DIN EN ISO 21549-4:2014-06

With a more mobile population, greater healthcare delivery in the community and at patients' homes, together with a growing demand for improved quality of ambulatory care, portable information systems and stores have increasingly been developed and used. Such devices are used for tasks ranging from identification, through portable medical record files, and on to patient-transportable monitoring systems. The functions of such devices are to carry and to transmit person-identifiable information between themselves and other systems; therefore, during their operational lifetime they may share information with many technologically different systems which differ greatly in their functions and capabilities. Healthcare administration increasingly relies upon similar automated identification systems. For instance prescriptions may be automated and data exchange carried out at a number of sites using patient transportable computer readable devices. Healthcare insurers and providers are increasingly involved in cross-region care, where reimbursement may require automated data exchange between dissimilar healthcare systems. The advent of remotely accessible databases and support systems has led to the development and use of "Healthcare Person" identification devices that are also able to perform security functions and transmit digital signatures to remote systems via networks. With the growing use of data cards for practical everyday healthcare delivery, the need has arisen for a standardized data format for interchange. The person related data carried by a data card can be categorized in three broad types: identification (of the device itself and the individual to whom the data it carries relates), and administrative and clinical data. It is important to realize that a given healthcare data card "de facto" shall contain device data and identification data and may in addition contain administrative and clinical data. It is specified that device data include the following: - identification of the device itself; - identification of the functions and functioning capabilities of the device. Identification data may include: - unique identification of the device holder or of all other persons to whom the data carried by the device are related. Administrative data may include: - complementary person(s) related data; - identification of the funding of healthcare, whether public or private, and their relationships that are insurer(s), contract(s) and policy(ies) or types of benefits; - other data (distinguishable from clinical data) that are necessary for the purpose of healthcare delivery. Clinical data may include: - items that provide information about health and health events; - their appraisal and labelling by a healthcare provider (HCP); - related actions planned, requested or performed. Because a data card essentially provides specific answers to definite queries while having at the same time a need to optimize the use of memory by avoiding redundancies "high level" Object Modelling Technique (OMT) has been applied with respect to the definition of healthcare data card data structures. This part of DIN EN ISO 21549 describes and defines the Extended Clinical Data objects used within or referenced by patient held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1). This part of DIN EN ISO 21549 does not describe and define the common objects defined within DIN EN ISO 21549-2 even though they are referenced and utilized within this part of DIN EN ISO 21549. The body responsible for this standard is NA 063-07-04 AA "Sicherheit" ("Security") at DIN.