The Record

Artificial Professional Advice

What does it mean to give professional advice, and how do things change when various forms of technology, such as decision-support software or predictive advice-generating algorithms, are inserted into the process of professional advicegiving? Professional advice is valuable to clients because of the asymmetry between lay and expert knowledge where professionals have knowledge that their clients lack. But technology is increasingly changing the traditional process of professional advice-giving.

Big Data: Destroyer of Informed Consent

The ‘Revised Common Rule’ took effect on January 21, 2019, marking the first change since 2005 to the federal regulation that governs human subjects research conducted with federal support or in federally supported institutions. The Common Rule had required informed consent before researchers could collect and use identifiable personal health information.

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.