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.