Abstract
The use of computers to help humans make diagnoses and prognoses in the practice of medicine or nursing is an exciting and unsettling development in the evolution of clinical and hospital practice. Such use engenders ethical and legal challenges paralleling those challenges seen regularly to arise with the introduction of many new technologies in healthcare. In the case of computational decision support systems, the most salient ethical issues involve standards of care, appropriate uses and users and professional relationships. Balancing patient safety against opportunities to improve care constitutes a tension that mirrors the difficulty encountered in debates about whether and how the government should regulate decision support systems. At ground are questions of accountability, responsibility and liability. In most cases, we lack adequate empirical data to arrive at uncontroversial conclusions. In the context of an exciting new technology, the reduction of that ignorance itself becomes an ethical imperative.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
Hippocrates. Prognosis. In Lloyd GER, ed. Hippocratic Writings (trans. by Chadwick J, Mann WN). London: Penguin Books; 1983; 170–185.
Miller RA, Schaffner KF, Meisel A. Ethical and legal issues related to the use of computer programs in clinical medicine. Ann Intern Med. 1985;102:529–36.
de Dombal FT. Ethical considerations concerning computers in medicine in the 1980s. J Med Ethics. 1987;13:179–84.
Miller RA. Why the standard view is standard: people, not machines, understand patients’ problems. J Med Philos. 1990;15:581–91.
Goodman KW. Ethics, medicine, and information technology: intelligent machines and the transformation of health care. Cambridge: Cambridge University Press; 2015.
Goodman KW. Addressing ethical issues in health information technology. Guest Editorial. Camb Q Healthc Ethics. 2015;24:252–4.
Berner ES, Webster GD, Shugerman AA, et al. Performance of four computer-based diagnostic systems. N Engl J Med. 1994;330:1792–6.
Goodman KW. Bioethics and health informatics: an introduction. In: Goodman KW, editor. Ethics, computing and medicine: informatics and the transformation of health care. Cambridge/New York: Cambridge University Press; 1997. p. 1–31.
Forrow L, Wartman SA, Brock DW. Science, ethics, and the making of clinical decisions. JAMA. 1988;259:3161–7.
Rubin MA. The collaborative autonomy model of medical decision-making. Neurocrit Care. 2014;20(2):311–8.
Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ. 2012;184(5):533–40.
Goodman KW. Outcomes, futility, and health policy research. In: Goodman KW, editor. Ethics, computing and medicine: informatics and the transformation of health care. Cambridge: Cambridge University Press; 1997. p. 116–38.
Brody BA. The ethics of using ICU scoring systems in individual patient management. Prob Crit Care. 1989;3:662–70.
Knaus WA. Ethical implications of risk stratification in the acute care setting. Camb Q Healthc Ethics. 1993;2:193–6.
Kullo IJ, Jarvik GP, Manolio TA, et al. Leveraging the electronic health record to implement genomic medicine. Genet Med. 2013;15:270–1.
Ginsburg GS, Haga SB. Translating genomic biomarkers into clinically useful diagnostics. Expert Rev Mol Diagn. 2006;6(2):179–91.
Altman RB. Translational bioinformatics: linking the molecular world to the clinical world. Clin Pharmacol Ther. 2012;91(6):994–1000.
Abugessaisa I, Saevarsdottir S, Tsipras G, et al. Accelerating translational research by clinically driven development of an informatics platform – a case study. PLoS One. 2014;9(9), e104382.
Zuradzki T. Preimplantation genetic diagnosis and rational choice under risk or uncertainty. J Med Ethics. 2014;40(11):774–8.
Gottesman O, Kuivaniemi H, Tromp G, et al. The electronic medical records and genomics (eMERGE) network: past, present, and future. Genet Med. 2013;15(10):761–71.
Lazaridis KN, McAllister TM, Babovic-Vuksanovic D, et al. Implementing individualized medicine into the medical practice. Am J Med Genet C Semin Med Genet. 2014;166C(1):15–23.
Pearson SA, Moxey A, Robertson J, et al. Do computerised clinical decision support systems for prescribing change practice? A systematic review of the literature (1990–2007). BMC Health Serv Res. 2009;9:154. doi:10.1186/1472-6963-9-154.
Brannigan VM, Dayhoff RE. Medical informatics: the revolution in law, technology, and medicine. J Legal Med. 1986;7:1–53.
Miller RA. Legal issues related to medical decision-support systems. Int J Clin Monit Comput. 1989;6:75–80.
Mortimer H. Computer-aided medicine: present and future issues of liability. Comput Law J. 1989;9:177–203.
Turley TM. Expert software systems: the legal implications. Comput Law J. 1988;8:455–77.
Anderson JG. Social, ethical and legal barriers to e-health. Int J Med Inform. 2007;76(5–6):480–3.
Lluch M. Healthcare professionals’ organisational barriers to health information technologies-a literature review. Int J Med Inform. 2011;80(12):849–62.
Beier B. Liability and responsibility for clinical software in the Federal Republic of Germany. Comput Methods Programs Biomed. 1987;25:237–42.
Brahams D, Wyatt J. Decision aids and the law. Lancet. 1918;ii:632–4.
Allaërt FA, Dussere L. Decision support system and medical liability. Proc Annu Symp Comput Appl Med Care. 1992;750–753.
Birnbaum LN. Strict products liability and computer software. Comput Law J. 1988;8:135–56.
Gill CJ. Medical expert systems: grappling with the issues of liability. High Tech Law J. 1987;1:483–520.
Snapper JW. Responsibility for computer-based decisions in health care. In: Goodman KW, editor. Ethics, computing and medicine: informatics and the transformation of health care. Cambridge: Cambridge University Press; 1997. p. 43–56.
Munsey RR. Trends and events in FDA regulation of medical devices over the last fifty years. Food Drug Law J. 1995;50:163–77.
Public Law No. 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. Sections 301 et seq. 1988.
Kessler DA, Pape SM, Sundwall DN. The federal regulation of medical devices. N Engl J Med. 1987;317:357–66.
Public Law No. 94-295, 90 Stat. 539 (1976), codified at 21 U.S.C. Sections 360c et seq. 1982.
Brannigan VM. Software quality regulation under the Safe Medical Devices Act of 1990: hospitals are now the canaries in the software mine. Proc Annu Symp Comput Appl Med Care. 1991:238–242.
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 SEC. 201, 2006–2010.
Karnik K. FDA regulation of clinical decision support software. J Law Biosci. 2014;1(2):202–8.
Young FE. Validation of medical software: present policy of the Food and Drug Administration. Ann Intern Med. 1987;106:628–9.
Miller RA, Gardner RM. Summary recommendations for the responsible monitoring and regulation of clinical software systems. Ann Intern Med. 1997;127(9):842–5.
Miller RA, Gardner RM. Recommendations for responsible monitoring and regulation of clinical software systems. JAMIA. 1997;4:442–57.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Goodman, K.W. (2016). Ethical and Legal Issues in Decision Support. In: Berner, E. (eds) Clinical Decision Support Systems. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-319-31913-1_8
Download citation
DOI: https://doi.org/10.1007/978-3-319-31913-1_8
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-31911-7
Online ISBN: 978-3-319-31913-1
eBook Packages: MedicineMedicine (R0)