Recommendations for the Ethical Development and Use of Medical Decision-Support Systems

Georg Marckmann, MD, MPH

Disclosures
In This Article

Abstract and Introduction

Medical decision support systems (MDSS) play an increasingly important role in medical practice. By assisting physicians with making clinical decisions, MDSS are expected to improve the quality of medical care. However, there are also concerns that malfunctioning or inappropriate use of MDSS could jeopardize the well-being of the patient. While several authors have already discussed ethical issues arising with the use of computer-assisted medical decision making, there is still no consensus about the ethically appropriate use of MDSS. Based on a review and synthesis of previous relevant work, this paper proposes a comprehensive set of recommendations for the ethical development and application of MDSS.

Medical decision-support systems (MDSS) are computer systems designed to assist physicians or other healthcare professionals in making clinical decisions.[1] While the diffusion of large-scale diagnostic systems has been slower than originally anticipated, the growing availability of electronic patient records and the increasing technical diversity of MDSS will promote the widespread use of computer-assisted medical decision making.[2] Currently, most MDSS provide decision support for particular diagnostic or therapeutic tasks such as interpreting pulmonary function tests, analyzing electrocardiograms, or managing the use of anti-infective agents. MDSS can help physicians to organize, store, and apply the exploding amount of medical knowledge. They are expected to improve the quality of care by providing more accurate, effective, and reliable diagnoses and treatments, and by avoiding errors due to physicians' insufficient knowledge. Evaluation studies demonstrate that MDSS can have a positive effect on clinician performance and patient outcomes.[3,4,5,6,7] In addition, MDSS can decrease healthcare costs by providing a more specific and faster diagnosis, by processing drug prescriptions more efficiently, and by reducing the need for specialist consultations.[3,6] However, the performance of MDSS is subject to some important limitations (which will be discussed in Section I), and their inappropriate use or malfunctioning might adversely affect the well-being of the patient. Some MDSS fail to achieve the same level of diagnostic performance as human experts.[8] This raises the ethical question: How can we design and use MDSS in a way that maximizes the benefits and minimizes the risks for the patients?[9]

While several authors have previously addressed ethical issues arising with the application of MDSS,[9,10,11] there is still no consensus on the ethically appropriate use of these systems. Based on a review and synthesis of previous relevant work, I will propose a comprehensive, yet certainly not exhaustive, set of recommendations for the ethical development and use of MDSS.

The suggested recommendations will require further discussion and elaboration among computer specialists, vendors of MDSS, healthcare professionals, bioethicists, regulatory agencies, and the public. Professional societies should take the lead in this process, and the "Summary Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems" is certainly one important step in the right direction.[12] In addition, any set of ethical or policy recommendations will need continuous updating to keep pace with the technologic progress: New systems with new applications will pose new ethical concerns that will call for a modification or extension of the proposed recommendations. To put the recommendations in some context, I will first review some limitations of MDSS in Section I and ethical issues arising from their use in clinical practice in Section II. I will then provide the sketch of an ethical framework to justify the recommendations in Section III. Recommendations for the ethical development of MDSS are subsequently presented in Section IV while Section V provides recommendations for the ethical use of MDSS.

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