Lifecycle regulation of artificial intelligence–and machine learning–based software devices in medicine

TJ Hwang, AS Kesselheim, KN Vokinger - Jama, 2019 - jamanetwork.com
Artificial intelligence–and machine learning (AI/ML)–basedtechnologiesaimtoimprovepatientcar…
by an individual patient and by the collective experience ofmanypatients …

The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

S Gerke, B Babic, T Evgeniou, IG Cohen - NPJ digital medicine, 2020 - nature.com
Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to
significantly improve health care, for example, by offering earlier diagnoses of diseases or …

Clinical implications and challenges of artificial intelligence and deep learning

WW Stead - Jama, 2018 - jamanetwork.com
Artificial intelligence (AI) and deep learning are entering the mainstream of clinical medicine.
For example, in December 2016, Gulshan et al1 reported development and validation of a …

Transparency of artificial intelligence/machine learning-enabled medical devices

AA Shick, CM Webber, N Kiarashi, JP Weinberg… - NPJ Digital …, 2024 - nature.com
Artificial intelligence/machine learning (AI/ML)-enabled medical devices (AI/ML devices,
hereafter) offer exciting new opportunities to continue the advancement of healthcare. These …

Artificial intelligence in health care: will the value match the hype?

EJ Emanuel, RM Wachter - Jama, 2019 - jamanetwork.com
Artificial intelligence (AI) and its many related applications (ie, big data, deep analytics,
machine learning) have entered medicine's “magic bullet” phase. Desperate for a solution …

Regulation of predictive analytics in medicine

RB Parikh, Z Obermeyer, AS Navathe - Science, 2019 - science.org
Artificial intelligence (AI) and increased computing power have long held the promise of
improving prediction and prognostication in health care (1). Now, use of predictive analytics …

Automation bias and assistive AI: risk of harm from AI-driven clinical decision support

R Khera, MA Simon, JS Ross - JAMA, 2023 - jamanetwork.com
At the point of care, artificial intelligence (AI) algorithms have been developed to augment
diagnostic decisions and suggest appropriate care pathways, 1 by leveraging complex …

The 2021 landscape of FDA-approved artificial intelligence/machine learning-enabled medical devices: An analysis of the characteristics and intended use

S Zhu, M Gilbert, I Chetty, F Siddiqui - International journal of medical …, 2022 - Elsevier
Background Machine learning (ML), a type of artificial intelligence (AI) technology that uses
a data-driven approach for pattern recognition, has been shown to be beneficial for many …

Unintended consequences of machine learning in medicine

F Cabitza, R Rasoini, GF Gensini - Jama, 2017 - jamanetwork.com
Overthepastdecade, machinelearningtechniqueshave made substantial advances in many
domains. In health care, global interest in the potential of machine learning hasincreased; …

Beware explanations from AI in health care

B Babic, S Gerke, T Evgeniou, IG Cohen - Science, 2021 - science.org
Artificial intelligence and machine learning (AI/ML) algorithms are increasingly developed in
health care for diagnosis and treatment of a variety of medical conditions (1). However …