Consumer Protection Privacy Health

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CMS Recommendations Regarding Protection from Cybersecurity Risks

On January 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued Recommendations to Providers Regarding Cyber Security. In general, the Recommendations are intended to remind providers and suppliers to keep...more

SAMHSA Issues Final Rule Modernizing Confidentiality Requirements for Patients Receiving Substance Use Disorder Treatment

Last month, the U.S. Department of Health and Human Services (“HHS”) Substance Abuse and Mental Health Services Administration (“SAMHSA”) released a Final Rule updating the Confidentiality of Alcohol and Drug Abuse Patient...more

$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

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

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

TCPA Violations Claimed Against Rady Children’s Hospital in San Diego

Rady Children’s Hospital-San Diego (Rady) was hit with a proposed class action in California federal court this week for alleged violations of the Telephone Consumer Protection Act (TCPA) for autodialed debt-collection calls...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

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

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

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

Final Rule Modernizes Substance Use Disorder Patient Record Confidentiality Regulations

On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its long-awaited final rule amending the confidentiality regulations at 42 CFR Part 2 (Part 2) that apply to federally...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 Reaches $2.2 Million Settlement With Life Insurance Company For Impermissible Disclosure Of ePHI

On January 18, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS OCR”) announced that it had agreed to a $2.2 million settlement with MAPFRE Life Assurance Company of Puerto Rico (“MAPFRE Life”),...more

Litigation Alert: The Third Circuit Holds That Allegations That Personal Information Was Improperly Disclosed in Violation of the...

Last week, the Third Circuit held that allegations of the unauthorized disclosure of personal information in violation of the Fair Credit Reporting Act (FCRA) constituted a de facto injury sufficient to confer standing at the...more

Recent HIPAA Enforcement Actions

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health,...more

Blue Shield Avoids TCPA-Related Liability

A federal court in California recently granted a summary judgment motion filed by Blue Shield of California (“Blue Shield”), allowing it to avoid liability for alleged violations of the Telephone Consumer Protection Act...more

Do Routine Calls by Health Plans to Patients and Health Plan Members Constitute “Telemarketing” Under the Telephone Consumer...

Covered entities have a long list of laws and regulations governing their conduct, including their communications with patients, customers, and members. Specifically, the Health Insurance Portability and Accountability Act...more

Enough is Enough: Court Dismisses TCPA Class Action Against A Health Plan That Placed Reminder Calls To Its Members That They...

Plaintiffs across the country have continued to file class actions against companies of all stripe for violation of the Telephone Consumer Protection Act (“TCPA”), often for communications far afield from the classic...more

What You Need To Know About the FDA’s Guidance on Postmarket Cybersecurity

The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year. You can link to a full copy here, and we gave you our detailed take on the draft...more

Failure to Timely Notify Results in Enforcement Action and Significant Settlement

For the first time, on January 9, 2017, the Department of Health and Human Services, Office for Civil Rights (HHS/OCR) settled a HIPAA enforcement action based on the untimely reporting of a breach of unsecured protected...more

Joint Commission Confirms Ban on Texting of Patient Care Orders

After briefly considering a reversal of its prohibition on texting orders, The Joint Commission (TJC), in consultation with the Centers for Medicare & Medicaid Services (CMS), announced last month that its ban would continue...more

FDA Issues Final Guidance on Postmarket Cybersecurity

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

FDA Releases Guidance on Cybersecurity and Medical Devices

The FDA represents the latest federal agency to show a focus on cybersecurity issues with the release December 28 of new guidance. While the prospect of network-enabled medical devices increasingly offers the promise of...more

OCR’s 2016 Ransomware ‘Guidance’: A Health Care Provider’s New Best Friend?

Background on Ransomware Attacks - Doomsday-esque ransomware scenarios are having an increasing impact on the health care industry, becoming commonplace in 2016. Security experts and the media have reported that health...more

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