Authors: Michelle Petruzzelli und Yvonne Wolski
A little more than a year ago, in March and April 2019, the German National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung – KBV) conducted a representative insurance survey (german site) to find out how the insured assessed the medical care situation in Germany. Of those interviewed, 37% said they were generally willing to make use of the offer of video consultations. This interest has strongly increased as a result of the coronavirus pandemic. For example, the number of certified providers of platforms for such video consultations has about doubled over the last weeks. In addition, the regulation limiting the amount of video consultations to 20% of the cases treated by a doctor was suspended until the end of the second quarter of the year 2020. Despite the advantages that are involved in video consultations both for doctors and for patients, there are, however, also disadvantages. In addition, regulatory requirements exist that need to be complied with.
Video consultations are part of telemedicine, which can be described as the provision of remote medical services via information and telecommunication technologies. Such services can include diagnosis, therapy and rehabilitation, as well as consultations among physicians with regard to a particular patient. Video consultations can help reduce the risk of infection for doctor and patient and improve access to medical services, especially in times of a shortage of physicians. On the other hand, the risk of errors in treatment can rise. This is because the doctor is possibly unable to get a clear picture of the patient and his/her symptoms due to not being able to get a first-hand impression of the patient and to having to rely on the information provided by the patient. This may even lead to an increase in the amount of work for the medical practice if it turns out at the end of the video consultation that the patient needs to appear in person after all. To this must be added the risks regarding the protection of patient data and the related confidentiality of the doctor-patient relationship.
As a rule, doctor and patient only need a camera, a microphone and a loudspeaker, as well as an internet connection, to be able to hold a video consultation. The medical practice cooperates with an appropriate video services provider (“provider”), who warrants that the applicable special standards are complied with. The German National Association of Statutory Health Insurance Physicians makes available a list of certified providers for this purpose. The patient then receives, either from the medical practice or from the provider, an appointment for the video consultation, a link to the provider’s website and a dial-in code for the consultation. After the patient has dialled into the system, he/she waits in the virtual waiting room until he/she is invited by the doctor to the video consultation.
The patient is not normally required to register separately with the provider. The patient must, however, provide his/her name correctly in order for the doctor to be able to identify the patent correctly. Patients who have never visited the medical practice may be required to hold their health insurance card into the camera to allow their identity to be verified and the necessary data to be collected.
At the beginning of the consultation, all persons present are introduced to each other. The doctor is additionally obliged to inform the patient about how the video consultation will take place. In addition to the fact that the patient’s participation in the video consultation is voluntary, this also includes the prohibition of recordings, of whatever kind. After the consultation has ended, doctor and patient log out of the website.
Rules for video consultations are contained in the German Model Professional Code of Conduct for Physicians (Musterberufsordnung-Ärzte – MBO-Ä), amongst other things. The Model Professional Code of Conduct for Physicians contains the basic professional and ethical rules for the medical profession. It sets out the rights and obligations of physicians towards patients, colleagues and the Regional Medical Associations (Landesärztekammern). While it is used by the Regional Medical Associations as a model, thus contributing to the development of uniform professional law, it does not constitute applicable law. Instead, the Model Professional Code of Conduct for Physicians only produces a legal effect if it is adopted by the Regional Medical Associations as by-laws. The Regional Medical Associations may, however, also adopt different rules.
Pursuant to Section 7(4) sentence 3 of the Model Professional Code of Conduct for Physicians, it is permissible for a consultation or treatment to take place exclusively via communication media in individual cases if this manner of proceeding is reasonable from a medical perspective, the exercise of due care is guaranteed, and the patient is appropriately informed. This is, however, an exception to the general rule of personal contact between doctor and patient, which is the “gold standard” pursuant to Section 7(4) sentence 1 of the Model Professional Code of Conduct for Physicians.
The assessment of the “reasonableness from a medical perspective” depends on the physician’s judgment und must especially take into consideration whether the requirements for the treatment are met by remote treatment. This may change during the course of the treatment, for example, when a physical examination becomes necessary. The requirement of reasonableness from a medical perspective essentially requires a medical indication to carry out the remote treatment. The reference to the requirement of due care clarifies that physicians are bound by the obligation to exercise their profession diligently, as set out in Sections 2(2) and (3), 11 of the Model Professional Code of Conduct for Physicians, also when practising telemedicine. In particular, this means that the physician must have the required professional qualifications and meet the accepted standards. The requirement to inform the patient serves the purpose of strengthening the patient’s right to self-determination. Otherwise, the patient would be unable to make an informed decision and validly give his/her consent. Further details about the information of patients are contained in Section 630e of the German Civil Code (BGB).
Details regarding video consultations are additionally contained in Annex 31b to the German Federal Master Agreement for Physicians (Bundesmantelvertrag-Ärzte) in conjunction with Section 291g(4) sentence 1 of the German Social Code, Book V (SGB V). Said Master Agreement is an agreement between the German National Association of Statutory Health Insurance Physicians and the German Central Federal Association of Health Insurance Funds (Spitzenverband Bund der Krankenkassen – GKV-Spitzenverband), with the German National Association of Statutory Health Insurance Physicians representing the interests of physicians and psychotherapists providing ambulatory care in their medical practices and the German Central Federal Association of Health Insurance Funds representing the interests of statutory health insurance and nursing care funds. The rules stipulate requirements for the participants in video consultations and expressly point out the obligation to comply with data protection and information security law.
As part of the video consultation, both the medical practice and the provider process personal data of the patient. This means that the data processing must be carried out in compliance with the requirements under the European General Data Protection Regulation (GDPR). In particular, the patient must be provided with a privacy notice that contains information about all processing activities carried out as part of the video consultation, Articles 12 et seq. of the GDPR.
In addition, there are special rules for the processing of health data, as such data requires special protection. Pursuant to Article 9(1) of the GDPR, the processing of health data is generally prohibited unless it is legitimised, for example, pursuant to Article 9(2) of the GDPR or Section 22 of the German Federal Data Protection Act (BDSG). The permissibility of the processing of health data generally results from consent pursuant to point (a) of Article 9(2), Article 7 of the GDPR, or from the provision of health care or treatment, point (h) of Article 9(2) and (3) of the GDPR, Section 22(1) b of the German Federal Data Protection Act (BDSG).
Consequently, before a video consultation is held, physicians are generally obliged to obtain the patient’s consent to the data processing activities carried out as part of the video consultation. This can be done electronically. The consent must, however, fulfil the requirements stipulated in point (a) of Article 9(2) in conjunction with Article 7 of the GDPR, which means that it must be given expressly, voluntarily, on an informed basis and for a specific purpose.
The provider generally acts as a contractor and, hence, as a processor within the meaning of the European General Data Protection Regulation on behalf of the physician, Article 28 of the GDPR. As a result, physician and provider must make a contractual agreement in the form of a processing agreement that sets out the two parties’ obligations under data protection law. Pursuant to the provisions of the European General Data Protection Regulation, the physician is responsible for ensuring that he/she only uses providers that provide adequate guarantees for data protection compliance. Section 4(4) of Annex 31b to the German Federal Master Agreement for Physicians adds to the obligations under the European General Data Protection Regulation as far as physicians are concerned by requiring physicians to use exclusively providers that are in possession of a data protection certificate or of a seal of quality issued or recognised by a data protection authority.
It must be ensured that adequate privacy is guaranteed during the video consultation. For example, there should be no listeners in the room of whom the patient is not aware. Furthermore, all kinds of recordings are prohibited during the video consultation. In addition to the above, medical confidentiality must be maintained, which is also secured by criminal law under Section 203 of the German Criminal Code (StGB).
Physician and provider must guarantee IT and data security in connection with the video consultation. The provider must additionally be able to present a certificate evidencing such security. This means that physician and provider must take technical and organisational measures to ensure the confidentiality, integrity and availability of the data. In this context, it is of particular importance that the technology used and the electronic transfer of data allow adequate and failure-free communication. To this end, a minimum bandwidth of 2,000 kbit/s and end-to-end encrypted transmission are prescribed.