Digital Healthcare 2021

Last Updated June 30, 2021

Russia

Law and Practice

Authors



Lidings is a highly ranked law firm in Russia, advising local and multinational companies with different industrial backgrounds in Russia and the Commonwealth of Independent States (CIS). The firm has extensive experience in the life sciences sector, assisting large multinational and Russian life sciences companies across the entire scope of their needs. The practice group comprises 11 qualified lawyers and provides a full service to the industry; everything from IP and product liability support to highly specialised regulatory support, to day-to-day corporate, commercial, tax and employment advice, and bankruptcy assistance.

From a non-regulatory perspective, the description “digital healthcare” seems broader than “digital medicine”: “digital health” covers any IT technology which supports digital interaction in the medical sphere, as well as storage of the received data, whereas “digital medicine” refers to IT systems, which support remote interaction between patients and doctors. In Russian, however, no distinction is made between these two terms. The same goes for the legislation (for more information, see 1.2 Regulatory Definition).

Russian legislation does not provide for the terms “digital health” and “digital medicine” directly. Instead, there is an umbrella definition - “telemedicine technologies”.

In accordance with Federal Law No 323-FZ “On fundamental healthcare principles in the Russian Federation”, dated 21 November 2011, telemedicine technologies are regarded as information technologies providing remote interaction between health workers, patients or their representatives, as well as identification and authentication of specified persons, recording of the actions during conciliums (that is, convocations of three or more experts to confer and give advice), consultations, and remote medical supervision of a patient’s health status. Hence, the current definition is quite objective and covers any process in digital healthcare that is carried out through any kind of information technologies. The initial communication between doctor and patient is the only exclusion stage of healthcare which cannot be done with telemedicine technologies.

The key technologies enabling new capabilities in digital healthcare are mobile apps, video- and audio-conference services, artificial integrity, etc. They all help, almost, to replace the personal visit to the medical organisation and provide clear and secure channels of communication.

The main emerging legal issue in digital health is the physician-patient privilege. The digital communication channels become subject to third parties’ interference, which leads to certain concerns about further telemedicine technologies' protection and its security development in Russia. Another crucial problem is the storage of patients’ personal data. It has been raised due to the specific and quite complicated General Data Protection Regulation (GDPR) legislation in Russia. In particular, there are many mandatory requirements that should be met by any personal data-provider and the realm of medicine is no exception. The problem of under-qualified specialists in digital healthcare market should also be highlighted. Currently, the legislation is trying to solve this problem by requiring a mandatory connection to the Unified State Information System in the field of Healthcare (EGISZ) and this has already produced some good results.

The COVID-19 pandemic has given rise to a powerful launch of the development and implementation of telemedicine, both in Russia and around the world. Firstly, the digital trade of non-receipt drugs and medical devices has seen an increase in demand, as Russian law provides no strict restrictions on their sale and delivery. As a result, not only pharmacies but also groceries and digital marketplaces have started selling drugs and medical devices with “door-to-door” delivery. Secondly, remote medical consultation increased in popularity during 2020. For example, the official statistic of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) reveals that the number of requests increased in times. Thirdly, a global system of COVID-19 monitoring has been launched. This system provides people with information on possible contact with infected people, if they have visited similar places, as well as having a special reporting mode for people with positive COVID-19 test results, who should inform the government through this system on their health status and location, on a daily basis.

Digital healthcare can play an important role in addressing the public-health dangers driven by climate change because of faster provision of medical help and spreading access to more highly qualified specialists around the world. For the spring of 2021, so far, no specific decisions driven by digital healthcare instruments have been taken, nor plans and strategies established to eliminate or reduce public-health dangers related to climate change.

The key regulatory agencies in the Russian Federation (RF) are the Ministry of Health of the Russian Federation and the Federal Service for Surveillance in Healthcare.

The Ministry of Health (Minzdrav) is the federal executive body responsible for drafting and implementing government policy and legal regulation in the areas of:

  • healthcare;
  • mandatory health insurance;
  • the production and distribution of pharmaceuticals for medical use, including disease-prevention measures (such as for AIDS and other infections);
  • medical treatment;
  • rehabilitation and appraisals (excluding medical-social and military medical appraisals);
  • pharmaceuticals' activities such as ensuring the quality, efficacy and safety of pharmaceuticals for medical use;
  • the production and distribution of medical products;
  • the sanitary and epidemiologic welfare of the population;
  • medical and sanitary support for people employed in industries with dangerous working conditions;
  • the medical-biological assessment of the health hazards associated with hazardous physical or chemical factors; and
  • the resort and recreation industry;

as well as:

  • the management of state property and provision of state services related to healthcare, such as medical services;
  • the introduction of modern medical technology, new disease-prevention methods, diagnostics, treatment and rehabilitation methods, forensic tests and psychiatric appraisals, organisation of associate, university level, postgraduate and additional medical and pharmaceutical education, and resort and rehabilitation services.

According to Government RF Regulations No 608, dated 19 June 2012, develops the procedure for organising and providing medical care via tele-medicine technologies.

The Ministry of Health co-ordinates and supervises the operation of its subordinated services and agencies, including the Federal Supervision Service for Healthcare, the Federal Medical-Biological Agency, federal state institutions and unitary enterprises, and co-ordinates the work of the Federal Mandatory Health Insurance Fund.

Federal Service for Surveillance in Healthcare (Roszdravnadzor) was established by the President of the Russian Federation in Decree on 9 March 2004 No 314 “On the System and Structure of the Federal Executive Bodies” and is a federal executive body responsible for the control and supervision of the healthcare system.

The Federal Service for Surveillance in Healthcare operates directly or through its regional offices in co-operation with other federal agencies, state executive bodies, local authorities, public associations and other institutions.

Firstly, the amendments to Federal Law No 323-FZ, dated 21 November 2012, which introduced tele-medical technologies as an integral part of the medicine, were adopted. They provided the ground for the future development and regulatory acknowledgement of digital healthcare. For example, lately, the Ministry of Health has approved the "Procedure for the organisation and provision of medical care using telemedicine technologies".

Secondly, the labelling system of medical drugs began; its main purpose is to control the entire route of medicine drugs from manufacturer to consumer and, as a result, decrease the number of fabricated, defective or infringing medical drugs to a minimum on the Russian market. According to clause 7.1 Article 67 of Federal Law No 61-FZ, dated 12 April 2010, all medical drugs manufactured after 1 July 2021 should be labelled with a special code. Also, manufacturers and sellers should be registered in a national monitoring system under Government RF Regulations No 1556, dated 14 December 2018.

In future, it is intended that mandatory labelling will be extended to medical devices as well. Currently, the national monitoring system is one of testing and showing positive results.

Current practice reveals that the key areas of regulatory enforcement include medical drug circulation and supervision over medical organisations' activity. Under Regulations on state supervision over quality and safety of the medical activity (approved by the order of Roszdravnadzor, the department of Ministry of Health (RZN), No 5974, dated 10 July 2020) the RZN carries out the investigation of medical organisations and medical personnel as well as the evidentiary purchase, in order to test the complying of medical products and services with standards and quality. As a result of the investigation, the RZN provides the inspected party with an instruction to cure the revealed breach within a certain period and, generally, a fine for its breach. The amount of the fine is specified under Articles 6.28, 6.33, 6.34 of the Code of the Administrative Offences of the Russian Federation and can vary from RUB50,000 RUB to RUB5 million, depending on the severity of the offence. In serious cases the activity of the imposed party can in addition be suspended for a period of up to 90 days.

Respectively, the investigated party should pay the fine and cure the revealed breach. If the investigated party fails to comply with the RZN’s instruction, more serious sanctions such as licence revocation can be imposed. Also, the investigated party is entitled to dispute the RZN’s instruction if it does not agree with it.

The Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor) and the Federal Service for Supervision of Communications, Information Technology and Mass Media (Roskomnadzor) are non-healthcare regulatory agencies involved in digital healthcare.

Rospotrebnadzor provides supervision and control of wellbeing and consumer rights and protection of the citizens in Russia. It also adopts legislation in the field of consumer rights' protection, as well as the development and approval of the state sanitary and epidemiological guidelines and hygienic norms. In addition, Rospotrebnadzor is responsible for the sanitary and epidemiological surveillance and monitoring of consumer rights' protection.

Roskomnadzor is a federal executive body responsible for supervision over GDPR. It concerns the digital healthcare in the realm of data storage and transition via telemedicine technologies.

The wellness, fitness and self-care organisations are preliminary commercial in Russia. However, their activity is also subject to state regulation by the aforementioned organisations. Due to the development of IT, wellness, fitness and self-care organisations have raised popularity by providing remote or at-home services via a special internet service platform or mobile apps. The state healthcare technologies and the IT used by commercial organisations are different. Nevertheless, there is the possibility of data exchange between different IT systems.

According to Article 38 of Federal Law No 323-FZ, dated 21 November 2011, any software can be used as a medical device if it is designated for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the condition of the human body. The state authority in charge of medical-device registration (including software) is Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Under the Order of the Ministry of Health of the Russian Federation (Minzdrav RF) No 686н, dated 7 July 2020, the potential risk class is assigned to the software regardless of the potential risk class of the medical device in combination with which it is used. Also, the classification is based on the following criteria: the type of information and the conditions for using the software. Each piece of software can be assigned to only one class of potential risk of use:

  • class 1 – low-risk software;
  • сlass 2a – medium-risk software;
  • class 2b – high-risk software;
  • сlass 3 – high-risk software.

It should be noted that Russian law recognises the AI software as a type of software, which is subject to registration as a medical device if it also meets the aforementioned criteria. At the same time, there are no legislative clarifications regarding further steps/amendments with respect to development of the software, which is a big concern for the business and society today. 

The goals of using telemedicine technologies are:

  • prevention, collection, analysis of patient complaints and anamnesis data;
  • evaluation of the effectiveness of medical and diagnostic measures;
  • medical monitoring of the patient's health status;
  • making decisions about the need for an in-person doctor's appointment (examination, consultation).

Telemedicine technologies can be used in the provision of:

  • primary healthcare;
  • specialised care, including high-tech, medical care;
  • emergency medical services, including specialised emergency medical services;
  • palliative care.

According to experts from the healthcare industry A. L. Tsaregorodtsev and A. A. Karpunov, in Russia in the current conditions of strong inequality in access to medical services, telemedicine can expand the opportunities of the population to receive qualified medical care. The prospects for the development of telemedicine in the Russian Federation are determined by a number of factors, including:

  • low population density in most regions;
  • the remoteness of localities from district and regional centres;
  • insufficiently developed transport infrastructure, depending in addition on the time of year and weather;
  • the irregularity and high cost of passenger transportation;
  • severe climatic conditions in the northern regions and in locations equivalent to the northern regions of the country;
  • lack of qualified medical personnel in sparsely populated and remote regions of the country.

At the same time, another important function of telemedicine, in addition to overcoming geographical inequality, is to reduce the costs of the health system.

Due to the fact that telemedicine regulation was formed before COVID-19, there were not many changes in this regard. The crucial impact of COVID-19 was the widespread lack of information about such remote possibilities for people to access medical information. The main concern of medical organisation now is the delivery of medical drugs and devices from door to door. The regulation has to be improved in this respect, but no certain news has been provided yet.

The Russian government does not provide a special-regulation status for online platforms such as Zoom and Microsoft Teams, etc.

There are no special rules regarding payment for new telehealth services. Generally, such kinds of services are paid for by bank cards via virtual payment services.

From pregnancy testing kits to surgical instruments, artificial joints and MRI scanners, the medical technology (medtech) industry designs and manufactures a wide range of products. Technology is allowing these devices to generate, collect, analyse and transmit data, creating the Internet of Medical Things (IoMT). The Internet of Medical Things (IoMT) is an amalgamation of medical devices and applications that can connect to healthcare information technology systems using networking technologies. Medical devices equipped with Wi-Fi allow the machine-to-machine communication that is the basis of the IoMT. The IoMT is also known as the healthcare IoT. Examples of the IoMT include remote patient-monitoring of people with chronic or long-term conditions; tracking patient-medication orders and the location of patients admitted to hospitals; and patients' wearable mobile health devices, which can send information to care-givers. Infusion pumps that connect to analytics dashboards and hospital beds rigged with sensors that measure patients' vital signs are medical devices that can be converted to or deployed as IoMT technology.

Wearable technology devices can provide up-to-date monitoring of high-risk patients to determine the likelihood of a major health event.

Some of the most common of these devices include:

  • heart-rate sensors;
  • exercise trackers;
  • sweat meters – used for diabetics to monitor blood-sugar levels;
  • oximeters – monitors the amount of oxygen carried in the blood and is often used by patients with respiratory illnesses such as COPD or asthma.

Chatbots and virtual health assistants are AI-based technology that patients are becoming familiar with. Chatbots can fill a multitude of roles from customer service representatives to diagnostic tools and even therapists. However, relying entirely on chatbots is a big risk for the patient. Artificial intelligence can only suggest a diagnosis based on a set of symptoms, but for an accurate diagnosis, a doctor must be consulted.

The increasing numbers and capability of connected medical devices present additional risks for data security. The scale and cost of breaches is often significant and far-reaching.

Currently, 5G networks are still under a period of examination in very limited territories and providers and are not allowed for the use of most civilians in Russia. Thus, it is impossible to evaluate the impact of the 5G networks on digital healthcare in Russia.

The goals of using telemedicine technologies do not include such areas of pharmaceutical industry as research and trial settings.

Regulatory frameworks for other goals previously mentioned do not differentiate between data use and data sharing. Communication between doctor (consultant) and patient or between doctors with regard to the patient, data use and data sharing can be done only in the relevant governmental system or other systems which comply with the applicable requirements. In addition, the doctors or consultants can enter the system only by using their personal enhanced qualified electronic signature.

AI has become a focus of developments for healthcare in Russia starting from the period of the COVID-19 pandemic. Several companies in Russian focused on MedTech technologies. At the moment, only anonymised data can be submitted for AI services.

In order to use the technology in real medical practice, a medical-device registration certificate is required. The task is complicated by the fact that Russian legislation still does not have specific standards governing the operation of AI services. This applies to the preparation of datasets, the conduct of clinical and technical tests of services, and the standard for integrating these services into the business processes of medical institutions.

The National Programme "Digital Economy" launched by the Russian government prioritises the digitalisation of healthcare. A large-scale experiment conducted by the Department of Health of the City of Moscow on the use of AI services in the radiation diagnostics is being conducted. The results of the project will form the basis for national standards governing the use of AI in clinical medicine.

The National Centre for Informatisation (NCI) has created a technological system for making medical diagnoses and prescribing treatment using machine learning and artificial intelligence algorithms. This information was announced on 21 April 2021. The NCI has purchased specialised software for big data analysis to implement the project. It is assumed that the AI will compare the patient's anamnesis with the depersonalised data of other patients whose electronic medical cards are entered in the governmental system. The AI will analyse medical records, tests, X-rays, CT scans, and make a diagnosis with a certain degree of probability, as well as recommend the optimal therapy.

However, it would be incorrect to draw any conclusions on common-use scenarios, specific regulations, particular upgrades and trends before the results of the large-scale experiment are known.

It is too early to give a definitive answer, as the first approved experiments of using AI and machine learning (including a legal base) in Russia are still in progress. The relevant conclusion is drawn in 10. AI and Machine Learning.

It is too early to give a definitive answer, as the first approved experiments of using AI and machine learning (including a legal base) in Russia are still in progress. The relevant conclusion is drawn in 10. AI and Machine Learning.

The scope of patent, copyright and trade-secret protection in digital health is the same as in a general rule.

Patent protection covers inventions representing a technical solution in any field relating to a product or process; utility models that are devices which are the result of intellectual activities in the scientific and technical field, and industrial designs that are the result of intellectual activities in terms of the appearance of the product. The invention can only be protected if it is new, if it has an inventive level, and if it is capable of industrial application. A utility model can only be protected if it is new and capable of industrial application. An industrial pattern can only be protected if it is new and original.

In contrast to copyright, which has protected the copyright work since its foundation, the patent is only protected after registration with Rospatent. The right to obtain a patent belongs to the inventor, his or her employer (in the case of an invention of the employee) or his or her successor or successors. The patent application is filed with Rospatent for examination.

The maximum period of patent protection is 20 years from the date of the patent application for an invention, with the possibility of extending the patent for pharmaceutical products, pesticides and agrochemicals for up to five years, for years from the date of application for a utility model, and for five years from the date of application for an industrial design, with the possibility of extending the period by five years, which may be extended so that the total term of the patent for an industrial design may be up to 25 years.

A patent licence and/or assignment agreement must be registered with Rospatent. It is possible to obtain a compulsory licence by a court decision.

Copyright covers scientific, literary or artistic work that is the product of creative activity, regardless of the value, type or mode of expression of the work. Copyright protects both disclosed and undisclosed works. Copyright protection arises when a work is created. There are no registration requirements.

Chapter 70 of the Civil Code sets out exclusive property rights over the work, as well as moral rights for the author of the work.

Exclusive rights include the right of reproduction, the right of distribution, the right of demonstration to the public, the right to import or export originals, and the right to provide access to the work by any means of telecommunication (including the internet).

Moral rights include the right of authorship, the right to the name, the right to preserve the integrity of the work, and the right of publication.

The exclusive rights to the works are protected for the lifetime of the author plus 70 years.

Trade secrets and confidential information can be protected as know-how. Know-how must not be registered. However, the owner of confidential information must undertake certain reasonable measures to maintain the confidentiality of the relevant information. If such measures are not implemented, the confidential information will not be protected. The know-how must have an actual or potential value for it to be legitimately protected from third parties.

One of the legal ways to acquire know-how protection is to implement the "trade secrets regime" under the Federal Law of the Russian Federation No 98-FZ "On Trade Secrets" dated 29 July 2004. The owner must identify the confidential information properly, limit access to the confidential information (by establishing the appropriate procedure for dealings with the same), affix the notice "trade secret" to the medium where the confidential information is stored (along with the owner's details), and follow the other steps required by the law (for example, define the procedure for dealings with the confidential information).

If one or more of these steps is ignored or omitted by the owner of the confidential information, the "trade secrets regime" will not apply and the information will not be protected as know-how. However, the "trade secrets regime" is not the only option for know-how subsistence and protection, as the owner of confidential information may take certain other (reasonable) measures to preserve secrecy.

Know-how is protected for as long as it is kept secret by its holder. If confidentiality is lost, the exclusive right to know-how will lapse immediately.

Databases, in as far as concerns their protection against unauthorised retrieval and repeated use of the materials available in the contents thereof, are covered by allied rights.

The manufacturer of a database owns the following:

  • the exclusive right of the manufacturer of the database;
  • a right to indicate his or her or its name on copies of the database and/or on the packaging thereof;
  • a right to promulgate a database, that is, to make the database in the first instance  accessible for the general public by way of its publication, bringing it to public notice, broadcasting over air or by cable, or in some other way.

The manufacturer of a database whose creation (including the processing or presentation of the relevant materials) requires significant financial, material, organisational or other costs owns an exclusive right to retrieve materials from the database and subsequently use them in any form and in any manner (the exclusive right of the manufacturer of the database). The manufacturer of the database may dispose of that exclusive right. Unless otherwise proven, a database whose creation requires significant cost is a database comprising at least 10,000 independent elements (materials) of information making up the content of the database.

Nobody is entitled to retrieve materials from a database and subsequently use them without the permission of the right-holder.

The exclusive right of the manufacturer of a database comes into being as of the time of completion of its creation and it will be in effect for 15 years, from January 1st of the year following the year in which it was created.

Inventions and works of authorship created by AI technologies without direct human contributions are not regulated by law. Therefore, they are not subject to IP. However, the State Duma proposes to introduce norms on artificial intelligence (AI) into the Civil Code of the Russian Federation. In particular, it is proposed that intellectual property rights, including audio and video content or analytical materials created with the help of AI, be assigned to its developers. Regulation of this industry is overdue, but in practice, authorship will be difficult to divide between human and machine.

As a rule, the exclusive rights to the results of an employee's intellectual activity belong to the employer.

However, if the employer cannot use, license or assign the work of its employees within a certain period of time, or if the employer does not inform the employee that it has decided to keep the work secret, the exclusive rights to the work (or invention) will be transferred to its author. This does not apply to know-how.

The exclusive rights to the results of intellectual activity created under a contract which has the creation thereof as its subject-matter (by order), shall be held by the client.

It is too early to give a definitive answer, as the first approved experiments of using AI and machine learning (including a legal base) in Russia are still in progress. The relevant conclusion is drawn in 10. AI and Machine Learning.

It is too early to give a definitive answer, as the first approved experiments of using AI and machine learning (including a legal base) in Russia are still in progress. The relevant conclusion is drawn in 10. AI and Machine Learning.

It is too early to give a definitive answer, as the first approved experiments of using AI and machine learning (including a legal base) in Russia are still in progress. The relevant conclusion is drawn in 10. AI and Machine Learning.

It is too early to give a definitive answer, as the first approved experiments of using AI and machine learning (including a legal base) in Russia are still in progress. The relevant conclusion is drawn in 10. AI and Machine Learning.

Lidings

1st Krasnogvardeysky proezd
15, Mercury Tower
Moscow
123100
Russia

+7 495 989 44 10

+7 495 989 44 20

Moscow@lidings.com www.lidings.com
Author Business Card

Trends and Developments


Authors



Lidings is a highly ranked law firm in Russia, advising local and multinational companies with different industrial backgrounds in Russia and the Commonwealth of Independent States (CIS). The firm has extensive experience in the life sciences sector, assisting large multinational and Russian life sciences companies across the entire scope of their needs. The practice group comprises 11 qualified lawyers and provides a full service to the industry: everything from IP and product liability support to highly specialised regulatory support, to day-to-day corporate, commercial, tax and employment advice, and bankruptcy assistance.

Trends and Developments in Digital Healthcare

In 2021, digital healthcare continues to develop and new trends in it are appearing, such as the use of 3D-printing technologies and the creation of new automated systems for data storage in hospitals. Despite great development in digital healthcare during the COVID-19 pandemic, much has yet to be done in the direction of medical healthcare. Among new trends in the development of healthcare, the following can be highlighted.

Development of regenerative and cellular technologies for human organ transplantation

One of the trends which is appearing in Russia and in the world is the development of 3D-printing technologies for creating skin and organs. Companies established in Russia for these purposes help to create functional living organs, which can be implanted in the human body. This will eliminate the need for human organ transplantation. The use of 3D bio-printing technology to create organs from a patient’s stem cells could be the solution to the problem of immune-system compatibility, and with time, the technology could open up the possibility of receiving organ prototypes. It would lead to great improvements in human health and could also help to create a new industry and high-tech jobs.

Using automated expert systems (big data, blockchain technology, etc)

In order to accumulate, collect and store data, medical organisations use different information systems. In this way, the mutual transfer of information between different medical information systems (and medical institutions) can be carried out correctly and fully.

Well-known projects in Russia include “SMSmame” (https://SMSmame.ru, an innovative educational service for pregnant women and young mothers), and “Button of Life” or “Life Button” (https://knopka24.ru/, medical social panic-button for the elderly, adults and children with disabilities). One mobile solution that should be mentioned is the “Alive Heart and Activity Monitor” system (http://www.alivetec.com/), developed by Alive Technologies (Australia) in co-operation with the Moscow State University. It is used for the diagnosis and monitoring of chronic heart disease. The Alive Heart Monitor is a wireless health-monitoring system for the screening, diagnosis and management of chronic diseases, and for consumer health and fitness.

Use of innovative technologies for training and professional development of doctors and medical insurance agents

Development in this direction will establish a real practice to attract medical colleagues for remote consultations; this is especially important for Russia, with its huge territory and profusion of remote localities, since it will allow a doctor to obtain advice remotely from more experienced colleagues and to solve a patient's complex problem. In this sphere, there are the following trends:

  • the provision of technology to search for, integrate and process medical information about a patient from various information sources using modern intelligent systems (Semantic Web);
  • the integration into a common network of distributed semantic repositories created by various organisations (health authorities, medical organisations, research centres, professional communities, universities, etc), based on common open standards (Linked Open Data);
  • the implementation of joint projects to organise an interstate electronic medical data space;
  • the systematisation, cataloguing and classification of all types of medical knowledge, and the provision of access to this data;
  • the provision of support for electronic scientific journals and other online resources that support the publication of scientific results.

Disruptive technologies and disruptive innovations in digital healthcare lead to the reform of the legal environment

The main trends in digital healthcare which have an impact on legal regulation are as follows:

  • the rise of on-demand healthcare;
  • the importance of big data in healthcare;
  • treating patients by means of virtual reality;
  • the growth of wearable medical devices;
  • mobile health;
  • predictive healthcare;
  • the wonders of artificial intelligence;
  • blockchain and the promise of better electronic health records.

Among the legal challenges that digital healthcare is faced with that can be named:

  • the crucial issue that medical software developers have to deal with is cybersecurity;
  • another key point is regulatory requirements.

There is an increasing demand for transparency and data exchange, which fuels insightful decisions. There are new challenges and opportunities for digital healthcare manufacturers connected with the new business models (eg, health-based social platforms – patients querying symptoms, discussing disease burdens and care opportunities, health apps – prevention via lifestyle management, using electronic medical records, medical devices, mobile health – bringing treatment to the patients rather than patients to the treatment). COVID-19 has highlighted the importance of digital health to the critical role of medicines across the patient-care pathway in the future. From a legal standpoint, it seems that companies carrying out activities in the sphere of digital healthcare are changing management and compliance culture and integrating compliance principles into business practice.

The main legal trend which can be found in the field of digital healthcare in Russia is the development of the legal environment to support automatic systems used in the healthcare sphere. In particular, this support is connected to personal data protection and developments regarding the form and order of obtaining a personal data processing consent from a patient. In order to make personal data processing in digital healthcare more effective and safe, it is necessary to improve legal regulations governing the exchange of information in the healthcare sector, eg, the Regulations on the Unified State Information System in Health Care approved by the Government of the Russian Federation. One of the legal trends in telemedicine technologies is to make regulation applicable to telemedicine more flexible. There are proposals to change the rules for providing medical care remotely in emergency situations or when there is a threat of spreading an infectious disease. It will allow doctors in epidemic or emergency situations to conduct primary examinations, make final diagnoses and prescribe treatment remotely, using telemedicine technologies without the need for face-to-face admissions. However, the bill has still not been introduced to the State Duma of the Russian Federation, although available since June 2020. One of the main problems in Russian telemedicine is that there is no clear distinction between consultant services and telemedicine services. The main goal of future legal developments is to clarify where the dividing line between these two different services is to be found.

There is a growing tendency for pharmaceutical companies to turn from simple manufacturers and sellers of medical drugs and devices into multi-functional medical corporations. Pharma or medical-device producers sponsor medical care for their consumers through their own programmes, dedicated to supporting, counselling, and training patients and care-givers. Producers have also introduced to the Russian market products containing a so-called "digital component" (eg, a dashboard) which provides healthcare professionals (HCPs) with the possibility of the remote control of a patient’s health information, which is also regarded as telemedicine. The aforementioned tendencies in the pharmaceutical market suggest to legal practice new challenges regarding the regulatory aspects of patient-support programmes and the circulation of digital pharmaceutical products. Advertising in the healthcare sphere is also becoming digital. Marketing communication has developed from a single channel to multiple channels and is primarily concentrated in social media (Instagram, Youtube) and influencers, at the same time that content marketing is gaining strength. In this regard, one of the legal trends in the sphere of digital healthcare advertising is compliance with so-called "soft" rules of law developed by professional associations or digital platforms.

Thus, telemedicine, artificial intelligence-enabled medical devices, and blockchain electronic health records are just a few concrete examples of the digital transformation in healthcare which is completely reshaping the methods of interaction with health professionals, the way data is shared among providers and the way decisions are made about a patient’s treatment plans and health outcomes and thus in this respect is facilitating the reshaping of the legal environment.

Lidings

1st Krasnogvardeysky proezd
15, Mercury Tower
123100
Moscow
Russia

+7 495 989 44 10

+7 495 989 44 20

Moscow@lidings.com www.lidings.com
Author Business Card

Law and Practice

Authors



Lidings is a highly ranked law firm in Russia, advising local and multinational companies with different industrial backgrounds in Russia and the Commonwealth of Independent States (CIS). The firm has extensive experience in the life sciences sector, assisting large multinational and Russian life sciences companies across the entire scope of their needs. The practice group comprises 11 qualified lawyers and provides a full service to the industry; everything from IP and product liability support to highly specialised regulatory support, to day-to-day corporate, commercial, tax and employment advice, and bankruptcy assistance.

Trends and Development

Authors



Lidings is a highly ranked law firm in Russia, advising local and multinational companies with different industrial backgrounds in Russia and the Commonwealth of Independent States (CIS). The firm has extensive experience in the life sciences sector, assisting large multinational and Russian life sciences companies across the entire scope of their needs. The practice group comprises 11 qualified lawyers and provides a full service to the industry: everything from IP and product liability support to highly specialised regulatory support, to day-to-day corporate, commercial, tax and employment advice, and bankruptcy assistance.

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