hot topic. “Digital health” features prominently in the coalition agreement of the newly elected German federal government. At the same time, skepticism persists within the medical community as to whether quality standards could fall victim to these rapid developments. Now, the German Federal Civil Court has addressed some of those concerns. In its judgment of December 2021 (I ZR 146/20), the court ruled that advertising for the comprehensive teletreatment of patients (Fernbehandlung) violates applicable law.
In May 2018, the German Medical Assembly approved a crucial amendment to the Professional (Model) Code for Physicians in Germany ((Muster) Berufsordnung der Ärzte (MBO-Ä)). While treatment of patients exclusively remotely (i.e. without any physical contact between doctor and patient during the entire treatment) was previously prohibited under MBO-Ä, the new version of Sec. 7 para 4 MBO-Ä now states:
It is permitted, in individual cases, to provide medical consultation or treatment exclusively through means of communication when this is medically justifiable and when the necessary medical care is provided…
In response to this change in medical professional legislation, in December 2019, the German legislator aligned the drug advertising law accordingly. Under the original wording of Sec. 9 German Medicines Advertising Act (Heilmittelwerbegesetz (HWG)), advertising for the diagnosis or treatment of diseases that is not based on the personal perception of the person to be treated was generally prohibited. In its new version, Sec. 9 HWG now contains a second sentence, which clarifies that advertising remote treatment via means of communication (teletreatment) will be permitted “if, according to generally accepted professional standards, personal medical contact with the person to be treated does not is not necessary.”
These changes in medical professional law and drug advertising law have opened the doors to the implementation of teletreatments on a larger scale. Video consultation is being implemented by more and more doctors. Additionally, the COVID-19 pandemic has accelerated the transition to the “digital doctor”. At the same time, uncertainties remain regarding several legal aspects of teleprocessing. Therefore, the recent decision of the German Federal Civil Court regarding telemedicine advertising is likely to significantly influence the telemedicine market.
Facts of the case
In 2019, a private health insurance fund promoted a “digital medical appointment” on its website. According to the advertisement, diagnosis, treatment recommendations and even sick notes should all be available via an app, in this case provided by Swiss doctors. In other words, the entire medical treatment was supposed to take place without any physical contact between the patient and the doctor. The Munich District Court considered this a clear violation of the old version of Art. 9HWG. The Munich Higher Regional Court subsequently agreed with this opinion despite the new wording of Art. 9 HWG, which came into force before the verdict. Courts have argued that while teleprocessing itself may be permitted under medical professional law, its advertising may still be prohibited if done too broadly.
Judgment of the German Federal Civil Court
When the German Federal Civil Court had to decide the case in December 2021, it finally upheld the opinion of the lower courts: an advertisement for teleprocessing, if done as comprehensively as in the case of the credit union. private health insurance, violates art. 9 HWG and is therefore not permitted. Although the full verdict is not yet available, the main reasons for the court’s decision can be taken from the press release.
The German Federal Civil Court points out that, according to Art. 9 HWG, advertising of teletherapy is only permitted if no personal contact between patient and doctor is required according to generally accepted professional standards. The tribunal further clarifies that these standards are not solely based on the applicable medical professional legislation. Rather, they are determined by ever-changing medical advances. As these standards may change in the future, the court argues that the promotion of complete teletreatment without any physical contact with the doctor during the entire treatment process cannot sufficiently take into account the applicable medical standards. Therefore, advertising as broad as the subject of the court’s decision violates s. 9 HWG and is prohibited.
When advertising teletherapy, care must be taken not to choose wording that might be too comprehensive or too broad. Any company wishing to engage in teleprocessing and related advertising will need to carefully craft and adapt promotional claims, taking into account the state and changing medical standards.