Traceability in Healthcare Innovation Maintaining the Relations Between Needs and Solutions

Abstract: Healthcare is an important arena for improvement and innovation by the use of e-health solutions. But many obstacles exist, such as insufficiency in interoperability and usability. One reason for this problematic situation is that the development process has been inadequate. Swedish healthcare serves under regulations for public procurement. Hence, almost every e-health solution has to be procured to prevent an orientation towards illegal direct award of contracts. Specifying requirements that explain what the customer and users needs and why, is one of the most critical parts of that process. The customer gets what asked for, but often the requirements are on a high level of interpretation and not explicit or traceable enough. This prevents interoperability and usability from being a vital part of the prioritizing activity. Today knowledge about requirement processes and traceability is fragmented, and often more based on ideal models than on practical, real life experiences. The aim of this work is therefore to understand how traceability is managed and how it can be improved. I investigate who is most suitable to perform the “traceability activity” and, maybe even more important, the skill needed to fulfil that task. With a practice-based and ethnographical approach several studies have been conducted in different healthcare settings in Sweden, all closely connected to the design- and development process in e-health projects. The research shows that traceability maintains the relation between needs and solutions by providing a reality check for every step in the procurement and development. To accomplish that, requirements must be made explicit and interpretable for different stakeholders. The actors best suited for this “traceability activity” must have a holistic approach and know how to identify needs and relate them to the context. This demands a domain-specific knowledge about the healthcare setting and understanding how the organisation works practically and politically. It is crucial to also be skilled at usability, design, development and procurement. In addition, implementing IT in healthcare cannot be separated from business development. I argue that it is time to update the way healthcare development is managed and by whom. First, healthcare management must pay more attention on usability and the crucial role that healthcare professionals have as change leaders and needfinders to strengthening existing initiatives. Second, the design community must match existing initiatives and roles in healthcare with the designers’ special knowledge to support innovation and design processes.