Integrated Evidence Plans for Digital Health Technologies

Without a structured approach to evidence generation, many promising technologies risk delayed adoption, high costs, and commercial failure.

DiMe’s recent Digital Health Industry Regulatory Needs Assessment reaffirmed the top priority from industry leaders: aligning FDA regulatory requirements with downstream payor and purchaser decision-making is critical to success. To address this, DiMe, in partnership with Peterson Health Technology Institute (PHTI), ZS Associates, and other industry leaders, developed the Integrated Evidence Plans (IEP) for Digital Health Technologies (DHTs) toolkit. This resource creates a clear, cost-effective evidence pathway to support your DHTs’ commercial success by meeting the needs of all decision-makers.

Use this framework to build an integrated evidence plan

We have identified the core components of an integrated evidence plan you can follow to streamline the collection of necessary evidence for all decision-makers on your path to market success. The toolkit walks you through three key stages:

Stage A

If you are in the early stages of product development, start here. This stage helps you identify your target markets, create your target product profile, and build an aligned regulatory and reimbursement strategy.

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Stage B

If you’ve already identified your market and built a clinical strategy for your product, start here. This stage guides you through building comprehensive evidence packages while engaging key stakeholders.

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Stage C

If you are ready to develop and execute a strong commercial strategy to ensure market adoption and long-term success, start here.

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See how others have done it

Explore these successful IEP examples to learn how each organization built strategies that led to commercial success. Use them to strengthen your own approach!

Expanding access to cardiac ultrasound through AI-guided digital technology

Chronic pain management: Virtual reality (VR)-based home therapy

Our partners

This project brought together leaders in digital health product development, regulation, reimbursement, and commercial strategy with U.S. payors, purchasers, policymakers, clinicians, and patient groups.