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Laura
9/17/2024
FDA Regulation of Mobile Devices in Medical Care
The concerns brought by the mobile devices in healthcare further increased with use of clinical decision support (CDS) tools and machine learning (ML) algorithms have led to debates regarding the regulatory frameworks of the U. S Food and Drug Administration (FDA). At the moment, there is no FDA oversight of mobile technologies including mobile phones or tablets through which many health applications or functionalities may be accessed. However, it does control specific mobile medical applications that fall under the definition of a medical device more particularly where they are designed for diagnosis or therapy. Such applications have to meet the general requirements of the FDA in terms of safety and efficiency in health care (FDA, 2022). While the FDA does not directly regulate mobile app stores, it concentrates on the utility of the applications in question, specifically, those which might pose safety risks to patients.
In the interest of public health, the regulation of mobile application with relation to medical purpose but not the device is useful but at the same time has it drawbacks. In one way, FDA regulation of mobile medical apps has been a positive move, as safe and effective mobile apps that are intended for diagnosis and treatment do not pose a danger to the patient. For example, some applications that help diagnose skin cancer or manage diabetes need to meet the FDA requirements, thus increasing their usability and contribution to the decision-making process in the healthcare field (Llorens-Vernet & Miró, 2020). This regulation is helpful to the general public as it provides an added layer of credibility about the application, which is crucial in ensuring that the right information is given to patients.
On the other hand, there are some risks in the lack of regulation for mobile devices and app stores. The devices on which such applications are deployed, such as smartphones and tablets, are susceptible to hacking or breakdown, which may compromise patients’ information or lead to mistakes in diagnostics or treatment. Considering the fact that the delivery of healthcare has shifted heavily on mobile devices it may be time for the FDA to regulate not only the apps but also the underlying devices and platforms. This would help to reduce the risk associated with device failure and also take a holistic view to mobile Health safety.
Therefore, even though the FDA currently monitors mobile medical apps, there is a need for the scope of supervision to embrace mobile devices and app stores. This could offer a better safeguard in public health and also prevent the healthcare solutions delivered through mobile platforms from being fragmented or even insecure.
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