Uppsatsen tar upp blockchain-teknologin och undersöker om den kan användas vid hantering av patientjournaler i ett svenskt patientjournalsystem. Genom att kombinera en genomförbarhetsstudie och SWOT-analys har tre aspekter; tekniska, legala och organisatoriska undersökts med hjälp av perspektiven från SWOT. De tekniska, legala och organisatoriska aspekterna berör viktiga faktorer och frågor som bör uppfyllas för ett projekt ska anses genomförbart. Uppsatsen är en explorativ fallstudie med dokumentanalys som metod. Primärt har akademisk litteratur samt lagar och författningar undersökts och analyserats. Med hjälp av informationen från insamlade dokument analyseras och diskuteras innehållet utifrån teknisk, legal genomförbarhet och organisatorisk genomförbarhet. Den tekniska samt legala aspekten antyder att blockchain i dess nuvarande form inte är genomförbart för att användas som stöd i svenskt patientjournalsystem. Emellertid har en hög genomförbarhet identifierats inom den organisatoriska aspekten. / This paper examines whether blockchain-technology can be used to assist an EHR system (electronic health records) in Sweden. By combining a feasibility study and SWOT-analysis, three major aspects; technical, legal and organizational, have been examined with help from the perspectives in SWOT. The aspects cover key factors and questions which ought to be fulfilled for a project to be considered feasible. An exploratory case study has been conducted combined with the method of document analysis. The documents have primarily consisted of academic literature and law acts and constitutions such as GDPR. The feasibility aspects have been analysed and discussed with the help of found literature. The technical and legal aspects suggest that the use of blockchain in its current shape and form is not feasible in assisting an EHR system. However, within the organizational aspect, a high level of feasibility has been concluded

On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device directive (MDD 93/42/EEC) to MDR are a series of adverse events involving medical devices. The main goal of MDR is to strengthen and improve the already existing legislation and thus will entail large changes for manufactures, one of them being manufacturers of Electronic Health Record (EHR) systems. For medical software, such as EHR systems, the new regulation will imply an upgrade in risk classification. This upgrade will bring additional requirements for EHR manufacturers. Furthermore, the released guidelines have been insufficient regarding the specific requirements for medical device software and thus EHR manufacturers are in need of tools and guidance to fulfill MDR. This thesis examines the new regulation for medical devices and thus identifies main requirements for EHR manufacturers. A qualitative approach was conducted comprising a literature study as well as a document study of the medical device regulation along with interviews with experts within the field of medtech regulatory affairs and quality assurance. The information gathered was analyzed to create a process description on how EHR manufacturers are to fulfill MDR. The process description is a general outline and presents the main steps on the route to be compliant with MDR in a recommended order of execution. The main steps are: divide the system into modules, qualify the modules, classify the modules, implement a quality management system, compile a technical documentation, compile the declaration of conformity, undergo a conformity assessment and finally, obtain the CE-mark. To each of the main steps additional documentation provides further information and clarification. The process description functions as a useful tool for EHR manufacturers towards regulatory fulfillment. Even though the process description is created for EHR manufacturers, it can be useful for other medical device software manufacturers. The process description provides an overview of the path to a CE mark and functions as a guidance. It can be used in educational purposes as well as to serve as a checklist for the experienced manufacturer to make sure everything is covered. However, it is not sufficient to rely solely on the process description in order to be in full compliance with MDR. Moreover, there is still a need for further clarifications from the European Commission regarding specific requirements on medical device software.