When hospitals began implementing their electronic medical records/electronic health records systems (EMR/HER) the pharmaceutical companies that were conducting clinical trials at those hospitals wanted to sue the date from those systems instead of having the hospitals enter the data in their EHR systems and also in the study data entry system. However, the FDA regulations would require that the hospital systems be "validated". The hospitals and the companies developing the systems argued that was "over-regulation." HIMSS published their Developer Code of Conduct where they said instead they would use Quality Management techniques.
This book covers how to use Quality Management (ISO 9001) to develop computer systems, specifically EMR systems. It gives a basic introduction to how to implement computer systems. It also covers the topic of compliance because the hospitals are required to comply with regulations other than FDS regulations.
The book also discusses the topics of risk management and conducting audits, both of which are part of ISO 9001 quality management of computer systems. The book is designed to give the reader an introduction to the things you have to do when implementing a computer system that has to satisfy some standards and where the accuracy of the information could impact the accuracy of a person’s medical treatment.
Preface
Chapter 1 : Introduction : The Basics
Chapter 2 : Quality Management
Chapter 3 : Managing Patient Information
Chapter 4 : Applying the Organization to Observation Processes
Chapter 5 : Applying Quality Management to Computers
Chapter 6 : The HIMSS-EHR Developer Code of Conduct
Chapter 7 : Developing Standard Operating Procedures (SOPs)
Chapter 8 : Compliance
Chapter 9 : Conducting Audits
Chapter 10 : Risk Management
Chapter 11 : Risk Analysis
Chapter 12 : If All Else Fails
Appendix A : Deming-Key Principles
Appendix B : FDASIA Health IT Report
Appendix C : Sample SOPS
Index
