| Healthcare software assurance. | |
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MedLine Citation:
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PMID: 17238324 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Jason G Cooper; Keith A Pauley |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium Volume: - ISSN: 1942-597X ISO Abbreviation: - Publication Date: 2006 |
Date Detail:
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Created Date: 2007-01-22 Completed Date: 2007-09-28 Revised Date: 2009-11-18 |
Medline Journal Info:
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Nlm Unique ID: 101209213 Medline TA: AMIA Annu Symp Proc Country: United States |
Other Details:
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Languages: eng Pagination: 166-70 Citation Subset: IM |
Affiliation:
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Mid-Atlantic Technology, Research, and Innovation Center, South Charleston, WV, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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 |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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