FDA Considers the Risks of Mobile Medical Apps

As technology continues to advance, just about everything is becoming more readily available. Ask and you shall receive. In fact, just imagine something you may have never thought possible and there’s an app for that, or will be in the near future.
If you have an iPhone, iPad, Android, PDA or any other mobile device, you may have come across new medical apps such as iHealth’s Blood Monitoring System or AirStrip Technologies’ AirStrip Cardiology app. These are the types of products that the FDA will be reviewing in order to determine whether or not they need to be more closely monitored.
The agency plans to regulate only a small subset of mobile medical apps that present the greatest risk to patients. More specifically, any applications that market the diagnosis, cure, treatment or prevention of a disease or other condition will be more closely reviewed. The guidelines also indicate that applications that require patient-specific information are highly likely to be part of that subset.
Some of these products act as an accessory to medical devices used by doctors or transform a mobile device into a regulated medical device with the use of attachments or adapters. Others give patients medical advice based on specific data that is entered into the application. For example, WellDoc’s Diabetes Manager functions as a virtual coach for type 2 diabetes patients. Users are prompted to log their medication, carbohydrate intake, and blood glucose in order to receive reminders as well as recommendations regarding their health.
The FDA recognizes the possible risks that these types of applications may create. Devices do not always work properly. Results could get mixed up. Although many of these applications are supposed to provide the analyses that doctors would traditionally provide, those recommendations might not always be right. Therefore, the FDA has a duty to current, as well as prospective, patients to evaluate these applications and their intended functions.
Guidance documents for these regulations are still being reviewed and the agency is welcoming feedback from the public for the next 90 days.