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2017 Fiscal Year Final Research Report

Clinical and social impact of introducing Unique Device Identifier (UDI) to electronic health records and patient registries

Research Project

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Project/Area Number 25350585
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical engineering assessment
Research InstitutionJuntendo University

Principal Investigator

SASE Kazuhiro  順天堂大学, 医学部, 教授 (00420828)

Project Period (FY) 2013-04-01 – 2018-03-31
Keywords医療技術評価学(HTA) / レギュラトリー・サイエンス / 医療機器 / レジストリ / 国際医療機器識別コード(UDI) / 国際規制調和 / リアル・ワールド・データ(RWD) / リアル・ワールド・エビデンス(RWE)
Outline of Final Research Achievements

[Introduction] The balance between promotion of medical innovation and protection of patients is one of the most important issue of the Regulatory Science. Unique Device Identifier (UDI), a core element in the strategically coordinated registry network, is already mandated in the United States for phased implementation.
[Objective and Method] In this research, in collaboration with internationally coordinated registry networks, we examined the significance of UDI for health care providers.
[Result and Discussion] To build a sustainable ecosystem, the FDA highlighted the significance of UDI in care providers through its public-private partnership (MDEpiNet). Through Japan-US Harmonization by Doing (HBD), this study supported an internationally coordinated registry network (INTERMACS/J-MACS). Our experience was shared among Japanese stakeholders, and was referenced in the guidance document of the International Medical Devices Regulators Forum (IMDRF) as being applicable to other fields.

Free Research Field

レギュラトリー・サイエンス

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Published: 2019-03-29  

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