News & Analysis as of

Risk Mitigation Department of Health and Human Services (HHS)

Goodwin

OIG Issues Two Favorable Advisory Opinions for Dental Supply Loyalty Program and Pharmaceutical Manufacturer Sponsor of Genetic...

Goodwin on

In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more

Wyrick Robbins Yates & Ponton LLP

Addressable No More: HHS Proposes Significant Changes to HIPAA Security Rule

On December 27, 2024, the Department of Health and Human Services (“HHS”) proposed substantial revisions to the 20-year-old HIPAA Security Rule. Comments on the proposal will be due within sixty days of its publication in the...more

Burr & Forman

HHS OIG Launches Segment-Specific Compliance Guidance for Nursing Facilities

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On November 20, 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued the Nursing Facility Industry Segment-Specific Compliance Program Guidance (Nursing Facility ICPG). This...more

Baker Donelson

Enhancing Compliance in Nursing Facilities: OIG's New Guidance

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The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued new Nursing Facility Industry Segment-Specific Compliance Program Guidance (Nursing Facility ICPG) for nursing facilities...more

Venable LLP

Event in Review: Major Fraud and Abuse Laws: Anti-Kickback and Self-Referral Prohibitions and False Claims

Venable LLP on

Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Robinson+Cole Data Privacy + Security Insider

CISA Issues Advisory on Black Basta Ransomware

On May 10, 2024, CISA, along with the FBI, HHS, and MS-ISAC, issued a joint Cybersecurity Advisory relating to Black Basta ransomware affiliates “that have targeted over 500 private industry and critical infrastructure...more

King & Spalding

Senators Introduce New Bill for Transparency and Oversight in Health Care Transactions and Investment

King & Spalding on

On April 3, 2024, Senators Ed Markey (D-Mass) and Elizabeth Warren (D-Mass) released draft legislation titled the “Health Over Wealth Act” (the Proposed Bill). This Proposed Bill is another attempt to regulate private...more

Foley & Lardner LLP

Health-Related Social Needs: Three Trends in Leveraging Community Partnerships

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Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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

Society of Corporate Compliance and Ethics...

Good news, bad news

There’s good and bad news out there for compliance departments, and it’s also the same news: Governments now very much appreciate strong compliance programs. On the one hand, that is very good (if not great!) news....more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - March 1st, St. Louis, MO

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

BakerHostetler

HHS Publishes ‘Voluntary’ Healthcare Cybersecurity Performance Goals in Record Time but Leaves Questions Unanswered

BakerHostetler on

As previously reported in this blog, on Dec. 6, 2023, the Department of Health and Human Services (HHS or the Department) released a “concept paper,” which laid out its vision of future action regarding healthcare...more

Health Care Compliance Association (HCCA)

‘An Unknown Individual Walked In’: Protecting Against Telehealth Risks Includes Non-IT Threats

The HHS Office for Civil Rights (OCR) and other government agencies aren’t just worried that providers understand—and mitigate—the privacy and security risks of telehealth. In fact, in 2022, the Government Accountability...more

Jones Day

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

Jones Day on

The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more

Mintz - Health Care Viewpoints

HHS, ONC HTI-1 Final Rule Introduces New Transparency Requirements for Artificial Intelligence in Certified Health IT

The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy...more

NAVEX

From Healthcare Sector, a Big Push for CCO Autonomy

NAVEX on

For the better part of a decade, the U.S. Justice Department has led the way on calls for a strong, independent corporate compliance function – until recently, that is. Then the Department of Health and Human Services leaped...more

Ankura

OCR Issues Guidance to Patients and Providers on Telehealth Privacy and Security

Ankura on

On October 18, 2023, the Department of Health and Human Services (DHHS) through the Office for Civil Rights (OCR) issued an update1 containing two resource documents to help educate patients regarding privacy and security...more

Foley & Lardner LLP

New Biden EO on AI Oversight, Development, and Use: Implications for the Health Care Industry

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On Monday, October 30, President Biden signed an executive order (EO) aimed at overhauling the governance and oversight of artificial intelligence (AI) and technological infrastructure, including setting standards for AI used...more

Ankura

DHHS OCR and FTC Issue Warning to Hospital Systems and Telehealth Providers Regarding Privacy and Security Risks

Ankura on

On July 20, 2023, the Department of Health and Human Services (DHHS) through the Office of Civil Rights (OCR) and the Federal Trade Commission (FTC) issued a joint letter to hospitals and telehealth providers alerting them to...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

McDermott Will & Emery

[Webinar] How Not to Lose $1M: Preparing for HHS-OIG Info Blocking Enforcement - August 15th, 1:00 pm - 2:00 pm EDT

The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more

Foley & Lardner LLP

Child Labor: 9 Key Strategies to Mitigate Risk of Child Labor in the Supply Chain

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Since 2018, the U.S. Department of Labor has seen a 69 percent increase of children being employed illegally by companies. Last month, the U.S. Department of Labor (“DOL”) and Department of Health and Human Services (“DHHS”)...more

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