Consumer Protection Health

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House Republicans and Trump Administration File Joint Motion to Delay Suit Challenging Obamacare Subsidies

An interesting development transpired Tuesday, February 21, 2017 in a case pending in Federal District Court in the District of Columbia that challenges subsidy payments from the Federal Treasury to support Obamacare. The...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

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

Your Cyber Minute: The Implications of the GDPR for Cybersecurity [Video]

Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran discuss the Global Data Protection Regulation and what companies need to know now. ...more

Health Update - February 2017

Securing the Safety Net for America's Vulnerable Populations - Editor's Note: America's population is aging rapidly. By 2029, 75 million baby boomers will have reached age 65 and older, and older adults will represent...more

FDA Changes Warning For Fluoroquinolones

Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs: - Avelox (moxifloxacin); - Cipro (ciprofloxacin); - Cipro extended-release (Cirpofloxacin...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

Non-Physician Learned Intermediaries

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...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

Advocating for Patient Safety: Coalition for Patient Vision Care Safety submits comments in response to FTC Proposed Rule...

The Coalition for Patient Vision Care Safety (“Coalition”) is a group of health care providers, medical device manufacturers and academic institutions dedicated to ensuring the safe and appropriate use of contact lens so that...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

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...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

Plain Packaging and Warning Labels—While the WTO is Examining the Legality of Packaging and Labeling Requirements that Prohibit...

There have been several pieces of research recently calling for the use of plain packaging and graphic health warnings, similar to those used on tobacco products, on soft drinks and alcoholic beverages as a means of...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

New Hampshire Finalizes Opioid Prescribing Rules

New Hampshire is starting 2017 with stepped-up efforts to manage its oft-described opioid epidemic. Though the most recent regulations are directed at individual prescribers, and do not apply to the administration of opioids...more

Aetna-Humana Merger Blocked

The District of Columbia federal court recently ruled that a proposed $37 billion merger between health insurance giants Aetna and Humana cannot proceed, granting the US Department of Justice’s bid to block the combination 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

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