The article originally appeared in eHealth Law & Policy, Volume:3, Issue:7 (July 2016), and has been re-published with permission.
Draft Bill does not provide for detailed regulation
The advent of high speed internet and telecommunications has made telemedicine possible in Russia. Aiming to overcome geographical barriers and increase access to healthcare services, more medical institutions are using telemedicine. With the growth of IT infrastructure and network speeds, new online telemedicine platforms have been launched over the past few years. Although de facto telemedicine is used in the country, de jure it does not exist, with no regulation specific to telemedicine. This means that a remote diagnosis is not formally recognised and thus a patient cannot be treated based on such a diagnosis.
The country’s first attempt to regulate telemedicine and eHealth was in 2001. The Ministry of Healthcare (‘MoH’) adopted The Concept of Development of Telemedicine Technologies No 76, dated 27 August 2001 (‘Concept’). Even though this did not provide for legal regulation and the document was of a declaratory nature, it provided some useful definitions. It defined telemedicine as ‘medical-diagnostic consultations, administrative, educational, scientific measures in healthcare carried out with the help of telemedicine technologies.’ It set out the main telemedicine trends in Russia, including:
- Consultancy/mentoring where communication is established between a patient and a consulting physician or a medical student and a professor;
- Telemonitoring of functional indications where patients’ data is transmitted to a consulting centre;
- Telemedicine lecture/seminar where communication is established with the lecturer speaking to all participants, and where the participants can speak only to the lecturer; and
- Telemedicine meeting, a symposium where all participants can communicate with each other.
Four types of telemedicine consultation were established:
- Where the patient’s situation is discussed by the doctor or medical consultant in the patient’s presence or absence;
- Where the patient’s data is transmitted directly from the medical equipment;
- Where the doctor consults members of a rescue team; and
- Where the general public are provided with access to a doctor’s consultation.
The Concept states that ‘internet medicine’ includes: informational support on clinical medicine with respect to patient consultancy; healthcare directory services; medical and statistical information; access to library databases; information of an administrative character; information in the sphere of telemedicine; and plans on conducting conferences, exhibitions and informational messages upon termination.
Implementation was a lengthy process. When the bill On Information Communication Technologies in Medicine No. 308883-4 was introduced in 2011 to Parliament, it was soon excluded from consideration. In 2016, a new Bill on telemedicine was introduced. Governmental organisations such as the Internet Initiatives Development Fund drafted a bill No. 1085466-6 on amending federal law On the Fundamentals of Health Protection in the Russian Federation and Article 10 of the federal law On Personal Data (the ‘Bill’). The Bill was introduced to the State Duma on 30 May 2016 and is still under consideration.
It defines telemedicine technologies as ‘a complex of organisational, technical and other measures used for rendering medical services to the patient with the use of procedures, means and methods of transmission of data via communication channels which ensure authentic identification of the participants of informational exchange, i.e. a healthcare practitioner and a patient or his/her lawful representative.’ The idea behind this broad definition was to enable the MoH to adjust to industry developments.
The Bill envisages two main goals of telemedicine: to establish communication between health practitioners, and between health practitioners and patients. In relation to the latter, the Bill has as a condition that such communication must be aimed at determining whether a live consultation is required.
The Bill resolves the issues of identification of healthcare practitioners and patients in the course of rendering medical services via telemedicine. The document does restrict medical practitioners to certified doctors. In other words, the provisions of the Bill enable the conduct of consultations remotely between paramedics and certified doctors, often an issue in rural areas of Russia with limited access to medical institutions.
Russian law does not contain any eHealth legislation but there is no legal prohibition on a patient contacting their consulting physician in any manner, including online. The current Bill does not provide for detailed regulation but does draw telemedicine out of legal uncertainty.