The procedure has been approved for organising and providing medical assistance using telemedicine

Pepeliaev Group advises that the Russian Ministry of Healthcare has approved Order No. 965n “On approving the procedure for organising and providing medical assistance using telemedicine technologies” dated 30 November 2017 (the “Procedure”).

The regulatory act was registered with the Russian Ministry of Justice on 9 January 2018 and came into force on 21 January 2018.

Please be reminded that also in 2017 the so-called Law on Telemedicine[1]was adopted, which was aimed at regulating the area of telemedicine technologies and provided for a number of current laws to be amended, in particular, federal laws No. 323-FZ “On the fundamentals of health protection in Russia” dated 21 November 2011, No. 3-FZ “On narcotics and psychotropic substances” dated 8 January 1998, and No. 61-FZ “On the circulation of medicines” dated 12 April 2010.

The Russian Ministry of Healthcare has approved a new Procedure to develop the above regulation in the area of telemedicine. In general the Procedure regulates the fundamentals of organising and providing medical assistance using telemedicine technologies.

Key developments

Remote interaction at the ‘doctor-doctor’ and ‘doctor-patient (authorised representative)’ level has been regulated

According to the Procedure, interactions between doctors are permitted for the purpose of obtaining an additional opinion for a consultation and/or so that a doctor participates in a board of doctors with respect to assessing a patient’s state of health, specifying the diagnosis, determining the prognosis and tactics for a medical examination and treatment, or determining whether it is reasonable to transfer the patient to a specialised unit of the medical institution, or to carry out a casualty evacuation. At the same time such interaction is permitted to be in emergency, first aid or planned form; a consultation can be given in a real-time and/or in a mode when a doctor may respond offline at a later time.

Remote interaction between healthcare specialists is also possible for the purposes of obtaining a protocol of the board of doctors with respect to assessing a patient’s state of health, specifying the diagnosis, determining the prognosis and tactics for examination and treatment, determining whether it is reasonable to transfer the patient to a specialised unit of the medical institution, or to carry out a casualty evacuation.

According to the Procedure, remote interaction between the doctor and patient (his/her authorised representative) is also possible. In this respect the Procedure repeats the provisions of article 36.2 of Federal Law No. 323-FZ dated 21 November 2011 which regulates the possible purposes of such interaction.

The rules for organising remote interaction have been determined for medical institutions that provide consultations: requirements for the infrastructure and employees

The Procedure permits the provision of first aid, specialised assistance, including hi-tech, medical assistance, emergency assistance, including specialised emergency medical assistance, and palliative medical care using telemedicine technologies.

In order to properly perform the above functions, the medical institution must ensure the corresponding infrastructure and technical support (premises, equipment, mobile devices, etc.) for providing medical consultations remotely. it can be organised, among other things, using the Unified State Healthcare Information System, as well as using the information system of a constituent entity of the Russian Federation, the system of the medical institution or a system of third parties, such systems being designated for collecting, storing, processing and providing information related to the activities of medical institutions and their services.

However, please note that the Regulation on the Unified State Healthcare Information System has been submitted for approval to the Russian Government, and has not yet been adopted.

At the same time the patient (his/her authorised representative) should be provided in a clear form, including by way of publishing on the Internet, with the corresponding information about all parties involved in the remote interaction, including about the information system itself and the procedure and conditions of providing telemedicine advice (including, but not limited to, the procedure of documenting the informed voluntary consent of the patient to medical treatment, the consent to the processing of personal data and data about the patient’s state of health, issues of the patient’s identification and authentication, technical requirements for electronic documents that are provided by the patient (his/her authorised representative) to the doctor, etc.).

It is specified separately that medical consultation can be provided only by current employees who are medical personnel of the medical institution which is providing the medical consultation. Information about these employees must be entered into the Federal Register of Medical Personnel. For the consultations they provide, doctors will be liable to the extent of the medical opinion they have given.

In order to start providing medical assistance using telemedicine technologies on a lawful basis, the medical institution that provides medical consultations must register with the Federal Register of Medical Institutions of the Unified State Healthcare Information System.

It is permissible to provide remote medical assistance outside of the medical institution, on an outpatient basis, day-patient basis and inpatient basis. The conditions of medical assistance are determined by the actual location of the patient.

When the doctor in charge provides remote advice, he/she can adjust the previously prescribed treatment, including generating prescriptions in electronic form for a medicine, and can perform remote monitoring of the patient’s state of health (provided that the patient was diagnosed and the treatment was prescribed by the doctor in charge during an appointment which took place in person). The information is to be sent to the patient (his/her authorised representative) in electronic form, or the specified persons shall be granted remote access to the corresponding information.

Issues with respect to the identification and authentication of the parties involved in interaction have been regulated

According to the Procedure, for the purposes of identifying and authenticating the parties involved in the remote interaction the Unified Identification and Authentication System must be used. It follows from this that persons, including patients, who are not logged in with the Unified Identification and Authentication System will not be able to use this option of providing telemedicine assistance. This fact significantly restricts the number of potential users.

The rules have been established for documenting and storing the information received as a result of telemedicine interaction

The Procedure establishes that all the documents and information relating to interaction using telemedicine technologies must be stored for the timeframes established, including with the help of the information systems used by the medical institution which provides consultations. The documents must be certified by an encrypted digital signature. The corresponding information will be also entered into the patient’s electronic medical record; the patient is entitled to obtain excerpts and copies from such electronic medical record in accordance with the procedure stipulated by the law.

Importance and prospects

The application of the Law on Telemedicine will, as before, be largely determined by the the corresponding second level regulations approved by the Russian Ministry of Healthcare and other authorised regulators. When the Procedure was approved (which is currently the most detailed regulatory act that directly regulates practical aspects of applying telemedicine), this in fact was the beginning of the lawful usage of telemedicine technologies in the provision of medical assistance.

Please note that the Law on Telemedicine still requires the adjustment and enhancement of a significant amount of regulations and standards for the provision of medical assistance with a detailed regulation of instruments which are presupposed by telemedicine technologies. In this regard the approval of the Procedure has become the first, but is not the only, step for the institution of telemedicine consultation to work in Russia.

Please note that the Procedure covers only the area of providing medical assistance using telemedicine technologies. And the medical activity is not limited to providing medical assistance using telemedicine technologies as follows from its definition specified in Federal Law No. 323-FZ dated 21 November 2011. For this reason the Procedure cannot be extended to other types of medical activities provided for by the law.

In addition, the state regulator still leaves a number of important issues undeveloped in relation to the integration of medical legislation and legislation on information technologies and legislation on personal data, the regulation of the usage of digital signatures, electronic medical records, the storage of documents, the compatibility of information systems, methods and so on with aspects of participation in the provision of telemedicine consultation. These gaps and discrepancies currently significantly restrict the number of potential users.

What to think about

The adoption of the Procedure offers practical implementation with the opportunities for lawful, efficient and regular interaction between doctors, and for doctor-patient interaction, as well as for providing the patient with large amounts of information about new methods, ways and means of treatment, for adjusting prescriptions, for performing preventive care of diseases, for increasing such interactions, and for collecting information about the state of a patient’s health and the systematic monitoring of same.

We recommend that players on the healthcare market, including suppliers of hardware and software based solutions in this area, review the new regulation, and conduct an audit of current telemedicine consultation activity in terms of whether it complies with the legislation on telemedicine.

Help from your adviser

Pepeliaev Group’s lawyers are ready to provide advice on any matters connected with consulting and legal assistance during the implementation and organisation of the work of the new instruments in accordance with the legal regulation of telemedicine.