FDA Law Blog

JANUARY 6, 2022

Note that while EKRA was passed as part of a bill to combat the opioid crisis, its definition of “laboratory” applies to lab activities far beyond those involving opioid or other drug testing. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations. 18 U.S.C. §

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 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. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

Patient-Centered 52

Patient-Centered Patients Medical IT 52

FDA Law Blog

JANUARY 6, 2022

Note that while EKRA was passed as part of a bill to combat the opioid crisis, its definition of “laboratory” applies to lab activities far beyond those involving opioid or other drug testing. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations. 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

GeriPal

AUGUST 4, 2022

My take home from this is that while the most preferred explanation for deprescribing statins and sedative-hypnotics is one focused on the risk of side effects, we also need to individualize it to the patient and the medication that they are taking. Maybe that’s where the individualizing it, the person that’s front of me.

Specialization 105

Specialization Medical Patient-Centered Provider 105

FDA Law Blog

OCTOBER 10, 2022

Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Here again, FDA’s novel interpretation of statutory terms effectively narrows the scope of information that a software product can display, analyze, or print and still be considered Non-Device CDS.

Clinic 52

Clinic Medical Provider Patients 52

GeriPal

FEBRUARY 9, 2023

They look at the signs and symptoms, they do a physical exam, maybe some lab tests or some imaging. And so the control room is a contiguous room, but the individual rooms where the patients, the actors and the doctors are separated by a wall. Try to really understand what’s happening. They’re side to side.

Patient-Centered 112

Patient-Centered Patients IT Healthcare 112