Read need-to-know updates, commentary, and analysis on Communications & Media issues written by leading professionals.
FCC Proposes New Rules On Local Wireless Siting
Data Center Networks – Interview with Jeff Moerdler, Member, Mintz Levin
What to expect from FCC Post-Governement Shutdown
Employer Social Media Policies – Interview with Mitch Danzig, Member, Member, Mintz Levin
Jason Maloni on Data Security
JOBS Act Implementation Regulations
Ernest DelBuono on Aviation
Jack Deschauer on Government Investigations
PODCAST - Inside Law - Public Policy Issues in 2013
Condo Adviser: Condominium Rules and Enforcement
Condo Adviser: What is 'FHA approved,' exactly?
Condo Owners and Dealing with Uncooperative Management Companies
Reserve Funds: Purposes and Common Mistakes
Instapundit: America's IP Laws Need to be "Pruned Back"
Social Media At Work - What's Allowed and What Isn't? PODCAST - Inside Law
Release of new book on the 'Best Practices Under the FCPA and Bribery Act"
[Legal Perspective] When Is It NOT Okay to Delete Your Social Media Account?
Tips for Mobile App Privacy Compliance
Serving Legal Documents Through Social Media
Social Media Law Report - Who Owns Your LinkedIn Account, FTC Guidance on Social Ads, More...
On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more
The bad news for 23andMe keeps coming. In late November, we learned that the U.S. Food and Drug Administration had ordered the company to stop selling its $99 DNA testing kit owing to a number of accuracy and validity...more
Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more
The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious...more
In September 2013, the Food and Drug Administration (FDA) issued final guidance regarding its regulation of mobile device medical apps. As expected, it reserved its scrutiny for apps that are truly “medical devices” (because...more
I’ve hesitated to write this post because the law is always changing and you can’t cover it all in one blog post (thank goodness for linking). I did a presentation to the Houston Interactive Marketing Association this week...more
On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved...more
This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more
States have increasingly brought actions under Medicaid fraud or consumer protection statutes seeking civil penalties and restitution from the makers of prescription drugs. Many top-selling drugs have been...more
The Center for Drug Evaluation (“CDE”) in China recently published the draft Guidelines for the Administration of Post-Market Studies on Chemical Drugs and Therapeutic Biologics (“Draft Guidelines”) for public comments...more
As health care providers continue to try to navigate the world of social media, the Rhode Island Board of Medical Licensure and Discipline (the “Board”) has issued policy guidelines (the “Guidelines”) to address the use of...more
In this issue:
- Heard On the Hill
- House Bipartisan Working Group Considers Privacy Around the Agencies
- New TCPA Rules Effective October 16, 2013
- FTC to Hold Workshop on Native Advertising
- New HIPAA...more
On October 16, 2013, new Federal Communication Commission rules took effect to further protect consumers under the Telephone Consumer Protection Act of 1991 (TCPA). See 47 U.S.C. § 227; 47 C.F.R. § 64.1200. The changes...more
The Telephone Consumer Protection Act (TCPA) generally limits automatically dialed and prerecorded telemarketing calls to wireless and residential phones. In the past, healthcare providers and other "advertisers" could rely...more
Yesterday, the Belgian Privacy Commission’s announced its intention to make enforcement its number one priority:
- A dedicated inspection task force will be set up pro-actively monitoring companies and organisations...more
In This Article:
Federal Government; Alberta; British Columbia; Manitoba; New Brunswick; Newfoundland; Northwest Territories; Nova Scotia; Nunavut; Ontario; Prince Edward Island; Québec/Quebec; Saskatchewan; and...more
Over two years after the Food and Drug Administration issued draft guidance on “mobile medical applications,” the agency recently issued its greatly anticipated final guidance. As FDA considered comments from stakeholders...more
Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its...more
Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more
In this issue:
- How to Expedite Examination of a Patent Application
- The FDA Releases Final Guidance for Mobile Medical Applications
- Creating Value in the Medtech Industry Using a Gender Lens
On October 1, 2013, seven national councils representing French health care professionals posted on their publicly accessible websites information submitted by affected enterprises (i.e., companies) that produce or market...more
NEW SEC GENERAL SOLICITATION AND “BAD ACTOR” RULES RE PRIVATE STOCK SALES NOW IN EFFECT -
New Securities and Exchange Commission rules concerning private stock sales are now in effect.
Under these rules, for...more
On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more
Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients.
On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more
On September 25, 2013, the Food and Drug Administration (FDA) issued its long-awaited final guidance on health-related software applications intended for use on mobile devices. Under the guidance, FDA will regulate only those...more