News & Analysis as of

Health Science, Computers & Technology Consumer Protection

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

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

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition

by Jones Day on

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more

Gone Phishin’: Hack Leads to HIPAA Settlement

Earlier this week, the HHS Office for Civil Rights (“OCR”) announced a $400,000 settlement with Metro Community Provider Network (“MCPN”) related to a 2012 HIPAA breach caused by a phishing scam. The phishing scam, carried...more

Guest Post – Come Together: Is UK Product Liability Law Getting More Like the U.S.?

by Reed Smith on

This guest post – only our second post ever on European issues is brought to you by Reed Smith partners Marilyn Moberg and (in the UK) associate Bond, Kathryn Bond (sorry, couldn’t resist). Our previous (and only) foray into...more

Recent HIPAA Privacy and Security Settlements and Lessons Learned

by Perkins Coie on

Although the fate of the Affordable Care Act remains undecided, enforcement of the HIPAA privacy and security regulations by the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services is ongoing,...more

The State AG Report Weekly Update April 6, 2017

by Cozen O'Connor on

Consumer Protection - Delaware and Massachusetts Attorneys General Settle with Auto Lender Over Subprime Loans - Delaware AG Matt Denn and Massachusetts AG Maura Healey reached separate settlements with finance and...more

The TCPA: An Unexpected Deterrent to Patient Engagement Tools

by McDermott Will & Emery on

In an age where providers are increasingly taking the management of their patient’s health online and out of the doctor’s office, the creation of scalable and nimble patient engagement tools can serve to improve patient...more

Trump's Proposed 2018 Budget Will Double FDA User Fees

by Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

Your Cyber Minute: Attorney-client privilege in the midst of a cybersecurity breach  [Video]

by Hogan Lovells on

In the wake of a cyber attack, it’s a common assumption that attorney-client privilege is ironclad. It’s not that simple. Partners Harriet Pearson and Michelle Kisloff examine the nuances and offer best practices. ...more

Your Cyber Minute: Lessons learned from the automotive sector  [Video]

by Hogan Lovells on

The internet of things has presented new challenges across all industries. Hear partners Harriet Pearson and Tim Tobin discuss what others can learn from automotive in this sharing of best practices. ...more

662 Results
|
View per page
Page: of 27
Cybersecurity

Follow Health Updates on:

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.

Feedback? Tell us what you think of the new jdsupra.com!