News & Analysis as of

Corrective Actions 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

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Holland & Hart LLP

OIG Issued Updated General Compliance Program Guidance for Healthcare Providers and Stakeholders

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On Monday, November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released its General Compliance Program Guidance (“GCPG”) for the general healthcare compliance community and...more

Saul Ewing LLP

No Snooping Nor Snitching Are the Key Takeaways From the Two Most Recent HIPAA Settlements With Covered Entities

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The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently announced two settlements with HIPAA-covered entities – one in Washington State and one in New Jersey with settlements of $240,000...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 3. In This Month's E-News: March 2023

Report on Research Compliance Volume 20, Number 3. February 23, 2023 - The Office of Management and Budget (OMB) is planning to revise the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for...more

Foley Hoag LLP - Security, Privacy and the...

Password Security & Best Practices – A Refresher

As more and more of us return to the office, it’s a good time to revisit the passwords you use.  It is therefore timely that the U.S. Department of Health and Human Services, Health Sector Cybersecurity Coordination Center...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 9. In This Month's E-News: September 2022

Report on Research Compliance Volume 19, Number 9 (September, 2022) - According to the HHS Office of Research Integrity (ORI), Janina Jiang, M.D., Ph.D., a former assistant researcher in the University of California, Los...more

Saul Ewing LLP

(Un)Lucky Thirteenth HIPAA Right of Access Initiative Investigation Results in Primary Care Provider Paying $36,000 to OCR

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On December 22, 2020, the Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced a settlement of a thirteenth enforcement action under its HIPAA Right of Access Initiative (the...more

King & Spalding

Orthopedic Clinic Agrees to $1.5 Million Settlement with OCR and Two-Year Comprehensive Corrective Action Plan

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On September 21, 2020, the HHS Office of Civil Rights (OCR) announced a $1.5 million settlement with Athens Orthopedic Clinic, a Georgia orthopedic clinic, to settle potential violations of the Health Insurance Portability...more

King & Spalding

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

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Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

Health Care Compliance Association (HCCA)

Under New Settlement, Ambulance Co. Pays OCR $65K, Must Quickly Encrypt Computers

Report on Patient Privacy 20, no. 1 (January 2020) - In the waning days of 2019, the HHS Office for Civil Rights (OCR) didn’t halt the HIPAA enforcement momentum it had built up during the last quarter of the year, dinging...more

Tucker Arensberg, P.C.

Ambulance Company Pays $65,000 Settlement

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On December 30, 2019, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) announced a $65,000 settlement with West Georgia Ambulance, Inc. for  violations of the Health Insurance Portability and...more

Saul Ewing LLP

OCR Settles Second Case in HIPAA Right of Access Initiative

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On December 11, 2019, the Office for Civil Rights (“OCR”), within the U.S. Department of Health and Human Services , announced a settlement with a covered entity, Korunda Medical, LLC (“Korunda”), to resolve alleged...more

Fox Rothschild LLP

Clear Message From OCR: Don’t Ignore (Or Overcharge For) Patient Requests For Records

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Last week, the Office for Civil Rights (OCR) announced its second enforcement action and settlement with a provider for failing to comply with HIPAA’s patient access requirements. Korunda Medical, LLC, a primary care and...more

Health Care Compliance Association (HCCA)

'Misinterpretation' of Breach Rule, Lack of Internal BAA Cost Hospital Group $2.1M

Report on Patient Privacy 19, no. 12 (December 2019) - Sentara Hospitals, a nonprofit group of 12 medical centers in Virginia and North Carolina, will implement a fairly minimal two-year corrective action plan (CAP) and...more

Tucker Arensberg, P.C.

$3,000,000 Settlement by University of Rochester Medical Center for Numerous HIPAA Violations

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On November 5, 2019, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) announced a $3,000,000 settlement with the University of Rochester Medical Center (“URMC”) for violations of the Health...more

Health Care Compliance Association (HCCA)

First HIPAA Right of Access Initiative settlement announced by OCR

Compliance Today (November 2019) - On September 9, 2019, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced its first enforcement action and settlement in its Right of Access...more

Hinshaw & Culbertson LLP

OCR Settles First Case in HIPAA Right of Access Initiative

On September 9, 2019 the Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services announced its first enforcement action and settlement of its Right of Access Initiative. This follows an OCR...more

Ballard Spahr LLP

HIPAA Right to Access Information Enforced

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With all of the attention on Health Insurance Portability and Accountability Act (HIPAA) requirements to safeguard the privacy and security of a patient’s health information, covered entities sometimes overlook the HIPAA...more

Ballard Spahr LLP

HIPAA Guidance and Enforcement: A New Alignment?

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The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) announced that it has entered into a settlement with a business associate that provides electronic medical records services to health...more

Ballard Spahr LLP

OCR Announces $3 Million HIPAA Enforcement Settlement for Breach of 300,000 Patients’ PHI

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On May 6, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced an agreement  with Touchstone Medical Imaging, LLC (Touchstone)...more

King & Spalding

OCR Recovers $28.7 Million from 2018 HIPAA Enforcement Actions

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According to a summary released by the HHS Office for Civil Rights (OCR), in 2018, OCR settled 10 cases and was granted summary judgment in one case totaling $28.7 million in recoveries for alleged violations of the Health...more

Holland & Knight LLP

$500K HIPAA Mistake for Florida Healthcare Company

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Another government settlement demonstrates that not having a HIPAA compliance program can be costly. U.S. Department of Health and Human Services (HHS)'s Office for Civil Rights (OCR) announced, on Dec. 4, 2018, that Advanced...more

Holland & Knight LLP

Public Information is Still Protected by HIPAA

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Allergy Associates of Hartford, P.C., entered into a Resolution Agreement and agreed to pay $125,000 to the U.S. Department of Health and Human Services, Office for Civil Rights (HHS) in order to settle certain Health...more

Bricker Graydon LLP

HIPAA settlement highlights need for caution when speaking with media

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On November 26, 2018, the U.S. Department of Health and Human Services (HHS) announced that it reached a settlement with a Connecticut physician group practice for compromising the privacy of a patient’s protected health...more

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