Russian Federation: Telemedicine Law In Russia

Last Updated: 22 February 2018
Article by Ilya Goryachev

Most Read Contributor in Russian Federation, August 2018

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

Information Systems

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.

Unified system

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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions