A new report explores the largely unregulated mobile health app industry and provides some insight into whether the apps you and your patients use have been approved for use or otherwise proven to be helpful.
Mobile health apps—from fitness support to disease management—deliver health-related services via mobile phones, smartphones or tablets. An estimated 97,000 mobile health apps are available for download across major app stores, but only a small portion have been approved by the Food and Drug Administration (FDA) or otherwise proven through scientific studies, according to a new report (log in) by the AMA Council on Science and Public Health.
Most mobile health apps are targeted to patients to assist in their own health management, but there are some targeted to physicians and other health care professional as tools to improve patient care, including apps that:
- Provide access to medical textbooks and references, or offer training materials for physicians
- Give general patient education
- Allow patients to track symptoms
- Use GPS data to alert patients or track movement
- Offer preventive screening information
Certain diabetes and weight loss apps have proven effective in clinical practice, such as the WellDoc Diabetes Management system, a software-based patient-coaching and clinical decision support system. With this app, a patient can upload blood glucose readings and other diabetes-related information and receive real-time feedback from a physician or member of WellDoc’s research team. After a year, a clinical trial group saw its A1c decrease by 1.9 percent and also experienced improvements in diet, medication adherence and exercise.
The WellDoc app is approved by the FDA, one of only a small subset of health apps that the FDA will oversee. The agency is regulating mobile apps that act as medical devices and could pose a risk to patient safety if used incorrectly or if they malfunction. Included among these apps are ones that:
- Use a sensor or lead that connects to a mobile platform to measure and display heart rhythm
- Create a stethoscope
- Generate controlled tones for audiologic testing
- Use an attachment to a mobile platform to measure blood oxygen saturation, alter the function or setting of an infusion pump, or allow remote perinatal monitoring
The FDA also is exercising “enforcement discretion” for some other mobile medical apps that function as medical devices but have little risk, including apps that provide periodic reminders or motivational guidance, or apps that use a checklist of common symptoms to provide a list of possible medical conditions. Examples of mobile health apps approved by the FDA are available on the agency’s website.
Still, the mobile health market has no way of measuring the quality of mobile health apps, or whether these apps help patients or physicians achieve their intended purposes. A number of systematic app reviews found that most mobile health apps lacked overall quality, and only limited advice is available to help guide users’ choices of apps that may be more reliable and useful.
A process, private certification or evaluation platform is needed to sort through the huge amount of mobile health apps that won’t be subject to FDA approval, the report said.
The FDA and other regulatory bodies will work toward greater oversight in the future. The FDA, along with the Federal Communications Commission and the U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology, are collaborating to produce a risk-based, regulatory framework for health IT. Part of this proposal includes creating a safety center to monitor patient safety problems with health IT. However, it is unclear whether this safety center would play a role in evaluating mobile health apps.
The AMA will work with stakeholders to identify guiding principles for promoting a vibrant, useful and trustworthy mobile health app market, the report said.
