Hall Render

NOVEMBER 30, 2023

However, the evolution of LDTs, including their increased complexity and broader application, has caused the FDA to “become increasingly concerned that some LDTs may not provide accurate test results or perform as well as FDA-authorized tests or other complying with FDA requirements,” according to an FDA news release.

FDA 40

FDA Public Health Compliance Hospitals 40

Jane Sarashon

DECEMBER 19, 2022

When the meet-up convenes over 100,000 tech-folk in Las Vegas at the start of 2023, we’ll see even more health and self-care tools and services at #CES23 — along with new-new things displayed in aisles well outside of the physical space on the Las Vegas Convention Center map labeled “digital health” at this year’s CES in the North Hall.

COVID-19 52

COVID-19 FDA Public Health Telemedicine 52

AIHC

FEBRUARY 16, 2024

Lessons Learned about Consequences & Incentives Submitted by the AIHC Education Department Introduction The Office of Inspector General has released the new General Compliance Program Guidance or “GCPG” in late 2023. Even well-meaning changes and upgrades to policies can make a previously compliant industry noncompliant.

Compliance 52

Compliance US Department of Health and Human Services COVID-19 Hospitals 52

AIHC

FEBRUARY 16, 2024

Lessons Learned about Consequences & Incentives Submitted by the AIHC Education Department Introduction The Office of Inspector General has released the new General Compliance Program Guidance or “GCPG” in late 2023. Even well-meaning changes and upgrades to policies can make a previously compliant industry noncompliant.

Compliance 52

Compliance US Department of Health and Human Services COVID-19 Hospitals 52

Health Populi

JULY 1, 2019

Get a cup of coffee and sit back, because this is a long one – not the usual short and sweet entry that each of us endeavors to craft on our respective blogs. We three don’t know what process ensued and what bidders came to the table, but in the end, it was UHG that stepped into iCarbonX’s shoes to become the new owner.

Health Insurance 86

Health Insurance Pharmaceutical Industry HIPAA Bioethics 86

Health Populi

MAY 11, 2023

This week, three intriguing examples are resonating with us: The ever-evolving weight-loss industry FDA favors OTC use for Perrigo’s Opill daily oral contraceptive birth control pill The convergence of fashion and health — specifically, how an over-the-counter medicine converges with clothing that helps us feel better.

FDA 62

FDA Telemedicine Health Care Access 62

Jane Sarashon

DECEMBER 20, 2023

At the end of each year since I launched the Health Populi blog, I have put my best forecasting hat on to focus on the next year in health and health care. In what the Federal Reserve Bank of New York sees as an “only-in-the-U.S.” Consumer in the Big/Macro U.S. Another positive aspect of the U.S.

Prescription Drug Pricing 67

Prescription Drug Pricing Medical Billing Health Insurance Public Health 67

Health Law Advisor

JULY 21, 2023

15] An Overview of the Proposed TCET Pathway An FDA-designated breakthrough device that has been determined to be within a Medicare benefit category, is not already the subject of an existing Medicare NCD, and is not otherwise excluded from coverage through law or regulation may be eligible for the proposed TCET pathway.

FDA 52

FDA Medicare Medicare Patient Advocacy 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. Armstrong World Industries, Inc. , Bowie Industries, Inc. ,

Governance 52

Governance Payment Systems Hospitals Licensing 52