News & Analysis as of

Dept. of Health and Human Services Covered Entities

The United States Department of Health and Human Services is a federal executive department established in 1953, as part of the Department of Health, Education and Welfare. The Agency became independent in 1980... more +
The United States Department of Health and Human Services is a federal executive department established in 1953, as part of the Department of Health, Education and Welfare. The Agency became independent in 1980 and was renamed The Department of Health and Human Services at that time. HHS is charged with protecting and improving the health of the American population, as well as providing essential services.    less -

First HIPAA Settlement Involving a Wireless Health Services Provider

by Saul Ewing LLP on

?On April 24, 2017, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that CardioNet, Inc. (CNI) agreed to pay $2.5 million and enter into a Corrective Action Plan (CAP) to settle...more

Failure to Implement Business Associate Agreement Results in $31,000 Settlement For Health Care Provider

by Saul Ewing LLP on

On April 20, 2017, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Children’s Digestive Health (CDH) agreed to pay HHS $31,000 for its failure to have a business associate...more

Fate Uncertain for HHS’s Extension of ACA Discrimination Protections to Abortion & Gender Transition

by Genova Burns LLC on

In May 2016 HHS issued a final rule implementing the Affordable Care Act’s Section 1557 nondiscrimination provision, which applies to recipients of funding from HHS. The rule prohibits discrimination on the basis of gender...more

Recent HIPAA Privacy and Security Settlements and Lessons Learned

by Perkins Coie on

Although the fate of the Affordable Care Act remains undecided, enforcement of the HIPAA privacy and security regulations by the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services is ongoing,...more

OCR Identifies Continuing HIPAA Enforcement Issues, Areas of Future Guidance and Regulations

Last week the Health Care Compliance Association hosted its annual “Compliance Institute.” Iliana Peters, HHS Office for Civil Rights’ Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA...more

HHS Expected to Release Significant HIPAA Privacy Guidance This Year; Compliance Audits Proceed; Guide on Compliance Program...

by WilmerHale on

HIPAA privacy guidance, audits, and enforcement are continuing under the new Administration. On March 27, 2017, Iliana Peters, Senior Adviser for HIPAA Compliance and Enforcement at the US Department of Health and...more

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

by Baker Ober Health Law on

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...more

HIPAA for HR - Some Good News for Employers

by Foley & Lardner LLP on

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that was enacted to ensure protection of individuals’ protected health information (PHI). The Standards for Privacy of Individually...more

HIPAA Enforcement Update (October 2016 – January 2017)

by Locke Lord LLP on

Since October 2016, the Department of Health and Human Services, Office for Civil Rights (OCR) announced four settlement agreements to resolve allegations of Health Insurance Portability and Accountability Act (HIPAA)...more

HIPAA Small Breach Notification Due March 1: “In Like a Lion, Out Like a Lamb” if You Submit Timely

by Davis Wright Tremaine LLP on

March 1, 2017 is the date by which HIPAA covered entities must notify the U.S. Department of Health and Human Services Office for Civil Rights (OCR) of “small” breaches of unsecured protected health information that were...more

Tracking the Data Bandits

by Poyner Spruill LLP on

In the iconic western, Butch Cassidy and the Sundance Kid, Butch and Sundance are hard pressed to evade a posse led by the semi-mythical lawman, Joe Lefors, who is so adept that he manages to track them across solid rock. The...more

[Webinar] HIPAA in the Cloud – OCR Guidance on HIPAA and Cloud Service Providers - Jan. 31st, 1:00pm ET

by Davis Wright Tremaine LLP on

As the health care sector further embraces the benefits of cloud computing, numerous challenges have arisen with applying HIPAA to cloud computing services....more

HIPAA Breach? Notify Promptly or Face Significant Potential Fines from HHS OCR

by Arnall Golden Gregory LLP on

On January 9, 2017, the Department of Health and Human Services Office of Civil Rights (HHS OCR), which enforces the privacy requirements contained in Health Insurance Portability and Accountability Act (HIPAA), announced a...more

HHS Gets Agressive: HIPAA Audits from 2016

by Kiesewetter Law Firm on

HHS has become more aggressive with audits, and with increased penalties, covered entities and business associates simply cannot afford an audit on HIPAA rules and regulations. In March of 2016, HHS's Office for Civil Rights...more

340B Update: HRSA Finalizes 340B Pricing & Penalties for Drug Manufacturers

by K&L Gates LLP on

On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more

Federal Court Enjoins Part of ACA Final Non-Discrimination Rule

by BakerHostetler on

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide injunction in Franciscan Alliance, Inc. v. Burwell, N.D. Tex., No. 16-cv-108, holding that portions of the final rule issued...more

The Ball Dropped on New Year’s Eve for Some ACA Section 1557 Nondiscrimination Rules

Some employers may want to reconsider their approach to gender transition benefits after a federal court enjoined the U.S. Department of Health and Human Services (HHS) from enforcing its 2016 nondiscrimination regulations...more

Final Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

by McDermott Will & Emery on

The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more

Time is of the Essence When Reporting a Breach of PHI

The failure to timely report a breach of unsecured protected health information (PHI) has cost Presence Health (one of the largest health systems in Illinois) almost half of a million dollars. Earlier this month,...more

Healthcare Provider Obligations For Individuals With Limited English Proficiency

by Fisher Phillips on

This summer I wrote about the dangers of English-only policies in this age of multiculturalism. These policies tend to emerge more frequently in the healthcare workplace, the reason being – the provision of quality care is...more

Health Care Group News: Texas District Court Preliminarily Enjoins Partial Enforcement of Section 1557

by Murtha Cullina on

In May of last year, the United States Department of Health and Human Services ("HHS") enacted regulations implementing Section 1557 of the Affordable Care Act. These regulations aimed to enhance language assistance and...more

Federal Judge Blocks Transgender Protections

by 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

Portions of Section 1557 of the Affordable Care Act Enjoined by Texas Federal Court – Majority of Regulation Remains Intact.

In May 2016, the Office of Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“DHHS”) issued a Final Rule implementing Section 1557 of the Affordable Care Act (“ACA”). Section 1557 prohibits “covered...more

Looking Back at the HIPAA Resolution Agreements in 2016

by BakerHostetler on

In 2016, Health and Human Services’ (HHS) Office for Civil Rights (OCR), the enforcement arm for HIPAA, continued robust enforcement efforts. There were 12 reported resolution agreements (RA) in 2016. An RA is a settlement...more

21st Century Cures Act - HIPAA & Other Privacy Considerations

by Bass, Berry & Sims PLC on

On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more

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