In September of 2013 the FDA released its final guidance on Mobile Medical Apps and listed the apps that fall under it’s jurisdiction, and a number of these application types that would be given “enforcement discretion” and not require 510(k) certification. All three types of app lists were updated:
Apps that are regulated
- Mobile apps that use a microphone or speaker within a mobile platform to serve as a audiometer to allow healthcare providers to determine hearing loss at different frequencies.
- Mobile apps that analyze an image of a skin lesion using mathematical algorithms, such as fractal analysis, and provide the user with an assessment of the risk of the lesion.
- Mobile apps that are used to calibrate hearing aids and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer.
- Mobile apps that are intended to display images for both diagnostic review and non-diagnostic review may be regulated.
Apps given a pass under “enforcement discretion”
- Mobile apps for providers that help track or manage patient immunizations by assessing the need for immunization, consent form, and immunization lot number.
- Mobile apps that provide drug-drug interactions and relevant safety information (side effects, drug interactions, active ingredient) as a report based on demographic data (age, gender), clinical information (current diagnosis), and current medications.
- Mobile apps that enable, during an encounter, a health care provider to access their patient’s personal health record (health information) that is either hosted on a web-based or other platform.
Apps that are not regulated
- Digital education tools, quizzes, games, and questionnaires that help engage patients to actively participate in their general health and wellness (calorie consumption, benefits of physical activity).
- Provide access to education materials using digital media to help patients cope with stress
- Allow healthcare providers or staff in healthcare setting to process payments (for example a HIPAA compliant app);
- Track or perform patient satisfaction survey after an encounter or a clinical visit
- Allow health care providers to communicate in a secure and protected method (for example HIPAA compliant