Standards
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Advantages
Standards are a necessary part of the cycle of maturation of any emerging technology. Lets give a very simple example to illustrate why standards are important.
Typically the cycle of technology development would start from a concept, idea or a market need (market pull). This would then perhaps be taken maybe in an academic environment to a design-of-prototype stage. Once a prototype is available testing begins on the device and the initial user requirements are analysed against actual performance. Probably after some tweaking and maybe even re-design (this can take a considerable length of time) the prototype passes through this stage to a full blown beta version. Further stress testing may be performed (for medical applications, in accordance with regulations) before it is decided that the device is capable of being commercialised. Once the device is commercialised, it can be sold to an end customer.
However now the real problems begin ! If the device can not work with other devices in the area (unreliable, loss of data, latency, interference, communications, privacy compromised etc) or if the device can not communicate with the 'outside world' (i.e. operate in a 'sandbox'), then the device is effectively useless and as a result there will be no market demand. The technology will just sit and wait for the standards to catch up. In the case of personalised healthcare systems it is even more important than just a commercial loss to some trading company, the potential of wellness and improved healthcare for individuals will not be realised and there will be a major societal impact.
Standards are the means by which the proven/working/very cool technology can actually 'reach out' and proliferate. All the "How Do I...?", "What if..?" questions will be answered in advance and the devices should operate seamlessly ideally in a 'plug and play manner'. The user doesn't have to be technical or understand anything about the technology, the system just works. A great example is the USB standard where any device from a camera to a phone to a printer can just plug in and 'work'.
From a manufacturer/supplier perspective standards ensure that their product will 'fit' the market need, it will integrate easily and will not become obsolete before its time. Because standards are usually share efforts between many organisations working to a common goal, the associated costs of this work would be dramatically reduced (as opposed to going it alone), so it makes sense for organisations to band together as much as possible.
Therefore standards are necessary to encourage and accelerate adoption of new technologies and to enable a faster time to market.
In summary standards;
- Encourages value-added innovation
- Accelerates adoption of new technologies
- Catalyses industry growth and creates opportunity for many companies in the industry
- Faster time-to-market with improved features and price/performance.
Disadvantages
The main drawback to standard creation is the complexity (and tediousness) of the work. To specify standards to a very detailed level requires great discipline, focus and expertise. Many organisations simply can not commit resources to the level of activity required and overhead required. It is also often also leveled against standards that they can stifle innovation in that if there is 'one way to do something' then it doesn't encourage people to look for smarter methods (the bureaucracy required to influence the change can put of people).
Initiatives
Bluetooth SIG
Bluetooth [1] wireless technology is a short-range communications technology intended to replace the cables connecting portable and/or fixed devices while maintaining high levels of security. The key features of Bluetooth technology are robustness, low power, and low cost. The Bluetooth specification defines a uniform structure for a wide range of devices to connect and communicate with each other.
Bluetooth technology has achieved global acceptance such that any Bluetooth enabled device, almost everywhere in the world, can connect to other Bluetooth enabled devices in proximity. Bluetooth enabled electronic devices connect and communicate wirelessly through short-range, ad hoc networks known as piconets. Each device can simultaneously communicate with up to seven other devices within a single piconet. Each device can also belong to several piconets simultaneously. Piconets are established dynamically and automatically as Bluetooth enabled devices enter and leave radio proximity.
Bluetooth technology operates in the unlicensed industrial, scientific and medical (ISM) band at 2.4 to 2.485 GHz, using a spread spectrum, frequency hopping, full-duplex signal at a nominal rate of 1600 hops/sec. The 2.4 GHz ISM band is available and unlicensed in most countries. More information on Bluetooth is available at [2] or here
Bluetooth profiles have been defined for healthcare applications and they define how different applications use Bluetooth wireless technology to set up a connection and exchange data. The Medical Devices Working Group of the Bluetooth SIG (ref) developed this profile to ensure that devices used in medical, health and fitness applications can transfer data between devices in a secure and well defined way via Bluetooth wireless technology.
USB Personal Health Device Specification
In April 2007 the USB Implementers Forum (IF) announced [3] that it was a Personal Healthcare Devices Working Group. The groups initial goal is to develop a USB based medical device specification. The group comprised of 14 major players in technology and healthcare will work to develope a standardised device class for transporting personalised messages and data.
ISO/IEEE Standards for Personal Health
ISO/IEEE have published a set of standards [4] pertaining to personal health devices and telehealth. As recently as October 2008 new standards were added. A list of these currently available is as follows;
- ISO/IEEE 11073-10404 - Pulse Oximeter
- ISO/IEEE 11073-10406 - Pulse / Heart Rate
- ISO/IEEE 11073-10407 - Blood Pressure
- ISO/IEEE 11073-10408 - Thermometer
- ISO/IEEE 11073-10415 - Weighing Scale
- ISO/IEEE 11073-10417 - Glucose
- ISO/IEEE 11073-10441 - Cardiovascular Fitness Monitor
- ISO/IEEE 11073-10442 - Strength Fitness Equipment
- ISO/IEEE 11073-10471 - Independent Living Activity
- ISO/IEEE 11073-10472 - Medication Monitor
- ISO/IEE 11073-20601 - Optimized Exchange Protocol
- ISO/IEE 11073-00101 - Guidelines for the Use of RF Wireless Technology
CEN
The European Committee for Standardization (CEN) is defining and revising a 5 part EHR standard: CEN/TC 251 - Health informatics: Reference Model, Archetype Interchange Specification, Reference Archetypes, Security, Exchange Models.
Routing over Low-power and Lossy Networks (Roll)
The Internet Engineering Task Force IETF has begun a standards effort to provide one of the missing puzzle pieces for wireless sensor networks. Aiming to define a spec for Internet Protocol by June 2009, the IETF's Routing over Low-power and Lossy Networks (Roll) group [5] is pursuing a standard way for control and sensor nodes on Bluetooth, Wi-Fi and 802.15.4 nets to link to the broader Internet.The Roll effort which is led by Cisco will assess requirements in sensor nets for use in home and industrial automation as well as in urban settings. It is building on the work of the IETF WPAN group, which has specified use of IPv6 over low-power wireless nets. The current model of wireless sensor net deployments feature ad-hoc networks with many translation gateways, leading to a complex and expensive architecture that doesn't scale. There are thousands and thousands of sensor networks in place in cars and buildings today, but most do not use IP. The Roll initiative aims at standardising the communications around IP.
Integrating the Healthcare Enterprise (IHE)
The IHE Initiative [6] is a long-term program sponsored by many professional societies to promote the coordinated use of healthcare IT standards and to provide a common framework for multi-vendor systems integration. IHE uses existing standards such as DICOM and HL7 as the building blocks for assembling larger integrated solutions, thus the IHE framework is not re-inventing a new standard in healthcare but provides a practical method to make these standards work. IHE also stages "connectathons" and "interoperability showcases" in which many vendors assemble to demonstrate the interoperability of their products. The IHE initiative acts at a higher level that the 'on the ground' standards bodies such as HL7 and DiCOM and works with these bodies where they exist. The IHE remit is more of an end to end one i.e. ensuring total interoperability of a system end to end, and not just one piece of it (as is the focus with most standards bodies). The IHE focus is primarily on medical imaging devices, radiology, cardiology, and Hospital Information Technology (HIT) Systems.
Health Level 7 (HL7)
The Health Level 7 (HL7) organisation [7] was founded in 1987 as a not for profit organisation to produce a standard for hospital information systems exchange. HL7, Inc. is a standards organization that is accredited by the American National Standards Institute (ANSI); it became accredited in 1994. It is an international community of healthcare subject matter experts and information scientists collaborating to create standards for the exchange, management and integration of electronic healthcare information. HL7 is now adopted by ISO as a centre of gravity in international standardization and accredited as a partnering organization for mutual issuing of standards. The name "Health Level-7" is a reference to the seventh "application" layer of the ISO OSI Model. The name indicates that HL7 focuses on application layer protocols for the health care domain, independent of lower layers. HL7 effectively considers all lower layers merely as tools.
The basic idea of HL7 is to provide a common messaging format for health information systems to communicate with each other i.e. to provide a 'language' that all systems understand. EDI in the retail is a simple messaging system for the interchange of trading information such as Advanced Shipping Notice and Order Transactions. HL7 aims at a area it defines very structured and semantic messaging schemes. However unlike EDI, HL7 is very detailed and semantically structured. Typically healthcare information systems will be incompatible and not communicate with each other as very often they have 'grown up' in the organisation separately. So when the situation exists where data is needed to be exchanged, the different systems essentially speak a different language. HL7 is designed to define a common language and enable disparate systems to communicate effectively. HL7 will be very important for the proliferation of Electronic Medical Records if a truly nationwide solution (and even trans-national solution) is to be realised. HL7 will be very important for wireless sensor networks also, as when the amount of intelligent devices producing healthcare information grows as it will, a common framework will be needed to maximise the promise of these networks. As with an emerging technology, there are many different approaches in many academic/research settings at present that are essentially trying to do the same thing. HL7 will be an important component in developing a common standard system for interoperability. For example, there is very little point in having a sensor network system that can not communicate its data with physicians, caregivers, medical records etc in a secure and reliable manner.
An example HL7 Message is shown here.
Continua - Promoting Personal Health Systems Interoperability
The Continua Alliance [8] is a group of leaders from the medical device, technology and healthcare provider industries that have come together to promote a set of interoperable standards specifically for personal health or 'telehealth'. The Alliance which numbers over 176 members including many blue chip technology companies and leading healthcare providers, looks at design guidelines that will enable vendors to build interoperable sensors, home networks, telehealth platforms, and health and wellness services. They are also working on providing a 'certification' process for products that conform to the continua standards and such products will carry the Continua logo. They also have a brief of working with government agencies and health care providers to proliferate lower cost telehealth solutions.
Continua aims to enable alignment of different vendors and domains.
- Disease management - Chronic disease management
- Aging independently - Using technology and services to live in your home longer
- Health and Fitness - Expanding personal health and wellness
The Continua Alliance has selected what they call the 'Version One' connectivity standards (see IEEE Device Connectivity standards section) and is working to identify and resolve gaps in some standards bodies so that personal telehealth solutions are interoperable and contribute toward improved health management. Additionally, the Alliance is writing guidelines on specifically how to use the standards to achieve true interoperability across many companies and many devices.
References
- ↑ http://www.bluetooth.com/bluetooth/
- ↑ http://www.bluetooth.com/bluetooth/
- ↑ http://www.usb.org/press/press20/2007_04_03_usbif.pdf
- ↑ http://www.itu.int/itudoc/itu-t/workshop/e-health/addinfo/info009.html
- ↑ http://www.ietf.org/html.charters/roll-charter.html
- ↑ http://www.ihe.net
- ↑ http://www.hl7.org
- ↑ http://www.continuaalliance.org/
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