Medical software - Issues and best practices

Abstract

Introduction: The design and functional complexity of medical software has increased during the past 50 years, evolving from the use of a metronome circuit for the initial cardiac pacemaker to functions that include electrocardiogram (EKG) analysis, laser surgery, and networked systems for monitoring patients across various healthcare environments. Software has become ubiquitous in healthcare applications, as is evident from its prevalent use for controlling medical devices, maintaining electronic patient health data, and enabling healthcare information technology (HIT) systems. As the software functionality becomes more intricate, concerns arise regarding efficacy, safety and reliability. It thus becomes imperative to adopt an approach or methodology based on best engineering practices to ensure that the possibility of any defect or malfunction in these devices is minimized. © 2013 Springer-Verlag Berlin Heidelberg.