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New FREE course! DiMe is excited to share Google's Generative AI for Healthcare course with our community. Take this brief survey and begin the course specifically designed for medical professionals, administrators, and researchers who want to leverage AI in healthcare settings!

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Interact with regulators early and often

Develop digital health products that best meet your commercial goals and the needs of patients.

The value of digital health regulations

With trust in the emerging digital health products being essential to their adoption, regulatory oversight offers a robust path for digital health product developers to demonstrate the safety and efficacy of their solutions. Regulatory oversight also opens the door to additional reimbursement pathways. However, there is uncertainty among digital health product developers, their clinical partners, and digital health investors. This document illustrates the value of digital health regulations along with 3 illustrative examples.

Communication Toolkit

Use this toolkit to better understand the formal and informal engagement options and resources to best communicate with FDA.

Identify

Use the RegPath tool and other resources to navigate and identify your regulatory pathway.

Build

Create and integrate a fit-for-purpose regulatory strategy into your business plan for commercial success.

Interact

Ongoing, interact with regulators to develop digital health products that best meet your goals and patients’ needs.

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

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