Healthcare
and disease management are critical issues affecting our national agenda and
spending priorities on a daily basis. Concerns over improving the availability,
access to and quality of care are not limited solely to the U.S. These same
urgent challenges impact most, if not all, countries on Earth. Despite these
dramatic statistics, there is still reason for optimism: technology-driven
disease diagnosis and treatment innovations, such as personal health devices
(PHDs), are advancing at a steady pace, opening new avenues to better quality
and more readily accessible healthcare.
However,
with the increasingly disparate range of new personal health technologies in
play, having a stable, common technical foundation is essential to ensuring
treatment accuracy and consistency in the quality of care. The creation of
widely accepted standards has become a linchpin in the development and
production of an efficient and effective telehealth ecosystem. International
standards development organizations (SDOs) such as IEEE have stepped in to fill
this vital role, leveraging its unique breadth of knowledge and resources to
provide needed architectures. Its concentration on standards, delivering needed
interoperability, ensures that devices within the rapidly expanding telehealth
ecosystem can continue to reliably exchange and use all data generated to the
patient's advantage.
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Where
Are We Now?
Telehealth
technologies generally fall into three categories: disease management, health
and fitness, and independent living/aging. These technologies span a diverse
array of monitoring, preventative and quality-of-life devices like weight and
body mass scales, blood pressure cuffs, glucose monitors, carbon monoxide
sensors and pedometers.
Since
its inception five years ago, the Working Group (WG) has produced a portfolio
of 11 standards that have been developed with and adopted by ISO, covering
devices based around a common, modular, transport-agnostic framework. Standards
completed to date include a wide array of devices ranging from pulse oximeters
to body composition analyzers to medication monitors, and an optimized protocol
standardizing data exchange between personal health devices and computer
engines such as mobile phones, personal computers and set top boxes: ISO/IEEE
11073-10404, device specialization: pulse oximeter; ISO/IEEE 11073-10407,
device specialization: blood pressure monitor; ISO/IEEE 11073-10408, device
specialization: thermometer; ISO/IEEE 11073-10415, device specialization:
weighing scale; ISO/IEEE 11073-10417, device specialization: glucose meter;
IEEE Std 11073-10420, device specialization: body composition analyzer; IEEE
Std 11073-10441, device specialization: cardiovascular; IEEE Std 11073-10442,
device specialization: strength; ISO/IEEE 11073-10471, device specialization:
activity hub; IEEE Std 11073-10472, device specialization: medication monitor;
and ISO/IEEE 11073-20601, optimized exchange protocol.
The
WG continues to develop new standards, as well as revisions to existing
standards, addressing emerging technologies and breakthroughs and additional
device types: IEEE P11073-10406, device specialization: basic ECG (1- to 3-lead
ECG); IEEE P11073-10413, device specialization: respiration rate; IEEE P11073-10418,
device specialization: international normalized ratio (INR)/blood coagulation;
IEEE P11073-10419, device specialization: insulin pumps; IEEE P11073-10421,
device specialization: peak flow; IEEE P11073-10404a, device specialization
revision: pulse oximeter; IEEE P11073-10417a, device specialization revision:
glucose meter; IEEE P11073-10441a, device specialization revision: addition of
3D accelerometer physical activity monitor; and
IEEE P11073-20601a, application profile amendment: optimized exchange protocol.
(See figure for an illustrated example of IEEE standards status.)
Both
the completed standards and those in development are aimed at achieving maximum
interoperability, coexistence and connectivity by defining specific objects,
attributes, nomenclature identification and services. Additionally, the IEEE
11073 PHD WG is harmonized with key constituencies, regulatory bodies and other
relevant organizations such as the Continua Health Alliance, National Institute
of Standards and Technology (NIST) and the U.S. Food and Drug Administration
(FDA). IEEE has particularly fostered collaborative, cooperative leadership and
development efforts with the International Organization for Standardization
(ISO), a critical avenue for the definition and introduction of internationally
recognized standards required by the marketplace. By leveraging shared
knowledge and expertise, and optimizing resource usage, partnerships such as
this shortens time-to-market and provide clear, considered leadership in a
dynamic, evolving environment.
Areas
of Standards Definition
The IEEE 11073 PHD WG is focused on defining standards
for OSI layers 5-7 and does not dictate specific transport standards that must
be used for personal health devices. Instead transport decisions are left to
the discretion of each device manufacturer. However, there has been close
collaboration between the WG and key stakeholders, such as the USB and
Bluetooth SIGs, whose work centers on OSI layers 1-4, and Health Level 7 (HL7).
HL7 standards for the exchange, management and integration of electronic
healthcare information are the most commonly used worldwide, with USB and
Bluetooth being the most frequently used communications protocols. In addition,
there is a growing momentum in the number of devices being certified for use
with the new, highly secure ZigBee radio standard, based on IEEE 802.15.4 and
ZigBee packet networks. Lastly, the IEEE 11073 PHD WG is also actively engaged
with the Continua Health Alliance to accelerate certification of personal
health devices meeting implementation and interoperability standards and
requirements.
In its five-year history, the IEEE 11073 PHD WG has
achieved significant progress in the successful development of numerous
standards for personal health devices. It has also made substantial gains in
improving interoperability, as well as increasing compatibility with both
existing and emerging communications technologies. As telehealth technologies
mature, PHDs will continue to evolve and capitalize on the latest advancements.
For
example, patients with early stage Alzheimer's disease may benefit from
sophisticated sensors capable of detecting when appliances are mistakenly left
on or if a thermostat has been set too low or too high. Doppler radar could be
used for non-contact respiration monitoring, recording when and for how long
sleep apnea sufferers stop breathing. New cardiac devices will be able to
record a richer variety of data, including heart rhythm and waveforms,
providing earlier detection of myocardial infarction and other events.
Douglas
P. Bogia is a standards architect in Intel's Digital Health Group and a member
of IEEE. For more information about his work, the working group's efforts or to
join the team, e-mail phd-chair@ieee.org.