Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Academic Article uri icon

Overview

abstract

  • OBJECTIVES: Surface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software. MATERIALS AND METHODS: We use sepsis as a case study to highlight the patient safety and regulatory compliance tradeoffs that 6129 hospitals in the United States must navigate. RESULTS: Sepsis CDS remains in broad, routine use. There is no commercially available sepsis CDS system that is FDA cleared as a medical device. There is no public disclosure of an HDO turning off sepsis CDS due to regulatory compliance concerns. And there is no public disclosure of FDA enforcement action against an HDO for using sepsis CDS that is not cleared as a medical device. DISCUSSION AND CONCLUSION: We present multiple policy interventions that would relieve the current tension to enable HDOs to utilize artificial intelligence to improve patient care while also addressing FDA concerns about product safety, efficacy, and equity.

publication date

  • May 20, 2024

Research

keywords

  • Artificial Intelligence
  • Decision Support Systems, Clinical
  • Patient Safety
  • United States Food and Drug Administration

Identity

Digital Object Identifier (DOI)

  • 10.1093/jamia/ocae119

PubMed ID

  • 38767890