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.
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