Communications & Media Science, Computers & Technology Health

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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

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

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

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

Product Liability 2014 Year in Review

In This Issue: - Letter From The Chair - Key Practice Trends + Highlights - Consumer Products - Pharmaceutical Products and Medical Devices - Aviation - Toxics Regulation and Toxic...more

FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

FCC Forbears “For Now” From Requiring Universal Service Contribution From Broadband Providers

Section 254(d) of the Act requires providers of “telecommunications services” to contribute to the federal Universal Service Fund (USF), which is used to subsidize telephone and broadband service in high-cost areas, for...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

FDA Regulatory and Compliance Monthly Recap - February 2015

FY 2016 budget request reflects FDA’s broadening scope of activities - The regulator’s requested budget of $4.9 billion for the upcoming fiscal year represents a 9% increase from the enacted FY 2015 budget, with $147.7...more

Safety Labeling: Public Meeting Later This Month and Comment Period Extended – Key Dates Coming Up

On March 27, 2015, FDA plans to hold a public meeting entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. The meeting was announced in a Federal Register Notice posted...more

Consumer Health Information Update from Both Sides of the Atlantic

As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) —...more

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