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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

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. Criterion 3 : Non-Device CDS software functions are intended for the purpose of supporting or providing recommendations about a patient’s care to a health care professional (HCP) user.

Clinic

Clinic Medical Provider Patients

What can we learn from simulations? Amber Barnato

GeriPal

FEBRUARY 9, 2023

Amber tells the moving story of how these findings led a clinical colleague, her chief, to question and change his behavior. As we’ve written about on GeriPal when we were a blog (a decade ago!) They look at the signs and symptoms, they do a physical exam, maybe some lab tests or some imaging. Amber: Thank you guys.

Patient-Centered

Patient-Centered Patients IT Healthcare

Primary Care Digest

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

What can we learn from simulations? Amber Barnato

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