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.