Medical devices and telemedicine
After implementation of Federal Law, No 242-FZ dated 07.29.2017 “On the implementation of changes in certain legislative acts of the Russian Federation regarding the application of information technologies in healthcare” (also known as “the Telemedicine Act”), the question may emerge (and for many it has long since emerged): what is the proper definition for the term “telemedicinal device”. There are also many associated issues and questions, such as: Whether it is important to distinguish such medical devices among the general ones, or whether they have certain specific features. Shall we expect new medical devices of that kind to appear on the market? How many medical devices of that kind are already circulating within the territory of the Russian Federation, and would this number be enough to satisfy potentially increased demand? Are there any additional requirements related to the devices concerned? Etc., etc.,
Regulations and legislation discussed in terms of the application of telemedicinal technologies and information technologies in healthcare mostly detail related services, the way those services are to be rendered and their specific features, describe related information systems and how to build them, although the scope of telemedicinal devices is rather poorly clarified.
If we look at the definition of “telemedicinal technologies” (Federal law dated November 21, 2011, No, 323-FZ, “On the basics of public healthcare in the Russian Federation”), it states the following:
“Telemedicinal technologies are information technologies aimed at providing remote communication between health care providers (HCP) and between HCP and patients (or their legal representatives), and to ensure identification and authentication of the said persons, as well as documenting any and all action they take or perform during consultancy sessions, consensus meetings, or remote patient monitoring”.
Based on this, one can suppose that various medical devices might be necessary for the above stated purposes, such as:
- Medical systems for conference calls
- Medical systems for consultation sessions
- Various information-related systems or modules to be used with the systems already available, e.g., software or software-hardware bundles, intended for tasks such as identification, documenting, data transfer etc.
- Devices for remote monitoring and observation of health parameters
Etc. etc. “Expansion modules” also may emerge, both of a general nature and/or specific items, used for the transformation of “non-telemedicinal” into “telemedicinal” ones.
Speaking about items 1 and 2 of the above list, one can say that it is quite possible to identify specific features and provide an acceptable definition for a “telemedicinal device for conference calls and/or consultations”. Moreover, the Nomenclature Classification of Medical Devices by Type, posted on the Roszdravnadzor website, already has similar code types, namely:
- 234250, System for telemedicinal video conferences; an integrated universal system to be used within the telemedicinal service area in order to provide remote medical advice and/or assistance in live mode by means of computerized networks and video conference call equipment in various settings such as within the same hospital, between hospitals, and also during nation-wide or international conferences.
- 353150, Telemedicinal system for video consultancy: an electrically driven device designed for telemedicinal usage and for the provision of live broadcasting of video and audio materials between two or more locations in order to allow HCPs to communicate between each other or directly with the patient. The system concerned contains a video display unit, camera, speakers and headphone set, which may be either integrated or connected to the mobile or portable assembly powered by the accumulator batteries; or the aforementioned components might be connected to the TV set; the system may also include specific accessories such as a stethoscope, to provide extra functionalities. The system may be used within the same hospital or as a communication link between the healthcare facility and the patient’s home.
One can note that the first type code is more suited for HCP-HCP interaction, while the second may be used both in HCP-HCP and HCP-Patient settings. The wording used in the first code description, such as close combination of “remote medical advice and/or assistance in live mode” and “nation-wide and international conferences”, may possibly look somewhat strange since the scale of interaction is quite different for both cases, but it may possibly reflect the idea that this code has to provide a comprehensive description. The second type code seems to be more ‘narrow’ and precise, and, most probably, it is intended for mobile telemedicinal sets for field usage.
One can see that both the type code description and its name are somewhat vague, or appear to be non-precise or limited due to various reasons, but this is clearly because of the complexity of the general task (to make an adequate description of the device in one short text or in one paragraph of descriptive text). For example, it is not clear why the type code for video consultation devices includes the wording saying “electrically driven” — does it mean that there are some parts which are intended to spin or move?
At the same time, whilst both descriptions are clearly oriented for video communication, this makes the status of audio consultation or audio conference calls rather unclear.
Now let’s go to item 3 in our list. It could be many variations for such medical devices, both individual or designed for integration or interaction with those already in existence, such as MIS (medical information systems). For example, they can provide a telemedicinal channel for the aforementioned teleconferences, or may be used for documentation, recording and storage of video and audio data flow during such communications.
If we talk about item 4 of our list of possible telemedicinal devices, namely about “devices designed for the remote control of the patient’s state of health”, let’s first have a closer look at the term “remote”. Can we consider a portable monitor or registering device placed on the patient in order to transfer information and data from the patient in the hospital ward to the central device, as “remote”? Such systems for now are called “telemetry systems” in the Nomenclature Classification of Medical Devices by Type. Or “remote” means that the patient necessarily has to be located outside the healthcare facility premises and therefore does not have any closely located central device?
Also the term “medical observation” is quite confusing, as since any portable medical device for such purpose is already classified in the above cited type code, then what are the medical devices coded as below:
349730, Diagnostic system for the rapid evaluation of a patient’s condition: a set of devices operated under a specific PC workstation, intended for the registration of the patient’s main medical indices during remote medical assessment conducted by a remote HCP intended for the preliminary control of the patient’s condition by means of telemedicinal technologies. The system contains a specific personal computer, software and commutated medical devices for measuring main vital signs such as body temperature, blood pressure, heartbeat rate, alcohol content in exhaled air, etc. The system may include a single storage space where data for all persons examined may be stored, with the possibility of trending and follow up.
From this description, one can conclude that should the medical device possess a diagnostics function and medical data transfer function (regardless of the exact implementation of this feature), it might be considered as “telemedicinal”, regardless of whether it is designed for rapid testing or for long-term monitoring.
As a summary of everything above, one can compile a preliminary description of a “telemedicinal device” as a device intended for the remote communication of health care providers (HCP-HCP or HCP-Patient), or for the transfer of medical data between remote medical devices, and those telemedicinal devices also have to be involved in the aforesaid interaction at various levels and stages, including storage, safety, identification, etc.
But all in all, is it really so important to know if any specific device is “telemedicinal” or not? Most probably the answer will be “no”. Instead, what is important is our ability to understand whether certain regulations (including standards) are applicable to this particular medical device or to the interactions in which it is involved. As examples of such requirements one can name the requirements for the integration of medical devices into the single system, their interactions, proper identification, authentication, safety and confidentiality of data handling, and also medical standards and data transfer protocols.
The following standards might be regarded as good examples of this:
- GOST 34244-2017 “Telemedicine systems. General requirements for the basic safety and essential performance of stationary telemedicine consultative and diagnostic centers”.
- GOST 34243-2017 “Telemedicine systems. General requirements for the basic safety and essential performance of mobile telemedicine laboratory diagnostic kits”.
- GOST R ISO/TC -16056-1-2009 “Health informatization. Interoperability of telehealth systems and networks. Part 1. Introduction and definitions”
which have been in force since September 1, 2018.