display:none
Skip to main content

Join the Virtual First Care Coalition to shape a healthcare system that's intentionally designed with patients at the center.

Join Today

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

About this resource

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

Related Resources That Might Interest You

Workbook: Inclusive Support for End Users

Tool

Workbook: Inclusive Deployment

Tool

Woebot Health – Making behavioral health radically accessible

Case Study

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

Tool, Publication

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

Tool

Value-Driven Framework for Evaluating Healthcare Innovations

Tool, Publication

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

Brief

Value of a Successful Measure: Translating Patient Value to Commercial Value

Brief

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

Brief

Value of a Successful Measure: Key Insights and Action Items

Brief

V3+: An extension to the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies

Tool, Publication

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

Brief

Using evidence from digital endpoints to demonstrate the value of a new drug: Considerations and recommendations

Brief

Use the Market Opportunity Calculator

Tool

Use Real-World Data and Real-World Evidence

Tool

U.S. RegPath flowchart

Tool

Tidepool’s Regulatory Journey Case Study

Case Study

Tidepool – First fully interoperable automated insulin dosing device: From DIY to FDA clearance

Case Study

The V3+ Usability Validation Glossary

Definition

The Resource Library: Inclusive Deployment

Library

The Primer on Digital Health Measurement

Brief

The Playbook: Digital Healthcare Edition

Tool, Brief, Case Study

The Library of Evidence

Library

The Framework for Inclusive Development

Tool

The Digital Health Measurement Product Development Process

Tool

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

Tool

Terminology and ontology: “scratch”

Definition

Terminology and ontology: “nocturnal”

Definition

Technology performance considerations for selection of devices measuring nocturnal scratch

Tool

Systematic Literature Review of Qualitative Evidence of Sleep Disturbance

Publication

Support and train clinical trial site staff

Tool

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

Brief

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

Brief

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

Brief

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

Template, Brief

Specific Actions – Diversity Plan

Tool

Snapshot of Sleep Library of Digital Measurement Products

Library

Sensor Data Glossary

Definition

Sensor Data Design Flow Tool

Tool

Select Click Therapeutics – Defining robust drug-like evidence: Bringing novel software products to the US market Click Therapeutics – Defining robust drug-like evidence: Bringing novel software products to the US market

Case Study

Scientific Figures of Sleep Disturbance

Tool

Sample End User License Agreement

Template

Risk Assessment Model for Digital Health Product Lifecycle

Tool

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

Brief, Case Study

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

Tool

Regulatory Engagement Pathways Map for Digital Health Product

Brief

Reference Data Architecture

Case Study

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

Brief

Recommendations for pharma at-a-glance

Brief

Recommendations for pharma

Brief

Recommendations for payers at-a-glance

Brief

Recommendations for payers

Brief

Recognize the Need for Diversity

Tool

Qure.ai – Bringing novel AI-powered devices to the US market

Case Study

Quickstart Guide: V3+ Use-Related Risk Analysis

Tool

Quickstart Guide: V3+ Use Specification

Tool

Quick Start Guide: Inclusive Engagement Plan

Tool

Quick Start Guide: Community Partnerships

Tool

Quick start guide to drug reimbursement – U.S.

Tool

Quick start guide to drug reimbursement – Europe

Tool

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

Tool

Questions to Ask – Patient/Participant Perspective

Tool

Quantitative Survey Results Dataset

Dataset/code

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

Tool

PMA Request Review Process

Brief

PMA Preparation Guide

Tool

PMA Checklist

Tool

PMA At-a-Glance

Brief

Plan for Diverse, Equitable, and Inclusive Engagement

Tool

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

Tool

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

Brief

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

Brief

Ontology: Walking speed

Tool

Ontology: Walking bout at specified bout durations

Tool

Ontology: Time spent in moderate to vigorous physical activity

Tool

Ontology: Step count

Tool

Ontology: Postural sway

Tool

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

Publication

Market Opportunity Calculator

Tool

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

Tool

Lunit – From 2D to 3D: Charting a new course in imaging analytics in the US Oncology market

Case Study

Logical Data Architecture

Tool, Template, Case Study

Library of Standards

Library

Library of Human Factors Resources for Digital Health Technologies

Library

Library of Digital Measurement Products

Library

Library of Digital Endpoints

Contribute!, Library

Learning About Context of Daily Life

Tool

Key Terms Glossary for 3Ps

Definition

JOGO – From FDA to multiple US market access pathways

Case Study

Investigational Device Exemption (IDE) for Digital Health Products

Brief

Interactive Landscape of Data Standards

Brief

Insights from the FDA

Brief

Informed Consent – Considerations for Inclusivity

Tool

Inclusive Deployment Plan Worksheet

Tool

Inclusive Deployment Checklist

Tool

Inclusive Communications Guide

Tool

Implement Digitized Clinical Trials

Tool

Identifying your Role in Driving Regulatory Strategy for Digital Health Products

Tool

Hire a Digital Clinical Trials Navigator

Tool

HDE Submission Checklist

Tool
    Join our next project

    Help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients

    Join the Integrated Evidence Plans project

    Join us
    Not today