Covered Entities

News & Analysis as of

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

OCR Transmits Pre-Audit Screening Surveys to Covered Entities for Phase 2 HIPAA Compliance Audits

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently transmitted HIPAA pre-audit screening surveys to covered entities that may be selected for a second phase of HIPAA compliance audits...more

OCR Enforcement of HIPAA Affects Entities of all Sizes Small Pharmacy Enters into Latest Settlement

U.S. Department of Health and Human Services (HHS) announced late last week that Cornell Prescription Pharmacy (Cornell) agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996...more

OCR Announces Another HIPAA Settlement and Warns Not to Forget About Paper Records

On April 27, 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that Cornell Prescription Pharmacy (“Cornell Pharmacy”) had entered into a resolution agreement to settle,...more

2015 Phase Two HIPAA Audits – Delayed Again

Recently, the Director of the Department of Health and Human Services Office for Civil Rights (“OCR”) confirmed that OCR is still working to finalize the procedures for “Phase Two” HIPAA audits. OCR had initially planned to...more

HIPAA Rules and Procedures in the Event of a Data Breach, Part Two

My last post focused on the discovery and investigation of a data security breach to determine if breach notification is needed. Today’s post now turns to the requirements of breach notification triggered by a data security...more

HHS Settlement: Dumpster-Diving Leads to Settlement for Improper Disposal of Documents Containing Protected Health Information

The U.S. Department of Health and Human Services Office for Civil Rights (HHS) recently announced that it has reached an agreement with a small pharmacy to resolve potential HIPAA violations. The settlement arose from the...more

Blog: HIPAA FAQ Series: Do You Need a BAA with Your Cloud Storage Provider?

This week, the HIPAA FAQ series continues with another topic about business associate agreements (BAAs). As most Covered Entities and Business Associates know, in the event that a Covered Entity utilizes a service provider...more

Friendship, Commerce and Navigation Treaties and Title VII

On April 15, 2015, former employee Steven Heldt sued Tata Consultancy Services, Ltd. in United States District Court for the Northern District of California for discrimination. Tata is multinational corporation headquartered...more

EEOC Issues Proposed Wellness Program Amendments to ADA Regulations

On April 16, 2015, the Equal Employment Opportunity Commission (“EEOC”) released its highly anticipated proposed regulations (to be published in the Federal Register on April 20, 2015, for notice and comment) setting forth...more

Should You Sharpen Your Diversity Policies & Practices under Dodd-Frank Mandates?

The much-publicized Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 became effective on August 12, 2011. Section 342 of the Dodd-Frank Act, requiring the implementation of diversity practices for both...more

Open Internet Order Published and to Become Effective on June 12, 2015—Numerous New Appeals Expected

The FCC’s Open Internet Order (the “Order”) was published in the Federal Register today, Monday, April 13, and, unless the Order is stayed, will become effective after sixty days, on June 12, 2015. Publication in the Federal...more

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