2017 Fiscal Year Final Research Report
Clinical and social impact of introducing Unique Device Identifier (UDI) to electronic health records and patient registries
| Project/Area Number |
25350585
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical engineering assessment
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| Research Institution | Juntendo University |
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Principal Investigator |
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| Project Period (FY) |
2013-04-01 – 2018-03-31
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| 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) |
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| 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.
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| Free Research Field |
レギュラトリー・サイエンス
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