Digital Technology as a Medical Device

Volledige vakbeschrijving

The emergence of digital technologies, mainly conceived outside healthcare, is impacting the traditional way of thinking about the delivery of care. Automation, Analytical, and digitalization technologies will transform medicine into a data-driven learning healthcare system.  Nevertheless, the pacing of the above-mentioned technologies is much faster in our daily activities than in healthcare. This is because healthcare is a particular de-centralized ecosystem where different “actors” (healthcare providers) produce data and interact with it to perform clinical decisions that impact delivery of care. While the introduction of hardware technologies such as newer medical devices is well established by regulations and with pre-defined professional roles in charge of it, understanding the complexity of the introduction of newer digital technologies in healthcare is still an open issue.  This complexity will only be broken down by re-thinking any digital technology as a medical device, whose introduction impacts the workflow and processes of the above-mentioned actors. Successful “bridge builders” in healthcare need to go beyond the knowledge of algorithms used to extract knowledge from data and they must place these technologies in the context of healthcare actors, impact, innovation, and regulations.

The digital technology as a medical device course covers the definition and placing of digital technologies as medical devices within the healthcare providers. This module is designed around the fundamental steps that need to be evaluated when considering the introduction of a newer digital technology within healthcare.  Students will gain knowledge on how to formulate an implementation plan or a feasibility analysis for the introduction of a newer digital technology within healthcare. Students will become familiar with the concepts of data usage / re-usage, medical devices, clinical trials,  impact and innovation. Next to that, the students will learn soft skills related to the ability of presenting data and data analytics prototype to the broader audience represented by the healthcare actors. The students will interact directly with the healthcare providers during the lectures and the practical labs.