The article addresses the aspects related to the products used for the provision of telemedicine services.
The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published a guidance document dedicated to the regulatory requirements for Software as a Medical Device product. The guidance provides additional clarifications regarding the existing regulatory framework, as well as recommendations to be considered by medical device manufacturers (software developers) to ensure compliance thereto. However, the guidance is non-binding in its legal nature, nor is intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
In particular, the document provides answers to the most important questions raised by the industry concerning the regulatory status of SaMD and specific aspects to be considered in this respect when placing such products on the market.
One of the examples provided in the guidance describes a platform developed for the integration of healthcare, telemedicine, and health management. The said solution will be based on the app and virtual assistant, keep clinical data and also include data analysis tools to be used to process the data uploaded. The platform will also provide communication means to be used in the course of teleconsultations and telemonitoring. Apart from this, the system will use Machine Learning (ML) technology to recognize the voice. The question raised is whether the above product would be subject to regulation as a SaMD.
As explained by the authority, a platform for the integration of healthcare data, telemedicine, and health management, including an application and a virtual assistant facilitating the access of the professional user, as well as the user with the functionalities described in this consultation, which are limited to agenda, marketing, construction electronic medical record, patient situation record, communication does not fall under the rules described in RDC 185/2001 and RDC 657/2022. Hence, such a product would not be subject to registration as a SaMD, and the respective requirements will not apply.
Information Transmission Software
Another example describes the software intended to transmit information from multiparameter monitors, including alarms and remote monitoring. Concerning such a product, the authority states that in case it is used only for data transmission, registration as a medical device will not be required. However, in case the software can be used with different medical devices, it could be subject to regulation following the risk classes such devices (monitors) are falling too.
The guidance also describes the approach to be applied concerning software intended to be used for providing medical care by the virtue of videoconferencing. In this respect, the authority mentions that:
- Software intended solely for ensuring communication between patients and healthcare professionals, including data transmission, is considered to be a general purpose software and, consequently, is not subject to registration.
- Software used to collect data from patients, analyze it and make decisions regarding the treatment to be applied should be subject to regulation as a medical device.
The authority also mentions that the software intended to transmit signals from medical devices (remote monitoring) will be subject to the same regulatory requirements applied to the medical device itself. Furthermore, such software could be included in the registration of a medical device as an accessory.
Monitoring Software for Hospital Use and Chronic Illness
One of the questions raised by the industry relates to the software intended to be used in a clinical environment (hospitals) together with special hardware for patient monitoring while ensuring connection to the local network of the respective healthcare institution. According to the explanation provided by ANVISA, such software will be assigned to the same risk category as medical devices the software connects to a hospital’s network.
The document also describes the software intended for monitoring chronic injuries by images to be reviewed by healthcare professionals. The software will monitor the wound dimensions, provide tissue classification and indicate potential complications. As an option, the software will not provide any recommendations. In this respect, the authority explains that the software indicated for the monitoring of chronic wounds in adults by images with the classification of the wound tissue and triage of possible complications of the wounds falls under Regulation 10 of RDC 185/2001 and may be risk class II or III depending on the type of assessment that is capable of issuing wound involved.
As it was mentioned before, in case the software in question is intended solely to ensure efficient communication between healthcare professionals and patients, it will be considered general-purpose software and will not be subject to SaMD regulations since it does not impact the medical decision-making process.
Software as an Accessory
The industry also raises a question regarding the regulatory status of a software product that is initially intended to be used only in connection to a specific medical device, and will not be available on the market separately. As explained by ANVISA, there is no standard approach to be applied in such situations, and each time a separate review should be conducted to determine the regulatory status of the product in question on a case-by-case basis, since depending on the specific features, such software could sometimes fall within the scope of SaMD framework.
In summary, the present guidance describes the approach to be applied in the case of software products intended to be used in telemedicine. In particular, the document highlights the key aspects to be considered when determining the regulatory nature of such products.
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