ABSTRACT

The field of "mobile health," or mHealth, is anticipated to significantly transform patient care through a range of applications. When utilized for therapeutic purposes, mobile applications are increasingly recognized by regulatory agencies as medical devices. Though they are not obvious, the dynamics of technical advancement and market conception, in particular, are significant forces behind mHealth achievements. To address these matters, the current study looks into the primary drivers of the mHealth sector's growth as well as promising directions for innovation that companies should incorporate into their corporate development plans. mHealth products that the FDA has approved so far, based on the innovation of the market and/or goods, and create that new but only a small percentage was accounted for by diversification or new market development. In the case of radical innovation, officers in the pharmaceutical and health device industries are collaborating with newcomers or start-ups with experience in the realm of data and communication skill to shape the current mHealth industry. Because of the rapid emergence of mobile health (mHealth) apps, the general public and medical experts are confused if goods are evidence-based. The Food and Drug Administration of the United States has little authority over mHealth apps. The accreditation and certification system for laboratory testing under the Clinical Laboratory Improvement Amendment could serve as a model for setting basic quality and safety criteria for mobile health apps. This and that system are interchangeable. When these devices are used to diagnose and treat patients, doctors and patients will have more clout to demand safe and high-quality mHealth apps. Keywords: Approved, Diagnosis, FDA, mHealth, Therapeutic reasons
Publication date: 01/07/2025

https://ijbpas.com/pdf/2025/July/MS_IJBPAS_2025_9231.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2025/14.7.9231