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        

The Standardization Process with Continua Alliance.

The personal telehealth system has the potential to cope with today’s major challenge and as any complex domain it consists of various levels of specifications. These various levels vary from the very concrete, for example WSDL interface definitions, to the abstract, for example the information structures, and each of these levels should be significantly dependent on each other. Now we can understand what kind of problem we have to deal with. As a starting point, a good assumption can be to think that we should relay on official standards bodies to standardize the wireless oriented health. So it would seem that creating standards for eHealth should not be that difficult. Is this assumption realistic? Not very realistic, we should say. Today, the entire eHealth sector is slowly progressing, but is still paralyzed by the national eHealth programmes. The principal problem is the national programmes need a system of uniform standards, while what they get is only a confusing and incoherent output. In my previous blog post, I have already mentioned the relevant contribute that Continua Health Alliance is having in the ecosystem of eHealth standardization. Continua Health Alliance is the only group of technology, healthcare and fitness that is succeeding in creating an ecosystem of connected personal health. According to Continua’s mission “establish a system of interoperable personal telehealth solutions that fosters independence and empowers people and organizations to better manage health and wellness”, the alliance formed by more than 220 company members around the world, plans to select connectivity standards and set guidelines for the desired interoperability. A good question that comes to my mind is to investigate if Continua Alliance isn’t just another standards body and why is this alliance different from the others. Continua is not a standards body, since the objective is not to develop new standards but to adapt or modify existing ones as much as possible. Alongside with leveraging the existing standards, also guidelines are considered essential by this open industry organization, in order to identify and resolve gaps in some standards bodies so that interoperability is improved in the eHealth system. More specifically, the Alliance is writing these guidelines for understanding how to use standards to achieve true interoperability across a variety of devices all oriented to personal telehealth. The core role of Continua is not always easy to understand. When the eHealth system was starting to appear, Continua was created as a non-profit, open industry organization to provide guidelines for the health ecosystem. If we simply analyze what this alliance is doing in the health sector, we can superficially assume that its key function is to ensure that devices from different manufacturers are compatible. Wrong assumption, because this is just a consequence of what Continua is doing in the standardization process. Its real effort is to ensure the integrity of the data flow from the measuring system to the electronic health record, which is the last component of the entire process. If we consider a typical eHealth structure, what is requested for the medics consulting a health record is to have accurate and reliable information that can flow automatically in the records. In the wireless world not always the data exchanged is not corrupted and secure. Whenever a data is flowing over an electronic link, especially if we consider a wireless link, it can be transformed and during the conversion process it might be converted to different units or manipulated in a variety of ways. This means that when the piece of data is finally ready to get to the final stage, it may have undergone to a set of manipulated data that can entirely corrupt the entire process. Therefore, we can finally understand the importance of Continua and why it is dramatically affecting the standardization process: the goal of the Continua Alliance is to provide a certification ensuring that if each stage of the process is conformed to their guidelines, then the received data will not be corrupted from that generated by a piece of medical equipment. Here comes the creation of the Continua logo, meaning that the path from the medical instrument to the medical health record is secure and that products are expected to work together. In addition, the Continua certification imposes a rigorous testing of products by independent test organizations. Of course, publishing and defining a standard is not enough to ensure a correct data flow and interoperability; this is why Countinua is very oriented towards logo certification and testing in a rigorous testing environment. As we saw previously, when the Bluetooth low energy approached the ICT market, the idea of using it for eHealth solutions didn’t take so long to become real, and obviously Continua has selected the Bluetooth Low energy in the guidelines. The testing procedure for certain standards has to follow a certain pre-decided procedure, generally selected by the standardization body. Due to the importance and diffusion of the Bluetooth technology, the Bluetooth SIG organization decided to invest millions of dollars in interoperability testing, thus making sure that once in the market its adoption was fast and diffused.
On the technical side Continua has decided to adopt a backward compatibility point of view, to ensure that devices supported by different versions of the guidelines are interoperable. At the same time regulatory changes and new reimbursement models are still studied and accepted.

Regarding the architectural structure of personal eHealth systems, Continua has the role of defining interoperable interfaces for the whole structure starting from the medical device at the patient’s home to the medical health records services. Since the beginning of its adventure, Continua selected a variety of wireless standards for the connection of medical devices to the system, including Bluetooth, USB, ZigBee amongst others; time has shown us that BL LE or Bluetooth more generally, is the selected technology for its robustness, data integrity and interoperability. In addition, for connections regarding the patient’s home to the back-end services some candidates are Cable, GPRS or CDMA, WiMax and DSL. Besides the technical aspects, the alliance plans to collaborate with the regulatory agencies of the government, such as FDA, regarding policies for the use of personal health wireless devices at home. This is the contribution of the Continua Health Alliance to the standardization process and it is a step forward in the right direction.

The Continua Health Alliance organizational structure.

Since Continua was formed, the market of smartphones and applications for health and fitness care has incredibly blossomed. Continua’s vision of end to end secure data flow remains stable through the years and the technological advancements, but how will it embrace the consumer health with the use of mobile phones is still not clear. I mentioned before the importance of the Continua certification logo; now, Continua has the complicated problem of deciding what their logo means when present in a medical device. If a consumer decides to buy a wireless health device with their logo, it means that the standard of end-to-end integrity is assured or that it is a device that connects to any consumer medical application? The boundaries between these two situations are not very defined, but what is sure is that the product bearing the mark has successfully met the certifications requirements, thus is ready to be used in the eHealth system. What is important in the standardization process, not mentioning for a second the wireless technology and compatibility issues, is that Continua’s major achievement was to stimulate partners from a diverse range of industry to come together for the commune cause of eHealth development. Even more, they have formed a regulatory group, which is discussing these issues with the powerful FDA and with other regulators around the world. This is the process necessary if we want to see evolution and standardization take place in the eHealth system.