Covered Entities

News & Analysis as of

$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

NIST Standards Provides An Oasis Of Mobile Device Security In The EHR Desert

The healthcare industry has long awaited some certainty in the arena of mobile devices in light of the continued push for electronic health records (“EHR”) and coordinated care. The prevalence, convenience, and speed of such...more

HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

St. Elizabeth’s Medical Center Pays $218,400 to Settle Alleged HIPAA Security Case Stemming from Use of Cloud-Based Document...

Alleged HIPAA Violations Resulted from Medical Center’s Failure to Risk Assess Internet-Based Document Sharing Application and Inadequate Breach Response. The US Department of Health and Human Services (HHS) Office for...more

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

A summary and analysis of HRSA's proposed 340B program guidance

On August 28, 2015, the US Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published its long-awaited, if still only proposed, 340B program guidance (Proposed Guidance). 80 Fed....more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

Breaking News: Proposed 340B Omnibus Guidance Released

The Health Resources and Services Administration (“HRSA”) released an advanced copy of its long-awaited proposed 340B Omnibus Guidance (“Guidance”) today. The document can be found here. Polsinelli is currently reviewing the...more

Hacking Your Health: For Healthcare Providers, Risk Analysis Must Be Ongoing

Healthcare providers would be wise to keep in mind that if a patient is harmed by a hacked medical device, Exhibit A in the negligence suit against them may be that provider’s risk analysis, or lack thereof....more

Striking a Balance: Alabama’s Newly-Amended Restrictive Covenant Statute

When Alabama Governor Robert Bentley signed House Bill 352 into law on June 11, 2015, he repealed Alabama’s bare bones restrictive covenant statute and replaced it with a detailed codification of much of Alabama’s restrictive...more

SEC Adopts Final Pay Ratio Rules

On August 5, 2015, the Securities and Exchange Commission (SEC) voted 3-2 to approve its controversial pay ratio rules. The rules were adopted pursuant to the mandate of Section 953(b)(1) of the Dodd-Frank Wall Street Reform...more

HHS issues fact sheet on HIPAA rules and resources

The Department of Health and Human Services (HHS) has released a fact sheet on the privacy, security, and breach notification rules of the Health Insurance Portability and Accountability Act (HIPAA). Designed to apply to...more

Is Your Health Plan HIPAA Compliant?

Data breaches with respect to medical information are on the rise, given that such information is generally more valuable on the black market than stolen credit card data. The 2015 breach of healthcare company Anthem, Inc.,...more

Regulators Issue Final Dodd-Frank Standards for Assessing Diversity Policies and Practices of Covered Entities in the Financial...

On June 9, 2015, six federal agencies (“Agencies”) subject to the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (“Act”) issued much-anticipated joint final standards (“Final Standards”) in accordance with...more

Proceed With Caution: Does HIPAA Apply to Your Business?

Even if your business is not in the health care industry, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as updated by the Health Information Technology for Economic and Clinical Health Act (HITECH...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

HIPAA and Jason Pierre-Paul’s Medical Chart – Setting the Record Straight

Last night, ESPN reporter Adam Schefter tweeted a photo of New York Giants defensive end Jason Pierre-Paul’s medical chart, which chart indicated that Pierre Paul had his index finger amputated. The amputation was apparently...more

Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges

A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed...more

HRSA Publishes Proposed Rule on 340B Ceiling Prices and Manufacturer CMPs

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a Proposed Rule that would codify standards for the calculation of ceiling prices by manufacturers for covered outpatient drugs under the...more

New CFRA Amendments Take Effect July 1

On July 1, 2015, as previously reported, new California Family Rights Act ("CFRA") regulations will take effect. These amended regulations clarify areas of confusion and bring the CFRA into closer alignment with its federal...more

Upcoming HIPAA Audits May Target Financial Institutions—Here’s How to Prepare

Much like a tornado watch, the conditions appear to be right for a coming storm: the upcoming Phase 2 HIPAA audits. The Department of Health and Human Services Office for Civil Rights (OCR) has begun verifying contact...more

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

Blog: HIPAA FAQ Series: Does HIPAA Protect the PHI of Deceased Individuals?

In order to protect the privacy and security of patients’ information, the Health Insurance Portability and Accountability Act (HIPAA) imposes substantial obligations on covered entities (certain providers, plans, and health...more

Proposed Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

On June 16, 2015, the U.S. Department of Health and Human Resources (HHS) and the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Notice) related to the 340B Drug Pricing Program...more

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