Health Care Law Brief

FEBRUARY 16, 2024

On February 6, 2024, the New York State Department of Financial Services (“DFS”) released “pre-proposed” consolidated rulemaking related to the business practices of Pharmacy Benefit Managers (“PBMs”) licensed to operate in New York. from the August 2023 proposed rules.

Licensing 52

Licensing Medicare Medicare Regulatory Compliance 52

Health Care Law Brief

JANUARY 19, 2022

In an approval memo, Governor Hochul described the New York legislation as the most comprehensive regulatory framework in the country for PBMs. The new law requires PBMs to register with the State Department of Financial Services (DFS) by April 1, 2022 and thereafter to be licensed by January 1, 2023. 1] [link].

Prescription Drug Pricing 52

Prescription Drug Pricing Licensing Compliance Medicaid 52

MedTrainer

AUGUST 2, 2023

Listen to a candid discussion on lessons learned from the 2023 federal investigation that uncovered fraudulent medical practice nationwide in this on-demand webinar: Moving Forward From the Nursing Fraud Scheme. Primary source verification is done by contacting educational institutions, licensing boards, and other relevant authorities.

Malpractice 52

Malpractice Due Diligence Compliance Licensing 52

AIHC

NOVEMBER 3, 2023

Weight and Height Juxtaposition in the Electronic Medical Record Causing an Accidental Medication Overdose (posted on the Patient Safety Network October 31, 2023) A 2-year-old girl presented to the emergency department (ED) with joint swelling and rash following an upper respiratory infection. 1 through June 30, 2023.

Department of Veterans Affairs 59

Department of Veterans Affairs Hospitals Compliance Nurses 59

Health Care Law Brief

JULY 25, 2023

On June 27, 2023, the Office of Inspector General (“ OIG ”) for the U.S. Unlike developers, exchanges, and networks, the Act does not empower OIG to directly assess penalties for non-compliance against health care providers. [6] 1] See 21st Century Cures Act, Pub.

HIPAA 52

HIPAA Payment Systems Compliance Licensing 52

Healthcare IT Today

JANUARY 9, 2024

As 2023 uncovered some less-than-optimal situations where automation and AI were at odds on either side of the fence, my hope is in 2024 that deeper connectivity and collaboration will make those solutions obsolete in some form or fashion. Data scientists need to focus on analyzing information to discover actionable insights.

Hospitals 97

Hospitals Regulatory Compliance Compliance Licensing 97

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. products in color and typeface and uses the BTNX Inc. device identifier “COV-19C25.”

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Health Care Law Brief

FEBRUARY 6, 2023

On February 1, 2023, New York Governor Kathy Hochul announced the 2024 Executive Budget. See 2023 New York Senate-Assembly Bill S4007 , A3007 , Part M § 5. The legislative proposals related to health care, as contained in the Governor’s budget, were introduced as Senate Bill 4007 and Assembly Bill A3007.

Patient Satisfaction 52

Patient Satisfaction Licensing Health Insurance Health Outcomes 52

Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

HIT Consultant

DECEMBER 6, 2022

Telemental health providers were not immune to this activity in 2022, and providers should prioritize regulatory compliance as the industry looks ahead to 2023. “As That call was answered in 2022, and now the industry must ensure that services maintain quality and compliance for real change to occur.”.

Compliance 98

Compliance Medicaid Medicaid COVID-19 98

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105