Digital health—the convergence of healthcare, devices, genomics (in some instances),1 and 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.2 Digital health encompasses a broad range of products, including:
In this WSGR 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
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).8 CMS 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."9 In 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).11 Benefits 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
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.
Charles Andres and Feng Tian contributed to the preparation of this WSGR Alert.