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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

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Medical information about a patient. Other medical information.

Clinic 52
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District Court Interprets EKRA

FDA Law

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. S&G Labs Haw., 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). Background Facts.

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District Court Interprets EKRA

FDA Law

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. S&G Labs Haw., 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). Background Facts.