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 -
News & Analysis as of

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

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

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

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

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

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

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

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

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

AGG Food and Drug Newsletter - December 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Legal Update on Select Health and Welfare Plan Issues

In a presentation to the Silicon Valley Employers Forum, Susan M. Nash discussed recent updates to select health and welfare plans while outlining some potential issues. The agenda included changes to exchange notices,...more

HHS OCR Levies Significant HIPAA Penalties in a Series of Recent Settlements: Covered Entities and Business Associates Alike...

Between June and November 2016, the Department of Health and Human Services Office of Civil Rights (HHS OCR) has announced seven high-dollar settlements to resolve alleged violations of the HIPAA privacy, security, and breach...more

No Phishing: OCR Warns of Phishing Attempts Disguised as Official HIPAA Audit Program Emails

What’s worse than receiving an email indicating that you have been selected for an audit by your favorite government regulator? Clicking on a link in the email and discovering that it is a phishing attack that has just...more

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

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

Five Key Issues Impacting Health Care Employers

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

The Clock Is Ticking – ACA Nondiscrimination Rules Will Take Effect January 1

Earlier this year, the Department of Health and Human Services (HHS) and the Office of Civil Rights (OCR) published a final rule to implement Section 1557 of the Affordable Care Act (ACA). Most prominently, this rule...more

OCR Issues Alerts Regarding Phishing Email Disguised as Official OCR Audit Communication

The HHS Office for Civil Rights (OCR) published an alert on November 28 describing a phishing email being circulated on mock HHS departmental letterhead under the signature of OCR Director Jocelyn Samuels. The email prompts...more

HHS Issues Warning About Phishing Campaign Disguised As Official Communication

As part of its efforts to assess compliance with the HIPAA Privacy, Security and Breach Notification Rules, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) engages in audits of covered...more

Additional Clarification regarding HHS OCR Phishing Email Alert

More information from HHS OCR about the phishing threat... ..On November 28, 2016, the HHS Office for Civil Rights issued a listserv announcement warning covered entities and their business associates about a phishing...more

OCR Alerts Listservs About Fake Phishing Email to Covered Entities and Business Associates

On November 28, 2016, the Office for Civil Rights (OCR) issued an Alert to its listservs that a phishing email is being circulated on “mock HHS Departmental letterhead under the signature of OCR”s Director, Jocelyn Samuels”...more

OCR Issues Alert Regarding Phishing Email Disguised as Official OCR Audit Communication

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Nov. 28 describing a phishing email being circulated on mock HHS departmental letterhead under the signature of OCR...more

HHS OCR Alert: Phishing Email Disguised as Official OCR Audit Communication

This alert just in from HHS OCR: “It has come to our attention that a phishing email is being circulated on mock HHS Departmental letterhead under the signature of OCR’s Director, Jocelyn Samuels. This email appears to...more

OCR Warns of Phishing Campaign Disguised as Official OCR Communication

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Monday describing a phishing campaign disguised as an email from OCR. The email is being circulated on mock HHS...more

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