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PubMed

Navigating through regulatory frameworks for digital therapeutics and biomarkers.

PMID: 41067729 ·

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JournalHealth informatics journal
Year
PMID41067729

Abstract

Background: Digital health technologies are often subject to regulatory requirements. Regulatory auditing processes are complex but necessary to guarantee quality, efficacy and safety of patients. Evolvements such as digitalized clinical trials, and digital biomarkers require a constant adaption of regulatory frameworks. Objective: This review aims to provide an overview on current regulations and standards for digital therapeutics and digital biomarkers, from technical development to market acc

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