Telemedicine in Germany: legal framework, challenges and perspectives

Ulrich Grau
D+B Attorneys-at-Law, Berlin
grau@db-law.de

Christian Pinnow
D+B Attorneys-at-Law, Dusseldorf
pinnow@db-law.de

Alexander Meyberg
D+B Attorneys-at-Law, Dusseldorf
meyberg@db-law.de

Telemedicine has gained significant importance in recent years and has become a key element of modern healthcare. Especially since the Covid-19 pandemic, awareness of digital treatment options and their legal frameworks has grown considerably. This also holds true for telemedicine services in Germany. Nevertheless, Germany faces unique challenges compared to other European countries. While medical care in Germany is highly developed, the digital transformation of the sector has been rather slow. In the meantime, various legislative initiatives and regulatory actions have laid important foundations for integrating telemedicine into healthcare.

Definition and legal context

Telemedicine refers to the provision of medical services at a distance using information and communication technologies. This includes video consultations, the electronic transmission of medical findings, remote specialist consultations (teleconsultations) and remote monitoring of chronically ill patients. The primary goals of such services are to improve healthcare delivery in underserved regions, reduce waiting times and increase the efficiency of medical services.

In Germany, telemedicine is regulated differently depending on whether the care is provided according to statutory health insurance (vertragsaerztliche Versorgung) or private medical care (privataerztliche Versorgung). Telemedical treatments provided as a result of statutory insurance are subject to stricter rules. Therefore, many telemedicine business models focus primarily on private medical care. Additionally, physicians practicing in Germany are not the only healthcare providers to offer telemedicine services to German patients. There is a growing number of physicians from other EU countries treating patients in Germany via video consultation. At this point, the question always arises as to which legal regulations apply: the law in the country where the patient is located or the law in the country where the doctor is based.

In practice, the number telemedicine platforms that connect patients with physicians over the internet is constantly growing, so is the amount of regulations and court rulings.

Professional regulations

In the private healthcare sector, Section 7 para 4 of the Model Professional Code for Physicians in Germany (Musterberufsordnung für Ärzte or MBO-Ä) is the key provision governing telemedical practice. This section was amended in 2018 to allow the provision of telemedicine in certain conditions.

According to Section 7 para 4 sentence 3 of the MBO-Ä, telemedicine is permitted on a case-by-case basis, provided it is medically justifiable, conducted with due diligence and the patient is informed about the special nature of the remote treatment to be provided.

A medical justification exists when the telemedicine can meaningfully contribute to the patient’s recovery, and when the disadvantages do not outweigh the benefits.^[1]

The due care requirement means that the physician must have the necessary qualifications and adhere to the recognised standards of medical science. Diagnostic and treatment procedures must align with current medical guidelines.^[2]

The German Federal Court of Justice (Bundesgerichtshof or BGH) held that the physician must provide treatment in accordance with the German professional standards at the time of the treatment.^[3] These standards are typically defined by relevant clinical guidelines or directives issued by the Federal Joint Committee (Gemeinsamer Bundesausschuss or G-BA). However, the BGH has clarified that a previous in-person visit is no longer mandatory to meet these standards.

Advertising regulations

In addition to professional rules, telemedicine business models must also comply with the Health Care Advertisement Act (Heilmittelwerberecht or HWG). In Germany, advertising remote treatment is only permitted under strict conditions. Section 9 of the HWG states:

‘Advertising for the detection or treatment of diseases, ailments, bodily harm, or pathological complaints that is not based on the advertiser’s own personal perception of the individual being treated (remote treatment) is prohibited. This does not apply to advertising for remote treatments conducted via communication media, provided that, according to generally accepted professional standards, no personal contact with the patient is necessary.’

In a landmark decision () in 2021,^[4] the BGH ruled against an insurance provider that advertised a digital primary care model (Primärversorgungsmodell) offered by its subsidiary. The subsidiary offered diagnoses and sick notes via an application from physicians based abroad, without the need for an in-person visit. The Court ruled that the advertisement failed to clarify that such treatment was only permissible according to specific medical standards and, thus, did not fall within the legal exception.

In our view, the 2021 decision by the BGH was a key factor in enabling the implementation of telemedicine. Not every illness requires physical contact between the physician and the patient. In such cases, telemedicine can make a valuable contribution to improving healthcare delivery, particularly in rural areas, where there is often a shortage of physicians.

Telemedicine in regard to the statutory healthcare system

Telemedicine is increasingly relevant in regard to Germany’s statutory healthcare system. Since the E-Health Act (E-Health-Gesetz, 2015) and the Digital Healthcare Act (Digitale-Versorgung-Gesetz or DVG, 2019), services such as video consultations, electronic patient records (elektronische Patientenakte or ePA) and electronic prescriptions have been explicitly authorised. The DVG also introduced digital health applications (Digitale Gesundheitsanwendungen or DiGA), namely prescribable health applications covered by insurance under Section 33a of Social Code Book V (Sozialgesetzbuch Fünftes Buch or SGB V),provided certain criteria are met.

Since the 1 March 2025, a new agreement (Anlage 31c Bundesmantelvertrag Ärzte or BMV-Ä) outlines the quality standards for telemedicine in statutory care, as per Section 87 para 2o of SGB V. It regulates the requirements when services are provided outside a medical practice. The treatment location must still be in Germany. Remote treatment from abroad under statutory insurance is not permitted.

In our opinion, the legislator should have taken a much more far-sighted approach here. There are recurring therapies, such as psychotherapy, that require regular treatment by a physician or therapist. In situations where the physician or therapist is on holiday or has traveled abroad for other reasons, the treatment cannot be continued.

Telemedicine in the EU context

EU law also increasingly shapes telemedicine regulations in Germany. New EU directives and regulations, such as the Cross-Border Healthcare Directive, Medical Device Regulation (Medizinprodukteverordnung or MDR) and the new European Health Data Space Regulaion (Europäischer Gesundheitsdatenraum or EHDS), are regularly being introduced.

Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (Patientenmobilitätsrichtlinie) clearly defines patient rights when seeking medical treatment in other EU countries. The costs for such treatment are reimbursed up to the amount that would have been covered in Germany.

Data protection and data security

Protecting sensitive health data is a key issue in telemedicine. The processing of personal data is subject to the EU General Data Protection Regulation (Datenschutz-Grundverordnung or DSGVO) and the Federal Data Protection Act (Bundesdatenschutzgesetz or BDSG). Central to this framework is the requirement for informed, voluntary and documented patient consent.

Furthermore, secure communication channels are essential, this includes end-to-end encrypted video platforms and the use of certified service providers. Data security is not only a legal requirement, but a prerequisite for building patient trust.

Reimbursement and billing

Telemedical services within the statutory system are reimbursed under the German fee scale for physicians (Einheitlicher Bewertungsmaßstab or EBM). Since the DVG came into effect, services such as video consultations, teleconsultations and telemonitoring are eligible for reimbursement. Private health insurers in Germany are also increasingly recognising telemedical services, generally applying the statory scale of fees for physicians (Gebührenordnung für Ärzte or GOÄ).

Liability aspects

Telemedicine is subject to the same liability rules as traditional medical treatment. Physicians must fulfill their duty to inform patients, even remotely. If a patient is harmed due to misdiagnosis or improper treatment, the physician may be held liable. Proper documentation is essential to prove that treatment was delivered according to the relevant standards.

Cybersecurity

Cyberattacks on healthcare systems are a growing threat. In 2023, several hospitals in Germany were hit by such attacks, some targeting telemedicine systems. IT security requirements, such as those under Section 75c of SGB V for hospitals, must keep up with technological advances.

Conclusion

Telemedicine is legally permitted in Germany and continues to offer significant opportunities for improving healthcare. The continued legal developments show growing openness towards digital care models. Nevertheless, the legal requirements in the field of telemedicine are high, making the practical implementation of telemedicine concepts in Germany challenging.

This is also true in regard to recent case law involving digital platforms that provide their customers with telemedical treatment services. As digitalisation advances, the role of telemedicine will continue to grow. In our view, the legislator has made important efforts in recent years. However, this is still not enough. There is still a need for a clear and practical legal framework for digital health.

This is especially true in light of artificial intelligence (AI)-based diagnostic and treatment tools, which are increasingly being used within healthcare settings. These innovations will further shape telemedicine, but also raise new ethical and legal questions, such as who is responsible if AI causes harm? How can transparency be ensured?

Notes