Consumer Protection Health

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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

FDA Says Sharing Medical Product Information is Caring, to an Extent

FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...more

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

Monthly TCPA Digest - January 2017

We are pleased to present the latest edition of our Monthly TCPA Digest, providing insights and news related to the Telephone Consumer Protection Act (TCPA). This month’s issue features updates on the latest regulatory...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

FDA Recommends Maximum Level of Lead in Cosmetic Products . . . But Finds that Most Products Surveyed are Already Well Below the...

As 2016 comes to an end, the Food and Drug Administration (FDA or agency) is turning its attention to cosmetics by issuing a draft guidance on December 21, 2016 recommending a limit of “no more than 10 parts per million (ppm)...more

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