In July 2011 the FDA released its draft guidance on the use of mobile medical applications. This first effort is regarded by many as long overdue; it also only addresses a restricted segment of the applications market. The comment period ended October 21 (view the guidance at Draft Guidance for Industry and Food and Drug Administration Staff–Mobile Medical Applications).
In fairness to the FDA, this is a huge arena with all kinds of confusing technologies, applications, and risk factor
Accordingly, the FDA is moving carefully and acknowledged this draft is the first of several; the agency will establish a base position using the most obvious medical applications of the highest risk, from which it can move forward and regulate other application segments. There is also big pressure for the FDA to stay on task with this challenge—it’s been estimated that 500 million smartphone users worldwide will be using a health care application by 2015.
This first draft guidance targets two application categories that impact the performance or functionality of currently regulated medical devices:
- Applications that are an accessory to a medical device already regulated by the FDA (such as viewing a medical image on a smartphone or a tablet)
- Applications that transform a mobile communications device into a regulated medical device using attachments, sensors, or other devices (such as converting a smartphone to read glucose test strips or measure heart rate)
- Most of the comments received by the FDA pertain to definition, segmentation, and education, including:
- Linking level of regulation to intended use, likelihood of failure, and the severity of outcome if a failure occurs
- Classifying applications into five categories: medical information and measurement capture, data aggregators, communication technologies, network infrastructure, and health-care provider graphic user interfaces
- Establishing whether software on the devices is off the shelf or has a specific, intended use, and evaluate and classify according to risk
- Expand the definition and clarity of intended use so that manufacturers will know which intended uses will trigger regulation
- Change the accessory provision so that an accessory to a medical device does not necessarily fall into the same regulatory classification as the medical device
- Establish a grace period that begins when the guidance is finalized, giving developers more time to assemble and submit filings
- Educate the medical community on these regulation policies and deal with clinical decision support (CDS) applications and functionality in a separate draft
The Healthcare Information and Management Systems Society (HIMSS) is encouraging the FDA to “use every opportunity” to educate hospitals, health systems, providers, and current and future developers on FDA regulations.
“Education by the FDA is going to be critical to achieving compliance, ensuring patient safety, and promoting innovation in mobile health,” HIMSS noted in its comments to the agency. This is especially critical for hospitals and providers who self-develop their own mobile medical apps and don’t have experience being regulated as mobile medical device manufacturers by the FDA.
Some apps the FDA does intend to presently regulate include electronic viewing of textbooks or reference materials in a clinical setting, applications for logging and recording decisions, admin-related functions such as billing and insurance, and electronic health records.
“HIT software and electronic health records vendors should continue to monitor the developments coming out of White Oaks,” warned Dane Stout of The Anson Group, a biomedical and medical device consulting firm. “Frequently FDA guidance or rules are misconstrued, particularly by those companies new to health care and who are unfamiliar with the nuances of health care regulation, FDA or otherwise. What they don’t say is important, and how they say what they say is equally important. The exclusion of electronic health records and other systems from the MDDS rule, for example, did not say they would not be regulated by FDA; it simply said they would not be regulated as MDDS systems. Likewise, clinical decision support (CDS) systems are not off the hook; they are simply not addressed directly in this guidance document.”