Telemedicine technologies have been legalised for usage in healthcare
Pepeliaev Group advises of the adoption of Federal Law No. 242-FZ “On amending certain legislative acts of the Russian Federation regarding the application of information technologies in healthcare” dated 29 July 2017 (the “Law on Telemedicine”).
The new regulation mostly comes into force from 1 January 2018. However, certain special provisions on prescriptions for separate categories of strong drugs will take effect on 1 January 2019.
The Law on Telemedicine has not been passed as a separate legislative act aimed at the individual regulation of telemedicine technologies. Instead, it provides for amendments to be made to a number of current laws, in particular: Federal Law No. 323-FZ “On the fundamentals of health protection in Russia” dated 21 November 2011 (“Law No. 323-FZ”): Federal Law No. 3-FZ “On narcotics and psychotropic substances” dated 8 January 1998 (“Law No. 3-FZ”):and Federal Law No. 61-FZ “On circulation of medicine” dated 12 April 2010 (“Law No. 61-FZ”).
Innovative solutions and technologies, the application of which is to be legalised by the Law on Telemedicine, do not require additional licensing from persons who use them. New instruments can be applied within the framework of current licences to perform medical activities.
It should be noted that, at present, the Law on Telemedicine does not reflect all opportunities provided by modern technologies that might be used in Russian healthcare; however, it is important that legislature has made the first step in this direction. In fact the new regulation provides for a smooth transition to innovative methods of interaction between those involved in the healthcare sector.
Telemedicine as an innovative auxiliary area of medicine is based on the application of modern communication and information technologies to provide remote medical assistance to patients. This type of medicine has been developing for a long time and is widely used all over the world.
If we look at foreign experience of applying telemedicine technologies, then, as one would expect, this area has become the most developed in the USA, Australia and European countries. In the USA, for example, the main drivers are insurance companies which, as distinct from the current Russian healthcare system, apply a risk-related insurance system.
In countries with a developed market of telemedicine technologies, doctors use almost all forms of audio and video conferencing to communicate with the patient, and they broadly use different formats for the transfer and storage of information in medical archives. In addition, at the level of state programmes, electronic systems are actively implemented, mobile applications are being developed as well as other technological resources used for storing medical information and providing quick access to information for the doctor and the patient. The list of medical services supplied, among other things, by applying modern technologies, in such countries is also constantly growing. It should be noted that in the Western system of healthcare regulation, telemedicine is considered to be an element of a larger and more intensively developing area – eHealth/Mobile Health.
Key developments
The term 'telemedicine technology' has been defined and its designation has been determined
The corresponding amendments have been made in the list of general definitions of Law No. 323-FZ (article 2). These amendments define telemedicine technologies as information technologies that ensure remote interaction of healthcare professionals between themselves, with patients and/or their authorised representatives, the identification and authentication of the above persons, and the documentation of all actions performed by the above persons when they have a meeting of board of doctors, provide consultations, and remotely supervise their patients’ health.
Also article 10 of Law No. 323-FZ, which characterises the quality and availability of medical assistance, has been amended with a provision that at present the specified principles shall be ensured using telemedicine technologies. Therefore, telemedicine is intended not only to improve access to medical services, but to have a positive influence on the quality of care and supervision of patients, as well as on increasing the professional standard of healthcare specialists, and their practical skills.
The composition of medical assistance supplied using telemedicine technologies has been determined.
To have an opportunity to implement in practice the meaning of the above telemedicine technologies, article 36.2 has been inserted into the new version of Law No. 323-FZ. This article is dedicated to the provision of medical assistance using the above technologies. Consultations with individual doctors and groups of them, and remote monitoring of the patient’s state of health now can be conducted using telemedicine technologies ensuring remote interaction based on the principle ‘doctor-doctor’, ‘doctor-patient/authorised representative’. When a doctor and a patient are interacting using telemedicine technologies it is permissible to provide consultations for preventive care purposes, to collect information about the patient, to assess how efficient diagnostic and treatment measures are and to adjust them, and for medical supervision. Yet, a remote supervision is prescribed only after an initial consultation in person between the patient and the doctor.
The legislature has set this restriction on purpose in the process of the adoption of the draft of the Law on Telemedicine because the healthcare sector had misgivings and was not ready to make an absolute and total transition to remote consultations.
It has also been established that remote interaction will be performed after authentication and identification those taking part in such interaction, and all information must be collected, stored and processed taking account of the requirements established by the legislation on personal data, and in compliance with patient confidentiality.
The provision concerning information support in healthcare has been amended
A Unified State Healthcare Information System is intended to be created and used within the framework of federal state healthcare information systems, information systems of the Federal Fund of Compulsory Medical Insurance and its regional funds, state information systems of constituent entities, and medical information systems of medical and pharmaceutical organisations.
In the near future, we can expect the above information systems to be created in the healthcare sector, and integrated at the federal as well as at the regional levels, and in the private sector; they will be able to compete between themselves, actively developing the new market.
It is permitted to execute and issue medical documents and information in electronic form
The Law on Telemedicine, in addition to other medical documents, has introduced an opportunity to issue prescriptions, including prescriptions for strong drugs (narcotic and psychotropic substances) in electronic form with an enhanced encrypted digital signature. The corresponding adjustments have been made in article 26 of Law No. 3-FZ, and to the relevant provisions of Law No. 323-FZ and Law No. 61-FZ.
It is also permitted to document the informed voluntary consent of the patient (its authorised representative) to medical treatment or a refusal of such treatment, and at the request of the patient (his/her authorised representative) to provide documents and information reflecting the state of the patient’s health.
Importance and prospects
Now that the Law on Telemedicine has been adopted, the development is in progress of its legal use when providing medical assistance.
As technologies develop and as they are actively implemented in healthcare, the issue of the availability of medical assistance may be solved in the near future.
However, it appears that the use of innovative instruments will most likely be unable to reduce the quantity of medical consultations, except for areas in which the need is solely to deliver information to the patient. Moreover the quantity of necessary ‘patient-doctor’ interactions may even increase, especially in areas which require constant monitoring, for example, with respect to chronic diseases, infections, oncology, diabetes, arterial hypertension, etc.
Also, there is a risk that intermediaries (providers of telemedicine services), working mainly in private healthcare would impose additional services on patients. This led to one of the reasons why, at the stage of adopting the draft law, the legislature significantly restricted potentially wider opportunities to apply telemedicine.
It is important to note that the Law on Telemedicine provides for references to additional regulation by the authorised federal executive body. This means that the practical application of the Law on Telemedicine will be largely defined by the corresponding regulations of the Russian Government, the Russian Ministry of Healthcare and other authorised regulators. The Law on Telemedicine require a significant number of current legislative acts, procedures and standards of medical assistance to be adjusted and worked through, with detailed regulation of what instruments are permitted to be applied, as well as of how and in what situations they are applied.
The practical implementation of the new developments of the Law on Telemedicine, in particular, in the state sector, may face technical difficulties – at the outset, not all regions will be duly equipped with the necessary technical means to implement new opportunities in practice. Such difficulties, in our opinion, may arise in the state healthcare sector and in the compulsory medical insurance system owing to the principle of per capita financing under which local organisations may lack the financing needed for re-equipment and practical training for specialists to provide medical assistance using telemedicine. In this regard, private healthcare may be more flexible and adapt quicker to the innovative approach, which will create competitive advantage; this, of course, relies on patients being ready to pay for new opportunities.
The appearance in Russia of the institution of telemedicine certainly stimulates the development of other areas of legal regulation which may be applied to it. Therefore, telemedicine will be implemented in the private sector in the form of paid medical services; accordingly, the requirements for information about such services fall under the regulation of consumer protection legislation.
What to think about
The adoption of the Law on Telemedicine opens new opportunities for efficient and regular doctor-patient interaction, 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. This will lead to a new telemedicine market in the healthcare sector being formed that will function on legal grounds. It will also create a new market for suppliers of hardware and software based solutions.
Help from your adviser
Pepeliaev Group’s lawyers are ready to provide advice on any matters connected with advising and legal assistance during the implementation and organisation of the work of new instruments in accordance with the legal regulation on telemedicine.