Artificial intelligence clinical trials and critical appraisal: a necessity.

Regulation, particularly relating to intellectual property and commercial considerations are relatively unexplored, particularly when artificial intelligence algorithms are being implemented within public healthcare systems. Accordingly, a stepwise and rigorous process is required to demonstrate that artificial intelligence algorithms improve patient outcomes. As more artificial intelligence algorithms near clinical implementation, regulatory authorities and professional colleges and societies must carefully consider how these algorithms are evaluated. However, the regulation of the use of clinical artificial intelligence algorithms will be inherently related to evidenced generated through artificial intelligence clinical trials. [Extracted from the article]