The Library of Evidence

The DATAcc Inclusion | Library of Evidence is a curated catalog of 100+ publicly available resources providing evidence for the benefits of inclusive digital health product development. Use these resources to access real numbers to further build out your business case

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Clinical Trials, Digital Measures Development Projects in Practice

The Library of Evidence

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Workbook: Inclusive Support for End Users

Workbook: Inclusive Deployment

Verification, Analytical Validation, and Clinical Validation (V3) framework

Vendor selection considerations for clinical trial design utilizing digital measurement of nocturnal scratch

Value-Driven Framework for Evaluating Healthcare Innovations

Value of Regulations for Digital Health Products in the U.S.

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Value of a Successful Measure: Modeling Potential Increases in Drug Utilization

Value of a Successful Measure: Key Insights and Action Items

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Utilizing a modified Delphi approach to select digital measures of physical activity

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Use the Market Opportunity Calculator

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U.S. RegPath flowchart

Tidepool’s Regulatory Journey Case Study

The V3+ Usability Validation Glossary

The Resource Library: Inclusive Deployment

The Primer on Digital Health Measurement

The Playbook: Digital Healthcare Edition

The Library of Evidence

The Framework for Inclusive Development

The Digital Health Measurement Product Development Process

The Conceptual Model: A core set of digital measures for physical activity

Terminology and ontology: “scratch”

Terminology and ontology: “nocturnal”

Technology performance considerations for selection of devices measuring nocturnal scratch

Systematic Literature Review of Qualitative Evidence of Sleep Disturbance

Support and train clinical trial site staff

Study population considerations for clinical trial design utilizing digital measurement of nocturnal scratch

Strategies to optimize site and investigator experience in clinical trial design utilizing digital measurement of nocturnal scratch

Strategies to optimize atopic dermatitis patient experience in clinical trial design utilizing digital measurement of nocturnal scratch

Standardized Rationale for the Use of the Core Digital Measures of Sleep

Specific Actions – Diversity Plan

Snapshot of Sleep Library of Digital Measurement Products

Sensor Data Glossary

Sensor Data Design Flow Tool

Scientific Figures of Sleep Disturbance

Sample End User License Agreement

Risk Assessment Model for Digital Health Product Lifecycle

Reimbursement for Clinicians: Getting paid for caring for your patients using digital measures of sleep

Regulatory Strategy for Digital Health Products in the U.S.

Regulatory Engagement Pathways Map for Digital Health Product

Reference Data Architecture

Recommendations for subject privacy assurance, data collection and study monitoring in clinical studies utilizing digital measurement of nocturnal scratch

Recommendations for pharma at-a-glance

Recommendations for pharma

Recommendations for payers at-a-glance

Recommendations for payers

Recognize the Need for Diversity

Quickstart Guide: V3+ Use-Related Risk Analysis

Quickstart Guide: V3+ Use Specification

Quick Start Guide: Inclusive Engagement Plan

Quick Start Guide: Community Partnerships

Quick start guide to drug reimbursement – U.S.

Quick start guide to drug reimbursement – Europe

Quick Guide on Intended Use and Indication for Use for Digital Health Products

Questions to Ask – Patient/Participant Perspective

Quantitative Survey Results Dataset

Project charter template for clinical studies utilizing digital measurement of nocturnal scratch

PMA Request Review Process

PMA Preparation Guide

PMA Checklist

PMA At-a-Glance

Plan for Diverse, Equitable, and Inclusive Engagement

Patient usability form for uniform usability testing of devices measuring nocturnal scratch

Patient research: A systematic review to uncover meaningful concepts of physical activity for patients

Opportunities and challenges to using digital clinical measures to inform reimbursement decisions in drug development

Ontology: Walking speed

Ontology: Walking bout at specified bout durations

Ontology: Time spent in moderate to vigorous physical activity

Ontology: Step count

Ontology: Postural sway

Narrative Review Objective Clinical Measures of Sleep in Real-World Settings

Market Opportunity Calculator

Mapping the Steps Forward: Decision tree for endpoint strategy for digital measures of physical activity

Logical Data Architecture