Medical app development has been a thriving area of software development for some time. But FDA oversight has been a source of concern—particularly for apps that are used on mobile devices. Fortunately, the FDA recently clarified that software is only considered a ‘mobile medical app’ when designed for use as an accessory to a regulated medical device or if it transforms a mobile platform into such a device. Other types of healthcare software won’t be subject to the same regulations. Here are a few quick examples of how the FDA breaks down mobile apps into categories:
1. Subject to Regulatory Oversight
These are apps that meet the regulatory definition of a “device” and must go through the FDA’s approval process. Some types of apps that are subject to regulatory oversight include:
- Imaging software used to measure and analyze lesions and assess the risk of skin cancer
- Apps that use the built-in accelerometer on a mobile device to monitor sleep apnea
- Software that controls the delivery of insulin doses
2. Enforcement Discretion
These are apps that qualify as devices but pose minimal threat to their users. The FDA does not intend to enforce FD&C requirements for these apps, which include things such as:
- Apps that allow providers or patients to interact with electronic health records
- Electronic resources to help patients manage their own daily care in general terms (without providing recommendations to alter or change a previously prescribed treatment or therapy)
- Software used for automating simple tasks in a healthcare environment
3. Not Medical Devices
Apps that are not deemed medical devices will have no FDA oversight. These include:
- General training resources for physicians and health education for patients
- Software that enables secure, protected communication among healthcare providers
- Automation of general operations in a healthcare setting (scheduling, billing, electronic check-in, etc.)
Ayoka is equipped to help our healthcare clients design and develop a wide variety of apps in categories 2 and 3. If your organization is seeking to deliver better patient care through improved operational efficiency and compliance, we can build an app for that! Contact us today to get started.
