디지털 헬스 시대와 의료기기의 정의

The medical device industry’s adoption of information technology has brought about innovative products that have come to be known as “digital health” devices. From a regulatory perspective, it often becomes a controversial question whether a novel digital health device category constitutes a medical device under the Medical Devices Act of South Korea. Both the regulator and the court of South Korea have held that a device that functions in a manner substantially similar to a medical device will constitute a medical device, even when there is no intent of medical use on the part of the actor. This article argues that such construction will broaden the scope of medical devices to a degree that is beyond the reasonable interpretation of the medical device definition under the Medical Devices Act. The medical device jurisprudence of the United States and the European Union lends support to the author’s argument as well. Based on these analyses, this article proposes a narrower construction of the medical device definition that is solely based on the objective intent of the actor. Any over-regulation or under-regulation that may result from a narrower construction will have to be addressed through legislation. Since the Korean regulator does not have the authority to exercise enforcement discretion as in some other jurisdiction, the Medical Devices Act should be amended to grant rule-making authority to the regulator to carve out low-risk digital health devices that do not warrant regulation. Conversely, new rule-making authority will enable the regulator to bring into regulation high-risk borderline devices that may otherwise lie outside a narrower construction of the medical device definition.