Module Description

This module examines the legal, regulatory, and ethical frameworks that govern the generation and use of RWE. Learners will explore key U.S. laws and FDA guidance shaping data use and communication, including privacy protections, pre-approval information exchange, and ethical responsibilities when applying RWE to payer and regulatory decision-making.

Learning Objectives:

• Outline what implementation (or interpretation) of these laws and regulations looks like in RWE and communication.
• Differentiate legal requirements for data collection vs. payer communication.
• Recognize how legal considerations impact both payers and pharmaceutical manufacturers in formulary, contracting, and evidence exchange.