Telemedicine bill passes its first reading

28.06.2017

Legal Update No. 601

Goltsblat BLP advises that the telemedicine bill 1 (“the Bill”) passed its first reading on 15 June. Its purpose is to establish a legal framework for using telemedicine technologies in the Russian Federation.

Legislative gaps have hampered broad introduction of telemedicine technologies into the medical system. 2015–2016 saw public discussions of several draft acts on the legal status of telemedicine technologies. The main disputes between the stakeholder authorities and the public focused on how far telemedicine services can replace (or supplement) the existing “physical” ones, the limits on introducing telemedicine services and their status. For instance, can prescriptions be issued electronically and is seeing a medical specialist online the same as face-to-face?

Telemedicine technologies are defined quite broadly in the Bill as healthcare information and communications technologies allowing information exchange participants to collaborate remotely in providing healthcare, including their identification and electronic exchange of medical documents.

The Bill’s main points include:

  • the possibility of using healthcare telemedicine technologies for patient and medical staff consultations and collaboration between medical personnel;
  • recognition of the results of remote monitoring of a patient’s state of health;
  • the possibility of issuing legally significant medical documents (opinions, statements, prescriptions for medical devices and medicines, including ones containing narcotic and psychotropic substances) as electronic documents signed with a qualified electronic signature;
  • for organising use of telemedicine technologies, creation of a Unified State Health Information System (USHIS), with its rules to be elaborated by the RF Government.

The Bill charges the Government and responsible executive authorities with handling a significant number of questions. These authorities might be the Ministry of Health, Roszdravnadzor and, for certain aspects, the Ministry of Communications and/or Roskomnadzor.

The lack of a subordinate regulatory framework would make practical introduction of more advanced telemedicine services difficult. After all, even with the law, there will be no technical specifics or rules for collaboration and a service offered on the market might necessitate adaptation to subsequent regulations.

The Bill (rather than regulations) could do with specifying a number of the provisions more precisely:

  • a clearer mechanism is required for patients to consent to their data being entered in USHIS and for identifying users within USHIS;
  • no restrictions have been set on access to USHIS information for various categories of user, including insurance and pharma companies, this being crucial for pharmacies to recognise electronic prescriptions;
  • considering the multitude of private healthcare information systems on the market, a procedure for information exchange and protection of patient details on transfer to (integration into) USHIS is vital;
  • the requirements on services and devices receiving patients’ medical information in real time, as well as how and by whom the results of such remote patient health monitoring can be used, should be specified in detail;
  • deadlines should be set for competent state bodies to develop and enact the requisite regulations.

The effective date set in the Bill is 1 January 2018, apart from the provisions on issuing controlled drug prescriptions, which come into force on 1 January 2019.

Comments on the Bill are to be presented by mid-July 2017. We will let you know how consideration of the Bill goes and any amendments to it.

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1Draft act No. 174692-7 “On amendment of certain legislative acts of the Russian Federation on application of information and telecommunications technologies and maintenance of electronic documents in healthcare”

  

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