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New Standard Launched for Artificial Intelligence in Healthcare

March 03, 2020 -More than 50 organizations recently developed the first-ever ANSI-accredited standard for the use of artificial intelligence (AI) in healthcare.

Standards are designed to serve the public through removal of any misunderstandings between manufacturers and purchasers, boosting interchangeability and improvement of products, and assisting the purchaser in selecting and obtaining the appropriate product for their particular need, according to a CTA document.

CTA announced working groups consisting of a wide range of decision-makers from 52 organizations to launch a standard based on consensus to tackle the confusion of AI-related terms such as telehealth and remote patient monitoring.

The standard includes definitions for the contentious term assistive intelligence, which leaders agreed to define as a category of AI software that pushes a diagnosis or clinical management of a patient, the group highlighted.

Other definitions mentioned included machine learning, which creates AI systems using algorithms, data, tools, and techniques, and regression, defined as technique used in AI and ML in which the application continuously estimates the relationship between outputs through numeric values.

Event Title Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging February 25 - 26, 2020

The intent of this public workshop is to discuss emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition.

Artificial intelligence (AI), including machine learning technologies, has the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of health care every day.

The potential for independent action by these devices to bypass human clinical review is an important factor in their benefit-risk profile, and it heightens expectations for the safety and effectiveness of these devices.

Clinical AI applications may assist the acquisition of standardized images independent of the operator, guiding both sonographers and non-experts in sonography, potentially including lay users, to acquire images with equivalent diagnostic quality.

The addition of such clinical AI applications and the potential for new users of these devices, similarly affect the benefit risk profiles for these devices and the expectations for the safety and effectiveness of these devices.

In this workshop, FDA is also seeking innovative and consistent ways to leverage existing methods and to develop new methods for validation of these AI-based algorithms and explore opportunities for stakeholder collaboration in these efforts.   During the workshop, we will be discussing specific topics outlined in the Agenda below.

All requests to make oral presentations must be received by January 10, 2020, 4 p.m. If selected for presentation, FDA will notify presenters by January, 24, 2020 and presentation materials must be emailed to by February 5, 2020 to present at the event.

FDA-2019-N-5592 by March 26, 2020.  Please refer to the instructions for submitting comments to the docket to ensure that your feedback is received.  Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at  For questions regarding workshop content please contact: Jennifer A.

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