Abstract
Artificial intelligence needs big data to develop reliable predictions. Therefore, storing and processing health data is essential for the new diagnostic and decisional technologies but, at the same time, represents a risk for privacy protection. This scoping review is aimed at underlying the medico-legal and ethical implications of the main artificial intelligence applications to healthcare, also focusing on the issues of the COVID-19 era. Starting from a summary of the United States (US) and European Union (EU) regulatory frameworks, the current medico-legal and ethical challenges are discussed in general terms before focusing on the specific issues regarding informed consent, medical malpractice/cognitive biases, automation and interconnectedness of medical devices, diagnostic algorithms and telemedicine. We aim at underlying that education of physicians on the management of this (new) kind of clinical risks can enhance compliance with regulations and avoid legal risks for the healthcare professionals and institutions.
Highlights
Digital revolution is changing and will radically change the way healthcare is conceived [1]
The review question was “what are the main medico-legal and ethical issues of general interest concerning artificial intelligence applied to healthcare?” Since the question is very broad, the targets are very diverse and the aim is to describe an overview of the available research evidence, a systematic review approach was not chosen
artificial intelligence (AI) products designed for healthcare are considered by European Union (EU) Commission as “high-risk” and, before they can be put on the market, have to meet these requirements: adequate risk assessment and mitigation systems, high-quality datasets, logging of activity, detailed documentation to prove the compliance with legal requirements, clear and adequate information to the user, appropriate human oversight measures and high level of robustness, security and accuracy
Summary
Digital revolution is changing and will radically change the way healthcare is conceived [1]. From a legal point of view privacy is never an “absolute” right, but it has many trade-offs, that must always be carefully considered to decide what right should prevail in the specific situation [16]. This scoping review is aimed at underlying the medicolegal and ethical implications of the main artificial intelligence applications to healthcare. Starting from a summary of the United States (US) and European Union (EU) regulatory frameworks, the current medico-legal and ethical challenges are discussed in general terms before focusing on the specific issues regarding informed consent, errors/cognitive biases, diagnostic algorithms and telemedicine
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