The Record

Digital Health and Regulatory Experimentation at the FDA

For well over a decade the U.S. Food and Drug Administration (FDA) has been told that its framework for regulating traditional medical devices is not modern or flexible enough to address increasingly novel digital health technologies. Very recently, however, the FDA introduced a series of digital health initiatives that represent important experiments in medical product regulation, departing from longstanding precedents applied to therapeutic products like drugs and devices.

Extraterritoriality and Proximate Cause After WesternGeco

The Supreme Court’s decision in WesternGeco LLC v. ION Geophysical Corp. had the potential to reach into a number of trans-substantive areas, including the nature of compensatory damages, proximate cause, and extraterritoriality. Instead of painting with a broad brush, however, the Supreme Court opted to take a modest, narrow approach to the issue of whether lost profits for foreign activity were available to a patent holder for infringement under 35 U.S.C. § 271(f)(2).

Artificial Intelligence: Risks to Privacy and Democracy

A “Democracy Index” is published annually by the Economist. For 2017, it reported that half of the world’s countries scored lower than the previous year. This included the United States, which was demoted from “full democracy” to “flawed democracy.” The principal factor was “erosion of confidence in government and public institutions.” Interference by Russia and voter manipulation by Cambridge Analytica in the 2016 presidential election played a large part in that public disaffection. 
 

Traditional Notions of Fair Play and Substantial Justice in the Age of Internet Interconnectivity: How Masking an IP Address Could Constitute Purposeful Availment

Personal jurisdiction has been a time-honored judicial concept since the 1800s. The Supreme Court has considered the ramifications of personal jurisdiction and its application in various factual scenarios over the years, often leading to plurality opinions where the Justices disagreed on the reasoning behind the judgements. The confusion resulting from this lack of consensus over the doctrine’s application has been further compounded by advances in technology.

Objects, Places and Cyber-Spaces Post-Carpenter: Extending The Third-Party Doctrine Beyond CSLI: A Consideration of IoT and DNA

At the November 2017 oral arguments in the case Carpenter v.