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Final Rules Reporting Requirements Healthcare

Bradley Arant Boult Cummings LLP

OSHA Terminates COVID-19 Emergency Temporary Standard for Healthcare Workers

Is COVID-19 still a thing, and does OSHA care about it? Yes and yes. We all know that COVID-19 is still around. On the OSHA front, the agency seems to be focused less exclusively on COVID-19 and plans to take a broader...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

McCarter & English, LLP

New Jersey Regulatory Update Part II - February 2025

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more

McCarter & English, LLP

New Jersey Regulatory Update Part I - January 2025

Below is Part I of our New Jersey Regulatory Update focusing on regulations that were finalized in 2024 by various New Jersey agencies that impact healthcare. The final regulations range from additional transparency...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Jones Day

FTC's Final Health Breach Notification Rule: Expanded Scope, New Obligations, and Modified Reporting Requirements

Jones Day on

The Federal Trade Commission ("FTC") intends to "strengthen and modernize" the Health Breach Notification Rule with revamped and increased scrutiny on entities holding health information, including health apps, websites, and...more

King & Spalding

FTC Announces Final Rule Sweeping Consumer Digital Health Tech Under the Health Breach Notification Rule

King & Spalding on

On April 26, the Federal Trade Commission (FTC) approved its Final Rule revising the Health Breach Notification Rule (HBNR) (“Final Rule”) by a 3-2 vote. The HBNR requires vendors of personal health records (PHR) and related...more

Carlton Fields

4 Tips for Health Tech Apps After the FTC’s Revised Breach Notification Rule

Carlton Fields on

On April 26, the Federal Trade Commission announced its final rule updating the health breach notification rule. According to the FTC, the update seeks to “clarify” the scope of the rule by adding new definitions and revising...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

Troutman Pepper Locke

CMS Publishes Final Rule on Civil Monetary Penalties for Section 111 Reporting

Troutman Pepper Locke on

The Centers for Medicare and Medicaid Services (CMS) published the final rule outlining how civil monetary penalties will be calculated and imposed when Responsible Reporting Entities (RRE) fail to meet their Medicare...more

McDermott+

Policy Update - CMS Releases FY 2024 IPPS Final Rule

McDermott+ on

On August 1, 2023, the Centers for Medicare & Medicaid Services (CMS) released the fiscal year (FY) 2024 Inpatient Prospective Payment System (IPPS) final rule. The rule updates Medicare payment policies and quality reporting...more

Quarles & Brady LLP

New DEA Form 106 Theft & Loss Reporting Deadlines and Submission Requirements

Quarles & Brady LLP on

On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more

McDermott Will & Emery

CMS Final Rule Strengthens Integrity of Medicare Provider Enrollment Process

McDermott Will & Emery on

On September 10, 2019, the US Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) expanding Medicare, Medicaid and Children’s Health Insurance Program...more

Polsinelli

New Clinical Trial Rule Alters Reporting Requirements

Polsinelli on

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

Robinson & Cole LLP

CMS Makes Significant Changes to Stage 2 Meaningful Use and Finalizes Stage 3

Robinson & Cole LLP on

On October 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) that streamlines Stage 2 and finalizes Stage 3 of the Medicare and Medicaid electronichealth record (EHR) Incentive...more

Sheppard Mullin Richter & Hampton LLP

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

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