compliance program implications.
That’s a long list. However, we will attempt to break down these considerations and briefly summarize them as described below.
1. Statutory, Regulatory and Common Law Requirements
Regardless of whether you encounter AI as a health care provider or a developer (or both), there are statutory, regulatory and common law requirements that may be implicated when considering AI in the health care space. Depending on the functionality that the AI is discharging, there could be state and federal laws that require a health care provider or an AI developer to seek licensure, permits and/or other registrations (for example, AI may be employed in a way that requires FDA approval if it provides diagnosis without a health care professional’s review). Additionally, as AI functionality expands (and potentially replaces physicians in the provision of physician services), the question may be raised as to how these services are regulated, and whether the provision