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

Second CMP Assessed for HIPAA Violations: Do You Know Where Your Data Is?

For only the second time in its history, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has imposed a civil money penalty (CMP) on a covered entity for allegedly violating the HIPAA...more

HIPAA Privacy Regulations Amended to Allow Disclosures of Mental Health Information for Firearm Background Checks

On January 4, 2016, the Department of Health and Human Services (HHS) modified the HIPAA Privacy Rule to expressly permit certain covered entities to disclose to the National Instant Criminal Background Check System (NICS)...more

Health Care: HIPAA Covered Entities - Your Organization’s Liability after a Cyber-Attack (12/15)

It is difficult for companies to manage the rapidly evolving legal landscape of cybersecurity. All companies, no matter the size, are potential targets for a cyber-attack. A common question posed by concerned In-House...more

HIPAA and Text Messaging

Text messaging is pervasive. Doctors and other health care providers, covered entities, and business associates currently use (and embrace) the technology. Texting is easy, fast and efficient. It doesn’t require a laptop...more

OCR Audits to Begin in 2016

Beginning in 2016, the United States Department of Health and Human Services’ Office for Civil Rights (OCR) will conduct another round of audits to gauge compliance with privacy provisions in the Health Insurance Portability...more

HHS’ Selection of Contractor Provides Latest Update on Impending Second Round of HIPAA Audits

On October 27, 2015, a U.S. Department of Health and Human Services (“HHS”) official stated that the agency has hired FCi Federal, a provider of management and professional services to government agencies in Ashburn, VA, to...more

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

Alphabet Soup and Data Security

In the span of two days, mobile device users learned of two data breaches that could compromise their personal data. In one, Experian (a credit reporting agency) reported that it was hacked, potentially putting 15 million...more

HHS Releases Far-Reaching Proposed Rule to Prohibit Discrimination by “Covered Entities” Pursuant to Section 1557 of the...

On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule titled “Nondiscrimination in Health Programs and Activities” (“Proposed Rule”)[1] to implement the nondiscrimination...more

Privacy, Security, Risk: What You Missed At IAPP Conference

Earlier this month, privacy and security professionals from around the globe gathered for “Privacy. Security. Risk. 2015”—the second joint conference between the International Association of Privacy Professionals and the...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Is Your HIPAA Compliance Program Ready for the FTC?

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

Reports Instruct Office of Civil Rights to Increase HIPAA Enforcement Activities

On September 29, 2015, the Office of Inspector General (OIG) released two reports that reviewed the Office of Civil Rights’ (OCR) enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The...more

Blog: HHS To Launch New HIPAA Audits in Early 2016 in Response to OIG Reports

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

HHS Proposes Rules for Nondiscrimination in Health Care

On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) proposed new regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). Section 1557 prohibits...more

Cure of Security Rule Violations Following Breach of EPHI Cannot Save Covered Entities from $750,000 Settlement; Non-Breach...

More than three years after the Cancer Care Group, P.C. (“CCG”) notified the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) of a breach of unsecured electronic protected health...more

Don’t Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called “Phase 2 Audits” are set to commence...more

Don't Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called "Phase 2 Audits" are set to commence...more

$750,000 HIPAA Settlement Reinforces Need to Be Proactive

As the Department of Health and Human Services’ (“HHS”) Office of Civil Rights (“OCR”) proceeds with its second round of HIPAA audits, this time covering business associates as well as covered entities, a recent settlement...more

340B Guidance: Eight Key Points Covered Entities Should Consider

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

Nondiscrimination in Health Programs and Activities: Proposed Rules from HHS

...So, why did HHS need over five years to propose the set of rules published September 8? Here are a few highlights. For brevity’s sake, we omit foreign language service requirements, disability accommodation, compliance...more

Drastic Changes in "Patient" Definition as HHS Releases the Long-Awaited Proposed 340B Omnibus Guidance

After years of fits and starts, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) has finally released its proposed omnibus guidance for the 340B Drug Discount...more

$750,000 Settlement Agreement Reiterates Importance of HIPAA Security Rule Compliance

On September 2, 2015, the U.S. Department of Health and Human Services ("HHS") announced that it had entered into a Settlement Agreement with an Indiana-based medical practice for alleged violations of the Health Insurance...more

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