This article was originally published in the July issue of Digital Health Legal, and has been republished with permission.
The telemedicine market in Russia has been rapidly developing for the past few years. The advent of high speed internet and advanced telecommunications has made telemedicine accessible across the country. Before State Duma approved a long anticipated Bill on Telemedicine and Federal Law No. 242-FZ 'On Amending Certain Legal Acts of the Russian Federation on the Use of Information Technologies in the Area of Health Care' (the 'Law on Telemedicine'), which became effective as of 1 January 2018, telemedicine services were operating without a legal framework in Russia. Julianna Tabastajewa and Meldir Erbulekova of Gowling WLG, discuss the Law on Telemedicine and the likely impact on the provision of healthcare in Russia.
The Law on Telemedicine
The Law on Telemedicine amended Federal Law No. 3-FZ 'On Narcotic Drugs and Psychotropic Substances' dated 8 January 1998, Federal Law No. 61-FZ 'On Circulation of Medicines' dated 12 April 2010, and Federal Law No. 323- FZ 'On Fundamentals of Healthcare of Russian Citizens' dated 21 November 2011. It introduces the concept of telemedicine technologies, resolves the issue of the identification of healthcare practitioners and patients during the provision of medical services with the use of telemedicine technologies, and provides for the creation of a 'Unified state information system in healthcare.' Article 2 of the Law on Telemedicine, in its introduction concerning the telemedicine technologies concept, defines such technologies as 'information technologies, which provide remote interaction of medical employees between each other, with patients and (or) their legal representatives, identification and authentication of those persons; documenting the actions they take when holding consultations; and remote medical monitoring of the patient's health.' For the purposes of identifying all participants in remote medical communication, the Telemedicine Law introduces the use of the Gosuslugi portal (https://www.gosuslugi.ru/), a unified information system, which through the process of identification and authentication, provides access to information contained in a database run by state authorities. The Law on Telemedicine also provides for the creation of a 'Unified state information system in healthcare' (the 'Unified System'). The Unified System intends to provide an online platform for citizens, which offers access to healthcare services and interaction with all healthcare information systems.
The Unified System will include the following information:
- information contained in federal healthcare information systems, federal healthcare databases and federal healthcare registers;
- information on medical organisations (except for medical organisations subordinate to the federal executive authorities, in which military service is obligatory);
- information on persons who conduct medical activities;
- depersonalised information on persons who receive medical aid as well as persons who are under medical expertise, examination or medical certification;
- information regarding medical records which do not allow the determination of the health condition of a citizen, or allow the provision of information on a medical organisation in which records are stored;
- information of statistical monitoring in healthcare, as well as analytical information on medical activity and medical aid;
- information on an organisation that is using hi-tech medical aid;
- information required for conducting monitoring and control in healthcare medical procurement for state and municipal purposes; and
- classifiers, reference books and other normative and referential information on healthcare.
The Law on Telemedicine also establishes regulation of e-document circulation.
All medical information obtained with the use of telemedicine technologies needs to be recorded by using the qualified electronic signature of the medical employee. Informed voluntary consent to medical intervention, or the refusal of medical intervention, which is a key part of an obligatory document to be completed prior to the provision of medical services, will soon be made available as an electronic document as well as in standard paper form.
The telemedicine market
Over the last six months, the telemedicine market has taken shape with the following key participants:
traditional medical clinics offering telemedicine services;
telemedicine aggregators; and
Medical clinics with telemedicine services are traditional licensed clinics with certified doctors, who in addition to offering face-to-face consultations may also conduct the consultation online. The prime examples are DoctorRyadom and ABC-medicine.
Telemedicine aggregators are online services, which provide platforms for conducting telemedicine consultations for offline clinics and patients. Being a middleman in telemedicine services the goal of such platforms is to simplify the search for a professional online for a patient and to simplify the process of making appointments for doctors. Since such platforms merely provide a technological solution, obtaining a medical licence is not required. The top telemedicine aggregators include DocDoc, Doctor Smart, and Medkompas.
Finally, online clinics are medical clinics, which provide telemedicine services and have medical licences. Telemedicine services are conducted by certified medical clinics but only after an initial faceto- face consultation has occurred and a prescription has been issued. Currently there are two online clinics operating in Russia - Yandex.Health and Doc+.
The impact on the healthcare industry Even though telemedicine has finally been legally allowed, the Law on Telemedicine is still considered to be rather restrictive. Under the new regulations, providing medical aid remotely with the use of telecommunications is possible only if an initial face-to-face consultation has occurred and a prescription has been issued. Therefore, telemedicine technologies cannot be used for establishing a diagnosis and prescribing medicines in the first instance.
Another restrictive factor is the obligation imposed on patients to login through the Gosuslugi portal, the unified information system, which through the process of identification and authentication, provides access to information contained in the database run by state authorities. Statistically, only 25% of the population of Russia have verified their Gosuslugi account, which significantly limits the scope of coverage of telemedicine services in Russia.
Despite the fact that information obtained through medical aid with the use of telemedicine technologies must comply with existing Russian laws on personal data and the requirements provided for physician-patient privilege, a lot of concern has been raised about the possible negative effects of shifting medical data to third party services, including the breach of physician-patient privilege, leaks of information and the disclosure and sale of personal medical data. Unfortunately, the remaining uncertainties on how to resolve these issues have not yet been addressed.
The Law on Telemedicine has provided a general framework for telemedicine technologies. Despite the expectations however, the new Law does not provide the grounds for reshaping the architecture of the healthcare industry since it only allows for the provision of medical checkups, not remote treatment itself. Even though the adoption of the Law on Telemedicine has not led to a revolutionary boom in telemedicine in Russia, businesses see the emergence of the new market positively. Wide territorial application and overcoming geographical barriers are deemed to be the main prerequisites for the sustainable development of telemedicine in Russia.