News & Analysis as of

Software Developers

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

by Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

GAO Report on Automated Vehicles Finds DOT Needs Roadmap

On November 30, 2017, the U.S. Government Accountability Office (GAO) released a report (“Report”) outlining its findings of the key challenges facing policy-makers as the regulatory environment seeks to promote the...more

Can a Software Developer Copyright the Output of Its Software?

As technology becomes increasingly advanced and complex, it seems that a new software emerges every day to perform some novel function. Whether it is computer generated imagery (CGI) or deciphering a code in a bible, software...more

Video Game Software Industry Seeks a Final Disabilities Access Waiver Extension

by Kelley Drye & Warren LLP on

The Federal Communications Commission (“Commission” or “FCC”) recently released a Public Notice seeking comment on a petition filed by the Entertainment Software Association (“ESA”) seeking a one year final extension of its...more

Alert: When Will Video Game Software Need to Meet FCC Accessibility Requirements?

by Cooley LLP on

Since 2010, equipment and technology that allow consumers to communicate with each other using "advanced communications services" (ACS) has been required to provide access for consumers with disabilities. For video games,...more

Clinical trials Part II: Privacy, cybersecurity risks, and managing ePHI

by Thompson Coburn LLP on

The ongoing digitization of the drug and medical device industries continues, and, as a result, new considerations have come to the forefront for companies engaged in clinical trials. In Part 1 of this series, we described a...more

The IRS Attacks Taxpayers’ Section 199 (Computer Software) Deductions

by McDermott Will & Emery on

Taxpayers’ section 199 computer software deductions are under attack! The issue is being coordinated within the IRS, and at Exam and Appeals taxpayers are running into a brick wall. A resource-starved IRS is trying to treat...more

Global In-House Centers in India, v2.0

GICs in India are evolving from cost-saving platforms into Innovation Centers for emerging digital technologies that can provide a competitive advantage. Recent years have seen a resurgence of interest in GICs in India...more

Shearman & Sterling’s Digest on Federal Circuit Jurisprudence Concerning the “Abstract Idea” Exception to 35 U.S.C. § 101

by Shearman & Sterling LLP on

At first glance, the development of Section 101 jurisprudence appears chaotic. The Supreme Court captured several different kinds of problems in Alice and its earlier patentable-subject-matter opinions, and the Federal...more

Se Reglamenta la Exclusión de IVA Para la Creación de Contenidos Digitales

by Holland & Knight LLP on

La Ley 1819 de 2016 (Reforma Tributaria), excluyó del impuesto sobre las ventas (IVA), entre otras los siguientes operaciones: (i) La prestación de servicios de educación virtual para el desarrollo de contenidos digitales, de...more

Regulation of the Exclusion of VAT for the Creation of Digital Contents

by Holland & Knight LLP on

Law 1819 of 2016 (Tax Reform) excluded among others, the following operations from value added tax (VAT): (i) the provision in Colombia or abroad, of virtual education services for the development of digital content in...more

A Dynamic Digital Health Sector Means More and Bigger Deals

The digital health sector is beginning to mature and investors are pouring more money into more deals, reports Rock Health in its survey of digital health investment in the first half of 2017. And, we might add, into bigger...more

Ending Data Scraping Dispute, Craigslist Reaches $31M Settlement with Instamotor

Craigslist has used a variety of technological and legal methods to prevent unauthorized parties from violating its terms of use by scraping, linking to, or accessing user postings for their own commercial purposes. For...more

Plaintiff in Gridiron Battle Over Place of Expert Testimony in Software Copyright Claim Requests Supreme Court to Be Referee

by Dorsey & Whitney LLP on

The software engineer who first coded the popular “John Madden Football” (now Madden NFL) computer video game has asked the U.S. Supreme Court to allow expert witness testimony to support his software copyright claim, over 25...more

Why having a clear understanding with employees is important

by McNair Law Firm, P.A. on

Over the years, we have written a number of articles about the importance of making sure your employment documents contain clear, understandable language. One of our federal district judges was recently faced with an...more

New York Attorney General Unveils Latest Ticket Bot Enforcement Actions against Ticket Vendors and Software Developer

With summer concerts and music festivals in full swing, many fans will be surprised to find $145 face value tickets reselling online for $3,000 to $11,000....more

Restricted Rights Under DFARS 252.227-7014: Practitioner Advice for Avoiding DoD Licensing Pitfalls

This article focuses on contractor licenses that grant “Restricted Rights” in “Noncommercial Software” to the federal Government under Defense Federal Acquisition Regulation Supplement (“DFARS”) 252.227-7014. DFARS...more

San Francisco’s Mass Transit Agency Accused of Illegally Collecting and Transmitting Smart Phone Data Through Security App

by Reed Smith on

San Francisco’s public transportation agency and the creator of the agency’s suspicious activity reporting smart phone application have been accused of illegally collecting, tracking, and storing users’ personal information...more

100 Million Reasons For Open Source Compliance

CoKinetic Systems Corporation filed suit against Panasonic Avionics Corporation, seeking damages in excess of $100 million, in part, for violation of the GPL v2 open source license. CoKinetic alleged that Panasonic blocked...more

Court Ruling Supports Contractual and Statutory Enforcement of Open Source Software Licenses

Despite the prevalence of open source software and its ubiquitous use in the software industry, there has been little litigation in the United States analyzing and interpreting the terms of open source licenses. On April 25,...more

The Tanium Affair Reminds Us That Cybersecurity Risks Are Everywhere

The Wall Street Journal recently reported that well-known cybersecurity startup Tanium, Inc. had been inadvertently exposing one of its clients’ sensitive data during product demonstrations....more

Open Source Software….A Quick FAQ

Some complicated topics are easy and some easy topics are complicated. This one is actually both. So let’s just start with some of the fundamentals: What is the difference between “closed” source and “open”...more

Intellectual Property Bulletin - Winter 2017

by Fenwick & West LLP on

A Smooth Patch in a Rough Road? Governmental Transition and Intellectual Property - Whenever a new Congress convenes, some IP issues come to the fore while others take a back seat. Transition to a new administration in the...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

U.S. Government Open Source Software: OMB’s Memorandum on Federal Source Code Policy Exposes IP Ownership Risk

by McCarter & English, LLP on

On August 8, 2016, the U.S. Office of Management and Budget (“OMB”) promulgated an Open Source Software (“OSS”) policy via the Memorandum for the Heads of Departments and Agencies, M-16-21 (“Memorandum” or “M-16-21”). The...more

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