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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

Alex 13:24 Eric is pushing on the like, the clinical, practical stuff. But that combination is actually quite common, and it’s quite challenging to diagnose and manage, at least in the traditional sense. Now, again, in the context of a busy clinical visit, you may not have the time to really go through it in detail.

IT 121
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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

Certainly we would expect clinical communications, as well as HCP-patient communications, to include discussions of test results over time as these would seem highly relevant to clinical decision making. Criterion 4: The fourth criterion seeks to ensure that Non-Device CDS does not supplant an HCP’s independent clinical judgment.

Clinic 52
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FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. FDA notes the use of data collected outside the U.S.