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District Court Interprets EKRA

FDA Law Blog

S&G Labs Hawaii, LLC (“S&G Labs”) is a Hawaiian laboratory company that performs various lab testing services including toxicology (for both legal and illicit substances) and COVID testing. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

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District Court Interprets EKRA

FDA Law Blog

S&G Labs Hawaii, LLC (“S&G Labs”) is a Hawaiian laboratory company that performs various lab testing services including toxicology (for both legal and illicit substances) and COVID testing. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

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

Permanente Medicine

And I quickly found myself in a role of access lead for Orange County and where I managed over 300 doctors. They’re due for cervical cancer screening, that they get that if they are due for a lab test, they get that. I know for a fact that the government or legislators looked to us in Permanente.

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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

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.

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