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District Court Interprets EKRA

FDA Law Blog

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” S&G Labs Haw., 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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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. And then, so from that point on, I began to look at technology systems, processes for all settings, inpatient, outpatient care at home, a hospital at home. Now you noticed I said everyone but the doctor.

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District Court Interprets EKRA

FDA Law Blog

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” S&G Labs Haw., 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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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 final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Interpretation of Statutory Criteria Under the Final Guidance.

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