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Digital Health Technology (DHT) Evidentiary Templates

Problem Statement

  • No standard template for regulatory submissions for novel digital methods (DHT)

  • Leads to inconsistencies in regulatory submissions

  • Creates hurdles for both sponsors and regulators

  • Potential delays in drug development program

Why a Template

Helpful to have a template to follow and ensure that the information presented is what the agency wants to see.

  • Support innovation by providing structured approach
  • Facilitate preparation of high-quality briefing package

Development, regulatory acceptance, and adoption of digital derived endpoints take a significant amount of time.

BIO Digital Health Technology (DHT) Evidentiary Template

BIO DHT Biomarker Template
BIO Digital COA Template