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Health Consumer Protection

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

South Carolina Insurance Department Amends Privacy Regulations

by Weiner Brodsky Kider PC on

The South Carolina Department of Insurance recently amended its Privacy of Consumer Financial and Health Information provisions (Regulation 69-58) to eliminate the annual privacy notice requirements for financial institutions...more

Latest Challenge to Affordable Care Act Arises in Idaho

The decision of Blue Cross of Idaho to offer health insurance plans that appear to violate federal law begins the latest chapter in the continuing saga of the Affordable Care Act’s increasingly tenuous existence. Blue Cross...more

Patience is Waning: Courts Start Reversing Themselves on TCPA Stays as Delay on Omnibus Ruling Continues

by Dorsey & Whitney LLP on

It has been 15 months since oral argument in the ACA’s appeal of the FCC’s 2015 Omnibus, and courts are starting to lose patience waiting for a decision by the D.C. Circuit. Last week, two district courts in California...more

Window on Washington - Vol. 2, Issue 6

by Clark Hill PLC on

Outlook for This Week in the Nation's Capital - FY18 Appropriations Work Already Underway. Since the passage of the bipartisan budget deal this past Friday, House and Senate Appropriations Committees have already begun...more

Massachusetts Launches New Online Breach Reporting Form

by Murtha Cullina on

On Monday, February 5, 2018, the Massachusetts Attorney General’s Office (AGO) sent an e-mail blast regarding their new online form for businesses needing to report breaches under Chapter 93H of the Massachusetts General...more

Window on Washington - Vol. 2, Issue 5

by Clark Hill PLC on

Another Shutdown? Congress needs to pass another short-term spending bill by Friday in order to keep the government open, but some House Republicans are against the plan for a fifth continuing resolution that would fund the...more

A Client's Guide to FDA Recalls

Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more

Angry Text Message Recipient Loses Court Challenge On Flu Shot Reminder

by Farrell Fritz, P.C. on

It’s flu season again. Your PCP at WPMG is thinking of you! So began the health care provider’s text message that prompted this month’s Second Circuit decision applying the Telephone Consumer Protection Act to a flu shot...more

Window on Washington - Vol. 2, Issue 4

by Clark Hill PLC on

Another Continuing Resolution. Or Two? Within days of passing the CR to reopen the government, multiple Members of Congress expressed the possibility of needing another CR to fund the government after February 8. ...more

More on BMS & Nationwide Class Actions

by Reed Smith on

Speed. Some things move faster than others. When we viewed last August’s solar eclipse, in Tennessee, the Moon’s shadow was moving along the Earth at a rate of about 1,450 miles per hour. Depending mostly on latitude, your...more

A Shot in the Arm: Second Circuit Holds Flu Shot Text Messages Didn’t Violate TCPA

Earlier this month, the Second Circuit ruled that Mount Sinai Health System did not violate the Telephone Consumer Protection Act (TCPA) when it sent automated flu shot text message reminders to patients. The three-judge...more

Potential Impacts on Telehealth From Net Neutrality Repeal

On December 14, 2017, the Federal Communications Commission (FCC) passed the Restoring Internet Freedom Order (RIFO), repealing the FCC’s 2015 “net neutrality” rules and shifting the responsibility for regulating the conduct...more

Pennsylvania Risperdal Decision Doesn’t Go As Far As Plaintiffs Suggest

by Reed Smith on

While the recent Pennsylvania Superior Court Risperdal decision is not a defense victory, it is certainly not as favorable for plaintiffs as they are making it out to be. While several issues were presented for appeal in...more

Partner Colin Zick Speaks to Bloomberg BNA about Cyberthreats and Healthcare Data

The federal government has identified two new cyberthreats that put patients’ personal data at risk for exposure. The threats, known as Spectre and Meltdown, exploit a vulnerability in many commercial computer chips...more

Window on Washington - Vol. 2, Issue 3

by Clark Hill PLC on

Shutdown. The government officially shutdown at 12:01am on Saturday but the effects have not yet been fully felt given it was the weekend. Yesterday, Senate Majority Leader Mitch McConnell announced that the Senate would vote...more

NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book

by Mintz Levin on

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more

FDA Proposes to Delay Off-Label “Intended Use” Rule

by Reed Smith on

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

No Old Kentucky Home for Parallel FDCA-Based Tort Claims

by Reed Smith on

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: "In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the...more

Second Circuit Holds Flu Shot Reminder Did Not Violate the TCPA

The Second Circuit has affirmed a lower court decision that a flu shot reminder sent by text message by a medical provider did not violate the Telephone Consumer Protection Act (the “TCPA”). The decision is important because...more

FDA to step up enforcement of homeopathic medicine

by Thompson Coburn LLP on

Homeopathic medicine has long occupied a niche in American culture. Since 1988, with the issuance of the Compliance Policy Guide, § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed,” the FDA has had a...more

Antitrust enforcement priorities for 2018

by Bricker & Eckler LLP on

Health care antitrust in 2017 saw governmental agencies successfully pursue a number of enforcement actions. Examining these actions provides insight and guidance as to what might happen in antitrust enforcement in 2018 and...more

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

by McDermott Will & Emery on

Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

Where To Find Our Research 3.0

by Reed Smith on

Happy New Year! - It’s been 3 ½ years since we last updated our index to our online research resources. That’s almost ? of the total life of the blog, which started in way back in 2006. We’ve been blogging now for well...more

Court Finds Calls Regarding Medicaid Coverage Not Telemarketing

A Nevada federal court granted summary judgment in favor of a Telephone Consumer Protection Act (TCPA) defendant after concluding that the plaintiff granted prior express consent to be contacted when she provided her phone...more

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