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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., 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 18 U.S.C. §

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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., 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 18 U.S.C. §

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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

Criterion 4 : Non-Device CDS software functions provide sufficient information about the basis for the recommendations to the HCP user, so that the HCP user does not rely primarily on any of the recommendations to make a clinical decision about an individual patient. Interpretation of Statutory Criteria Under the Final Guidance.

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