FDA Report: Unregulated Medical Apps Significantly Improve Health Outcomes
(Thursday, November 19, 2020]​
Mobile apps and wearable devices that track general health related information such as mobility, temperature, blood pressure pose little or no risk to the users and significantly improve healthy lifestyles, FDA reports in an analysis released this week. General health awareness software such those associated with common use wearable devices such as smart watches are not regulated by the FDA as medical devices. These devices do not claim to diagnosis, cure, mitigation, prevention, or treatment of a disease or condition, but the information collected by these could be used to increase awareness of one’s lifestyle and diet that in turn is related to diseases and general well-being. FDA’s reviewed information from a variety of sources such as government departments involved in health information technology, peer reviewed publications, outside experts such as patient advocates, consumers, healthcare providers, developers of health-related apps, and other stakeholders. The conclusion by the FDA was that the current policy of not regulating general health awareness software applications is good and is leading to more benefits than risks to the users. These devices capture various kinds of data related to one’s general health and lifestyle. Tracking of such information triggers good behavior by the user. For example, blood pressure monitoring devices lead to increased medication adherence, healthy diet and exercise, and stress management. Better tracking of health-related goals was directly related to the management of healthy dietary habit, weight loss and quality of life. Participants using application to track diets had a reduction in unplanned dietary lapses, and a decrease in body weight and body mass index. For example, randomized trials showed that software led monitoring of behavior, tracking of health outcomes, and automated messages or notifications encouraged incorporation of vegetables and healthy cooking habits in the users. In special populations such as adolescent and young adult patients with cancer, digital wearable technology to track physical activity was associated with “significant improvements in eight dimensions of health-related quality of life, i.e., physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions”. The report also evaluated other applications of health-related unregulated software such as those used for administrative support, electronic patient records, and assistive applications for healthcare workers, and concluded that the current policies are working as planned and should continue. Although the report summarized information in the public domain such as peer reviewed publications, and individual experts, and confirms generally accepted expectations from such apps, getting a formal FDA support document should be helpful to the developers of such devices.