Design Guidelines – The process

In 2009 the Version One Design Guidelines was published. These guidelines focus exclusively on the interoperability features of devices and not on particular functionalities. The method of coming up with these results was based on analyzing the interoperability requirements from different use cases submitted by the members of the alliance. The guidelines on their own, however, revolve around already existing industry standards. The process kicks off by receiving use cases from member companies on interoperability issues regarding one of the three target areas: Living Independently, Disease Management, Health & Wellness. Based on all use cases, a generalized list of problems is formulated, which in turn is used to prioritize capabilities, interfaces and requirements. The next step is to search the industry and the standard bodies for standards which answer questions related to the capabilities and requirements. Aspects like how well the standards address the capabilities in under discussion, is the standard international and can if not can it be made so, what is the relation between the standard under scrutiny and other standards in the same area, what is the associated intellectual property claims, what are the specification access and control mechanisms, what is the level of adoption and maturity, are analyzed. All these issues narrow down the possible standards available to meet the initial requirements. The final decision is taken according to a performance comparison between candidates with respect to the requirements.

The final stage consists of defining profiles over selected standards and including them in the interoperability guidelines as a basis for product certification. In addition, the alliance also develops a certification and testing program that includes a detailed set of test specifications and automated testing tools so that the candidate vendors can verify compliance to the selected standard. A product that passes the certification and testing program will receive certification and can display the Continua interoperability logo. There is already a list of product displaying this logo here.

The current standards used are as follows

• IEEE 11073 for defining device architectures
•  Bluetooth, Bluetooth Low Energy, Zigbee and USB for transporting data
•  HL7 for categorizing data in clinical area
•  IHE for interfacing which include the clinical data architecture and SNOMED.