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The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance).The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Clinical data standards are used to store and communicate information related to healthcare so that its meaning is unambiguous. They are used in clinical practice, in activity analysis and finding, and in research and development. There are many existing and proposed standards and many bodies working in this field.
The National Committee for Quality Assurance (NCQA) is an independent 501(c)(3) nonprofit organization in the United States that works to improve health care quality through the administration of evidence-based standards, measures, programs, and accreditation. The National Committee for Quality Assurance operates on a formula of measure ...
Health care quality is the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes. [2] Quality of care plays an important role in describing the iron triangle of health care relationships between quality, cost, and accessibility of health care within a community. [3]
Health Plan Descriptive Information; Measures Collected Using Electronic Clinical Data Systems; Measures are added, deleted, and revised annually. For example, a measure for the length of stay after giving birth was deleted after legislation mandating minimum length of stay rendered this measure nearly useless.
It was established as the Agency for Health Care Policy and Research (AHCPR) in 1989 as a constituent unit of the Public Health Service (PHS) to enhance the quality, appropriateness, and effectiveness of health care services and access to care by conducting and supporting research, demonstration projects, and evaluations; developing guidelines ...