Health Communications & Media

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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

“Ring my friend, I said you call Doctor Robert, day or night he'll be there”*

The first lawsuit, in what may be a wave of antitrust litigation challenging professional board regulations in the wake of the U.S. Supreme Court’s decision in North Carolina State Board of Dental Examiners v. Federal Trade...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

BakerHostetler Data Security Incident Response Report Shows Human Error is More Often to Blame

Human error was the number one cause of data security incidents according to a new report released today by the Privacy and Data Protection Team at BakerHostetler. In the incidents that the firm worked on last year, employee...more

Telemedicine in Texas: New requirements approved by Texas Medical Board

Compliance with telemedicine rules are tricky these days, as many individual state medical boards regulate the practice of telemedicine within state borders. It is important to keep track of the changing laws related to...more

"Defamation Claims Brought by Texas Health Care Providers Will Be Subject to Anti-SLAPP Act Requirements"

Health care providers should keep in mind that virtually any suit alleging defamation or other harm from a “communication” relating to the provision of services by a health care professional will be subject to the demanding...more

Can My U.S. Company Offer Online Second Opinions in China?

This post is the sixth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market. As U.S. companies continue...more

Hold the Phone! Washington Adopts Telemedicine Parity Law

On April 17, Washington Governor Jay Inslee signed Substitute Senate Bill 5175 (the “Parity Law”), which expands coverage for telemedicine services paid by health plans in the state of Washington. With the new law, Washington...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

Food Recalls Increase in First Quarter of 2015

Food producers are reporting a sharp rise in food recalls so far this year. During the first quarter of 2015, the U.S. Food and Drug Administration (FDA) published notices of 118 food recalls (excluding pet foods), and the...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

Dazed and Confused: The TCPA’s Health Care-Related Call Exemption

In early 2012, Robert Kolinek received an automated call on his cell phone from Walgreens reminding him to refill an eligible prescription. Despite the fact that even the plaintiff’s lawyers ultimately acknowledged that these...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

Walgreen Settles Prescription Robocall Suit for $11 million

Walgreen Co. this week settled a putative class action law suit alleging that it violated the Telephone Consumer Protection Act (TCPA) for $11 million. The plaintiffs alleged that Walgreen violated TCPA when it placed...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

Blog: West Virginia Repeals State’s Pharmaceutical Advertising Disclosure Law

The Governor of West Virginia signed last week Senate Bill 267 to repeal the Code provisions that created the Governor’s Office of Health Enhancement and Lifestyle Planning (GOHELP)....more

FDA Holds Public Hearing On Proposed Label Change Rule

On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more

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