Consumer Protection Health

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Hey Dentists: No Business Associate Agreement, No Problem

According to the U.S. Health and Human Services Office for Civil Rights (OCR), dental practices are not required to have a business associate agreement with their dental laboratory before sharing protected health...more

FDA’s Public Meeting on the Use of the Term “Healthy” in the Labeling of Human Food Products – A Summary of Key Points

On March 9, 2017, the Food and Drug Administration (FDA or Agency) held a public meeting in Rockville, MD, which FDA officials described as a way to engage in a dialog with the public and regulated industry and allow for...more

Antitrust Not Always Available in Competitor Disputes in the Healthcare Sector

The antitrust injury and antitrust standing defenses/doctrines are alive and well in healthcare.  A recent case, SCPH Legacy Corp. et al. v. Palmetto Health et al., shows that a competitor is not always the most legally...more

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

Privacy and Information Security a Top Priority in California under Xavier Becerra

Governor Jerry Brown’s selection of Congressman Xavier Becerra to succeed (now Senator) Kamala Harris as the new Attorney General of California was a surprising move that brings into power in California a seasoned advocate of...more

Menu Labeling Excluded From ACA Repeal and Replace Bill

The American Health Care Act (AHCA), released by House Republicans late on March 6, 2017, would repeal and replace certain portions of the Affordable Care Act (ACA). The legislation does not address section 4205 of the ACA,...more

Better Healthcare Newsletter from Patrick Malone - March 2017

Avoid diabetes' dire harms - You’ve heard an earful about the dangers of diabetes since you were a kid. Your parents may have tried to grab back that big bag of Halloween candy by telling you that too much sugar causes...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

FDA Publishes Guidance on Off-Label Use Communications

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the...more

Charging for Medical Records Can Cost You

Health care providers often are unaware of federal laws that regulate the process by which they charge patients for copies of medical records. Many providers incorrectly assume that only the law of the state in which the...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

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

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Cybersecurity

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