Deus ex Machina: Regulating Cybersecurity and Artificial Intelligence for Patients of the Future
5 Savannah L. Rev. 177 (2018)
34 Pages Posted: 15 Nov 2017 Last revised: 18 Jan 2019
Date Written: November 1, 2017
Translated as “god from a machine,” the deus ex machina mechanically suspended Greek gods above a theatre stage to resolve plot issues by divine intervention. The implement’s name has since extended to the rapidly expanding Artificial Intelligence (AI) field, as AI has similarly promised miraculous resolution to any number of human challenges, including chronic health conditions. Modern medical devices and other health applications use AI to automate computer functionality, including Internet-connected medical devices, ubiquitous mobile device use, and individual self-monitoring consumer health devices. Unlike human algorithmic programming of the past, AI enables more powerful and automated dynamic algorithmic calculation, or automation, which surpass human data science in accuracy. AI has the potential to revolutionize modern medicine, yet exceptionally large data volumes coupled with automated functionality and Internet connectivity will likely introduce previously unanticipated device safety issues. Although businesses increasingly integrate AI services into medical devices worldwide, the United States (U.S.) and the European Union (EU), typically global leaders in regulating health and medical device technology, have not established legal frameworks to adequately addresses big data, cybersecurity, and AI risks. With new technology, the principles informing medical device risk management activities no longer effectively manage patient safety risks. The U.S. and the EU must consider alternative strategies for regulating medical devices that adequately anticipate cybersecurity and AI risks.
Keywords: Cybersecurity, cyber security, artificial intelligence, law, FDA, medical device, EU, MDD, PMA, 510(k)
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