Bits and Pieces over Interoperability Standards

Bits and Pieces of Conclusions

2011-06-13T08:25:00.000-07:00

…SO FAR

Attempts are being made to digitize healthcare services with the introduction of personal health devices, and with connecting them to the aggregation manager and the health care. Different producers have come up with various connectivity profiles, either wired or wireless, making it impossible to use multiple devices at the same time. Continua assumed the role of the arbiter trying to control the ehealth connectivity. The concepts of PAN connection attract most attention since there are currently many different wireless standards battling over which function to perform and where. Continua has selected Bluetooth, Bluetooth Low Energy, ZigBee and USB for transporting data since these technologies proved most efficient for devices in the chain of healthcare data collection and transportation.

For the wide area network (WAN) interface that connects the aggregation manager and the health service center, platforms such as Wi-Fi are commonly used, but GSM, GPRS or EDGE also can be options. Standards used in the WAN are commonly high power and can help achieve long range connection, unlike those used in the PAN which require low power, long operation time and small ranges (typically 10-100m).

Bluetooth low energy (BLE) has been introduced by the Bluetooth Special Interest Group (SIG) and has been adopted by Continua Alliance to fulfill the PAN interface connectivity. BLE targets data exchange using lower power consumption than Bluetooth classic. It operates within the same spectrum range (2402 MHz to 2480 MHz) as classic Bluetooth, but with a different set of channels. The power reduction in BLE can be explained by the reduction of the synchronization word, as well as connection mechanism. The duration of a BLE link does not exceed 3ms; this is why it consumes little power – most of the time the device is in standby mode.

Built on top of the IEEE 802.15.4 PHY layer, ZigBee uses the 802.15.4 standard. The 2.4 GHz band remains the most used frequency band as of today. Unlike IEEE 802.15.4, ZigBee allows full mesh networks. ZigBee was chosen to fill in the connectivity requirements at LAN level. Many argue that because BT LE comes packaged together with the classic Bluetooth and given the current reign of Bluetooth, ZigBee will be replaced. However both Bluetooth and BT LE cannot perform LAN functions and will therefore just remain steady complements of ZigBee in medical devices not competitors.

I have talked a lot about the standardization process of Bluetooth Low Energy: how it started as a Nokia project and then was salvaged by Bluetooth and then how it was selected as a standard by Continua even before it was officially released. After reading specifications and technical reports, it comes out that Continua is not a knight in shining armor or a mean monster driven by profit (no meaner than any other standardization organization), but the BT LE technology actually is the key of the future mobile devices. In addition, a lot of friction in the process arises from formal standardization bodies which either introduce barriers or require additional checking. However, the necessary steps are known by now, all there is left is a solid implementation method. Due to the fact, that the alliance is gathering together all stakeholders in one union, the industry cooperation provides additional input and brings the market closer to the end customer.

With the ubiquity of wireless technologies and the emergence of new standards, the healthcare industry is experiencing a revolution in the way healthcare is being delivered. With the support of wireless technologies and the logo certification Continua is implementing, telehealth offers the potential to help control the cost of healthcare while enabling patients to maintain a good quality of life.

Trends in Health Care - Recap

2011-06-13T05:09:00.000-07:00

I have said it over and over again: the healthcare market is one cow ready to be milked. Market Forces like an aging population, health care economics/politics (more and more laws regard the prevention of disease – preventative management), acute need for highly trained specialists and care takers, consumerism drive, increasing demand for portability, ease of use, targeted use, miniaturization and a confusing regulatory pathway shape it into a profitable yet difficult market.

As far device technology goes, the importance of interoperability cannot be stressed enough while the limitations of batteries drive innovation into specific target areas. Wireless is becoming ubiquitous under these considerations (e.g., Bluetooth Health Device Profile) and low energy consumption is also becoming an ardent issue with research into LPR (Low Power Radio) e.g. Zigbee Healthcare and Bluetooth LE. Flexible platforms systems and auto managed power technologies together with and increased RF traffic challenge the tasks of designers.

Data Management (e.g., PHR, EMR, HIO, HIE) is another aspect of the entire environment that sets its fingerprint on the evolution of things. The general impression is that of organized chaos with the basics being still undecided. The principles of ownership, security, privacy, reimbursement, mobility, management, metadata, flexibility, useful sharing or those of regional vs state vs interstate vs national are still under heated debate. Continua tries to step in and shed light on some of these issues, but most of the times the time required is just too much for actual solutions to be adopted. Just two months ago in Brussels the report "Enabling smart integrated care: Recommendations for fostering greater interoperability of personal health systems" (The SmartPersonalHealth project is a Support Action project partially funded by the Directorate-General Information Society of the European Commission under the 7th Framework Programme) tries to pinpoint the major challenge for the growing personal health solutions market down to the failure to address interoperability. With so much government oversight and funding coming from different boosters competition between players does not fail to rise (e.g., Dossia, Google Health), despite the cooperation between companies that is obvious just by looking at the alliance and the decisions taken at this level about standards.

All these trends make companies invest a lot of money in products and mobile health applications. These are only the latest products but the numbers are increasing quickly approaching the market potential forecast up to $1,348 million in 2011, as projected by Park Associates in their Wireless Healthcare: Analysis and Forecast in 2009.

Promising Forecasts & False Suppositions

2011-06-12T08:31:00.000-07:00

The forecasts in the ehealth medium keep pouring down and they put forward very promising scenarios. Deloitte Center for Health Solutions' survey found that 50% of consumers want a "personal monitoring device" to alert and guide them to improve their state of health or treat an already existing condition. A research done by PricewaterhouseCoopers places the market of mobile health applications at $7.7 billion with 40% of U.S. adults "willing to pay". In 2009, McKinsey's survey on mobile health estimated the market at $50 billion to $60 billion worldwide and $20 billion in the U.S. Parks Associates projects the wireless home health monitoring market will reach $4.4 billion in 2013. Juniper Research places the market of remote patient monitoring via mobile network at $2 billion by 2014.

It cannot be denied that some of these reports are commissioned by various players looking to boost one aspect of the market or another. But what is there behind these numbers?

The talk about the healthcare and ehealth has reached such an extent that we can now no longer appreciate the market for what it is in reality. The Intel Health blog (Intel Healthcare is part of Continua Alliance) notes that when referring to mhealth "The phrase has become so slippery, so ubiquitous as to become almost useless. We must be more careful in defining and aligning what we're talking about." When I started this blog, I paid little attention to what the market actually was and is. I took it for granted, but as researching Continua and their strategy, I realized the market is comprised of manifold players (chip producers, standardization bodies, hospitals, product developers, middleware designers, basically a total of 230 representatives).

I mentioned the PricewaterhouseCoopers’ forecast since it was talked over in the online and offline. This survey found that 40% of consumers are willing to pay for mobile health applications. But what does pay mean? The same survey argues that a monthly subscription to a mobile phone-based service which can manage health problems can cost no more than $5, a meager figure for the billions projected for the entire market. The value isn’t yet given by what the customer is willing to pay since the market is still immature. Hmm…back to the market now, aren’t we? By immature I mean that end users are not yet aware of what they will actually buy and how it will actually impact their everyday life. And then it makes all the sense in the world to have a regulations body like Continua, which is not official in the very sense of the word but whose voice is heard because it listens in turn to all the market contenders.

As an organization that also decides upon involved standards, it is voluntary and open for new comers (companies able to pay a fee), open and public to some extent as they publish guidelines and additional information, and serves a general purpose for the society.

Another initial supposition of mine was to consider the alliance as a means to increase profits for companies joining the organization. When writing the first post, I already had the last one in mind entitled “Money makes the world go round” (They actually charge for information upon request). Now, I still believe that decisions taken are also based on financial aspects, but at the same time, I believe that the primary aim of Continua is to fill in the gaps necessary to accomplish a truly innovative healthcare system. The challenges for this organization are not negligible with both the FDA and EC lurking in the shadows, but the strategy is sound – cooperation between the majority of companies in the market will have the same effect as the imposed official regulations – and will achieve logo certified interoperability.

Clash of the Titans?

2011-06-12T05:13:00.000-07:00

Continua Alliance’s main goal is to achieve certified interoperability. For an industry organization, it faces a lot obstruction from official standardization bodies. On top of that, as Gianluca mentioned here, the FDA poses some problems and delays the entire market of healthcare. Continua is playing on an international market and is therefore affected by measures taken in the US. What is happening on the European continent? A serious contender boosted by the European bodies has appeared promoting the same goals as the international industry based organization, Continua Alliance.

CALLIOPE is coordinating an open, stakeholder-driven process to identify key challenges and issues related to interoperability, and define priorities for a European eHealth Roadmap. The Roadmap has been identified as a major policy instrument to support the European eHealth Governance Process.

I can definitely see the cooperation of the two bodies, with members from one attending events of the other and giving speeches and sharing information. But I cannot help wondering, why is there a need to have to bodies trying to achieve the same purposes. The model and the approach of both organizations seem to be rather similar in many aspects.

Standardization is one of the priorities of both based on use-case analysis. However, as part of the latest goals of the European Digital Agenda, Calliope tends to focus solely on the standardization process and how to implement this process within the member states, but less on the security of data from measuring device to the medical health records. The CALLIOPE recommendations support the need for a wider dialogue on how standards bring value to health care, with a framework for contribution from participants. It is important that standards are developed in response to well defined user needs, and users (especially professional organizations) need to play a stronger role in providing the use cases and enumerating the potential benefits of the standards they need. These organizations also need to play an active role in the education and promotion of the resulting system features that incorporate those standards. Beyond the application of standards in a public policy context, the benefits of standards should be promoted to the wider community and through the research arena, education system, the place of standards in the economy, and their role in meeting the needs of public authorities and society.

The advantage of this European body is that it has the support of the European Community and therefore it already has what it is desired to be an open and transparent, structured method of implementation at member state level. The guidelines imposed by the European Standards Organizations are to be followed to the letter by the local representatives, unlike the guidelines of Continua which are followed on a voluntary basis.

The standardization process of Calliope is open and accessible, very similar to that of the alliance. The CALLIOPE recommendations include pooling knowledge and talent from experts and promoting consortia in order to progress in certain fields. The interaction of stakeholders (potential end-users, large and small- to medium-sized enterprises) and the standardization organizations should be simple enough to encourage cooperation between the two. An important issue to be addressed is the assessment of intellectual property rights and license, as mentioned here. Dealing with a number of standards, which include various costs in terms of IPR, falls short of achieving interoperability by producers. However, Calliope argues that the prime beneficiary of the standardization program is the market, and their efforts strive to accomplish that with the aid of the European Commission directions.

Given the similar approach and similar goals of Continua Alliance and Calliope, the cooperation between them should be obvious. However, I cannot help thinking that the purpose of this European Standards Organization in the healthcare environment is purely to verify the actions and decisions taken at a worldwide level by companies on the market through Continua.

A Standard does not Secure Interoperability

2011-06-11T08:04:00.000-07:00

Publishing and adopting a standard is by no means enough. Without test documentation, certification services, and a logo license agreement, interoperability is an illusion.

As I’ve tried to point out the specific details of the healthcare infrastructure in this post, I want to dwell a bit more today on how interoperability is actually achieved with these different standards. The problem this market faces basically is that all measuring devices, weight scales or sensor running shoes, have to connect to a mobile phone and a telecom network and these phones cannot connect directly to one another but have to pass through the network. How many players are there on the mobile market? The big ones are relatively few but there are also small ones we are seldom aware of. All these companies undergo extensive tests before launching a product on the market but the bottom line has it that each and every single device in a family is different from the competition. And yet we expect them to synchronize different email address with them and take good quality pictures and have a good functioning time and connect to headsets and so on and so forth. We want it to achieve interoperability.

The testing against certain standards has to follow a certain procedure. Usually this procedure is established by the standardization body. What organizations like Bluetooth SIG have done is to invest in automated interoperability testing equipment. They did it in 2005 for Bluetooth. Bluetooth LE will follow in the same footsteps and will have millions of dollars invested so as to guarantee interoperability.

That is the story with Bluetooth Low Energy, but Continua Alliance has selected also ZigBee and a number of other standards to ensure the integrity of data from sensor to the medical record systems. Most people think there is a competition between these two low energy standards (ZigBee and BT LE), but in reality the organization has selected them to perform different functions.

Looking back, when Bluetooth was announced it was highly rumored and believed that the end of IEEE 802.11 wireless LAN’s was approaching fast, since the difference between LAN and PAN were not so concrete. History is repeating with many people believing that that BT LE and ZigBee PRO are competing for the winning spot. Many argue that Bluetooth low energy will be the next IT thing, because it is packaged together with classic Bluetooth, thus it will automatically be included in devices already using Bluetooth. However, there is not one single standard to achieve interoperability and Continua Alliance was able to accept it and formally introduce this concept.

BT LE cannot perform LAN functions and ZigBee cannot perform PAN functions and that is it. Do we accept it? As users, we have little influence. We cannot demand a certain technology to a producer. Perhaps we can compare devices with features implemented with the two technologies but when trying to fill the same gap. Continua will achieve interoperability while trying to get all these technologies to work together, complementing each other.

If this strategy of the organization can be put down to a good premonition of how the PAN and LAN will not evolve to become one single interface, or to a good business vision, since both standards are backed up by wealthy companies, cannot be asserted for sure. Nevertheless, interoperability with just one standard is rarely achievable even when the extensive tedious tests are complete. So, the more the merrier, I say.

Industry vs. Formal Standardization Bodies

2011-06-10T06:56:00.000-07:00

It appears that industry standards are not well regarded by formal standardization bodies. Then it makes all the sense in the world to have industry bodies like Continua Alliance to promulgate industry standards.

“ETSI is non-profit organization whose mission is to produce telecommunications standards for today and for the future. It is an open forum that unites over 800 Members from 53 countries and brings together manufacturers, network operators and service providers, administrations, research bodies and users. ETSI prides itself on being a market-driven organization; its Members, which represent all aspects of the industry, decide its work programme and allocate resources accordingly.”(ETSI 2000c)

However, in the quest for interoperability, European Standards committee tends to neglect the industry based standards. They consider them of lower quality. A standard developed by a formal standardization body has the advantage that it undergoes a certain process (apparently just the right one to give perfect quality) but the cherry on top is that governments may interfere and refer to it within a law. Thus, even though there is no quality guarantee besides word of mouth, the adaptation process is secured to some extent. Selection/adoption of any standard will entail, besides the actual technical details, a bit of drama over who can and will make more profit, irrespective if the environment is official or industry based.

Now it does seem a bit hypocritical for such official bodies not to trust the industry standards. Nonetheless, the industry has found the solution, at least in the Bluetooth Low Energy case. In this case the guarantees come both from the member companies working on it but also from the brand name that Bluetooth has become in this area. I have mentioned this before: BT LE has many technical advantages which makes it a technology worth considering. If governments are not going to include it in some law or regulation, an industry based organization, Continua Health Alliance, will.

The role of this organization is to deal with the problems if connected medical devices. Selecting standards is just one minor task it has to fulfill, a task that is supposed to ensure interoperability. The Continua logo will certify that data coming out of a medical device is safely delivered to the medical records and those able to operate them. An organization performing the function of an official law enforcing body. How can they accomplish that? By adding as many companies as possible, out of the market players or enablers. Not the straightforward, politically accepted way but a way that has proved efficient. It was successful with Bluetooth, it will undoubtedly work even better with BT LE since experience is a good learning source. Now the only danger is that the market might turn the tables and go against the current, as Gianluca mentioned in this post, refusing all guiding measures the companies enforce to control the outcome.

The Law Suit around the Corner with IP

2011-06-09T11:03:00.000-07:00

I have talked about the market and profit possibilities in my last post and this aspect of the whole standardization process is undoubtedly very important. The cost of a product is given by the size of silicon used or by the market gap it can fill out. Or at least that is how we usually look at the value for money of a product. It would be all hunky dory if it were so simple. Unfortunately, the danger with new technologies is that Intellectual Property rights can make the price of a product encompassing that particular technology to go way up. This is not even the major problem, because, if these rights are handled up front at the beginning, the cost can increase but will remain fixed. So no surprises! But what if chips start selling by the billions and greedy money makers claim rights in your product, in the technology you use? That’s known in this environment as the patent trolls and boy can they strip you down of a lot of pennies.

The reason this seldom occurs is ignorance. Ignorance is bliss but it can also be the beginning of the end and there were numerous cases (even the mighty Microsoft and Google have had the "pleasure" of spending a few valuable bucks on fighting off patent trolls). In the technical environment, there is a common misconception that if a producer buys the right to use a standard, then IP rights does not apply. It certainly depends on the standardization body and the conditioned negotiated beforehand.

With Bluetooth Low Energy it seems rather straightforward. But it might be because this is a company based standard. Bluetooth owns the intellectual property inside Bluetooth Low Energy and they can license it. However, with Bluetooth, where a lot of members contribute to the standard coming into force, the risk of relevant patents or IP being discovered later is very little. The members are asked to contribute in terms of proprietary knowledge owned so that everyone can use the standard. Therefore Bluetooth Low Energy is reasonable and non-discriminatory and it has the use of IP free from any form of license fee - RANDZ.

This is a two way pact. Companies agree to give up the right to make profit through proprietary rights by taking each other to court, but in turn sign away some of the value of their IP. Why would companies choose to do so? They have to give a little to take a little. They are aware that long term profits can be achieved if they cooperate in the early stages to grow the market to the point where it pays off. Like it happened with Nordic Semiconductor. They started developing the standard with Nokia, then surrendered to Bluetooth but got the chance to be among the first to produce a BT LE chip and they have little risk of trolls appearing from thin air. If more companies give away their IP license, more IP goes into the standards pool, thus the final version of the technology is likely to be better protected against being sued.

In many respects, Bluetooth LE comes with a good protection against IP issues. Its RANDZ basis as well as the strategic umbrella of Bluetooth as a corporation makes it a reliable standard. Nevertheless, no standard is law suit proof.

Healthcare – a procrastinated market ready to explode

2011-06-08T08:57:00.000-07:00

Bluetooth wireless technology already is a de facto standard and one of the measures that brought it here is the regulation for car drivers to have a hands free connection to the mobile phone while driving. I mention this because Bluetooth Low Energy has a similar faith. As I mentioned before, its chances of making it into the real world seemed slim at the beginning, but as soon as it was adopted by the Bluetooth SIG and the focus market shifted to healthcare products, there was only one tiny step left for it to be introduced in a regulation of some sort. And it was; Continua Alliance included it as a standard for certified healthcare products.

The growth of this technology was rather fast, faster than others for sure. An IMS Research predicts that by 2014 there will be over 1 billion Bluetooth low energy chip sets, with most of those units being dual-mode ICs. The same research reports that both dual and single mode ICs will be produced while only 10% of the BT LE chips will be single mode chips next year. All predictions have it that BT LE is bound to open the doors of innovation in healthcare/telehealth products. “By 2016, Bluetooth Low Energy connected healthcare and fitness devices will reach 467 million annual device shipments,” notes practice director Sam Lucero, ABI Research.

Bluetooth low energy is optimized for transmission of small amounts of data from the sensor/actuator to the Application Host Device. It goes without saying that pulse monitoring for the elderly or heart rate control for cardio activities are just some tangible examples in which the technology can connect to a mobile network and bring solutions that have been so long expected. ABI Research’s “Wireless Healthcare and Fitness Market Data” sees huge potential in the market. However, they too observe the delay of more than six months according to what many in the industry had expected.

The industry is fickle enough as it is, if you build up expectation, you might be surprised to see that producers turn to other wireless technologies. But why was there this procrastination? Is it the desire to improve the specs from the technological point of view? Or is it because major players wanted to buy some time and put out their products ahead of other competitors? Continua Alliance adopted the standard a while before its actual coming on the market. Now if we look at the products launched just after Bluetooth Low Energy being bundled up with Bluetooth v4.0 Core Specification, we do notice that some companies are also part of the alliance (I am thinking of Nordic Semiconductors but not only). Now maybe I like to put a dramatic light but it seems just too fishy for this delay to be purely technical. And there is another question to be answered: What business model can make the numbers with this innovation? Because let’s face it, a standard remains a standard. Technology can, undoubtedly, give it an upper hand, but if there is no marketing for the product encompassing the technology, it will surely fade out and die. Maybe the delay was buying marketing time to come up with the right product.

The winner takes it all

2011-06-06T08:02:00.000-07:00

Wireless is highly employed nowadays in various setups. The boom is partly due to the available technologies developed: Wireless LAN, Classic Bluetooth, IEEE 802.15.4/ZigBee, and Wireless HART serve different purposes. I mentioned in my last post the possible interfaces in the healthcare products ecosystem. The PAN devices (sensors and actuators) require a cheap, low energy, fast, reliable wireless connection method. Bluetooth low energy wireless technology, the hallmark feature of the v4.0 Bluetooth Core Specification, solves all problems.

This technology originated in 2001with Nokia as BTLite and was initially made public as Wibree in 2006 by an alliance between Nokia, Suunto, Nordic Semiconductors, etc. In June 2007, Nokia and the Bluetooth SIG announced that Wibree would be integrated with Bluetooth. Strategic move I might add. Back in 2006, Nokia’s purpose of developing “yet another wireless standard” (there already was Zigbee and Z-wave) was strictly related to connected watches and shoes, as well as keyboards and mice, as its target market. Making a standard public in its draft form was aimed at bringing other companies on board. Thus, the Bluetooth Special Interest Group has approved a low-power variant of the wireless standard, challenging Zigbee and Z-Wave and targeting heath care applications.

WiBree owes its birth to heart-rate-monitoring watches, an idea originating with Nokia who wanted to connect to its mobile phones with in-shoe sensors to enable tweeting over jogging progress. This idea was the one that brought the standard where it is now, irrespective of how funny and unrealistic it seemed at the time. Nonetheless, Nokia appears to have been lost somewhere down the way, since its original idea Wibree has suffered quite some transformations while under the protective wing of Bluetooth SIG. In 2009 Continua’s Version One Design Guidelines became public including Bluetooth low energy technology. “We are pleased that Continua Health Alliance has selected Bluetooth low energy wireless technology for inclusion in its next Design Guidelines, and are excited about the compelling Bluetooth-enabled devices Continua members will bring to the market,” said Michael Foley, Ph.D., executive director, Bluetooth Special Interest Group. However, Nokia was neither part of the founding companies of Continua Alliance nor is it currently part of the contributing members. Nokia should have been the winner of the healthcare race showing insight in this domain but came on the market with a technology standard that was not strong enough and with a marketing idea worth billions. Partnering with Bluetooth should have strengthen its position as THE PLAYER, but this move only boosted the technology on its own, while Nokia was gradually removed.

In June 2010, Bluetooth Core Specification v4.0 with the hallmark feature of low energy technology was published. Bluetooth technology now encompasses low energy (Bluetooth v4.0), Classic Bluetooth and high speed (Bluetooth 3.0 + HS). BT LE looks like prince charming, all sugar and spice and everything nice. However, this prince seems a bit too familiar to another fairytale.

The BT LE technology is actually not entirely new. While the low-power option for Bluetooth doesn’t seem to have inherited much from its predecessor, since there is no backward compatibility between the two standards (it’s just possible for them to co-exist), the complete novelty in this technology isn’t exactly striking. There are aspects within the standard that were long established through Classic Bluetooth such as the Bluetooth radio, HCl logic and physical transport layers, and L2CAP packets. The new aspects relate to the efficient discovery and connection setup, the very short packets, the asymmetrical design for small peripheral devices and the client - server architecture.

Bluetooth SIG was able to read the profit into the bleak Nokia idea and transformed it at a time when “yet another wireless standards” seemed useless. Its advantages include cheap, simple solutions such as integrating sensors. Areas like phone accessories, home automation, P2P intelligent transport systems are bound to take off in terms of profit. Billions are predicted in these areas, while the areas of health, wellness, sports & fitness or the assisted living are already making the projected numbers. These barely exploited possibilities are what make BT LE a standard to stay and make an impact on wireless technology. Here's one video on the ramifications of Bluetooth Low Energy in consumer wellness applications:

Bluetooth Low Energy – The technology

2011-06-06T07:50:00.000-07:00

The main advantage of Bluetooth Low Energy as its name has it is low power consumption. This is due to features like sleep mode, less than 15mA peak and 1uA average power consumption, which in turn were achievable through very fast connection time and very short message lengths. Therefore, BT LE can be up to 10 times more energy efficient than Bluetooth. I keep looking at the big brother when analyzing the performance tests of BT LE not because this newer standard is supposed to replace the older one but because it gives assessment criteria.

The layered architecture can be seen in the picture to the right. BT LE uses the unlicensed 2.4 GHz ISM (Industrial Scientific Medical) band like other proprietary radios. The frequency planning is hence crucial for data integrity. Just like classic Bluetooth, BT LE uses frequency hoping with 40 2MHz channels instead of 79 1MHz ones, in order to reduce costs. Out of the 40 channels, 3 are used for discoverability, connect ability, broadcasting and to avoid know 802.11 frequencies, while the rest are used to send application data in a connection (see picture below). The simple state machine in a star topology can advertise, scan, initiate connection or be connected. The advertising function, repeated periodically, enables a unit to announce if, for example, a process value or an event has occurred. The active scanning is used to get more data out of the advertiser.

In order to achieve backwards compatibility with Classic Bluetooth and not to unnecessarily increase costs, the chipset is available in the following two versions:

Dual-mode: Bluetooth low energy technology as well as Classic Bluetooth functionality
Stand-alone: Bluetooth low energy technology only in order to optimize cost, power consumption, and size which are particularly useful for small battery powered devices.

An additional improvement of 3dB in the link budget is due to a modified modulation, which allows a BT LE unit to be up to 200-300 meters in line of site without the need of an additional power amplifier. Despite the fact that this number is rarely used in any application (usually up to 50 m is required), it is important to have a large reserve in order to bridge temporary obstacles and interference, so as to really ensure robustness and reliability.

The BT LE technology meets all the requirements of a wireless solution for sensors and actuators and was chosen as standard in healthcare by Continua Alliance. “Devices that support Bluetooth low energy Gateway functionality provide a transparent pipe from a device to an IP address. Middleware at the IP address can access the device directly as if it were a collector talking to it locally. The Gateway device plays no part other than in acting as a pipe.” – Joe Decuir, Standards Architect, CSR plc; IEEE Region 6 NW Area chair

Bluetooth Low Energy has the differentiation it takes to stick around for a long time:

Simple star topology to reduce complexity
Small silicon footprint to make it cost effective for stand-alone solutions
Robustness inherited from Classic Bluetooth - the most robust industrial wireless solution with more than 10 years experience
Long range
Very fast connection
Low latency
Low power consumption

The Global Architecture of Interrelated Devices

2011-06-05T08:21:00.000-07:00

In this attempt to learn more about the standards and the standardization process, let’s take a closer look at the architecture of what is referred to as “ecosystem” of devices so as to better understand the capabilities and requirements a standard should satisfy.

This architecture puts forward five different devices classes (PAN, LAN, Application Hosting, WAN and Health Record Device) and four interfaces. Maybe it’s not quite obvious, but these interfaces actually make up the concept of interoperability between devices; based on how devices are able to connect across these interfaces, the certification is issued or not.

The PAN (Peripheral Area Network) interface makes the connection between PAN devices (sensors or actuators) and AHD (Application Hosting Devices) like mobile phones, PDAs or personal computers. This interface has a lower layers level, also known as the transport level (encompassing the classic open-systems interconnection layers 1–4) and an upper layer level – the data level encompassing the classic OSI layers 5–7. For transportation, both wired and wireless methods are accounted for in the form of Bluetooth and USB. The PAN interface upper layers are implemented using the ISO/IEEE 11073-20601 Optimized Exchange Protocol, which leverages work from the ISO/IEEE 11073 Medical Device Communications working group.

The LAN (Local Area Network) interface connects a LAN device with an AHD. The LAN device can has a proxy function implemented which allows it to access the information of a PAN device through a network. A LAN device can also implement sensor and actuator functionality directly. Therefore, the same data model can be implemented in both the PAN and the LAN interface (the ISO/IEEE 11073-20601 data model), which is a milestone in the interoperability quest.

The WAN (Wide Area Network) interface links an AHD to a WAN device – a device which gathers information from one or more AHD and can perform other forms of processing as well, like a heart monitoring program hosted on a network server. The data format on the WAN interface upper layer is also compatible with the data format on the LAN upper layer, giving once again way to interoperability.

The xHRN (Electronic/Personal Health Records Network) interface deals with the connection between user services (WAN Devices carrying out services like weight loss and disease management), and electronic/personal health records (Health Record Devices). In order to ensure the connection between WAN devices and xHR systems, Integrating the Healthcare Enterprise (IHE) Cross-Enterprise Document Reliable Interchange (XDR) profile was chosen. On top of this profile the Health Level 7 (HL7) Personal Health Monitoring (PHM) Report document format was chosen to ensure consistent data encoding.

Now, here comes the dilemma: since electronic health records originate from hospitals health data archives, the patient has no access or control rights. Patients can be given the right to access their own personal data in electronic format, but that means a huge amount of work for most hospitals still keep their files on paper. Commendable initiatives from Microsoft HealthVault or Google Health allow patients to collect and store their own health information and have full control over it. However, these systems, also called personal health records (PHR), should also ensure the security of this kind of information, since a personal computer as storage medium is highly prone to virus attacks or digital theft. In addition, let’s think twice about the reasons companies like Google and Microsoft who already have monopolistic control in their market would like to do apparently a totally altruistic deed for that matter. I would say they are just trying to grow roots in other areas and make our lives even more dependent on their products, chaining us irreparably to their reign.

Design Guidelines – The process

2011-06-05T03:48:00.000-07:00

In 2009 the Version One Design Guidelines was published. These guidelines focus exclusively on the interoperability features of devices and not on particular functionalities. The method of coming up with these results was based on analyzing the interoperability requirements from different use cases submitted by the members of the alliance. The guidelines on their own, however, revolve around already existing industry standards. The process kicks off by receiving use cases from member companies on interoperability issues regarding one of the three target areas: Living Independently, Disease Management, Health & Wellness. Based on all use cases, a generalized list of problems is formulated, which in turn is used to prioritize capabilities, interfaces and requirements. The next step is to search the industry and the standard bodies for standards which answer questions related to the capabilities and requirements. Aspects like how well the standards address the capabilities in under discussion, is the standard international and can if not can it be made so, what is the relation between the standard under scrutiny and other standards in the same area, what is the associated intellectual property claims, what are the specification access and control mechanisms, what is the level of adoption and maturity, are analyzed. All these issues narrow down the possible standards available to meet the initial requirements. The final decision is taken according to a performance comparison between candidates with respect to the requirements.

The final stage consists of defining profiles over selected standards and including them in the interoperability guidelines as a basis for product certification. In addition, the alliance also develops a certification and testing program that includes a detailed set of test specifications and automated testing tools so that the candidate vendors can verify compliance to the selected standard. A product that passes the certification and testing program will receive certification and can display the Continua interoperability logo. There is already a list of product displaying this logo here.

The current standards used are as follows

IEEE 11073 for defining device architectures
Bluetooth, Bluetooth Low Energy, Zigbee and USB for transporting data
HL7 for categorizing data in clinical area
IHE for interfacing which include the clinical data architecture and SNOMED.

The buzz about E-Health

2011-06-04T10:55:00.000-07:00

The aging population of the West has opened a new booming profitable market: E-health. Nevertheless, it’s not only about the elderly, there are chronic diseases (diabetes, heart diseases, etc.), where 24/7 monitoring is of utmost importance, and also staying fit equipment for those striving to improve their figure. However, e-health has proven to be an ongoing crusade for the healthcare policymakers. While attempts are being made to achieve an integrated European e-health market, since the technology is available so as to secure state-of-the-art user friendly products, the actual results are far from ideal – a few independent solutions introduced by remote companies.

The slow progress can be attributed to the medical fact that different systems used in healthcare perform measurements but cannot communicate results in a format known by other devices or by the ever non-existent databases. Such systems/devices should be able to connect to different measurement devices like blood pressure monitors, weighing scales, glucose meters, pulse oximeters, ECG monitors, peak flow meters, etc. The problem intervenes when data from the measurement set should be transported to a processing unit; this problem is not necessarily related to the transport medium (Bluetooth, USB, Infrared, serial cable) cause this can be easily fixed but also the encoding over the channel becomes an issue. Once again, it becomes obvious that standards are important.

As I mentioned here And there was the need for interoperability I will focus more on the de facto standards, therefore, I will talk about an organization which deals with the standardization process for the personal healthcare: The Continua Health Alliance. This is a non-profit, open industry organization where healthcare and technology companies work towards achieving better personal healthcare products. It all started in 2006 after various players on the market came to the conclusion that they needed to work together if innovation and profit through innovation was to be adopted in the healthcare world. Companies among which BodyMedia, Cisco Systems, GE Healthcare, IBM, Intel, Kaiser Permanente, Medtronic, Motorola, Nonin Medical, Omron Healthcare, Panasonic, Partners HealthCare, Polar Electro, Royal Philips Electronics, RMD Networks, Samsung Electronics, Sharp, The Tunstall Group, Welch Allyn and Zensys decided to form a working group so as to achieve an ecosystem of connected personal health and fitness products and services. With more than 230 member companies nowadays, Continua is dedicated to establishing a system of interoperable personal connected health solutions.

Continua is not a regular standards body since its aim is to improve health management, make interoperable devices and doing so, not by just selecting standards and writing guidelines on how to use that particular standard, but also by involving itself in other regulatory standards bodies. In addition, the organization puts effort into overcoming the barriers of the market in all three aspects: technical, regulatory and financial.

It has several working groups among which The Marketing Group is focused increasing the collaboration by getting new members (providers & payers in the medical/personal healthcare industry), the Technical Working Group which evaluates existing standards against requirements in order to identify gaps and take steps to reconcile, the Use Case Group which is responsible for identifying and prioritizing user experiences to be addressed by the Continua Interoperability Guidelines, the Market Adoption Group which establishes a value proposition for innovative connected health solutions that effectively manage the health, wellness, and fitness of the health consumer by using Continua-certified solutions and systems, the Regulatory Group which is responsible with the clarification and description of interoperable devices functions in a regulatory environment, the Test & Certification Group which creates and maintain the Test and Certification Program for Continua Health Alliance. - Continua Alliance

And there was the need for interoperability

2011-06-04T07:26:00.000-07:00

Technology is a hot buzz nowadays with so many smart phones emerging the market and hybrid cars developing characteristics comparable to a Ferrari. While all this technology development is going on at supersonic speeds, there aren’t so many people interested in reading about what goes behind the curtains, how a certain motor is devised or how a standard is introduced.

This blog will try to look a bit deeper into the plot that takes places behind closed doors before certain standards are adopted. I am only a Telecom Master student, but the academic environment has brought me into contact with standards, thus nudging me to search further and discover the reasons why certain technologies are adopted into standards. I wanted to make this quest for the truth public so that other people get the chance to accompany me in this adventure I am embarking on. I do believe that there are others like me, wretched with the need to know and the desire to discover hidden details in the technology world, but at the same time also be willing to share their vision on this particular topic: INTEROPERABILITY STANDARDS IN THE MEDICAL WORLD. Thus, if you are one of those people, and find my blog the least bit interesting, please don’t hesitate to leave a comment and I will reply, for sure.

I mentioned standards. Why did I choose this topic, might sound surprising to some. There are thousands of standards people use on a daily basis but are seldom aware of it; without them, few things would actually work. Standardization is the process responsible for creating a sort of model rule, which if used in practice ensures that other devices may interconnect. Compatibility is important for products to be considered successful in terms of usage; standards like USB, Ethernet, GSM give customers an idea of what technology they are using and if they want to connect two devices together they can do it provided there is the same technology or compatible version. Standards are meant to make the technical details of a certain method available to both the producers and the future customers so as to bridge the gap in knowledge between the two sides. First of all, let me make the distinction between the de facto standards and the de jure ones. The former is the one that becomes a standards by frequently usage. There is no formal body to adopt it or check it every couple of years, like it happens with the de jure standards. The focus of our discussions from now on will be the de facto standards, because the dynamics of the process is fascinating, given that there are no/little external regulators to influence its faith. In addition, its status becomes rooted with the passage of time, which makes it even more interesting to see what is exactly the amount of time that must pass in order for a technology to be considered a standard.

In the last day, God created Adam. Well, in the last couple of decades, there have been so many devices that communication between them is almost unthinkable. Thus, there was the need for interoperability. I hear this word all around me "interoperability". When I hear it, I also hear the cha-ching in the back of my head. Why? What's the big deal with interoperability? Imagine a world where transfer between all devices was possible without any intervention. Not such a big deal you would say, but if I tell you that YOU, Mac owner, would no longer need so many cables to connect to a regular projector, or would no longer need to download so much software to use the same programs like a Windows (Microsoft Windows is also an example of a de facto standard) based computer? These are just some minor examples to make you visualize it. But the fact is, interoperability goes far beyond one can imagine.

Due to the mobility of people in the one big oyster that is Planet Earth, systems in different countries all over the globe have to be remotely similar. Even the European Union has realized the extent to which this abstract concept is involved. Thus they came up with the European Interoperability Framework, which defines general rules and principles for the design of interoperable public services. But public services nowadays cannot be thought of without the aid of technology: we pay the taxes with the credit card and get the state of our health read with some gizmo or other. We do need these devices to be able to connect to the same base station and to be accessible in different regions.

When talking about Standardization within the European Framework, steps are being taken towards unifying the market. The Digital Agenda of Europe has come into action a few years ago, looking to settle the problems of the digital environment and maximize profits for all parties involved (governments, organizations, companies). The 2010 Digital Agenda analyzed among others the topic of Improving ICT standards-setting and Enhancing interoperability through coordination. The upcoming year has already been targeted with a project which aims at the increase of interoperability. In mid June, the European Commission Information Society will organize Digital agenda summit in the workshop on standards where two aspects of standards will be brought into focus: Provide guidance on ICT standardisation and public procurement and Identify and assess means of requesting significant market players to licence information about their products or services. What measures are there going to be taken to these respects? Leave in the hands of the European authorities for the producers or impose regulations on the market. We will find out after the 17th of June.