Covered Entities

News & Analysis as of

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

HIPAA Data Breaches

HIPAA has been on the books since 1996. With the advent of electronic health records, HHS adopted security regulations to require covered entities to protect the integrity, confidentiality, and availability of electronic...more

Promises of Enhanced HIPAA Enforcement by HHS Illustrated by a Recent Record-Breaking Settlement Agreement and Increased Focus on...

An attorney from the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) recently disclosed that covered entities could face increased scrutiny for HIPAA violations in 2014. Specifically, the...more

HHS to Continue Enforcing Orphan Drug Exclusion from 340B Program

The Department of Health and Human Services (HHS) through its Office of Health Resources and Services Administration (HRSA) announced last week that, although a court recently struck down its regulation addressing application...more

HIPAA/HITECH Business Associate Agreements: The Home Stretch

The one-year transition rule expires on September 22, 2014. The final regulations under the HIPAA Privacy, Security, and Enforcement Rules as amended by HITECH, make several changes, including modifying the...more

Health Law Alert: The Deadline for Amending Business Associate Agreements is Quickly Approaching

A key change from 2013’s HITECH “Omnibus” Rule was a requirement that Business Associate Agreements (“BAAs”) be modified to reflect revisions to HIPAA regulations. When the rule was issued on January 25, 2013, Covered...more

Proposed Federal-Contractor "Minimum Wage" Regulations Released

The U.S. Labor Department has released its proposed regulations implementing Executive Order 13658, President Obama's directive to raise the minimum-wage rate for workers on federal contracts from $7.25 per hour to $10.10 per...more

Health Law Alert: HIPAA Enforcement on the Rise, as OCR Audit Program Moves Forward

A recent settlement from New York—involving the largest fine levied to date in the history of HIPAA enforcement, a staggering $4.8 million imposed on two public hospitals—should remind health care providers, health plans and...more

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

Federal Court Vacates 340B Rule Regarding Orphan Drugs

On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. At...more

340B Drug Discount Program Orphan Drug Rule Vacated: ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs...

The D.C. District Court permanently enjoined the U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan...more

Policyholders Face Heightened Scrutiny Under OCR’s New Permanent Audit Program

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) has notably increased enforcement of compliance with the Health Insurance Portability and Accountability Act (“HIPAA”) and Health Information...more

50 for 50: Five Decades of the Most Important Discrimination Law Developments: Number 2: In 1972, The Law Expands and the EEOC...

Title VII of the Civil Rights Act of 1964 obviously broke new ground but advocates of the law recognized the immediate need to expand its scope and authority. After three unsuccessful attempts and eight years, Congress...more

Thinking Outside the HIPAA Box

On Wednesday, May 7, the Federal Trade Commission (FTC) held the third of its Spring Seminars on emerging consumer privacy issues. This session focused on consumer-generated health information (CHI). CHI is data generated...more

Two Health Care Organizations Pay Largest HIPAA Fine at $4.8 Million Resulting from Unsecured Shared Network

New York-Presbyterian Hospital and Columbia University entered into a settlement with the Department of Health and Human Services’ Office of Civil Rights (OCR) to resolve allegations that the organizations had violated the...more

$4.8 Million – Largest HIPAA Settlement to Date

On May 7, 2014, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) issued a press release announcing that two health care organizations—New York and Presbyterian Hospital (“NYP”) and Columbia...more

Server Breach Makes ePHI Accessible on Google, Costs Covered Entities $4.8 Million

It would be pretty unsettling if your patient status, vital signs, medications, and laboratory results were available for the world to see on Google, wouldn’t it? According to recent settlement agreements announced by the...more

Florida Legislature Passes Stringent New Data Breach Law

On April 30, the Florida Legislature passed Senate Bill 1524, otherwise known as the Florida Information Protection Act of 2014. If signed by the governor, starting July 1, this bill will impose stringent new requirements on...more

Coming Fall 2014: HHS Launches Permanent Audit Program

Beginning in the Fall of 2014, a substantial number of covered entities and business associates will receive a notification and data request from the Health and Human Services' (HHS) Office for Civil Rights (OCR). According...more

Theft Of Unencrypted Laptops Leads To Two HHS Settlements Totaling Nearly $2 Million

On April 22, the U.S. Department of Health and Human Services (HHS) announced settlements with both Concentra Health Services (Concentra) and QCA Health Plan, Inc. (QCA). Through these latest settlements, HHS is reiterating...more

A Many-Headed Hydra

The notorious regulation technically took effect on April 1. Covered entities must now pay closer attention to how they structure their trading activities, and their investments in fund-type vehicles. Perhaps not...more

Minimum Necessary and the Breach Standard

When the new HITECH rules came out OCR specifically said, “...uses or disclosures that impermissibly involve more than the minimum necessary information...may qualify as breaches.” But what exactly is the minimum necessary...more

OCR Announces the Results from it's Pilot Audit and it's Plans For Next Year

The Office of Civil Rights Audit Pilot Program has come to an end with 115 audits, primarily in person, having been completed. The Pilot Program had multiple revelations in privacy, some of which were probably, not so...more

Free HIPAA Help

Health care providers, health plans, business associates, and other entities affected by the federal HIPAA privacy and security regulations are quickly running out of excuses for not having a robust HIPAA compliance program...more

Future OCR Audits Have Little in Common With Previous Round—Here’s How to Prepare

The HHS Office for Civil Rights (OCR) recently presented information about the new look of its Phase 2 audit program. The new audits will look little like the old ones, with OCR conducting the audits itself and focusing on...more

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