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Health Consumer Protection Science, Computers & Technology

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

A Sometimes Overlooked Fact About Express Warranty

by Reed Smith on

The warranty is “express.” Before you say, “Well, duh,” this sometimes actually does matter. Here’s how. Most complaints in product liability actions involving prescription medical products that include express warranty...more

HIPAA in the Age of Ransomware

According to a recent US Government Interagency report, ransomware is the fastest growing malware threat, targeting users of all types, including health care facilities. This past spring, for example, the WannaCry ransomware...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

DeepMind Deal with NHS Trust Reveals Privacy Concerns

Back in 2015, DeepMind, a Google company, signed a deal with the Royal Free NHS Foundation Trust. The deal allowed DeepMind access to 1.6 million patients health information as well as the ability to develop an app called...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more

House Energy And Commerce Committee Hearing Examines Role Of The Department Of Health And Human Services In Health Care...

by King & Spalding on

On Thursday, June 8, 2017, the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce convened to hear testimony from representatives from the HHS and CMS to discuss the findings of two...more

Anthem Agrees to Pay Over $100 Million to Settle Data Breach Lawsuit: Cybersecurity Trends

by CloudNine on

One of the most notable data breaches in recent years was the one suffered by health insurer Anthem involving the personal information of nearly 80 million individuals. It looks like they are going to pay up big to make the...more

The State AG Report Weekly Update

by Cozen O'Connor on

Charities- New York Attorney General Reaches Settlement with Breast Cancer Charity over Fraud Allegations- New York AG Eric Schneiderman reached a settlement with the Breast Cancer Survivors Foundation, Inc. (“BCSF”)...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

Marketer In Hot Water for Inconspicuous TCPA Consent Language

by Klein Moynihan Turco LLP on

A recent decision issued by the United States District Court for the Northern District of Illinois has brought renewed emphasis to the importance of prominently displaying TCPA consent language in Internet marketing. In a...more

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems

by Knobbe Martens on

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017. The report recommends various protective actions for hospitals to take and points to...more

HHS Task Force Says Healthcare Cybersecurity is in “Critical Condition”

Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry’s cybersecurity challenges. That Task Force–a combination of public and private...more

(Un)Protected Health Information Held for Ransom

by Snell & Wilmer on

Recent experiences of major health care companies offer a reminder of the importance of data security and following a well-written policy for compliance with the HIPAA Privacy Rule....more

National Pharmacy Avoids TCPA Claim for Flu Shot Robocall under Health Care Rule Exemption

by Hinshaw & Culbertson LLP on

A judge in the Southern District of New York recently held that an automated, pre-recorded message sent on behalf of Rite Aid informing recipients to obtain a flu vaccine shot was exempted from the Telephone Consumer...more

HIPAA Settlement With Wireless Health Services Provider Is Less Than Meets The Eye

by King & Spalding on

On April 24, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a $2.5 million HIPAA settlement with CardioNet, a wireless health services provider. CardioNet provides remote mobile...more

Global Inquiries into Drug Price Increases

European competition authorities announced this week an investigation into Aspen Pharmacare’s recent price hikes of five cancer drugs. The European Commission said in a press release that it had “information indicating that...more

Are Healthcare Systems Being Held Hostage by Ransomware?

by Revision Legal on

Healthcare ransomware is one of the biggest cybersecurity concerns in existence and it may have particularly serious implications for healthcare systems. Ransomware is a form of malicious software code that is somehow...more

New York Attorney General Announces Settlements with Three Mobile Health Application Developers

by Jones Day on

New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney General's ("NY AG") March 23, 2017, announcement of settlements with three...more

French ANSM Clarifies Guidance Related to Raw Materials for Pharmaceutical Use

by Jones Day on

On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

New Mexico Enacts Data Breach Notification Law

by King & Spalding on

On April 6, 2017, New Mexico became the 48th state to enact a data breach notification law; the Data Breach Notification Act (the “Act”) will go into effect on June 16, 2017. The good news for many in the health care...more

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