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Outcomes of Guidelines from Health Technology Assessment Organizations: A Systematic Mixed Studies Review [Systematic review, meta-analysis, or scoping review]

Annals of Family Medicine

Context: Health Technology Assessment (HTA) organizations determine the value of health technologies such as medical devices, lab tests, or medications. Objectives: To explore and measure the outcomes of HTA organizations’ guidelines in family medicine.

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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

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. The reception does the same thing, the medical assistant does the same thing. Now you noticed I said everyone but the doctor.

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

FDA Law Blog

It came 16 years after Congress passed the Medical Device Amendments of 1976, without saying a word about FDA authority over laboratory testing. And it came four years after the comprehensive federal legislation governing laboratories, again without mentioning FDA or referring to such tests as devices. On the other side, Sen.