Health informatics — Personal health device communication – Part 10419: Device specialization — Insulin pump

This standard establishes a normative definition of communication between personal telehealth insulin pump devices and managers (for example, cell phones, personal computers, personal health appliances, set-top boxes) in a way that enables plug-and-play interoperability. In the context of personal health devices, an insulin pump is a medical device used to administer insulin in the treatment of diabetes mellitus. This practice is also known as continuous subcutaneous insulin infusion (CSII) therapy.

This standard leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and 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. A common core functionality of personal telehealth insulin pump devices is also defined.

Main sections:

· Scope

· Purpose

· Normative references

· Introduction to ISO/IEEE 11073 personal health devices (PHDs)

· Insulin pump device concepts and modalities

· Insulin pump domain information model (DIM)

· Insulin pump service model

· Insulin pump communication model

· Test associations

· Conformance

· Annex A: (informative) Bibliography

· Annex B: (normative) Any additional ASN.1 definitions

· Annex C: (normative) Allocation of identifiers

· Annex D: (informative) Message sequence examples

· Annex E: (normative) Schedule-store class

· Annex F: (normative) Schedule class ASN.1 definitions

· Annex G: (informative) The schedule-store concept

· Annex H: (informative) Schedule communication model

· Annex I: (informative) Protocol data unit (PDU) examples

· Annex J: (informative) Revision history