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Podcast: AI, innovation, and value-based care in medicine

Permanente Medicine

” Related AI scribes story: Analysis: AI scribes save physicians time, improve patient interactions and work satisfaction Dr. Nguyen also highlighted the potential to utilize artificial intelligence and Kaiser Permanente’s extensive medical database to develop predictive analytic models aimed at enhancing patient care.

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District Court Interprets EKRA

FDA Law

Note that while EKRA was passed as part of a bill to combat the opioid crisis, its definition of “laboratory” applies to lab activities far beyond those involving opioid or other drug testing. In particular, the employee exemption, relevant to the S&G Labs Haw., S&G Labs Haw., 18 U.S.C. § 24(b) (emphasis added).

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District Court Interprets EKRA

FDA Law

Note that while EKRA was passed as part of a bill to combat the opioid crisis, its definition of “laboratory” applies to lab activities far beyond those involving opioid or other drug testing. In particular, the employee exemption, relevant to the S&G Labs Haw., S&G Labs Haw., 18 U.S.C. § 24(b) (emphasis added).

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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

The CDS Guidance lists four general types of medical information that would meet the definition of “medical information about a patient”—a radiology study report, an ECG report, a blood pressure result, and a lab test result—but these examples shed little insight on how to apply the interpretation in practice.

Clinic 52
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It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

FDA Law

Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Of course, FDA’s August 3, 1992 statement that it could regulate LDTs came long after laboratories began offering diagnostic tests. It came 16 years after Congress passed the Medical Device Amendments of 1976, without saying a word about FDA authority over laboratory testing.