Communications & Media Science, Computers & Technology Health

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Connecticut Enacts Act concerning the facilitation of telehealth

Public Act 15-88 is the first comprehensive law in Connecticut to address telemedicine (also referred to as “telehealth”), and to establish regulatory requirements for providing telehealth services, and mandates certain...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Expect Focus - ONLINE HEALTH CARE: NOT SO FAST Telemedicine Hits A Few Speed Bumps, Volume II, Spring 2015

In This Issue: - IN THE SPOTLIGHT • Risky Business: Common Cyber Security Risks, Expensive Consequences - LIFE INSURANCE • Ninth Circuit Finds Bonus Indexed Annuity Delivers Exactly...more

Laws Governing Data Security and Privacy – U.S. Jurisdictions at a Glance

The below chart constitutes a summary of the laws of various jurisdictions that govern data breach notifications...more

All About That Base: Claim Against Fat Loss Supplement Maker Fails For Lack of Ascertainability

Adam Karhu bought a dietary supplement called VPX Meltdown Fat Incinerator (“Meltdown”) in reliance on advertising by Vital Pharmaceuticals, Inc. (“VPX”) that Meltdown would result in fat loss. Concerned that Meltdown did not...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

Telemedicine: Hitting a Few Speed Bumps

Despite faster Internet connections, better software, increased availability of devices with built-in video, and an increasingly tech-savvy public, the broad acceptance of telemedicine—the use of telecommunication and...more

The Internet of Things

In this Presentation: - Internet of Things - definition - But what is it all about? - But not just that... - The IoT market in figures... - Beecham Research - view of the World - The Connected...more

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

All Eyes on Homeopathics: FTC Workshop Signals Targeted Regulatory Scrutiny of Homeopathic Products

On Tuesday, the Federal Trade Commission “FTC” announced it will be hosting a workshop in September to evaluate advertising for over-the-counter homeopathic products. Homeopathy is an alternative medicine practice dating back...more

FDA Issues Guidance for Mobile Medical Apps

Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act...more

Telesurgery: A New Frontier or Just Risky Business?

Security experts at the University of Washington in Seattle recently set out to expose potential privacy and security vulnerabilities that exist in telesurgery. As first reported by MIT Technology Review, experts hacked a...more

Investment in eHealth: 2014, and what the future holds

Digital health, a category that was virtually nonexistent five years ago, has exploded in recent years and shows the potential to remake the way healthcare is delivered worldwide. Rock Health, the digital health incubator,...more

Partners HealthCare Hit with Phishing Expedition Exposing 3,300 Patient Records

Late last week, Partners HealthCare announced that it notified approximately 3,300 patients of a security breach involving a hacking incident where intruders accessed medical and personal information of patients....more

Decision Highlights Questions Over Substantiation for Weight Loss Claims

The Eleventh Circuit recently issued a decision in an contempt proceeding against Hi-Tech Pharmaceuticals and several individuals. The case highlights the ongoing debate over whether clinical trials are required for weight...more

Changes to the regulation of pharmaceutical business in Kazakhstan: implications for pharmaceutical companies

A significant number of amendments have been introduced to the Healthcare Code* of the Republic of Kazakhstan on 6 April 2015 by the adoption of the Law On Introduction of Amendments and Additions to Certain Legal Acts of the...more

Locke Lord QuickStudy: Medical Marijuana Apps – Illegal Communication Facilities or the Next Big Thing?

A number of recent news articles have discussed the increased activity in the area of technology companies that facilitate the delivery of medical marijuana to patients. For example, according to a recent Forbes Magazine...more

The FDA Gets an EARful on Label Changes

We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws. We have been remiss, however, in not mentioning the industry’s 2014...more

Legal and Regulatory Landscape for Mobile Health Technologies

Mobile health (mHealth) technologies continue to expand in application and implementation. Over the past decade, the breadth of these technologies has grown from the creation of healthcare-directed websites (think WebMD) to...more

Around the Virtual World: April 6 – 10, 2015

A weekly wrap up of interesting news about virtual worlds, virtual goods, and other social media. In This Issue: - Will Doctors Soon Prescribe Video Games? - 5 ways the Postal Service could save money...more

New Smartphone Software Provides Groundbreaking Opportunity for Medical Research

Smartphone applications ("app") are saturating the health care world in numerous and various ways. There is an app to track your sleep, one to track your heart rate, one to track steps and even one to measure your blood...more

Healthcare Legal News Volume 5 Number 2

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

FDA Issues Guidance on Mobile Medical Devices

The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more

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