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Medical devices serve a vital role in patient care, as they are used to produce patient data for diagnostic decision making and treatment. Health technology is evolving rapidly. Increasingly, in addition to costing less, medical devices are more complex (e.g., greater number of components), sophisticated, miniaturized, lighter, integrated, and connected. An increase has occurred in the general quality and selection of medical devices, with embedded computing and sensors that monitor and collect patient data for clinician use.
Medical devices have enhanced capabilities to integrate with other devices and health systems (a concept known as the Internet of Medical Things) and allow for remote monitoring, collaboration among stakeholders, and novel utilization of secondary and tertiary data.1
The digitization of healthcare has allowed for both the accumulation (e.g., cloud storage) of patient data (e.g., laboratory, imaging, medication, and descriptive data) and examination of this data using big data analytics.2
As healthcare delivery organizations (HDOs) attempt to bend the cost curve for patient care, cloud computing is being used to support analysis of big data and improve the safety and security of patient care services. This includes the use of more sophisticated data mining techniques to examine populations and predictive analytics and to support comparing individual patient descriptors with the population.3
According to ISO 18308,4 electronic medical records (EMRs) are being used to exchange medical information among healthcare stakeholders at the clinician, system, and institutional levels. It is worth noting that variation exists in the effectiveness of and clinician satisfaction with EMRs. In addition, although methods of ensuring the security, privacy, and availability of patient data continue to evolve, the protection of patient data remains a challenge for the healthcare industry.5
The purpose of the research described here was to examine changes occurring in the field of HTM, including biomedical engineering and clinical engineering departments (hereafter referred to as HTM departments), to advance the safety and effectiveness of medical devices in an environment of rapidly advancing technology. In addition, HTM and information technology (IT) departments are becoming increasingly integrated. The analysis focused on the strategic, structural, and operational activities undertaken by selected HDOs to adapt, support, and foster this evolution.
Drivers of change, response to change, evolution of strategies, and directions forward were examined. This article shares common...