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. 2022 Apr 1;14(1):48.
doi: 10.1186/s13098-022-00818-9.

Digital therapeutics and the need for regulation: how to develop products that are innovative, patient-centric and safe

Marcela Rassi-Cruz  1 , Fernando Valente  2 , Maria Vanina Caniza  3
Affiliations

Digital therapeutics and the need for regulation: how to develop products that are innovative, patient-centric and safe

Marcela Rassi-Cruz et al. Diabetol Metab Syndr. .

Abstract

Background: Digital therapeutics are defined as therapeutic interventions that are driven by high quality software programs to prevent, manage or treat a medical disorder. These products provide great potential to improve patient outcomes, particularly for chronic disease sufferers, including people with Diabetes.

Main text: As yet, regulatory pathways for these products are rather unclear across all jurisdictions, although somewhat more progress has been made in the US and UK. Since digital therapeutics use cutting-edge technology and a logic of continuous innovation, regulation used for medical devices may not be completely appropriate. However, these products could present risks to patients if not developed and used appropriately. In the article, we consider the importance of a regulation framework and the role of self-regulation by developers as a way of ensuring patient safety while promoting innovation. We particularly emphasize the inclusion of doctors and other medical professionals in the design of the products, not only as a way of ensuring safe and effective applications, but also to encourage their take-up by patients, who tend to have high levels of trust for their HCPs.

Conclusion: Developers of digital therapeutics have the duty to create products that are safe, ethical and effective, without waiting for government regulation. Further, by self-regulating, following principles such as those provided by the Digital Therapeutics Alliance, they can develop products that serve patients better, while continuing to innovate.

Keywords: Digital health; Digital therapeutics; Regulation.

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Conflict of interest statement

Marcela Rassi-Cruz and Fernando Valente are employed by Axenya, a digital health platform based in Latin America. María Vanina Caniza provides legal advice to Axenya.

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