Abstract P043: A Framework For The Evaluation Of Digital Tools

Le résumé fourni par la source

Digital health tools encompass a wide range of technologies that have been used in healthcare services including mobile applications, health information technology, smart wearable devices, remote monitoring and treatment, and health platforms. These tools walk a fine line between lifestyle consumer products and medical devices. Sleep applications can be used by consumers as a fun gadget to track sleep, but it may also be used as a medical tool to collect information concerning serious sleep disorders. The fast proliferation of these tools has put pressure on concerned stakeholders to make sense of this group of technologies. Various questions have been raised within this realm: What counts as medical as opposed to a lifestyle device? Which devices require regulation and under what standards? Which devices are allowed to be used in the medical context? And which are not? And under what conditions? Social scientists have highlighted the complexity of digital health tools that (include both medical and lifestyle characteristics and the difficulties accompanied with classifying these tools for regulatory purposes. In an attempt to do so, several regulatory bodies including the US Food and Drug Administration (FDA) have revised their existing standards to accommodate the regulation of digital health tools. As such, the FDA published a guidance document on Mobile Medical Applications; this led to various concerns questioning the boundaries between lifestyle and medical digital technologies that were defined by the FDA guidelines, which left a significant number of technologies that were considered to be low-risk, completely out of the FDA oversight and with no required compliance/quality control/effectiveness checks. This prompted many companies to develop hundreds of products that belong to the low-risk category, granting them the ability to ignore FDA regulations. Consequently, there remains considerable concern regarding the quality and safety of these digital health technologies that are being used within the medical context. Clear and well-defined regulation processes are needed to control the development and design of these tools, especially that many lack scientific evidence and data privacy. The framework ought to include a risk-based approach to classify devices for regulation in a way to ensure the safety and effectiveness of all digital health tools throughout their life cycle, even those classified as low-risk. The framework and regulatory process also need to take into consideration the rapid change in digital product development, as processes that extend for a long period of time may become obsolete in supporting decisions about these tools. As these digital health tools become more sophisticated, accessible, widespread, and cheaper, the need for classifying and regulating the sector becomes important, especially with the rapid evolution of these technologies.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.