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Telehealth Bill Moving Forward in Florida-But Medicaid Coverage Sacrificed

Last week, the Florida Senate Health Policy Committee removed language from proposed telehealth legislation that would require Medicaid reimbursement for telemedicine services at the same rates as face-to-face examinations....more

Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth 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....more

FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?

On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more

China Unveils Plans for National Telemedicine Network

This post is the third 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. We continue to work with...more

“PhysTexting” Is Not Enough to Form a Patient-Physician Relationship

The Texas Medical Board is proposing to modify its disciplinary rules to more specifically define the requisites for a physician-patient relationship required for prescribing. Under the proposed revision to 22 T.A.C. § 190.8,...more

Health Law Wire: New Telehealth Legislation Proposed in New York for 2016 (2/15)

On December 29, 2014, New York State Governor Andrew Cuomo signed into law the provisions of chapter 550 that requires commercial insurers and the medical assistance program (Medicaid) to reimburse for the delivery of health...more

How to Mitigate Compliance Risks with BYOD - EndNotes February 2015

I?f you have ever left your mobile phone on an airplane, in a restaurant or somewhere other than in your possession, you know it’s frightening enough to think of losing the device itself, which costs a premium, as well as...more

AliveCor, Inc., Maker of Smart Phone-Based ECG Device, Receives FDA Clearance for Two New Algorithms that Provide Users Immediate...

San Francisco-based AliveCor,Inc. recently announced that the U.S. Food and Drug Administration (FDA) granted the company clearance for two new algorithms for its Smart Phone-based ECG device, the AliveCor Heart Monitor and...more

Interface without Regulation – FDA Deregulates MDDS and Related Technologies

2015 has been a busy year for the Food and Drug Administration (FDA). In January, the FDA issued guidance documents addressing wellness applications as well as accessories to medical devices and it looks like the...more

FDA Revises Approach to Presentation of Risk Information in Brief Summary

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

SPECIAL FOCUS: D.C. Circuit Limits FTC’s Ability to Require Two Randomized Clinical Trials to Substantiate Disease Claims in...

On January 30, 2015, the U.S. Court of Appeals for the District of Columbia Circuit issued its long-awaited opinion in the POM case. In a press release, the Federal Trade Commission (FTC or the Commission) Chairwoman Edith...more

News from Second and State

Gov. Wolf continued to make headlines this week, this time with his activities in and around the judiciary. On Wednesday, the governor and newly-appointed–then-promptly-removed Open Records Director Eric Arneson had their day...more

FDA Regulatory and Compliance Monthly Recap - January 2015

In This Issue: - FDA’s CDER, CDRH and CBER put out 2015 guidance agendas - FDA to study limiting major risk statements in direct-toconsumer TV ads amid concern that information is getting lost on consumers...more

Regulatory Challenges Facing the mHealth Industry

Innovations in health care technology have created unique challenges for developers and investment companies. Among others, changing FDA guidelines, data security, and reimbursement are all substantial issues facing the...more

OCR Updates Breach Report Web Portal — Changes Could Impact Annual Breach Reports

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently launched an updated version of the portal covered entities must use to notify OCR regarding a breach of unsecured protected health...more

Wellness innovators take note: FDA reveals risk-based approaches to the regulation of health IT and mobile medical apps

The way consumers access and interact with health information has changed exponentially over the past few years thanks to rapid innovation in health IT. Mobile medical application developers and other health and wellness...more

2014 Year in Review: OPDP Warning and Untitled Letters

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

FDA Policy On Wellness Products Is Healthy For Industry

On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more

Viagra Ad Campaign Targets Women Amid Melanoma Risk

Viagra is so popular that it is a frequent target of counterfeiters. Here, a U.S. Customs and Border Patrol agent displays seized goods. Viagra (sildenafil) has featured prominently in the news over the past few months...more

HHS to Address Lack of Clarity Regarding Mobile Health

A letter from the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights to Rep. Peter DeFazio (D-Ore.) signals an intent to move forward with providing clearer regulatory guidance relating to the Health...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Are Non-Disparagement Clauses a Good Idea?

Creatively, some physicians have been turning to non-disparagement clauses within confidentiality agreements as a way to prevent patients and potential patients from posting negative online reviews....more

False Claims Act: 2014 Year In Review

In what is becoming an annual refrain, 2014 marked another year of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and mushrooming qui tam lawsuits by whistleblowers. Indeed, fiscal year 2014...more

Blog: FDA Submits Notice for Collection of Information Regarding Direct-to-Consumer Advertisements

The Food and Drug Administration (FDA) recently submitted a proposed collection of information on disclosing risks in direct-to-consumer (DTC) prescription drug television (TV) advertisements to the Office of Management and...more

Physician Plaintiff Bound by Arbitration Clause in Nonparty’s Contract

Today’s riddle: A physician sues defendants for defamation. The defendants move to compel the arbitration clause of a contract the physician used to have with a nonparty. The defendants win the argument. What’s the...more

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