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Review
. 2024 Sep 4;24(1):247.
doi: 10.1186/s12911-024-02653-6.

Trustworthy and ethical AI-enabled cardiovascular care: a rapid review

Maryam Mooghali  1   2 , Austin M Stroud  3 , Dong Whi Yoo  4 , Barbara A Barry  5   6 , Alyssa A Grimshaw  7 , Joseph S Ross  8   9 , Xuan Zhu  5 , Jennifer E Miller  8
Affiliations
Review

Trustworthy and ethical AI-enabled cardiovascular care: a rapid review

Maryam Mooghali et al. BMC Med Inform Decis Mak. .

Abstract

Background: Artificial intelligence (AI) is increasingly used for prevention, diagnosis, monitoring, and treatment of cardiovascular diseases. Despite the potential for AI to improve care, ethical concerns and mistrust in AI-enabled healthcare exist among the public and medical community. Given the rapid and transformative recent growth of AI in cardiovascular care, to inform practice guidelines and regulatory policies that facilitate ethical and trustworthy use of AI in medicine, we conducted a literature review to identify key ethical and trust barriers and facilitators from patients' and healthcare providers' perspectives when using AI in cardiovascular care.

Methods: In this rapid literature review, we searched six bibliographic databases to identify publications discussing transparency, trust, or ethical concerns (outcomes of interest) associated with AI-based medical devices (interventions of interest) in the context of cardiovascular care from patients', caregivers', or healthcare providers' perspectives. The search was completed on May 24, 2022 and was not limited by date or study design.

Results: After reviewing 7,925 papers from six databases and 3,603 papers identified through citation chasing, 145 articles were included. Key ethical concerns included privacy, security, or confidentiality issues (n = 59, 40.7%); risk of healthcare inequity or disparity (n = 36, 24.8%); risk of patient harm (n = 24, 16.6%); accountability and responsibility concerns (n = 19, 13.1%); problematic informed consent and potential loss of patient autonomy (n = 17, 11.7%); and issues related to data ownership (n = 11, 7.6%). Major trust barriers included data privacy and security concerns, potential risk of patient harm, perceived lack of transparency about AI-enabled medical devices, concerns about AI replacing human aspects of care, concerns about prioritizing profits over patients' interests, and lack of robust evidence related to the accuracy and limitations of AI-based medical devices. Ethical and trust facilitators included ensuring data privacy and data validation, conducting clinical trials in diverse cohorts, providing appropriate training and resources to patients and healthcare providers and improving their engagement in different phases of AI implementation, and establishing further regulatory oversights.

Conclusion: This review revealed key ethical concerns and barriers and facilitators of trust in AI-enabled medical devices from patients' and healthcare providers' perspectives. Successful integration of AI into cardiovascular care necessitates implementation of mitigation strategies. These strategies should focus on enhanced regulatory oversight on the use of patient data and promoting transparency around the use of AI in patient care.

Keywords: Artificial intelligence; Ethics; Machine learning; Medical devices; Transparency; Trust.

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Conflict of interest statement

Dr. Mooghali currently receives research support through Yale University from Arnold Ventures outside of the submitted work. Mr. Stroud has no competing interests. Dr. Yoo has no competing interests. Dr. Barry currently receives research support through the Mayo Clinic Department of Cardiology from Anumana, Inc. Ms. Grimshaw has no competing interests. Dr Ross reported receiving grants from the US Food and Drug Administration; Johnson and Johnson; Medical Device Innovation Consortium; Agency for Healthcare Research and Quality; National Heart, Lung, and Blood Institute; and Arnold Ventures outside the submitted work. Dr. Ross was also an expert witness at the request of relator attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled in September 2022. Dr. Zhu offers scientific input to research studies through a contracted services agreement between Mayo Clinic and Exact Sciences Corporation outside of the submitted work. Dr. Miller reported receiving grants from the US Food & Drug Administration during the conduct of the study and receiving grants from Arnold Ventures, and Scientific American and serving on the board of the nonprofit Bioethics International, and as bioethics advisor at GalateoBio outside the submitted work.

Figures

Fig. 1
Fig. 1
Sample Construction Using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Diagram
Fig. 2
Fig. 2
Ethical Concerns and Mitigation Strategies for the Use of Artificial intelligence-based Medical Devices in Cardiovascular Care
Fig. 3
Fig. 3
Trust Barriers and Facilitators for the Use of Artificial intelligence-based Medical Devices in Cardiovascular Care
See this image and copyright information in PMC

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References

    1. Fogel AL, Kvedar JC. Artificial intelligence powers digital medicine. NPJ Digit Med. 2018;1:5. 10.1038/s41746-017-0012-2 - DOI - PMC - PubMed
    1. Benjamens S, Dhunnoo P, Meskó B. The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database. NPJ Digit Med. 2020;3:118. 10.1038/s41746-020-00324-0 - DOI - PMC - PubMed
    1. de Marvao A, Dawes TJ, Howard JP, O’Regan DP. Artificial intelligence and the cardiologist: what you need to know for 2020. Heart. 2020;106(5):399–400. 10.1136/heartjnl-2019-316033 - DOI - PMC - PubMed
    1. Ladejobi AO, Cruz J, Attia ZI, van Zyl M, Tri J, Lopez-Jimenez F, et al. Digital health innovation in cardiology. Cardiovasc Digit Health J. 2020;1(1):6–8. 10.1016/j.cvdhj.2020.07.003 - DOI - PMC - PubMed
    1. Centers for Disease Control and Prevention. Leading Causes of Death 2023 [Available from: https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm.

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