Hello, SaaS | Trackers outlawed?
Very useful information for those who make cloud services, IoT startups and devices that work with the application in the field of medicine. I cite further the original Source Letter No. 01I-2358/15 of December 30, 2015 “On Registration of Software” . From the list of functional and software assignments, it is obvious, for example, that trackers synchronized with smartphones through the application require registration and certification with the Ministry of Health. Is it so?
On the subject matter
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In accordance with paragraph 1 of Art. 38 of the Federal Law of 21.11.2011 N 323- “On the basis of the protection of the health of citizens in the Russian Federation” (hereinafter the Law) medical products are any tools, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as with other accessories necessary for the use of these products for the intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation tion of diseases of the human body monitoring state, medical research, reduction, substitution, modification anatomical structure or physiological function of the body, preventing or interrupting pregnancy whose function is realized by pharmacological, immunological, genetic or metabolic effects on the human body.
Thus, in case the software is intended by its manufacturer for:
it is a medical device and is subject to state registration with Roszdravnadzor in the established manner, with mandatory confirmation by the manufacturer of its quality, effectiveness, and safety.
At the same time, we inform you that, depending on the purpose determined by the manufacturer of the specific software, the software can be classified as medical devices for self-use as well as for sharing with other medical products.
Thus, if the software gives the data for analysis to the doctor and he makes a diagnosis based on this data, then the software must be certified. For personal purposes, use anything.
What will help FRIA, Iran and Yandex
The main thing is not to help them - the list above closes the rather critical areas of health monitoring. As far as I know, the partially declared tasks of the institutional working groups will be tasks indirectly related to health. Rather, the idea was created for the lobby of the "business model" and the opportunity to earn (except for paragraph 1). According to my personal feelings, all the tasks are fairly simple in terms of legalization, but under point 1, the picture will be similar to the standardization of electronic interdepartmental workflow - it has been trying to create for about 20 years, and “it's still there”.
1) Development of standards for similar SNOMED CT, HIPPA , LOINC, ICD-CM and electronic recipes, as a result.
2) Creating a regulatory framework for the provision of medical advice through the Internet.
3) Calling doctors through the Internet.
4) Purchase of medicines and drugs online.
Telemedicine refers to "the processes of providing remote medical care using the Internet capabilities to a patient by a doctor, and if it is impossible to communicate with him, by an appropriate intellectual or robotic system." In addition to the traditional areas, the concept of "telemedicine" includes the possibility of buying drugs in electronic pharmacies, including using electronic recipes.
On the part of the Dental Cloud team, we will be pleased to take part in the work of groups of development institutions.
Previous materials of the author.
On the subject matter
')
In accordance with paragraph 1 of Art. 38 of the Federal Law of 21.11.2011 N 323- “On the basis of the protection of the health of citizens in the Russian Federation” (hereinafter the Law) medical products are any tools, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as with other accessories necessary for the use of these products for the intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation tion of diseases of the human body monitoring state, medical research, reduction, substitution, modification anatomical structure or physiological function of the body, preventing or interrupting pregnancy whose function is realized by pharmacological, immunological, genetic or metabolic effects on the human body.
Thus, in case the software is intended by its manufacturer for:
- management of equipment operation and monitoring of its operation;
- receiving diagnostic data from equipment, their accumulation and calculation in automatic mode;
- monitoring the functions of the human body and transmitting the received data (including through wireless technologies);
- calculating dose selection parameters (radiation, drug, radiopaque substance, etc.);
- for processing data obtained from diagnostic medical equipment, transferring them to planning and therapy systems;
- medical image processing (including changes in its quality, color resolution, etc.);
- for 3D modeling;
- communication diagnostic and therapeutic equipment;
- for processing digital images (including unaltered data from diagnostic equipment),
it is a medical device and is subject to state registration with Roszdravnadzor in the established manner, with mandatory confirmation by the manufacturer of its quality, effectiveness, and safety.
At the same time, we inform you that, depending on the purpose determined by the manufacturer of the specific software, the software can be classified as medical devices for self-use as well as for sharing with other medical products.
Thus, if the software gives the data for analysis to the doctor and he makes a diagnosis based on this data, then the software must be certified. For personal purposes, use anything.
What will help FRIA, Iran and Yandex
The main thing is not to help them - the list above closes the rather critical areas of health monitoring. As far as I know, the partially declared tasks of the institutional working groups will be tasks indirectly related to health. Rather, the idea was created for the lobby of the "business model" and the opportunity to earn (except for paragraph 1). According to my personal feelings, all the tasks are fairly simple in terms of legalization, but under point 1, the picture will be similar to the standardization of electronic interdepartmental workflow - it has been trying to create for about 20 years, and “it's still there”.
1) Development of standards for similar SNOMED CT, HIPPA , LOINC, ICD-CM and electronic recipes, as a result.
2) Creating a regulatory framework for the provision of medical advice through the Internet.
3) Calling doctors through the Internet.
4) Purchase of medicines and drugs online.
Telemedicine refers to "the processes of providing remote medical care using the Internet capabilities to a patient by a doctor, and if it is impossible to communicate with him, by an appropriate intellectual or robotic system." In addition to the traditional areas, the concept of "telemedicine" includes the possibility of buying drugs in electronic pharmacies, including using electronic recipes.
On the part of the Dental Cloud team, we will be pleased to take part in the work of groups of development institutions.
Previous materials of the author.
Source: https://habr.com/ru/post/299526/
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