The risks of Standardization and IP Protection.

The Continua Health Alliance has been working on creating a network of standards, drawing on the IEEE for standardized data formats and wired wireless standards groups to define the connectivity level over which the data can be transported. Their choice of wireless standard is the BL LE, which is already present in the majority of smartphones. Despite the technical reasons that make the Bluetooth Low Energy a good candidate for the eHealth systems, it is obvious that Continua ended up by selecting this standard simply because it is the one that manufacturers include mostly in their handsets.

The work of the GSM Association will certainly increase the role that mobile phones are going to play in the broadband structure. As a consequence, this will increase in terms of billions the number of broadband mobile phones that will include the Bluetooth Smart technology. The deeper meaning of this forecast is that clearly, the technology selection for a wireless health product will be impersonally made by product manufacturers since the market will ask for healthcare devices that have something to connect to. The role of regulators is limiting the manufacturers, as we already saw when considering the role of the FDA, but what can be considered a real risk in terms of costs for healthcare manufacturers, is the selection of a standard that is strictly connected with Intellectual Property disputes. The conflicts connected with the Intellectual Property can constitute a real risk for the system. In a public document, the Bluetooth SIG mentions that from the IP viewpoint, wireless standards are not equal. As the importance of wireless standards starts to increase, the concerns connected to Intellectual Property starts to increase exponentially, as already happened with patent trolls attacking ZigBee and Wi-Fi. The principal problem is that most people not consider Intellectual Property rights when undergoing through a standardization process [1]. There is the stupid conjecture that if a standard is selected, then as long as you have the right to use it there are no related IP problems. Not even the standards bodies, such as ETSI and IEEE give any IP assurance, which means that a lot of companies have been taken to court, only because of their ignorance. This lack of knowledge can cost to a company millions of dollars. Therefore, for the eHealth system is important to understand that the existence of a standard does not give to a company a free right to automatically possess  the IP within it. If we consider the two standards selected by Continua Health Alliance, Bluetooth Low Energy and ZigBee, they both impose to the company that uses the standard in their product to sign a member agreement, which contains a clause of IP ownership. To be more precise, this is connected with the concept of Necessary Claims; once the company decides to signup because has the necessity of that specific technology, it also gives up the right to claim for the violation of any IPR the company itself might own, which is used by other companies developing the standard. For example, in the Bluetooth technology you cannot ask for a fee for anyone using your IPR as complement of the standard, and this license is defined as RANDZ (Reasonable and Non Discriminatory- Zero cost). When considering the ZigBee technology the situation is different, because in theory it is possible to charge a fee for other ZigBee companies, and this is defined as a RAND license (Reasonable and Non Discriminatory).

Is this a good approach for Intellectual Property rights? I think it has a double- sided result: on one side, companies agree to not sue each other, but on the other side they give away part of the value of their IP. Basically, the problem is that is quite hard for industries to estimate the value that the IP use can have as a competitive tool. When a company signs this sort of agreement, it is also signing up to legally provide the future use of its IP that might be extremely valuable in the future. This means that a company with a conservative approach to IP, can prefer to take a conservative position and not sign. Before a standard is finalized, most of the standards groups do an IP evaluation to understand if there can be any problems from patents owned from outside the standard body. But of course none of the standards organizations give immunity to risks. When approaching to a standard, how can a company analyze the risks?

The first thing to do when selecting a standard is to look at how much that standard covers. Besides the largest adoption on smartphones, one of the major reasons behind the adoption of Bluetooth as a standard by Continua, is the fact that the Bluetooth specifications are very exhaustive starting from the radio specification going through the application profile. This means that all elements of the standard are included in the ember IP agreement. Instead, ZigBee agreement provides no IP cover for  the specifications, since it use external standards like the IEEE 802.15.4 for the radio and baseband layer. The main idea is that a standard can only offer IP protection for the parts it own.

 

Standards and IP protection

The more companies one can get to sign for the IP license, the more protection is ensured from prosecutors. Bluetooth is extremely good in convincing companies to sign the IP license, as they have over 13,000 members. Z-Wave is a standard created exactly to cover the full range from radio to application. The reason why this standard has not the same popularity of Bluetooth, is connected to the fact that only one company is the owner of the Z-Wave IP. Additionally, this standard can’t count on the security of having 13.000 contributing members for its IP, which instead Bluetooth has. Standards like Z-Wave haven’t contributed to the market enough to make it worth suing or attacking them with patent trolls. Also the presence of a standard in the market is essential to determinate possible risks; Continua is very well aware of this and since Bluetooth has been around longer than other standards, it ensures that the standard is safer and has more members. As a conclusion we can state that more recent standards are more risky. The Bluetooth Low Energy, despite being considered a recent standard, is a rather straightforward process, because it is a company-based standard that can count on the security and wide membership of a standard like Bluetooth. This is a key attribute for the selection of the BL LE technology as de facto standard for the health devices by Continua Alliance. Surely, the question that organizations specifying the standards, such as Continua Health Alliance, need to investigate is whether they are conscious of the risks they take when selecting a specific standard.

References:
[1] Nick Hunn, "Essentials of Short Range Wireless", Cambridge University Press, 8 Jul.2010

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

Technology meets Healthcare but faces Interoperability.

The use of information and communication technology to support health solutions is a good perspective for improving global access to healthcare services, data records and patient assistance. It would be great if we could access our medical records wherever they are needed, or if the monitoring of the heart bit rate for high risk cardiac respiratory patients could be performed directly form home simply by using a wrist-worn device with wireless connection to telemedicine centre, thus making life more easy, flexible, and efficient for everyone. The advancement of Wireless technology continue to hold great promises for a better health system, but how far are we in this process and what is the factor that can possibly slow down the advancement of eHealth?
The vision behind wireless oriented health systems is focused on a citizen centered structure where the citizen takes an active role in the entire process, receiving information about his own health and participating in every stage of the system from prevention, simple care to diagnosis and rehabilitation. Almost everyone has nowadays a smartphone or other mobile device, and constant efficiency improvements will easily allow individuals to access and manage a variety of health activities. These technologies should be clearly easy to use for the consumer in order to guarantee not only a transparent service but also a healthcare provider selection. So, easy technology for the consumer is a key requirement. Until now it doesn't appear to be any problem for the development of electronic oriented health devices: today let's say that almost everyone has a computer, a mobile phone or iPad and a Wireless connection at their home, so where does the problem stand? These technologies should be not only easy for the customer, but also secure (someone can access his own medical report modifying the data asking for more money form their insurance company), interoperable and therefore Standardized. Everything in this world is STANDARDIZED, from the A4 paper that we all use for printing, GSM specifications for mobile phone to most recent LTE standard. Thus, very generally a standard can be defined as a set of specifications for ensuring compatibility, accessibility and quality of the specific product. More specifically you can have an idea of what standards mean by reading the above definition form the ISO/IEC Guide 2:1996 [1], definition 3.2 that defines a standard as:

'A document established by consensus and approved by a recognized body that provides for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context'.

If a wireless system has to be integrated with health related devices then it is an obvious consequence that a common communication protocol needs to be established and the communication between various devices everywhere, should be functional, not complicated and should require the user to have little knowledge of the characteristics of those systems. Integrating an ICT system with a health device using standards, will indeed encourage innovation of the health sector along with technology evolution thus making also the consumer or citizen aware of the entire health process he will go through. In this complex process different information technology system and networks are involved, which means that those systems must have the ability to communicate and exchange data effectively and securely in various settings ensuring that the exchanged data are not altered. The combination of devices, technologies and networks, and their integration with the whole system involved, pose INTEROPERABILITY challenges making evident that interoperability must be seen as the key requirement if the promise of an integrated Wireless health is to be fulfilled. If different elements deriving form a variety of technological developments, can be combined into a health oriented product with interoperability, then the effectiveness will be increased and the quality of service will be superior. With interoperability not only large vendors can benefit, but also small companies can enter the market with their products creating a system where economy has less barriers, more competition and innovation. Interoperability is a term that can be referred to software or device as well as to the medical sector and its principal goal is to assure communication and exchange of data between autonomous systems without any external intervention. Specifically, analyzing the eHealth sector, interoperability means that all the heterogeneous information devices that are used in the process for exchanging health data, medical records or information from medical sensors, are designed to be compatible with each other and with the entire network that is involved in this health based data flow. Developing a wireless system that is based on interoperability is essential for the eHealth system and this can be achieved either by adopting an already published Standard or by making use of Structures that can convert different products interfaces to another. Once operability is granted a system can result in increased functionality, ease of use, lower costs, widespread and faster data flow. Developing standards common to individual devices is the solution for the wireless-health systems and the principal factor for achieving interoperability and it requires the involvement of all the parts involved in the process. 

Figure : ITU-T Technology watch report on Standards and eHealth, that illustrates visibly the various obstacles eHealth has to face and solve. 

Everyone involved in the development of eHealth systems is aware of the importance of interoperability, however for example less than 25% of the hospitals in the United States has adopted in their structure the electronic health record, which not only limits the diffusion of personal health record but also decrease the level of interoperability. On the other side of the world the lack of EU Standards in the eHealth market creates fragmentation and insufficient interoperability, reflecting the different national systems that are adopted by competent authority. The direct consequence of a tailored eHealth system is that the ICT devices proposed are not accessible everywhere and very often non-interoperable. The action taken form EU in order to ensure the creation of standards and interoperability while exchanging data, was the launch in March 2010 of the Digital Agenda for Europe, set out to define the role that the ICT development will have if the digital technology is oriented towards innovation and better quality of life for the Europeans. Specifically one of the main areas of interest of the Digital Agenda is the ICT for social challenges, Action 77 [2] which aims to ensure the creation and selection of Standards to promote interoperability and develop certification and testing for the eHealth sector. The commission by 2012 proposes to realize a European eHealth Interoperability Framework showing that interoperability and testing is possible on a European scale, and concentrate on the implementation of the EU-US Memorandum on eHealth signed by the end of 2010 which will ensure interoperability between the parts. At European level another important action taken by the European Commission is the creation of an EU Task Force on eHealth development. In May 2012 the Task Force's report "Redesigning health in Europe for 2020" was handed to the European Commission. The report is focused on the definition of the key issues faced by a possible ICT health care system in terms of  accessibility of data records, privacy and legislation on interoperability. Starting from the consideration that today more than ever, EU citizens move easily across the borders, the Task Force's report outlines that in order to ensure to every EU citizen mobility of data and health care assistance, we need to operate with the same rules, ensuring in this way that incompatible national rules or private companies initiatives will not put at risk fundamental health care rights. Despite the efforts that all the sectors involved in this process are making encouraging the production of interoperable devices, interoperability on a large scale remains still a major challenge. 



References: 

[1] ISO/IEC Guide 2:1996
[2] http://ec.europa.eu/information_society/newsroom/cf/pillar.cfm?pillar_id=43&pillar=Digital%20Single%20Market