Connecting the Dots on Digital Health Series: Payment, FDA, Public Policy and Advocacy Considerations
In this session we will explore the regulatory hurdles innovator companies must overcome to bring a Digital Health product to market, including the path to FDA clearance, quality measure requirements, and Medicare coding, coverage and payment issues for public and private insurers. We will outline key strategic considerations for Digital Health innovators, including pricing, clinical research design, stakeholder consensus, and coalition building. This session will include helpful issue checklists and employ common Digital Health scenarios to illustrate legal and advocacy concepts.
FDA and other regulatory approval requirements
Coding, coverage and payment considerations
Policy perspectives and advocacy strategies