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Tag: FTC

US FDA Approaches to Artificial Intelligence

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Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital, to market research at a benefits management organization, to optimizing manufacturing operations at a pharmaceutical company. The level of regulatory scrutiny of such systems depends on their intended use and associated risks.

In the U.S., for medical devices using AI, one of the key regulatory bodies is the Food and Drug Administration (FDA), especially its Center for Devices and Radiological Health (CDRH). CDRH has long followed a risk-based approach in its regulatory policies, and has officially recognized ISO Standard 14971 “Application of Risk Management to Medical Devices.” That standard is over 10 years old now, and therefore is currently undergoing revisions – some of which are meant to address challenges posed by AI and other digital tools that are flooding the medical-devices arena.

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FTC Announces Expanded Settlement with Uber

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The FTC withdrew its August 2017 administrative complaint and proposed consent agreement with Uber Technologies, Inc. (Uber) and issued a revised complaint against Uber Technologies, Inc. Uber has accepted a revised proposed consent agreement which will be subject to public comment for 30 days.

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Tabula Rasa: President Nominates Fifth FTC Commissioner

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As anticipated, President Trump nominated Rebecca Slaughter, Chief Counsel to Senator Charles Schumer, for the FTC’s fifth vacant commissioner slot. Ms. Slaughter identified the following items as the top three challenges facing the FTC:

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