Final answer:
The 1996 FDA workshop recommended competent human intervention as a guiding principle in the regulation of clinical software, emphasizing the importance of human oversight in technology use within medical settings.
Step-by-step explanation:
One of the recommendations from the 1996 FDA workshop on regulating clinical software was competent human intervention as a guiding principle. The concern for human factors in software design was emphasized, which is highlighted by the vital roles that human factor professionals play in the development of regulations and principles of best design. These regulations often pertain to work safety and the importance of human oversight in the use of technology in healthcare settings.
The relevance of human factors is also evident when considering the developments in the arena of human experimentation, where safeguards such as the creation of Institutional Review Boards (IRBs) were developed to ensure the protection of participants in clinical trials. Similarly, human intervention is necessary in the regulatory process as well, such as in the oversight of gene therapy clinical trials by various federal agencies including the FDA.