Telemedicine: remote treatment as a legal challenge

The progressive development of new technologies is also leading to new fields of application and innovations in the healthcare industry. A practice that has been established for decades in seafaring is now also finding its way into doctors’ surgeries: the remote treatment of patients without any physical real contact. In sparsely populated regions in particular, existing gaps in medical care can be closed through telemedicine, and even in urban areas the accessibility of specialist care can also be improved.

We provide an overview of the professional and liability issues, as well as the advertising of telemedical treatments.

What is telemedicine?

Many innovations of the increasingly digitised healthcare system fall under the term telemedicine. The use of digital means of communication to pass on findings between physicians and laboratories can already be classed as telemedicine. The range of usable communication means extends from simple telephony, text messaging or e-mail, to new chat functions including video transmission. The latter play a particular role in the area of remote treatment. In the legal sense, remote treatment means the "recognition or treatment of illnesses, suffering, bodily harm or pathological complaints which is not based on one's own perception of the person to be treated (...)" (Sec. 9 of the German Act on the Advertising of Medical Products [Heilmittelwerbegesetz, HWG]).

Remote treatment raises questions under professional law

Until 2018, physicians were prohibited under professional law from treating patients remotely (Sec. 7 (4) of the (Model) Professional Code for Physicians in Germany) [(Muster-) Berufsordnung-Ärzte, MBO-Ä)]. The 121st German Medical Congress in May 2018 remedied the situation: since then, it is possible in individual cases to provide advice or treatment exclusively via communication media, provided that this seems reasonable from a medical point of view and the patient has been informed accordingly.

This does not change the fact that direct patient contact in the context of medical treatment is still considered the "gold standard." In individual cases, therefore, whether the specific treatment or consultation can be carried out by telemedicine according to medical specialist standards must be carefully examined. Should the physician's assessment be erroneous, this may have consequences under professional law (Sec. 2 (2) MBO-Ä) and liability law.

Avoiding consultation and treatment errors

In order to assess liability risks in remote treatment, a distinction must be made between liability for consultation errors and treatment errors.

During the consultation prior to treatment (Sec. 630e (1) of the German Civil Code [Bürgerliches Gesetzbuch, BGB]), the physician must take several peculiarities of telemedical care into account. Here, consideration must be given above all to alternative, i.e. physically real, treatment options as well as to the risks of remote treatment. The latter includes, for example, the stability of the data transmission and possible limitations of the treatment. The consultation must always be provided verbally (Sec. 630e (2) No. 1 BGB). As a rule, this is assumed to be a personal consultation. Whether a conversation in the context of a video consultation also fulfils this requirement has not yet been decided by the courts. For reasons of practicability, several things favour this option. If the physician provides incorrect information and the patient subsequently suffers damage to his health, this can give rise to damage claims.

The medical specialist standard also applies to telemedicine treatment. An approach that deviates from this can constitute a treatment error that triggers a damages obligation. A point of particular relevance in remote treatment is the liability for technical monitoring negligence. Data transfer, in particular, represents an elementary basis for the treatment process. All technical equipment must be checked as to its proper functioning. Recognisable equipment faults or the use of low-quality communication media entail particular liability risks.

Issuance of sick notes by telephone

Since the beginning of the corona pandemic at the latest, this has been on everyone’s lips: the issuance of sick notes by telephone. Such a procedure is anything but self-evident, however. Until the liberalisation of the Professional Code for Physicians, this was not provided for in any form. In the meantime, the Federal Joint Committee [Gemeinsamer Bundesausschuss, G-BA] has stipulated in its Guideline on Incapacity for Work [Arbeitsunfähigkeitsrichtlinie, AU-RL G-BA] that the issuance of a sick note following a video consultation is possible (Sec. 4 (5) AU-RL G-BA).

The maximum duration of such sick leave depends on whether the patient is already known to the physician in the relevant area of expertise. If the patient is not known to the physician, the duration of the sick leave is limited to up to three calendar days; if he is known to the physician, up to seven calendar days. The purely telephone-based issuance of sick notes in the context of the special pandemic situation occupies an exceptional position. In case of mild upper respiratory illnesses, up to seven days of sick leave is possible after telephone contact. This regulation is currently limited until 30 November 2022. 

Data protection requirements for service providers

Physicians who use digital means of communication in the course of their treatment must be aware of the data protection requirements of the GDPR, the German Federal Data Protection Act [Bundesdatenschutzgesetz, BDSG], and the concretisations of these requirements under professional law.

In this context, the regulations in Annex 31b of the Federal Framework Collective Agreement for Medical Practitioners [Bundesmantelvertrag der Ärzte, BMV-Ä] on video consultation are of particular importance. This initially regulates that the video service provider is (also) the controller within the meaning of the GDPR (Sec. 2a (2)). Order processing pursuant to Art. 28 GDPR, under which the physician alone would remain responsible for data protection, is therefore ruled out.

Data processing may only be carried out within the EU or in a country equivalent thereto on grounds of an adequacy decision by the EU Commission. In addition, the attending physician may only conduct a video consultation with consent (Sec. 4 Annex 31b BMV-Ä in conjunction with Art. 9 (2) lit. a GDPR) and must use a service provider that meets the technical requirements of Sec. 5 Annex 31b BMV-Ä. Here, particular attention should be drawn to the safeguarding of confidentiality, integrity and availability of the data, end-to-end encryption and to the fact that the service provider cannot access the data. The service provider must be certified accordingly. A current list of certified providers is available on the website of the German National Association of Statutory Health Insurance Physicians [Kassenärztliche Bundesvereinigung, KBV].

Advertising of remote treatment

Physicians offering remote treatment wish to advertise this. This was extremely problematic until 2019, as the HWG stipulated a complete ban on the advertising of remote treatments (Sec. 9 HWG, old version). There is now an exception to this: the advertising of remote treatment is not prohibited if personal contact with the physician is not a necessary part of the treatment according to generally accepted professional standards (Sec. 9 sentence 2 HWG). Advertising is naturally aimed at reaching a wide range of people. Thus, its formulation cannot take specific illness situations into consideration.

Hence, with a view to the medical standards, it is not possible to determine in advance whether future treatment would be possible. This creates a fine line on which the legally compliant wording of advertisements must be balanced: first of all, the advertised remote treatment generally has to comply with the guidelines of the respective medical societies. Secondly, the advertising statement should include the proviso that whether remote treatment according to professional standards is possible can only be decided in the specific individual case. Thus, advertisements for remote treatment are possible if handled with skill and tact.

Conclusion

The establishment of remote treatments seems to be the logical consequence of our society’s ever increasing digitisation. In addition to the aforesaid advantages, there are also risks associated with diagnosis and treatment without any personal contact with the physician. Legislators are addressing these risks with new regulations that centre on patient safety. In the interests of both the patient and the practitioner, legal support for telemedicine services is therefore advisable.

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