Regulatory considerations to keep pace with innovation in digital health products

Torous, John; Stern, Ariel Dora; Bourgeois, Florence T.

doi:10.1038/s41746-022-00668-9

Cited by 52 publications

(42 citation statements)

References 18 publications

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“…Considering the six (1.1% of 537 marketplace app) that were deemed clinically appropriate, five apps (only available on Google Play App Store) solely provided information/psychoeducation, and only one app (available on both Apple App Store and Google Play App Store) included therapeutic and monitoring features. The paucity of apps with therapeutic features may be that apps with therapeutic or diagnostic features are subject to Food and Drug Administration’s regulation as those apps do not fall under the “wellness” app category 43 . However, all six apps are not currently updated with an average time since last updated being 1121 days (3.07 years ago).…”

Section: Discussionmentioning

confidence: 99%

Accessibility and availability of smartphone apps for schizophrenia

et al. 2022

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App-based interventions have the potential to enhance access to and quality of care for patients with schizophrenia. However, less is known about the current state of schizophrenia apps in research and how those translate to publicly available apps. This study, therefore, aimed to review schizophrenia apps offered on marketplaces and research literature with a focus on accessibility and availability. A search of recent reviews, gray literature, PubMed, and Google Scholar was conducted in August 2022. A search of the U.S. Apple App Store and Google Play App Store was conducted in July 2022. All eligible studies and apps were systematically screened/reviewed. The academic research search produced 264 results; 60 eligible studies were identified. 51.7% of research apps were built on psychosis-specific platforms and 48.3% of research apps were built on non-specific platforms. 83.3% of research apps offered monitoring functionalities. Only nine apps, two designed on psychosis-specific platforms and seven on non-specific platforms were easily accessible. The search of app marketplaces uncovered 537 apps; only six eligible marketplace apps were identified. 83.3% of marketplace apps only offered psychoeducation. All marketplace apps lacked frequent updates with the average time since last update 1121 days. There are few clinically relevant apps accessible to patients on the commercial marketplaces. While research efforts are expanding, many research apps are unavailable today. Better translation of apps from research to the marketplace and a focus on sustainable interventions are important targets for the field.

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Section: Discussionmentioning

confidence: 99%

Accessibility and availability of smartphone apps for schizophrenia

et al. 2022

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“…However, thousands of unregulated apps have appeared for mental health and wellness and make claims not backed by scientific studies to evaluate efficacy [21]. Websites are also emerging with words such as "accredited reviews," but no accredited medical societies are involved in those reviews [22,23]. Data security in mental health apps is also a significant concern [24].…”

Section: Digital Therapeutics Purpose Mechanisms and Regulationmentioning

confidence: 99%

Social Media is Addictive and Influences Behavior: Should it Be Regulated as a Digital Therapeutic?

Perakslis¹,

Quintana²

2023

J Med Internet Res

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Recently, we were deeply saddened by the findings of the coroner investigating the death of 14-year-old Molly Russell. Deeply saddened and angry but not surprised. This case should be seen as a sentinel event, given that this is the first time social media was directly implicated as a cause of death. We should use this opportunity to advance proposals for the regulations of the health effects of social media.

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“…FDA has since published a flurry of guidance documents attempting to clarify their evolving interpretation of the Cures Act (3,5,6). Specifically, these guidance documents attempted to clarify (1) what types of clinical decision support the FDA would and would not regulate, (2) what types of medical device functions FDA would and would not regulate, and ( 3) what information FDA would expect to see in a submission for regulated medical device functions.…”

Section: The Evolution Of Software Regulationmentioning

confidence: 99%

“…But, in part because of the speed with which prescription digital therapeutics (PDTs) have entered the health care ecosystem, some uncertainty exists about how rigorously these devices are evaluated and exactly how they are currently regulated by the Food and Drug Administration (FDA). Torous et al, recently outlined how regulatory approaches can improve innovation in digital devices ( 1 ). This perspective expands on this theme, explaining the history and current regulatory landscape in which digital therapeutics are approved for use and will examine the ways the FDA is adapting to this new paradigm.…”

Section: Introductionmentioning

confidence: 99%

FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate

Watson

Chapman

Shafai

et al. 2023

Front. Digit. Health

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Technological progress in digital therapeutics—and, in particular prescription digital therapeutics (PDTs)—has outpaced the processes that the Food and Drug Administration (FDA) uses to regulate such products. Digital therapeutics have entered the health care ecosystem so rapidly that substantial misunderstandings exist about how they are evaluated and regulated by the FDA. This review briefly explains the relevant regulatory history of software as medical devices (SaMDs) and reviews the current regulatory landscape in which prescription and non-prescription digital therapeutics are developed and approved for use. These are important issues because PDTs, and digital therapeutics in general, are an explosively growing field in medicine and offer many advantages over conventional face-to-face treatments for the behavioral dimensions of a wide range of conditions and disease states. By allowing access to evidence-based therapies remotely and privately, digital therapeutics can reduce existing disparities in care and improve health equity. But clinicians, payers, and other healthcare stakeholders must appreciate the rigor of the regulatory frameworks within which PDTs are approved for use.

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Regulatory considerations to keep pace with innovation in digital health products

Cited by 52 publications

References 18 publications

Accessibility and availability of smartphone apps for schizophrenia

Accessibility and availability of smartphone apps for schizophrenia

Social Media is Addictive and Influences Behavior: Should it Be Regulated as a Digital Therapeutic?

FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate

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