Digital health—the convergence of healthcare, devices, genomics (in some instances),1and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of digital health is the constant interaction between technical innovation and the U.S. Food and Drug Administration's (FDA's) medical device regulatory framework.2Digital health encompasses a broad range of products, including:
- Smart medicines (digital pills)
- Electronically monitored inhalers
- Mobile apps for delivering cognitive behavioral therapy
- Platforms for remotely programming implanted medical devices
- Devices (e.g., watch bands) that obtain, analyze, and transmit electrocardiograms (ECGs)
In this Wilson Sonsini Alert, we highlight some recent advances in digital health, and we offer selected strategic considerations.
Success Stories: mHealth App, Digital Pill, Telemedicine Platform, and ECG Band for Apple Watch
- mHealth App. On September 14, 2017, the FDA permitted the marketing of the first mobile medical application for substance use disorder (SUD).3Through the de novo pathway, this app became the first prescription digital therapeutic to be used in conjunction with standard outpatient therapy for SUDs related to alcohol, cocaine, marijuana, and stimulants. The device contains both a patient application and a clinician dashboard, through which patients receive cognitive behavioral therapy to treat SUD. In October 2017, a similar digital therapeutic device by the same manufacturer to treat opioid use disorder (OUD) received expedited access pathway designation from the FDA.4
- Digital Pill. On November 13, 2017, the FDA approved its first drug with an embedded sensor tracking the ingestion of a pill called Abilify MyCite for the treatment of schizophrenia, the acute treatment of bipolar disorder, and as an add-on treatment for depression in adults.5The pill works, in part, by sending a message from the sensor to a wearable patch when the pill contacts fluid in the stomach. Then the patch relays the information to a mobile application (i.e., a smartphone app). If permitted by the patient, the same information can be assessed through a web-based portal by caregivers or physicians. Thus, Abilify MyCite is designed to improve patient compliance with an Abilify therapeutic regimen.
- Telemedicine Platform. On November 17, 2017, the FDA approved the first telehealth option to program cochlear implants (hearing devices) remotely through a telemedicine platform.6Cochlear implants typically require regular programing visits with an audiologist to adjust various electronic settings of the implant. Allowing remote programming through the telemedicine platform can reduce patient burden and the associated travel costs.
- ECG Band for the Apple Watch. On November 30, 2017, the FDA cleared KardiaBand, the first medical device accessory for the Apple Watch.7This device can record an ECG reading in 30 seconds with a touch of its integrated sensor. After recording an ECG, the results can be displayed in real time on the watch face, and an accompanied algorithm can classify the ECG reading as a normal sinus heart rhythm or potential atrial fibrillation—the most common heart arrhythmia and a leading cause of stroke. Notably, the ECG watch band does not require a prescription.
Coverage Consideration: Telehealth Program Not Covered by Medicare Diabetes Prevention Program
On November 2, 2017, the Centers for Medicare and Medicaid Services (CMS) declined to reimburse providers for the use of virtual coaching platforms on weight management in the Medicare Diabetes Prevention Program (MDPP).8CMS maintained that telehealth programs exclusively relying on self-reported weight loss will not be covered by Medicare because "self-attested weight measurement is generally unreliable, therefore . . . in-person weight measurement is the most reliable and appropriate form of weight measurement for the MDPP expanded model."9In this particular case, face-to-face inventions trump corresponding telehealth options for CMS coverage.10
Market Reception of Digital Health Products
On November 16, 2017, Express Scripts, a large U.S. prescription benefit plan provider, struck a deal with Propeller Health to provide an FDA-cleared digital health product (inhaler sensor and companion app) to people using inhalers to manage asthma and chronic obstructive pulmonary disease (COPD).11Benefits include tracking inhaler usage and sending the data to a smartphone using Bluetooth. The collected data can help reduce overuse of rescue inhalers, manage patient adherence to a controller regimen, and reduce emergency room visits.12
Conclusion
Manufacturers should continue to embrace digital health, which includes considering: the FDA regulatory pathway to market, programs designed to accelerate the path to market (e.g., the FDA's Expedited Access Pathway), indications, enhanced patient compliance, HIPAA and privacy considerations, hacking safeguard considerations, coverage, coding, reimbursement, trademarks, patents, and the freedom to operate. Start-up companies also should consider the implications for IPOs and potential mergers and acquisitions.
For more information on digital health products or any other FDA regulatory matter, please contact David Hoffmeister or any member of the FDA regulatory or digital health practices at Wilson Sonsini.
Feng Tian contributed to the preparation of this Wilson Sonsini Alert.
