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

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