Covered Entities

News & Analysis as of

Family Businesses Outperform Publicly Traded Companies

In late 2012, researchers Nicolas Kachaner, George Stalk and Alain Bloch at the Harvard Business School published a study to compare family-owned businesses of certain sizes and industries with their non-family-owned...more

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Is Your HIPAA Compliance Program Ready for the FTC?

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Securities and Governance Update: October 2015 Update

This summer, the SEC proposed a new clawback rule (Proposed Rule 10D-1) to implement Section 954 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank). Section 954 of Dodd-Frank added a new...more

New CFTC Cybersecurity Standards Are Coming Soon

On September 29, 2015, Commodity Futures Trading Commission (CFTC) Chairman Timothy Massad delivered a “State of the Derivatives Marketplace” speech before the 3rd Annual OTC Derivative Summit North America. The speech...more

OIG Calls for Stronger HIPAA Compliance Efforts

The OIG has issued two reports calling for stronger ONC oversight of covered entity compliance with HIPAA standards. In the first report, “OCR Should Strengthen Its Oversight of Covered Entities’ Compliance with the HIPAA...more

SEC Ramps up Cybersecurity Scrutiny With Examination Priorities and an Enforcement Action

Why it matters - Signaling that it will continue to increase its scrutiny of firms' cybersecurity readiness, the Office of Compliance, Inspections and Examinations of the Securities and Exchange Commission (SEC) issued a...more

Reports Instruct Office of Civil Rights to Increase HIPAA Enforcement Activities

On September 29, 2015, the Office of Inspector General (OIG) released two reports that reviewed the Office of Civil Rights’ (OCR) enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The...more

OCR announces launch of Phase 2 of HIPAA audits

Although the Office for Civil Rights (OCR) has indicated in the past that it would start its next round of HIPAA audits, apparently it means business now. In the wake of an Inspector General report that the OCR was merely...more

Blog: HHS To Launch New HIPAA Audits in Early 2016 in Response to OIG Reports

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and...more

Just in Time for the Phase II Audits: OIG Criticizes OCR’s Enforcement Efforts

As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

Alert: UCLA Cleared in Lawsuit Alleging Lax Authentication Involving Insider Access to Medical Records

Earlier this month, a California jury found the University of California, Los Angeles Health System (UCLA) not liable for damages that allegedly resulted when a medical office assistant, Alexis Price, improperly accessed and...more

FCC’s New Order Provides Some Guidance for Imaging Centers Placing Autodialed Calls to Patients

The Telephone Consumer Protection Act (“TCPA”) protects consumers from unwanted telephone calls and text messages by requiring a business to obtain prior express consent before placing autodialed or prerecorded voice calls to...more

Fitbit Agrees to Sign Business Associate Agreements and Take on HIPAA Compliance

Is your Fitbit data covered by HIPAA? It depends upon where you got it (kind of). If you go to the store and pick up a Fitbit on your own, the data it generates is governed by the user agreement that you click through...more

HHS Proposes Rules for Nondiscrimination in Health Care

On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) proposed new regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). Section 1557 prohibits...more

Cure of Security Rule Violations Following Breach of EPHI Cannot Save Covered Entities from $750,000 Settlement; Non-Breach...

More than three years after the Cancer Care Group, P.C. (“CCG”) notified the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) of a breach of unsecured electronic protected health...more

Don’t Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called “Phase 2 Audits” are set to commence...more

Don't Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called "Phase 2 Audits" are set to commence...more

Recent Enforcement Shows the Importance of Encrypting Mobile Devices Containing Protected Health Information

With headlines every day announcing another release of Protected Health Information (PHI), providers are asking themselves – is there a way to protect against these breaches? Beyond improving the security of large...more

Summary of Key 340B Omnibus Guidance Proposals

As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more

$750,000 HIPAA Settlement Reinforces Need to Be Proactive

As the Department of Health and Human Services’ (“HHS”) Office of Civil Rights (“OCR”) proceeds with its second round of HIPAA audits, this time covering business associates as well as covered entities, a recent settlement...more

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