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Pharmaceutical Industry Medical Records

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Fox Rothschild LLP

Veterinary Medicine, Pet Products And Cannabis

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As a veterinarian, if a pet-owner comes to you with questions or concerns about the safety of hemp or CBD infused pet products, are you prepared to navigate the conversation? Practicing veterinarians are subject to the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

K&L Gates LLP

K&L Gates Triage: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

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In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more

K&L Gates LLP

K&L Gates Triage: Modernizing Confidentiality Rules for Substance Use Disorder Records (Again): 2019 Proposed Changes to 42 CFR...

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This week’s episode is the second in an ongoing series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic & the Confidentiality of Substance Use Disorder Records: an Update on 42 CFR Part 2 - Part 1...

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This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more

McDermott Will & Emery

SAMHSA Proposed Rule Would Reduce Barriers to Care Coordination

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SAMHSA has released a long-awaited proposed rule that would modify the federal regulations at 42 CFR Part 2 (Part 2) governing the confidentiality of substance use disorder (SUD) patient records created by federally assisted...more

Proskauer Rose LLP

HHS and SAMHSA Issue a Proposed Rule to Ease Coordination of Care for Patients with Substance Use Disorders

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On August 26, 2019, the U.S. Department of Health and Human Services ("HHS") and the Substance Abuse and Mental Health Services Administration ("SAMHSA") issued a proposed rule amending the regulations governing the...more

Mintz - Health Care Viewpoints

Part 2 Proposed Rule Brings Clarity and Reduces Regulatory Burdens for Substance Use Disorder Providers, but Challenges Remain

On August 22, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) announced a new proposed rule (the “Proposed Rule”) amending 42 CFR part 2 (“Part 2”), which is aimed at protecting patient records...more

Bass, Berry & Sims PLC

Proposed Changes Affect Privacy Protections of Patients Seeking Substance Use Disorder Treatment

On August 22, 2019, providers and other health industry participants involved in the provision of substance use disorder (SUD) services got some welcome news in the form of proposed regulatory changes. The U.S. Department of...more

ArentFox Schiff

CMS Releases CY 2020 Proposed Physician Fee Schedule

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The Centers for Medicare and Medicaid Services (CMS) recently released the CY 2020 Proposed Physician Fee Schedule....more

MoFo Tech

Transforming the U.S. Healthcare Industry with Blockchain Technology

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Patients accumulate vast quantities of healthcare data over the course of their lives. Those data are generally housed in centralized servers operated by various unrelated industry participants, including government...more

Sheppard Mullin Richter & Hampton LLP

Blog Series: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit,...

On October 26, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released for viewing a proposed rule that includes significant changes for Medicare Advantage organizations (“MAOs”), Part D prescription drug plan...more

Troutman Pepper

Negotiating the Tension Between Transparency and Privacy

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Making individual patient-level data available for other research presents companies with challenges, but researchers and companies can take steps to minimize the risks. Originally published in Drug and Medical Device,...more

Mintz - Health Care Viewpoints

Warner Chilcott HIPAA Lesson Revisited – Mass. Physician Convicted of Criminal Violation

Back in late 2015, we blogged about the interesting twist in the $125 million Warner Chilcott settlement that a Massachusetts physician had been criminally charged with violating the Health Insurance Portability and...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Mintz - Health Care Viewpoints

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

Mintz - Health Care Viewpoints

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

Mintz - Health Care Viewpoints

Data Breach Nightmare Scenario: News Affiliate Reports Improper Disposal of Patient Information

A tip from a local Denver news outlet lead to a compliance review, investigation and ultimately a resolution agreement between the Department of Health and Human Services’ Office for Civil Rights (“OCR”) and Denver-based...more

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