FDA Law Blog

OCTOBER 10, 2022

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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Physician's Practice

JUNE 27, 2025

Examples from my practice If we tell a patient that we will return a call to them in two days with a report of a lab test and the results are not available, it is essential to inform the patient of the situation and provide them with an alternative date for when someone will call with the results.

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Management Private Practice Patients Medical 52

Permanente Medicine

MAY 20, 2025

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. And I quickly found myself in a role of access lead for Orange County and where I managed over 300 doctors. Couldn’t imagine doing anything else.

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Patient-Centered Patients IT Medical 52

FDA Law Blog

JANUARY 6, 2022

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. S&G Labs Haw., 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). Background Facts.

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Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

JANUARY 6, 2022

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. S&G Labs Haw., 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). Background Facts.

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Lab Testing Individual Referral Patient-Centered 40

GeriPal

AUGUST 4, 2022

Alex: And we have Kevin McConeghy, who is a clinical pharmacy specialist at the VA Medical Center in Providence, and a PhD candidate at the Brown School of Public Health. And this paper really gave us some important insights into older adults’ priorities about medication use that can inform these conversations. Welcome, Ariel.

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Specialization Medical Patient-Centered Provider 104

GeriPal

SEPTEMBER 7, 2023

Based on this surge in evidence, the American Society of Clinical Oncologists recently updated their guidelines for care of older adults to state that all older adults receiving systemic therapy (including chemo, immuno, targeted, hormonal therapy) should receive geriatric assessment guided care. Mazie, welcome to GeriPal. William: Sure.

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Patient-Centered IT Patients Clinic 129