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.

The Development of Interoperability Guidelines and Certification.

Today, the healthcare industry is desperately searching to improve assistance methods and to reduce costs of current and anticipated needs. This can be only done if the ICT technology is used to cut additional costs of healthcare maintenance in the future. The major problem in achieving this system connectivity is to be referred to the difficult communication between medical devices and the other systems involved in the process. Measured medical data have different format in comparison with other devices working in the process, therefore the encoding of this data over the channel is a relevant problem to be solved through the standardization process. Continua’s guidelines and certification are focused on the connectivity in order to guarantee that all the devices involved are interoperable and can work together. The market allows different companies to produce a variety of electronic health devices for personalized health management, but if a product follows the Continua’s guidelines and has the certification logo, then the ability to plug different companies products together is assured, thus the so called Interoperability is verified.
The idea behind the collaborative health solution is that in an ideal situation a person that has a chronic disease, for example diabetes or hypertension, can use a glucose monitor from different companies connecting them with a mobile phone from yet another company. This is achievable only with standardization since there are a variety of interfaces, devices and vendors involved. The Continua Health Alliance has established a process for making personal eHealth a reality, where the development of guidelines is the first step that will enable different companies to build interoperable health platforms. Once the design guidelines are produced, then a product that follows the guidelines and has been tested will undergo to a certification program with the Continua logo, certifying that the specific device is interoperable with other certified products. As I have already mentioned Continua is absolutely focused on systems connectivity and by being a standardization organization, they try not to be innovative in their guidelines, based on already existing industry standards. The certification process is itself very important since it provides a standard based approach with common systems and tools for aggregating data, integrated data flows and economies of scale. The process of designing guidelines and certification is complex and comprehensive of diverse activities. First Continua focuses on the development of the interoperability guidelines that are not oriented toward innovative solutions but mostly, are based on a set of industry based standards. Developing design guidelines is an essential tool for enabling vendors to build interoperable health systems.The process starts by focusing on a restricted or few restricted areas of interest, by analyzing use cases submitted in detail. In addition, the submitted use cases subjects of previous analysis are summarized in a generalized list of cases and for each of them requirements are defined. Continua uses this list only after all the possible cases are evaluated with particular attention to system diversification, and the number of options has been reduced in order to increase interoperability and prioritize requirements for the guidelines design. After the guidelines requirements and specifications are defined Continua investigates the industry for existing connection standards that can best adapt to the specific device and creates guidelines. Once a health industry standard is selected Continua correlate the standard selected with the system specification in order to verify if there is a match.

The certification process is essential to make sure interoperability is verified and is preceded by a Continua Testing Method which is mainly constructed on two types: the first one is the Conformance testing where it is verified that the system meets the requirements of the standard considered, and after that an Interoperability testing is performed in order to verify that the specific device can work together with other devices already certified and tested.

The Continua Certification is only possible for its members and it is focused on verifying that a product has meat the requirements for the Continua certification. Generally certification takes only some days and then the company itself is responsible of any other possible action necessary for the launch of the product in the market.