News & Analysis as of

Department of Health and Human Services (HHS) Risk Mitigation

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

Manatt, Phelps & Phillips, LLP

[Webinar] Preparing for the Future of Health Care Antitrust Scrutiny - June 11th, 12:00 pm - 1:00 pm PST

Now, more than ever, health care organizations are facing complex antitrust issues as their mergers/acquisitions, hiring, contracting and private funding are being scrutinized by the federal and state governments. Proper...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

Foley & Lardner LLP on

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Clinical Research: FDA Issues Draft Guidance on Informed Consent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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more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

Foley & Lardner LLP on

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

Foley & Lardner LLP on

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

Baker Donelson

Beware of Cyber Attacks During the Holiday Season – Royal Ransomware Group Highlighted as Threats to the Health and Public Health...

Baker Donelson on

Statistics show that cybercrime increases significantly during the holiday season. Threat actors anticipate that workers are distracted and more likely to fall victim to a phishing email scam than any other time of the year....more

Parker Poe Adams & Bernstein LLP

How North Carolina Hospitals Can Navigate the Thorny Legal Landscape Involving Emergency Abortion Care

​​​​​​​In recent months, decisions and laws limiting abortion rights in the United States have forced health care providers that serve pregnant women to keep abreast of quickly changing legal restrictions affecting their...more

King & Spalding

Twenty-One State Attorneys General and the District of Columbia Back HHS’s Plan to Hold Hospitals and Other Providers Liable for...

King & Spalding on

On October 3, 2022, the Attorneys General for California, New York, and Massachusetts, in collaboration with Attorneys General from 18 other states and the District of Columbia (State Attorneys General) submitted a comment...more

Health Care Compliance Association (HCCA)

Telehealth regulatory oversight and enforcement trends

CT magazine (July 2022) - One of the notable impacts of the COVID-19 pandemic on the healthcare industry has been the boom in services provided via telehealth. This boom is in part due to temporary flexibilities applied...more

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