Healthcare Law Blog

MAY 16, 2022

Enrollee Participation in Dual Eligible Special Needs Plan (“D-SNP”) Governance (§ 422.107). Additional Opportunities for Integration through State Medicaid Agency Contracts (§ 422.107). With a few exceptions, the Final Rule is a wholesale codification of the proposed rule.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Redox

DECEMBER 4, 2020

Those challenges can be broken down into two general categories: How do we get it to everyone? Lisa Bari (she/her/hers) @lisabariMore accurate information about the number of distinct IIS in the US: Kate Ricker-Kiefert @k8kiefert@lisabari 64 IIS is for 50 states, 1 district, 8 territories, and 5 city local IIdNovember 17th 2020 2 Likes.

Public Health 52

Public Health Governance Doctors Medicare 52

SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. The reporting period begins on the day after the awareness date of a serious incident. Although the original awareness date in Section 1.2c

FDA 40

FDA Licensing Governance Compliance 40

SQA

APRIL 30, 2021

generic, biosimilar, or hybrid application), informed consent is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. European Medicines Agency (EMA) – Biologics. Nitrosamine Impurities, 12 April 2021.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

Health Law Advisor

AUGUST 10, 2023

In the last couple of years, each Fall, FDA has been updating a list of machine learning applications in health care that the agency has cleared or otherwise approved. [1] FDA has been regulating machine learning algorithms used in a clinical context for decades. 1] As of last Fall, the list included 521 products dating back to 1995.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. is a medical device or an accessory to a medical device.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 2014 WL 46696, at *5 (C.D. 19, comment d. 19, comment f. at 1291-92.

Governance 52

Governance Payment Systems Hospitals Licensing 52