Hall Render

OCTOBER 18, 2024

Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023. In August 2023, the U.S.

FDA 40

FDA Compliance Licensing 40

Hall Render

JUNE 5, 2024

Stage 2: Effective May 6, 2026 Two years after the Final Rule’s publication, the FDA will expand its regulatory scope to include establishment registration and listing, labeling and investigational use requirements. Part 820 ).

FDA 40

FDA Compliance Regulatory Compliance Licensing 40

AIHC

JULY 1, 2024

Written by Joanne Byron , BS , LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, OHCC, ICDCT-CM/PCS of the American Institute of Healthcare Compliance (AIHC), a non-profit healthcare education organization. The effective date of the Final Rule was June 25, 2024 with a compliance date of December 23, 2024. What is this Final Rule?

HIPAA 52

HIPAA Compliance Malpractice Licensing 52

SQA

MAY 6, 2025

SQA Regulatory Surveillance Summary for 3Q/4Q 2024 By: Laurel Hacche and Debra Cortner As we move through 2025, looking back at regulatory updates from Q3 and Q4 of 2024 provides critical insight into how the global compliance landscape is evolving. However, in practice, the NMPA expects compliance with industrial standards.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Compliance Licensing 52

C&M Health Law

JANUARY 4, 2024

The United States Core Data for Interoperability Version 3 (USCDI v3): ONC established the USCDI v3 as the new baseline standard of data classes and constituent data elements for certified health IT, effective January 1, 2026.

Public Health 52

Public Health Licensing HIPAA Governance 52

SQA

FEBRUARY 15, 2023

Finalization of the document is planned for 2026. ACT EU features ten priority action areas that are the basis for the ACT EU 2022-2026 workplan. The consultation period for the revised new Annex 11 ends on 16 January 2023, with a draft document to be released for consultation in December 2024. was conducted on 07 November 2022.

US Department of Health and Human Services 40

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

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The written procedure for recall was inadequate and this procedure had not been implemented.

FDA 40

FDA Licensing Governance Compliance 40

Provider Trust

OCTOBER 12, 2021

License verification, especially nursing license verification, is essential to ensuring that only the most qualified practitioners are seeing your patients. Additionally, of all licensed RNs, 84.5% government estimates that >200,000 new RN positions will be created each year from 2016 to 2026. with more than 3.8

Licensing 52

Licensing Nurses COVID-19 Public Health 52

Healthcare Law Blog

JANUARY 5, 2023

The HEI for the 2027 Star Ratings would be calculated using data collected or used for the 2026 and 2027 Star Ratings, and would replace the current reward factor that has been in place since the 2009 Star Ratings. That is, the HEI is specifically designed to create an incentive to reduce disparities in care.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Healthcare Law Blog

AUGUST 25, 2022

The first list of up to 10 Part D negotiation-eligible drugs will be published in 2026, the earliest “price applicability date” at which the Program takes effect. The drug publication date for 2026 will be chosen by September 1, 2023. Program Compliance. Penalties under the Program are severe.

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Medicare Medicare Medicaid Medicaid 52

Healthcare Law Blog

NOVEMBER 13, 2023

This proposal would shift the burden from CMS to the MA organization to demonstrate compliance with this standard. The Proposed Rule would lower the D-SNP look-alike threshold from eighty percent (80%) to seventy percent (70%) in 2025 and to sixty percent (60%) in 2026.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

Hall Render

OCTOBER 11, 2024

are among the nation’s highest. are among the nation’s highest.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

MedTrainer

JANUARY 16, 2025

As we step into the new year, the healthcare sector is positioned to once again navigate a variety of regulatory changes changes that could impact your organizations current operations, compliance, and financial performance. Ensuring readiness involves confirming compliance with telemedicine-specific requirements outlined in CFR regulations.

Compliance 52

Compliance Regulatory Compliance COVID-19 HIPAA 52

Hall Render

AUGUST 16, 2024

Luke’s Behavioral Health ARKANSAS LaDonna Johnston Named CEO of Unity Health Update: Hearing to Approve Sale of Wadley Regional Medical Center Rescheduled How Arkansas Children’s is diversifying its workforce Sale hearing for Steward Health, Debtors’ Hospitals in Louisiana and Arkansas moved to Aug. Therapist pleads guilty to $1.6M

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Hospitals Nurses 40

Hall Render

AUGUST 16, 2024

Luke’s Behavioral Health ARKANSAS LaDonna Johnston Named CEO of Unity Health Update: Hearing to Approve Sale of Wadley Regional Medical Center Rescheduled How Arkansas Children’s is diversifying its workforce Sale hearing for Steward Health, Debtors’ Hospitals in Louisiana and Arkansas moved to Aug. Therapist pleads guilty to $1.6M

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Hospitals Nurses 40

Hall Render

JANUARY 17, 2025

OrthoIndy to merge with Evansville, Fort Wayne practices St. accepted bid Dr. Josephs expands executive team with NJ health care industry veteran J&J set to acquire drugmaker for $14.6B New Jersey physician pleads guilty to illegal oxycodone distribution scheme New Jersey system taps chief clinical officer N.J.

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Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

MARCH 3, 2023

million for youth mental health care KENTUCKY Pike County nursing home officials release statement following loss of Medicare agreement Three Humana executives drop $11.2M What does it mean for you?

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Nursing Homes COVID-19 Nurses Hospitals 40