Real-world evidence now supports new indications and safety decisions, and AI increasingly generates it. Boards should know where their company relies on it, how well the design fits the question, and how its credibility is shown.

In November 2024 I expected 14 federal health policy shifts. Two years later the direction was mostly right and the mechanism often wrong. Boards should govern by instrument, not forecast, and treat deregulation as a shift of the burden of evidence, not permission.

The FDA's January 2025 draft guidance on AI used to support drug and biologic submissions is still a draft, but regulators, partners, and acquirers already expect the evidence it describes. This article explains the framework, what has changed since, and what boards should ask management to show.

AI has not changed what a board is for. It has changed what the board must see, ask, and record, and where the line with the chief executive falls.