Science, Computers & Technology Communications & Media Health

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:
News & Analysis as of

Borderline products: Marketing food supplements in the UK following the glucosamine case

In late December 2016, the Supreme Court rejected the Medicines and Healthcare Products Regulatory Agency's (MHRA) application for permission to appeal against the decision of the Court of Appeal in R. (on the application of...more

Blue Shield Of California Avoids TCPA Class Action Over Pre-Recorded Call

On January 13, 2017, the United States District Court for the Central District of California granted Blue Shield of California’s motion for summary judgment in a case on whether the insurer violated the Telephone Consumer...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Privacy and Data Security: 2017 Year in Preview

Few issues keep executives awake at night more than Privacy and Data Security. New regulations and threats alike are plentiful, varied, and evolving. The rate of change for cybersecurity and information governance continues...more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

FDA Response to Biosimilar Naming Petitionx Just Issued

On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their...more

Northern District of Illinois Dismisses Whistleblower’s FCA Suit for Failing to Connect Allegations of Misconduct with Submission...

In United States ex rel. Keen v. Teva Pharmaceuticals USA, Inc., relator Janice Keen sued her former employer—the pharmaceutical company Teva—for violations of the FCA. According to Ms. Keen, Teva trained its sales force to...more

FDA Issues Draft Guidance Addressing Communications with Payors

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

Blue Shield Avoids TCPA-Related Liability

A federal court in California recently granted a summary judgment motion filed by Blue Shield of California (“Blue Shield”), allowing it to avoid liability for alleged violations of the Telephone Consumer Protection Act...more

REDIAL: 2016 TCPA Year In Review – Analysis of Critical Issues and Trends

The Sutherland TCPA team has published its third annual REDIAL: 2016 TCPA YEAR IN REVIEW – ANALYSIS OF CRITICAL ISSUES AND TRENDS. This publication reflects our in-depth analysis of significant Telephone Consumer...more

Not So Fast! — Secure Text Messages May Not Be Used to Transmit Patient Care Orders After All

Reversing the position taken in May 2016, The Joint Commission (TJC) recently clarified that licensed independent providers (LIPs) or other practitioners may not utilize secure text messaging platforms to transmit patient...more

Over 3.1 Billion Records Breached So Far in 2016

The tally of records breached in 2016 (through November) globally was over 2.1 billion, according to IT Governance. With the announcement yesterday of Yahoo’s breach of another 1 billion records, that tally is now up to 3.1...more

Hearing Aid Deregulation to Affect Wireless Device Industry and Create Compatibility Issues

Within the last week, both the U.S. Senate and the U.S. Food and Drug Administration (FDA or the Agency) have taken significant steps to deregulate a large portion of hearing aid devices. Despite the benefits that hearing...more

HHS Issues Warning About Phishing Campaign Disguised As Official Communication

As part of its efforts to assess compliance with the HIPAA Privacy, Security and Breach Notification Rules, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) engages in audits of covered...more

OCR Alerts Listservs About Fake Phishing Email to Covered Entities and Business Associates

On November 28, 2016, the Office for Civil Rights (OCR) issued an Alert to its listservs that a phishing email is being circulated on “mock HHS Departmental letterhead under the signature of OCR”s Director, Jocelyn Samuels”...more

Beware of Phishing Email Disguised as Official OCR Audit Communication

The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) has posted an alert (and a follow-up alert) warning health plans, health care providers, and their vendors of a mock communication...more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

FTC Addresses Homeopathic Drug Advertising

The Federal Trade Commission (“FTC”) recently released an enforcement policy statement regarding marketing claims for products in the over-the-counter (“OTC”) homeopathic drug market. Long permitted to fly under the FTC’s...more

FDA Hosts Public Meeting on Off-Label Communications

The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

FDA to Study Social Media Promotion

On November 7, 2016, FDA announced in the Federal Register its plan to research methods for including risk information about pharmaceutical and medical device products in promotional Internet communications that have...more

Managing the Transition to Transformation: Digital Health Solutions: Essential Ingredients in Alternative Health Care Delivery and...

INTRODUCTION - Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the...more

HHS Designates Cloud Service Providers as Business Associates Under HIPAA

Cloud service providers that process electronic protected health information (ePHI) are business associates under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), even if the PHI is encrypted and the...more

Cybersecurity and Data Privacy: Federal Agencies Issue New Guidelines and Rules for Data Breaches and Online Security (11/16)

After recent high profile data breaches and threats to online privacy—ranging from Yahoo Inc.’s data breach of approximately 500 million accounts to the hacking of Hillary Clinton’s campaign manager, John Podesta’s email...more

Malware Attacks Against Healthcare Sector Rose 67 percent in Q3 of 2016

The NTT Security Q3 Quarterly Threat Intelligence Report states that the healthcare industry is the fifth most targeted industry for ransomware (behind financial services, retail, manufacturing and technology) for all cyber...more

366 Results
|
View per page
Page: of 15

Follow Science, Computers & Technology Updates on:

Popular Topics

"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 to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*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.
×