Legal Issues in Medical Computer Software and Expert Systems in United States. Legislation and Practice
Title: Legal Issues in Medical Computer Software and Expert Systems in United States. Legislation and Practice
Author: FIORIGLIO, Gianluigi
Series/Report no.: EUI MWP; 2010/11
Today, hospitals are heavily computerized, but this process is still far from its ultimate goals and suffers from many deficiencies. Good quality software, correctly used, can improve health care under many different circumstances, e.g. good administrative software can improve the efficiency of health care delivery and can speed up the flow of patient information; good clinical software can greatly improve health care, helping physicians in their work (for instance by assisting them in their decisions); good software embedded in medical devices can improve the quality of life of patients. In fact, every subject involved in the health care field is likely to be a user of very complex software, sometimes even without noticing it. However, the more complex the software, the more susceptible it may be to errors that may cause malfunctions. Although many ethical, legal and technology-related issues have been raised over years of public discussion, there are few definitive answers to these difficult questions. Questions continue to arise due to a range of forces: from the perceived necessity of adopting more complex, versatile and probably more expensive systems, to the need to assign responsibility for the consequences of their malfunction. Finding certain answers in this field at the intersection of health, law and technology is always difficult: only a comprehensive analysis of all the interdisciplinary aspects can help to achieve this task. This paper aims to explore and clarify the legal issues related to computer software and expert systems in the medical field, taking into account United States legislation on the one hand, and more general and theoretical aspects on the other hand.
Subject: Medical computer software; medical expert system; medical device; liability; tort law
This paper is the result of a research project started in 2005 at the Massachusetts Institute of Technology (Computer Science and Artificial Intelligence Laboratory) under the direction of Prof. Peter Szolovits (Head of the Clinical Decision Making Group) and completed at the European University Institute with the help of Prof. Giovanni Sartor.
Type of Access: openAccess