ISO TS 20405:2018 pdf free

ISO TS 20405:2018 pdf free.Health informatics – Framework of event data and reporting definitions for the safety of health software
The’ framework of event data and reporting definitions for the safety of health software is premised upon key principles, data concepts and a process model. Using these components, an organization can understand the rationale and methodology to undertake a structured effort in establishing or improving upon the recording, analysis and reporting on incidents, near-misses and unsafe conditions as these relate to the safety of health software.
It is important to note that this document takes an organizational focus in describing the actions necessary for the definition and implementation of the framework’s components, as the adoption and implementation of the framework should be a strategic decision of an organization. That said, there are important leadership and participation roles within the framework for individual stakeholders and interests whether these are in the context of an organization, e.g. as an employee or contractor, or as an organization-independent or ‘public-at-large’ individual.
A principle-based approach is useful to structure the overall framework of event data with respect to the safety of health software in the context of incident management, extending to the specific use (i.e. action) of the data by the organization, as well as any involved or interested parties including but not limited to the health software vendor, jurisdictional and regulatory authorities etc., as well as for ongoing vigilance and further corrective responses (i.e. monitoring and review).
In total, these principles should contribute towards a data-driven framework that supports the overall goal of available, useful and safe health software for clinicians and other end-users involved in caring of patients.
To ensure the effective and efficient surveillance and reporting of events with respect to the safety of health software, an organization’s approach shall be established in advance, optimally at the initial stage of determining the need for health software, and as a necessity before its commissioning and use.ISO TS 20405 pdf free download.