Monitoring went to the experiment – Newspaper Kommersant No. 235 (7436) of 12/19/2022

The Ministry of Economy and the Ministry of Health have agreed to launch the first pilot project in the field of medicine, which will be carried out using an experimental legal regime (EPR). Rostec’s initiative “Personal Medical Assistants”, which will provide remote monitoring of 25,000 patients with diabetes and hypertension by 2025, received approval from the departments. At the same time, as industry experts point out, it is not yet worth waiting for the approval of other projects in the field of medicine to be launched within the framework of the EPR due to disagreements between departments.

Rostec’s pilot project “Personal Medical Assistants” will be the first initiative in the field of medicine and healthcare, which is being implemented as part of the EPR. The government published the corresponding decree on Friday last week. Recall that the federal law “On experimental legal regimes in the field of digital innovations” came into force from the beginning of 2021. It allows the government to give the companies participating in the experiments the right to temporarily deviate from existing legislation within the so-called regulatory sandboxes in certain territories. According to the idea of ​​its developer, the Ministry of Economy, EPR should stimulate the creation and implementation of innovative technologies, including in the field of medicine. However, in almost two years that have passed since the appearance of the EPR, the Ministry of Economy and the Ministry of Health have not been able to agree on a single such initiative (for more details, see Kommersant of January 14).

This autumn, the Ministry of Health published a draft government decree on the launch in 2023 of a pilot for remote monitoring of the health status of patients with diabetes and hypertension. As Kommersant previously wrote, the development of the technological platform – the Personal Medical Assistant information system – is being carried out by the enterprises of the Ruselectronics holding, which is part of the Rostec state corporation. As follows from the version of the decree signed by the head of government Mikhail Mishustin, the pilot project will last two years, during which time 25 thousand people will gradually connect to it. To participate in the pilot, they must live in one of the six regions of the Russian Federation – Novosibirsk, Samara, Tyumen, Ryazan, Magadan regions and Tatarstan.

Boris Zingerman, a member of the ANO Tsifrovaya ekonomika working group on regulatory regulation, explains that this year alone, the group has considered eight applications for conducting pilot projects in the field of medicine as part of the EPR. “There were also initiatives to promote telemedicine technologies and remote examinations of workers and the processing of medical data. However, the Ministry of Economy was able to coordinate with the Ministry of Health only the pilot project of Rostec,” he says.

At the same time, according to Boris Zingerman, it is not clear why the pilot needs to be carried out as part of the EPR. “It is possible to examine a patient at an appointment, give him a diagnostic device and subsequently receive data from it under the current legislation,” confirms Vladimir Dmitriev, founder of TeleMedHub LLC. He recalls that similar projects have already been launched in the Russian Federation, and not only in pilot mode – for example, in Tyumen. “The Rostec initiative is hardly different from them, except for the scale and the desire, as part of the pilot, to create a new data exchange protocol, to which only a part of the participants in the medical device market will be able to connect,” he says. However, Vladimir Dmitriev believes that in the future, the emergence of such a project will indeed not only improve the monitoring of the health status of a large number of Russian patients with the most common pathologies, but will also increase the detection of diseases at an early stage and, as a result, may reduce the burden, including on primary health care.

At the same time, as Boris Zingerman says, it is not yet worth waiting for the approval of other projects in the field of medicine to be launched as part of the EPR, since the Ministry of Health “probably would like to regulate the parameters of their work by separate by-laws.” “Until business proposals are formulated taking into account the recommendations and opinions of doctors, hospitals and, as a result, the ministry itself, it is hardly worth waiting for successful coordination of such initiatives within the framework of the EPR,” adds Vladimir Dmitriev.

Anastasia Manuylova