Table 1.

Artificial Intelligence System Impact

Use Case	Description	Examples	Food and Drug Administration Oversight
Population care	Prioritization and triage with potential impact on groups of patients and individual patients	Care pathway assignment	Likely35
Individual patient care
Assistive AI	Assists a clinician who determines the patient’s management	Provides a probability or likelihood of a disease or condition or may highlight potential lesions that should be reviewed by a specialist	Likely35
Autonomous AI	Makes a medical decision without input from a clinician	For example, an autonomous AI system may evaluate for the presence of a disease, such as diabetic retinopathy and macular edema, or condition and notify the user whether the disease or condition is present	Likely35
Scientific research	Not used for individual patient or population care, although the results of the research may impact populations or patients downstream	Health care analytics	Unlikely
Operations and data management	Where this does not impact individual patient or population care; these often exist within the realm of health information technology systems as they relate to administrative purposes	VIM Referral Guidance, a triage system from EHRs (https://getvim.com/solution/referral-guidance)	Unlikely
Clinical decision support	Informs the clinician by aggregating, reformatting, or visualizing data, without providing analytical insights of the data, in a manner that allows the clinician to review the basis of the information provided by the software independently	AI system that suggests a G6PD test before prescribing an antimalarial therapy38	Depends*
General wellness	Collects physiologic information from devices and sensors, including wearables	Smart watch that captures heart rate	Depends*

AI = artificial intelligence; EHR = electronic health record.

See Center for Devices and Radiological Health, United States Food and Drug Administration.³⁸ This explains when a software function qualifies as nondevice CDS as well as device CDS, and which of these are regulated actively or for which compliance with applicable regulation would not be enforced.