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It is well-known that security issues in medical devices, services and applications have potentially catastrophic consequences. To avoid compromising patient data or information systems, it is essential that healthcare services and products meet the relevant information security and data protection requirements. For these reasons, the Digi-HTA assessment includes information security and data protection assessment domains. The outcome of the Digi-HTA process is a recommendation that decision-makers can use during the procurement process. We present results and experiences from the first assessments made in the Digi-HTA process. We have assessed six products so far and multiple assessments are in progress. The results indicate that healthcare product manufacturers have found the process useful, and usually, the manufacturers have had to improve the security of their product during the Digi-HTA process to get a favourable recommendation for their product. The assessment processes have taken longer than expected due to shortcomings and ambiguities in the provided self-assessment forms, and due to feedback cycles and meetings prompted by assessment findings. Of the six assessed products, four received a green light in information security and data protection, whereas two have received a yellow light due to issues that were not fixed during the process. In addition to shortcomings in adhering to best practices, we have also found exploitable security issues.

Finland aims to be a pioneer in digitalization by reforming the processes of public services and digitalizing services. In healthcare, the introduction of digital transaction services is aimed at bettering health care services and cost benefits. The use of digital transaction services in recent years has increased, but the realization of digitalization is still low. One of the challenges in increasing the use of digital transaction services is the non-renewable state of the care processes.In order to improve digital services in Southern Ostrobothnia, this study aimed to find out how healthcare processes are taken into account in the development of digital services in Southern Ostrobothnia. In order to achieve this goal, studies were performed to find out what kind of digital services are being used and developed in healthcare, the prevalence of these digital services, how the consortium of e-services and health care processes is being developed, how the development of e-services is being carried out, and what the effects of the Covid-19 pandemic are on e-services in healthcare.The basis of the study is described in a literature review, in which information was sought on digital health services in the Nordic countries. Information on the consideration of health care processes in the development of digital transaction services was collected from interviews with health care and information management professionals.There are several different electronic transaction services in healthcare, which need to be developed for the possibility of a smoother transaction experience. In deploying digital services, care processes will be modified, but these processes are not being redesigned to ensure that the benefits of the digital services can be achieved. It was desired that the development of digital transaction services would be advanced and to include process planning more firmly in the development process. There are good preconditions for formulating electronic transaction services and processes into a unified whole. In the future, it will be important to define the benefit of goals for digital services and to craft a strategy to achieve them. The benefits of digital transaction services materialize when defined processes are digitalized in such a way that they are part of working practices and citizens' transactions. publishedVersion

Funding Information: This study was supported by the Strategic Research Council of the Academy of Finland (project 327145) and the Ministry of Social Affairs and Health (project 414919001). ME was supported by the Academy of Finland (project 339 390). The authors would like to express their gratitude to all physicians who responded to the questionnaire as well as the Finnish Medical Association for collaboration. Publisher Copyright: © 2022 Journal of Medical Internet Research. All rights reserved. Background: In health care, the benefits of digitalization need to outweigh the risks, but there is limited knowledge about the factors affecting this balance in the work environment of physicians. To achieve the benefits of digitalization, a more comprehensive understanding of this complex phenomenon related to the digitalization of physicians'work is needed. Objective: The aim of this study was to examine physicians' perceptions of the effects of health care digitalization on their work and to analyze how these perceptions are associated with multiple factors related to work and digital health usage. Methods: A representative sample of 4630 (response rate 24.46%) Finnish physicians (2960/4617, 64.11% women) was used. Statements measuring the perceived effects of digitalization on work included the patients' active role, preventive work, interprofessional cooperation, decision support, access to patient information, and faster consultations. Network analysis of the perceived effects of digitalization and factors related to work and digital health usage was conducted using mixed graphical modeling. Adjusted and standardized regression coefficients are denoted by b. Centrality statistics were examined to evaluate the relative influence of each variable in terms of node strength. Results: Nearly half of physicians considered that digitalization has promoted an active role for patients in their own care (2104/4537, 46.37%) and easier access to patient information (1986/4551, 43.64%), but only 1 in 10 (445/4529, 9.82%) felt that the impact has been positive on consultation times with patients. Almost half of the respondents estimated that digitalization has neither increased nor decreased the possibilities for preventive work (2036/4506, 45.18%) and supportiveness of clinical decision support systems (1941/4458, 43.54%). When all variables were integrated into the network, the most influential variables were purpose of using health information systems, employment sector, and specialization status. However, the grade given to the electronic health record (EHR) system that was primarily used had the strongest direct links to faster consultations (b=0.32) and facilitated access to patient information (b=0.28). At least 6 months of use of the main EHR was associated with facilitated access to patient information (b=0.18). Conclusions: The results highlight the complex interdependence of multiple factors associated with the perceived effects of digitalization on physicians'work. It seems that a high-quality EHR system is critical for promoting smooth clinical practice. In addition, work-related factors may influence other factors that affect digital health success. These factors should be considered when developing and implementing new digital health technologies or services for physicians' work. The adoption of digital health is not just a technological project but a project that changes existing work practices.

The potential of mHealth is enormous for chronic conditions, yet the integration of these technologies into the clinical infrastructures and healthcare pathways remains an ongoing challenge. Digi-HTA has been developed to support health technology assessment activities for novel digital healthcare technologies. The use of Early Health Technology Assessment (EHTA) can help product development. The present study describes the way in which EHTA can guide the development of a product to anticipate future needs and market access.