During the past two decades, there has been an explosive volume of software applied in the field of heath care. As medical software becomes pervasive in all facets of health care services, the risk of software related patient injuries and patient deaths is also on the rise. To assure the quality of medical software, rigorous validation and verification methods must be employed to analyze all phases of development and final products. In this thesis, a systematic review was conducted to examine and summarize research in the area of medical software certification, which is the primary quality assurance approach taken by regulatory bodies. Key findings indicate that research in the field of medical software certification is sparse, with a limited range of focus and research methodologies. Greater effort using empirical research approaches is necessary for the improvement of current research in medical software certification. / Graduate

Effective leadership in healthcare improves the patient experience. Self-awareness drives leadership development, competence, and, in turn, leader effectiveness. The problem addressed by this study was the absence of knowledge regarding how healthcare leaders develop awareness of their leadership strengths and weaknesses: their competence. The purpose of this postintentional phenomenological study was to explore how healthcare leaders develop this awareness. Twelve midlevel nonclinical healthcare leaders from 3 hospitals in the Pacific Northwest region of the United States shared their experiences during semistructured interviews. Participants and their organizations contributed supporting documentation of competence and performance expectations. Following Vagle's postintentional process, data were reviewed holistically and then in detail in multiple iterations. A reflective plan, including a postreflective statement, created prior to data collection and reviewed throughout the study, elevated and abated researcher bias and potential for influence. This plan also served to question the emerging themes and contributed to the trustworthiness of the study. In response to the research question, the necessity of honest and constructive feedback and use of self-reflection to elevate understanding of leadership competence emerged. The shared participant experiences elevated five feedback mechanisms of greatest value: quantifiable results, person-person, recognized capabilities, environmental/relational, and self. Adoption of recommendations for practice, such as an improvement of performance-evaluation processes or the development of a feedback culture, could contribute to social change through the development of effective healthcare leaders. Honest and constructive feedback, with reflection, contributes to gained awareness and identification of developmental needs.