News & Analysis as of

Covered Entities Compliance

Health Care Compliance Association (HCCA)

Former OCR Director Fontes Rainer Reflects On ‘Imperfect’ RSP Law, Urges Final Security Reg

In October, the HHS Office for Civil Rights (OCR) fined Providence Medical Institute (PMI) $240,000, an amount that reflected a 20% discount for having “recognized security practices” (RSPs) in place. But many more covered...more

Ankura

HIPAA Security Risk Analysis – How should regulated entities prepare for the Office for Civil Rights (OCR) Risk Analysis Audit...

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Following the Office for Civil Rights (OCR) recent publication of four settlements as part of a new Risk Analysis Audit Initiative. We explore the current regulatory language for Risk Analysis, the proposed language for Risk...more

Davis Wright Tremaine LLP

Deadline Approaching: Covered Entities Must File Certifications of Compliance With Amended NYDFS Cyber Regulation by April 15

In November 2023, the New York Department of Financial Services (NYDFS) issued its second amendment to its "Cybersecurity Requirements for Financial Services Companies (the Cybersecurity Regulation or Part 500). This was the...more

Holland & Hart LLP

E-mailing and Texting PHI: Beware HIPAA

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The HIPAA Privacy and Security Rules require covered entities (including healthcare providers and health plans) and their business associates to protect patient information stored or transmitted electronically, including...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

Holland & Knight LLP

Proposed HIPAA Security Rule Shifts Warrant Study and Comment

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The U.S. Department of Health and Human Services (HHS) has issued a Notice of Proposed Rulemaking (NPRM) that strengthens the Security Rule of the Health Insurance Portability and Accountability Act (HIPAA), which, if...more

BCLP

Corporate Transparency Act Update: FinCEN Asks SCOTUS to Intervene

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As previously reported, on December 26, 2024, the Fifth Circuit first lifted—and then reinstated—a preliminary nationwide injunction staying the Corporate Transparency Act’s (“CTA”) reporting requirements pending appeal....more

Hinch Newman LLP

DOJ Issues Rule Addressing Threat Posed by Foreign Adversaries’ Access to Americans’ Sensitive Personal Data

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On Friday, December 27, 2024, the Justice Department issued a final rule to address “urgent national security risks posed by access to U.S. sensitive personal and government-related data from countries of concern and covered...more

BCLP

California Amends Its Sweeping Venture Capital Demographic Reporting Rule

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Last year, as we previously reported, California Governor Newsom signed into law Senate Bill 54, Fair Investment Practices by Investment Advisers, which requires “covered entities,” defined as a “venture capital company” that...more

Stevens & Lee

Compliance Deadline Imminent: HIPAA Final Rule to Support Reproductive Health Care Privacy

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Around the corner is the Dec. 23 deadline to have your organization bring its HIPAA Notice of Privacy Practices into compliance with the U.S. Department of Health & Human Services’ Office for Civil Rights Final Rule modifying...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

BakerHostetler

A New Budgetary Line Item for 2025 - New York-based Hospitals Should Plan Now for the Fiscal and Operational Costs Associated with...

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On October 2, the New York State Department of Health (NYSDOH) issued new cybersecurity regulations (Regulations) for all general hospitals in New York state (“hospitals”), creating a new Section 405.46 in Title 10 (Health)...more

Holland & Knight LLP

HIPAA Tidings: A Look at OCR's Recent Enforcement Actions

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In addition to holiday celebrations, the month of December typically ushers in a final round of enforcement actions by the U.S. Department of Health and Human Services' (HHS) Office of Civil Rights (OCR), and 2024 is no...more

King & Spalding

End of Year Compliance Updates

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On June 25, 2024, the Office for Civil Rights and the U.S. Department of Health and Human Services issued the HIPAA Privacy Rule To Support Reproductive Health Care (the “HIPAA Final Rule”) aimed at strengthening privacy...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - January 27th - 30th, Orlando, FL

HCCA's Healthcare Privacy Compliance Academy is a three-and-a-half-day interactive education program with a focus on the vast body of privacy laws and regulations in place to help you protect PHI and other critical data. Our...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

Ogletree, Deakins, Nash, Smoak & Stewart,...

Justice Department Rule on Accessible Medical Diagnostic Equipment Carries Broad Implications for Healthcare Industry

The U.S. Department of Justice (DOJ) recently published a final rule on the accessibility of medical diagnostic equipment (MDE) and other accessibility-related practices that promises to have broad impact on the health care...more

BakerHostetler

6 Important Takeaways for HIPAA Covered Entities and Business Associates from 2024 NIST HHS OCR Conference

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On October 23-24, 2024, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) Information Technology Laboratory hosted the Safeguarding...more

Winstead PC

HIPAA Gets a Potential Counterpart in HISAA

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Americans hear about cybersecurity incidents on a frequent basis. As the adage goes, it is not a matter of “if” a breach or security hack occurs; it is a matter of “when.”...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 & Knight LLP

Safeguarding Health Information: Takeaways from HHS and NIST 2024 HIPAA Security Conference

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President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more

Goodwin

NYDFS Publishes Guidance on AI-Related Cybersecurity Risks

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On October 16, 2024, the New York State Department of Financial Services (NYDFS or the “Department”) published an industry letter (the “Guidance”) regarding the increased reliance on artificial intelligence (AI) and the...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)

2nd Settlement Triggered by 2017 Ransomware Attack Costs WA Practice $100K; ‘Not a Breach’

Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more

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