Is Artificial Intelligence (AI) a Pipe Dream? Why Legal Issues Present Significant Hurdles to AI Autonomy

Abstract

The publication of this Accepted Manuscript is provided to give early visibility to the contents of the article, which will undergo additional copyediting, typesetting, and review before it is published in its final form. During the production process, errors may be discovered that could affect the content of the Accepted Manuscript. All legal disclaimers that apply to the journal pertain. The reader is cautioned to consult the definitive version of record before relying on the contents of this document.

The Regulation of Artificial Intelligence in Digital Radiology in the Scientific Literature: A Narrative Review of Reviews

“…The search on Pubmed returned 16 papers [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ] (Scopus returned 4 further works, which, being works at congresses in accordance with the qualification procedure, were excluded), all studies from 2018 to today.…”

“…The analysis showed that the scientific literature has produced important and far-reaching reviews. Twelve reviews [ 21 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 33 , 34 , 35 , 36 ] out of fourteen were focused on radiology in general, two reviews were more specific, one review was focused on nuclear medicine [ 24 ], and one on imaging in gastrointestinal pathology [ 22 ]. As far as the regulatory aspects were concerned, some interesting issues emerge.…”

“…Two other studies offered new and important points of view on the regulatory aspects in this area; one focused on AI in DR, stressing the concept of software as medical device (SaMD) [ 27 ]; the other one dealt with the importance of providing certified datasets in training AI systems [ 31 ]. The three most recent reviews focused on some heterogeneous problems of AI regulation [ 34 , 35 , 36 ]. The review proposed in [ 34 ] faced the problems of regulating the workloads and the relevant implications.…”

The state of the art for artificial intelligence in lung digital pathology

“…An equitable liability scheme needs to be designed to define the roles of AI tool developers, physicians, and healthcare institutions. This discussion would revolve around what is considered as the gold standard adopted by the clinical community, and whether AI would continue to remain as assistive technology, or become the gold standard against which the performance of a physician is evaluated [208].…”

European Society of Paediatric Radiology Artificial Intelligence taskforce: a new taskforce for the digital age

“…Whilst there are several novel uses for AI within radiology applied to adults and an increasing number of commercially available products entering a progressively crowded marketplace, few are tailored to the paediatric population [ 3 ]. New rules and regulations concerning safety and legal standards across different nations are important for these medical devices to follow [ 11 , 12 ], bringing with them ethical considerations not previously addressed in other medical domains [ 13 ]. As such, it is likely that the function and goals of this task force may evolve along with the developments in the field.…”