Implications for Japan from the Current Utilization of Health Information Exchange (HIE) and the Perspective of the HIE Legal System Concerning Patient Consent and Healthcare Providers' Responsibilities in the U.S.

Abstract

　In Japan, the adoption of health information exchange (HIE) has yet to be widespread, partly due to the absence of a suitable legal system to support it. This paper explores the current state of HIE adoption in the United States, delving into the analysis of two aspects of the U.S. legal system: obtaining patient consent for participation in HIEs and the responsibility of medical providers in processing information by HIEs. Under the federal legal system, providers are generally not obligated to ensure patient consent for HIE participation. However, the Department of Health and Human Services recommends offering patients at least the option to opt out of participating in an HIE. Furthermore, the federal rule establishes only limited liability for healthcare providers. It is important to note that both federal and state systems oversee HIEs in the U.S., with the state system having a substantial influence on the actual operation of HIEs. Drawing on the U.S. analysis, this paper puts forward potential amendments to the Japanese legal system for each of the two key elements, aiming to facilitate the advancement of HIE in Japan while taking into consideration its existing legal framework.