Institute for Clinical and Economic Review – Peterson Health Technology Institute value assessment framework for digital health technologies

Author:

Pearson Steven D1,Singh Prabhjot2,Beaudoin Francesca1,Campbell Jon1,Schapiro Lindsey2,Emond Sarah K1,Pearson Caroline2

Affiliation:

1. Institute for Clinical & Economic Review, MA 02108, USA

2. Peterson Health Technology Institute, NY 10022, USA

Abstract

Digital health technologies (DHTs) are a broad and rapidly innovating class of interventions with distinctive pathways for development, regulatory approval, uptake and reimbursement. Given the unique nature of DHTs, existing value assessment frameworks and evidence standards for health technologies such as drugs and devices are not directly applicable. The value assessment framework presented here describes a conceptual model and associated methods to guide assessments of DHTs. The framework seeks to accomplish two goals: to set evidence standards that guide technology developers to generate robust evidence on their products; and to provide reviews that help organizations adopt high-impact DHTs with the strongest evidence for delivering improved clinical outcomes and cost savings. This assessment framework will serve as the roadmap for future evaluations of DHTs by the Institute for Clinical and Economic Review (ICER) and the Peterson Health Technology Institute (PHTI). We believe that all stakeholders will benefit from comprehensive and explicit standards of evidence on the different dimensions necessary to understand the value of DHTs.

Publisher

Becaris Publishing Limited

Subject

Health Policy

Reference23 articles.

1. US Food & Drug Administration. What is Digital Health (2020). https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health (Accessed: 28 February 2023).

2. US Food & Drug Administration. Content of Premarket Submissions for Device Software Functions (2021). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions (Accessed: February 28 2023).

3. US Food & Drug Administration. Digital Health Center of Excellence (2023). https://www.fda.gov/medical-devices/digital-health-center-excellence (Accessed: 28 February 2023).

4. European Medicines Agency. Questions and answers: qualification of digital technology-based methodologies to support approval of medicinal products (2020) https://www.ema.europa.eu/en/documents/other/questions-answers-qualification-digital-technology-based-methodologies-support-approval-medicinal_en.pdf

5. Government of Canada. Building better access to digital health technologies (2019). https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness/improving-review-drugs-devices/building-better-access-digital-health-technologies.html (Accessed: 28 February 2023).

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