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Join FDA and DiMe during a 2-day virtual event to help advance the use of PGHD to support improved trials, medical device development products, and regulatory science!

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

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.

Stay tuned for more information about DiMe’s Digital Health Regulatory Pathway Work

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.

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