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Health Consumer Protection

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

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

Banking & Financial Services E-Note - September 2017

by Burr & Forman on

By now, most people that follow financial news are aware that the amount of troubled healthcare related companies are on the rise, which by its very nature, causes more distressed healthcare related debt in the market....more

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

FDA Approves First Qualified Health Claim about Allergy Prevention on Baby Food Labels

by Proskauer - Advertising Law on

Last month, the FDA announced that companies will be able to label baby food products with advice about how the early introduction of peanuts in an infant’s diet may reduce the risk of developing a peanut allergy. This marks...more

A Conversation on CMS’ Emergency Preparedness Compliance for Healthcare Providers

by Carlton Fields on

Hurricane Irma recently wreaked havoc on the Caribbean and much of the state of Florida. In the storm's aftermath, ten residents of a South Florida nursing facility died because the facility lost power, and did not have...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Nancy Rotering Announces Candidacy for Illinois Attorney General- Highland Park Mayor Nancy Rotering announced that she is entering the 2018 race for AG. Rotering is Mayor of Highland Park and previously...more

Better Healthcare Newsletter from Patrick Malone - October 2017

IN THIS ISSUE: - Need for nursing care may arise suddenly - Research, visit, consult. Repeat. And take all the time you can. - Make a decision, then make sure to stay engaged. - Care giving at home: It's a tough...more

Security Vulnerabilities Identified In Wireless Syringe Infusion Pumps

The U.S. Department of Homeland Security (DHS) recently issued a warning that Smiths Medical Medfusion 4000 wireless syringe infusion pumps contain a security vulnerability that can be exploited by hackers to alter the...more

Off-Label Marketing Case Tossed

by Reed Smith on

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them,...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Democrat Peter Neronha Declares Candidacy for Rhode Island Attorney General- Democrat Peter Neronha formally announced his bid to become Rhode Island AG in 2018. Neronha served as U.S. Attorney for the...more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

AGG Food and Drug Newsletter - September 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Emergency Rules Requiring Generators in Florida ALFs and Nursing Homes

by Holland & Knight LLP on

As a result of Hurricane Irma, eight nursing home residents died after a power failure in a Hollywood, Florida nursing home. In the wake of that tragedy, on Sept. 18, 2017, Florida regulators published emergency rules...more

As Medical Food Industry Grows, So May FDA Scrutiny

by Baker Donelson on

On September 1, the United States Food and Drug Administration (FDA) issued a Warning Letter to ND Labs, Inc. of Lynbrook, New York, regarding its LPS Cherry, Liquid Fiber Flow, and Nana Flakes 'medical food' products. The...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP on

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

In the Wake of Harvey and Irma, OCR Reminds Providers of HIPAA Rules

As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR)...more

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 26

by Clark Hill PLC on

House Finishes Work on Its Annual Appropriations Bills, For Now: The House narrowly passed a $1.2 trillion package of spending bills to fund the government for Fiscal Year 2018 by a vote of 211-198. Amendments offered to the...more

Recall Highlights Medical Device Cybersecurity Issues

by Knobbe Martens on

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

CMS Lifts Ban on Arbitration Agreements and Proposes Rules for Transparency in the Arbitration Process

by Baker Ober Health Law on

In a new proposed rule published in June 2017, the Centers for Medicare and Medicaid Services (CMS) proposed to abandon its previous rule prohibiting long term care facilities from entering into pre-dispute arbitration...more

Global Privacy & Cybersecurity Update Vol. 15

by Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more

Medical Monitoring Class Certification Fails

by Reed Smith on

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing...more

Essential Revisions to CMS' SNF Civil Money Penalty Policies

by Baker Ober Health Law on

On July 7, 2017, the Centers for Medicare and Medicaid Services (CMS) issued revisions to its Civil Money Penalty (CMP) policies and CMP Analytic Tool to increase national consistency amongst Regional Offices (ROs) when...more

Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit

by Reed Smith on

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from...more

Congressional Task Force Issues Report on Cybersecurity in the Health Care Industry

by Polsinelli on

Recently, the Health Care Industry Cybersecurity Task Force (the “Task Force”) issued its Report on Improving Cybersecurity in the Health Care Industry (the “Report”). The Task Force, which was created by Congress as part of...more

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