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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.
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
A systems development life cycle is composed of distinct work phases that are used by systems engineers and systems developers to deliver information systems.Like anything that is manufactured on an assembly line, an SDLC aims to produce high-quality systems that meet or exceed expectations, based on requirements, by delivering systems within scheduled time frames and cost estimates. [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.
HL7 International specifies a number of flexible standards, guidelines, and methodologies by which various healthcare systems can communicate with each other. Such guidelines or data standards are a set of rules that allow information to be shared and processed in a uniform and consistent manner.
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.
Ministries of health in several sub-Saharan African countries, including Zambia, Uganda, and South African, were reported to have begun planning health system reform including hospital accreditation before 2002. However, most hospitals in Africa are administered by local health ministries or missionary organizations without accreditation programs.
ISO/IEC/IEEE 12207 Systems and software engineering – Software life cycle processes [1] is an international standard for software lifecycle processes. First introduced in 1995, it aims to be a primary standard that defines all the processes required for developing and maintaining software systems, including the outcomes and/or activities of each process.