Covered Entities

News & Analysis as of

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When Alabama Governor Robert Bentley signed House Bill 352 into law on June 11, 2015, he repealed Alabama’s bare bones restrictive covenant statute and replaced it with a detailed codification of much of Alabama’s restrictive...more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

CFPB Finalizes Automobile Finance Larger Participant Rule and Publishes Examination Procedures

On June 10, 2015, the Consumer Financial Protection Bureau (CFPB) announced a final rule that will allow it to supervise larger nonbank automobile finance companies. Accompanying the rule, it also published the procedures...more

Deeper Dive: Healthcare Incidents Involving More Than 500 Individuals Are Investigated 100 Percent of the Time

We have released the inaugural BakerHostetler Data Security Incident Response Report, which provides insights generated from the review of more than 200 incidents that our attorneys advised on in 2014. The report confirms the...more

FCC Releases Emergency Information Accessibility Rules for Second-Screen Devices and Grants Compliance Waivers

The Federal Communications Commission (FCC) has released the text of its Second Report and Order (R&O) adopting rules requiring multichannel video programming distributors (MVPDs) to pass through the secondary audio stream...more

Blog: HIPAA FAQ Series: Are Covered Entities and Business Associates Required to Encrypt PHI?

The Health Insurance Portability and Accountability Act (HIPAA) mandates that both Covered Entities and Business Associates protect the security of Protected Health Information (PHI) in a variety of ways. Specifically,...more

How Transparent is Your Supply Chain? California AG Issues Guidance

After almost five years since passage, California’s Attorney General has finally produced guidance on The California Transparency in Supply Chains Act of 2010. With the Attorney General at last weighing in (the Resource Guide...more

Also In the News - Data, Privacy, & Security Practice Report - May 2015

ONC Releases Updated Guide To Privacy And Security of Electronic Health Information ? The Office of the National Coordinator for Health Information Technology (“ONC”) recently released Version 2.0 of the Guide to Privacy and...more

OCR Launches Phase 2 HIPAA Audit Program with Pre-Audit Screening Surveys

Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entities have reported that the U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently sent pre-audit screening surveys...more

New Study Finds That Criminal Attacks Are The Number One Cause Of Health Sector Data Breaches

On May 7, 2015, the Ponemon Institute released its Fifth Annual Benchmark Study on Privacy & Security of Healthcare Data (the “Study”), which surveyed 90 HIPAA covered entities and 88 business associates regarding their...more

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