|Edition Number:||1||SCC Approved:||--|
|Edition Date:||2019-02-25||DOD Approved:||--|
|Price Code:||A||ANSI Approved:||2019-02-25|
1.1 Multiple stakeholders may participate in the development, deployment, assembly, and operation of a medical system with interoperable elements. Such a system, referred to as an INTEROPERABLE MEDICAL SYSTEM, should minimize patient risks, maintain clinical effectiveness, ensure timely and adequate access to data while protecting its security, and enable adequate provision of care. In order to facilitate alignment of stakeholders around these aims, this Standard establishes a baseline set of requirements for assuring safe and secure interoperability.
1.2 The requirements in this Standard may be applied to medical devices, as well as other connected infrastructure elements, and interoperable medical systems constructed from these. The Standard can be used by an organization as detailed in Annex A.
1.3 Each stakeholder will need to determine the specific level and manner in which interoperability will be specified and assured for its INTEROPERABLE MEDICAL PRODUCTS. However, a specific system may be developed, assembled, deployed, and operated through a range of processes undertaken by multiple stakeholders. Specific activities in these processes assure interoperability. In order for stakeholders to collectively accomplish this, the processes need to be linked effectively.
1.4 Effective linkage of processes across multiple stakeholders is a core focus of this Standard. This first requires that each stakeholder adequately assesses and manages safety, security and essential performance vulnerabilities of its INTEROPERABLE MEDICAL PRODUCTS. Secondly, it requires that each stakeholder understands and conforms with interoperability aspects of disclosed specifications of an INTEROPERABLE MEDICAL PRODUCT which it acquires or with which it interoperates, including the consequent safety, security and essential performance characteristics. Finally, it requires that each stakeholder clearly communicates to the other stakeholders the information required to assure interoperability.
1.5 This Standard employs a lifecycle process approach to organizing requirements. In addition to a set of broad management functions, the Standard provides for a set of interoperability planning, realization, deployment, and monitoring activities. These activities also incorporate cross-cutting requirements for security and risk management. The Standard recognizes that a given organization may be responsible for only a part of the full range of activities required for an INTEROPERABLE medical system. Furthermore, its INTEROPERABLE MEDICAL PRODUCTS may provide only a specific or limited functionality. To accommodate this, the Standard provides for flexibility in the scope, sequence, and interaction of these activities. Finally, the Standard provides requirements and supplementary guidance on key clinical and engineering properties of an INTEROPERABLE medical system that are essential to assuring effective interoperability and provides guidance on lifecycle activities and artifacts to be generated.
2.1 This Standard is applicable to INTEROPERABLE MEDICAL PRODUCTS, including assembled systems of INTEROPERABLE MEDICAL PRODUCTS that comprise or are intended to be incorporated into INTEROPERABLE MEDICAL SYSTEMS within an INTEROPERABLE ENVIRONMENT.
2.2 This Standard specifies a baseline set of requirements for assuring safe and secure interoperability for INTEROPERABLE MEDICAL SYSTEMS.