News & Analysis as of

Covered Entities Trump Administration

Holland & Knight LLP

U.S. Health Data Affected by New National Security Restrictions on International Data Transfers

Holland & Knight LLP on

Health Insurance Portability and Accountability Act (HIPAA)-covered entities and business associates should be familiar with restrictions on the use or disclosure of protected health information (PHI) under HIPAA rules....more

Health Care Compliance Association (HCCA)

Former OCR Director Fontes Rainer Reflects On ‘Imperfect’ RSP Law, Urges Final Security Reg

In October, the HHS Office for Civil Rights (OCR) fined Providence Medical Institute (PMI) $240,000, an amount that reflected a 20% discount for having “recognized security practices” (RSPs) in place. But many more covered...more

Health Care Compliance Association (HCCA)

$1.5M Warby Parker Fine a Holdover; OCR Focuses On Men in Sports, Antisemitism, ‘Biological Truth’

Nearly six years to the day that Warby Parker reported a breach affecting nearly 200,000 individuals, the HHS Office for Civil Rights (OCR) imposed a $1.5 million fine on the eyewear giant. Investigated by OCR under the Biden...more

ArentFox Schiff

HIPAA Reproductive Privacy Rule Takes Effect Amid Legal and Political Uncertainties

ArentFox Schiff on

As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more

Vinson & Elkins LLP

Proposed Cybersecurity Regulation Uncertain Under Trump Administration

Vinson & Elkins LLP on

Proposed cybersecurity regulation may face changes or challenges in view of the incoming Trump administration that is intent on reducing the perceived regulatory burden on American companies and streamlining government...more

Mintz - Health Care Viewpoints

HIPAA Amendments and Other Trump Regulatory Actions on Hold

In the waning days of the Trump administration, the Office for Civil Rights (“OCR”) announced a number of new initiatives, including proposed HIPAA amendments, and a very recent COVID-19 related Notice of Enforcement...more

Sheppard Mullin Richter & Hampton LLP

The 340B Drug Pricing Program: New CMS Final Rule Draws a Motion for Preliminary Injunction from Hospital Groups

On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more

Polsinelli

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

Polsinelli on

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

Hogan Lovells

HRSA Releases Ceiling Price and CMP Final Rule

Hogan Lovells on

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

Fisher Phillips

Federal Judge Blocks Transgender Protections

Fisher Phillips on

On Saturday, December 31, 2016, a federal judge in Texas entered a nationwide preliminary injunction barring the enforcement of antidiscrimination protections pertaining to transgender and abortion health services and...more

K&L Gates LLP

What a Trump Administration Could Mean for the 340B Drug Program

K&L Gates LLP on

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

Epstein Becker & Green

Five Key Issues Impacting Health Care Employers

Epstein Becker & Green on

Employers in the health care industry are likely to face significant changes under President-elect Donald J. Trump’s administration and should expect a healthy dose of uncertainty for the next few months. During his campaign,...more

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