The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
We recently had the opportunity to speak with Bakul Patel, MSEE, MBA, the lead author at the FDA of the Draft Guidance, about the Workshop. Mr. Patel combines a focused interest in mobile software with a broad background in business and technology to bear on this issue. He pointed out that developing this particular guidance was more intricate than many others since it had to be cleared by not only our center and the larger FDA but also our parent agency, the HHS. Even the Office of Management and Budget in the White House expressed an interest due to the possible economic impact….as soon as you touch something like “mHealth”, more entities get involved.
It must be remembered, though, that this process will eventually produce a guidance, not new regulations. The distinction is an important one. A guidance provides principles on how the FDA intends to apply existing regulations. Therefore, once the Draft Guidance is finalized, medical software publishers and device makers should be able to predict what types of apps the FDA believes require pre-market clearance and whether they will likely be considered Class I, II or III devices. This will be very valuable for the continued development of mHealth devices and software.
In contrast, regulations have the force of law. The rule making process can be very time consuming since often numerous disparate outside comments are incorporated into the final rules. For example, the regulation designating Medical Device Data Systems (MDDS) as Class I devices was proposed in 2008 but finalized only in 2011 (see our previous post for details about MDDS).
Nevertheless, producing the Draft Guidance is painstaking work, as Mr. Patel explained, because you’re making national policy and that the document has to be legally sound while addressing the different audiences, including lawyers, users, doctors, manufacturers and the medical device industry. Convening a two day workshop on mobile medical apps is a sign of the importance the FDA has placed on this topic.
Mobile Apps as Accessories
As we have discussed recently, the FDA has long been regulating software as a medical device. However, when the medical device is a hybrid of separate software and hardware components, new questions arise. As an example, think of the IBG Glucometer, a device not yet cleared by the FDA. In this case, the software is a separate downloadable app and thus an “accessory” in FDA lingo, which means it is considered a medical device. The clearance process required for a device is determined in large part by the potential risk to a patient. The question the FDA is posing is to what classification should the software be assigned? Should the classification of the software be the same as the hardware or different?
As the companion apps become more sophisticated in the future and begin to offer more features than just reporting the raw data, this question will take on increasing importance. For some of their thinking, refer to the regulation docket where more details about this issue are included.
Clinical Decision Support Software
Among the most exciting developments for physicians using smartphones and tablets for patient care is the potential for improved clinical decision making due to the ready availability of vast amounts of clinical information at the point of care. Everyday physicians combine clinical findings, such as physical observations, laboratory values and imaging findings to make decisions for their patients. What if mobile software could take some of the same information, refer to the best available clinical evidence and suggest better, cheaper or safer alternative diagnoses or therapies? This type of software is generally termed “Clinical Decision Support Software’ (CDDS). Here is the FDAs definition of CDDS from the Draft Guidance:
“Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions.
Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.”
As can be seen, this is potentially very broad, from simple apps that calculate fracture risk based on osteopenia scores to sophisticated prognosis modeling software for ICU patients. Since, in the future, this may well be the most widely and frequently used class of software by primary care physicians and specialists, getting this regulation right now will help determine what new tools we physicians will have in the future.
More details of the FDA’s thinking can be seen in the Workshop agenda. Again, your input will be very valuable in drafting the final guidance.
Recent FTC action
Among the first statements in the Draft Guidance is to define what types of apps the FDA intends to regulate. In doing so it offers the following definition:
“This subset, which we are calling mobile medical apps as defined in section III, includes only those that meet the statutory definition of a device; and either:
- are used as an accessory to a regulated medical device;
- or transform a mobile platform into a regulated medical device”
At iMedicalApps, we recently reported on the recent and important precedent of the Federal Trade Commission (FTC) removing a consumer health app from the iTunes and Android app stores that purported to improve acne using light from a smartphone. It is useful to remember that the FDA’s mandate is to regulate any medical device or implement that is designed or purports to diagnose or treat disease. The Draft Guidance explicitly excludes
“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.”
In this case, the FTC acting on the behalf of consumers, intervened in the “Medical” section of an App store but, according to the FDA, which does not fit the definition of a “Mobile Medical App”
The lesson for physicians is that the arrival of the FDA into the mobile software world does not and cannot mean that inaccurate or even fraudulent consumer health care apps will be eliminated or even deterred. We must remain vigilant on behalf of our patients and help them safely navigate the app stores, much as we have now become accustomed to the perils of patients consulting “Dr. Google”.
The increasing involvement of the FDA, and to a lesser extent, the FTC in the mobile medical software and devices arena is another sign of the maturation of this space. Like many other industries, we can predict more consistent regulation will likely lead to more entrants and a richer marketplace. In this instance, the input of clinicians into the regulatory process is not only invited but vital to its evolution.
*This blog post was originally published at iMedicalApps*