18 May 2022
“The Future is Digital Health” – the German healthcare system is about to be revolutionised: health goes digital.
Digital technologies offer a broad range of possibilities. The innovations include significantly improved treatment and diagnostic options, previously unimaginable optimisation and saving potentials for healthcare providers, or personalised “patient journeys” to be controlled by apps and wearables from the patient’s home. The legal implications of the new digital and personalised healthcare are diverse and complex. Our experts in data privacy, regulatory, IP/IT and venture capital transactions closely monitor the latest trends and topics in digital health, providing a view from all angles in “Digital Health – 360°” to assess and address the most relevant legal challenges.
The grounds of the judgment handed down by the I. Civil Division of the German Federal Court of Justice (BGH) on 9 December 2021 (case no. I ZR 146/20), relating to telehealth advertising, have now been published. They provide an in-depth discussion of the increasingly important topic of remote treatment and information about the requirements for admissible advertising.
The BGH considers that a private health insurance provider’s advertising of a remote therapy offered by Switzerland-based physicians violates Sec. 9 1st sentence HWG (Healthcare Advertising Act), the defendant having advertised the diagnosis and treatment of diseases which is not based on any personal observation of the patient. The decision addresses the interpretation of § 9 2nd sentence HWG and the applicable rules.
In its judgment the BGH notes that it is the purpose of the advertising restrictions laid down in the Healthcare Advertising Act to combat risks caused by improper medication to the health of individuals and the health interests of the general public, whether or not the risks actually materialise in the specific case. In particular, health may be at risk where persons not subject to codes of professional conduct advertise distance treatment. The purpose of the advertising restrictions is to protect health, whether or not the remote treatment is admissible under professional law.
The exemption provided in § 9 2nd sentence HWG, which permits advertising for remote treatments where, applying generally accepted professional standards, the physician is not required to be in personal contact with the patient, was found inapplicable in the BGH case. The important factor is the interpretation of the term “generally accepted professional standards”. By providing the exception in § 9 2nd sentence HWG, the legislator sought to accommodate the development of telemedicine and presumed that accepted professional standards are observed as soon as they generally allow for proper treatment and consultation using communication media. According to the BGH, the legislator relied on a dynamic process where the accepted professional standards may change as the technical possibilities keep advancing.
The term “generally accepted professional standards” shall be interpreted by reference to the term defined in § 630a (2) BGB (German Civil Code) and the principles developed in that context. From the BGH judgment:
“This interpretation of § 9 2nd sentence HWG is supported not only by the fact that § 630a (2) BGB also uses the term “generally accepted professional standards”. Under systematic and teleological aspects as well, it seems appropriate to also make use of the term, which is relevant for the due and proper fulfilment of the physician’s obligations arising out of the treatment contract, to determine whether these obligations permit remote treatment, and remote treatment advertising therefore is allowed. Furthermore, such a convergent interpretation permits reverting to the extensive case law on § 630a (2) BGB and thus is conducive to a predictable and legally certain application of the exemption provided in § 9 2nd sentence HWG.”
The BGH rejected the appellate court’s assumption that medical consultations and treatments involving personal contact between and the physical presence of doctor and patient are the “gold standard” of medical practices, while an exclusively remote treatment neglects the obligation to make a diagnosis because a basic examination is always required. Instead, telehealth advertising may be admissible if the accepted professional standards are duly observed. The decisive factor is the definition of “accepted professional standards”, which is constantly changing. Reference must be made to § 630a (2) BGB as no accepted generally standards have been developed yet with a view to § 9 2nd sentence HWG:
“A professional standard defines the conduct that can be expected of a conscientious and observant physician in the specific treatment situation, from the professional perspective of the physician’s discipline at the time of the treatment. The physician represents the state of the scientific knowledge and medical experience that is required to achieve the medical treatment objective and has been tried and tested. When defining the accepted professional standards, one must consider the guidelines of medical organisations and the directives of the Federal Joint Committee as set out in §§ 92, 136 SGB V. Professional standards also may develop independently. It is for the trial court to determine the applicable standard in each case, involving experts as required.”
In summary, remote treatment advertising is not contrary to § 9 HWG if the accepted professional standards are observed, which are subject to continuous development. The BGH has flung the door wide open for the further digitalisation of the healthcare system and the resulting telemedicine options. More and more accepted professional standards are likely to evolve over time, offering more advertising possibilities.
Authors: Dr. Daniel Tietjen and Katharina Hölle