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

“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 conditions 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 technologies may enhance capabilities for improving health through 3 modalities: improved data communications, miniaturization, and decentralization of devices. Electronic medical records, mobile health apps, and wearable devices and sensors contribute to an increasing flow of digital health data. To provide meaningful health applications, these data require standardized high-quality formats, seamless communications, and integration across health information technology systems.

[..] Commonly used digital health technologies work via miniaturized biosensors incorporated into some physical device such as a watch. [..] it is important for clinicians and patients to understand that even though these devices may offer longer monitoring times, they have less signal fidelity, resulting in false-positive diagnoses that may incur additional expenses and anxiety. For example, recent studies of home arrhythmia monitoring have prompted warnings regarding the lack of evidence to support routine screening for arrhythmias in healthy, asymptomatic people.

[..] It is important to understand that digital health devices can be approved or cleared by the US Food and Drug Administration. Approved devices have been studied clinically and determined to provide benefits that outweigh any corresponding risks (eg, software-based digital therapeutics for treatment of addiction). Cleared devices need only to demonstrate “substantial equivalence” to an already approved device for the same indication (eg, heart rhythm monitors on smart watches). This lower bar provides rapid entry into the market for innovators but does not consider the quality of the chosen predicate device, so caution is urged, especially as the lay press may use these terms incorrectly and interchangeably.

Technologic innovation often comes with a new set of ethical considerations and challenges. [..] Probably the most important issue is the unprecedented amount of information about users that is captured by digital health and the competing needs for cybersecurity and privacy, risks that amplify geometrically with the increasing capabilities for monitoring and surveillance. Beyond the familiar potential risks, such as identity theft, digital health tools carry an array of hidden risks. Accelerometer and global positioning system (GPS)–enabled devices track gait, step counts, and exercise but also transmit detailed physical location data over mostly unsecured networks. Theft of these data has been shown to lead to burglary and physical tracking by stalkers. Virtual assistant–enabled communication can be an aid to people with disabilities or to older adults, but it is impossible to determine what is actually recorded or filmed and with whom these data are being shared. More concerning is how these risks amplify geometrically.

[..] Some tools bring convenience, others bring novel capabilities; both are valuable but difficult to quantify because of lack of comparators. Second, with respect to direct clinical utility, few of these technologies are currently reimbursed, and the financial costs will likely be patients’ responsibility for the foreseeable future. Increasingly, some case reports suggest that digital health is providing new diagnoses and opportunities for treatment that would otherwise not be realized. For these patients, there is value. But to justify ubiquitous use and reimbursement for novel digital health tools will ultimately require clinical trials to demonstrate utility. Third, more information may not necessarily lead to an improvement in patient outcomes, which is the true test of importance and value.

[..] Few digital health technologies have been rigorously shown to be equivalent to standard, accepted measurement devices. Clinical trials are ongoing and there is clear interest in determining the full potential of digital health. Thus, given the expense and unknown benefit-risk profiles of many digital health tools, they should, for the moment, be considered experimental.

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.”

Risk-Benefit and Value Assessment in Digital Health

Full editorial, Perakslis E and Ginsburg GS. JAMA 2020.12.28