eHealth - Tele-Monitoring and Tele-Medicine - Digital Innovation in the Life Science Sector in Germany
by Dr. Wolfgang Rehmann
eHealth transfers the potential of modern information technology to health systems to improve the exchange of information, diagnostics and treatment, including an enhanced, because targeted, supply of medicinal products to patients. Along with an improved information exchange and the associated knowledge transfer an enhanced therapy will be combined with an increased efficiency and, in particular, with an interlinked and integrated patient care. Consequently, many are calling for a promotion of electronic health services; the advantages associated with it have long been discussed and are in the centre of a recent public consultation initiated by the European Commission.
There is a wide range of legal topics associated with the tele-medical services offered. It ranges from regulatory analysis of the devices used in tele-medicine and questions with respect to data protection and professional law for physicians to liability legislation.
About the legal issues relating to eHealth
1. Collection, evaluation and transfer of patient data
Is eHealth creating the "patient who is under constant surveillance"? This is not, first and foremost, a matter of privacy protection. The legal instrument to protect patient-related data in form of the Federal Data Protection Act (Bundesdatenschutzgesetz, BDSG) and the General Data Protection Regulation (Datenschutzgrundverordnung, GDPR), respectively, are in place. This is about trust. How can we prevent aggregated health data of patients from being used inappropriately? We also have to provide a secure IT environment to be able to technically protect data. In this respect, from a patient perspective it will be desirable that health professionals, including pharmacies, to which patients turn to for purposes of healthcare provision, have comprehensive knowledge and make full use thereof. Patients will have reservations about the fact that private and public health insurance providers as well as governmental bodies aggregate their data, and also to the extent to which it concerns a transfer of their data to third parties. Without patient consent, the latter is already prohibited in Germany and also in bordering European countries according to currently applicable data protection laws and a violation thereof will be sanctioned accordingly.
Health data are protected as individual details about the personal situation of a particular or identifiable individual. The collection of relevant health data as well as its processing and use are subject to Section 4 of the BDSG. Appropriate actions are only permissible if the individual affected gives his/her consent, for which the principle of "informed consent" applies pursuant to Section 4 of the BDSG. This principle is also the basis of the GDPR, which will apply in the future and provide, in particular, special protection to health data (1). This also applies, above all, to the transfer of data to third parties such as physicians and pharmacists. Section 291a of the German Social Security Code V (Sozialgesetzbuch V, SGB V) contains special provisions for the use of data stored on eGKs. Furthermore, attention should still be paid to Section 203 of the German Criminal Code (Strafgesetzbuch, StGB), protecting the personal privacy of patients. The physician has to be explicitly authorised by the patient to pass on the data collected and processed at the physician's office. Moreover, violations against the BDSG will be, if committed wilfully, punishable by criminal law, as can be seen from Section 43 Para. 2 in connection with Section 44 of the BDSG.
Data related to a patient's disease are already aggregated today to a great extent at the individual providers, in particular, at insurance providers and the patient is known to its insurer, regardless of the fact whether the patient is insured privately or statutory. However, a consequent introduction of health telematics will lead to a much larger and more comprehensive data collection, which gains efficiencies, but also bears the risk of misuse up to and including a withdrawal from the solidarity system. Even though health insurance companies already build up today a health profile of the people insured through the billing of disease-related services of individual service providers. These are, however, incomplete and full of gaps. Introducing the Electronic Health Card (eGK), medication plans and electronic patient records lead to more and more transparency. This evidently should involve the protection of a patient's reputation.
The key challenge of digitalised medicine is the interaction of law and technology (2). The German E-Health Act (Gesetz für sichere digitale Kommunikation und Anwendungen im Gesundheitswesen, E-Health-Gesetz - "the Act") intends to follow this approach by creating a safe IT environment on the one hand and by stipulating the use of established systems to gain access to services provided by the statutory health system (Section 15 of the SGB V), e. g., in the form of the eGK, on the other hand, thus, introducing further regulations, which establish uniform minimum standards, also in terms of content as far as the types of IT systems used by health providers are concerned. Furthermore, the Act justifies the basis for the provision of a medication plan (Section 31a of the SGB V), which shall also be used in an electronic version in the future. This constitutes a major step towards increasing patient security and, at the same time, enhancing its compliance.
A significant element in a future interlinked care is the tele-monitoring, i.e., constant monitoring of patients, whose clinical presentation require this clinical measure, and a patient-physician exchange during the ongoing treatment based on tele-medicine. This raises legal questions with respect to medical devices, professional law, pharmaceutical advertising, and finally about liability.
a) Legislation on medical devices
Devices used to measure a patient's health data, passing these on to physicians are, as a rule, to be qualified as medical devices. This, however, does not apply to media that serve the pure exchange of data and communication.
Tele-monitoring mainly uses apps or other computerised systems with a user interaction technique and a measuring function as well as apps and computerised systems for transferring, reading and storing patient data, along with systems that are only used for the physician-patient communication. Software and other computerised systems, which according to its purpose are used for therapy planning, measuring the functions of the body, including blood pressure, blood sugar and other vital signs serve a medical purpose pursuant to Section 3 of the German Medical Device Act (Medizinproduktegesetz, MPG) and, thus, are to be qualified as medical devices. This also applies to stand-alone software, e.g., in form of apps, which has to be considered a medical device with respect to the compliance of its medical purpose (3). Hence, apps and other computerised systems used in tele-monitoring for medical purposes are only allowed to be placed on the market if they are certified in accordance with the MPG and have a CE marking. What needs to be certified is the application or the system fulfilling the medical purpose, not the mobile device itself, i.e., this does not apply to the smartphone, iPad, or desktop on which the app or the system is to be used or to a device intended for the pure exchange of data, data storage, data management, and physician-patient communication. This definition also includes apps used by doctor's practices to communicate with their patients such as to schedule appointments, pass on information supporting their treatment, enhance compliance, or which are intended for the purpose of any other kind of physician-patient information exchange. In the event that mobile devices are used in a hospital setting, the applicable hygiene requirements have to be met.
These new EU regulations on medical devices do not provide for a fundamental change in the aforementioned currently applicable regulations. Pursuant to the definition in Art. 2 Para. 1 of the Medical Device Regulation (MDR) a medical device is, including, but not limited to, software which, according to the manufacturer is intended for humans and, alone or in combination, is to fulfil one or more medical purposes under this Art. 2. Pursuant to Art. 2 Para. 4 of this Regulation, a stand-alone software still qualifies as an active medical device. Annex 1, Section 14 contains regulations on software as a component of a product and on stand-alone software for so-called mobile computer platforms. There is also no fundamental change in the classification regulations (4). Sentence 2 of the new regulation makes it clear that if a stand-alone software is independent of other products it has to be qualified in its own right.
Insofar as tele-monitoring uses apps or other computerised systems with a user interaction technique and a measuring function as well as systems for transferring and reading patient data, these systems are subject to the regulations of the MDR, if and to the extent that they each individually fulfil a medical purpose, which may not be readily answered in the affirmative with products that have a user interaction technique and a measuring function in place; this does not apply, however, for systems which are only used for storing, managing or transferring data as these do not have a medical purpose strictu sensu (5). Systems used for reading patient data, on the other hand, may support diagnostics and, therefore, in individual cases fulfil a medical purpose, qualifying them as a medical device.
b) Professional Code for Physicians
Professional codes for physicians should even today no longer preclude the attending physician from providing tele-monitoring to his/her patients in Germany. Above all, this should normally not constitute a violation of the German Ban on Tele-therapy (Fernbehandlungsverbot). Consequently, the E-HealthG plans a fast introduction of such services.
Pursuant to Section 7 Para. 4 of the German Professional Code for Physicians in Germany (Berufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte "MBO-Ä") in the version of the decision of the 118th German Medical Assembly (Deutscher Ärztetag) 2015, physicians are not allowed to exclusively offer individual medical treatment, including particularly providing medical advice, via print and communication media. It also has to be ensured in tele-medicine procedures that a physician is directly treating his/her patient. An existing treatment relationship, however, does not necessarily always involve a personal physician-patient interaction. Thus, only the exclusive treatment by means of tele-medicine is banned (6). The consultation via video conference call, which will be offered to the patient after having received primary diagnostics as well as other services offered in tele-monitoring are, on the other hand, not affected by the Ban on Tele-therapy (7). According to the Federal Medical Association (8), informing a patient about his/her lab results or issuing prescription refills, and medical surveillance of chronically-ill patients by way of tele-monitoring or giving emergency instructions over the phone is permitted. The resolution of the 118th German Medical Assembly 2015 in Frankfurt - medical positions on areas of application in tele-medical patient care - also considers the possibility of tele-monitoring vital signs in the therapy of chronic diseases (9). This would require, however, an existing treatment relationship between physician and patient, apart from emergency situations.
In addition, it is worth pointing out that Section 7 Para. 4 of the MBO-Ä only covers the individual consultation and treatment, and focuses on medical information alone. This includes, inter alia, vaccination advice for people travelling abroad and similar topics. It is prohibited, for example that call centres give patients specific advice or an individual diagnosis, or make a recommendation on therapies without having had any personal contact with the patient. An existing treatment relationship, however, does not necessarily always involve a personal physician-patient interaction as this is not a preclusive tele-treatment.
Tele-medicine is a key component of a computerised integrated patient care, which may be seen as an interlinked eHealth solution. Legal questions in connection with pure tele-monitoring have been described previously. In contrast, tele-medicine, which should also include the primary consultation of a patient, is facing legal obstacles that de lege lata cannot yet be overcome nationally, but in a cross-border provision of services, insofar as foreign countries have less stringent regulations in place with respect to the Ban on Tele-therapy, as it is the case in, e.g., Switzerland and the United Kingdom.
a) Ban on Tele-therapy
As described above, Section 7 Para. 4 of the MBO-Ä only covers the individual consultation and treatment and allows general, indicative medical information alone (10). According to the ban, an individual medical consultation or treatment shall be given if it refers to a specific patient and his/her symptoms and if it will lead to a recommendation for diagnosis or therapy in a concrete situation (11), which means that the symptoms described by the patient are the reason to give him/her specific advice (12).
The case law does not make any exceptions, unlike occasional voices in literature, when it exclusively comes to the treatment of nervous disorders or to patients who are in general healthy, but asks questions about diseases which are usually treated by way of self-medication (13). It rather considers any kind of tele-therapy received by a patient without having been personally examined at least once by the physician in relation to the specific treatment as a potential health endangerment (14). Thus, it shall be forbidden to prescribe any medicine simply on the basis of information given by a patient over the phone (15), with the same applying to call centres giving patients specific advice or an individual diagnosis, or making a recommendation on therapies without having had any personal contact with the patient (16).
b) Tele-therapy provided by physicians located abroad
The Ban on Tele-therapy, however, only applies to medical services provided by a physician located in Germany. The provisions of the Ban on Tele-therapy pursuant to Section 7 of the respective professional codes only applies if the practicing physician is a member of the respective medical association or which he/she should be a member of. Memberships in medical associations regulate the legislation concerning medical professions and professional bodies of the German federal states. For Bavaria, for example, Art. 4 Sect. 2 Legislation concerning Medical Professions and Professional Bodies (Heilberufekammergesetz, HKaG) regulates that members of medical district associations are all physicians who are entitled to practice their profession, or, without practicing medicine, have their main residence in Bavaria within the meaning of the Law of Residence (Melderecht). The Legislation concerning Medical Professions and Professional Bodies thereby permits the connection to the usual place of residence in the respective federal state or the professional practice there. Thus, it is essential whether the respective service offered is a tele-therapy or a medical service offered by a physician in Germany.
The respective medical consultation service is not based on German provisions under professional law, if German patients make use of services offered abroad by physicians located abroad and who are subject to the respective local professional laws. In this respect, there is no difference whether the respective physician abroad provides his/her services directly to the patient during a practice visit by the patient, or whether the physician offers his/her services by means of tele-medical services, because the patient wants to save making the trip. This is the only purpose a tele-medical service shall offer, which is facilitating medical consultations by saving time making a trip, or sitting in waiting rooms. The physicians themselves always provide their services at their professional residences. The provisions under professional law applicable for the physician's place of practice apply in this case.
The underlying legal conditions for the provision of telematic diagnostics and therapy are each specified by the individual member state in which the healthcare provider has his/her place of practice. In this respect, the principle of country origin applies (17). This also follows from Directive 2011/24/EU. Art. 4 of the Directive specifies that medical services for cross-border healthcare provision shall be provided in accordance with the legislation of the member state offering the treatment. Consequently, the provision under Section 7 Para. 3 of the MBO-Ä and the standardised Ban on Tele-therapy therein do not apply to the physician practicing abroad. If the legislation governing the physician's place of practice allows the provision of services by way of tele-therapy, the physician does not act unlawfully.
eHealth in the form of a computerised, interlinked healthcare provision has been gaining ground. Both the EU Commission and the German legislative body have recognised the potential of a significant increase in efficiency and in enhancing compliance by use of eHealth and are trying to support it. While tele-monitoring is already permissible de lege lata, tele-medicine continues to face legal obstacles, in particular, in form of the Ban on Tele-therapy. The most important questions relating to data protection law, however, seem to have been answered and resolved by the legislator by way of a more effective protection. By following legal standards, the technical implementation should additionally help improve the users' confidence in the protection of their data. It should be reviewed whether patients ought to be protected beyond the existing level of protection with respect to the use of their health data being aggregated in a way that would harm their legitimate interests, e.g., in form of establishing patient profiles through insurance providers. Along with an access restriction on these data, the legislator should consider additional measures to protect patients from disadvantages to strengthen patients' trust in a collection of specifically health-related data and their use for the benefit of the patients.
Dr. Wolfgang Rehmann is Partner at TaylorWessing and one of Germanys leading experts in the field of pharmaceutical and medical product law. His clients include middle-sized and worldwide companies dealing with the manufacture and distribution of pharmaceutical, medical and medical technical products. Wolfgang Rehmann advises leading companies from the life science sector and represents them before the German courts as well as the European Courts in Luxemburg. Wolfgang Rehmann is also a Lecturer at the Universities of Münster and Marburg.
(1) see Paal/Pauly, General Data Protection Regulation - GDPR (original title: Datenschutz-Grundverordnung), 1st edition 2017, Art. 4 Para. 106 et seq.
(2) see also Büchner, Data protection and data security in the digitised medicine (original title: Datenschutz und Datensicherheit in der digitalisierten Medizin), MedR (Medical Law) 2016, 660 et seq.
(3) cf. MEDDEV (Medical Devices Guidance Document), 2.1/6. July 2016, Section 2 and examples for classification in Annex 1
(4) cf. Section II, 3. Annex VII of the new MDR
(5) see also MEDDEV 2.1/6, July 2016, http://www.mp-recht.de/images/PDF%20Startseite/2_1-6_Jul-2016_StandAlone_Software.pdf
(6) Scholz in Spickhoff, Medical law (original title: Medizinrecht) 2nd edition 2014, MBO Section 7 Para. 17; Krüger-Brand, Instructions on tele-therapy (original title: Hinweise zur Fernbehandlung), German Medical Association, yr. 113, issue 1–2, 11 January 2016, A8 et seq.
(7) Paland/Holland, Act on secure digital communication and applications in the health care system - E-Health Act (original title: Das Gesetz für sichere digitale Kommunikation und Anwendungen im Gesundheitswesen), NZS (new magazine on social legislation) 2016, 247
(8) Notes and explanations to Section 7 Para 4 of the MBO-Ä of 11.12.2015, www.bundesaerztekammer.de
(9) Minutes of the resolution, 118th German Medical Association, Annex to VI-07, Medical positions on areas of application in tele-medical patient care (original title: Ärztliche Positionen zu Einsatzgebieten telemedizinischer Patientenversorgung)
(10) Higher Regional Court of Cologne (OLG Köln), judgement of 10 August 2012, Ref. no. 6 U 235/11
(11) Krüger-Brand, Instructions on Tele-Therapy (original title: Hinweise zur Fernbehandlung), German Medical Association, yr. 113, issue1–2, 11. January 2016, A8 et seq. Higher Regional Court of Cologne, judgement of 10 August 2012, Ref. no. 6 U 235/11 – Juris margin no. 22; Regional Court of Munich I (LG München I), judgement of 31 January 2012, Ref. no. 1 HKO (County Constitution of Hesse) 14006/11
(12) Kern, About the admissibility of medical treatment via the internet (original title: Zur Zulässigkeit der ärztlichen Behandlung im Internet), MedR 2001, 495 (496); Hübner/Kreitz, Principles of tele-therapy and new approaches to further develop the ban on tele-therapy relating to the professional code for physicians (original title: Grundsätze der Fernbehandlung und neue Ansätze zur Weiterentwicklung des berufsrechtlichen Fernbehandlungsverbotes) in Fuchs/Kurth/Scriba, Report on care research (original title: Report Versorgungsforschung) vol. 4, Tele-medical methods in patient care (original title: Telemedizinische Methoden in der Patientenversorgung), p. 173 et seqq. (178); position of the German Medical Assembly - Hinweise und Erläuterungen zu § 7 Absatz 4 MBO-Ä)
(13) Higher Regional Court of Cologne (OLG Köln), judgement of 10 August 2012, Ref. no. 6 U 224/11.
(14) cf. Higher Regional Court of Cologne (OLG Köln), judgement of 19 October 2004, Ref. no. 21 BG (Employers' Liability Insurance Association) 1748/04
(15) Administrative Court of Frankfurt (Verwaltungsgericht Frankfurt), judgement of 19 October 2004, Ref. no. 21 BG 1748/04; see also Regional Court of Appeal for Medical Professions of Münster (Landesberufsgericht für Heilberufe Münster), judgement of 29 January 2003, Ref. no. 13T A 1039/01.T
(16) according to previous unanimous case law, see e.g., Higher Regional Court of Munich (OLG München), judgement of 2 August 2012, Ref. no. 29 U 1471/12; Scholz in Spickhoff, Medical Law (original title: Medizinrecht) 2nd edition 2014, MBO Section 7 Para. 14 et seqq.
(17) see also Beatrix Karl, Legal questions on cross-border diagnostics and therapy (original title: Rechtsfragen der grenzüberschreitenden Diagnostik und Therapie), Med 2016, 675, 677; Anna Kristina Kuhn, Limitations of digitised medicine de lege late and de lege ferenda (original title: Grenzen der Digitalisierung der Medizin de lege late und de lege ferenda), Health Law (Gesundheitsrecht, GesR) 2016, 748 et seqq.
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