News & Analysis as of

Dept. of Health and Human Services Covered Entities

The United States Department of Health and Human Services is a federal executive department established in 1953, as part of the Department of Health, Education and Welfare. The Agency became independent in 1980... more +
The United States Department of Health and Human Services is a federal executive department established in 1953, as part of the Department of Health, Education and Welfare. The Agency became independent in 1980 and was renamed The Department of Health and Human Services at that time. HHS is charged with protecting and improving the health of the American population, as well as providing essential services.    less -

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

How Can Healthcare Organizations Prepare for the Next Cyberattack?

by Latham & Watkins LLP on

HHS OCR issues checklist, iterative guidance in wake of WannaCry and Petya attacks; Anthem breach settlement provides additional lessons. Key Points: ..Healthcare organizations are particularly vulnerable to ransomware...more

HHS Publishes Health Care Cyber Attack Checklist

by Tucker Arensberg, P.C. on

HHS has published a very brief guide, in the form of a checklist, to explain the steps for a HIPAA covered entity or business associate to take in response to a cyber related security incident. You can access the checklist at...more

Healthcare Data Breach Enforcements and Fines

by Bryan Cave on

The Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) is responsible for enforcing the Privacy and Security Rules of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)....more

My Entity Just Experienced a Cyber-Attack! What Do We Do Now?

by Balch & Bingham LLP on

On June 9, 2017, the U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) released a cyber-attack “Quick Response” checklist (the Checklist) for the benefit of HIPAA covered entities and business...more

New HHS Cybersecurity Preparedness Checklist

by Carlton Fields on

The Department of Health and Human Services’ Office of Civil Rights (OCR) recently published a checklist to guide HIPAA-covered entities and business associates through an appropriate response to a ransomware or cybersecurity...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

Causes of Healthcare Data Breaches (Update)

by Bryan Cave on

Pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), covered entities (e.g. healthcare providers and health plans) must notify the Department of Health and Human Services (“HHS”) of breaches...more

Complying With HIPAA Following a Ransomware Attack

by Morris James LLP on

In 2016, the U.S. Department of Health and Human Services (“HHS”) issued guidance to help covered entities and business associates understand, among other things, how to respond appropriately to ransomware attacks under the...more

Impermissible Disclosure of HIV Information Results in $387,000 HIPAA Settlement

by Saul Ewing LLP on

St. Luke’s-Roosevelt Hospital Center, Inc. (SLRHC), a member of the New York-based Mount Sinai Health System, paid $387,000 to the U.S. Department of Health and Human Services (HHS) and entered into a corrective action plan...more

Employers: Are You Ready for a Cyberwar? Attackers Using Ransomware are Saying Show Me Your Bitcoin!

by Dechert LLP on

Recently, the WannaCry ransomware attack impacted 150 countries and over 300,000 computers. Not all ransomware attacks are so massive but they all are fast moving and require swift action to prevent destruction and lose of...more

Three Things Health Care Employers Should Know About Affordable Care Act Section 1557

by Baker Ober Health Law on

Health care providers are likely familiar with the Affordable Care Act's (ACA) prohibitions on discriminating against the recipients of their services, but providers also must be mindful that the ACA may also make them...more

Failure to Ensure Vendor Safeguarded Protected Health Information Costs Small Health Care Provider $31,000

by Reed Smith on

Having proper internal systems and procedures in place to manage data security is essential for organizations storing personal information in any industry. But health care organizations that rely on external vendors to...more

2017 HIPAA Enforcement – Appears Not To Be Slowing Down

by Snell & Wilmer on

To state the obvious, there has been some uncertainty regarding how the Trump Administration will affect federal agency enforcement efforts. However, at least, in regard to HIPAA Privacy and Security, the U.S. Department of...more

Settlement Highlights Need for HIPAA-Covered Entities to Have Business Associate Agreements in Place with PHI Vendors

by Dickinson Wright on

The Department of Health and Human Services’ Office for Civil Rights (ORC) announced an agreement to settle possible Health Insurance Portability and Accountability Act (HIPAA) violations with The Center for Children’s...more

Another HIPAA Settlement: Stolen Laptop Costs $2.5 Million Plus Encryption Requirement

by Perkins Coie on

The U.S. Department of Health and Human Services (HHS) recently announced yet another HIPAA privacy and security settlement involving Protected Health Information (PHI) on a stolen laptop. Although this might be seen as just...more

$2.5 Million Settlement Reached as HIPAA Crackdown Continues on Unsecured Portable Devices

by Jones Day on

A recent settlement of $2.5 million for alleged violations of the Health Insurance Portability and Accountability Act ("HIPAA") continues a trend of government enforcement targeting health care providers and vendors that fail...more

First HIPAA Settlement Involving a Wireless Health Services Provider

by Saul Ewing LLP on

?On April 24, 2017, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that CardioNet, Inc. (CNI) agreed to pay $2.5 million and enter into a Corrective Action Plan (CAP) to settle...more

Failure to Implement Business Associate Agreement Results in $31,000 Settlement For Health Care Provider

by Saul Ewing LLP on

On April 20, 2017, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Children’s Digestive Health (CDH) agreed to pay HHS $31,000 for its failure to have a business associate...more

Fate Uncertain for HHS’s Extension of ACA Discrimination Protections to Abortion & Gender Transition

by Genova Burns LLC on

In May 2016 HHS issued a final rule implementing the Affordable Care Act’s Section 1557 nondiscrimination provision, which applies to recipients of funding from HHS. The rule prohibits discrimination on the basis of gender...more

Recent HIPAA Privacy and Security Settlements and Lessons Learned

by Perkins Coie on

Although the fate of the Affordable Care Act remains undecided, enforcement of the HIPAA privacy and security regulations by the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services is ongoing,...more

OCR Identifies Continuing HIPAA Enforcement Issues, Areas of Future Guidance and Regulations

Last week the Health Care Compliance Association hosted its annual “Compliance Institute.” Iliana Peters, HHS Office for Civil Rights’ Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA...more

HHS Expected to Release Significant HIPAA Privacy Guidance This Year; Compliance Audits Proceed; Guide on Compliance Program...

by WilmerHale on

HIPAA privacy guidance, audits, and enforcement are continuing under the new Administration. On March 27, 2017, Iliana Peters, Senior Adviser for HIPAA Compliance and Enforcement at the US Department of Health and...more

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

by Baker Ober Health Law on

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

by Foley & Lardner LLP on

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

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Cybersecurity

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