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
- 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