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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

Health Update - March 2015

Supporting Informed Decision Making in the Health Insurance Marketplace: A Progress Report - Editor’s note: As Affordable Care Act (ACA) implementation moves forward and the marketplace continues to evolve, there is a...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FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more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

Tapping Into the Big Value of Health Care Big Data

In This Issue: - Executive Summary - Improving Care by Tapping Into the Data Goldmine - Big Opportunities Available in Big Data - Government Programs Supporting the Use of Big Data -...more

Competition and Regulation Update: Health Sector Under ACCC Spotlight In 2015

ACCC ENFORCEMENT PRIORITIES - The Australian Competition and Consumer Commission (ACCC) has released its enforcement priorities for 2015, with the Chairman of the ACCC giving a speech on the topic last week. Each year,...more

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

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