The regulation of mobile health applications

Abstract

In July 2011, the United States Food and Drug Administration issued draft guidance concerning the regulation of mobile medical applications (applications on a wireless device that are used as accessories to medical devices or to convert a mobile platform to a medical device). While the suggestion of regulation is rooted in patient safety, concerns about limits on innovation and discovery as well as the evolving nature of both mobile health and current healthcare delivery have emerged. This article discusses the prevalence of mobile health, the context of regulation concerning mobile medical applications, and implications for the future.

Scope of mobile health in Indian health care system – the way forward

“…33,34 Increased self-care and self-monitoring by mHealth innovations, though beneficial might invite risk as judicial interventions by healthcare professionals is inevitable in some instances. 35,36 The growing number of self-testing devices are also a concern regarding ethical, psychological and social aspects of individuals.…”

“…mHealth, though has the potential to supply cost-effective care to rural India has many challenges. 36 Some of the issues that may hinder successful implementation of mHealth technology include poor phone access in rural households (58%), lack of reliable power supply to charge phones, poor smart phone user rates, and low literacy rates.…”

“…Customised application and sustainable financial models which could suit the existing local healthcare delivery networks would yield beneficial outcomes. 36 Interventions as telephone based appointment scheduling, SMS prescription refill services, consultation via 3G video or telephone provides quality care just a smart phone away. 38 mHealth interventions would effectively tackle the rising burden of chronic diseases as demonstrated by few studies.…”

“…Therefore, mHealth has the potential to fill the gaps in the system by providing expanded access at lower cost. 36 India is still far away from achieving universal immunization. 44 Short Message Service (SMS) texts using existing MCTS services may offer a potential low-cost solution in India and may leverage India's drive to vaccinate all children against vaccine preventable disease.…”

Mindfulness-Based Symptom and Stress Management Apps for Adults With Chronic Lung Disease: Systematic Search in App Stores (Preprint)

“…These users were also found to place high trust in these apps' accuracy and experienced positive health effects [14]. Despite the frequency and use of these technologies, there is no regulatory authority to validate the legitimacy of health-related content published through these commercial apps, nor is there a mechanism to enforce standards to ensure the information is accessible by diverse populations [15].…”