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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 National Safety and Quality Health Service Standards (NSQHS Standards) are Australia's principal health care standards, and apply to all health services including inpatient, outpatient, and community care. [5] There are 8 standards: Clinical governance; Partnering with consumers; Preventing and controlling infections; Medication safety
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 ...
National Quality Forum (NQF) is a United States–based non-profit membership organization that promotes patient protections and healthcare quality through measurement and public reporting. [ 1 ] [ 2 ] It was established in 1999 based on recommendations by the President's Advisory Commission on Consumer Protection and Quality in the Health Care ...
Health Level Seven, abbreviated to HL7, is a range of global standards for the transfer of clinical and administrative health data between applications with the aim to improve patient outcomes and health system performance. The HL7 standards focus on the application layer, which is "layer 7" in the Open Systems Interconnection model.
In 2015 CMS identified 254 quality measures for which providers may choose to submit data. The measures map to U.S. National Quality Standard (NQS) health care quality domains: [4] Communication and Care Coordination; Community/Population Health; Effective Clinical Care; Efficiency and Cost Reduction; Patient Safety
Historically, it had been maintained as a public resource by the Agency for Healthcare Research and Quality (AHRQ) of the U.S. Department of Health and Human Services. The NGC aimed to provide physicians, nurses, and other health professionals, health care providers, health plans, integrated delivery systems, purchasers and others an accessible ...