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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

The New EU Regulation on Medical Devices Aims at Enhanced Product Safety and Further Harmonization

by McDermott Will & Emery on

On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) have been published in the European Official Journal. The Regulations will become effective 20 days after...more

“Pre-Approval” Design Defects - No Such Thing

by Reed Smith on

As our post-Levine preemption cheat sheet demonstrates, Mensing/Bartlett preemption is breathing down the necks of all prescription drug design defect claims. Recent cases finding preemption of design defect claims due to...more

HHS to Launch Cybersecurity Center

The Department of Health and Human Services (HHS) will soon launch a healthcare focused cybersecurity initiative modeled on the Homeland Security Department’s National Cybersecurity and Communications Integration Center...more

OCR Settlement Lessons - Failing to Perform an Electronic Access Risk Analysis Before an Unauthorized Access Occurs

by Ruder Ware on

Failure to conduct a risk assessment before a hacking incident occurred resulted in a $400,000 settlement between the Office of Civil Rights (OCR) and a Federally Qualified Health Clinic (FQHC). The FQHC filed a breach...more

OCR Announces First HIPAA Settlement with Wireless Health Services Provider

by Morgan Lewis on

The $2.5 million settlement reflects the agency’s focus on mobile health privacy. On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with CardioNet, a...more

Lessons from OCR HIPAA Settlements - Mobile Device Security Standards

by Ruder Ware on

In the first known case involving a wireless provider, a cardiology service provider agreed to pay a $2.5 million settlement based on the impermissible disclosure of unsecured electronic protected health information (ePHI)....more

Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers

by McDermott Will & Emery on

On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on...more

$2.5 Million Settlement Reached as HIPAA Crackdown Continues on Unsecured Portable Devices

by Jones Day on

A recent settlement of $2.5 million for alleged violations of the Health Insurance Portability and Accountability Act ("HIPAA") continues a trend of government enforcement targeting health care providers and vendors that fail...more

Mylan Sued For Illegally Protecting EpiPen®’s Market Share

Last Monday Sanofi brought an antitrust suit against Mylan, alleging that Mylan engaged in illegal conduct to suppress competition in the epinephrine auto-injector (“EAI”) market, which is dominated by Mylan’s billion-dollar...more

HIPAA and the Cloud’s Shared Responsibility Models

by Snell & Wilmer on

Cloud-based service providers (CSPs), like Amazon Web Services and Microsoft Azure, offer online access to shared computing resources. As such, they have developed a “shared responsibility model” for how CSPs and companies...more

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Cybersecurity

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