Table 2 Key terms defined for eligibility assessment

Legal Concerns

Law is “the formal rules of a country passed by a government or its delegated representatives to regulate conduct” [25, 26].

This encompasses formal laws (e.g., constitutions, statutes, the common law) and regulations (e.g., rules passed pursuant to statutory authority).

‘Law’ here does not include ‘soft’ law (e.g., professional college rules).

A ‘legal concern’ is one that is identified as requiring a formal governmental response.

Artificial Intelligence (AI)

Per the World Health Organization ([13]: xi, 4), ‘artificial intelligence’ (AI) is “the ability of algorithms encoded in technology to learn from data so that they can perform automated tasks without every step in the process having to be programmed explicitly by a human” and as the “performance by computer programs of tasks that are commonly associated with intelligent beings.”

AI, then, refers to machines that can perform acts that typically require human cognition without direct human assistance. This covers a range of tools including those that read medical images to possible future surgical robots.

AI does not include electronic tools that merely aid in data collection that do not have an associated AI component (e.g., wearable sensors, computer-assisted decision supports).

Health-Related

AI in this review is ‘health-related’ if it pertains to “healthcare” or “public health.”

Healthcare is understood as “efforts made to maintain or restore physical, mental, or emotional well-being especially by trained and licensed professionals” [27].

This also includes activities by trainees or AI where the trainee or AI functions in the same capacity as the licensed professional.

“Public health” is understood as “the art and science dealing with the protection and improvement of community health by organized community effort and including preventive medicine” [28].

This definition focuses on activities typically performed by health professionals (and those serving their functions) and the organization of the healthcare settings in which they work.

It includes activities in and the regulation of hospital, physician, long-term care home, and other healthcare provider settings as well as at-home goods and services for curative, diagnostic, and preventative purposes.

For greater certainty, it includes activities performed by healthcare professionals and basic features of healthcare systems and their regulation (e.g., rationing decisions, insurance).