Clinical efficacy and safety studies as well as healthcare economics studies are an important basis for Health Technology Assessment (HTA) today. Other factors such as organizational, ethical or strategic issues are rarely described. However, making difficult decisions requires consideration of all relevant factors (Dubromel et al., 2020). Evaluations of new drugs, medical devices, medical or surgical technologies, and organizations such as existing pathways of care do not take into account all of the factors that make up a healthcare organization. This trap leads to suboptimal resource consumption and illogical decisions. According to Leavitt’s model, the four interrelated components of an organization are people, mission, structure, and technology. A modified Leavitt model of organization takes environmental interactions into account (Dubromel et al., 2020). Examining the expected impact on one or more of these entities, as well as changes caused by other entities and circumstances, is all part of assessing the organizational impact of an invention. They are more important to evaluate for disruptive innovations that generate or replace them, rather than incremental innovations that improve. Healthcare organizations are also characterized by high complexity and highly dynamic environments. As such, assessment of organizational impact is increasingly seen as a key part of the decision-making process alongside clinical and economic considerations. continue…
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