Health Science, Computers & Technology Privacy

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$5.5 Million HIPAA Settlement Underscores Importance of Audit Controls

On February 16, 2017, the HHS Office for Civil Rights (OCR) disclosed a $5.5 million settlement with Memorial Healthcare Systems (MHS) for HIPAA violations affecting the protected health information (PHI) of 115,143...more

$5.5 Million HIPAA Settlement Matches Largest Payment To-Date

On February 16, 2017, the U.S. Department for Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced that Memorial Healthcare Systems of Florida (“MHS”) agreed to pay $5.5 million and enter into a...more

Want to Know Why Memorial Healthcare Systems Is Paying HHS OCR $5.5 Million?

On February 16, 2017, HHS OCR announced that Memorial Healthcare Systems (MHS) had paid the U.S. Department of Health and Human Services (HHS) $5.5 million to settle potential violations of HIPAA’s Privacy and Security Rules...more

Modernization? SAMHSA Falls Short in Updating 42 C.F.R. Part 2

On January 18, 2017, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (“SAMHSA”) published a final rule amending 42 C.F.R. Part 2 (“Part 2”), with an effective date that...more

New HHS Secretary Delays Effective Date of Part 2 Final Rule

We previously reported that the 30 year old regulations (last updated in 1987) relating to the disclosure of substance abuse treatment information has been updated by SAMHSA to bring it into the modern world of electronic...more

HIPAA for HR - Some Good News for Employers

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that was enacted to ensure protection of individuals’ protected health information (PHI). The Standards for Privacy of Individually...more

Health Care E-Note - Februaury 2017

Ransomware: A Reportable Breach? In the past several years, a huge increase has occurred in the number of electronic attacks in the United States using ransomware, a form of malware that targets and encrypts critical...more

Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

Technical Noncompliance with HIPAA Can Lead to Big Penalties

As discussed in prior client alerts, the Office of Civil Rights (OCR), the agency charged with HIPAA enforcement, has increased HIPAA compliance initiatives in recent months and is poised to continue its enforcement...more

Cybersecurity 2017: The Year in Preview

Introduction - Cybersecurity was a prominent factor in 2016 in all aspects of government, business and personal affairs. Russian and other foreign national hacking has the potential to spark a new form of cold...more

The Anthem Breach – A Retrospective (Part II)

We published Part I of our “Anthem Breach Retrospective” in January 2017. Coincidentally, at around the same time several plaintiffs in one of the earliest filed cases arising out of the Anthem data breach voluntarily asked...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

To Settle or Not to Settle – That Is the Question Raised by Recent HIPAA CMPs

On February 1, 2017, the Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that the Children’s Medical Center of Dallas (“Children’s”) has paid a civil monetary penalty (“CMP”) of $3.2 million...more

TortSource: Ransomware: A Reportable Breach?

In the past several years, a huge increase has occurred in the number of electronic attacks in the United States using ransomware, a form of malware that targets and encrypts critical data and systems for the purpose of...more

HIPAA Enforcement Update (October 2016 – January 2017)

Since October 2016, the Department of Health and Human Services, Office for Civil Rights (OCR) announced four settlement agreements to resolve allegations of Health Insurance Portability and Accountability Act (HIPAA)...more

FDA 2016 Year in Review

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

HIPAA Small Breach Notification Due March 1: “In Like a Lion, Out Like a Lamb” if You Submit Timely

March 1, 2017 is the date by which HIPAA covered entities must notify the U.S. Department of Health and Human Services Office for Civil Rights (OCR) of “small” breaches of unsecured protected health information that were...more

St. Jude Cybersecurity Vulnerability Extended to Provider-Owned Devices

Earlier this week, the U.S. Department of Homeland Security (DHS) updated a prior advisory revealing cybersecurity vulnerabilities in St. Jude Medical’s Merlin@home transmitter....more

After the Fact: FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices

The Food and Drug Administration (FDA) recently issued nonbinding guidance focusing on the software vulnerabilities of networked medical devices that are already on the market. The guidance focuses on the importance of...more

Hospital pays $3.2M Resulting from HIPAA Security Rule Noncompliance

In one of the last health care related acts of President Obama’s administration, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), imposed a multimillion-dollar HIPAA civil money penalty (CMP)...more

Lack of Timely Action and Knowledge of Risk Results in $3.2 Million Civil Monetary Penalty for HIPAA Violations

Children’s Medical Center of Dallas (Children’s) was hit with a $3.2 million civil penalty from the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) for failing to take steps to properly protect...more

Blue Shield Of California Avoids TCPA Class Action Over Pre-Recorded Call

On January 13, 2017, the United States District Court for the Central District of California granted Blue Shield of California’s motion for summary judgment in a case on whether the insurer violated the Telephone Consumer...more

Substance Abuse and Mental Health Services Administration (SAMHSA) Issues Confidentiality of Alcohol and Drug Abuse Patient...

On January 13, 2017, SAMHSA issued a Final Rule updating the Confidentiality of Alcohol and Drug Abuse Patient Records regulations (42 C.F.R. Part 2). SAMHSA also issued a Supplemental Proposed Rule requesting comments on...more

HHS Finalizes Toned-Down Version of Common Rule Overhaul

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

Children’s Medical Center of Dallas Clobbered by OCR

In a rare move by the OCR, it assessed a $3.2 million fine against Children’s Medical Center of Dallas (Children’s) after it issued a Notice of Proposed Determination against Children’s and Children’s failed to request a...more

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