The Imperative For Regulatory Oversight Of Large Language Models (or Generative Ai) In Healthcare

The United States’ Food and Drug Administration (FDA) has been leading the global discussions on regulatory oversight and has been a prominent example in providing regulations about emerging technologies from 3D printed medications to AI-based medical tools. The FDA has been adapting its regulatory framework to specifically address AI and machine learning (ML) technologies in medical devices, proposing a total product lifecycle (TPLC) approach to regulating AI/ML-based Software as a Medical Device (SaMD). Currently, the FDA does not have specific categories exclusively for AI-based technologies but evaluates them within the existing regulatory framework for medical devices, and they may also be subject to the FDA’s Digital Health Software Precertification (Pre-Cert) Program. As of April, 2023, 521 devices are included in the FDA’s database of specifically AI-based medical technologies with regulatory approvals.