FDA

Safeguards Needed for Generative AI EHR Data Summarization

January 31, 2024 - While generative AI shows promise for EHR data summarization, using large language models (LLMs) to summarize clinical data brings risks that are not clearly covered by existing Food and Drug Administration (FDA) safeguards, according to a viewpoint published in JAMA.   A little over a year after ChatGPT’s public release, the healthcare...


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FDA Selects Cerner Enviza to Develop EHR AI Tools for Drug Safety

by Hannah Nelson

FDA’s Sentinel Innovation Center has partnered with John Snow Labs and Cerner Enviza, an Oracle company, to create AI tools to extract critical information from EHR notes for improved drug...

RWE Alliance Commends FDA Draft Guidance for EHR Data Use

by Hannah Nelson

The RWE Alliance has submitted a comment letter in response to the FDA draft guidance on using medical claims and EHR data for real world evidence (RWE) to support regulatory decision making. The RWE...