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Department of Health and Human Services (HHS) Drug & Alcohol Abuse

Quarles & Brady LLP

New Rules Relating to Confidentiality of Substance Use Disorder Patient Records

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On April 16, 2024, the U.S. Department of Health and Human Services (HHS) finalized a rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records (the Final Rule) codified at 42 C.F.R. Part 2 (Part 2)....more

Venable LLP

Sharing of Addiction Treatment Records Gets Biden HHS Overhaul

Venable LLP on

After a nearly two-year delay, the U.S. Department of Health & Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights, promulgated a Final Rule...more

Manatt, Phelps & Phillips, LLP

Changes to the Substance Use Disorder Confidentiality Regulation: Implications for Stakeholders

Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more

Robinson+Cole Health Law Diagnosis

HHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use...

On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder...more

Brownstein Hyatt Farber Schreck

Part 2 Redo: HHS Issues Rulemaking on SUD Privacy Laws

For years, federal privacy laws relating to substance abuse disorder (SUD) treatment records have differed in significant ways from federal privacy laws relating to other medical records. Changes, however, are afoot. Almost...more

Mintz - Health Care Viewpoints

HHS Further Amends 42 CFR Part 2, Easing Some, But Not All, Burdens on Substance Use Disorder Treatment Providers

The U.S. Department of Health and Human Services (HHS) recently released a final rule further amending 42 CFR Part 2 regulations (Part 2) to allow greater sharing of patient records related to substance use disorder (SUD)...more

Bass, Berry & Sims PLC

OHRP Releases Guidance for Institutions Conducting Human Subjects Research During COVID-19

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The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Manatt, Phelps & Phillips, LLP

Using Presidential Power to Address the Opioid Epidemic

Increased prescribing of opioid medications over the course of nearly two decades has led to widespread misuse of both prescription and nonprescription opioids. In 2018 alone, 10.3 million people misused prescription opioids,...more

Searcy Denney Scarola Barnhart & Shipley

Has Big Tobacco Found a New Appeal to Our Youth? - E-cigarettes

The home page of a Web site dedicated to disclosing the dangers of e-cigarettes features a pensive picture of a Justin Bieber-esque teen who possibly could be thinking about taking a puff off a Juul device. The site,...more

Wilson Sonsini Goodrich & Rosati

FDA Prioritizes Review Generic Drug Products to Treat Opioid Overdose

Introduction: The Opioid Crisis - Every day in the United States, more than 130 people die after overdosing on opioids, such as prescription pain relievers, heroin, and fentanyl. These deaths are part of the ongoing,...more

Arnall Golden Gregory LLP

HHS OCR Launches Public Education Campaign on Nondiscrimination and the Opioid Crisis

In response to the national opioid crisis, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has launched a public education campaign on the civil rights protections surrounding...more

Bass, Berry & Sims PLC

Congress Takes Action to Curb the Opioid Crisis

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In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24,...more

Sheppard Mullin Richter & Hampton LLP

Congress Passes “SUPPORT for Patients and Communities Act” — A Rare Example of Bi-Partisanship

In a September 14, 2018 Proclamation, President Donald Trump announced that the week of September 16 through September 22, 2018 would be Prescription Opioid and Heroin Epidemic Awareness Week (“Awareness Week”). As described...more

Harris Beach PLLC

With Marijuana Still Illegal in U.S., Personal Use or Involvement in Cannabis Industry Can Affect Entry at Border

Harris Beach PLLC on

As the legal landscape of marijuana use shifts in both the United States and Canada, new questions arise as to the impact of drug use on admission to the United States. Currently, under both U.S. and Canadian federal law,...more

Bradley Arant Boult Cummings LLP

'Opioids and Legal Enforcement — A Primer' - HarrisMartin's Drugs & Medical Devices

The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more

Knobbe Martens

The FDA's Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

Knobbe Martens on

On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including...more

Foley & Lardner LLP

Health Care Policy Newsletter - May 2018 pt 3

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly Health Care Newsletter” in which we compile the latest health care policy news and legislation....more

K&L Gates LLP

K&L Gates Triage: Opioid Epidemic: Recent HIPAA Guidance – What Does It Mean?

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In the second episode of our series on the national opioid crisis, Gina Bertolini discusses the overlay of recent guidance concerning privacy laws such as the Health Insurance Portability and Accountability Act (HIPAA) and...more

BakerHostetler

Capitol Hill Healthcare Update

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CONGRESS RECONVENES WITH FOCUS ON OPIOID LEGISLATION - Congress reconvenes today after a weeklong recess, and a House subcommittee is scheduled to begin a series of hearings focusing on bipartisan efforts to combat the opioid...more

Baker Donelson

Opioid Epidemic Continues to Worsen

Baker Donelson on

Health care stakeholders, the Administration, and Congress are likely to continue responding to the worsening nationwide opioid abuse epidemic. Last October, President Trump declared a Nationwide Public Health Emergency to...more

Burr & Forman

Office of Civil Rights Issues Guidance on HIPAA in Light of Opioid Crisis

Burr & Forman on

With an increased focus on opioid use and addiction, the Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) has issued guidance related to the Health Insurance Portability and Accountability Act of...more

Baker Donelson

OIG Work Plan – October 2017 Update

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The OIG added five new items to its Work Plan with its October 2017 monthly update. This is a decrease from the nine new items added to the Work Plan with the September 2017 update. (For more information on last month's Work...more

McDermott Will & Emery

The Opioid Crisis: Declaring a National Emergency and the Effect on Remote Prescribing through Telemedicine

McDermott Will & Emery on

On July 31, 2017, President Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis recommended that he declare the opioid epidemic a national emergency. In August 2017 and again on October 16, 2017, the...more

Baker Donelson

OIG Work Plan – September 2017 Update

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Beginning in June 2017, the OIG began making monthly Work Plan updates. These monthly updates create some practical challenges for health care providers and compliance professionals trying to make operational and compliance...more

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