Covered Entities

News & Analysis as of

New York Finalizes Cybersecurity Regulations for Financial Institutions

On February 16, the New York State Department of Financial Services (NYDFS) issued cybersecurity regulations for banks, insurance companies and other financial institutions subject to NYDFS jurisdiction. ...more

New York Department of Financial Services Promulgates First-in-the-Nation State Cybersecurity Regulation

On February 16, 2017, the New York Department of Financial Institutions (“DFS“) promulgated a regulation that requires “Covered Entities” to establish and maintain a cybersecurity program designed to protect consumers and the...more

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...more

HIPAA for HR - Some Good News for Employers

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that was enacted to ensure protection of individuals’ protected health information (PHI). The Standards for Privacy of Individually...more

HIPAA Enforcement Update (October 2016 – January 2017)

Since October 2016, the Department of Health and Human Services, Office for Civil Rights (OCR) announced four settlement agreements to resolve allegations of Health Insurance Portability and Accountability Act (HIPAA)...more

HIPAA Small Breach Notification Due March 1: “In Like a Lion, Out Like a Lamb” if You Submit Timely

March 1, 2017 is the date by which HIPAA covered entities must notify the U.S. Department of Health and Human Services Office for Civil Rights (OCR) of “small” breaches of unsecured protected health information that were...more

New York's Cybersecurity Requirements for DFS Licensees: A New Item at the Top of the To-Do List

With a compliance date a few months away, licensees of the New York Department of Financial Services (DFS) must start taking action in response to coming cybersecurity requirements, which will be more onerous and difficult...more

Insurance Companies Need to Prepare for Swap Margin Rules in Effect on March 1, 2017

March 1, 2017, is the scheduled implementation date applicable for all insurance companies for the mandatory posting of variation margin to their swap dealer counterparties under U.S. margin rules. Although the...more

Children’s Medical Center of Dallas Clobbered by OCR

In a rare move by the OCR, it assessed a $3.2 million fine against Children’s Medical Center of Dallas (Children’s) after it issued a Notice of Proposed Determination against Children’s and Children’s failed to request a...more

New York State Department of Financial Services Cybersecurity Regulation Poised to Reshape Existing Regulatory Landscape

In late December, New York State’s Department of Financial Services (“DFS”) released its revised proposed cybersecurity regulation (the “DFS Rule”). While the revisions pare back some of the DFS Rule’s original requirements...more

Lessons Learned from Recent OCR Settlements

We can learn some valuable lessons about compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) from settlements that are announced by the U.S. Department of Health and Human Services, Office...more

Mark Your Calendars: NY Cybersecurity Regulations to Go into Effect

A covered entity will need to arrange for someone to perform the CISO function, dedicate resources to conduct periodic risk assessments, develop and implement policies and procedures, and retain appropriate personnel and...more

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

Recent HIPAA Enforcement Actions

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health,...more

Tracking the Data Bandits

In the iconic western, Butch Cassidy and the Sundance Kid, Butch and Sundance are hard pressed to evade a posse led by the semi-mythical lawman, Joe Lefors, who is so adept that he manages to track them across solid rock. The...more

[Webinar] HIPAA in the Cloud – OCR Guidance on HIPAA and Cloud Service Providers - Jan. 31st, 1:00pm ET

As the health care sector further embraces the benefits of cloud computing, numerous challenges have arisen with applying HIPAA to cloud computing services....more

Employment and Benefits Advisory: 2017 Reminders and Developments

New Relief for Small Employer Health Reimbursement Arrangements - As mentioned in prior advisories, the Departments of Labor, Health and Human Services and Treasury have taken the position that employers cannot reimburse...more

HIPAA Breach? Notify Promptly or Face Significant Potential Fines from HHS OCR

On January 9, 2017, the Department of Health and Human Services Office of Civil Rights (HHS OCR), which enforces the privacy requirements contained in Health Insurance Portability and Accountability Act (HIPAA), announced a...more

The New York Department of Financial Services’ Cybersecurity Regulation Will Soon Take Effect

The New York Department of Financial Services (“NYDFS”) is in the final days of accepting public comment on its revised cybersecurity regulation, which would be codified at 23 NYCRR 500. As the comment period winds down to a...more

HHS Gets Agressive: HIPAA Audits from 2016

HHS has become more aggressive with audits, and with increased penalties, covered entities and business associates simply cannot afford an audit on HIPAA rules and regulations. In March of 2016, HHS's Office for Civil Rights...more

Do Routine Calls by Health Plans to Patients and Health Plan Members Constitute “Telemarketing” Under the Telephone Consumer...

Covered entities have a long list of laws and regulations governing their conduct, including their communications with patients, customers, and members. Specifically, the Health Insurance Portability and Accountability Act...more

Health Care Group News: OCR Releases New Clarifying Guidance In Response To Orlando Pulse Nightclub Attack

In an emergency, when there is a flurry of activity in a hospital, covered entities often struggle with who they are permitted to release patient information to under HIPAA. On January 11, 2017, the Department of Health and...more

Enough is Enough: Court Dismisses TCPA Class Action Against A Health Plan That Placed Reminder Calls To Its Members That They...

Plaintiffs across the country have continued to file class actions against companies of all stripe for violation of the Telephone Consumer Protection Act (“TCPA”), often for communications far afield from the classic...more

NYDFS: A Lawyer’s Responsibility

New York Financial Regulator to Enforce First-of-Its-Kind Cybersecurity Regulations in Coming Weeks - On December 28, 2016, the New York Department of Financial Services (NYDFS) issued revised cybersecurity regulations...more

340B Update: HRSA Finalizes 340B Pricing & Penalties for Drug Manufacturers

On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more

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