Tag Archives: Preemption

AI Update: Medical Software and Preemption

In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification … Continue Reading

N.Y. Court Holds that DMCA Safe Harbor Applies to Pre-1972 Sound Recordings

Recently, in UMG Recordings v. Escape Media Group, a New York state court held that the safe harbor provisions of the Digital Millennium Copyright Act (“DMCA”) may provide the operator of the website grooveshark.com protection against state law copyright claims based on pre-1972 sound recordings. The DMCA provides a “safe harbor” against legal liability for … Continue Reading