Wearables: Are they anything like the ‘real thing?’
New mobile medical applications – often in the form of watches, patches or apparel – keep on coming. Consumers have little to lose – except cash – by buying (or subscribing to) them. But for doctors, nurse practitioners and others, the stakes are higher. They need to know, “Are these things accurate?” “Can I trust them enough to base treatment plans on the information they give me?” “Do they really work?”
To gain clarity, JHC asked Bakul Patel, director of the U.S. Food and Drug Administration’s digital health division, to respond to some questions.
JHC: In April 2016, the Federal Trade Commission created a web-based tool for developers of health-related mobile apps in conjunction with FDA, the Office of the National Coordinator for Health Information Technology (ONC) and the Office for Civil Rights. The purpose was to give app developers clear information about the laws that apply to their health-related products. Three and a half years later, how would you characterize mobile app developers’ understanding and compliance with those laws?
Bakul Patel: The FDA often engages with digital health developers through a variety of channels to ensure that developers are aware of FDA regulations. Through guidances, webinars, external conferences and our email address (DigitalHealth@fda.hhs.gov), developers have multiple ways to engage with the FDA.
Some of the bright spots include our engagement with companies and organizations as we design and develop the software precertification pilot program for software as a medical device. While nine companies are formally involved in the program, the FDA has engaged with many companies and stakeholders to hear critical feedback as we look at ways to find efficiencies in our regulation of digital health products.
JHC: It has been reported that the industry is seeing a rise in FDA-cleared digital therapeutics. Do these things really work? Can a doctor trust the EKG readings that a patient’s watch is recording? Can he or she feel confident making a diagnosis or treatment plan based on it?
Patel: [Makers of] medical devices – including software as a medical device (SaMD) – that require premarket review by the FDA demonstrate to the agency in their application that the product is both safe and effective for the intended use.
It is important to note, though, that many medical products, including SaMD, may have limitations in their use. These limitations, contraindications and other important information about the use of the product are included in the FDA-required labeling for a product. Doctors, patients and their caregivers can understand the specific FDA-reviewed use of the product. In the case of SaMD product, it could include information about additional confirmatory tests being required.
For example, the Apple ECG application provides users very specific guidelines in its labeling: “The ECG App is a mobile app that is used with the Apple Watch to create, record, store, transfer and display a single channel electrocardiogram (ECG). The ECG App is also intended to detect the presence of AF and regular (sinus) rhythm. The app displays the heart rhythm as one of the following: sinus rhythm, AF, inconclusive due to other rhythms, or inconclusive due to poor signal quality. The ECG data displayed is intended for informational use only and does not replace traditional methods of diagnosis or treatment. If AF is detected, a health care provider should be consulted for additional testing and monitoring.The ECG App is not recommended for patients with other known arrhythmias.”
JHC: Who decides if a developer of a mobile medical application or device should seek FDA clearance? Is it the developer of the application or device? The FDA? Somebody else?
Patel: Medical device manufacturers or developers are responsible for ensuring they fulfill all applicable FDA regulatory requirements. FDA has several resources and has published several guidances to help developers decide when a clearance is required. We encourage all developers to review these resources and make that determination.
JHC: Who decides whether a mobile medical application or “wearable” can be administered only through a prescription?
Patel: Manufacturers submit product applications (premarket approval, a de novo or premarket clearance) with information about the intended use of the product, including whether the product will be for prescription use only or over the counter.
JHC: The FDA defines a device as something “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” If that’s the case, shouldn’t all mobile medical applications be subject to FDA approval?
Patel: No, not all mobile medical applications are making a claim to treat, cure, mitigate or prevent a disease or condition. For example, sleep tracking applications may help users track their sleep patterns, which is informational only and not meant to diagnose or treat a disease or condition.
JHC: In April 2019, then-FDA Commissioner Scott Gottlieb announced that the agency was building a Digital Health Center of Excellence “to develop more efficient ways to ensure the safety and effectiveness of technologies like smart watches with medical apps.” Can you talk about the two or three most important initiatives in which the Center of Excellence is engaged?
Patel: The Center is not yet formally launched. We plan to create a Center of Excellence on Digital Health to establish the regulatory paradigm, build new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. Implementing these regulatory innovations and information technology improvements are essential for advancing software-based technologies that improve the health and quality of life of patients while assuring critical safeguards, as the current regulatory framework is not well-suited for driving the development of safer, more effective software-based devices, including the use of machine learning and artificial intelligence.
To view a sampling of pre-market submissions that include mobile medical applications cleared or approved by the FDA, go to https://www.fda.gov/medical-devices/mobile-medical-applications/examples-pre-market-submissions-include-mmas-cleared-or-approved-fda.
Readers should also note that the FDA launched its “Pre-cert pilot program” as part of its “Digital Health Innovation Action Plan” in July 2017. The gist is to scrutinize the software developer or digital health technology developer, rather than primarily at the product. After reviewing systems for software design, validation and maintenance, FDA would determine whether the company meets quality standards and if so, would precertify the company.
The agency compares it to the Transportation Security Administration’s Precheck program, which screens travelers and awards them with a “Known Traveler Number,” speeding up their airport security checks.
With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for precertification and identify ways that precertified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool. The FDA is also considering — as part of the pilot program — whether and how precertified companies may not have to submit a product for premarket review in some cases.