Annals of Family Medicine

NOVEMBER 20, 2024

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.

General Practitioner 130

General Practitioner Lab Testing Relationship Family Physician 130

Permanente Medicine

MAY 20, 2025

Khang Nguyen, MD, chief transformation officer of the Southern California Permanente Medical Group, discusses how AI can increase clinicians’ joy in medicine and improve patient outcomes with Chris Grant, chief operating offer and executive vice president of Kaiser Permanente, The Permanente Federation, and host of the Permanente Medicine Podcast.

Patient-Centered 52

Patient-Centered Patients IT Medical 52

FDA Law Blog

JANUARY 6, 2022

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).

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

JANUARY 6, 2022

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).

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

AUGUST 3, 2022

These products are subject to the same regulatory requirements as any unapproved medical device”). Of course, FDA’s August 3, 1992 statement that it could regulate LDTs came long after laboratories began offering diagnostic tests. As we began to prepare this blog, we thought it might be both birthday card and death notice for LDTs.

Lab Testing 98

Lab Testing Government IT Manufacturing 98