News & Analysis as of

A New Era of HIPAA Enforcement

Traditionally, HIPAA enforcement is assigned to the Department of Health and Human Services’ Office for Civil Rights (OCR). In November 2013, Health and Human Services’ Office of Inspector General sharply criticized OCR’s...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

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

ONC Releases Privacy and Security Guidance Geared Toward Small Providers

The HHS Office of the National Coordinator for Health Information Technology (“ONC”) recently released a new and improved version 2.0 of their Guide to Privacy and Security of Electronic Health Information. This revamped...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

OCR Settles Alleged HIPAA Violations with Small, Single Location Pharmacy for $125,000 – Emphases Importance for Secure Disposal...

The U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced yesterday a new settlement relating to potential violations of the Health Insurance Portability and Accountability Act of 1996...more

Colorado Compounding Pharmacy Enters Six-Figure Settlement Agreement to Settle Alleged HIPAA Privacy Rule Violations

On April 27, 2015, the U.S. Department of Health and Human Services (HHS) announced that Cornell Prescription Pharmacy (CPP), a single-location pharmacy in the Denver, Colo. metropolitan area, agreed to settle alleged HIPAA...more

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

As discussed in my prior post, recent massive data breaches at major retailers and health insurance providers paint a bleak picture of modern data and emphasize the importance of strong security safeguards and plans for...more

HHS/Office of the National Coordinator issues report that health information sharing is being blocked to gain a competitive edge

In a scathing report released last Friday, the Department of Health and Human Services Office of the National Coordinator (ONC) accused hospitals and software vendors of preventing the sharing of health information in order...more

Pharmacies: Watch Out for Future HHS Crackdowns on Security Rule Violations

As we all know by now, HIPAA required the Secretary of the U.S. Department of Health and Human Services (HHS) to adopt regulations protecting the privacy of "protected health information" (PHI). HHS responded to that...more

California Prosecutors Settle PHI Breach with Retailer

Beginning in 2012, California environmental regulators and others began investigating the grocery store chain Safeway relating to the company’s waste disposal practices. During the investigation, certain documents listing...more

OCR Updates Breach Report Web Portal — Changes Could Impact Annual Breach Reports

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently launched an updated version of the portal covered entities must use to notify OCR regarding a breach of unsecured protected health...more

8 Things Healthcare Providers Should Know About E-Signatures

Electronic signatures can be legally valid to execute documents that require written signatures, and electronic documents can be legally valid when applicable laws require documents to be in writing....more

Health Headlines: Also in the News - January 2015 #3

ALSO IN THE NEWS - HHS Publishes Goals on Alternative Payment Models with Continued Focus on Quality – In its continued efforts to base Medicare payments on quality over quantity, this morning HHS made public its goal...more

Deadline Approaching to Report Certain HIPAA Breaches to Federal Officials

The HIPAA Breach Notification Rule requires covered entities to notify the Secretary of the Department of Health and Human Services (HHS) if a breach of unsecured protected health information (PHI) is discovered. As most...more

IT Maintenance Crucial for HIPAA Compliance

The Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) recently announced an agreement with a medical center to settle charges stemming from the center’s failure to prevent malware from infecting its...more

Department Of Health And Human Services Issues Proposed New Rules Implicating The Use Of Electronic Health Records And Patient...

On December 8, 2014, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule related to changes to the Medicare Shared Savings Program. These revisions promote the use of electronic health records by...more

What Can You Expect in 2015 Regarding HIPAA Enforcement?

As of earlier this month, 1, 170 breaches involving 31 million records have been reported to the Department of Health and Human Services (HHS) since mandated reporting of breaches began in September 2009.  An increase in the...more

News from the Health Law Gurus™

Patient Medical Records Stolen from New Jersey Storage Facility – Tribeca Medical Center is notifying patients that their protected health information may be compromised. According to a privacy notice posted on Tribeca...more

Grand Theft PHI – Are Vendors Putting You at Risk for a HIPAA Breach?

Your vendor’s employee goes home after a long day of collecting wellness questionnaires and biometric screening results only to wake up the next day to discover that her car has been stolen from her driveway. As you can...more

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

OIG’s New Work Plan Focuses on the Security of Health Information

On October 31, 2014, The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for fiscal year (FY) 2015. The Work Plan summarizes “new and ongoing reviews of activities...more

HIPAA Privacy in Emergency Situations

In light of the Ebola outbreak and other events, the U.S. Department of Health and Human Services, Office for Civil Rights, released a bulletin to ensure HIPAA covered entities are aware of the ways in which patient...more

Health Update - November 2014

“Healthcare-Related” Calls: Ambiguity at the Intersection of HIPAA and TCPA - Editor’s Note: The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer...more

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