Document Detail

Healthcare software assurance.
MedLine Citation:
PMID:  17238324     Owner:  NLM     Status:  MEDLINE    
Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA's software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted.
Jason G Cooper; Keith A Pauley
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium     Volume:  -     ISSN:  1942-597X     ISO Abbreviation:  AMIA Annu Symp Proc     Publication Date:  2006  
Date Detail:
Created Date:  2007-01-22     Completed Date:  2007-09-28     Revised Date:  2013-06-06    
Medline Journal Info:
Nlm Unique ID:  101209213     Medline TA:  AMIA Annu Symp Proc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  166-70     Citation Subset:  IM    
Mid-Atlantic Technology, Research, and Innovation Center, South Charleston, WV, USA.
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MeSH Terms
Delivery of Health Care
Device Approval / legislation & jurisprudence*
Equipment Design
Equipment and Supplies / standards
Quality Assurance, Health Care
Risk Management
Software / legislation & jurisprudence,  standards*
Software Validation*
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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