News & Analysis as of

Covered Entities Healthcare Compliance

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...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

Epstein Becker & Green

Recent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook

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As Cyberattacks targeting the health care sector have continued to intensify over the past year, including ransomware attacks that have resulted in major data breaches impacting health care organizations, the protection of...more

Davis Wright Tremaine LLP

Whether Naughty or Nice, Compliance Deadline for HIPAA Reproductive Care Privacy Is Coming to Town

We just want to provide a friendly reminder that, before key staff depart for the holidays, HIPAA covered entities and business associates should finalize their compliance with the 2024 HIPAA amendments related to...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

Health Care Compliance Association (HCCA)

BAAs: If and when third parties receiving PHI for research qualify as BAs under HIPAA

A business associate agreement (BAA) is a written contract between a covered entity (CE) and a business associate (BA) that—among other requirements—(1) establishes the permitted and required uses and disclosures of protected...more

Holland & Hart LLP

Are You Ready for It? Section 1557's Upcoming Deadlines

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The Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) published its final rules implementing the anti-discrimination provisions under Section 1557 of the Affordable Care Act (“Final Rule”) on May...more

Health Care Compliance Association (HCCA)

HHS Abandons Appeal in Public Website Pixel Case, But CEs and BAs Should Expect Continued Scrutiny

The HHS Office for Civil Rights (OCR) has abandoned its appeal of a federal judge’s ruling overturning OCR’s guidance prohibiting covered entities (CEs) and business associates (BAs) from using the web-tracking technologies...more

Health Care Compliance Association (HCCA)

What does the HIPAA final rule regarding reproductive health information mean for your organization?

On April 26, 2024, the U.S. Department of Health and Human Service Office for Civil Rights issued a final privacy rule to support reproductive health privacy. The rule does not allow the sharing of reproductive health...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

ArentFox Schiff

OCR Finalizes HIPAA Privacy Rule to Support Reproductive Health Care Privacy

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On April 26, the US Department of Health and Human Services Office for Civil Rights (OCR) published a Final Rule that adds protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule...more

Health Care Compliance Association (HCCA)

11 Years After First Disclosure, L.A. Care Pays $1.3M, Says ‘Processing Errors’ Caused Breaches

Report on Patient Privacy 23, no. 10 (October, 2023) By 2016, it should have been clear to HIPAA covered entities that a security risk analysis—and corresponding risk management plan—were compliance basics. Yet, a new...more

Bilzin Sumberg

Alphabet Soup and Data Security

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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

Orrick, Herrington & Sutcliffe LLP

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

Womble Bond Dickinson

Is Your HIPAA Compliance Program Ready for the FTC?

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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

Saul Ewing LLP

Reports Instruct Office of Civil Rights to Increase HIPAA Enforcement Activities

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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

Robinson+Cole Data Privacy + Security Insider

OCR announces launch of Phase 2 of HIPAA audits

Although the Office for Civil Rights (OCR) has indicated in the past that it would start its next round of HIPAA audits, apparently it means business now. In the wake of an Inspector General report that the OCR was merely...more

Holland & Knight LLP

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

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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

K&L Gates LLP

HHS Proposes Rules for Nondiscrimination in Health Care

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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

Orrick, Herrington & Sutcliffe LLP

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

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

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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

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Saul Ewing LLP

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

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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

Robinson+Cole Data Privacy + Security Insider

HHS issues fact sheet on HIPAA rules and resources

The Department of Health and Human Services (HHS) has released a fact sheet on the privacy, security, and breach notification rules of the Health Insurance Portability and Accountability Act (HIPAA). Designed to apply to...more

Holland & Knight LLP

Free HIPAA Help

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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

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