Corrective Actions

News & Analysis as of

Shifting CPSC Recall Landscape? Agency Announces Major “Repair Program” that is not Labeled a “Recall”

Yesterday the CPSC and major furniture company IKEA jointly announced a “repair program” to address the serious and complex hazard of furniture tip over posed by 27 million chests and dressers sold by the company. The repair...more

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

Blog: St. Elizabeth’s Medical Center Reaches Agreement to Settle Alleged HIPAA Breach

Last week, St. Elizabeth’s Medical Center (SEMC), a hospital located in Brighton, Massachusetts, agreed to settle alleged violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by paying...more

HIPAA Settlement Regarding Use of Internet Applications

On July 10, 2015, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced a settlement agreement with St. Elizabeth's Medical Center (SEMC) in Brighton, Massachusetts, regarding potential...more

Use of File-Sharing Service Leads To $218,400 Fine For HIPAA Violations

Internet-based file-sharing services such as Dropbox and Google Drive can be easy and convenient to use, whether via the touch of an app on a mobile device or by opening a browser on a PC. Healthcare professionals are often...more

Massachusetts Hospital Agrees to Six-Figure Payment Related to HIPAA Compliance Allegations

St. Elizabeth’s Medical Center (SEMC), a tertiary care hospital based in Brighton, Mass., agreed to pay $218,400 to address deficiencies in its HIPAA compliance activities. The SEMC settlement continues a pattern of...more

Missed Deferrals - New 401(k) Correction Procedures

The IRS has recently issued three new, less expensive safe harbor procedures for correcting missed elective deferrals. These new procedures require either no employer corrective contribution to make up the missed elective...more

UK's Information Commissioner's Office Enters Corrective Action Agreement With Shoe Retailer For Data Breach

On January 19, 2015, the United Kingdom’s Information Commissioner’s Office (“ICO”) — an independent UK body created to uphold information rights — published a corrective action agreement with shoe retailer Office Holdings...more

Environmental Alert: "Clearly Allocate Risk of Change Interpretations in Transactions"

When buyers request that sellers warrant compliance with environmental law, sellers need to appreciate that agency interpretation or agency enforcement discretion may have played a role in the seller’s apparent ongoing...more

Securing Corrective Action May Raise Further Challenges

According to the latest statistics available from the U.S. Government Accountability Office (GAO), roughly half of all bid protests filed at the GAO are dismissed within 30 days of filing. Of these, the majority of dismissals...more

Employee Plans Compliance Resolution System – Q&A #2

If an employer unintentionally fails to comply with the qualification requirements of the Internal Revenue Code with respect to its qualified plan, the employer may be able to avoid disqualification of the retirement plan if...more

PilieroMazza Legal Advisor - Second Quarter 2014

In this issue: - Protecting Your Website - The Top Eight Things You Should Know - Securing Corrective Action May Raise Further Challenges - Get in the Ring: Contractors Opposed to the Proposed Extension...more

CPSC is Now Publicly Posting “Letters of Advice” to its Website

In his keynote address at the annual conference of the International Consumer Product Health & Safety Organization (ICPHSO), Acting Chairman Adler announced that the agency had recently started posting what it calls “letters...more

What’s New In Risk Based Corrective Action In Florida?

Over the last several years, under the direction of Governor Rick Scott, the Florida Department of Environmental Protection (FDEP) has embarked on an aggressive program to streamline regulatory processes across program areas,...more

Paying the Price: Physician Group Faces Hefty Penalty and OCR Oversight After Failure to Conduct Security Risk Assessment and...

What you need to know: The Office for Civil Rights of the US Department of Health & Human Services is continuing its trend toward more aggressive enforcement of HIPAA violations. Small provider entities are not immune...more

CFPB releases FY 2013 independent audit

The CFPB has released the independent audit conducted by KPMG of selected CFPB operations and budget in FY 2013. An annual independent audit is required by the Dodd-Frank Act....more

A $1.2 Million Photocopier Mistake: Health Plan Settles with HHS in HIPAA Breach Case

We have heard the well-publicized stories of stolen laptops and resulting violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and we generally recognize the inherent security risks and...more

Shasta Regional Medical Center Pays $275,000, Enters into Corrective Action Plan to Resolve Alleged HIPAA Privacy Rule Violations...

Shasta Regional Medical Center (Shasta) has agreed to pay $275,000 and enter into a corrective action plan (CAP) with the U.S. Department of Health and Human Services Office for Civil Rights (OCR) to resolve allegations that...more

Employment Law Blog - Lucky 13 - The Office of Civil Rights Enters into its 13th Corrective Action Plan

Charged with enforcing HIPAA and chided along by Congress to do a more proactive enforcement job, the Office of Civil Rights at HHS has entered into its 13th Corrective Action Plan for a covered entity....more

Is Your Firewall On? Are You Sure? Idaho State University Settles Privacy Rule Violations for $400,000

The HHS Office of Civil Rights (OCR) recently announced a $400,000 settlement with Idaho State University (ISU) following a lengthy investigation of the privacy and security practices at ISU outpatient clinics. In addition to...more

Under HIPAA, You Have the Right to Remain Silent

Last week a regional California medical center entered a $275,000 settlement for disclosing patient information to the media, spotlighting HIPAA’s tight reign over covered health providers even when they try to defend their...more

Hospital Disclosure of PHI to Media and Workforce Results in $275,000 Fine

HHS OCR announced today its second resolution agreement of 2013. Shasta Regional Medical Center (SRMC) has agreed to pay $275,000 and enter into a comprehensive corrective action plan (CAP) to settle an investigation opened...more

Large Educational/Health System Targeted For HIPAA Enforcement

Idaho State University (ISU) was recently the target of an investigation and enforcement action for violations of the privacy and security rules of the Health Insurance Portability and Accountability Act (HIPAA)....more

First HIPAA Resolution Agreement of 2013 — and it certainly will not be the last

The HHS Office of Civil Rights (OCR) announced its first HIPAA Resolution Agreement of 2013 last week. According to the press release, Idaho State University (ISU) must pay OCR $400,000 and comply with the terms of a...more

Idaho State University Pays $400,000 and Agrees to Implement Corrective Action Plan to Resolve Alleged HIPAA Violations

Idaho State University (ISU) has agreed to pay $400,000 to the U.S. Department of Health and Human Services (HHS) and implement a corrective action plan (CAP) to resolve allegations that it violated the HIPAA Security Rule by...more

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