Medical robotics—Regulatory, ethical, and legal considerations for increasing levels of autonomy

Yang, Guang; Cambias, James; Cleary, Kevin; Daimler, Eric; Drake, James M.; Dupont, Pierre E.; Hata, Nobuhiko; Kazanzides, Peter; Martel, Sylvain; Patel, Rajni V.; Santos, Veronica J.; Taylor, Russell H.

doi:10.1126/scirobotics.aam8638

Cited by 393 publications

(262 citation statements)

References 3 publications

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“…The safeguards only apply to decisions "based solely on automated processing," which may exclude many robotic systems (9). There is reluctance in high-risk areas (e.g., transport) to remove humans entirely from the loop.…”

Section: This Tension Can Be Seen In Recent European Policy Debate Onmentioning

confidence: 99%

Transparent, explainable, and accountable AI for robotics

2017

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Section: This Tension Can Be Seen In Recent European Policy Debate Onmentioning

confidence: 99%

Transparent, explainable, and accountable AI for robotics

2017

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“…With advancements in technology, especially artificial intelligence and imaging processing, the level of autonomy [51] in endoscopy will certainly increase. However, even if the technology is ready, ethical issues are another hurdle.…”

Section: Conclusion and Discussionmentioning

confidence: 99%

Robotic Endoscopy

Chiu²

2018

Visc Med

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Endoscopes extend the eyes of the physician into the patient's body. They are widely used in gastrointestinal (GI) diagnostics and minimally invasive surgery. Endoscopes can be classified into 3 types: rigid, flexible, and capsule endoscopes. Rigid and flexible endoscopes are traditionally held and manipulated by the physician to visualize the region of interest, while capsule endoscopes move passively along with the GI peristalsis. With the advancement of technology, robotic endoscopy has been increasingly developed and accepted. In this work, robotic endoscopy from 3 categories (robot-assisted rigid endoscopy, robot-assisted flexible endoscopy, and active GI endoscopy including active flexible colonoscopy and active capsule endoscopy) is reviewed by PubMed search with the criteria (‘Robotics' OR ‘Robot') and (‘Endoscopy' OR ‘Endoscope').

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“…Similar discussion is found in the editorial by Yang et.al. [3], that advancement of AI-based technologies and resultant higher degree of autonomy will change the relationship between the doctors and the patients. Although the future AI may acquire the ability to provide diagnosis or even treatment plan without human intervention, this paper does not discuss this…”

Section: Degree Of Autonomymentioning

confidence: 99%

“…Yang, et al proposed the levels of autonomy of medical robots for consideration of regulatory issues [3].…”

Section: Ai Surgical Robotmentioning

confidence: 99%

Regulatory Science on AI-based Medical Devices and Systems

Chinzei

Shimizu

Mori

et al. 2018

ABE

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AI-based medical and healthcare devices and systems have unique characteristics including 1) plasticity causing changes in system performance through learning, and need of creating new concepts about the timing of learning and assignment of responsibilities for risk management; 2) unpredictability of system behavior in response to unknown inputs due to the black box characteristics precluding deductive output prediction; and 3) need of assuring the characteristics of datasets to be used for learning and evaluation. The Subcommittee on Arti cial Intelligence and its Applications in Medical Field of the Science Board, the Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan, examined new elements speci c to AI not included in conventional technologies, thereby clarifying the characteristics and risks of AI-based technologies. This paper summarizes the characteristics and clinical positioning of AI medical systems and their applications from the viewpoint of regulatory science, and presents the issues related to the characteristics and reliability of data sets in machine learning.

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Medical robotics—Regulatory, ethical, and legal considerations for increasing levels of autonomy

Abstract: A proposed framework for regulatory, ethical, and legal discussions identifies six levels of autonomy for medical robotics.

Cited by 393 publications

References 3 publications

Transparent, explainable, and accountable AI for robotics

Transparent, explainable, and accountable AI for robotics

Robotic Endoscopy

Regulatory Science on AI-based Medical Devices and Systems

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