Key gaps preventing digital health technologies (DHTs) from meeting their full potential in assisting with the prevention, early detection and better management of cardiometabolic disease is the topic of a Special Communication article published Dec. 4 in JACC.

Haider J. Warraich, MD, et al., describe gaps in evidence, clinical integration, and patient access and retention that contribute to the lack of effective utilization of DHTs in health care and propose a roadmap for DHTs to demonstrate value to patients, clinicians and payers.

“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,” they write.

They also describe current efforts by the U.S. Food and Drug Administration (FDA), such as the “Home as a Healthcare Hub” initiative, to help support integration of DHTs in the patient’s home environment.

Expounding on the role of clinicians and health systems in helping to design and test up-and-coming DHTs, the authors acknowledge how lack of reimbursement pathways for these technologies in clinical practice has presented challenges to encouraging early clinician engagement. They point to newly added codes for DHTs for mental health in the latest Medicare Physician Fee Schedule and recent updates to CPT code to include digital therapeutic interventions for remote patient monitoring as a promising start.

“The FDA continues to attempt to stimulate a positive environment for the development of DHTs for the prevention and treatment of chronic conditions,” write the authors. “However, the FDA is one part of an 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 disease.”

Keywords: United States Food and Drug Administration, Cardiovascular Diseases