Att utveckla medicintekniska informationssystem på rätt sätt : En studie om regulatoriska aspekters påverkan på systemutveckling och IT-innovation inom hälso- och sjukvård

• Main Author: Hedin, Hampus
• Format: Others
• Language: Swedish
• Published: Umeå universitet, Institutionen för informatik 2014
• Subjects: medical device; medical information system; health informatics; regulators; Actor-network theory; ANT; standards; IT-innovation; medicintekniska informationssystem; medicinteknisk produkt; regulatorer; regulatoriska aspekter; actor-network theory; standarder; IT-klimat
• Online Access: http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-90136

IT is often seen as a solution to many problems concerning effectiveness in organizations. Information systems within the healthcare sector is often viewed as medical devices rather than just systems or services. These medical devices are thoroughly regulated by laws, standards and certifications. In this study I participated in an innovative project that aimed to bring new life and use to the old fashioned patient journal by giving it a visual representation through the use of an avatar. I aimed to study the effects of regulators connected with the patient journal as a source of information for the innovative project. I drew upon Actor-network theory as a theoretical lens to trace the patient journal and connect it with regulatory aspects important to innovative projects such as the studied scenario. I also aimed to research the possibilities and obstacles provided with today’s IT-climate in Swedish healthcare. I found that regulatory aspects according to Actor-network theory proved to be an actor that stabilizes the network that is the innovative project. Certain regulatory aspects such as quality management standards provided support for unifying the vision concerning the innovation. Further the regulatory aspects proved to be an actor that can shift power between project developers and external actors. The regulatory aspects did not show any significant effect on the innovation or its original vision. These aspects did however show proof of being a heavy provider of project complexity and experience concerning these aspects was shown to be hard to find. I also found that there are two distinct ways for an innovator to realize a vision within Swedish healthcare, the healthcare way and the patient way, these two ways are represented in a model framework for future research. Last but not least I presented a framework for future IT-architecture based on modern technology and the results found in this study.