News & Analysis as of

Pharmaceutical Industry Office of Civil Rights

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - March 2024 #3

News Briefs - New HHS Task Force Aims to Oversee AI in Healthcare - Details are emerging on a new HHS task force faced with a monumental task: creating a regulatory structure to oversee utilization of artificial intelligence...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #2

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more

McDermott+

McDermottPlus Check-Up: February 9, 2024

McDermott+ on

House Passes Legislation to Prohibit Use of QALYs in All Federal Health Programs. The House passed H.R. 485, the Protecting Health Care for All Patients Act of 2023, a bill designed to prohibit the use of QALYs and similar...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2023 #4

News Briefs - 2024 FDA Guidance Likely to Include AI, Cybersecurity - The Food and Drug Administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for its 2024 financial...more

McGuireWoods Consulting

Washington Healthcare Update - September 2023 #2

This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to...more

Burr & Forman

Hot Topics in Health Care July 2023  

Burr & Forman on

Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more

Mintz - Health Care Viewpoints

Recap of Our Health Law and Policy Year-in-Review Posts for 2019

Over the past month or so, our Health Care Team has published a number of posts examining important developments and trends in health law and policy during 2019, as well as providing some thoughts on what we expect to see in...more

McDermott Will & Emery

Healthcare Enforcement Quarterly Roundup | Q2 2019

McDermott Will & Emery on

In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts...more

K&L Gates LLP

K&L Gates Triage: Triage in 2018: Health Care Topics to Watch in the New Year

K&L Gates LLP on

We expect 2018 to be another year of rapid change within the health care industry. In this episode, Mary Beth Johnston highlights some of the key topics that the health care practice group will monitor in the coming year,...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

Holland & Knight LLP

Healthcare Law Update: June 2017

Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...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

Cooley LLP

Blog: Colorado Pharmacy Reaches HIPAA Settlement with OCR Following Improper Records Disposal

Cooley LLP on

Yesterday, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that Cornell Prescription Pharmacy of Denver, Colorado (“Cornell Pharmacy”) has agreed to settle potential violations of...more

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