Wellness and Health Apps Face FDA Oversight
The Food and Drug Administration (FDA) has recently issued guidance for general wellness and health apps. The guidance is focused on a very small part of the market, namely the apps and devices that could cause harm if they don’t work as advertised. Most apps are designed to promote a healthy lifestyle. In other words, while they can improve the health of a patient, they aren’t intended to treat diabetes or heart disease. There is a fine line between what the health app is intended to do and what it claims it can do, and the medical device or app manufacturers must be able to make this fine line very clear.
Right now, the FDA isn’t taking a hard stance on the health apps that are proliferating in the digital marketplace. According to “FDA Issues New Guidance on Wellness and Health Apps,” posted on StoneHearthNewsletters.com, the FDA appears to have set its sights on only those apps that could harm a patient if they fail or don’t work as intended. The remaining general wellness and health apps, including weight loss and activity tracking apps, will be left up to enforcement discretion. The FDA is taking a hard look at the ‘intended use’ of these health apps. For example, there are apps that can help users lose weight; however, the FDA doesn’t want to see those apps claim to ‘treat’ obesity. Similar to how the Federal Trade Commission is watching for ‘truth in advertising,’ these health apps must be able to deliver on their claims. It’s also important to note that as more physicians recommend certain apps for their patients, whether it’s to support an illness or encourage a healthier lifestyle, the physician will also take a closer look at the app, and it’s capabilities or weaknesses, in order to make prudent decisions for their patients.
Show Medical Device Transparency and Accuracy with ERP
Medical device manufacturers can use an enterprise resource planning (ERP) solution to collect data from research and development, manufacturing operations, and pilot or bench tests. Business intelligence and reporting features highlight the relevant data and trends surrounding a device or app. Manufacturers can then use this information to show their devices and apps are able to deliver the services or information as intended.
Contact AKA Enterprise Solutions for more information about using ERP to capture the data needed to show transparency and device accuracy.
By AKA Enterprise Solutions, a Microsoft Dynamics CRM and ERP Partner for Life Sciences