SQA

JUNE 10, 2021

There are 11 regulatory projects for the medical devices’ field: Implementation of the National Implant Registry (RNI) in Brazil’s public and private health services. Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH).

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

Healthcare IT News - Telehealth

DECEMBER 16, 2020

In March, as states were issuing stay-at-home orders, the FDA published pandemic-specific guidance for trial sponsors, institutional review boards and investigators on how to ensure the safety of their trial participants and reduce risks to trial integrity, while sustaining compliance with good clinical practice.”

COVID-19 213

COVID-19 Hospitals Doctors Health Insurance 213

Kaiser Health News

MAY 13, 2022

” said Lucia Savage, chief privacy and regulatory officer for Omada Health, a digital therapeutics company. ” Period-tracking apps are often not covered under the Health Insurance Portability and Accountability Act, or HIPAA, though if the company is billing for health care services, it can be.

US Department of Health and Human Services 99

US Department of Health and Human Services HIPAA Governance Health Insurance 99

Hall Render

DECEMBER 22, 2023

Yale New Haven sale key to Prospect hospitals’ survival, CEO says YNHH sale ‘paramount’ to CT Prospect hospitals’ survival, CEO says Connecticut hospital cut ED visits by nearly 50% Hartford HealthCare unveils new ‘health desk’ model Connecticut physician sentenced for $2.6M

Nursing Homes 40

Nursing Homes Nurses Hospitals COVID-19 40

Hall Render

DECEMBER 29, 2023

hospitals for maternity care UMass Memorial Medical Center to reinstate caregiver mask mandate Massachusetts health system sees over $17M FY ’23 profit Mass. system turns profit for 1st time in 4 years Mass.

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses COVID-19 40

Hall Render

APRIL 21, 2023

Billion in Community Benefit in 2021 OhioHealth buys land in Canal Winchester – 3 miles from competitor’s ER Quipt Home Medical inks $26M stock deal with Beacon Securities, Canaccord Genuity Corp.,

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nurses Nursing Homes 40

Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. FDA , 119 F. Caronia , 703 F.3d 3d 149 (2d Cir. 3d 196 (S.D.N.Y.

FDA 64

FDA Health Insurance Nurses Medicare 64