FDA and patent law create dual hurdles for AI-enabled medical technologies

AI reshapes healthcare by powering more precise and adaptive medical devices and diagnostic systems.

Yet, innovators face two significant challenges: navigating the US Food and Drug Administration’s evolving regulatory framework and overcoming legal uncertainty under US patent law.

These two systems, although interconnected, serve different goals. The FDA protects patients, while patent law rewards invention.

The FDA’s latest guidance seeks to adapt oversight for AI-enabled medical technologies that change over time. Its framework for predetermined change control plans allows developers to update AI models without resubmitting complete applications, provided updates stay within approved limits.

An approach that promotes innovation while maintaining transparency, bias control and post-market safety. By clarifying how adaptive AI devices can evolve safely, the FDA aims to balance accountability with progress.

Patent protection remains more complex. US courts continue to exclude non-human inventors, creating tension when AI contributes to discoveries.

Legal precedents such as Thaler vs Vidal and Alice Corp. vs CLS Bank limit patent eligibility for algorithms or diagnostic methods that resemble abstract ideas or natural laws. Companies must show human-led innovation and technical improvement beyond routine computation to secure patents.

Aligning regulatory and intellectual property strategies is now essential. Developers who engage regulators early, design flexible change control plans and coordinate patent claims with development timelines can reduce risk and accelerate market entry.

Integrating these processes helps ensure AI technologies in healthcare advance safely while preserving inventors’ rights and innovation incentives.

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