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Artificial intelligence in health and bioethical implications: a systematic review

Abstract

The presence of artificial intelligence in healthcare is growing, helping in diagnosis and decision making. However, its application raises doubts, mostly related to ethics. This study aimed to identify its uses in health and its bioethical implications from a systematic literature review using the PRISMA guidelines. The ScienceDirect and Scopus databases were searched, using the descriptors “artificial intelligence,” “bioethics” and “health.” Works in English, published between 2017 and 2021 were considered, resulting in 102 articles found and, after applying the established criteria, 11 were selected. The studies reported on the bioethical principles of beneficence, non-maleficence, autonomy and justice, adding an element, explainability. Relationships were found between artificial intelligence in health and unpredictability, predictability, trust, physicians’ role, systems development, privacy, data security, financial and social aspects. Developers, healthcare professionals and patients must maximize the benefits and limit the risks of tools that use this technology.

Keywords
Health care; Machine learning; Big data; Ethics

Resumen

El uso de la inteligencia artificial en salud va en aumento por facilitar el diagnóstico y la toma de decisiones, pero sus implicaciones plantean dudas relacionadas con la ética. Esta revisión sistemática desde las directrices Prisma identificó los usos de la inteligencia artificial en salud y sus implicaciones bioéticas. Las búsquedas se realizaron en Science Direct y Scopus utilizando los descriptores “artificial intelligence”, “bioethics” y “health”. De los trabajos en inglés publicados entre 2017 y 2021, se obtuvo 102 artículos. Aplicados los criterios, quedaron 11. Los estudios abordaron los principios bioéticos de beneficencia, no maleficencia, autonomía y justicia, añadiendo el elemento explicabilidad. La inteligencia artificial se correlacionó con la imprevisibilidad, previsibilidad, confianza, papel de los médicos, desarrollo de sistemas, privacidad, seguridad de los datos y aspectos financieros y sociales. Los desarrolladores, los profesionales sanitarios y los pacientes deben maximizar los beneficios y limitar los riesgos que involucra esta tecnología.

Palabras clave
Atención a la salud; Aprendizaje automático; Macrodatos; Ética

Resumo

A presença de inteligência artificial na saúde vem crescendo, ajudando em diagnósticos e tomadas de decisão, mas suas implicações geram dúvidas relacionadas à ética. Esta revisão sistemática, baseada nas diretrizes Prisma, identificou os usos de inteligência artificial na saúde e suas implicações bioéticas. Foi realizada busca nas bases de dados Science Direct e Scopus usando os descritores “artificial intelligence”, “bioethics” e “health”. Trabalhos em inglês, publicados entre 2017 e 2021 foram considerados, resultando em 102 artigos. Após aplicação dos critérios estabelecidos, 11 foram selecionados. Os estudos discutiram os princípios bioéticos da beneficência, não maleficência, autonomia e justiça, adicionando o elemento explicabilidade. Inteligência artificial mostrou correlação com imprevisibilidade, previsibilidade, confiança, papel do médico, desenvolvimento de sistemas, privacidade, segurança de dados, e aspectos sociais e financeiros. Desenvolvedores, profissionais da saúde e pacientes devem maximizar os benefícios e limitar os riscos das ferramentas que usam essa tecnologia.

Palavras-chave
Atenção à saúde; Aprendizado de máquina; Big data; Ética

Artificial intelligence (AI) is being increasingly adopted in different areas. The term itself is difficult to define since this phenomenon depends on different factors 11. Holzinger A, Langs G, Denk H, Zatloukal K, Müller H. Causability and explainability of artificial intelligence in medicine. Wiley Interdiscip Rev Data Min Knowl Discov [Internet]. 2019 [acesso 5 nov 2021];9(4):e1312. DOI: 10.1002/widm.1312
https://doi.org/10.1002/widm.1312...
. However, despite the difficulty in defining it and its various concepts, the common understanding is that AI is associated with machines and computers to help humanity solve problems and facilitate work processes 22. Tai MCT. The impact of artificial intelligence on human society and bioethics. Tzu Chi Med J [Internet]. 2020 [acesso 5 nov 2021];32(4):339-43. DOI: 10.4103/tcmj.tcmj_71_20
https://doi.org/10.4103/tcmj.tcmj_71_20...
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AI systems work using complex algorithms and large datasets that generate conclusions, thus replacing human reasoning with routine analysis 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
. To achieve human-level intelligence, AI needs guidance as a model of reality 11. Holzinger A, Langs G, Denk H, Zatloukal K, Müller H. Causability and explainability of artificial intelligence in medicine. Wiley Interdiscip Rev Data Min Knowl Discov [Internet]. 2019 [acesso 5 nov 2021];9(4):e1312. DOI: 10.1002/widm.1312
https://doi.org/10.1002/widm.1312...
. Machine learning (ML) is an AI system that can learn from models and eventually become autonomous, making decisions and generating conclusions that were previously considered only within the competence of the human mind 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
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The expansion of computing for storing, managing, accessing and processing data through a network of remote servers—such as cloud storage—has led to the expansion of AI applications for healthcare 44. Wahl B, Cossy-Gantner A, Germann S, Schwalbe NR. Artificial intelligence (AI) and global health: how can AI contribute to health in resource-poor settings? BMJ Glob Heal [Internet]. 2018 [acesso 5 out 2021];3(4):e000798. DOI: 10.1136/bmjgh-2018-000798. AI and ML have the potential to revolutionize the provision of service in this health 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
. These technologies can be used in health informatics, which is the business that describes the acquisition, storage, retrieval and use of information to improve patient care by interactions with the system 44. Wahl B, Cossy-Gantner A, Germann S, Schwalbe NR. Artificial intelligence (AI) and global health: how can AI contribute to health in resource-poor settings? BMJ Glob Heal [Internet]. 2018 [acesso 5 out 2021];3(4):e000798. DOI: 10.1136/bmjgh-2018-000798. Big data tools, that is, the storage and analysis of voluminous data, such as those used in healthcare, can also be used in association with AI 55. Xafis V, Schaefer GO, Labude MK, Brassington I, Ballantyne A, Lim HY et al. An ethics framework for big data in health and research. Asian Bioeth Rev [Internet]. 2019 [acesso 5 nov 2021];11(3):227-254. DOI: 10.1007/s41649-019-00099-x.

AI has improved clinical diagnosis and decision-making performance in several domains of medical work 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
. In fact, these tools can help adapt public health programs, ensuring that relevant information is available for solid policy and decision making 44. Wahl B, Cossy-Gantner A, Germann S, Schwalbe NR. Artificial intelligence (AI) and global health: how can AI contribute to health in resource-poor settings? BMJ Glob Heal [Internet]. 2018 [acesso 5 out 2021];3(4):e000798. DOI: 10.1136/bmjgh-2018-000798. Automated medical imaging diagnosis is arguably the most successful domain of AI use in the medical field today. Many medical specialties, including radiology, ophthalmology, dermatology, and pathology, rely on image-based diagnoses 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
.

However, it is important to note that patients recognize and are beginning to address the many issues raised by AI applications in healthcare 77. Richardson JP, Smith C, Curtis S, et al. Patient apprehensions about the use of artificial intelligence in healthcare. NPJ Digit Med [Internet]. 2021 [acesso 5 nov 2021];4(1):140. DOI: 10.1038/s41746-021-00509-1
https://doi.org/10.1038/s41746-021-00509...
. These demands are legal, commercial, social and, mainly, ethical 88. World Health Organization. Ethics and governance of artificial intelligence for health [Internet]. Geneva: WHO Guidance; 2021 [acesso 4 nov 2021]. Disponível: https://bit.ly/3Ry4M8P
https://bit.ly/3Ry4M8P...
. Designing these systems and using them is not a merely technical challenge, as it requires attention to bioethical principles 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
.

Bioethics focuses on the relationship between living beings and, as AI emerges, humans must ethically engage with something that is not natural by itself, that is, with its own creation 22. Tai MCT. The impact of artificial intelligence on human society and bioethics. Tzu Chi Med J [Internet]. 2020 [acesso 5 nov 2021];32(4):339-43. DOI: 10.4103/tcmj.tcmj_71_20
https://doi.org/10.4103/tcmj.tcmj_71_20...
. Concerns about the potential loss of control in the human-AI relationship are growing, such as the extent to what AI can or should support medical decisions or even make them on its own 11. Holzinger A, Langs G, Denk H, Zatloukal K, Müller H. Causability and explainability of artificial intelligence in medicine. Wiley Interdiscip Rev Data Min Knowl Discov [Internet]. 2019 [acesso 5 nov 2021];9(4):e1312. DOI: 10.1002/widm.1312
https://doi.org/10.1002/widm.1312...
.

Although a key technology today, in many cases, it will be necessary to understand how a machine’s decision was made and to evaluate the explanation for such a choice 11. Holzinger A, Langs G, Denk H, Zatloukal K, Müller H. Causability and explainability of artificial intelligence in medicine. Wiley Interdiscip Rev Data Min Knowl Discov [Internet]. 2019 [acesso 5 nov 2021];9(4):e1312. DOI: 10.1002/widm.1312
https://doi.org/10.1002/widm.1312...
. As AI advances, bioethical frameworks need to be adapted to address the problems these systems may pose, just as the development of these technologies needs to be adapted to incorporate bioethical principles 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
. Thus, this study aimed to carry out a systematic literature review to identify the applications of artificial intelligence in health and its bioethical implications.

Method

This study is a systematic review conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA Statement) 99. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ [Internet]. 2009 [acesso 5 set 2021];339(7716):332-6. DOI: 10.1136/bmj.b2535. The Population, Intervention, Comparison, Outcome (PICO) strategy was used. This method is used in evidence-based practice and is recommended to structure the bibliographic search for evidence for reviews 1010. Santos CMDC, Pimenta CADM, Nobre MRC. A estratégia PICO para a construção da pergunta de pesquisa e busca de evidências. Rev Latinam Enferm [Internet]. 2007 [acesso 5 set 2021];15(3):508-11. DOI: 10.1590/S0104-11692007000300023. The PICO description used in this review is presented in Table 1 and was used to answer the question: what are the applications of artificial intelligence in health and its bioethical implications?

Table 1
Description of the PICO strategy

The search for articles was performed manually in the ScienceDirect and Scopus databases in October 2021. The health sciences descriptors (DeCS/MeSH) “artificial intelligence,” “bioethics” and “health” were used, interrelated by the Boolean locator ‘‘AND’’.

The following inclusion criteria were considered: scientific articles published between 2017 and 2021, in English and that had online access. Books, book chapters, theses, dissertations, papers presented and published at events, review articles and editorial notes were excluded.

For the first selection, the titles and abstracts of the articles were read. The selected articles were read in full, strictly observing the inclusion and exclusion criteria, verification of duplicity and if they met the research theme. The articles selected for review were systematized in a framework for the analysis of the results. The stages of selection and full reading of the articles were performed by three independent reviewers.

Results

In total, 102 articles were identified in the databases following the search criteria. Of these, 72 were found in the ScienceDirect database and 30 in Scopus. After reading the titles and abstracts, 86 articles were excluded due to not meeting the proposed subject. One article was excluded because it was a duplicate. Thus,15 potentially eligible articles were selected,of which 11 were selected after full reading. The selection procedure is shown in Figure 1.

Figure 1
Flowchart of the study selection process for the systematic review

Of the total selected publications, seven (63.64%) were accessed in ScienceDirect and four (36.36%) in Scopus. As for the publication year, seven (63.64%) of the articles were published in 2021, and one (9.09%) article was published each year for the remainder of the period included in the search, that is, between 2017 and 2020. In the analysis of the origin of the studies, most (45.45%) were developed in North America or in collaboration with institutions in that continent.

Regarding the type of study, most are cross-sectional studies (45.45%), but prospective studies (9.09%), case studies (9.09%) and descriptive studies (9.09%) were also found, as well as exploratory studies (9.09%), randomized clinical trials (9.09%) and a multidimensional approach study (9.09%).

Based on the 11 selected publications, a table was created to analyze the objectives, type of study, main results and conclusions (Table 2).

Table 2
Analysis of the objective, type of study, main results and conclusions of the selected publications

Discussion

Although new technologies that use AI hold great promise for healthcare, ethics and human rights must be at the center of their design, deployment and use 88. World Health Organization. Ethics and governance of artificial intelligence for health [Internet]. Geneva: WHO Guidance; 2021 [acesso 4 nov 2021]. Disponível: https://bit.ly/3Ry4M8P
https://bit.ly/3Ry4M8P...
. The incorporation of bioethical principles in the development of these technologies can help protect patient rights, minimize risks, establish responsibilities, and institute robust metrics to study their effectiveness and benefits 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
.

From this point of view, some studies selected in this review established a direct relation between their results and the principles of bioethics: beneficence, nonmaleficence, autonomy and justice 1414. Cawthorne D, Robbins-van Wynsberghe A. An ethical framework for the design, development, implementation, and assessment of drones used in public healthcare. Sci Eng Ethics [Internet]. 2020 [acesso 11 out 2022];26(5):2867-91. DOI: 10.1007/s11948-020-00233-1,2020. Spiegel JM, Ehrlich R, Yassi A, Riera F, Wilkinson J, Lockhart K et al. Using artificial intelligence for high-volume identification of silicosis and tuberculosis a bio-ethics approach. Ann Glob Heal [Internet]. 2021 [acesso 11 out 2022];87(1):58. DOI: 10.5334/aogh.3206
https://doi.org/10.5334/aogh.3206...
. Another principle considered in the ethics of AI is explainability, which deals with the understanding of tools that use this technology 1313. Lysaght T, Lim HY, Xafis V, Ngiam KY. AI-assisted decision-making in healthcare. Asian Bioeth Rev [Internet]. 2019 [acesso 11 out 2022];11(3):299-314. DOI: 10.1007/s41649-019-00096-0
https://doi.org/10.1007/s41649-019-00096...
,1414. Cawthorne D, Robbins-van Wynsberghe A. An ethical framework for the design, development, implementation, and assessment of drones used in public healthcare. Sci Eng Ethics [Internet]. 2020 [acesso 11 out 2022];26(5):2867-91. DOI: 10.1007/s11948-020-00233-1,1818. Martinho A, Kroesen M, Chorus C. A healthy debate: exploring the views of medical doctors on the ethics of artificial intelligence. Artif Intell Med [Internet]. 2021 [acesso 11 out 2022];121(October):102190. DOI: 10.1016/j.artmed.2021.102190
https://doi.org/10.1016/j.artmed.2021.10...
. The elaboration of these systems must consider the principles of beneficence, maintenance of values, responsibility and transparency—which comprises explainability 22. Tai MCT. The impact of artificial intelligence on human society and bioethics. Tzu Chi Med J [Internet]. 2020 [acesso 5 nov 2021];32(4):339-43. DOI: 10.4103/tcmj.tcmj_71_20
https://doi.org/10.4103/tcmj.tcmj_71_20...
.

Explainability is fundamental because the necessary and lasting trust can be built from it to promote the acceptance of AI with future users 11. Holzinger A, Langs G, Denk H, Zatloukal K, Müller H. Causability and explainability of artificial intelligence in medicine. Wiley Interdiscip Rev Data Min Knowl Discov [Internet]. 2019 [acesso 5 nov 2021];9(4):e1312. DOI: 10.1002/widm.1312
https://doi.org/10.1002/widm.1312...
. In one study, trust in the healthcare system and technology were the strongest and most consistent correlates of openness, concern, and perceived benefit 1515. Antes AL, Burrous S, Sisk BA, Schuelke MJ, Keune JD, DuBois JM. Exploring perceptions of healthcare technologies enabled by artificial intelligence: an online, scenario-based survey. BMC Med Inform Decis Mak [Internet]. 2021 acesso 11 out 2022];21(1):221. DOI: 10.1186/s12911-021-01586-8
https://doi.org/10.1186/s12911-021-01586...
. In another survey, participants felt uncomfortable relying solely on recommendations made by an AI tool, without being able to directly assess its rationale 77. Richardson JP, Smith C, Curtis S, et al. Patient apprehensions about the use of artificial intelligence in healthcare. NPJ Digit Med [Internet]. 2021 [acesso 5 nov 2021];4(1):140. DOI: 10.1038/s41746-021-00509-1
https://doi.org/10.1038/s41746-021-00509...
. Although systems are important in the decision-making process, experts must be able to understand and redo this process 11. Holzinger A, Langs G, Denk H, Zatloukal K, Müller H. Causability and explainability of artificial intelligence in medicine. Wiley Interdiscip Rev Data Min Knowl Discov [Internet]. 2019 [acesso 5 nov 2021];9(4):e1312. DOI: 10.1002/widm.1312
https://doi.org/10.1002/widm.1312...
.

Even experts in AI development cannot determine how inputs are transformed into outputs, that is, how a personal profile generates a decision 2121. Stahl BC, Andreou A, Brey P, Hatzakis T, Kirichenko A, Macnish K et al. Artificial intelligence for human flourishing: beyond principles for machine learning. J Bus Res [Internet]. 2021 [acesso 11 out 2022];124:374-88. DOI: 10.1016/j.jbusres.2020.11.030. Unpredictability in ML thus becomes the key to the discussion, as it is a method for automating data analysis using algorithms that iteratively identify patterns in data and learn from them 44. Wahl B, Cossy-Gantner A, Germann S, Schwalbe NR. Artificial intelligence (AI) and global health: how can AI contribute to health in resource-poor settings? BMJ Glob Heal [Internet]. 2018 [acesso 5 out 2021];3(4):e000798. DOI: 10.1136/bmjgh-2018-000798. The consequences are impossible to measure when the machine is programmed to learn by itself 2121. Stahl BC, Andreou A, Brey P, Hatzakis T, Kirichenko A, Macnish K et al. Artificial intelligence for human flourishing: beyond principles for machine learning. J Bus Res [Internet]. 2021 [acesso 11 out 2022];124:374-88. DOI: 10.1016/j.jbusres.2020.11.030.

What should machines be allowed to decide autonomously and who is responsible for the decision? There are no answers to these questions yet. For now, physicians must participate and understand AI, and then decide autonomously, though based on the AI recommendation 2121. Stahl BC, Andreou A, Brey P, Hatzakis T, Kirichenko A, Macnish K et al. Artificial intelligence for human flourishing: beyond principles for machine learning. J Bus Res [Internet]. 2021 [acesso 11 out 2022];124:374-88. DOI: 10.1016/j.jbusres.2020.11.030.

Like unpredictability, prediction is another relevant point discussed in AI. A tool capable of predicting the risk and prioritizing patients for the treatment of chronic kidney disease helped in the rapid identification of individuals in need of renal replacement 1717. Green JA, Ephraim PL, Hill-Briggs F, Browne T, Strigo TS, Hauer CL et al. Integrated digital health system tools to support decision making and treatment preparation in CKD: the PREPARE NOW Study. Kidney Med [Internet]. 2021 [acesso 11 out 2022];3(4):565-75.e1. DOI: 10.1016/j.xkme.2021.03.009
https://doi.org/10.1016/j.xkme.2021.03.0...
. Another study evaluated the reaction and decision of nurses about the practice of euthanasia in terminal patients using eye-tracking technology, bringing a division between rational and emotional decisions, demonstrating the effectiveness of the prediction model 1111. Fernandes DL, Siqueira-Batista R, Gomes AP, Souza CR, Costa IT, Cardoso FSL et al. Investigation of the visual attention role in clinical bioethics decision-making using machine learning algorithms. Procedia Comput Sci [Internet]. 2017 [acesso 11 out 2022];108:1165-74. DOI: 10.1016/j.procs.2017.05.032
https://doi.org/10.1016/j.procs.2017.05....
. Even when AI indicates treatments, health professionals and patients can make moral judgments that the program is uncapable of producing 1313. Lysaght T, Lim HY, Xafis V, Ngiam KY. AI-assisted decision-making in healthcare. Asian Bioeth Rev [Internet]. 2019 [acesso 11 out 2022];11(3):299-314. DOI: 10.1007/s41649-019-00096-0
https://doi.org/10.1007/s41649-019-00096...
.

Despite any indications made by the AI, the final decision regarding health must be made by a professional 1313. Lysaght T, Lim HY, Xafis V, Ngiam KY. AI-assisted decision-making in healthcare. Asian Bioeth Rev [Internet]. 2019 [acesso 11 out 2022];11(3):299-314. DOI: 10.1007/s41649-019-00096-0
https://doi.org/10.1007/s41649-019-00096...
. A study conducted on patients who had been in a primary care unit found that they believe that their physicians should protect them from harm resulting from AI errors, so that the final decision should rest with the physician and the health insurance company 77. Richardson JP, Smith C, Curtis S, et al. Patient apprehensions about the use of artificial intelligence in healthcare. NPJ Digit Med [Internet]. 2021 [acesso 5 nov 2021];4(1):140. DOI: 10.1038/s41746-021-00509-1
https://doi.org/10.1038/s41746-021-00509...
. In this regard and considering malpractice, insurance companies must be clear about coverage when decisions are made by AI systems, even if partially 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
.

AI in the healthcare context is likely to give physicians more time for other tasks, such as establishing direct contact with their patients 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
. However, AI may cause conflicts about the role of physicians, who must provide care while feeding the system with patient data for support and clinical research purposes 1313. Lysaght T, Lim HY, Xafis V, Ngiam KY. AI-assisted decision-making in healthcare. Asian Bioeth Rev [Internet]. 2019 [acesso 11 out 2022];11(3):299-314. DOI: 10.1007/s41649-019-00096-0
https://doi.org/10.1007/s41649-019-00096...
. As AI is implemented for specific clinical tasks, the roles of health professionals will continue to evolve since various AI modules will be incorporated into care 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
.

Professional integrity is one of the three main ethical values for big data in decision making since it encompasses responsibility for the patient, meaning medical training becomes central 1313. Lysaght T, Lim HY, Xafis V, Ngiam KY. AI-assisted decision-making in healthcare. Asian Bioeth Rev [Internet]. 2019 [acesso 11 out 2022];11(3):299-314. DOI: 10.1007/s41649-019-00096-0
https://doi.org/10.1007/s41649-019-00096...
. Physicians will need to adapt to their new roles as integrators and interpreters of information and as supporters of patients, and the medical education system will have to provide them with the necessary tools and methods 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
. AI tools are useful, but physicians have not been trained to understand them and, at the same time, their active participation in its development is vital 1818. Martinho A, Kroesen M, Chorus C. A healthy debate: exploring the views of medical doctors on the ethics of artificial intelligence. Artif Intell Med [Internet]. 2021 [acesso 11 out 2022];121(October):102190. DOI: 10.1016/j.artmed.2021.102190
https://doi.org/10.1016/j.artmed.2021.10...
.

To face the challenges, AI researchers and clinicians need to work together to prioritize and develop applications that meet crucial clinical needs 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
. Given the potential risk of causing harm, involving bioethicists in the design of these technologies is necessary 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
. Multidisciplinary and multisectoral collaborations will be needed to facilitate the development and deployment of AI applications in the medical field 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
.

Several datasets must be manipulated to develop AI tools, meaning this technology can only advance with the use of big data 55. Xafis V, Schaefer GO, Labude MK, Brassington I, Ballantyne A, Lim HY et al. An ethics framework for big data in health and research. Asian Bioeth Rev [Internet]. 2019 [acesso 5 nov 2021];11(3):227-254. DOI: 10.1007/s41649-019-00099-x. To develop and train algorithms, data from health records need to be accessed, and patients are not always aware that such information is being shared 1616. Batlle JC, Dreyer K, Allen B, Cook T, Roth CJ, Kitts AB et al. Data sharing of imaging in an evolving health care world: report of the ACR Data Sharing Workgroup, part 1: data ethics of privacy, consent, and anonymization. J Am Coll Radiol [Internet]. 2021 [acesso 11 out 2022];18(12):1646-54. DOI: 10.1016/j.jacr.2021.07.014
https://doi.org/10.1016/j.jacr.2021.07.0...
. This dilemma requires an in-depth study of these emerging technologies, and the evolution of bioethical principles of patient privacy and confidentiality 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
.

Discussions around the ethics of electronic health records and AI have primarily focused on privacy, confidentiality, data security, informed consent and data ownership; however, the relevance of each varies depending on differences in culture, literacy, relationships. patient-provider relationship, available infrastructure and the regulations of each country 44. Wahl B, Cossy-Gantner A, Germann S, Schwalbe NR. Artificial intelligence (AI) and global health: how can AI contribute to health in resource-poor settings? BMJ Glob Heal [Internet]. 2018 [acesso 5 out 2021];3(4):e000798. DOI: 10.1136/bmjgh-2018-000798.

Despite the many discussions about the ethics of big data in a variety of contexts, little guidance is available on what values are at stake and how decisions should be made in an increasingly complex healthcare and research environment 55. Xafis V, Schaefer GO, Labude MK, Brassington I, Ballantyne A, Lim HY et al. An ethics framework for big data in health and research. Asian Bioeth Rev [Internet]. 2019 [acesso 5 nov 2021];11(3):227-254. DOI: 10.1007/s41649-019-00099-x. Anonymity and patient privacy are essential to create trust, in addition to the need to list permission levels in the connections between health institution, data owner (patient) and related for-profit institutions (health plans, providers and treatment/exam partners) 1616. Batlle JC, Dreyer K, Allen B, Cook T, Roth CJ, Kitts AB et al. Data sharing of imaging in an evolving health care world: report of the ACR Data Sharing Workgroup, part 1: data ethics of privacy, consent, and anonymization. J Am Coll Radiol [Internet]. 2021 [acesso 11 out 2022];18(12):1646-54. DOI: 10.1016/j.jacr.2021.07.014
https://doi.org/10.1016/j.jacr.2021.07.0...
.

Several complex ethical issues arise when considering the use of big data and, therefore, an ethical framework to address them and guide actions is important 55. Xafis V, Schaefer GO, Labude MK, Brassington I, Ballantyne A, Lim HY et al. An ethics framework for big data in health and research. Asian Bioeth Rev [Internet]. 2019 [acesso 5 nov 2021];11(3):227-254. DOI: 10.1007/s41649-019-00099-x. Likewise, such ethical planning must be applied in other projects that involve AI in health, such as a structure to be used in all stages of obtaining drones in public health, involving ethical principles, human values, design standards and requirements 1414. Cawthorne D, Robbins-van Wynsberghe A. An ethical framework for the design, development, implementation, and assessment of drones used in public healthcare. Sci Eng Ethics [Internet]. 2020 [acesso 11 out 2022];26(5):2867-91. DOI: 10.1007/s11948-020-00233-1.

The role of big data and AI companies, a profit-oriented segment, is questioned given ethical implications in the organization of health 1818. Martinho A, Kroesen M, Chorus C. A healthy debate: exploring the views of medical doctors on the ethics of artificial intelligence. Artif Intell Med [Internet]. 2021 [acesso 11 out 2022];121(October):102190. DOI: 10.1016/j.artmed.2021.102190
https://doi.org/10.1016/j.artmed.2021.10...
. The sustainability of health systems is currently undermined by how health innovations are designed and brought to market undermines 1212. Silva HP, Lehoux P, Hagemeister N. Developing a tool to assess responsibility in health innovation: results from an international delphi study. Heal Policy Technol [Internet]. 2018 [acesso 11 out 2022];7(4):388-96. DOI: 10.1016/j.hlpt.2018.10.007
https://doi.org/10.1016/j.hlpt.2018.10.0...
. The financial aspects and the power concentrated in the owners of data and technologies seem to be more relevant than those related to equity, prejudice and inequalities 1818. Martinho A, Kroesen M, Chorus C. A healthy debate: exploring the views of medical doctors on the ethics of artificial intelligence. Artif Intell Med [Internet]. 2021 [acesso 11 out 2022];121(October):102190. DOI: 10.1016/j.artmed.2021.102190
https://doi.org/10.1016/j.artmed.2021.10...
.

Who will control or profit from the application of AI remains to be determined, so, the priority must be the balance between regulatory safeguards and market forces to ensure that patients benefit 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
. The creation of regulations is a fundamental point in the evolution of this topic 1818. Martinho A, Kroesen M, Chorus C. A healthy debate: exploring the views of medical doctors on the ethics of artificial intelligence. Artif Intell Med [Internet]. 2021 [acesso 11 out 2022];121(October):102190. DOI: 10.1016/j.artmed.2021.102190
https://doi.org/10.1016/j.artmed.2021.10...
.

Despite holding immense potential to correct human errors and improve care delivery, ML-based AI applications can also aggravate biases 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
. Patients are concerned that AI tools may reinforce existing biases, which can occur if a learning dataset is biased or developers unintentionally incorporate their own bias into an algorithm 77. Richardson JP, Smith C, Curtis S, et al. Patient apprehensions about the use of artificial intelligence in healthcare. NPJ Digit Med [Internet]. 2021 [acesso 5 nov 2021];4(1):140. DOI: 10.1038/s41746-021-00509-1
https://doi.org/10.1038/s41746-021-00509...
, which is already a possibility with CDSS AI algorithms 1313. Lysaght T, Lim HY, Xafis V, Ngiam KY. AI-assisted decision-making in healthcare. Asian Bioeth Rev [Internet]. 2019 [acesso 11 out 2022];11(3):299-314. DOI: 10.1007/s41649-019-00096-0
https://doi.org/10.1007/s41649-019-00096...
.

AI can be transformative in social aspects for public health in countries with few resources, because as these locations become more connected and create higher quality data, the ability of AI tools to address health challenges is likely to increase 44. Wahl B, Cossy-Gantner A, Germann S, Schwalbe NR. Artificial intelligence (AI) and global health: how can AI contribute to health in resource-poor settings? BMJ Glob Heal [Internet]. 2018 [acesso 5 out 2021];3(4):e000798. DOI: 10.1136/bmjgh-2018-000798.

Portability is another important aspect when discussing AI availability in remote locations, for example, more affordable and portable MRI scanners offer opportunities to address unmet health needs and inequities in remote and resource-limited settings 1919. Shen FX, Wolf SM, Bhavnani S, Deoni S, Elison JT, Fair D et al. Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings. Neuroimage [Internet]. 2021 [acesso 11 out 2022];238:118210. DOI: 10.1016/j.neuroimage.2021.118210. The infrastructure required in these environments demands substantial investments to be implemented, thus not always having the necessary access to upload large datasets to cloud systems 44. Wahl B, Cossy-Gantner A, Germann S, Schwalbe NR. Artificial intelligence (AI) and global health: how can AI contribute to health in resource-poor settings? BMJ Glob Heal [Internet]. 2018 [acesso 5 out 2021];3(4):e000798. DOI: 10.1136/bmjgh-2018-000798. In this case, data privacy and security regulations (local and international) and how to provide support and clinical referral in these communities located in remote locations become relevant 1919. Shen FX, Wolf SM, Bhavnani S, Deoni S, Elison JT, Fair D et al. Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings. Neuroimage [Internet]. 2021 [acesso 11 out 2022];238:118210. DOI: 10.1016/j.neuroimage.2021.118210.

In the study of AI in computer-assisted diagnosis, claims for compensation for mineworkers with occupational lung cancer were accelerated 2020. Spiegel JM, Ehrlich R, Yassi A, Riera F, Wilkinson J, Lockhart K et al. Using artificial intelligence for high-volume identification of silicosis and tuberculosis a bio-ethics approach. Ann Glob Heal [Internet]. 2021 [acesso 11 out 2022];87(1):58. DOI: 10.5334/aogh.3206
https://doi.org/10.5334/aogh.3206...
. Even with low demand for public and private investments and a high risk of disqualification of the tool in legal spheres, this approach provides a proven social benefit when ethical protocols and monitoring are part of the process from the beginning.

Two predictive AI technologies were better evaluated among older adults and individuals with lower digital literacy, demonstrating that relief for serious diseases such as heart attack and cancer, cases involving urgency, vulnerability and risk, can be accepted under a reliability premise 1515. Antes AL, Burrous S, Sisk BA, Schuelke MJ, Keune JD, DuBois JM. Exploring perceptions of healthcare technologies enabled by artificial intelligence: an online, scenario-based survey. BMC Med Inform Decis Mak [Internet]. 2021 acesso 11 out 2022];21(1):221. DOI: 10.1186/s12911-021-01586-8
https://doi.org/10.1186/s12911-021-01586...
.

While patients are generally excited about the possibility of AI improving their care, they are also concerned about the safety and oversight possibilities 77. Richardson JP, Smith C, Curtis S, et al. Patient apprehensions about the use of artificial intelligence in healthcare. NPJ Digit Med [Internet]. 2021 [acesso 5 nov 2021];4(1):140. DOI: 10.1038/s41746-021-00509-1
https://doi.org/10.1038/s41746-021-00509...
,1515. Antes AL, Burrous S, Sisk BA, Schuelke MJ, Keune JD, DuBois JM. Exploring perceptions of healthcare technologies enabled by artificial intelligence: an online, scenario-based survey. BMC Med Inform Decis Mak [Internet]. 2021 acesso 11 out 2022];21(1):221. DOI: 10.1186/s12911-021-01586-8
https://doi.org/10.1186/s12911-021-01586...
. Concerns that AI tools can increase healthcare costs and that such costs may be passed on to patients are also raised 77. Richardson JP, Smith C, Curtis S, et al. Patient apprehensions about the use of artificial intelligence in healthcare. NPJ Digit Med [Internet]. 2021 [acesso 5 nov 2021];4(1):140. DOI: 10.1038/s41746-021-00509-1
https://doi.org/10.1038/s41746-021-00509...
. However, since medical decisions are made by automated systems, cost-effectiveness and expense rationing can be prioritized 33. Nabi J. How bioethics can shape artificial intelligence and machine learning. Hastings Cent Rep [Internet]. 2018 [acesso 5 nov 2021];48(5):10-3. DOI: 10.1002/hast.895
https://doi.org/10.1002/hast.895...
.

The use of AI in clinical decision making is probably inevitable given the rising costs of healthcare 1313. Lysaght T, Lim HY, Xafis V, Ngiam KY. AI-assisted decision-making in healthcare. Asian Bioeth Rev [Internet]. 2019 [acesso 11 out 2022];11(3):299-314. DOI: 10.1007/s41649-019-00096-0
https://doi.org/10.1007/s41649-019-00096...
. Prospective studies will be able to better identify the weaknesses of AI models in heterogeneous clinical environments and indicate ways to integrate them into current clinical workflows 66. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng [Internet]. 2018 [acesso 5 nov 2021];2(10):719-731. DOI: 10.1038/s41551-018-0305-z
https://doi.org/10.1038/s41551-018-0305-...
. However, efforts to overcome technical challenges in AI deployment must be followed from the beginning by ethical aspects 2020. Spiegel JM, Ehrlich R, Yassi A, Riera F, Wilkinson J, Lockhart K et al. Using artificial intelligence for high-volume identification of silicosis and tuberculosis a bio-ethics approach. Ann Glob Heal [Internet]. 2021 [acesso 11 out 2022];87(1):58. DOI: 10.5334/aogh.3206
https://doi.org/10.5334/aogh.3206...
.

Corroborating the literature, evident benefits and risks in the use of AI in health exist. In order to maximize the benefits to the public interest and limit the threats, the World Health Organization proposes six principles for the use of AI and that focus on the topics addressed in this discussion, namely: 1) protecting human autonomy; 2) promoting well-being, security and the public interest; 3) ensuring transparency, explainability and intelligibility; 4) promoting responsibility and accountability; 5) ensuring inclusion and equity; and 6) promoting technologies that are responsive and sustainable 88. World Health Organization. Ethics and governance of artificial intelligence for health [Internet]. Geneva: WHO Guidance; 2021 [acesso 4 nov 2021]. Disponível: https://bit.ly/3Ry4M8P
https://bit.ly/3Ry4M8P...
.

Final considerations

Understanding AI in healthcare requires understanding its steps. Data feeding, development of algorithms, and decisions come out; in this process, the four principles of bioethics, added to those of explainability and human rights legislation, are the guarantor constructs of ethics in the process.

The guarantee of anonymity and consent for the use of data, without commercial purposes holding greater relevance in AI implementation, remain diverse and legally regionalized in research, diagnosis and treatment procedures. Transparency is, therefore, the main foundation in AI in healthcare and the questions are broader than the answers.

Understanding how decisions were programmed, taking them out of the black box of incomprehensible technology, is the central aspect. When the machine learns by itself, can the physician be held accountable for the decisions? Regulations need to evolve, both in defining responsibilities and in understanding and trusting the autonomy of these decisions generated by AI. Permissions for machines to decide on their own, based on their own learning, is an evolving concept, given that not even specialists in this development can foresee its consequences, both in terms of assertiveness and reliability, as well as in maintaining the initially defined use.

What can be said is that we are at a path of no return where all the issues raised in this article will need to be regulated considering access, privacy, social issues and justice, still being touched by interests of control, power and profitability.

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  • This study did not receive any specific funding from public, commercial or non-lucrative agencies.

Publication Dates

  • Publication in this collection
    05 Apr 2024
  • Date of issue
    2023

History

  • Received
    07 Apr 2023
  • Reviewed
    07 June 2023
  • Accepted
    10 Dec 2023
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E-mail: bioetica@portalmedico.org.br