News & Analysis as of

Risk Management Department of Health and Human Services (HHS) Healthcare

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Alston & Bird

New York Department of Health Issues Urgent Cybersecurity Warning Following U.S. Strikes on Iranian Nuclear Facilities

Alston & Bird on

The New York State Department of Health has issued an urgent cybersecurity advisory (the Advisory) warning of increased threat levels and a higher likelihood of cybersecurity attacks from Iranian state-backed actors following...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

BakerHostetler on

On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Epstein Becker & Green

Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...more

Warner Norcross + Judd

OCR Enforcement Intensifies: Key Takeaways on Risk Analysis and Right of Access

Warner Norcross + Judd on

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has renewed its focus on two critical areas of HIPAA compliance: risk analysis and individual right of access. These enforcement...more

McDermott Will & Schulte

FDA, OHRP Issue Joint Guidance on Collection of Tissue Biopsies in Clinical Trials

On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

Frost Brown Todd on

In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

Dentons on

Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more

Bradley Arant Boult Cummings LLP

HHS’s Proposed Security Rule Updates Will Require Adjustments to Accommodate Modern Vulnerability and Incident Response Issues

In this week’s installment of our blog series on the U.S. Department of Health and Human Services’ (HHS) HIPAA Security Rule updates in its January 6 Notice of Proposed Rulemaking (NPRM), we are exploring the proposed updates...more

Stotler Hayes Group, LLC

CMS Cracks Down on Responsible Party Liability in LTC Admission Agreements

A nursing facility that participates in the Medicaid or Medicare programs may not require a third party to guarantee payment for a resident’s admission or continued stay. However, facilities are allowed to require a resident...more

Kerr Russell

The Difference Between ‘Non-Covered’ vs. ‘Disallowed’ Services

Kerr Russell on

Question: I have had several colleagues describe their experience with dental plan audits. All of them have had to pay something back. Sometimes they say this is due to a service being deemed a “noncovered service.” Other...more

Baker Donelson

OCR Issues "Dear Colleagues" Letter Regarding AI in Medicine

Baker Donelson on

On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more

Foley & Lardner LLP

New Artificial Intelligence (AI) Regulations and Potential Fiduciary Implications

Foley & Lardner LLP on

Fiduciaries should be aware of recent developments involving AI, including emerging and recent state law changes, increased state and federal government interest in regulating AI, and the role of AI in ERISA litigation. While...more

Ballard Spahr LLP

HHS Proposes Significant Updates to HIPAA Security Rule

Ballard Spahr LLP on

On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more

Foley & Lardner LLP

HHS Proposes Changes to Strengthen HIPAA Security Rule

Foley & Lardner LLP on

Material updates to the HIPAA Security Rule could be on the way — affecting all HIPAA-regulated entities — for the first time in two decades. The Department of Health and Human Services (HHS) issued a Notice of Proposed...more

Brownstein Hyatt Farber Schreck

Bipartisan AI Task Force Report Sets the Stage for Health Care AI Action in 2025

The House Task Force on Artificial Intelligence (AI) released a comprehensive 253-page report providing a roadmap for Congress as it develops policies to regulate and optimize the use of this rapidly advancing technology. The...more

Ropes & Gray LLP

A Flurry of Healthcare Sector Cybersecurity Regulatory Developments in 2024

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2024 was a record year for cyberattacks in the healthcare sector. According to the Breach Portal maintained by the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”), to date this year, there...more

Arnall Golden Gregory LLP

OIG Updates Compliance Guidance for Nursing Facilities

In 1998, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services began issuing voluntary, compliance program guidance for various segments of the healthcare industry. Recently, the OIG has...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

McDermott Will & Schulte

Special Report: Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more

McDermott+

COVID-Era Flexibilities Granted in Wake of Change Healthcare Cybersecurity Attack

McDermott+ on

Today marks one month since United Health Group’s (UHG) Change Healthcare reported that it had been hit by a cybersecurity attack. The attack has caused a major disruption to the US healthcare system, significantly impacting...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Spilman Thomas & Battle, PLLC

HHS Cybersecurity Performance Goals and the Healthcare Industry

The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare industry is such a ripe hunting ground for cybercriminals, the...more

Brooks Pierce

Business Associate Victim of Ransomware Attack Pays $100,000 to HHS OCR

Brooks Pierce on

Is your organization a business associate? You could be subject to enforcement action if you fail to protect health information within your control from ransomware attacks. In October, for the first time, the U.S....more

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