Remove 2019 Remove Government Remove Individual Remove Medical
article thumbnail

Approaches for Quelling Stigma related to COVID-19

BMJ

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. Psychological health during the coronavirus disease 2019 pandemic outbreak. Scholars such as Wen et al.

article thumbnail

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

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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.

Clinic 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Three Entities (and a Part Owner and Pharmacist in Charge) Likely Must Swallow A Bitter PIL for Their Role in the Opioid Crisis; But … For Now, The District Court Denies Government’s Motion for Preliminary Injunction

FDA Law

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. attorneys’ offices since 2019, the Complaint seeks monetary and permanent injunctive relief ( see 21 U.S.C. §§ 832(f)(1) and 882(a)).

article thumbnail

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of the approximately $13,000 annual copay. The Medicare program would pay most of the remaining $225,000 in annual cost.

article thumbnail

District Court Interprets EKRA

FDA Law

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.” 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 18 U.S.C. §

article thumbnail

District Court Interprets EKRA

FDA Law

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.” 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 18 U.S.C. §

article thumbnail

Episode 200: Antiracism in Medicine Series – Episode 11 – Racism, Redlining, and the Path Towards Reconciliation

The Clinical Problem Solvers

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Adopting this worldview removes any obligation to remedy the consequences of segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. Episode Takeaways: 1.