On September 25th, 2013, the FDA released its final draft for Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. The FDA intends to apply its regulatory oversight to mobile apps that meet the definition of medical device and whose functionality could pose a risk to a patient’s safety if the mobile app failed to function as intended. The FDA refers to this subset of mobile apps as mobile medical apps and the purpose of the guidance document is to clarify this subset. The FDA acknowledges that many mobile apps do not meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) and thus the FDA does not regulate them.
Some apps may meet that definition but pose a lower risk to the public in which case the FDA states it “intends to exercise enforcement discretion over these devices” indicating it will not be looking to enforce requirements under the FD&C Act in those instances. According to the FDA “mobile medical apps” are determined by their intended use which may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. Which intended uses lead to classification as mobile medical apps? Those that are for the ”diagnosis of disease or other conditions; the cure, mitigation, treatment, or prevention of disease; or those with “an intended effect on the structure or any function of the body of man”.
A mobile medical app may still avoid FDA imposed regulation requirements if it poses low risks to patients. Apps that refrain from providing specific treatment or treatment suggestions; provide simple tools for organizing and tracking health information; provide easy access to information related to patients’ health conditions or treatments; aides patients in documenting, showing, or communicating potential medical conditions to health care providers; automate simple tasks for health care providers; or apps that enable patients or providers to interact with health record systems such as Personal Health Record (PHR) or Electronic Health Record (EHR) systems are all considered low risk and not subject to enforcement of the FD&C Act at this time.
Mobile apps that are subject to regulatory oversight are identified as apps that transform a mobile platform into a regulated device by using attachments, display screens, sensors, or other methods. These include the following types of apps:
Any apps that are designed as an extension of other medical devices, such as connecting to a medical device to control it or to display, store, analyze, or transmit patient-specific data from the device.
Any apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Examples that are given are attachments that act as glucose meter; electrocardiograph (ECG) electrodes to measure, store, and display ECG signals; accelerometers to collect motion information for sleep apnea; or internal or external sensors for creating electronic stethoscope functions.
Any apps that perform patient-specific analysis and provide patient –specific diagnosis, or treatment recommendations. These could be apps that take information about the patient and calculate dosage or create a dosage plan or Computer Aided Detection software (CAD).
The FDA’s Guidance documents provide further information as well as various examples of types of medical apps they will subject to regulatory oversight and examples of apps that will not be subject to regulatory oversight. In addition to FDA regulation, mobile app developers should investigate any other laws and regulations that might apply to their specific app, including but not limited to the Anti-Kickback Statute, the Physician Self-Referral Law (Stark Law), the Americans with Disabilities Act (ADA) & Affordable Care Act (ACA), the National Committee for Quality Assurance (NCQA) Certification, and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
According to data this year from the Pew Research Center’s Internet & American Life Project, 61% of cell phone owners or 56% of all American adults own a smartphone. As most smartphone users tend to be younger this is sure to be a growing trend that many companies and entrepreneurs have already begun to target. Innovators looking to target these growing smartphone users with apps related to health or medical solutions should be aware that depending on their product FDA regulations may apply.
Information in this article is based on research performed by Syracuse University J.D. student, Garin Murphy in connection with a recent research report.