BSI IST/35 Portfolio In Health Informatics, Device interoperability
Posted By Grant Forrest | last update 14-Apr 2022
I was contacted recently by SCATA member Melvin Reynolds on the topic of ISO/IEEE Standards relevant to peri-operative medicine.
After some further reading, I volunteered to represent SCATA on the BSI IST/35 Health Informatics committee.
The scope of the Standards is "Interoperability of health (medical and personal health) devices". They are split into 2 working groups: one for Personal Health Devices and one for Point-of-Care Medical Devices (PoCD). For anaesthetists the PoCD WG is particularly relevant to the various electronic components of the anaesthesia machines, monitors and other anaesthetist-managed devices and interconnection with the surgical side of the OR (tables, lights, insufflators, pedals, etc.) Besides the cybersecurity standards mentioned below, they are working on a Service Oriented Device Connectivity (SDC) based series of standards based on technology developed and refined by the OR.Net project based in Europe. The aim is to integrate all of the electronic devices in the OR.
I appreciate that from a clinical standpoint, IEEE standards can be challenging to understand fully, and seem far removed from daily clinical activity. Saying that, I do appreciate that there are enthusiasts out there, and Melvin has forwarded an email to me from the IEEE 11073 chairman, Ken Fuchs.
Essentially, IEEE is transitioning to a more open form of a Standards Committee where anyone who is interested is welcome to participate. Whilst you can join at any time, they plan to hold an election for the officers at the end of October, and only members will be able to vote or stand for office.
Cybersecurity is the theme of two new standards, links for which are copied below :
11073-40101 - Health informatics - Device interoperability - Part 40101: Cybersecurity - Processes for vulnerability assessment (https://standards.ieee.org/project/11073-40101.html) and 11073-40102 - Health informatics - Device interoperability - Part 40102: Cybersecurity - Capabilities for Mitigation (https://standards.ieee.org/project/11073-40102.html) There is a draft P&P (policies and procedures) document that I can share for anyone interested in participating.
If you need a gentler introduction to IEEE 11073, there is a really good article on Wikipedia.
My understanding is that the meetings are all held using Webex, often alongside HL7 meetings, so there is no cost to the individual to participate. The expectation is that it would take a couple of hours of your time per year. The focus will be on strategic directions for IEEE 11073, management of Working Group activities and dealing with topics that are 11073-wide including our relationship with ISO/TC 215.
Addendum 5-Nov 2019
Melvin has kindly provided two documents with further background info - links below
Introducing BSI IST/35 Portfolio IV
Health Informatics, Device interoperability
International standardisation of health care device