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电子处方软件认证方法。

Approaches for certification of electronic prescription software.

作者信息

Niinimäki J, Forsström J

机构信息

Health Care Informatics Centre of Excellence, Satakunta Hospital District, Pori, Finland.

出版信息

Int J Med Inform. 1997 Dec;47(3):175-82. doi: 10.1016/s1386-5056(97)00101-9.

Abstract

The proper management of drug treatment is essential, since adverse drug reactions are common reasons of hospitalisations. Expenditure on drug therapy has also been growing faster than any other aspect of health care in many countries. Savings and quality improvements in drug treatment could be achieved with computerised prescribing. In this paper, the architecture of an electronic prescription system is described in the light of software certification and registration. An electronic prescription system is an example of a system supporting shared care and therefore it should be person based, integrated, secure and confidential and data should be shared among health care institutions. The system architecture shares the idea of a virtual patient record and a smart card will be used as a key to prescription data located on the network. The certification and registration of medical software is a difficult and costly procedure. Ensuring the quality of software can be based on; certification of development process, voluntary evaluation, and post-market surveillance. Voluntary evaluation practice would be a precious tool for both the customers and software developers, and it would also be an invaluable source of information in terms of developing new software.

摘要

药物治疗的合理管理至关重要,因为药物不良反应是住院的常见原因。在许多国家,药物治疗的支出增长速度也比医疗保健的其他任何方面都要快。通过计算机化开处方可以实现药物治疗的成本节约和质量提升。本文根据软件认证和注册来描述电子处方系统的架构。电子处方系统是支持共享护理的系统的一个示例,因此它应该基于个人、集成、安全且保密,并且数据应该在医疗机构之间共享。该系统架构采用了虚拟患者记录的理念,智能卡将用作访问网络上处方数据的密钥。医疗软件的认证和注册是一个困难且成本高昂的过程。确保软件质量可以基于:开发过程认证、自愿评估和上市后监测。自愿评估实践对客户和软件开发人员来说都是一个宝贵的工具,并且在开发新软件方面也是一个宝贵的信息来源。

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