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District Court Interprets EKRA

FDA Law Blog

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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District Court Interprets EKRA

FDA Law Blog

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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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

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.

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