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CRC Press Planning Quality Project Management of EMR/EHR Software

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Description

Managing the development of Electronic Medical Records and Electronic Health Records (EMR/EHR) requires a deep understanding of regulatory landscapes and data integrity. This volume from the HIMSS Book Series addresses the complex challenges faced by hospitals and pharmaceutical companies during the implementation of these critical systems. As clinical trials moved into hospital settings, the need to extract data directly from EMR/EHR systems became a priority for pharmaceutical companies. However, FDA regulations regarding system validation created significant hurdles. This book examines the tension between hospital systems, developers, and regulatory requirements, including the role of the HIMSS Developer Code of Conduct. Designed for professionals working at the intersection of healthcare technology and clinical research, this resource provides context on the evolution of data entry and the regulatory debates surrounding over-regulation and system validation. It is an essential read for those navigating the history and management of healthcare software products.

Key Features

Part of the HIMSS Book Series, providing specialized knowledge on healthcare information technology management.

Explores the historical regulatory challenges involving FDA requirements and the validation of hospital EMR/EHR systems.

Covers the relationship between pharmaceutical companies and hospital data systems during clinical trials.

Provides context on the HIMSS Developer Code of Conduct and its role in software development standards.

Examines the debate regarding over-regulation in the development of electronic health record software.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
16 November 2017
Listed Since
15 June 2017

Barcode

No barcode data available

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