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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!

Work with DiMe on an upcoming project

Stage B

Evidence strategy & planning

In Stage B, you’ll build the foundation for successful adoption and commercialization of your DHT.

Begin your work in Stage B

Check your work

Your work in Stage B should allow you to answer the following questions:

Regulatory strategy

  • Did you engage with the FDA for pre-submission meetings to validate study designs?
  • Have you built evidentiary packets for regulatory submissions?

Reimbursement pathways

  • Are you prioritizing the development of a reimbursement dossier that includes economic models and outcomes data?
  • Have you initiated discussions with payors to explore provisional coverage pathways?

Business priorities

  • Are you assessing and validating business model fit through stakeholder feedback and early partnerships?
  • Have you evaluated technology scalability and planned for its integration into clinical workflows?

Use the tools in this section at your own pace. Consider this process an ongoing journey rather than a one-time task, allowing you to adapt and refine your approach as needed.

Additional resources to support your success

High Quality Evidence Checklist

Use this comprehensive checklist to generate high-quality evidence aligning to the evidentiary needs of downstream decision makers. It focuses on patient-centered outcomes, cost-effectiveness, and real-world usability to facilitate adoption and sustained market success for your DHT. 

Use DiMe’s Evidence DEFINED framework to support you evidence evaluations. DiMe collaborated with healthcare stakeholders to create this framework and support give you a a harmonized, rigorous, rapid approach to assessing the clinical value of DHTs.

Explore Caption Health’s success in Stage B where they gained evidence for clinical efficacy, safety, and economic value.

Learn how AppliedVR secured De Novo market authorization and aligned with Medicare reimbursement frameworks in Stage B.

    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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