News & Analysis as of

Ethics Department of Health and Human Services (HHS)

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...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

The Volkov Law Group

HHS-OIG Guidance — Chock Full of Compliance Best Practices and Strategies (Part II of III)

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Board Oversight of the Compliance Program - The GCPG cross-references the US Sentencing Guidelines board responsibility requirements of the organization’s compliance program, and provides that the board shall “be...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: October 2023

Report on Research Compliance Volume 20, no. 10 (October, 2023) The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will have two new members when it meets this month. In an email sent to its...more

Pillsbury Winthrop Shaw Pittman LLP

White House Announces Plan to Boost AI Research and Deployment

On May 23, the White House revealed three new steps advancing the research, development and deployment of AI technology nationwide. The Biden Administration has updated the National Artificial Intelligence R&D Plan for...more

Foley & Lardner LLP

FAQs About Bias In Artificial Intelligence (AI) – Avoiding the Dystopian Potential of an Utopian Tool

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Why is bias in AI an issue? One reason: A natural human fear of trusting AI’s vaunted omniscience, whether for individuals or groups. AI is a blessing for business and big data analysis of every kind, the support of...more

King & Spalding

AdvaMed Updates Code of Ethics on Interactions with HCPs: What’s the Impact on MedTech?

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On March 18, 2022, the Advanced Medical Technology Association (“AdvaMed”) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (“Code”). The revised Code will take effect June 1, 2022. ...more

Hogan Lovells

HHS offers flexibility on human subjects protection regs during COVID-19 pandemic

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On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more

Bass, Berry & Sims PLC

OHRP Releases Guidance for Institutions Conducting Human Subjects Research During COVID-19

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The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 27th - 28th, Anchorage, AK

This two-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Health Care Compliance Association (HCCA)

[Event] Board & Audit Committee Compliance Conference - February 24th - 25th, Fort Lauderdale, FL

The Office of Inspector General of Health and Human Services expects board members, board audit/compliance committee members, and senior level leaders of organizations to be experienced in compliance oversight. The Board &...more

McDermott Will & Emery

Revised AdvaMed Code Reflects an Evolving Industry

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In its first update in a decade and effective January 1, 2020, the revised Advanced Medical Technology Association (AdvaMed) Code of Ethics in Interactions with Health Care Professionals (Code) in the United States contains...more

Patrick Malone & Associates P.C. | DC Injury...

After feds bust U.S. rep for insider trading in Pharma stock, will Congress drain ethics swamp?

At a time when prescription drug prices keep skyrocketing and Americans pay hundreds of billions of dollars for medications that account for as much as 15 percent of all U.S. health care spending, federal law enforcers...more

Holland & Knight LLP

Ten Things to Know About the CMS Long-Term Care Requirements Final Rule

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Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more

NAVEX

2016 Trends #3: Board Expectations for Ethics & Compliance Oversight Get More Specific, Uniform and Comprehensive

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According to the U.S. Sentencing Guidelines for Organizations—and similar provisions found in other guidelines worldwide—an organization’s governing body is responsible to “exercise reasonable oversight with respect to the...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

Polsinelli

Impending Deadline: CMS Issues Proposed Rule Reform for Long Term Care Facilities – Part 3 of 4

Polsinelli on

On July 16, 2015, the Federal Register published Centers for Medicare and Medicaid Services’ (CMS) proposed rule to reform the requirements for Long Term Care Facilities participating in Medicare and Medicaid. CMS will be...more

NAVEX

Real Guidance (Finally) On the Compliance Oversight Role of Boards

NAVEX on

New guidance for boards of directors on what it means to have “reasonable oversight” for the implementation and effectiveness of corporate compliance programs could signal the beginning of a global trend towards more—and more...more

The Volkov Law Group

Healthcare Compliance Programs: Stepping Up the Game

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The Affordable Care Act was enacted in 2010 – can anyone remember back that far? The ACA required Medicare and Medicaid providers to have an ethics and compliance program....more

Cooley LLP

Blog: Federal Advisory Group Considers Patient Data Standards

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This week, the Privacy and Security Workgroup within the Health IT Policy Committee was tasked by the U.S. Department of Health and Human Services (“HHS”) to discuss certain patient data protections. Specifically, they were...more

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