Est. 1997: Mobile Medical Applications and the FDA
The FDA describes mobile apps as “software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.” The FDA defines mobile medical applications (MMAs) as “medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.”
The FDA’s MMA guidance document describes three categories of MMAs:
- MMAs that the FDA will not regulate: Mobile apps used in a health care environment (i.e., in clinical care, patient management or lifestyle management) that do not diagnose, cure, mitigate, treat or prevent a disease.
- MMAs for which the FDA intends to exercise enforcement discretion: Mobile apps that fit the definition of a medical device, but pose a low risk to public health.
- MMAs that the FDA will regulate: Mobile apps that meet the definition of a medical device and pose a potential risk to public safety if they do not function as intended by the manufacturer.
While the FDA’s MMA guidance document is relatively new, in 1997 the FDA first cleared the RhythmStat XL System, a Class II medical device MMA that telephonically received and recorded electrocardiograph (ECG) data from a cardiac event recorder and transmitted it to a Palm device. Between 1997 and 2011, when the first MMA Draft Guidance document was published, approximately 50 MMAs were cleared by the FDA. Since 2011, this number has more than doubled. Most MMAs are Class II medical devices, follow the pre-market notification pathway and are predominately used in chronic disease management, ECG and remote patient monitoring. They have begun to emerge in image diagnostics and in medication management and adherence. Within the last decade, numerous MMAs have become game changers in delivering improved outcomes and enabling cost-effective health care. For example:
Launched in 2012, the AliveCor Heart Monitor enables health care providers and patients to record, display, store and transfer single-channel ECG rhythms. AliveCor has continuously evolved since its launch, adding new features and mobile operating platforms, and obtaining additional FDA clearances in 2013, 2014 and 2015. The evolved versions are able to display ECG rhythms and detect the presence of atrial fibrillation. One reason for AliveCor’s early market success is that it was able to utilize, from launch, existing Current Procedural Terminology (CPT) coding widely covered and adequately reimbursed by traditional payers (i.e., third-party insurers). This enabled physicians to adopt the technology without financial penalties (even under the traditional fee-for-service reimbursement environment).
AirStrip Technologies develops remote patient monitoring MMAs. As with AliveCor, AirStrip MMAs have evolved since their launch in 2004 as AirStrip OB, intended to be used by obstetricians to remotely review critical real-time data from labor and delivery (e.g., fetal heart tracings, maternal contraction patterns). As with AliveCor, AirStrip has added features and additional modules, expanding to a total of 11 cleared MMAs to date. AirStrip’s success is due to its ability to demonstrate improved clinical outcomes as well as improved financial performance to end users and payers (which, in the case of a technology used during inpatient hospitalizations, are one and the same).
WellDoc develops MMAs that function off of its diabetes management platform system. One of its MMAs, BlueStar, was the first mobile prescription therapy cleared by the FDA for adults with type 2 diabetes. At the system’s foundation is an integration of technology, real-time data, analytics, ease-of-use and collaboration that ultimately drive improved metabolic outcomes and reduced health care costs. In addition to covering BlueStar as a pharmacy benefit, many traditional third-party insurers have embraced WellDoc’s MMAs (e.g., DiabetesManager) as a part of their own disease management programs. WellDoc achieved market success through the conduct of rigorously designed, randomized and controlled clinical trials to demonstrate improved clinical outcomes and improved cost-effectiveness in the management of type 2 diabetes. These studies went beyond what was required for FDA regulatory approval, which facilitated early adoption and coverage by third-party insurers.
MMAs: Evidence and Success
As demonstrated by the cases above, MMAs regulated by the FDA follow a life cycle that is typical of a medical device. As such, it’s not surprising that regulatory, clinical and reimbursement strategies are the critical success factors for an MMA to gain marketing approval as well as widespread market utilization. As with pharmaceutical, biotechnology and other medical device products, MMA developers seeking widespread coverage and utilization by the health care ecosystem must understand market access and reimbursement factors for their particular site(s) of service and utilization scenarios. They must also go beyond the minimum requirements of establishing safety and efficacy in pre-market clinical studies to obtain evidence of effectiveness under conditions of actual use and cost-effectiveness according to the payer’s perspective (noting that the “payer” may be a traditional third-party insurer, a health care provider or facility or a patient).
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