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Your Cyber Minute: Lessons learned from the automotive sector  [Video]

The internet of things has presented new challenges across all industries. Hear partners Harriet Pearson and Tim Tobin discuss what others can learn from automotive in this sharing of best practices. ...more

Advice to Healthcare Providers on Ransomware from the Head of the FBI

On Wednesday, March 8, James B. Comey, Director of the FBI, was at Boston College to deliver the keynote address for the inaugural Boston Conference on Cyber Security (BCCS 2017). Director Comey addressed various industry,...more

Your Cyber Minute: Intersection of cybersecurity and the automotive industry  [Video]

Technological vulnerabilities, regulators’ watchful eyes, and personal connections with our vehicles – create a collision course for cyber risk. Partners Harriet Pearson and Tim Tobin dissect these three simple reasons why...more

OCR Releases Guidance on Reporting and Monitoring Cyber Threats

Last week, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) released new guidance on reporting and monitoring cyber threats. The guidance urges covered entities and business associates to...more

Advertising Law - March 2017

FTC Fights Back in LabMD Suit - The Federal Trade Commission demonstrated its intention to fight for the power to regulate data security by filing a 111-page brief with the U.S. Court of Appeals for the Eleventh Circuit...more

Your Cyber Minute: Importance of the GDPR to the global business community [Video]

Ambitious and broad-reaching, the Global Data Protection Regulation is impacting companies around the world. Listen as Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran talk...more

On Alternative Design, Take Two - Negligence

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.” Taking the alternative design requirement for strict liability as a given, we...more

Your Cyber Minute: Current GDPR regulatory and enforcement landscape  [Video]

The conversation continues with Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran as they go deeper into what clients need to know when it comes to compliance around 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

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

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

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

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

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Cybersecurity

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