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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

Better Healthcare Newsletter from Patrick Malone - September 2017

Deflating the hype and exposing the risks of stem-cell treatments - Stem cells and regenerative medicine—a promising and complex field that has been a preoccupation of no less than popes, presidents, and top health policy...more

The State AG Report Weekly Update

by Cozen O'Connor on

Antitrust- Washington Attorney General Files Antitrust Lawsuit Against Health Care Providers Over Alleged Price-Fixing- Washington AG Bob Ferguson filed a lawsuit against health care providers Franciscan Health System...more

FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more

Guest Post – Before the Flood: Fifth Circuit Oral Argument on Writ of Mandamus From Pinnacle Hip Implant MDL

by Reed Smith on

Today’s guest post is by Reed Smith Houston office associate Curtis Waldo. Given the Noachic weather down there recently, one might ask “where’s Waldo?” The answer is safe and sound, if not quite high and dry. Curt is...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Three)

Even though the GDPR is a general regulation, some provisions are expressly addressing the specificities of the processing of personal data in the healthcare/life science sectors....more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part One)

The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation (“the GDPR”) will apply in all Member States of the European Union (“EU”) and will replace the Directive 95/46/CE...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Two)

New General Features of the GDPR - Some of the GDPR general features may be of particular interest for companies in the healthcare/life science sectors....more

D.C. Circuit Moves Data Breach Suit Forward

The U.S. Court of Appeals, D.C. Circuit issued a decidedly pro-consumer opinion recently in addressing what is required to establish standing for a data breach class action....more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Republican Whitney Westerfield Announces Bid for Kentucky Attorney General- Republican state Senator Whitney Westerfield formally announced his candidacy to become Kentucky AG. He is the first Republican...more

Recent HHS Activity Following International Cyber Attacks

by Steptoe & Johnson PLLC on

Following recent international cyber attacks, the U.S. Department of Health and Human Services (HHS) has issued warnings to healthcare organizations, provided a cyber attack checklist, and launched its revised HIPAA Breach...more

Lessons Learned from 2017 OCR HIPAA Enforcement Actions

by Foley & Lardner LLP on

So far 2017 is proving to be an active year for Health Insurance Portability and Accountability Act (HIPAA) enforcement. This comes on the heels of 2016, which saw an unprecedented level of enforcement actions, with 13 total...more

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