Personal Health Device Standards Update

Healthcareand disease management are critical issues affecting our national agenda andspending 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 sameurgent challenges impact most, if not all, countries on Earth. Despite thesedramatic statistics, there is still reason for optimism: technology-drivendisease diagnosis and treatment innovations, such as personal health devices(PHDs), are advancing at a steady pace, opening new avenues to better qualityand more readily accessible healthcare.

However,with the increasingly disparate range of new personal health technologies inplay, having a stable, common technical foundation is essential to ensuringtreatment accuracy and consistency in the quality of care. The creation ofwidely accepted standards has become a linchpin in the development andproduction of an efficient and effective telehealth ecosystem. Internationalstandards development organizations (SDOs) such as IEEE have stepped in to fillthis vital role, leveraging its unique breadth of knowledge and resources toprovide needed architectures. Its concentration on standards, delivering neededinteroperability, ensures that devices within the rapidly expanding telehealthecosystem can continue to reliably exchange and use all data generated to thepatient's advantage.

WhereAre We Now?

Telehealthtechnologies generally fall into three categories: disease management, healthand fitness, and independent living/aging. These technologies span a diversearray of monitoring, preventative and quality-of-life devices like weight andbody mass scales, blood pressure cuffs, glucose monitors, carbon monoxidesensors and pedometers.

Sinceits inception five years ago, the Working Group (WG) has produced a portfolioof 11 standards that have been developed with and adopted by ISO, coveringdevices based around a common, modular, transport-agnostic framework. Standardscompleted to date include a wide array of devices ranging from pulse oximetersto body composition analyzers to medication monitors, and an optimized protocolstandardizing data exchange between personal health devices and computerengines such as mobile phones, personal computers and set top boxes: ISO/IEEE11073-10404, device specialization: pulse oximeter; ISO/IEEE 11073-10407,device specialization: blood pressure monitor; ISO/IEEE 11073-10408, devicespecialization: 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; IEEEStd 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.

TheWG continues to develop new standards, as well as revisions to existingstandards, addressing emerging technologies and breakthroughs and additionaldevice types: IEEE P11073-10406, device specialization: basic ECG (1- to 3-leadECG); 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 specializationrevision: pulse oximeter; IEEE P11073-10417a, device specialization revision:glucose meter; IEEE P11073-10441a, device specialization revision: addition of3D accelerometer physical activity monitor; andIEEE P11073-20601a, application profile amendment: optimized exchange protocol.(See figure for an illustrated example of IEEE standards status.)

Boththe completed standards and those in development are aimed at achieving maximuminteroperability, coexistence and connectivity by defining specific objects,attributes, nomenclature identification and services. Additionally, the IEEE11073 PHD WG is harmonized with key constituencies, regulatory bodies and otherrelevant organizations such as the Continua Health Alliance, National Instituteof Standards and Technology (NIST) and the U.S. Food and Drug Administration(FDA). IEEE has particularly fostered collaborative, cooperative leadership anddevelopment efforts with the International Organization for Standardization(ISO), a critical avenue for the definition and introduction of internationallyrecognized standards required by the marketplace. By leveraging sharedknowledge and expertise, and optimizing resource usage, partnerships such asthis shortens time-to-market and provide clear, considered leadership in adynamic, evolving environment.

Areasof Standards Definition

The IEEE 11073 PHD WG is focused on defining standardsfor OSI layers 5-7 and does not dictate specific transport standards that mustbe used for personal health devices. Instead transport decisions are left tothe discretion of each device manufacturer. However, there has been closecollaboration between the WG and key stakeholders, such as the USB andBluetooth SIGs, whose work centers on OSI layers 1-4, and Health Level 7 (HL7).HL7 standards for the exchange, management and integration of electronichealthcare information are the most commonly used worldwide, with USB andBluetooth being the most frequently used communications protocols. In addition,there is a growing momentum in the number of devices being certified for usewith the new, highly secure ZigBee radio standard, based on IEEE 802.15.4 andZigBee packet networks. Lastly, the IEEE 11073 PHD WG is also actively engagedwith the Continua Health Alliance to accelerate certification of personalhealth devices meeting implementation and interoperability standards andrequirements.

In its five-year history, the IEEE 11073 PHD WG hasachieved significant progress in the successful development of numerousstandards for personal health devices. It has also made substantial gains inimproving interoperability, as well as increasing compatibility with bothexisting and emerging communications technologies. As telehealth technologiesmature, PHDs will continue to evolve and capitalize on the latest advancements.

Forexample, patients with early stage Alzheimer's disease may benefit fromsophisticated sensors capable of detecting when appliances are mistakenly lefton or if a thermostat has been set too low or too high. Doppler radar could beused for non-contact respiration monitoring, recording when and for how longsleep apnea sufferers stop breathing. New cardiac devices will be able torecord a richer variety of data, including heart rhythm and waveforms,providing earlier detection of myocardial infarction and other events.

DouglasP. Bogia is a standards architect in Intel's Digital Health Group and a memberof IEEE. For more information about his work, the working group's efforts or tojoin the team, e-mail [email protected].