News & Analysis as of

Investigations Department of Health and Human Services (HHS)

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

Nelson Mullins Riley & Scarborough LLP

HHS Final Rule Targets Suspicious Billing Practices for Medical Equipment (CMS-1799-F)

Summary: On September 24, 2024, the Biden administration issued a final rule designed to address suspicious billing for durable medical equipment that may have cost the Medicare program more than $2 billion....more

K&L Gates LLP

Long-Awaited Changes to Research Misconduct Rules Have Arrived

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On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more

Foley & Lardner LLP

Research Misconduct: ORI Issues Final Rule with Modernized and Streamlined Regulations

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On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

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On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more

Foley & Lardner LLP

Understanding the Risk vs. Reward of Department of Justice’s Corporate Criminal Whistleblower Awards Pilot

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The Securities & Exchange Commission, the Department of Health & Human Services, and other agencies have long had established bounty programs that reward successful tipsters. On August 1, 2024, the Department of Justice’s...more

Davis Wright Tremaine LLP

21st Century Cures Act Information Blocking Rule Finally Has Teeth With Respect to Providers

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more

King & Spalding

HHS Finalizes Disincentives for Healthcare Providers That Have Committed Information Blocking

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Last week, HHS published its final rule outlining disincentives for certain healthcare providers that have committed information blocking (the Final Rule). The Final Rule also provides information related to OIG’s...more

Foley & Lardner LLP

HIPAA: Amendments to Protect Reproductive Health Care Information Can Now be Implemented with OCR’s Final Rule

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Share on Twitter Print Share by Email Share Back to top HIPAA regulated entities may now begin implementing the amendments to the HIPAA Privacy Rule to provide additional protections for reproductive health care information...more

ArentFox Schiff

Providers Face HIPAA Compliance Questions After Change Healthcare Cyberattack

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Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more

Mintz - Health Care Viewpoints

DOJ Releases COVID-19 Fraud Enforcement Task Force Report Touting Its Successes and Urging Lawmakers to Enact New Legislation

The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task...more

King & Spalding

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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

HHS Office for Civil Rights Reaches Second Health Care Ransomware Settlement

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently announced its second settlement in four months growing out of a ransomware attack on a health care business. Maryland-based Green Ridge...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Bass, Berry & Sims PLC

HHS Finalizes Rule: “Safeguarding the Rights of Conscience as Protected By Federal Statutes”

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On January 11, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Final Rule that seeks to provide clarity regarding OCR’s enforcement authority and processes relating to federal...more

Akin Gump Strauss Hauer & Feld LLP

FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more

Cozen O'Connor

DOJ Signals Increased Emphasis on Data Analytics to Prosecute FCPA Global Corruption

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On November 29, 2023, Department of Justice (DOJ or Department) policymakers announced explicitly that they are, for the first time, leveraging data analytics to help proactively identify and prosecute crimes in foreign...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

Mintz - Health Care Viewpoints

HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

Akin Gump Strauss Hauer & Feld LLP

Research Security: New NIH Policy Requires Foreign Subrecipients to Share Lab Notebooks & Research Data With the U.S. Prime...

On September 15, 2023, the National Institutes of Health (NIH) moved forward with a controversial new policy requiring foreign subrecipients to provide, at least once per year, copies of lab notebooks, data and documentation...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

Foley & Lardner LLP

Clinical Trials: Consent Process Clarified in New FDA Final Guidance

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The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more

Foley & Lardner LLP

Ensuring Child Labor Law Compliance Amid Growing Scrutiny

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In February, the New York Times published an investigative report regarding alleged employment of underage migrants, many from Central America, at U.S. companies. While employment of certain minors is permitted under federal...more

Hinch Newman LLP

FTC and HHS Warn Hospital Systems and Telehealth Providers About Use of Technologies That Share Sensitive Health Information

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The Federal Trade Commission and the U.S. Department of Health and Human Services' Office for Civil Rights are cautioning hospitals and telehealth providers about the privacy and security risks related to the use of online...more

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