Digital Health Technologies for Cardiometabolic Disease and Diabetes: A Perspective From the U.S. Food and Drug Administration

Abstract

Section snippets

Overview of DHT Regulation

DHTs that meet the definition of a medical device are regulated by the FDA, which applies regulatory controls and marketing pathways based on the intended use and potential risk of the device (Figure 1). Devices are classified from Class 1 with the lowest risk (eg, a toothbrush, Digital Visual Acuity Test), Class 2 with intermediate risk (eg, CGMs, WellDoc’s Bluestar, a digital therapeutic for type 2 diabetics to help them manage their condition), to Class 3 with the highest risk (eg,

Gaps in Evidence

A major limitation inhibiting widespread adoption of DHTs is the lack of evidence of a causal link between recommendations to use particular DHTs, actual use, and improved clinical outcomes in the population for whom the DHT is recommended. Although studies have shown that the detection of cardiometabolic disease by DHTs can be successfully validated relative to measures like blood glucose or hemoglobin A1c, it remains unclear whether their use makes a difference in the clinical status of those

Gaps in Clinical Integration

Lack of integration can affect the effectiveness of DHTs, particularly in the postmarket phase. The tendency for each new “app” to exist as a standalone product or point solution without integration into a coherent base of technologies or unified applicably at the point of care creates an enormous barrier to uptake and leads to skepticism among clinicians, health systems, and payers. Many stand-alone DHTs may be unlikely to provide definitive diagnostic information or be comprehensive enough to

Gaps in Patient Access and Retention

Cardiometabolic disease is disproportionately concentrated among people who face broad socioeconomic challenges. However, DHTs have greater uptake in groups with lower disease prevalence rates, exacerbating the “digital divide.” This digital divide is worsened by the poor evidence base leading to sparse insurance coverage, making these technologies accessible only to more affluent patients. Many disadvantaged groups can face additional barriers such as mistrust of institutionalized health care

Developing a Value Proposition for DHTs

The prime deficiency of most DHTs is a lack of evidence showing their use leads to health benefits for patients, improved care management for clinicians, and economic value to payers. Careful testing and validation has been used for decades by manufacturers of drugs, devices, and biologics, resulting in great success for manufacturers, the health system, payers, and the public. This results in an ecosystem wherein manufacturers have incentive to innovate, and health systems, payers, and the

The Role of Clinicians and Health Systems

Clinicians can play critical roles in ensuring DHTs are designed and tested in ways that streamline clinical workflows and ensure best outcomes for patients. One barrier to clinician engagement has been lack of reimbursement pathways for these technologies in clinical practice. The recent proposed revision of the physician fee schedule rule by the Centers for Medicare and Medicaid includes codes for DHTs for mental health, including payment for time allocation to assist the patient in dealing

Conclusions

The FDA continues to attempt to stimulate a positive environment for the development of DHTs for the prevention and treatment of chronic conditions, such as cardiometabolic disease. However, the FDA is one part of the entire ecosystem that will need to collectively step up to ensure that DHTs that lead to improved clinical outcomes are developed, tested, and integrated into the health care system in a manner that enables them to serve as vital instruments to prevent and manage cardiometabolic

Funding Support and Author Disclosures

Dr Warraich has previously served on the medical advisory board for GoodRx. Dr Pai serves as an unpaid consultant to Health Tequity, LLC. Dr Califf has previously been an employee of and held equity in Verily Life Sciences and Google Health (Alphabet); and has served on boards of directors for Cytokinetics, Centessa, Clinetic, Keystone Symposia, the Critical Path Institute (C-Path), the Clinical Research Forum, and One Fifteen. Dr Tazbaz has previously been an employee of and held equity in