On April 22, 2018, 18-year-old Deanna Recktenwald stared death square in the face and didn’t even know it, at least not until her robotic side kick—her Apple Watch—notified her to seek immediate medical attention.[I] Calmy sitting at church Deanna’s smartwatch pinged her, alerting her that her resting heart rate had skyrocketed from a normal rate of “60 beats per minute to a rate of 190 beats per minute.”[II] Her watch instructed her to reach the nearest hospital and upon arrival, emergency room physicians performed a series of tests confirming that Deanna’s smartwatch was correct—her Apple Watch “helped catch a serious condition from which she was unaware she was suffering,” a genetic condition known as Alport System.[III] Doctors warned her that she is lucky to be alive, telling her that if the smartwatch had not alerted her to the symptoms, she would have died.[IV] Deanna’s story isn’t unique, but is one of the many stories considered at the start of a technological revolution in the healthcare world—an Artificial Intelligent revolution (“AI”).[V] The words “artificial intelligence” and revolution in one sentence may evoke futuristic images of robotic machines who become more innovative and advanced than their creators, ultimately deciding to annihilate civilization.[VI] But in reality?[VII] Imagining a dyspostic future with an impending doom is not necessary to see just how AI can change the way we live our lives.[VIII] Wearables such as the Apple Watch or Fitbit are no longer engineered to just monitor how many steps a user takes in one day or a user’s resting heart rate—they employ a form of AI technology that mimic the human brain to detect irregular heartbeats and spot health issues. The very first glimpse of AI occurred in the early 1950’s.[IX] AI has come a long way since, but as innovation continues to move at the speed of light, complex issues begin to present themselves.[X] One of the biggest and most worrisome issues facing regulatory agencies is AI as applied to the healthcare world, its medical devices, and its drugs.[XI] The daunting task of determining what is the best route to regulate AI medicine so it is safe and effective falls to the purview of the FDA.[XII] The FDA has issued guidance and attempted to get ahead of innovation, promoting AI in healthcare—But that begs the question, is caution warranted?[XIII]
[I]. Inside Edition Staff, Teen’s Life Saved by Apple Watch That Alerted Her Heart Condition, Inside Edition (May 4, 2018, 8:23 AM), http://www.insideedition.com/teens-life-saved-apple-watch-alerted-her-heart-condition-43024.
[IV]. Inside Edition Staff, supra note 1.
[V]. Carrie Marshall, The Doctor on Your Wrist: How Wearables Are Revolutionizing Healthcare, TechRadar (July 6, 2018).
[VI]. Scott Bennett et al., Artificial Intelligence in Health Care: Welcome to the Machine 16–20 (Ana Greene et al., ed. 2018), http://www.healthlawyers.org/News/Connections/Documents/2018/PDFs%20For%20Archive/18_June_Connections_DIGITAL.pdf.
[VII]. Id. at 16.
[IX]. Tom Simonite, The Wired Guide to Artificial Intelligence, Wired: Business (Feb. 2, 2018, 9:22 AM), http://www.wired.com/story/guide-artificial-intelligence/.
[X]. Michael Guihot et al., Nudging Robots: Innovative Solutions to Regulate Artificial Intelligence, 20 Vand. J. Ent. & Tech. L. 385, 393 (2017); see also Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753 (1996).
[XI]. See Id.
[XII]. See id.
[XIII]. See id.