Can Laws Be Flexible? Rethinking Legislation for Innovation.

Schneider, Nick K; Stern, Ariel Dora; Price Ii, W Nicholson; Lennerz, Jochen K · NPJ Digit Med · 2026

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Abstract

Agile legislation adapts principles from agile software development to lawmaking, emphasizing iteration, multi-stakeholder feedback, and embedded revision. We outline this learning-oriented governance model using three case studies: Germany’s stepwise digital health legislation, the EU AI Act, and U.S. FDA user-fee reauthorization. These examples highlight legislative designs that enable structured generation of real-world data and evidence during implementation, informing regulatory interpretation and iterative refinement in rapidly evolving technological domains.