Welcome to the Artificial Intelligence Law Blog, brought to you by the AI, Robotics, and Autonomous Transportation Systems team at the law firm of Eckert Seamans.

The purpose of this blog is to present legal developments in the fields of artificial intelligence, robotics and autonomous transportation systems, legal issues on subjects that relate to these fields, and commentary about how the law might impact each of those cutting-edge areas of technology.

The co-editors of this blog are Mark C. Levy, Jodi Dyan Oley, and Francis G.X. Pileggi.

Our focus will include addressing the legal needs of innovative companies developing AI technology,  manufacturers that employ this technology in the transportation industry, and companies using AI/robotic tech in the medical device, pharmaceutical, biologic, food product, health care, consumer product, and industrial products industries, among others.

We will also address the impact of AI on corporate governance and related legal topics. We welcome comments and suggestions from our readers.

FDA is taking steps to embrace and enhance innovation in the field of artificial intelligence. It has already permitted the marketing of an AI-based medical device (IDx-DR) to detect certain diabetes-related eye problems, a type of computer-aided detection and diagnosis software designed to detect wrist fractures in adults (OsteoDetect), and most recently, a platform that includes predictive monitoring for moderate to high-risk surgical patients (HemoSphere).

FDA also embraced several AI-based products in late November when the Agency chose several new technologies as part of a contest to combat opioid abuse which it launched in May 2018. FDA’s Innovation Challenge, which ran through September 30, 2018, sought mHealth (mobile health) technology in any stage of development, including diagnostic tools that identify those with an increased risk for addiction, treatments for pain that eliminate the need for opioid analgesics, treatments for opioid use disorder or symptoms of opioid withdrawal, and technology that can prevent the diversion of prescription opioids.

The opioid crisis continues to ravage cities and towns across America. The selection of AI-based devices by FDA to aid in the opioid crisis is important as it shows

  • FDA’s commitment to its Action Plan to address the opioid crisis
  • FDA’s recognition that AI is an important technology that it must address and encourage;
  • FDA’s willingness to work with developers of AI devices to establish new pathways for approval and
  • The need for FDA to clarify its understanding of AI and how it will guide and regulate industry moving forward.

FDA received over 250 entries prior to the September deadline. In each proposal, applicants described the novelty of the medical device or concept; the development plan for the medical device; the team who would be responsible for developing the device; the anticipated benefit of the device when used by patients; and, the impact on public health as compared to other available alternatives. Medical devices at any stage of development were eligible for the challenge; feasibility and the potential impact of the FDA’s participation in development to expedite marketing of the device were factors considered when reviewing the submissions.

A team from the FDA’s Center for Devices and Radiological Health (CDRH) evaluated the many entries and chose eight of them to work with closely to accelerate develop and expedite marketing application review of innovative products, similar to what occurs under its Breakthrough Devices Program.

Several of the selected entries involve pattern recognition, whether by predefined algorithm or machine learning, to prevent, detect or manage and treat opioid abuse. For example, Silicon Valley-based startup CognifiSense is developing a virtual reality therapy as part of a system to treat and manage pain. CognifiSense uses a software platform that provides psychological and experiential training to chronic pain patients to normalize their pain perception. Another FDA chosen product, iPill Dispenser, uses fingerprint biometrics on a mobile app that aims to cut over-consumption by dispensing pills based on prescriptions, and which permits physician interaction with usage data to adjust dosing regimens. Yet another, Milliman, involves predictive analytics and pattern recognition to assess a patient’s potential for abuse of opioids before prescribing as well as detection of physician over-prescribing.

U.S. states with autonomous vehicle laws

The Autonomous Vehicle Legislative Survey provides a description of latest actions (regulations, executive orders, committee investigations, or the like) regarding autonomous vehicles taken by each U.S. state and territory. The survey also includes analysis of how the position of each state compares to other states.

The survey is meant to be an evolving document.  It will be updated quarterly by its authors, Jodi Dyan Oley, Monakee D. Marseille,  and Karen O. Moury of Eckert Seamans,  to keep readers abreast of the ever-changing developments in this emerging topic.  The authors are also working on a survey of the U.S. cities that are at the forefront of autonomous vehicle testing and development.  If interested, please subscribe to the AI Blog for notifications of updates on our surveys.

A wealth of information is available that discusses the intersection of artificial intelligence and the law.  Most people are familiar with the nearly ubiquitous examples of artificial intelligence in daily life such as Siri and the Amazon Echo.

Most lawyers are familiar with existing applications of artificial intelligence such as “computer assisted review”, sometimes called predictive coding, that allows for the review of large volumes of documents in a manner that is often faster and more accurate and less expensive than using only human review of documents.  See, e.g., a Delaware Court of Chancery decision, nearly requiring attorneys to consider that form of high-tech document review.

The confluence of artificial intelligence and corporate governance will require increasing attention.  For example, a venture capital firm reportedly attempted to “appoint” an artificial intelligence program as a member of the board of directors of a company.  That action, however, conflicts with a provision in the Delaware General Corporation Law at Section 141(b) that requires board members to be “natural persons.”

Another example of AI applied to the practice of law was explained in a recent article in Forbes, which described work performed by LawGeex, whose automated contract review platform answered questions about whether a non-disclosure agreement should be signed. The accuracy of that review was determined to be faster and better than the review of the same agreements by “human lawyers.”

Thomson Reuters has a website devoted to AI topics, and explains that AI is not a single technology. It combines a number of different technologies that are applied to different functions through various applications.  They provide examples of existing applications of AI in the practice of law such as:

  • legal research
  • litigation strategy analytics
  • online legal services, and
  • analysis of prior decisions by particular judges to assist in the prediction of how that particular judge would decide a particular issue.

We hope to provide more examples on these pages in the weeks to come about the intersection of law and AI.

Robert Campedel

In an “Expert Analysis” piece published by Law360, Eckert Seamans Member Robert Campedel addresses how the rise of autonomous vehicles and the transportation as a service (TaaS) industry are affecting the insurance industry, particularly in regard to product liability coverage. Read the full article on Law360. (Subscription may be required to access third-party content.)

  David Rockman

In an “Insights” piece published by Bloomberg Environment, Eckert Seamans Member David Rockman discusses why artificial intelligence is an emerging issue of great potential interest in the world of environmental law. Read the full article on Bloomberg Environment. (Subscription may be required to access third-party content.)

Steven Kramer

In an “Expert Analysis” piece published by Law360, author Steven Kramer, member-in-charge of Eckert Seamans’ White Plains office, explores unique product liability issues that are coming into play in online marketplaces and companies involved in the transportation as a service, or TaaS, industry. Read the full article on Law360. (Subscription may be required to access third-party content.)