Tag Archives: software

Covington AI/IoT Update: Product Liability Risks for AI-Facilitated Shopping

Algorithms define online shopping, allowing for individualized product recommendations driven by customer data. To date, this technology has spurred little litigation. Few if any courts have explicitly ruled on responsibilities related to AI-driven product recommendation software. Still, developers should be aware of potential legal risks from this novel technology. For example: What happens if AI … Continue Reading

House to Consider Bill Excluding Clinical and Health Software from Regulation as Medical Devices

On October 22, Rep. Marsha Blackburn (R-TN) introduced a bill serving to “provide for regulating medical software, and for other purposes” in the House of Representatives.  The bill, entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (“SOFTWARE”) Act (“the bill”), was co-sponsored by a bi-partisan group of lawmakers. The bill creates a regulatory … Continue Reading

FDA Releases Final Mobile Medical Apps Guidance

On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.    The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the final guidance retains the basic framework of … Continue Reading

Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As our colleagues discussed in a previous post on InsideMedicalDevices, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) … Continue Reading

U.S. “Cracks” Software Piracy Scheme: Chinese Seller and U.S. Customers Plead Guilty

Earlier this week, Xiang Li pleaded guilty in Delaware federal court to one count of conspiracy to commit criminal copyright infringement and one count of conspiracy to commit wire fraud.  Li, a Chinese national, was charged with selling “cracked” software (i.e., software for which access controls had been circumvented) to customers around the world through … Continue Reading
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