Integrating Image-Based Artificial Intelligence in the Operating Room: Enhancing Safety and Efficiency While Navigating Legal and Ethical Considerations

Background: Image-based artificial intelligence (IBAI) platforms offer the potential to improve operating room (OR) safety and efficiency through real-time monitoring of clinical workflows. However, implementing these platforms poses complex challenges related to data privacy, ethical oversight, legal compliance, and the need for robust governance structures. Objective: This study aimed to describe the implementation of IBAI across a multihospital health system in the United States, the legal and ethical challenges encountered, and the strategies used to support safe and compliant integration. Methods: An IBAI platform was deployed across more than 50 ORs across the health system. The platform uses artificial intelligence-driven audio-video analysis to support performance metrics such as first case on-time starts and turnover time. A governance framework addressing recording access, retention, and consent was developed. Key stakeholders, including department chairs, quality officers, and OR committees, were granted review authority under a structured policy. Results: Initial skepticism among surgical staff centered on data security, liability risk, and consent. Policy refinement, transparent communication, and updated consent language led to increased support of platform use. Video retention was set at a maximum of 30 days (audio at 7 days), with access limited to designated leaders. These parameters are provisional and may be modified in response to evolving legal and ethical guidelines. Early qualitative feedback suggests improved confidence in the system, with further quantitative evaluations underway. Conclusions: This use case highlights the importance of ethical policy development, stakeholder engagement, and transparent communication to successfully implement IBAI in surgical settings. Ongoing refinements are being made based on stakeholder feedback as the health system evaluates expansion to other clinical applications.