Signed and published decree government on the establishment of a new experimental legal regime for remote monitoring of the state of health of citizens using special devices – personal medical assistants (PMA), which will transmit and accumulate data in a special information system.
How informs Ministry of Economic Development, these data will be anonymized. Patient participation in the experiment will be voluntary. Attending physicians will be able to use the data to monitor the vital signs of patients in real time (at the first stage: blood pressure, heart rate, glycemia), which will be recorded mainly by domestic medical devices.
The experiment involves medical organizations of the Republic of Tatarstan, Novosibirsk, Samara, Tyumen, Ryazan and Magadan regions. The experiment will allow “not only to carry out remote monitoring of the health status of patients, but to accumulate an array of data, which is planned to be subsequently analyzed and processed using artificial intelligence technologies,” the Ministry of Economic Development reports.
The gained experience of remote monitoring of the state of health of citizens, as expected, will make it possible to develop legal mechanisms and, with their help, change the general regulation.
The draft resolution was presented in September. The document explained that the initiative involves remote monitoring of the health of patients with chronic diseases (diabetes mellitus, arterial hypertension) using medical devices and wearable devices (for example, smart watches, fitness bracelets) that can collect, store and transmit data on the health status of individuals as an additional source of information in the provision of disease prevention services.
The experiment will last two years, Rostec has been appointed its operator.
Simplified legal regimes in the field of digital innovation are called the regulatory sandbox. This is a special legal environment for testing new products, which helps to reduce business costs and accelerate the implementation of promising ideas. The rules that apply in the sandbox are limited to a certain territory. If the pilot regulation proves effective, it could be extended to the entire country.
The President signed the Law on Experimental Legal Regimes on July 31, 2020. It entered into force on January 28, 2021. The law defining the scope of innovative “regulatory sandboxes” was signed in July 2021 and came into force from the day of its official publication.