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Healthcare › Life Sciences › Final Rules

Vorys, Sater, Seymour and Pease LLP

Just Say No!  HIPAA and Requests for Reproductive Health Information

Vorys, Sater, Seymour and Pease LLP on

On April 22, 2024, the Office of Civil Rights issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Privacy Rule). Originally Published by the American Bar Association....more

Manatt, Phelps & Phillips, LLP

CMS and ONC Issue Final Rule on E-Prescribing

Manatt, Phelps & Phillips, LLP on

On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D. ...more

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

Quarles & Brady LLP on

On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

Manatt, Phelps & Phillips, LLP

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests

Manatt, Phelps & Phillips, LLP on

On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the...more

Polsinelli

FDA Finalizes Rule Regulating Laboratory Developed Tests

Polsinelli on

FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of...more

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

Quarles & Brady LLP on

In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

Jones Day

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

Jones Day on

Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more

Epstein Becker & Green

SAMHSA Final Rule Regarding OTPs Expands Access, Increases Flexibility for Patients

Epstein Becker & Green on

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more

Quarles & Brady LLP

Key Considerations for Healthcare Providers Responding to Law Enforcement Requests

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Why is everyone talking about provider disclosures to law enforcement of late? The Senate Finance Committee authored a letter to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), outlining...more

Quarles & Brady LLP

California Follows the Lead of Other States in Heightening the Scrutiny of Health Care Transactions

Quarles & Brady LLP on

California is taking steps to broaden its regulatory oversight of health care related transactions, joining a growing list of states that have recently either attempted to or have been successful in enacting similar...more

Arnall Golden Gregory LLP

In Through the Out Door: FDA Issues Guidance on Its Importation of Prescription Drugs Final Rule

Arnall Golden Gregory LLP on

Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity...more

King & Spalding

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

King & Spalding on

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more

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