Legal Update No. 607
Goltsblat BLP advises that the Telemedicine Law1 has been signed by the Russian President. Its purpose is to establish a legal framework for using telemedicine technologies in Russia and allow electronic exchange of medical documents and legal recognition of electronic forms of medical documents.
The lack of regulation for remote medical services has long held back broad introduction of telemedicine technologies. The main disputes between the relevant authorities and the public have focused on how far telemedicine services could replace (or supplement) existing "physical" practices, on the limits to introducing telemedicine services and their status, specifically, the legal status of "virtual appointments" with specialists.
As adopted, the Law allows use of telemedicine technologies in/for:
- communications between doctors;
- communications between doctors and patients (their authorised representatives);
- identifying telemedicine service users
- documenting the actions of medical staff and patients (their representatives);
- holding case conferences and/or consultations;
- monitoring a patient's health remotely.
This list of telemedicine technology applications is exhaustive, limiting the possibility of remote diagnosis and full medical care and considerably narrowing the opportunity to use telemedicine services. Please note that the version of the Law considered by the State Duma in the first reading (see GBLP legal update dated 28 June 2017) gave much broader scope for application of telemedicine technologies.
Even so, the Telemedicine Law provides legal grounds for remote information exchange by medical institutions and pharma companies (their staff) with patients by:
- creating a Unified State Health Information System (USHIS) for information exchange between doctors, patients, medical institutions and pharma companies;
- allowing existing information healthcare systems to be integrated into the USHIS;
- allowing legally significant medical documents (opinions, statements, prescriptions for medical devices and medicines) to be issued as electronic documents signed with a qualified electronic signature;
- altering prescriptions remotely (following a compulsory initial face-to-face check-up).
Importantly, the Law makes the Government and relevant executive authorities responsible for a broad range of issues: among other things, they will have to elaborate a procedure for providing medical care using telehealth technologies and to develop USHIS requirements.
The Law comes into effect on 1 January 2018, apart from provisions relating to prescriptions for medicines containing narcotic or psychotropic substances, which come into force on 1 January 2019.
1 Federal Law of 29 July 2017 No. 242-FZ "On Amending Certain Legislative Acts of the Russian Federation Concerning Application of Information Technologies in Healthcare"
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