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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

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

Clinic 52
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You don’t need labs to medically clear a psych patient

PEMBlog

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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District Court Interprets EKRA

FDA Law Blog

220 and was described on HP&M’s blog here. 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. EKRA is codified at 18 U.S.C. § 18 U.S.C. §

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District Court Interprets EKRA

FDA Law Blog

220 and was described on HP&M’s blog here. 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. EKRA is codified at 18 U.S.C. § 18 U.S.C. §

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What is primary care? Part 2

Noreta Family Medicine

Part 2 Here are some frequently asked questions I get as a Primary Care Provider. Therefore, family physicians are trained to do minor surgical procedures in the office, care for kids and adults, provide various GYN services, among many other comprehensive services for patients. Other family doctors only see patients in their clinics.

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What can we learn from simulations? Amber Barnato

GeriPal

Amber tells the moving story of how these findings led a clinical colleague, her chief, to question and change his behavior. As we’ve written about on GeriPal when we were a blog (a decade ago!) Amber: Well, simulation is pretending, so I think of the way I use simulation is in trying to simulate clinical care. I love this song.

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Podcast Episode: Febrile Seizures

PEMBlog

Well, they say that LP should be performed when there are meningeal signs or symptoms or other clinical features that suggest possible meningitis or intracranial infection. And the clinical clues that a seizure has ended are often subtle. And use lab tests, and especially CT scans of the brain judiciously.

Illness 59