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DiMe Resources

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The sDHT Adoption Navigator

Regulations, Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Defining core digital measures for Pediatric rare disease research & care

Digital Measures Best Practices

The Playbook: Implementing AI in Healthcare

DiMe Case Study: Generative AI to Draft Patient Portal Messages at Stanford Medicine

DiMe Case Study: Piloting the Sepsis Watch in a silent trial

DiMe Case Study: Partnering to build a streamlined prior authorization process

Advancing a Sustainable Hospital-at-Home Ecosystem at Scale

Digitally enabled healthcare

Benchmarking Survey Report

Removing harmful race-based clinical algorithms: A toolkit

Digital Health Equity

Simulator of study power for Parkinson’s Disease trials

Digital Measures Best Practices

Digital Endpoints Business Case Template

Digital Measures Best Practices

Advancing digital biomarkers to accelerate Parkinson’s disease drug development

Digital Measures Best Practices

Value of novel digital endpoints in late-stage trials

Digital Measures Best Practices

Multimodal digital health technologies (DHTs) allow for more efficient and less costly recruitment and reduced patient burden with decentralized clinical trials

Digital Measures Best Practices

Digital Endpoints ROI Calculator

Digital Measures Best Practices

Estimating the benefits of digital and plasma-based pre-screening in Alzheimer’s Disease trial recruitment

Digital Measures Best Practices

Digital Endpoints Value Framework

Digital Measures Best Practices

Enhancing clinical insights: De-risking traditional outcome measures in Bellerophon Therapeutics REBUILD study

Digital Measures Best Practices

Multimodal digital measures demonstrate greater responsiveness and sensitivity to disease progression and treatment effects than traditional clinical scales

Digital Measures Best Practices

Driving innovation in Huntington’s Disease by tracking progression through at-home digital measurements

Digital Measures Best Practices

Advancing nano-rare disease treatment with Syde technology in clinical trials

Digital Measures Best Practices

Accelerated trial setup & operations: A case study in Cystic Fibrosis to illustrate the ROI of improved data availability

Digital Measures Best Practices

DiMe Resource: IEP Business Model Template for DHTs

DiMe Resource: IEP Stakeholder Mapping Templates

High-Quality Evidence for DHTs — A Checklist

Digital Health Equity

DiMe Case Study: Caption Health – Stage C

Digital Health Equity

DiMe Case Study: Caption Health – Stage B

Digital Health Equity

DiMe Case Study: Caption Health – Stage A

Digital Health Equity

DiMe Case Study: Applied VR – Stage C

Digital Health Equity

DiMe Case Study: Applied VR – Stage B

Digital Health Equity

DiMe Case Study: Applied VR – Stage A

Digital Health Equity

Target patient value profile (TPVP) template for digital health technologies (DHTs)

Target product profile template for DHTs

The Playbook: Pediatric Digital Medicine

Digital Health Products

CAHMI: The Well Visit Planner: Improving provider and family experiences

Digital Health Products

PedsMrkt: Disseminating pediatric digital innovation

Digital Health Products

Children’s Mercy Kansas City: Including clinicians in product design delivers impact

Digital Health Products

Cincinnati Children’s Hospital: Helping patients and families use DHTs: lessons at scale

Digital Health Products

Gabi SmartCare: Establishing a market opportunity for pediatrics

Digital Health Products

Gabi SmartCare: Co-designing a pediatric digital health technology with caregivers and clinicians

Digital Health Products

Protokinetics: Improving objectivity in pediatric trials

Clinical Trials

Lessons learned from Catalonia: A pediatric healthcare innovation ecosystem

Regulations

Stanford Medicine: Where’s the data going? An example of adolescent data management

Digital Health Products

Summus: Driving sustainable specialty care solutions

Digital Health Products

CLOC: Including families in product development

Digital Health Products

Boston Children’s Hospital: Building a toolkit to support innovators

Digital Health Products

Mightier: Empowering emotional regulation: Boston Children’s innovation

Digital Health Products

CLOC: Supporting families within healthcare settings

Digital Health Products

Xploro: Personalizing pediatric education

Digital Health Products

Building CRS De-risking Products: A Practical Guide for Developers

Digital Measures Best Practices

Leveraging DATAcc by DiMe’s ontology for data transfer specifications development for early detection of CRS in CAR-T and BiTE therapy patients

Clinical Trials, Digital Measures Development Projects in Practice

Ontology of tachycardia

Digital Measures Best Practices

Optimizing sepsis and CRS detection: A data-driven approach to improve patient outcomes

Digital Measures Best Practices

Ontology of hypotension

Digital Measures Best Practices

Ontology of hypoxia

Digital Measures Best Practices

Ontology of fever generation

Digital Measures Best Practices

Ontology of early warning signs of CRS

Digital Measures Best Practices

Simulation Toolkit for Digital Clinical Measure Validation

Digital Measures Best Practices, Digitally enabled healthcare

Build Your Study: Novel Digital Clinical Measure Analytical Validation Planning

Digitally enabled healthcare

Interactive Guide to Validating Novel Digital Clinical Measures

Digitally enabled healthcare

Identifying and defining a remote, at-home assessment of visuospatial memory in ADRD

Clinical Trials, Digital Measures Best Practices

Navigating emerging global AI regulations: How-to guide for DHT developers

Regulations, Digital Health Products

Empatica: Utilizing US data in Europe

Regulations, Clinical Trials

WELT: Navigating clinical trial comparators

Regulations, Clinical Trials

Huma: Clinical evidence transferability

Regulations, Clinical Trials

Big Health: Cross-jurisdictional recognition

Regulations, Clinical Trials

Oviva: Leveraging UK data in Germany

Regulations, Clinical Trials

Luca: Conducting clinical trials in China

Regulations, Clinical Trials

Transforming the delivery of obesity care without adding complexity

Digitally enabled healthcare

Sleep disruption discussion guide

Clinical Trials, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Ontology of expressive communication

Regulations, Clinical Trials, Digital Measures Best Practices

Ontology of sleep disruption

Regulations, Clinical Trials, Digital Measures Best Practices

Ontology of non-sedentary behavior

Regulations, Clinical Trials, Digital Measures Best Practices

Core Digital Measures of ADRD conceptual model

Regulations, Clinical Trials, Digital Health Products

Standardized rationale for the use of the Core Digital Measures of ADRD

Clinical Trials, Digital Health Products, Digital Measures Best Practices

Visuospatial memory discussion guide

Clinical Trials, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Expressive communication discussion guide

Clinical Trials, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Non-sedentary discussion guide

Clinical Trials, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Transforming cardiopulmonary care and outcomes with Predictive Patient Care

Digitally enabled healthcare

Ontology of visuospatial memory

Regulations, Clinical Trials, Digital Measures Best Practices

Revolutionizing chronic disease management and preventive care with Ciba Health

Digitally enabled healthcare

V1C Outcomes & Evidence Directory

Digitally enabled healthcare

Enhancing maternal care and experience with SimpliFed’s virtual approach

Digitally enabled healthcare

Beating opioid addiction from home with Ophelia’s patient-first virtual platform

Digitally enabled healthcare

Enabling scalable high-quality healthcare with a primary care model powered by AI

Digitally enabled healthcare

Improving access, retention, and revenue with Oshi Health’s partnership model

Digitally enabled healthcare

Expanding networks and addressing shortages with virtual care providers

Digitally enabled healthcare

Omada: Navigating payment and coding for virtual first care (V1C)

Digitally enabled healthcare

Dreem: Navigating payment and coding for virtual first care (V1C)

Digitally enabled healthcare

Creating a holistic V1C environment just for women

Digitally enabled healthcare

COPD V1C addresses access issues and provides care at scale

Digitally enabled healthcare

Leveraging virtual-first care to increase accessibility & affordability of specialist-level care for migraine patients

Digitally enabled healthcare

V1C enhances episodic care when patients call an ambulance to take them to the ED

Digitally enabled healthcare

Personalizing virtual care at scale for people living with chronic conditions

Digitally enabled healthcare

Rising to the growing standards of virtual first care (V1C)

Digitally enabled healthcare

Cardiovascular disease care anytime, anywhere avoids exacerbations

Digitally enabled healthcare

Virtual sleep clinic provides comprehensive consult, diagnosis and treatment solution

Digitally enabled healthcare

CareHive: Navigating patients across the continuum of care transitions

Digitally enabled healthcare

CovidCare at Home demonstrates benefits of remote patient monitoring

Digitally enabled healthcare

Insight transcription supports patient retention of in-appointment conversations

Digitally enabled healthcare

V1C Health System Maturity Model Assessment

Digitally enabled healthcare

V1C Health System Maturity Model

Digitally enabled healthcare

V1C Health System Checklist: Maturity Stages & Growth Opportunities

Digitally enabled healthcare

V1C Health System Framework for Maturity

Digitally enabled healthcare

Digital Measures Development: Lessons Learned from an Expert Workshop Addressing Cross-Therapeutic Area Measures of Sleep

5 innovative ways to bring DHTs to market successfully

Regulations, Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Capturing the Value of V1C for Healthcare Delivery

Digitally enabled healthcare

Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort

Clinical Trials, Digital Measures Best Practices

5 Ways to Check Your Claims

Digitally enabled healthcare

A Tech Stack for Effective V1C Care Transitions

Digitally enabled healthcare

Necessary Conditions for Effective V1C Care Transitions

Digitally enabled healthcare

V1C Coalition Guide to Effective Virtual-First Care (V1C) Care Transitions

Digitally enabled healthcare

Quickstart Guide to Partnerships between V1C Providers & Employers

Payment, Digitally enabled healthcare

Quickstart Guide to Partnerships between V1C Providers & ACOs

Payment, Digitally enabled healthcare

Overview of Core Competencies

Digitally enabled healthcare

Core Competencies

Digitally enabled healthcare

Engaging Key Partners for Effective V1C Care Transitions

Digitally enabled healthcare

Guide to Payor-V1C Contracting (Contract & Exhibits Only)

Digitally enabled healthcare

V1C Shareable Slides

Digitally enabled healthcare

Guide to Payor-V1C Contracting (Full Version)

Digitally enabled healthcare

Quickstart Guide: How to get paid for V1C

Digital Health Equity

Quickstart Guide to Partnerships between V1C Providers & Health Insurance Companies (Payors)

Payment, Digitally enabled healthcare

Supplemental Guide: Basics of Billing & Coding for V1C

Digitally enabled healthcare

V1C Directory

Digitally enabled healthcare

Engaging Informal Care Partners Along the Patient Journey for Optimal V1C Care Transitions

Digitally enabled healthcare

The V1C Payment & Coding Library

Digitally enabled healthcare

Guide to Virtual Care First (V1C) Payment Models

Payment, Digitally enabled healthcare

Payment & Coding Toolkit

Digitally enabled healthcare

Payor-V1C Contract Toolkit

Digitally enabled healthcare

V1C Care Transitions Toolkit

Digitally enabled healthcare

V1C Core Competencies

Digitally enabled healthcare

Improving access to novel virtual reality (VR) therapies for chronic lower back pain

Regulations, Digital Health Products

Expanding access to cardiac care with the first FDA-authorized AI ultrasound software

Regulations, Digital Health Products

Defining robust drug-like evidence: Bringing novel software products to the US market

Regulations, Digital Health Products

Integrated platform for digitally monitoring health

Regulations, Digital Health Products

Designing a safe and effective pediatric digital health platform for the US market

Regulations, Digital Health Products

From FDA to multiple US market access pathways

Regulations, Digital Health Products

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

Regulations, Digital Health Products

Bringing novel AI-powered devices to the US market

Regulations, Digital Health Products

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

Regulations, Digital Health Products

Making behavioral health radically accessible

Regulations, Digital Health Products

Assessing the Net Financial Benefits of Employing Digital Endpoints in Clinical Trials

Clinical Trials, Digital Measures Best Practices

The team at Boston University (BU) Chobanian & Avedisian School of Medicine include sleep as a core assessment area in their research across therapeutic areas.

Clinical Trials, Digital Health Products, Digital Measures Development Projects in Practice

Bayer Pharmaceuticals’ development portfolio often raises the question of sleep assessment as an important quality-of-life pillar of patients’ health, which can be positively affected by the new therapies.

Clinical Trials, Digital Health Products, Digital Measures Development Projects in Practice

Beacon Biosignals is a leader in sleep data analytics, and with the power of their Dreem headband, they are leaders in naturalistic sleep measurement at the brain activity level

Clinical Trials, Digital Health Products, Digital Measures Development Projects in Practice

TNO is a pioneering applied science and technology organization. Their mission is to create impactful innovations for the sustainable well-being and prosperity of society

Clinical Trials, Digital Health Products, Digital Measures Development Projects in Practice

Sleep Map for Core Digital Measures of Sleep

Clinical Trials, Digital Health Products, Digitally enabled healthcare

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

Clinical Trials, Digital Measures Development Projects in Practice

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

Payment

Example Data Structure for the Core Digital Measures of Sleep

Clinical Trials

Core Measures: Sleep Measurement System

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Total sleep time

Clinical Trials

Core Digital Measure of Sleep: Total sleep time (Duration)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Connecting Core Measures: Suggested Recommendations for Interpreting Data

Digitally enabled healthcare

Frequently Asked Questions about Total Sleep Time

Clinical Trials, Digital Health Products

Checklist: Essential Questions for DHT Vendor Selection

Clinical Trials, Digitally enabled healthcare

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Initial sleep onset latency

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Number of wake events in the primary sleep period

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Sleep efficiency

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Total napping time

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Wake after sleep onset

Clinical Trials

Conceptual model: Sleep Disturbance

Clinical Trials

Core Digital Measure of Sleep: Number of wake events in the primary sleep period (Count)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Core Digital Measure of Sleep: Sleep efficiency (Percentage)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Core Digital Measure of Sleep: Total napping time (Duration)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Core Digital Measure of Sleep: Wake after sleep onset (Duration)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Emerging Digital Measure of Sleep: Sleep regularity index (Percentage)

Digital Health Products

Emerging Digital Measure of Sleep: Symptomatology impact on sleep

Digital Health Products

FAQ: Justifying the Inclusion of the Core Digital Measures of Sleep

Clinical Trials, Digital Health Products

Frequently Asked Questions about Sleep Onset Latency

Clinical Trials, Digital Health Products

Frequently Asked Questions about Sleep Onset (WASO)

Clinical Trials, Digital Health Products

Frequently Asked Questions about Number of wake events in the primary sleep period

Clinical Trials, Digital Health Products

Frequently Asked Questions about Sleep efficiency

Clinical Trials, Digital Health Products

Frequently Asked Questions about Total napping time

Clinical Trials, Digital Health Products

Systematic Literature Review of Qualitative Evidence of Sleep Disturbance

Clinical Trials

Scientific Figures of Sleep Disturbance

Clinical Trials, Digitally enabled healthcare

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

Regulations, Clinical Trials, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Snapshot of Sleep Library of Digital Measurement Products

Clinical Trials, Digital Health Products

Core Digital Measure of Sleep: Initial sleep onset latency (Duration)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Workshop Review: Digital Measures Development: Lessons Learned from an Expert Workshop Addressing Cross-Therapeutic Area Measures of Sleep

Digital Health Equity, Digital Measures Best Practices

Library of Digital Measurement Products

Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

A Snapshot of ADRD in the Library of Digital Measurement Products

Digital Health Products, Digital Measures Best Practices

A Snapshot of Physical Activity in the Library of Digital Measurement Products

Digital Health Products, Digital Measures Best Practices

A Snapshot of Parkinson’s Disease in the Library of Digital Measurement Products

Digital Health Products, Digital Measures Best Practices

Expanded lexicon of diversity dimensions for the digital era of medicine

Digital Health Equity

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

A systematic scoping review of studies describing human factors, human-centered design, and usability of sensor-based digital health technologies

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Quickstart Guide: V3+ Use Specification

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Quickstart Guide: V3+ Use-Related Risk Analysis

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Checklist: Essential Questions for DHT Vendor Selection

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

At-a-Glance: Selecting Metrics for Evaluating sDHT Usability

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

At-a-Glance: Incorporating Human-Centered Design Into sDHT Development

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

The V3+ Usability Validation Glossary

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

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

Regulations, Clinical Trials, Digital Measures Best Practices

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

Digital Measures Best Practices

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

Clinical Trials, Digital Health Products, Digitally enabled healthcare

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

Digital Measures Best Practices

Ontology: Postural sway

Digital Measures Best Practices, Digital Measures Development Projects in Practice

Ontology: Walking speed

Digital Measures Best Practices, Digital Measures Development Projects in Practice

Ontology: Time spent in moderate to vigorous physical activity

Digital Measures Best Practices, Digital Measures Development Projects in Practice

Ontology: Step count

Digital Measures Best Practices, Digital Measures Development Projects in Practice

Ontology: Walking bout at specified bout durations

Digital Measures Best Practices, Digital Measures Development Projects in Practice

Capabilities Maturity Calculator

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Caption Health’s Regulatory Journey Case Study

Regulations, Digital Health Products

Library of Digital Health Regulations

Regulations, Digital Health Products

Digital Health Industry Regulatory Needs Assessment

Regulations

Library of Digital Endpoints

Regulations, Digital Measures Best Practices

Decision tool: Integrating digital endpoint evidence into integrated evidence plans

Clinical Trials, Digital Health Products, Digital Measures Best Practices

Key Terms Glossary for 3Ps

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

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

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Quick start guide to drug reimbursement – Europe

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Quick start guide to drug reimbursement – U.S.

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Recommendations for payers

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Recommendations for pharma

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Recommendations for payers at-a-glance

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Recommendations for pharma at-a-glance

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

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

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Case study: Defining value and identifying benefits of integrating digital measurement of nocturnal scratch to clinical studies

Regulations, Clinical Trials, Digital Health Products

Conceptual Model: Nocturnal Scratching in Atopic Dermatitis Patients

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Insights from the FDA

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Considerations to support endpoint strategy for clinical trials utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

The Library of Evidence

Digital Health Products, Digital Health Equity, Digital Measures Best Practices

Analytical Validation Library

Digital Health Products, Digital Measures Best Practices

The Framework for Inclusive Development

Digital Health Products, Digital Health Equity, Digital Measures Best Practices

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Market Opportunity Calculator

Digital Health Products, Digital Health Equity, Digital Measures Best Practices

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Value of a Successful Measure: Key Insights and Action Items

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Terminology and ontology: “nocturnal”

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Terminology and ontology: “scratch”

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Technology performance considerations for selection of devices measuring nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Decision tree supporting endpoint strategy for clinical trials utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Evidence considerations for selecting digital tools for measuring nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Quantitative Survey Results Dataset

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Unlocking Regulatory Success for Digital Health Product Developers

Rigorous and rapid evidence assessment in digital health with the evidence DEFINED framework

Digital Health Products

The Playbook: Digital Healthcare Edition

Digital Health Products, Digitally enabled healthcare

Federal Comment Toolkit

Regulations, Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Expert Speaker Directory

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

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

Regulations, Digital Health Products

U.S. RegPath flowchart

Regulations, Digital Health Products

Tidepool’s Regulatory Journey Case Study

Regulations, Digital Health Products

Risk Assessment Model for Digital Health Product Lifecycle

Regulations, Digital Health Products

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

Regulations, Digital Health Products

Regulatory Engagement Pathways Map for Digital Health Product

Regulations, Digital Health Products

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

Regulations, Digital Health Products

PMA Request Review Process

Regulations, Digital Health Products

PMA Preparation Guide

Regulations, Digital Health Products

PMA Checklist

Regulations, Digital Health Products

PMA At-a-Glance

Regulations, Digital Health Products

Investigational Device Exemption (IDE) for Digital Health Products

Regulations, Digital Health Products

Identifying your Role in Driving Regulatory Strategy for Digital Health Products

Regulations, Digital Health Products

HDE Submission Checklist

Regulations, Digital Health Products

HDE Preparation Guide

Regulations, Digital Health Products

HDE Decision Making Flowchart

Regulations, Digital Health Products

HDE At-a-Glance

Regulations, Digital Health Products

General Wellness & Low Risk Digital Health Products

Regulations, Digital Health Products

Flowchart to Help Identify your Role in Driving Regulatory Strategy for Digital Health Products

Regulations, Digital Health Products

FDA Classification Overview for Digital Health Products

Regulations, Digital Health Products

FAQs for PMA Pathway

Regulations, Digital Health Products

FAQs for HDE

Regulations, Digital Health Products

FAQs for De Novo Pathway

Regulations, Digital Health Products

FAQs for 510(k)

Regulations, Digital Health Products

Engagement Pathways to Communicate with the U.S. Regulators (FDA – Food and Drug Administration)

Regulations, Digital Health Products

Digital Health Product Categorization Guide

Regulations, Digital Health Products

Decision Map: Digital Health Product Classification

Regulations, Digital Health Products

De Novo Request Review Process

Regulations, Digital Health Products

De Novo Preparation Guide

Regulations, Digital Health Products

De Novo Checklist

Regulations, Digital Health Products

De Novo At-a-Glance

Regulations, Digital Health Products

Comparison Chart for the U.S. Regulatory Pathways

Regulations, Digital Health Products

Checklist for Pre-Submission Meeting Preparation

Regulations, Digital Health Products

Checklist for 513(g) Request

Regulations, Digital Health Products

Breakthrough Devices Program for Digital Health Products

Regulations, Digital Health Products

Best Practices for Interacting with the U.S. Regulators (FDA – Food and Drug Administration)

Regulations, Digital Health Products

510(k) Submission Checklist

Regulations, Digital Health Products

510(k) Preparation Guide

Regulations, Digital Health Products

510(k) Decision Making Flowchart

Regulations, Digital Health Products

510(k) At-a-Glance

Regulations, Digital Health Products

5-Step Approach to Classifying Your Digital Health Product in the U.S.

Regulations, Digital Health Products

Evidence DEFINED Supplementary Table 2 (Checklist)

Payment, Digital Health Products

Evidence DEFINED Framework (Quick Start Guide)

Payment, Digital Health Products

Value-Driven Framework for Evaluating Healthcare Innovations

Regulations, Payment, Digital Health Products

Use the Market Opportunity Calculator

Clinical Trials, Digital Health Equity

Use Real-World Data and Real-World Evidence

Clinical Trials, Digital Health Equity

Support and train clinical trial site staff

Clinical Trials, Digital Health Equity

Specific Actions – Diversity Plan

Clinical Trials, Digital Health Equity

Recognize the Need for Diversity

Clinical Trials, Digital Health Equity

Plan for Diverse, Equitable, and Inclusive Engagement

Clinical Trials, Digital Health Equity

Implement Digitized Clinical Trials

Clinical Trials, Digital Health Equity

Hire a Digital Clinical Trials Navigator

Clinical Trials, Digital Health Equity

Evidence Based References and Resources Supporting Diversity, Equity, and Inclusion

Clinical Trials, Digital Health Equity

Empower With Information and Education

Clinical Trials, Digital Health Equity

Empower Through eConsent: Key Considerations

Clinical Trials, Digital Health Equity

Elements of a Diverse, Equitable, & Inclusive Digitized Clinical Trial – Expanded

Clinical Trials, Digital Health Equity

Elements of a Diverse, Equitable, & Inclusive Digitized Clinical Trial

Clinical Trials, Digital Health Equity

Diversify Clinical Teams to Build Trust

Clinical Trials, Digital Health Equity

Develop community partnerships

Clinical Trials, Digital Health Equity

Develop a Virtual Participant Support Network to Build Trust

Clinical Trials, Digital Health Equity

Design an inclusive engagement plan

Clinical Trials, Digital Health Equity

Design a Diversity Dashboard

Clinical Trials, Digital Health Equity

Define Diversity, Equity, & Inclusion in Digitized Clinical Trials

Clinical Trials, Digital Health Equity

DE&I Resources-in-Action_Updated June 21.2023

Clinical Trials, Digital Health Equity

Address Clinical Trial Challenges

Clinical Trials, Digital Health Equity

Sensor Data Glossary

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Sensor Data Design Flow Tool

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Reference Data Architecture

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Logical Data Architecture

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Library of Standards

Regulations, Clinical Trials, Digital Health Products, Digitally enabled healthcare

Interactive Landscape of Data Standards

Regulations, Clinical Trials, Digital Health Products, Digitally enabled healthcare

Considerations and Best Practices

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Capabilities Maturity Model

Clinical Trials, Digital Health Products, Digitally enabled healthcare

ART Criteria Prioritization Tool

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Add to the Landscape – Data Standards

Clinical Trials, Digital Health Products, Digitally enabled healthcare

‘ART’ Criteria

Clinical Trials, Digital Health Products, Digitally enabled healthcare

The Digital Health Measurement Product Development Process

Digital Health Products, Digital Health Equity, Digital Measures Best Practices

FAQ for Market Value Calculator

Digital Health Products, Digital Health Equity, Digital Measures Best Practices

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

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

The Primer on Digital Health Measurement

Clinical Trials, Digital Measures Best Practices, Digitally enabled healthcare

Considerations When Deploying a Digital Health Measurement Product

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Digital Health Literacy Resources

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Digital Readiness Workflow

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

FAQs for Digital Health Measurement Product

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

End User Onboarding Checklist

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Workbook: Prepping End Users

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Library of Human Factors Resources for Digital Health Technologies

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Clinical & Operational Integration

Digitally enabled healthcare

Personalized Patient Experience

Digitally enabled healthcare

Technology-Assisted Financial Navigation

Digitally enabled healthcare

Digitally Enabled Access

Digitally enabled healthcare

CancerX Digital Strategy for Improving Equity in Access and Reducing Patient Financial Toxicity: Health System Core Competencies Guide

Digitally enabled healthcare

Solutions Catalog

Digitally enabled healthcare

Financial Navigation Guide

Digitally enabled healthcare

The Playbook: Digital Clinical Measures

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Workbook: Inclusive Support for End Users

Workbook: Inclusive Deployment

The Resource Library: Inclusive Deployment

Quick Start Guide: Inclusive Engagement Plan

Quick Start Guide: Community Partnerships

Guide for Inclusive Engagement

Guide for Developing Community Partnerships

Sample End User License Agreement

Questions to Ask – Patient/Participant Perspective

Learning About Context of Daily Life

Informed Consent – Considerations for Inclusivity

Inclusive Deployment Plan Worksheet

Inclusive Deployment Checklist

Inclusive Communications Guide

Guide for In Person Site Visits

Flowchart of Calls for End User Support

End User Bill of Rights

FAQs for End User Privacy & Security