Regulation and Reimbursement of Medical Products: Practice and Policy

Description from DukeHub

The objective of the course is to give a practical overview of the current regulatory and reimbursement landscape for medical products (drugs, devices, and biologics), as well as understanding of current issues that may influence existing and/or future regulatory and reimbursement practices and policies. The focus will be primarily on US regulation and reimbursement policy, but international context will be included as appropriate. Students can expect to gain basic understanding of how drugs, devices, and biological products are tested and regulated as well as the multiple stakeholders involved in the purchase and reimbursement of medical products. Area Designator(s): GE

Skills

• policy and lawdescription: "regulatory" and 5 more

AI-resilient: 1 of 5 1/5

• No: Physical, lab or field work
• No: Live work with people
• ✓Yes: Judgment someone is accountable for · "policy"
• No: A craft you practice with your hands or body
• No: Small, in-person format

The checks lean on Microsoft Research, Working with AI (2025), which found generative AI applies least to physical work and hands-on work with people. A signal, not a promise. How the score works

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