By Carmelina G. Allis –
With information technology taking on an increasingly important role in the healthcare system, software app developers are focusing their efforts on developing programs intended to facilitate health, wellness, and disease management. Some of these apps are developed for and implemented by corporations, hospitals, and providers to promote general health and wellness among their employees or members, or to create a team effort between users, family members, and healthcare providers to establish wellness goals to improve overall health. Other forms of health and wellness apps are developed for use by the general population for a fee or at no cost, and can be easily accessed via a desktop computer, a smartphone, or an iPad.
These health and wellness apps come in different configurations, and their contents can often be tailored and constructed to meet the needs of the customer. The apps may help the user establish certain health goals, such as a weight or an exercise objective, and can be configured to track or trend data for review by the user and/or others, such as a doctor, nurse, nutritional advisor, a personal trainer, or friends in a support network. Other apps can assist users establish wellness plans to manage chronic conditions like asthma, heart disease, Crohn’s disease, or diabetes, by promoting and providing access to activities (e.g., dietary or exercise plan suggestions) and general information.
With the advent of FDA’s regulation of mobile software technology, a legal question that often arises is whether these health and wellness apps are subject to FDA regulation as medical devices. So how can a software developer recognize whether its health and wellness app is a medical device under the Federal Food, Drug, and Cosmetic Act (“FDC Act”)?
Historically, products intended for use for general health and wellness that are intended to help change a person’s lifestyle in healthy way have not been subject to FDA regulation unless they are intended for medical purposes. A product, such as software, may be subject to FDA regulatory requirements if it meets the definition of a “device” in section 201(h) of the FDC Act. A “device” is defined as “an instrument, apparatus, implement, machine, contrivance . . . which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man,” among other things. FDC Act § 201(h). Thus, a software product may be subject to FDA regulation as a “device” if the developer of the software (or the person responsible for its labeling) markets, promotes, labels, or advertises the software for diagnosis, prevention, or treatment of disease or other conditions (e.g., stroke, pregnancy, high blood pressure, migraines).
At present, FDA does not have a comprehensive policy or guidance on the regulation of software devices. The regulatory status of software devices, however, has been discussed in various FDA documents, such as the agency’s “Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications,” which was issued on July 11, 2011 (see our previous post here). Although the guidance on mobile apps is a draft document subject to revision by FDA and not intended for implementation, it provides a window into the agency’s current thinking on the matter.
According to this draft guidance, it appears that FDA will continue to apply the medical purpose / general health and wellness distinction to mobile apps (and, by logical extension, other software based products). For example, according to the draft guidance, software apps that have the following functionalities will not be regulated by FDA:
- Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness, if not intended to cure, treat, diagnose, or mitigate a specific disease, disorder, patient state, or any specific, identifiable health condition.
- Mobile apps that are used as dietary tracking logs and appointment reminders, or provide dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness and are not intended to cure, mitigate, diagnose, or treat a disease or condition.
Draft Mobile Medical App Guidance at 11.
The key to avoid regulation is that the software app cannot be intended for medical purposes. Thus, for example, an app that is intended to be used “to maintain general wellness by supporting a low-sugar or low-carbohydrate diet to maintain a healthy lifestyle” would likely fall under the general health and wellness non-regulated area. On the other hand, if that same app is intended to be used to help patients “manage their diets to prevent the progression of prediabetes to diabetes and lower the risk of heart disease,” then the product would more likely be subject to FDA regulation as it is intended to treat a condition (i.e., prediabetes) to mitigate or prevent a disease (i.e., diabetes or cardiovascular disease).
Examples of software products intended for use by consumers that the draft guidance says may be subject to “device” regulation include:
- Apps that allow users to input their health information and through the application of formulas, data comparisons, or processing algorithms, issue a diagnosis or treatment recommendation that is specific to that person, such as his or her risk for colon cancer or heart disease, or recommend that the patient take a certain medication or seek a particular treatment.
- Software that is intended to be used to physically or wirelessly connect to and download information from a diagnostic device like a glucose meter to allow the user to display, store, analyze, and/or keep track of his or her medical data values.
Draft Mobile Medical App. Guidance at 14.
In short, if an app is intended to maintain and establish general health and wellness, FDA has said that the product will not likely meet the “device” definition and would therefore not be subject to regulation. Otherwise, if an app is promoted or intended to be used by a patient or health facilitator as an instrument in the cure, mitigation, diagnosis, or treatment of a disease or condition, the app could be subject to FDA regulation. Of course, FDA has not finalized its draft mobile app guidance, so things could change. However, FDA has long kept its distance from devices merely intended to promote health and wellness while subjecting devices intended to prevent or treat disease to regulatory requirements. It seems unlikely that this well established distinction would be omitted from the final guidance.