January 2018 was the first time in a Russian jurisdiction a specific law on telemedicine technologies took effect—namely the Federal Law on amending certain legislative acts of the Russian Federation on issues of applying information technologies in healthcare systems.
For effective operation, the telemedicine law requires a number of by-laws.
So far, on 9 January 2018 the Russian Ministry of Justice registered the Ministry of Health Regulation on approving procedure of arranging and rendering medical care with use of telemedicine technologies, which specifically deals with telemedicine technologies in medical care.
As such, adoption of the telemedicine law is a reflection of the Russian authorities’ incentives of increasing level of using the modern technologies in healthcare sector.
It should be noted that telemedicine as such is not unknown in Russia, and there were examples of use of telemedicine technologies in the Russian healthcare system.
The attention of the Russian government was on telemedicine technologies in 2015 when the development of telemedicine technologies was listed among the government priorities in healthcare sector.
The government-approved development strategies for the specific Russian regions listed a necessity to provide healthcare entities with telemedicine devices. In 2016, the Russian president specifically outlined in his speech before the Russian Parliament that use of information technologies would significantly increase efficiency of control over essential medicines resulting in elimination of fake and counterfeit products. Furthermore, mobile application technologies relating to healthcare sector were also introduced. For instance, Yandex, one of the major IT companies in Russia and Europe, launched its online medical consultation service Yandex-Zdorovie.
Until recently there was no specific legislation of telemedicine technologies, as well as no framework rules or procedures.
Furthermore, impossibility to issue online prescription orders by medical professionals was viewed as a restraint on developing modern IT use in the healthcare sector.
One of the purposes of the telemedicine law is to make available medical aid with the use of telemedicine technologies by having medical advice and case conferences, ensuring remote cooperation between doctors as well as between a doctor and a patient or their legal representative, and the distant monitoring of a patient’s health.
Definition of telemedicine technologies
Telemedicine law defines telemedicine technologies as information technologies ensuring:
- Remote cooperation of medical professionals with each other, with patients and / or their representatives
- Identification and authentication of medical professionals, patients and / or their representatives
- Record-keeping of measures taken during case conferences, medical advice, remote medical monitoring of a patient’s health
Use of telemedicine technologies is now a tool ensuring access and quality of medical aid.
General personal data protection rules as well as provisions on physician-patient privilege are mandatory.
The record-keeping process will involve the use of encrypted certified digital signature.
Medical organisations receive a right to develop information systems containing data on the patients, on medical aid and medical activity personal data laws and physician-patient privilege needs to be complied with.
The Telemedicine law sets forth purposes of medical advice with use of telemedicine technologies:
- Preventive care, gathering and analysis of a patient’s complaints and previous case history, evaluation of diagnostic and treatment activities as well medical surveillance
- Decision-making process on whether a face-to-face visit is required
While giving medical advice with the use of telemedicine technologies the attending professional is allowed to adjust the treatment on condition that the diagnosis was set and treatment was prescribed during a face-to-face visit.
Remote medical surveillance over a patient is exercised by the attending professional after a face-to-face visit, based on the data:
- Registered with use of the medical devices, intended for health monitoring
- State healthcare information system (unified federal or regional): [i] medical information system [ii] other information systems under conditions to be approved by the Russian government
Types of telemedicine technologies
The Telemedicine Regulations provide that telemedicine technologies are used for the following types of medical aid:
- Primary healthcare
- Specialised medical care, including high-technological medical care
- Urgent (including high-technological) medical care
- Palliative medical care
The main principle behind the use of telemedicine technologies is that they may be rendered under any conditions: outside the medical organisation, on outpatient or inpatient basis and as a day-patient department mode.
Conditions of medical aid are determined based on the actual location of the patient.
Case conferences (councils of physicians) with use of telemedicine technologies are held:
- Urgent form: in case of sudden acute diseases and conditions as well as during acute exacerbation of a chronic disease when there is a threat to the patient’s life
- Emergency form: in case of sudden acute disease and conditions as well as during acute exacerbation of a chronic disease without evident signs of a threat to the patient’s life
- Regular form: during preventive actions, in case of diseases and conditions that do not pose a threat to the patient’s life and not requiring urgent and emergent medical care, if the delay of it does not entail health deterioration or a threat to the patient’s life and health
The telemedicine law provides that data support in healthcare is exercised by developing and using the healthcare information systems:
- Federal state healthcare information systems
- Healthcare information system of the federal or territorial compulsory medical insurance funds
- State health information system of the constituent part of the Russian Federation
- Information system of a medical organisation
- Information system of a pharmaceutical organisation
The healthcare information system deals with the information on entities in state, municipal and private healthcare systems, as well as with other information in healthcare.
Personal data operation rules as well as physicianpatient privilege are mandatory for the healthcare information system.
The healthcare information systems will be managed by:
- The Ministry of Healthcare and other federal authorities and their territorial divisions
- Regional healthcare authorities and entities authorised by them
- Federal or territorial compulsory medical insurance funds
- Medical and pharmaceutical organisations
Specific requirements for the healthcare information system will be set by the Ministry of Healthcare.
The telemedicine law provides for the unified information system which will be set to ensure access to healthcare services in the electronic form as well as cooperation in the healthcare information system. The unified system of identification and authentication will be implemented to ensure use of telemedicine technologies.The Russian government will approve the rules on managing the unified system, access to information in it and the information exchange procedure.
The unified system will include the following data:
- From the federal healthcare information systems as well as from federal databases and registers
- Information on medical organisations, except for medical organisations under jurisdiction of federal authorities where military service is held
- Information on medical professionals
- Information on patients and persons for medical examinations, health inspection and medical clearance is exercised
- Information on medical documentation from which it is possible to determine health condition, and information on a medical organisation where the documents at issue are gathered and stored
- Information of statistical survey in healthcare sector, as well as consolidated analytical information on medical activity and medical aid
- Information on high-technological medical aid
- Data necessary to exercise monitoring and control in state and municipal tenders for drugs
- Information on provision of drugs, medical devices and specialised medical food under the social care legislation
- Classification codes, reference texts and other regulatory references
The sources of information for the Unified system will be:
- The Ministry of Health and other competent federal executive authorities
- Competent regional executive authorities as well as municipal authorities
- Federal compulsory medical insurance fund and regional compulsory medical insurance funds
- Medical and pharmaceutical organisations as well as operators of Information systems; The unified system will allow the user to obtain medical services on-line by using the unified portal for state and municipal services.
Drug prescription orders in electronic form
Prescriptions, including for drugs that contain narcotics and psychotropic substances under the specific rules on the form, may be issued in the electronic form on consent of the patient or their representative. However, the decision whether electronic prescriptions will be used in the specific constituent part of the Russian Federation is at the discretion of the local healthcare regulators. It shall be noted that on 13 December 2017, the lower chamber of the Russian Parliament adopted in the first hearing the draft law, which specifically allows online retail sale of over-the-counter medicines by drug stores.
Telemedicine technologies and intellectual property
Taking into account that use of telemedicine technologies are closely linked to information system, IT solutions applied will require due protection. The general rule is that patents are not granted for software in Russia.
Software is protected as a copyright asset. The exclusive right to software emerges in Russia due to the fact of creation of copyright. However, discretional registration of the software in the Russian Patent Office may be exercised, thus increasing the level of protection.
Furthermore, since use of telemedicine technologies affects the use of medical devices with data transmittance functions, the specific attention is invited to claim construction for invention and utility model patents. Industrial design protection for such medical devices is also useful.
Since as a result of the telemedicine law the drug prescriptions orders will be kept in electronic form, the question remains open on whether the data on such prescriptions may be used in patent enforcement litigation, in particular, in cases relating to patents involving treatment process claims.
Overall, the telemedicine law may be seen as a welcoming sign in terms of the increasing use of information technologies in the healthcare sector.
While a lot needs to be done (also in terms of adopting by-laws and infrastructure development), the telemedicine law is among the necessary steps in creating a more enhanced market for software and medical devices.