Karilynn Bayus

Karilynn Bayus

Saul Ewing LLP

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OCR to Investigate More HIPAA Breaches Affecting Fewer Than 500 Individuals

On August 18, 2016, the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced plans to expand its investigations of reported breaches of the Health Insurance Portability and...more

8/25/2016 - Breach Notification Rule Data Breach HHS HIPAA OCR OIG

FTC Finds Laboratory Security Practices Caused Consumer Harm

On July 28, 2016, a panel (the “FTC Panel”) of three acting Federal Trade Commission (“FTC”) commissioners issued an opinion that found that LabMD, Inc. (“LabMD”) failed to implement reasonable security measures to protect...more

8/22/2016 - ALJ Business Associates Covered Entities Data Security FTC FTC Act HIPAA LabMD Popular Section 5

Largest HIPAA Settlement Announced Against A Single Entity: $5.55 Million

On August, 4, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced that Advocate Health Care Network (Advocate) agreed to pay a settlement amount of $5.55 million and adopt a...more

8/10/2016 - Business Associates Corrective Actions Covered Entities Data Breach Data Security HIPAA OCR PHI Risk Management Settlement

Two Multi-Million Dollar HIPAA Settlements Emphasize Importance of a Comprehensive Security Program

The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced two settlements of more than $2 million each with respect to alleged violations of the Health Insurance Portability and...more

7/29/2016 - Breach Notification Rule Corrective Actions HIPAA OCR PHI

Could There Be A “Stark” Law Change?

There appears to be momentum on Capitol Hill in Washington, DC to modify and/or repeal the Ethics in Patient Referrals Act of 1989, more commonly known as the Stark Law, which was enacted to curb overutilization of certain...more

7/18/2016 - CHIP CMS Medicare Medicare Access and CHIP Reauthorization (MACRA) Stark Law

OCR Releases Guidance on Ransomware & HIPAA

On July 11, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) issued guidance (the “Guidance”) for health care entities relating to ransomware and the Health Insurance Portability and...more

7/14/2016 - HHS HIPAA Malware OCR PHI Ransomware

Business Associate Enters Into Mid Six-Figure HIPAA Settlement

On June 30, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that a business associate providing management services to nursing homes in the Philadelphia, Pa. region agreed to...more

7/6/2016 - Business Associates HHS HIPAA OCR PHI

Higher Education Highlights - Summer 2016

On March 21, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”), announced the launch of the 2016 Phase 2 Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Audit...more

6/24/2016 - DOL EEOC FLSA Health Care Providers HIPAA HIPAA Audits Minimum Salary OCR Over-Time Title VII Transgender White-Collar Exemptions

Two Additional HIPAA Settlements Demonstrate Breadth of HIPAA Enforcement Activity

During the week of April 18, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced two significant settlements with a large New York City hospital and a North Carolina orthopaedic...more

4/26/2016 - Business Associates Covered Entities Enforcement Actions Film Industry HHS HIPAA Hospitals OCR Patient Privacy Rights PHI Prior Authorization Public Disclosure Settlement

Be Prepared: Phase 2 HIPAA Audits Set to Begin

On March 21, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”), announced the launch of the 2016 Phase 2 Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Audit...more

4/1/2016 - Breach Notification Rule Business Associates Covered Entities Health Care Providers HIPAA HIPAA Audits HIPAA Breach OCR PHI

Improper Disclosure of Research Information Results in $3.9 Million Settlement

On March 17, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that the Feinstein Institution for Medical Research (“Feinstein”) agreed to pay $3.9 million to resolve...more

3/29/2016 - Corrective Actions Health Care Providers HHS HIPAA HIPAA Breach OCR PHI Settlement Agreements

Seven-Figure Settlement Reinforces Necessity of Business Associate Agreements

On March 16, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that North Memorial Health Care of Minnesota (“Memorial”) agreed to pay $1.55 million to resolve allegations that...more

3/22/2016 - Business Associates Corporate Counsel Corrective Actions Covered Entities Data Breach HIPAA OCR Personally Identifiable Information PHI

Six-Figure January HIPAA Enforcement Activities Highlight Importance of Maintaining Privacy Protections

The U.S. Department of Health & Human Services’ (“HHS”) Office for Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) were each involved in the resolution of high profile privacy matters in January 2016. The two...more

2/23/2016 - ALJ FTC HHS HIPAA OCR PHI Popular

Highly Anticipated Final Rule from CMS on Returning Overpayments Affords Providers a Roadmap for Avoiding FCA Claims

In the February 12, 2016 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) with respect to reporting and returning overpayments by Medicare Part A and Part B providers to...more

2/18/2016 - 60-Day Rule CMS False Claims Act (FCA) Health Care Providers Medicare Part A Medicare Part B Overpayment Recovery Time Limits

CMS Releases Highly Anticipated Final Rule on Returning Overpayments

In the February 12, 2016 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) with respect to reporting and returning overpayments by Medicare Part A and Part B providers to...more

2/17/2016 - 60-Day Rule Affordable Care Act CMS False Claims Act (FCA) Health Care Providers Medicare Part A Medicare Part B Overpayment Recovery Time Limits

Deadline for Reporting “Small” 2015 HIPAA Breaches Approaching

For those covered entities who experienced one or more HIPAA breaches involving less than 500 individuals during the calendar year 2015, the deadline for reporting those breaches to the Secretary of the U.S. Department of...more

2/3/2016 - Breach Notification Rule Corporate Counsel Deadlines Health Insurance HHS HIPAA Breach PHI Reporting Requirements

HIPAA Privacy Rule Amended To Permit Reporting of Firearm Background Check Information

The January 6, 2016 Federal Register included a final rule (“Final Rule”) amending the HIPAA Privacy Rule to expressly permit certain “covered entities” to disclose to the National Instant Criminal Background Check System...more

1/8/2016 - Background Checks Final Rules Firearms Gun Laws Gun Permits HIPAA NICS Privacy Rule

University with Multiple Covered Entity Components Enters Into $750,000 HIPAA Settlement

On December 14, 2015, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced a $750,000 settlement with the University of Washington (UW). This is the third HIPAA settlement announced by OCR...more

12/18/2015 - Data Breach Healthcare HIPAA PHI Settlement

Stolen, Unencrypted Laptop Leads to $850,000 Settlement and Comprehensive Corrective Action Plan for Massachusetts Teaching...

The U.S. Department of Health and Human Services, Office of Civil Rights (OCR), has announced a settlement with Lahey Hospital and Medical Center (Lahey) that arose out of a HIPAA breach involving a stolen laptop. The...more

12/10/2015 - Data Breach Electronic Medical Records Healthcare HIPAA OCR Settlement

2016 OIG Work Plan Released; Providers and Payors Should Carefully Review

In November 2015, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) released its investigative plans for fiscal year 2016 (the OIG Work Plan). The OIG Work Plan highlights more...more

12/1/2015 - Health Care Providers HHS OIG Work Plans

CMS and OIG Issue Final ACO Waivers

On Thursday, October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) jointly issued a rule (the “Final Rule”) to finalize five (5) waivers of certain fraud and abuse...more

11/5/2015 - ACOs Anti-Kickback Statute Civil Monetary Penalty CMS Federal Register Final Rules Gainsharing Healthcare Healthcare Fraud Interim Rule Kickbacks Medicaid Medicare Medicare Shared Savings Program OIG Self-Referral Shared Savings Program Stark Law

Reports Instruct Office of Civil Rights to Increase HIPAA Enforcement Activities

On September 29, 2015, the Office of Inspector General (OIG) released two reports that reviewed the Office of Civil Rights’ (OCR) enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The...more

10/6/2015 - Compliance Covered Entities Data Breach Enforcement Actions Healthcare HHS HIPAA OCR OIG Privacy Rule

$750,000 Settlement Agreement Reiterates Importance of HIPAA Security Rule Compliance

On September 2, 2015, the U.S. Department of Health and Human Services ("HHS") announced that it had entered into a Settlement Agreement with an Indiana-based medical practice for alleged violations of the Health Insurance...more

9/4/2015 - Breach Notification Rule Compliance Covered Entities Cyber Attacks Cybersecurity Data Breach Data Security De-Identified Protected Health Information Health Care Providers Healthcare HHS HIPAA Personally Identifiable Information PHI Popular Privacy Policy Settlement Agreements

Proposed 2016 Medicare Physician Fee Schedule Includes Changes to Stark Regulations

The Centers for Medicare & Medicaid Services ("CMS") recently released the proposed 2016 Medicare Physician Fee Schedule (the "Proposed Rule"), which includes a number of proposed revisions to the regulations under the...more

8/27/2015 - CMS FQHC Health Care Providers Healthcare Medicaid Medicare Physician Fee Schedule Physicians Rural Health Care Providers Self-Referral Stark Law

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

7/15/2015 - Compliance Corrective Actions Covered Entities Data Breach Electronic Medical Records HHS HIPAA Laptop Computers OCR

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