Digital Health—The Need to Assess Benefits, Risks, and Value

Eric Perakslis; Geoffrey S. Ginsburg

doi:10.1001/jama.2020.22919

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December 28, 2020

Digital Health—The Need to Assess Benefits, Risks, and Value

Eric Perakslis, PhD¹; Geoffrey S. Ginsburg, MD, PhD²

Author Affiliations Article Information

¹Duke Forge, Duke University Medical Center, Durham, North Carolina
²Duke Center for Applied Genomics and Precision Medicine, Duke University Medical Center, Durham, North Carolina

JAMA. 2021;325(2):127-128. doi:10.1001/jama.2020.22919

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Digital health is a broad spectrum of measurement technologies that include personal wearable devices and internal devices as well as sensors in people, homes, cars, and communities. Digital health can help identify health risks and assist with diagnosis, treatment, and monitoring of health and disease conditions¹ and offers novel ways to capture continuous data on individuals and populations that complement the episodic data on individuals that are captured by current health care approaches. Digital health has potential to improve health management, but the current state of technology development and deployment requires a “buyer beware” cautionary note.

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December 30, 2020

Digital technology: Buyer Beware --Time to reform is now

Hunasikatti Mahadevappa, MD , FCCP | Fairfax Hospital, Falls Church , VA and FDA Silver Spring, MD

The authors state that ‘Given the considerable commercial pressures to drive digital health adoption, clinicians may need to decide whether to recommend a digital tool before evidence-based guidelines exist to guide adoption’. But recommending a digital tool without robust evidence based clinical studies serves no rational purpose in taking care of patients’ health. In the name of transparency the clinician should be honest enough to say to their patients’ I do not know if I can make any firm recommendations as I do not have any evidence about their effectiveness’.

Digital health (DH) technology should be evaluated by each of the specialty medical societies. They should evaluate if the DH device makes a clinically meaningful difference to patients with specific medical conditions. As the guidelines are plagued by the experts in the field with many conflicts of interest, this should be minimized by including the experts who are not affiliated with industry. This should also be enhanced by including representatives from DHHS who should not have any conflict of interest with industry anyway, as they are supposed to follow federal guidelines on ethics.

The popularity of Apple Watch may be a good clinical study. Atrial fibrillation is the most common type of cardiac arrhythmia (ie, irregular heartbeat), and its prevalence increases with age, affecting about 3% of men and 2% of women aged 65 to 69 years and about 10% of adults 85 years and older. Atrial fibrillation is a major risk factor for ischemic stroke, increasing risk of stroke by as much as 5-fold. Approximately 20% of patients who have a stroke associated with atrial fibrillation are first diagnosed with atrial fibrillation at the time of stroke or shortly thereafter. The USPSTF found inadequate evidence to assess whether screening with ECG identifies adults 65 years and older with previously undiagnosed atrial fibrillation more effectively than usual care.

The money being spent for devices with little clinical value should not be encouraged in the name of innovation. Greed should be replaced with desire to improve digital health technology which can lead to improvement in health outcomes. The risk of these devices being interfered by an outside hacker may also result in harm to the patient or even deaths.

Wearable devices may become useful in cardiac monitoring, and further studies are needed with the same rigor the medical systems are used to: Randomized double blind controlled trial to evaluate the value of the devices regarding the diagnostic/therapeutic outcome.

“This article reflects the views of the author and should not be construed to represent agency views or policies.”

References:

Atrial Fibrillation: Screening With Electrocardiography
https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/atrial-fibrillation-screening-with-electrocardiography

Karmen CL, Reisfeld MA, McIntyre MK, Timmermans R, Frishman W. The clinical value of heart rate monitoring using an Apple watch. Cardiol Rev. 2019;27(2):60-62.

First ransomware-related death reported in Germany. Security Magazine. Published September 21, 2020. Accessed October 31, 2020. https://www.securitymagazine.com/articles/93409-first-ransomware-related-death-reported-in-germany

CONFLICT OF INTEREST: None Reported

Digital Health—The Need to Assess Benefits, Risks, and Value

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