1. Legal Issues in Japan for Making Adequate Balance between Privacy and Public Benefit in Using Large Scale Health Databases
10.3820/jjpe.17.101
- VernacularTitle:1．データベースの二次活用における法規制上の問題と今後
- Author:
Ryuichi YAMAMOTO
- Publication Type:Journal Article
- Keywords:
health database;
clinical database;
privacy;
public benefit;
legislation
- From:Japanese Journal of Pharmacoepidemiology
2013;17(2):101-107
- CountryJapan
- Language:Japanese
-
Abstract:
In Japan, large scale health databases were constructed in a few years, such as National health insurance claim and health checkup database(NDB) and Japanese Sentinel project. But the there are some legal issues for making adequate balance between privacy and public benefit by using such databases. NDB is carried based on the act for elderly person's health care but in this act, nothing is mentioned for using this database for general public benefit. Therefore researchers who use this database are forced to pay much concern about anonimization and information security that may disturb the research work itself. Japanese Sentinel project is a National project to detecting drug adverse reaction using large scale distributed clinical databases of large hospitals. Although patients give the future consent for general such purpose for public good, it is still under discussion using insufficiently anonymized data. Generally speaking, researchers of study for public benefit will not infringe patient's privacy, but vague and complex requirements of legislation about personal data protection may disturb the researches. Medical science does not progress without using clinical information, therefore the adequate legislation that is simple and clear for both researchers and patient is strongly required. In Japan, fortunately, the specific act for balancing privacy and public benefit is planned to lay before Diet, but is still under discussion. The author recommended the researchers including the field of pharmacoepidemiology should pay attention to, participate in the discussion of, and make suggestion to this act. (Jpn J Pharmacoepidemiol 2012; 17(2): 101-107)
