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Invited Commentary

Artificial Intelligence in Health Care: The Challenge of Effective Regulation

, DPaed, FRACP, FRCPCH, FACLM, FCLM (Hon)ORCID Icon
Pages 75-86 | Published online: 24 Jan 2023
 

Notes

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3 Kulikowski CA. Beginnings of artificial intelligence in medicine (AIM): computational artifice assisting scientific inquiry and clinical art—with reflections on present AIM challenges. Yearb Med Inform. 2019;28(1):249–256.

4 Lyell D, Coiera E, Chen J, Shah P, Magrabi F. How machine learning is embedded to support clinician decision making: an analysis of FDA-approved medical devices. BMJ Health Care Inform. 2021;28:1–17. https://doi.org/10.1136/bmjhci-2020-100301

5 Reddy S. Artificial intelligence and healthcare—why they need each other? J Hosp Manag Health Policy. 2021;5:9.

6 Reddy S, Rogers W, Makinen VP, et al. Evaluation framework to guide implementation of AI systems into healthcare settings. BMJ Health Care Inform. 2021;28(1):e100444. doi: 10.1136/bmjhci-2021-100444

7 Australian Government, Australian Digital Health Agency. Privacy policy. https://www.myhealthrecord.gov.au/about/privacy-policy

8 Australian Government, Australian Digital Health Agency. My Health Record in Australia. https://www.myhealthrecord.gov.au/legislation-and-governance

9 Ho DE, Black E, Agrawala M, Li F-F. Evaluating Facial Recognition Technology: A Protocol for Performance Assessment in New Domains from HAI Stanford University Human-Centred Artificial Intelligence. Stanford Institute for Human-Centred Artificial Intelligence; 2020. White Paper. https://hai.stanford.edu/sites/default/files/2020-11/HAI_FacialRecognitionWhitePaper.pdf

10 Obermeyer Z, Topol E. Artificial intelligence, bias, and patients’ perspectives. Lancet. 2021;397(10289):2038. doi: 10.1016/S0140-6736(21)01152-1

11 Lepri B, Oliver N, Pentland A. Ethical machines: the human-centric use of artificial intelligence. iScience. 2021;24(3):102249. doi: 10.1016/j.isci.2021.102249

12 Müller VC. Ethics of artificial intelligence and robotics. In: Zalta EN (ed.). The Stanford Encyclopedia of Philosophy. Stanford, CA: The Metaphysics Research Lab, Stanford University; 2021. https://plato.stanford.edu/archives/sum2021/entries/ethics-ai/

13 Angwin J, Larson J, Mattu S, Kirchner L. Machine bias. https://www.propublica.org/article/machine-bias-risk-assessments-in-criminal-sentencing

14 Miller K. Healthcare algorithms don’t always need to be generalizable. https://hai.stanford.edu/news/healthcare-algorithms-dont-always-need-be-generalizable

16 AI for People. Tools for explainability and transparency. https://www.aiforpeople.org/tools-for-explainability-and-transparency/

17 Mathews SM. Explainable artificial intelligence applications in NLP, biomedical, and malware classification: a literature review. In: Ara K, Bhatia R, Kapoor S (eds.). Intelligent Computing. CompCom 2019. Advances in Intelligent Systems and Computing, Vol. 998. Cham, Switzerland: Springer; 2019:1269–1292. https://doi.org/10.1007/978-3-030-22868-2_90

18 Dwyer P. Legal implications of clinical practice guidelines. Med J Aust. 1998;169(6):292–293.

19 Barocas S, Selbst A. Big data’s disparate impact. Calif L Rev. 2016;104:671–732.

20 European Commission. Europe fit for the Digital Age: commission proposes new rules and actions for excellence and trust in Artificial Intelligence. Press release. https://ec.europa.eu/commission/presscorner/detail/en/ip_21_1682

21 The AI Act. The Artificial Intelligence Act. https://artificialintelligenceact.eu

22 Australian Government, Department of Health and Aged Care. Australian regulatory guidelines for medical devices (ARGMD). https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd

23 Hagendorff T. The ethics of AI ethics: an evaluation of guidelines. Minds Mach. 2020;30:99–120. https://doi.org/10.1007/s11023-020-09517-8

24 Reddy S, Allan S, Coghlan S, Cooper P. A governance model for the application of AI in health care. J Am Med Inform Assoc. 2020;27(3):491–497. doi: 10.1093/jamia/ocz192

25 U.S. Food & Drug Administration. AI and machine learning software as a medical device. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device

26 NAIRR Task Force. Envisioning a National Artificial Intelligence Research Resource (NAIRR): Preliminary Findings and Recommendations: An Interim Report by the NAIRR Task Force. https://www.ai.gov/wp-content/uploads/2022/05/NAIRR-TF-Interim-Report-2022.pdf

27 Ho D, King J, Wald R, Wan C. Building a National AI Research Resource; a Blueprint for the National Research Cloud. White Paper. https://hai.stanford.edu/sites/default/files/2021-10/HAI_NRCR_2021_0.pdf

28 Australian Government, Department of Industry, Science and Resources. Australia’s Artificial Intelligence Action Plan. https://www.industry.gov.au/data-and-publications/australias-artificial-intelligence-action-plan

29 CSIRO Data 61. Artificial intelligence roadmap 2019. https://data61.csiro.au/en/Our-Research/Our-Work/AI-Roadmap

32 Australian Commission on Safety and Quality in Health Care. Electronic medication management. https://www.safetyandquality.gov.au/our-work/medication-safety/electronic-medication-management

33 Sittig DF, Sengstack P, Singh H. Guidelines for U.S. hospitals and clinicians on assessment of electronic health record safety using SAFER guides. JAMA. 2022;327(8):719–720.

34 A cybernetics approach to ethical AI design (AI ethics: global perspectives) by Ellen Broad. https://www.youtube.com/watch?v=vfU5cnSRdFc

35 Richards B, Scheibner J. Health technology and big data: social licence, trust and the law. J Law Med. 2022;29(2):388–399.

36 Treleaven P, Batrinca B. Algorithmic regulation: automating financial compliance monitoring and regulation using AI and blockchain. The CAPCO Institute Journal of Financial Transformation. 2017;45:14–21.

38 Candelon F, di Carlo RC, De Bondt M, Evgeniou T. AI regulation is coming. Harv Bus Rev. 2021.https://hbr.org/2021/09/ai-regulation-is-coming

39 Vokinger KN, Gasser U. Regulating AI in medicine in United States and Europe. Nat Mach Intell. 2021;3(9):738–739.

40 Evas T. European framework on ethical aspects of artificial intelligence, robotics and related technologies. https://www.europarl.europa.eu/RegData/etudes/STUD/2020/654179/EPRS_STU(2020)654179_EN.pdf

41 U.S. Food and Drug Administration. Artificial intelligence and machine learning in software as a medical device. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device

42 Yeung K, Lodge M (eds.). Algorithmic Regulation. 1st ed. Oxford, UK: Oxford University Press; 2019.

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