DIN EN ISO 11073-10417:2014-06

Within the context of the ISO/IEEE 11073 family of standards for the communication of health devices, this standard establishes a normative definition of communication between personal telehealth glucose meter devices and compute engines (such as cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards especially ISO/IEEE 11073 standards for terminology, information models, application profile standards, and data transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This standard defines a common core of communication functionality for personal telehealth glucose meters. This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and compute engines (such as cell phones, personal computers, personal health appliances, and set top boxes). Interoperability is the key to growing the potential market for these devices and to enabling people to be better informed participants in the management of their health. In comparison to DIN EN ISO 11073-10417:2011-07, the following changes were implemented: a) in Table 6, the "Supplemental-Type attribute" was changed from Conditional to Optional; b) in the fourth paragraph of 6.9.1, the first sentence was reworded to specify that the "agent-init" will be disabled when a PM-store is present; c) in the second paragraph of 6.9.1, the use cases associated with "agent-init" versus "manager-init" transmission of measurement data were clarified; d) in Annex B, "Numeric class" to "Enumeration class" was corrected; e) a new standard configuration was added, which affects the following: 1) new paragraph in 6.4.2; 2) added a new Control Solution object separate from the Blood Glucose object (6.6.7); 3) removed "MDC CONC GLU CONTROL" from the "Blood Glucose object`s Type attribute"; 4) in 6.6.2, added +/- INFINITY as a way to indicate out-of-range sensor measurements. Also added this to the new "Control Solution object" in 6.6.7; f) in Table 13, the "Semantic-Modality" attribute was removed and the "Supplemental-Types" attribute was added; g) MDC CONC GLU UNDETERMINED PLASMA and MDC CONC GLU UNDETERMINED WHOLEBLOOD were added for meters that report plasma or whole blood glucose concentrations taken from an unknown sample source. Also, Table 1 was modified to add the "undetermined" sample source. The new OID was added to the Blood Glucose object extended configuration and the new standard configuration (Table 7); h) the MDC CTXT GLU MEAL BEDTIME nomenclature code was added to the "Context Meal enumeration object"; i) the "Confirm-Timeout" attribute was added, which was missing in Table 22; j) Table 13 was corrected. The recommended "Enum-Observed-Value" attribute should be Basic-Bit-Str instead of Simple-Bit-Str, as explained in the text following the table; k) in E.5.1, the encoding of "Measurement-Active-Period = 1 hour" was corrected to be a FLOAT type instead of a UINT-32; l) in C.3, the description of "Glucose Context Meal BeforeMeal" was corrected and lines were added for "Glucose Context Meal Fasting and Glucose Context Meal Bedtime"; m) in 8.3.2 and 8.3.3, the protocol-version text was modified to clarify what must be done when multiple protocol versions exist; n) in 8.2, the Ntx limitation requirement was modified such that there is a limit for non-PM-store configurations but not for a PM-store configuration. The Ntx value of 5120 for non-PM-store configurations is based on an event report that contains 25 measurements of each of the 11 defined objects; o) an additional use case description text to 5.1 was added; p) title, headers and footers, copyrights, formatting, references, etcetera, were updated per IEEE Standards publishing guidelines; q) in Table 7 for the "Simple-Nu-Observed-Value" and "Compound-Simple-Nu-Observed-Value", the qualifier to "C" was changed and the text in the Value column was expanded; r) in 6.6.1, the first sentence of the last paragraph was replaced with "For standard configurations the optional attributes are initially not present."; s) six occurrences of "manager device" were changed to "manager". The responsible committee is NA 063-07-02 AA "Interoperabilität" ("Interoperability") at DIN.