Medical device software - Software life-cycle processes

ISO 27799:2016 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s). It defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to that International Standard. ISO 27799:2016 provides implementation guidance for the controls described in ISO/IEC 27002 and supplements them where necessary, so that they can be effectively used for managing health information security. By implementing ISO 27799:2016, healthcare organizations and other custodians of health information will be able to ensure a minimum requisite level of security that is appropriate to their organization's circumstances and that will maintain the confidentiality, integrity and availability of personal health information in their care. It applies to health information in all its aspects, whatever form the information takes (words and numbers, sound recordings, drawings, video, and medical images), whatever means are used to store it (printing or writing on paper or storage electronically), and whatever means are used to transmit it (by hand, through fax, over computer networks, or by post), as the information is always be appropriately protected.

This European Technical Specification will provide a set of requirements for developers of health and wellness apps, intending to meet the needs of health care professionals, patients, carers and the wider public. It will include a set of quality criteria and cover the app project life cycle, through the development, testing, releasing and updating of an app, including native, hybrid and web based apps, those apps associated with wearable, ambient and other health equipment and apps that are linked to other apps. It will also address fitness for purpose and the monitoring of usage. The specification will inform the development of health and wellness apps irrespective of whether they are placed in the market, and including free of charge. The specification will not cover the processes or criteria that an app developer or publisher follow to establish whether a health and wellness app is subject to regulatory control (e.g. as a medical device, or related to information governance).

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of their healthcare. It is specifically aimed at supporting the use case’ scenario for ‘unplanned, cross border care’ and is intended to be an international patient summary (IPS). Whilst the data set is minimal and non-exhaustive, it provides a robust, well-defined core set of data items. The tight focus on this use case also enables the IPS to be used in planned care. This means that both unplanned and planned care can be supported by this data set within local and national contexts, thereby increasing its utility and value. It uses the European Guideline from the eHN as the initial source for the patient summary requirements, then takes into consideration other international patient summary projects to provide an interoperable data set specification that has global application. This document provides an abstract definition of a Patient Summary from which derived models are implementable. Due to its nature therefore, readers should be aware that the compliance with this document does not imply automatic technical interoperability; this result, enabled by this document, can be reached with the conformity to standards indicated in the associated technical specification and implementation guides. This document does not cover the workflow processes of data entry, data collection, data summarization, subsequent data presentation, assimilation, or aggregation. Furthermore, this document does not cover the summarization act itself, i.e. the intelligence/skill/competence that results in the data summarization workflow.