Regulations and barriers to new entrants.

Electronic wireless sensors could cut medical costs and everyone in the eHealth industry seems to think that this sector is ready to take off. According to a Juniper Research's recent report , the eHealth sector will enable a market growth with estimated sales of around $ 4 billion per year by 2014. The importance of this market can be seen everywhere in our life; networks operators are developing eHealth divisions while the improvement of eHealth applications for smartphones continues to increase exponentially.

If we can make this work the benefits will be infinite and it will finally lead to the disruption from an old and less technologic healthcare system. The eHealth system has all the features to be the next technological revolution, with the added benefit of saving our healthcare system form an already degenerated situation. A possible solution to the terminal meltdown of the health system is offered by Clayton Christensen in his book the Innovator’s Prescription, where he advises that “ the only way to effect a major change in healthcare is through the introduction of new, parallel business models to challenge those that our current healthcare structure is built on”.
Introducing new parallel business models means that new technologies will be needed for a more efficient and targeted diagnosis, as well as devices for monitoring and data exchanges that promote personal involvement of patients by making available personal health records. Clearly, this sounds familiar when considering the areas being targeted by Continua Alliance and by the eHealth society. Nevertheless, it is not simple to implement personal eHealth by developing parallel business models in opposition to the classical model, and there is a real problem in the regulations horizon, that can indeed put to an end the eHealth adventure. This “problem” is called FDA or Food and Drug Administration, which is an agency of the United States responsible for promoting and preserving the public health through a regulation process.

This means that the FDA has the possibility to apply regulations that will suffocate the development of eHealth. What is worrying is that by being a regulator, the FDA moves slowly when comparing it to the growing eHealth technology sector. The scenario is formed then by two parts; one part is the emerging eHealth market ready to develop, and the other one is a regulator structure that can reset the levels of expectations foe eHealth. The FDA programs for safety regulations have impact only in the U.S, which means that the eHealth expansion can only evolve outside the country, thus leading to a major disruption. It’s important for the manufacturers to understand the barriers of regulation and for the industry to engage with it to reform the levels of regulation for the eHealth system.

However, it is important to evidence that apart from slowing down the regulatory process, the FDA is also contributing to important improvements in the medical and fitness applications. More specifically, the U.S. Food and Drug Administration (FDA) and other medical bodies are concerned about the potential EMI generated by wireless connectivity medical devices. Over the years, many incidents of suspected electromagnetic interference (EMI) with medical devices have been documented [1]. Examples of the problems that could occur when radiated electromagnetic (EM) energy interacts with the sensitive electronics incorporated into many medical devices, can be seen when a ventilator suddenly changes its breath rate or when an apnea monitor fails to alarm. The key to addressing EMI is the identification that it involves not only the device itself but also the environment in which it is used, and anything that may come into that environment. The FDA states, “Wireless coexistence and data latency remain concerns because the data transfer rate can slow slightly or even dramatically with an increase in the number of similar transmitters in a given location. In many cases it is essential that medical data, including real-time waveforms and critical control signals and alarms, be transmitted and received without error” [2]. The Bluetooth low energy radios broadcast in the notoriously crowded 2.4 GHz band and it can be seen as the wireless technology that satisfy these conditions. That said, Bluetooth low energy operates at 1 mW (0 dBm) output power and only transmits for 1% (or less) of the time and then only in short bursts lasting a few hundred microseconds. Most modern medical devices have been created with a high degree of EMI immunity and the probability of malfunction in the presence of a short duration transmission is very low.

Typical Electromagnetic Environment for medical devices.

Licensing bodies such as the Federal Communications Commission (FCC) have attempted to mitigate the effects of EMI by restricting the power output of radio devices operating in the license-free parts of the radio spectrum to limit the possible EMI with sensitive electronics. Operating in the 2.4 GHz band is a major challenge with consequences for product design. More importantly, in order to ensure that communications are not disrupted, medical wireless monitors need a high level of immunity from other radio sources. To achieve this, Bluetooth low energy employs a frequency-hopping spread spectrum interference avoidance scheme. When making an initial connection, the two transceivers transmit using one of three fixed channels (trying the other two in turn if no signal is received) in order to establish the link. This is a faster and more power-efficient method of searching for a compatible radio source compared to scanning the whole band. If a clash occurs, the Bluetooth low energy transceivers switch to another channel in few milliseconds and report the corrupted channel so it is not used again. Even if the Bluetooth low energy technology seems to respond to the required features for interference avoidance, medical devices manufacturers would have to embark on a program of testing to ensure their products meet the electromagnetic compatibility requirements of the medical authorities. As new wireless medical systems have progressed to the consumer, one can easily think that by extending the sphere of influence of regulations structures, the quality, interoperability and adaptability of these devices is granted. In this scenario, the Continua Health Alliance is helping the FDA to understand the implications of eHealth, but this message is not influencing much of the industry involved. On the other hand, the situation is even more worsened by the regulatory consultants and legal firms that are more frequently evidencing the dangers that may exist within the actual regulation. The consequence is that the image of regulators as tyrants who interfere with the evolution of technology, is reinforced. Clearly the sphere of influence of the FDA’s agency is so wide that itself can regulate any device or application with a medical purpose. During March 2010, MobiHealthNews broke the story of the FDA’s removal of MIMvista’s radiology imaging iPhone app from Apple’s AppStore just months after the iPhone’s app marketplace opened. Since that, MIM’s application has been denied and is now in the process of filing a premarket approval. As with all regulation, the FDA helps to maintain the status quo, not least by providing a barrier to new entrants. However, in the actual health system where disruption and change is essential for the industry, that repulsion to new entrants threatens to deteriorate a possible change. At this point, we can say that if personal healthcare is to move forward then what we need is less rather than more regulation; the regulators can be seen as reason of delay instead of promoters of innovation for the eHealth sector. Indeed, regulators will hate the disruption that eHealth is generating in the healthcare scenario, not only because by creating a direct contact with the medical institutions and manufacturers it will possibly remove some of their powers, but also because new market entrants, who are far away from being part of the already established medical system will try to tell them how to work and regulate the emerging wireless technologies. In order to achieve innovation it’s essential to persuade manufacturers outside the medical regulations world, to join the health sector and help put pressure on the regulators while on the other hand we need to warn new manufacturers of the potential issues related with regulation. Continua Health Alliance as an open industry group is supporting as many companies as possible to enter the market. What is happening in the healthcare sector today, is that new companies that are thinking about entering the healthcare market hesitate to do so creating thus, a process that only makes slower and more complicated to lobby for regulatory issues. However, without any proof of support from the FDA, repeating the limits imposed by regulators will only worry the new entrants to access the market, or at least the US market, stopping investment and innovation. It is, of course more difficult to move the regulators towards the market demand, but what is certain until now, is that the wireless industries can really contribute to the development of eHealth, since their business structure is based on a user centric model as much as eHealth is based on being a patient centric model. If we want the eHealth market to develop further, it is essential to remove the possible barriers that regulators can impose and to achieve this health revolution we need to encourage as many companies as possible to invest in this adventure. This process can be slow and can be difficult, but if we keep on stressing the limits imposed, we may never capture the interest of the majority, which may expose to danger the whole future of eHealth.

References: 
[1] Silberberg J. L., Performance Degradation of Electronic Medical Devices Due to Electromagnetic Interference, Compliance Engineering (Fall 1993) pages 25-39
[2]  U.S. Food and Drug Administration. Draft guidance for industry and FDA staff: radio-frequency wireless technology in medical devices. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077210.htm#4        

Bluetooth Low Energy Features and coin cells

Bluetooth low energy (BLE) technology is the key feature of the Bluetooth Core Specification 4.0 (Bluetooth v4.0) and it is one of the latest technology to incorporate a very low power, relatively short range (50m) features [1] while using for communication a coin cell battery that can last almost two years. It has inherited several technical features from Classic Bluetooth technology, since it is a further evolution of it, thus provides power efficiency, excellent resistance to interference, small size and scalability. The key features of Bluetooth Low Energy can be summarized as follows:

• Ultra-low power consumption

• Ability to operate for long periods (months or even years) from a coin-cell batteries

• Low cost due to the already existing Bluetooth ecosystem

• Interoperability

• Robustness and Reliability

Bluetooth Low Energy has features similar to those of the Classic Bluetooth technology but in some ways, BLE technology is a very innovative wireless technology including new features such as proximity sensing and a variable connection interval up to few millisecond to transmit small amounts of data instead of the Classic Bluetooth fixed connection interval for periodic high activity connections. Similarly to the Classic Bluetooth, BLE uses Adaptive Frequency Hopping (AFH) spread spectrum for accessing to the shared channel, in order to have a robust transmission against the possible noise in RF environments such as medical environments or generic buildings. AFH also decrease interference probability from Bluetooth technology to other wireless technologies in the same radio space, since Bluetooth technology, IEEE 802.15.4/ZigBee ,Wireless LAN, use the license-free 2.4GHz Industrial Scientific Medical (ISM) band. However, since the priority of the BLE technology is to reduce energy consumption, the number of hops was reduced to 40 and the channel width is 2MHZ [2] as opposed to the Classic Bluetooth technology where the number of hops was 79 and the channel width was 1 MHz.

Bluetooth  low energy channels

Bluetooth Low Energy can operate either in a master or slave role, but never both; there is no scatternet topology for Bluetooth low energy technology. BLE has a star topology; a master can command multiple simultaneous connections with a number of slave devices controlling also how often the slaves are allowed to communicate, but a slave can only be connected to a single master communicating by request from the master. A relevant feature that can be seen when comparing the BLE with the Classic Bluetooth technology is the “advertising” functionality. In a BLE discovery is done so that a device acting as a slave advertises on one or several advertisement channels that it has something to transmit to the master. Then the devices acting as masters scan these channels in order to find possible slaves. Once there is a discovery, transmission messages can also include connection events in which the master and the slave wake up in synchrony for exchanging frames.
The ultra low power consumption and coin cell battery operations use also has it own limitations. The ultra Low power BLE technology has an average current consumption of less than 1 mA; this assures there is no overlap since a ultra low power standard can still work in this range if the data throughput is low, since transfer rates for BLE technology are below 100 kbps. This means that some applications works better with the Bluetooth Low Energy connection than others. The simple lithium coin cells batteries, also used for watches for example, have been selected for the BLE wireless applications, but in order to be able to function with a good battery lifetime some important improvements are necessary.The battery lifetime used in a typical ultra low power standard [3], is dependent on the battery capacity and the average current consumption. Therefore while working with ultra low power consumption it is not only important to focus on the average current consumption that should obviously be as low as possible, but it is also necessary to consider that unlike traditional coin cell applications, wireless applications battery capacity is not fixed and is dependent on the various usage pattern.When considering coin cell battery for ultra low power wireless operations to maximize the battery lifetime  it is important to select devices with the lowest peak current for minimizing the current drain; the low peak current is the main  reason why the coin cell battery is very suited to Bluetooth Low Energy applications. 

When talking about BLE technology, is it almost obvious form the definition and from the name itself that it consumes very little energy, but going through a more technological overview the truth is that, indeed this technology is low powered but there are some applications for which the BLE technology is not sufficiently low. In order to have low power consumption different solutions can be applied. For instance, a good approach can be to modify the way the radio operates. If the radio is switched “on” only when it has data to send for a very short period and then after sending data returns to its sleep mode, then the power consumption will be absolutely reduced. On the other side, with this type of solution, also transmitting and receiving times are quick and the connection is rapid and a “not connected” state is enabled. When the “not connected” state is used then the devices at the two ends are aware of each other but only connect when needed and for a very short time. 
In this case, the two ends of a link are aware of each other, but only link up when absolutely necessary and, even then, it’s for as short a time as possible.
There are other ways Bluetooth low-energy technology can control the energy efficiency. A good solution is to allow more packets to be sent within a connection event and by implementing AFH to avoid interference. In addition it is possible to reduce the low power consumption by sending very short packets; Bluetooth low-energy technology uses a modulation index of 0.5 for the Gaussian frequency-shift-keying (GFSK) modulation which is close to a Gaussian minimum-shift-keying (GMSK) scheme thus, lowers the radio’s power requirements. Moreover, lower modulation index does generate a couple of beneficial side effects: increased range and enhanced robustness.
When considering BLE technology, it is interesting to understand how it is implemented in tablets, mobile phones or health care centres. The Bluetooth devices are connected to a web based application where it can share its radio and can be considered thus, as a conventional Bluetooth Health Device Profile (HDP) and a BLE controller with the advantage of having very little additional circuital parts required in the chips, making this technology ideal for low power home and hospital medical applications.



References:
[1] C. Sorrel, “Casio Bluetooth low energy watch has two year battery life: http://www.wired.com/gadgetlab/2011/03/casio-bluetooth-low-energy-watch-has-two-year-battery-life/,” Wired magazine, Mar. 2011.
[2] http://www.connectblue.com/press/articles/bluetooth-low-energy-technology-and-healthcare/
[3] http://www.eetimes.com/ContentEETimes/Documents/Schweber/C0924/C0924post.pdf

Bluetooth Low Energy inside our bodies, Smartphones and Apple.

In my previous blog post I started an overview of the wireless technologies selected by Continua Alliance while trying to find the most convenient technology for the complex eHealth sector. At this point, I want to go on with the analysis I started for the Bluetooth Low Energy in order to have a better understanding of this technology that leads to a even more revolutionary Bluetooth technology adopted in the Continua’s 2012 Design Guidelines. From a general point of view, Bluetooth technology is the ideal wireless technology for wireless oriented health and fitness devices because it’s simple and adaptable, secure and as mentioned before it’s present everywhere in our mobile phones, or in our PCs that incorporate Bluetooth chips. In July 2010, the Bluetooth SIG announced the adoption of Bluetooth Low Energy (BLE) technology as the “emblem” of the Bluetooth Core Specification Version 4.0. It was clear at that time, that ultra low power communication mechanisms are essential for devises adopted not only in a possible eHealth ecosystem but also for future wireless connected devices, and of course BLE resulted to be the best candidate.

The original problem that generated the research of a low energy solution was the observation by the Nokia researchers in the early 2004 [1], that it was possible to use a variety of small devices that could enhance the wireless radio connection but cannot support the power consumption and the costs related to the Bluetooth technology. The idea behind it was to introduce minor additions to the Bluetooth chip thus, allowing a better saving in power consumption enabling the use of button cell batteries, and reducing costs. The result was that the low power consumption was achievable only if necessary changes were made in terms of radio improvements, reduced functionality and trade off in performance. At the same time it was, and I think it still is, surprising that the Wireless technology pervaded all sectors of our life, while the only sector that had adaptability problems was the health sector. Clearly the reason behind it is that the health sector has severe requirements and mainly has to assure a possible patient that the wireless technology used for monitoring, does not increase risks. As a result all the research done in this field lead to the adoption of Bluetooth Core Specification Version 4.0 hallmark feature, the Bluetooth low energy wireless technology. One of the main issues facing wireless medical devices is power consumption, which limits the wireless connections architecture and the variety of possible applications to the battery efficiency of the technology. A wireless technology needed some features in order to be applicable to a medical monitoring system or fitness system and mainly these features are related to sensors that require an ultra low power (ULP) system with streamlined protocol so they can work for several months or even years on a coin cell battery. Additional features required are again related to sensors that need to communicate with a distribution network so that the data can be communicated to the health care system, and need to be reliable, incorporate plug and play and simple pairing. Bluetooth Low Energy meets all these conditions and furthermore because BLE builds on the legacy of Bluetooth wireless technology it is easy to use for having a Personal Area Network (PAN) composed of several sensors for eHealth devices. Above all, let’s not forget that Bluetooth is the only wireless standard designed for end-to-end applications. The announcements by Microsoft and more recently in 2011 by Apple [2] supporting this new technology for their devices show the real importance that BLE has gained in communications platforms.
As an Apple Devices lover and follower, it was a surprise for me to read that the iPhone 4S is the first smart phone that supports the new Bluetooth 4.0 standard and is slowly extending the support throughout its entire family of products by introducing early this year the new IPad third generation thus, making it the world’s first tablet to support this technology that considerably reduces power consumption. For example, the Wahoo Blue HR, a heart rate monitor, was the first device to take advantage of the Bluetooth 4.0 technology, but was only compatible with the iPhone 4S since the adoption of the Bluetooth 4.0 technology, is really developing lately during 2012.

This shows that Apple can see the “future” developments of the technology as much as the benefits and the massive market impact that it will have in terms of money.
Apple was one of the last to adopt Bluetooth 2 or USB even though those standards were used in the industry, so probably according also to the Bluetooth SIG forecasts that the smartphone market is expected to reach 700 million units by 2015, has decided to be an early adapter this time. Advancements has been made towards the healthcare sector also for Apple devices but one evident omission Apple has made in the adoption of the new technology was the exclusion of the Near Field Communication (NFC) [3], a wireless protocol designed to allow data exchange over very short distances thus, allowing the doctors to have information about their patients. NFC was already selected for Android this year but the difficulty of Apple to follow this trend, shows that even if we are going further in this process still a lot has to be done.

References:
[1] M. Honkanen, A. Lappetelainen, K. Kivekas, "Low end extension for Bluetooth", Radio and Wireless Conference, 2004 IEEE, 19–22 September 2004
[2] http://www.worldnews.se/news/79314/bluegiga-enables-the-development-of-bluetooth-40-accessories-for-iphone-4s/
[3] http://www.nfcnearfieldcommunication.org/healthcare.html

Bluetooth and Zigbee: Two New Low Power Radio Standards. Technology and Adaptability.

After the Version1.0 Design Guideline was published in early 2009, Continua simplified any possible decision by selecting for the transport level of the PAN Interface the Bluetooth Health Device Profile for wireless communications and USB Personal Healthcare Devices for wired communication while for enabling data format interoperability the ISO/IEEE 11073 Personal Health Device family of standards was selected. After the first Version of Guidelines other updated versions were published and Continua’s 2012 Design Guidelines is currently undergoing to Interoperability testing since it will be released publicly by the end of 2012. Before analyzing the latest solutions picked in the new version of the Guidelines, I will first try to define the reasons behind the selection of Bluetooth as a predominant technology for eHealth devices, considering the key factors in the decision process.
Bluetooth is the only wireless technology included in Continua’s design guidelines. With the cooperation of Continua Health Alliance and IEEE 11073 Personal Health Devices Group the Bluetooth SIG created the Health Device Profile.

 

Continua Health Alliance PAN and LAN interfaces.

The Bluetooth wireless technology was chosen after analyzing other outstanding wireless technologies in a process that took almost 10 months of review. According to a recent market study developed by In-Stat during 2013 circa 2 billion of Bluetooth devices will be shipped worldwide , and considering also that today there are more than 40 million Bluetooth enabled healthcare devices, Bluetooth technology has to be considered for half of the ICs delivered worldwide for health devices by 2015; thus, it is not premature to assume that Bluetooth technology is already the de facto wireless standard for health devices. In the updated Version 1.5 Design Guidelines, Continua selected for the Personal Area Network (PAN) interface the Bluetooth Low Energy (BLE) standard and its health device profiles. Considering that the benefits of a healthy lifestyle and the independent monitoring of chronic diseases will increase the market for wireless health devices, the selection of the Bluetooth technology hasn’t come as a random solution, but was decided after thoroughly understanding the benefits of this technology. There are a variety of key factors that lead to the selection of Bluetooth Low Energy: between these factors, indeed the fact that Continua has always supported the selection of Bluetooth Low Energy in health care applications has been a predominant element. So why did Continua selected exactly the Bluetooth technology for wireless connectivity of personal health care devices? After months of research and analysis of a variety of low power technologies such as Sensium, ANT+, BodyLAN and Z-Wave, in late 2009 Continua announces the selection of two new low power radio standards: Bluetooth Low Energy wireless technology for low power mobile devices for monitoring a user’s health or fitness level, and ZigBee was instead selected for low power sensors in a variety of settings to promote independent living.
The differentiation between the selected technologies was made in terms ease of use between a list of devices that we have around us all day and we carry everywhere (PAN), such as a mobile phone or a tablet, and devices that are constrained to stay within a building, either a home or medical structure (LAN); Bluetooth Low Energy was selected for PAN (Personal Area Devices), while ZigBee was selected for LAN (Local Area Network).

The selected standards are relatively similar in terms complexity, but BLE have a longer battery life due to its faster data rate, the use of short packet overhead, excellent resistance to interference, reduced number of packet exchanges for a short connect time and power optimization, while Zigbee by using as a modulation scheme the Direct Sequence Spread Spectrum (DSSS) with orthogonal coding, has a better reliability and benefits from a longer range and a mesh like clustered star networking structure. While for most of the people outside the standardization groups this decision can look quite insignificant, it does have some relevant implications when considering that a medical device manufacturer cannot be able to decide which of these two wireless standards to choose. If we are developing a wireless connected healthcare system, it is important to not have confused manufacturers about which of two incompatible standards to use, because this can clearly lead to a delay in availability and implementation. The differentiation between PAN and WAN devices is going to disappear for consumer medical devices, since everything will be oriented towards mobile devices. For example, the implementation of smaller, mobile and personal medical devices is already happening in the sports and fitness devices sector. And that leads us to eliminate the distinction between PAN and WAN interfaces, because the medical devices simply become the things that we carry with us, without a reference of place or location. This simplification brings us to the dilemma of the device manufacturers that need to select one of the two technologies to go with.

Bluetooth Low Energy Devices

Although both interfaces were selected in the Version 1.5 Design Guidelines, this dual interface vision is a possible barrier to the spread of a wide number of eHealth systems, since the lack of specifications in terms of interoperability can be a real problem for the possible user. In terms of costs, having both BLE and Zigbee on the same device [1] doesn’t mean that the costs will double since both the solutions have many similarities: specifically, BLE has a Gaussian Minimum Shift Keying (GMSK) [2] modulation scheme and Zigbee is based on Offset QPSK (O-QPSK) [3], and this makes possible to support both standards in a device simply using a reconfigurable transceiver with a digital IF sub-sampling architecture on the receiver side. Now, everyone knows that Bluetooth is in their mobile phones and over half of the world's population owns a mobile phone, so it is obvious I think, that the Bluetooth was the dominator in this dilemma. This is connected with technical reasons but mainly is related to an ease of use, because Bluetooth provides the "scale". Bluetooth oriented medical devices can easily be connected with smart phones, without additional device, while Zigbee oriented medical devices have the requirement of an additional adaptor that can plug into a tablet or phone. Bluetooth Low Energy is designed for light and peripheral data exchange and results to be different from the Bluetooth that is used in medical devices, since it has the added value of being able to talk to the next generation of smart phones. It is also true that wireless technologies has to be in a certain way, adapted to the application they are intended for, and the choice is not simply between Bluetooth and Zigbee but is between Bluetooth Low Energy standard and Zigbee, thus the ability that has BLE to be provided in mobile phones and even more to be provided in the new generation of smart phones is the key advantage. The problem of having two alternatives is that the medical device manufacturers have to make a decision of which to add to their products, considering that adding both the standards in not a possible solution since it would be too expensive as an option. Without a regulation, the market will decide what technology to adopt. The situation that Continua Alliance had to face while working on the Version 1.5 Design Guidelines was clearly to have two alternatives in the eHealth system; my idea is that adaptation is a very predominant factor in life and principally in technology and the ability to connect to a cellphone will be the dominant decision. If we consider the features of each of the proposed wireless technologies, it is clear that each standard has good features, mainly Bluetooth Low energy has the mobile phone connection, and Bluetooth has a higher bandwidth but it is difficult to understand what ZigBee really offers in the eHealth market since the prospect of connecting a device with a mobile phone is a powerful tool for health devices. Let’s see now if the progress has followed adaptation.

References:
[1] http://ebinder.blogger.idv.tw/archives/633
[2] http://electronicdesign.com/article/communications/bluetooth-low-energy-set-to-storm-the-wireless-market
[3] http://webpages.uncc.edu/~jmconrad/ECGR6185-2007-01/notes/IEEE_ZigBee.pdf