Current regulation for surgery and surgical procedures is sparse and decentralized.
Incorporation of artificial intelligence (AI) into surgery presents unique and challenging problems that necessitate novel regulation.
Regulation for surgical AI must focus on ensuring safety, efficacy, equity, and privacy.
Beyond regulation, policy must adapt to clarify patient rights, malpractice liability, and adequate surgical training and competency maintenance.
In robotics, risk calculation, electronic health record analysis, and other elements of surgery, artificial intelligence (AI) is rapidly expanding into surgical care. Its technical utility in increasing precision, improving dexterity, and reducing tremor is being explored across multiple procedures but most notably in microsurgery and image-guided orthopedic surgery (see Chapter 12).1,2 There is also potential for AI to augment surgeon performance beyond the operating room and across the care continuum. When it comes to ensuring good patient outcomes, nuanced decisions outside of the operating room (eg, who to operate on, the timing of an intervention, and expedient recognition of complications postoperatively) are equally as important as the decisions made inside the operating room. AI tools are currently in development to allow for data-driven optimization of patient selection and the use of predictive analytics to determine which patients are at higher risk of complications.3,4 As AI technology evolves and integration into surgical care becomes a reality, it is imperative that policies are in place to ensure safety, efficacy, and equity for patients; to delineate accountability; and to mitigate the consequences of AI integration for health care providers.
Despite the abundance of surgical operations and the significant consequences that they can have for patients, no centralized state or federal agency approves new surgical procedures or directly regulates surgical procedures that are used today.5 The current surgical regulatory framework is decentralized and occurs indirectly through the regulation of surgeons, hospitals, and devices or drugs that are used during and after operations. This regulation is enforced by bodies including the American Board of Surgery, The Joint Commission, and the US Food and Drug Administration (FDA), respectively. In this context, AI presents new and unique challenges that will undoubtedly require regulation. Without a centralized surgical regulatory infrastructure, these novel policy needs will require diverse policy innovations. This chapter intends to outline these challenges and the policy approaches that might address them.
Before moving into an exploration of health policy, surgery, and the ways in which new AI technologies interact with the current policy framework, it will be helpful to outline a few of the key features of AI technologies that make them challenging from a regulatory perspective. These aspects of AI will appear repeatedly throughout this chapter, and the following section is intended to provide a brief overview of relevant concerns associated with each of these AI attributes. Although there are many unique and complex aspects of AI, the focus here will be on ...