IEEE 11073 Personal Health Device (PHD) Family of Standards

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For personal health devices to interoperate well, their design and implementation must conform to a messaging and communications standard. The IEEE 11073 Personal Health Device standard was created to help achieve device interoperability.

IEEE 11073 Personal Health Device Standards Overview

The IEEE 11073 Personal Health Device (PHD) standards are a broad family of standards that promote interoperability of personal medical devices such as pill dispensers, glucose meters, independent living activity hub, sleep apnea breathing therapy equipment, and urine analyzer. IEEE 11073 consists of an original “base” standard, and over time, the development of additional “specialization” standards. [1, 2]

“These standards aim to help patients enjoy more active and independent daily lives, support "on-the-go" mobile clinicians and caregivers and contribute to the elimination of gaps, waste and errors across the spectrum of healthcare delivery.” [1]

The IEEE Standards Association is one of many standards bodies and manufacturing companies that are part of the Continua Alliance. The IEEE 11073 family of standards is an important component of the Continua Alliance which works to promote device interoperability.

IEEE 11073 Working Groups and their Standards

Within the IEEE Standards Association, there are 22 Healthcare IT working groups, 7 of which are currently labeled Active as of 2013.

The following lists existing standards and active projects, and the responsible IEEE working groups. [3,4,5]

Health Informatics Personal Health Device Working Group – Active Projects

  • P11073-10423 - Device specialization - Sleep Monitor
  • P11073-10419 - Device specialization - Insulin pump
  • P11073-10413 - Device specialization - Respiration rate monitor
  • P11073-10422 - Device specialization - Urine analyzer
  • P11073-10424 - Device specialization - Sleep apnea breathing therapy equipment
  • P11073-10425 - Device specialization - Continuous Glucose Monitor (CGM)
  • P11073-10404 - Device Specialization - Pulse Oximeter

Health Informatics Personal Health Device Working Group – Existing Standards

  • 11073-10441-2013 - Device specialization--Cardiovascular fitness and activity monitor
  • 11073-00103-2012 - Overview
  • 11073-10406-2011 - Device specialization--Basic electrocardiograph (ECG) (1- to 3-lead ECG)
  • 11073-10417-2011 - Device specialization--Glucose meter
  • 11073-10418-2011 - Device specialization--International Normalized Ratio (INR) monitor
  • 11073-10421-2010 - Device specialization--Peak expiratory flow monitor (peak flow)
  • 11073-10404-2008 - Device Specialization - Pulse Oximeter
  • 11073-10407-2008 - Device Specialization - Blood Pressure Monitor
  • 11073-10408-2008 - Device specialization – Thermometer

Upper Layer Working Group – Active Projects

  • P11073-10301-1 - Device Specialization - Infusion pump, General
  • P11073-10302-1 - Device Specialization - Physiologic monitor, General
  • P11073-10303-1 - Device Specialization - Ventilator, General
  • P11073-20201 - Application profile -- Polling mode
  • P11073-20202 - Application profile -- Baseline asynchronous mode
  • P11073-20301 - Application profile -- Optional package, remote control
  • P11073-20401 - Application profile -- Common networking services
  • P11073-10101 - Point-of-care medical device communication – Nomenclature
  • P11073-20101 - Point-of-care medical device communication - Application profile - Base standard

Upper Layer Working Group – Existing Standards

  • 11073-10103-2012 - Nomenclature--Implantable device, cardiac
  • 11073-10102-2012 - Nomenclature —Annotated ECG
  • 1073.1.1.1-2004 - Nomenclature
  • 1073.1.2.1-2004 - Domain information model

Lower Layer working group

  • 11073-30200a-2011 - Transport profile--Cable connected Amendment 1
  • 11073-30400-2010 - Interface profile--Cabled Ethernet
  • 11073-00101-2008 - Guide--Guidelines for the use of RF wireless technology
  • 11073-30300-2004 - Transport profile – Infrared
  • 11073-30200-2000 - Transport profile - Cable connected


Architectural Overview

The IEEE 11073 standard defines “Agents” and “Managers”. An agent is typically a sensor device that has low power consumption, is battery operated, and has minimal user interface capabilities. Managers are devices that have more capable computing resources and can offer user interface control on behalf of Agents, as needed. Data that is furnished by the Agents and received by an appropriately configured Manager could conceivably be forwarded via the internet to a patient’s healthcare provider and stored in a patient’s electronic health record (EHR). An Agent can only talk to a single Manager. A Manager can talk to multiple Agents. Agents self-identify their configuration at the time they associate with a Manager. [6]

The IEEE 11073 standard defines messages, and does not define or restrict the transport mechanism. Three transport mechanisms have been used in conjunction with IEEE 11073 devices: Bluetooth Health Device Profile, USB Personal Healthcare Device Class, and ZigBee Health Care Profile.

Implementations Using IEEE 11073

Many devices have been implemented that conform to the IEEE 11073 standard. Some 80 certifications to date have been tracked by Continua Health Alliance. [7]

At the 2013 Consumer Electronics Show (CES), Michael Kirwan, IEEE 11073 PHD Vice Chair, identified 13 device specializations in the form of actual devices that connect to a gateway, or Manager within the 11073-20601 protocol. Mr. Kirwan demonstrated an Android application on a smart phone acting as a Manager that paired over Bluetooth with a Nonin Medical, Inc. device. The demonstration showed the Manager receiving data from the Agent, and forwarding that data on over a WAN to a Cloud recipient. [7]

Device Manufacturers that Use IEEE 11073

Personal Health Device manufacturers include: Phillips, A&D, LifeScan, Nonin, Tynetech, Pivotell, Optex, MindTree, Intel, Brunel University. [8,9,10]

Continua Health Alliance

Continua Health Alliance is a non-profit organization whose 200+ member companies are drawn from healthcare and technology industries. The Continua Design Guidelines incorporate various standards such as USB, Bluetooth Low Energy, ZigBee, and IEEE 11073. Among other activities, Continua Health Alliance is involved with product certification. [11]

The goal of certification is to assure interoperability with other Continua Logo certified products. To be able to display the Continua Certified logo, vendor’s products must successfully pass Continua conformance and interoperability testing. Conformance testing is defined as verifying that a device meets a requirement in a standard or specification. Interoperability testing is defined as verifying that two devices work together in the intended way.

Reference Design

Dr. Malcom Clarke (also Vice Chair IEEE 11073™ PHD Working Group) has led a group at Brunel University, London, to develop a reference design of a system bringing together devices from independent living and from the telehealth domain. [2]

Developer Tools

To simplify PHD development, a number of commercial software stacks and hardware boards are available to device manufactures.

To assist in prototype development, Intel offers an “Evaluation Kit with IEEE 11073 Continua Certified Software Stack for Medical Applications” and an embedded development board with Intel Atom processor, and Continua Certified USB interface, Continua-compatible Bluetooth interface, and IEEE 11073-20601 Protocol SQL Data Store. [12]

MindTree offers an IEEE 11073 Continua-certified software stack which includes: “the Bluetooth Health Device Profile and USB Personal Health Device Class. The solution is comprised of the IEEE 11073-20601 layer and a comprehensive suite of IEEE 11073 104xx manager and agent roles for a host of device specializations as per Continua v1.5 specifications. The stack’s compactness, maturity and completeness, allows consumer medical device makers tablet OEMs and smartphone OEMs to realize an easy path to commercializing Continua-enabled products.” [13]

Acute Technology manufactures wireless radio modules using the IEEE 11073 and Continua Alliance standards, and is compliant with the ZigBee Healthcare Profile. These radio modules are used in devices from several manufacturers to include: blood pressure monitors, weighing scales, medication dispensers, pulse oximeters, blood glucose meters, chair sensors, bed sensors, PIR motion sensors, temperature sensors, and Humidity sensors. [14]

Acute Technology manufactures a Hydra Radio Module designed to operate as an Agent. Hydra’s four main roles are outlined on Acute Technology’s web site:

  • It interfaces with the PHD sensor electronics, to collect the latest data from the Personal Health Device (PHD)
  • It converts the reading from the PHD into a format defined by the IEEE 11073 device specialization standard appropriate for the particular type of device (weigh scales, blood pressure monitor, pulse oximeter etc.)
  • It provides a ZigBee radio connection to the IEEE 11073 manager (typically the Hydra Healthcare Gateway) so that the agent and manager can exchange IEEE 11073 messages
  • It communicates with the IEEE 11073 manager to exchange IEEE 11073 messages, both initially to identify itself and its capabilities, then whenever a new measurement arrives.

Purchasing of Standards

Standards are available for purchase from the IEEE Standards Store. To purchase a standard, follow this three step process:

  • On the IEEE Standards web site, navigate to a particular standard, such as “11073-10404-2010 – Health Informatics – Personal Health Device Communication – Device Specialization – Pulse Oximeter”.
  • Scroll to the bottom of the page and click on “Buy” which opens a new window offering purchase options.
  • You may then select a “Print Edition” for $180.00, a PDF file for $180.00, or “Print + PDF” for $270.00.


Current Status

IEEE has the expectation of releasing at least four more specialization standards in 2013. Over time, existing standards are revised as needed. [7]

References:

[1] http://standards.ieee.org/news/2013/himss_2013.html
[2] http://www.youtube.com/watch?v=r3o84IZe9Eo
[3] http://standards.ieee.org/develop/wg/PHD.html
[4] http://standards.ieee.org/develop/wg/UL.html
[5] http://standards.ieee.org/develop/wg/LL.html
[6] http://en.wikipedia.org/wiki/ISO/IEEE_11073_Personal_Health_Data_(PHD)_Standards
[7] http://www.youtube.com/watch?v=vo79TxSVP70
[8] http://projecthydra.info/wp-content/uploads/2012/07/Standards_Project_Hydra.pdf
[9] http://www.continuaalliance.org/products/product-showcase
[10] http://www.zigbee.org/Products/ByFunction/HealthFitness.aspx
[11] http://www.continuaalliance.org/about-the-alliance
[12] http://www.intel.com/content/www/xr/en/intelligent-systems/medical-applications/ieee-11073-evaluation-kit-with-continua-certified-software-stack.html
[13] http://www.mindtree.com/company/news/press-release/mindtrees-ieee-11073-stack-connected-health-applications-achieves
[14] http://www.acutetechnology.com/products/health/

Submitted by Dan Collier