Digital Health 101: Artificial Intelligence In Medicine

Published date18 January 2021
Subject MatterFood, Drugs, Healthcare, Life Sciences, Technology, Biotechnology & Nanotechnology, New Technology
Law FirmYigal Arnon & Co
AuthorMr Roy Keidar and Tamar Tavory

It is evident that Artificial Intelligence (AI) is changing the face of medicine1: it detects pathological findings through imaging, assists in early diagnosis of high-risk patients, adapts medication to illnesses in a more precise and personal manner, and assists physicians in medical decision-making. For example, AI today can identify a "diabetic eye" - a dangerous medical condition that diabetic patients run a significant risk of contracting, and whose early detection is critical for treatment and prevention of blindness; AI "reviews" patients' medical information in the intensive care unit and helps identify those patients whose situation is about to deteriorate; AI "marks" moles suspected of being malignant, and even assists in directing patients in the hospital to the ER or once there, through its procedures.

As the number of AI applications expands, and the scope of its adoption in the medical diagnostic and treatment process grows, is it necessary to formulate a suitable regulatory framework.

For example, use of AI technology raises the risk of increasing discrimination in medical decision-making, given the biases inherent in medical data bases2. Moreover, difficulty arises in medical decision-making in a "black box" situation, where there is no clear linkage between the input, the data entered (e.g. medical records of all patients in similar condition) and the final output (such as a recommendation for a specific treatment). If we add to this the intricacy of long-term "learning" algorithms capable of generating different outputs even in similar situations, we see that existing legal categories fail to provide suitable solutions to this complex technology.

Presently, medical devices that include AI elements are classified in Israel according to existing traditional legal categories (regulation of medical devices etc.), in the absence of specific mandatory regulations addressing the unique characteristics of AI. For comparison's sake, in the United States, the FDA is undertaking initial steps to regulate special AI characteristics, including a pilot program for prior approval of an AI product that will change and "learn" during the period of its use, while monitoring it during its lifecycle.

At the same time, American and European regulatory bodies issue non-obligatory instructions and recommendations regarding AI, which eventually may become obligatory regulations and influence Israeli regulation3.

What must be considered when developing an...

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