Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent...more
Key Points - Congress is increasing oversight and legislative activity related to the role of private equity in health care. Sen. Markey and Rep. Jayapal jointly introduced the Health Over Wealth Act on July 25, which aims to...more
8/9/2024
/ Health Care Providers ,
Healthcare ,
Investment ,
Lease Back Transactions ,
No Surprises Act (NSA) ,
Private Equity ,
Proposed Legislation ,
Regulatory Oversight ,
REIT ,
Reporting Requirements ,
Transparency
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
Congress is taking a closer look at business practices in the health care sector and considering bipartisan reforms in light of increasing consolidation and its perceived affects on patient access and affordability. Various...more
On January 21, 2020, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was published in the Federal Register. Despite speculation that the publication timeline would be altered when the...more
3/3/2021
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Proposed Rules
Today, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was posted for public inspection on the Federal Register website. The rule is scheduled to be published in the Federal Register on...more
Key Points
- Enacted as part of the 2021 NDAA, the Act will require companies with no prior anti-money laundering reporting requirements to submit beneficial ownership information to FinCEN.
- FinCEN must issue...more
- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule.
- HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more
9/15/2020
/ Administrative Review ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Guidance Documents ,
Judicial Review ,
Notice of Proposed Rulemaking (NOPR) ,
Proposed Rules ,
Public Comment ,
Regulatory Agencies ,
Request For Information ,
Rulemaking Process
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
On September 4, 2019, the Federal Trade Commission (FTC or the “Commission”) announced a settlement with YouTube and its parent Google that resolves allegations that the companies violated the Children’s Online Privacy...more
9/10/2019
/ COPPA ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Trade Commission (FTC) ,
Google ,
Mobile Apps ,
Online Safety for Children ,
Parental Consent ,
Personally Identifiable Information ,
Privacy Policy ,
Settlement ,
Settlement Offer ,
Statutory Penalties ,
Statutory Violations ,
Website Owner Liability ,
Websites ,
YouTube
• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny.
• Conducting effective legal and regulatory due diligence can mean uncovering risks...more
5/2/2019
/ Acquisitions ,
Anti-Kickback Statute ,
Due Diligence ,
False Claims Act (FCA) ,
Health Care Providers ,
Investors ,
Life Sciences ,
Medicaid ,
Mergers ,
OIG ,
Patient Referrals ,
Private Equity ,
Provider Payments ,
Safe Harbors ,
Sunshine Act ,
TRICARE ,
Venture Capital
As we previously reported, on March 21, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) launched the long-awaited Phase 2 of the audit program that is intended to assess compliance with...more