Patient Information Maintained Electronically: A New Regulatory Action in Japan

Abstract

Healthcare institutions are legally required to maintain paper-based patient records and films for a prescribed period of time. In Japan, ten related laws and Ministerial ordinances, including a law for Medical Practitioners, are related to this maintenance of patient information. In view of the recent advances in information and communication technologies, however, the Japanese Ministry of Health and Welfare issued a notice on April 22, 1999, which allows patient information to be maintained on electronic media under the condition that a prescribed set of requirements is met. If they choose to do so, healthcare institutions are permitted to keep patient records now electronically without keeping paper-based records and films. This action is a part of deregulation efforts of the Ministry of Health and Welfare and it gives healthcare providers an alternative method of storing patient information, in addition to conventional media such as paper-based patient records and films. The notice does not oblige healthcare institutions to specifically maintain patient information electronically. The administrators of the institutions themselves are responsible for making the decision whether or not to adopt electronic media for storing patient information. The notice does not address any specifications for electronic media. The institutions may procure hardware devices that are the best in terms of cost-performance ratio, based on their own judgment and responsibility. Software systems to be adopted and security measures to be taken are also left to the individual institutions.