FDA“哨点行动”电子数据使用的法律政策框架解析

中国药物警戒 ›› 2015, Vol. 12 ›› Issue (1): 30-33.

FDA“哨点行动”电子数据使用的法律政策框架解析

沈璐

国家食品药品监督管理总局药品评价中心，北京，100045

收稿日期:2014-10-27 出版日期:2015-01-08 发布日期:2015-07-28
作者简介:沈璐，女，硕士，副主任药师，药事法规及上市后安全性监测。

Analysis of the Law and Policy Framework for Use of Electronic Health Data in FDA's Sentinel Initiative

SHEN Lu

Center for Drug Reevaluation, CFDA, Beijing 100045, China

Received:2014-10-27 Online:2015-01-08 Published:2015-07-28

摘要/Abstract

摘要： 目的通过深入研究分析FDA“哨点行动”中电子数据使用的法律规定和政策要求，挖掘对我国上市后药品安全性监测特别是主动监测工作的启示和帮助。方法解读了FDA哨点运行的数据模式，总结了FDA在哨点试行期间—迷你哨点阶段，如何遵守适用的联邦和各州法律法规。结果 FDA成功建立了良好的运行模式：在保障隐私和公信度的基础上，建立分散的数据系统并要求参与者执行强制的政策和程序以保证公平。结论保证隐私和公信度是实施主动药品安全监测的前提，强制性的法律和政策要求是监测开展的基础，科学高效数据模式是监测运行的工具和途径。

关键词: 隐私, HIPAA法案, 分散系统, 迷你哨点共同数据模式（MSCDM）, 政策

Abstract: Objective To analyze the law and policy framework for use of electronic health data in FDA's Sentinel Initiative to give some suggestions and help for post-marketing drug safety surveillance, especially active safety surveillance, in China. Methods This article studies the sentinel data model, and summarizes how the initial pilot phase of the FDA's Sentinel Initiative, Mini-Sentinel, is being conducted in compliance with applicable federal and state laws. Results FDA is successful in building a good operation model: based on privacy and public trust, FDA established a distributed data system and asked all the participants to obey the mandatory policies and procedures to assure the fairness. Conclusion The privacy and public trust is the premise of drug safety surveillance. The mandatory policies and procedures are the base of implementing surveillance practices. The efficient data model is the tool and way of surveillance operation.

Key words: privacy, health insurance portability and accountability act (HIPAA), distributed system, mini-sentinel common data model(MSCDM), policies

中图分类号:

沈璐. FDA“哨点行动”电子数据使用的法律政策框架解析[J]. 中国药物警戒, 2015, 12(1): 30-33.

SHEN Lu. Analysis of the Law and Policy Framework for Use of Electronic Health Data in FDA's Sentinel Initiative[J]. Chinese Journal of Pharmacovigilance, 2015, 12(1): 30-33.

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