Overview of AI regulation in healthcare: A comparative study of the EU and South Africa

Recent developments in the application of artificial intelligence (AI) in health care promise to solve many of the existing global problems in improving human health care and managing global legal challenges. In addition to machine learning techniques, artificial intelligence is currently being applied in health care in other forms, such as robotic systems. However, the artificial intelligence currently used in health care is not fully autonomous, given that health care professionals make the final decision. Therefore, the most prevalent legal issues relating to the application of artificial intelligence are patient safety, impact on patient-physician relationship, physician’s responsibility, the right to privacy, data protection, intellectual property protection, lack of proper regulation, algorithmic transparency and governance of artificial intelligence empowered health care. Hence, the aim of this research is to point out the possible legal consequences and challenges of regulation and control in the application of artificial intelligence in health care. The results of this paper confirm the potential of artificial intelligence to noticeably improve patient care and advance medical research, but the shortcomings of its implementation relate to a complex legal and ethical issue that remains to be resolved. In this regard, it is necessary to achieve a broad social consensus regarding the application of artificial intelligence in health care, and adopt legal frameworks that determine the conditions for its application.

The development of Artificial Intelligence (AI) in healthcare has had a significant impact on healthcare. AI in healthcare can provide more accurate diagnoses and interventions for patients. AI can predict, diagnose, and treat diseases, facilitate the maximum use of healthcare resources by integrating medical information, increase efficiency, and reduce overcrowding of healthcare resources. However, the application of AI in healthcare also faces challenges such as accountability, algorithmic security, and data privacy. This paper discusses the application of AI in healthcare and explores the challenges faced by AI, in-cluding accountability traceability, algorithmic safety, data security, and ethical issues, and makes targeted recommendations. This study provides an in-depth exploration of the application of AI in healthcare, helping to improve the accuracy and efficiency of AI ap-plications in healthcare, as well as providing necessary guidance and references for opti-mizing and enhancing AI technologies.

The purpose of the paper is to provide an overview of the issues related to artificial intelligence (AI) applications in the Indian healthcare sector and provide input to policymakers. A qualitative approach has been used in this study to identify government initiatives, opportunities, and challenges for applications of AI and suggest improvements in policy areas relevant to AI in healthcare. The study helps by providing comprehensive inputs for framing policy on AI in healthcare industry in India. The study also highlights that if the proper actions are taken to overcome the various challenges associated with applications of AI in healthcare sector in India by the government, then the healthcare sector will immensely benefit. This article has taken an attempt to provide inputs concerning to policy initiatives, challenges, and recommendations for improving the healthcare system of India using different applications of AI The purpose of the paper is to provide an overview of the issues related to artificial intelligence (AI) applications in the Indian healthcare sector and provide input to policymakers. A qualitative approach has been used in this study to identify government initiatives, opportunities, and challenges for applications of AI and suggest improvements in policy areas relevant to AI in healthcare. The India. The study also highlights that if the proper actions are taken to overcome the various challenges associated with applications of AI in healthcare sector in India by the government, then the healthcare sector will immensely benefit. This article has taken an attempt to provide inputs concerning to policy initiatives, challenges, and recommendations for improving the healthcare system of India using different applications of AI The purpose of the paper is to provide an overview of the issues related to artificial intelligence (AI) applications in the Indian healthcare sector and provide input to policymakers. A qualitative approach has been used in this study to identify government initiatives, opportunities, and challenges for applications of AI and suggest improvements in policy areas relevant to AI in healthcare. The study helps by providing comprehensive inputs for framing policy on AI in healthcare industry in India. The study also highlights that if the proper actions are taken to overcome the various challenges associated with applications of AI in healthcare sector in India by the government, then the healthcare sector will immensely benefit. This article has taken an attempt to provide inputs concerning to policy initiatives, challenges, and recommendations for improving the healthcare system of India using different applications of A The purpose of the paper is to provide an overview of the issues related to artificial intelligence (AI) applications in the Indian healthcare sector and provide input to policymakers. A qualitative approach has been used in this study to identify government initiatives, opportunities, and challenges for applications of AI and suggest improvements in policy areas relevant to AI in healthcare.

We would like to comment on "Artificial Intelligence in Senology -Where Do We Stand and What Are the Future Horizons?" (1). Artificial intelligence (AI), which includes deep learning, has brought interest owing to its feasibility to mimic human intelligence and further transform a number of activities and result in usefulness in industries as well as healthcare. AI-based image analysis in breast screening programs has demonstrated encouraging results in terms of reduction of workload and increasing sensitivity. ChatGPT as well as other natural language software have proven to be highly accurate in giving decisions, however, many issues with patient safety and legal requirements still require to be managed. The primary advantages of AI are the high speed and effectiveness in handling complicated works; nevertheless, there are certain drawbacks that had to be taken into concern, including cybersecurity, employment displacement in the healthcare industry, and stability of the system. AI is still in its early phase in the subject of senology, and there is still further opportunity for performance and dependability to be upgraded. For AI systems to be safe and effective in real-world usages, the systems must be responsibly trained using high-quality data and subjected to rigorous scientific review. To reduce hazards and maintain public confidence in emerging technologies, it will be necessary to strike a balance between AI promotion and control. Introduced in December 2023, the AI Act by the European Union is an important step in creating all-encompassing legal frameworks for AI governance as well as accountability. AI must be utilized in conjunction with human skill, empathy, and ethical considerations, even while the AI has the possibility to improve medical procedures and healthcare delivery. Achieving significant progress in senology and other medical sciences would require fusing the advantages of AI with human judgment and empathy. Sufficient research, cooperation, and regulatory monitoring are necessary for directing the conscientious and effective application of AI in healthcare and guaranteeing good consequences for both patients and healthcare providers. The importance of ethical considerations and human-machine collaboration in the development and application of AI in senology and healthcare in general have received little attention. A further interesting area of researching is the probability ethical conundrums that the application of AI in senology may exist. There are concerns over patient privacy and clinical safety, even while AI may help improve the effectiveness and accuracy of clinical procedures. The ethical concerns should be addressed to confirm that the AI application is ethical way and do not lead to violation of the patients' rights. Furthermore, lesson learnt from the clinical practitioners who have experience in using AI in their clinical practice will be useful. Topics that should be assessed include how the AI help perform clinical decision making and affect daily clinical workload. For example, in our area in Indochina, the use of AI in clinical senology is already implemented in some private clinical center. Some private hospital already offer the additionally service including AI decision making as an alternative option for the patient in selecting their ways of breast disease therapy (see example at https:// www.bumrungrad.com/th/health-blog/june-2022/using-ai-find-lung-disorders-and-breast-cancer). However, the technology is new and might be expensive and are currently limited used. The unofficial report from the private clinical setting claimed that the AI based breast radiology interpretation help early detect breast cancer in young female but there is still no publication on this issue in our area. Nevertheless, the derived data can further guide how the AI should be implemented in clinical senology practice. Accumulation of data from multi-setting about the advantages of using AI in clinical senology will help further better clinical care for the patients.

In recent years, the integration of artificial intelligence (AI) in healthcare has led to numerous groundbreaking applications that have transformed various aspects of medical practice. One of the primary areas where AI has made substantial contributions is in medical imaging analysis. By leveraging machine learning algorithms, AI systems can assist radiologists in interpreting medical images with greater accuracy and efficiency. AI-driven tools can detect subtle abnormalities, aid in early disease detection, and facilitate more precise diagnosis and treatment planning. Predictive analytics is another key application of AI in healthcare, wherein algorithms analyze vast amounts of patient data to forecast potential health outcomes and identify individuals at high risk of developing certain conditions. Additionally, the rise of virtual health assistants powered by AI has revolutionized patient care delivery by providing personalized and accessible healthcare services. These virtual assistants, often in the form of chatbots or voice-enabled interfaces, can interact with patients, answer medical queries, schedule appointments, and even provide medication reminders. Overall, the various applications of AI in healthcare, including medical imaging analysis, predictive analytics, personalized medicine, and virtual health assistants, have demonstrated significant potential in improving diagnostic accuracy, optimizing treatment plans, and enhancing patient care delivery. As these technologies continue to evolve and mature, they have the potential to revolutionize healthcare delivery and contribute to better health outcomes for individuals worldwide. This research paper contributes to the ongoing discourse surrounding the integration of AI in healthcare by providing a comprehensive overview of its advancements, challenges, and ethical considerations.

The integration of artificial intelligence (AI) in healthcare presents significant promise to enhance clinical procedures and patient outcomes. This research examines the setting, methodology, conclusions, and issues associated with AI in healthcare. The swift proliferation of digital health data, encompassing medical imaging and clinical records, has generated substantial prospects for AI applications. Artificial intelligence methodologies, including machine learning, natural language processing, and computer vision, facilitate the derivation of significant insights from intricate datasets, hence improving clinical decision-making. A thorough literature review examines the practical applications of AI, encompassing its roles in medical diagnostics, treatment planning, and patient outcome prediction. The report also examines ethical issues, data protection, and legal frameworks, which are crucial for the responsible application of AI in healthcare. The results illustrate AI's capacity to enhance diagnostic precision, facilitate administrative efficiency, and optimise resource distribution, resulting in tailored therapies and improved healthcare administration. Nonetheless, obstacles persist, such as data integrity, algorithm transparency, and ethical considerations, which must be resolved to guarantee the secure and efficient deployment of AI. Continuous research, cooperation between healthcare and AI experts, and the establishment of comprehensive regulatory frameworks are essential for optimising the advantages of AI while minimising hazards. This research highlights AI's capacity to transform healthcare, stressing the necessity for a multidisciplinary strategy to effectively harness its benefits and tackle the associated ethical and regulatory dilemmas.

BackgroundThe integration of artificial intelligence (AI) holds substantial potential to alter diagnostics and treatment in health care settings. However, public attitudes toward AI, including trust and risk perception, are key to its ethical and effective adoption. Despite growing interest, empirical research on the factors shaping public support for AI in health care (particularly in large-scale, representative contexts) remains limited.ObjectiveThis study aimed to investigate public attitudes toward AI in patient health care, focusing on how AI attributes (autonomy, costs, reliability, and transparency) shape perceptions of support, risk, and personalized care. In addition, it examines the moderating role of sociodemographic characteristics (gender, age, educational level, migration background, and subjective health status) in these evaluations. Our study offers novel insights into the relative importance of AI system characteristics for public attitudes and acceptance.MethodsWe conducted a factorial vignette experiment with a probability-based survey of 3030 participants from Germany’s general population. Respondents were presented with hypothetical scenarios involving AI applications in diagnosis and treatment in a hospital setting. Linear regression models assessed the relative influence of AI attributes on the dependent variables (support, risk perception, and personalized care), with additional subgroup analyses to explore heterogeneity by sociodemographic characteristics.ResultsMean values between 4.2 and 4.4 on a 1-7 scale indicate a generally neutral to slightly negative stance toward AI integration in terms of general support, risk perception, and personalized care expectations, with responses spanning the full scale from strong support to strong opposition. Among the 4 dimensions, reliability emerges as the most influential factor (percentage of explained variance [EV] of up to 10.5%). Respondents expect AI to not only prevent errors but also exceed current reliability standards while strongly disapproving of nontraceable systems (transparency is another important factor, percentage of EV of up to 4%). Costs and autonomy play a comparatively minor role (percentage of EVs of up to 1.5% and 1.3%), with preferences favoring collaborative AI systems over autonomous ones, and higher costs generally leading to rejection. Heterogeneity analysis reveals limited sociodemographic differences, with education and migration background influencing attitudes toward transparency and autonomy, and gender differences primarily affecting cost-related perceptions. Overall, attitudes do not substantially differ between AI applications in diagnosis versus treatment.ConclusionsOur study fills a critical research gap by identifying the key factors that shape public trust and acceptance of AI in health care, particularly reliability, transparency, and patient-centered approaches. Our findings provide evidence-based recommendations for policy makers, health care providers, and AI developers to enhance trust and accountability, key concerns often overlooked in system development and real-world applications. The study highlights the need for targeted policy and educational initiatives to support the responsible integration of AI in patient care.

Objectives The use of artificial intelligence (AI) in healthcare is a growing field of research and clinical application. The views of the general public, ie future healthcare users, need to be surveyed and interpreted so that researchers and the public have a shared understanding of the appropriate use of AI. Currently, there is only limited data on the public’s views. Methods An anonymous, quantitative questionnaire was administered as part of a public exhibition on AI. The questionnaire was based on previously validated questions designed to assess respondents’ views on the use of AI in healthcare. Brief demographic data were also collected. Results The population surveyed was more diverse and younger than the general UK population (65% white, 45% aged 18-29). Respondents were largely comfortable with the application of AI in healthcare: 80% felt positively about its use, 56% thought it would be safe. 70% did not feel that it would replace doctors, and most would not be happy for AI to make decisions without considering their feelings. Conclusions Our study shows that the population we surveyed, particularly young future healthcare users, are comfortable with the use of AI in healthcare, but do not see it as a replacement for doctors. Advances in knowledge This paper highlights views from the general public on the use of AI in healthcare, which is largely under researched.

The convergence of healthcare with the Internet of Things (IoT) and Artificial Intelligence (AI) is reshaping medical practice with promising enhanced data-driven insights, automated decision-making, and remote patient monitoring. It has the transformative potential of these technologies to revolutionize diagnosis, treatment, and patient care. This study aims to explore the integration of IoT and AI in healthcare, outlining their applications, benefits, challenges, and potential risks. By synthesizing existing literature, this study aims to provide insights into the current landscape of AI, IoT, and AIoT in healthcare, identify areas for future research and development, and establish a framework for the effective use of AI in health. A comprehensive literature review included indexed databases such as PubMed/Medline, Scopus, and Google Scholar. Key search terms related to IoT, AI, healthcare, and medicine were employed to identify relevant studies. Papers were screened based on their relevance to the specified themes, and eventually, a selected number of papers were methodically chosen for this review. The integration of IoT and AI in healthcare offers significant advancements, including remote patient monitoring, personalized medicine, and operational efficiency. Wearable sensors, cloud-based data storage, and AI-driven algorithms enable real-time data collection, disease diagnosis, and treatment planning. However, challenges such as data privacy, algorithmic bias, and regulatory compliance must be addressed to ensure responsible deployment of these technologies. Integrating IoT and AI in healthcare holds immense promise for improving patient outcomes and optimizing healthcare delivery. Despite challenges such as data privacy concerns and algorithmic biases, the transformative potential of these technologies cannot be overstated. Clear governance frameworks, transparent AI decision-making processes, and ethical considerations are essential to mitigate risks and harness the full benefits of IoT and AI in healthcare.

A study on the regulation of artificial intelligence (AI) in healthcare, includes a brief overview of the current state of use of AI in healthcare and its potential benefits and risks. The article summarizes the current regulations that exist for AI in healthcare, including any relevant laws, guidelines, and best practices, including information on regulatory bodies such as the FDA and HIPAA. The ethical considerations arising from the use of AI in healthcare, such as patient confidentiality and data security, bias in algorithms, and transparency in decision making, are given. Examples of AI in healthcare are given that illustrate the challenges and opportunities provided by the technology, including both successful and unsuccessful implementations. Future developments in AI and healthcare are described, including emerging technologies and trends, and predictions of how rules might evolve in response to these developments. Summarize and provide recommendations for addressing regulatory challenges related to AI in healthcare.

Purpose: This research aims to discuss how AI and machine learning can be used in healthcare, challenges associated with implementation and the ethics around the widespread adoption of AI in the health care ecosystem while understanding the regulations around the technology implementation. Methodology: By conducting qualitative analysis on various applications of AI and machine learning in health care and its impacts on patient care, the analysis summarizes the challenges and ethics associated with the implementation. Findings: Results indicate that in the last few years, the data collected in the healthcare industry has increased manifold. Some studies suggest that structured data is growing by 40% each year, unstructured data is growing by over 80% and global data produced is forty zettabytes (ZB) as of 2020. With the increased regulatory and compliance requirements, effective data governance is a mandate for industries like healthcare where there is greater focus on data privacy, data security and personal information protection. This rapid explosion of data and the need to ensure the data is available at the right time has led to increased adoption of artificial intelligence (AI) and machine learning solutions across healthcare organizations to gain meaningful insights from the data collected. These technologies are proving to transform many aspects of healthcare ecosystem from patient care to administrative functions. Unique contribution to theory, policy, and practice: Currently AI and machine learning are aiding providers and patients by improving the health outcomes, but further research is necessary to validate to ensure these technologies are complying the regulatory guidelines without comprising on the patient care and the ethics involved when it comes to patient security and privacy.

BackgroundWhile use of artificial intelligence (AI) in healthcare is increasing, little is known about how patients view healthcare AI. Characterizing patient attitudes and beliefs about healthcare AI and the factors that lead to these attitudes can help ensure patient values are in close alignment with the implementation of these new technologies.MethodsWe conducted 15 focus groups with adult patients who had a recent primary care visit at a large academic health center. Using modified grounded theory, focus-group data was analyzed for themes related to the formation of attitudes and beliefs about healthcare AI.ResultsWhen evaluating AI in healthcare, we found that patients draw on a variety of factors to contextualize these new technologies including previous experiences of illness, interactions with health systems and established health technologies, comfort with other information technology, and other personal experiences. We found that these experiences informed normative and cultural beliefs about the values and goals of healthcare technologies that patients applied when engaging with AI. The results of this study form the basis for a theoretical framework for understanding patient orientation to applications of AI in healthcare, highlighting a number of specific social, health, and technological experiences that will likely shape patient opinions about future healthcare AI applications.ConclusionsUnderstanding the basis of patient attitudes and beliefs about healthcare AI is a crucial first step in effective patient engagement and education. The theoretical framework we present provides a foundation for future studies examining patient opinions about applications of AI in healthcare.

This study focuses on the potential application of Artificial Intelligence (AI) in healthcare and hospitals to improve the quality of services for patients. The research objectives include the investigation of existing AI use cases in healthcare, exploration of potential areas in which AI can best be applied, and identification of the challenges to successful AI application. This research utilizes both primary and secondary data sources to investigate the potential of AI in healthcare and hospitals. The primary data is collected through published research papers, technical reports, and industry news to gain an understanding of the current state of AI applications in healthcare. The secondary data is gathered from expert opinions with experienced healthcare professionals such as physicians, hospital administrators, and IT experts to gain insights into existing use cases and potential applications of AI in healthcare and hospitals. The results of the study demonstrate that AI has a significant potential to deliver enhanced outcomes in various aspects of healthcare and hospitals, including diagnosis, treatment, and management. However, the successful integration of AI requires overcoming numerous challenges such as regulatory standardization, privacy protection, and data availability. To foster a positive development of AI in healthcare, it is recommended that healthcare organizations enhance their digital capabilities, enable secure data sharing and collaboration, and use AI tools to deliver a more comprehensive and personalized patient care experience.

BACKGROUND Artificial intelligence (AI) has potential to transform health care, but its successful implementation depends on the trust and acceptance of consumers and patients. Understanding the factors that influence attitudes toward AI is crucial for effective adoption. Despite AI’s growing integration into health care, consumer and patient acceptance remains a critical challenge. Research has largely focused on applications or attitudes, lacking a comprehensive analysis of how factors, such as demographics, personality traits, technology attitudes, and AI knowledge, affect and interact across different health care AI contexts. OBJECTIVE We aimed to investigate people’s trust in and acceptance of AI across health care use cases and determine how context and perceived risk affect individuals’ propensity to trust and accept AI in specific health care scenarios. METHODS We collected and analyzed web-based survey data from 1100 Finnish participants, presenting them with 8 AI use cases in health care: 5 (62%) noninvasive applications (eg, activity monitoring and mental health support) and 3 (38%) physical interventions (eg, AI-controlled robotic surgery). Respondents evaluated intention to use, trust, and willingness to trade off personal data for these use cases. Gradient boosted tree regression models were trained to predict responses based on 33 demographic-, personality-, and technology-related variables. To interpret the results of our predictive models, we used the Shapley additive explanations method, a game theory–based approach for explaining the output of machine learning models. It quantifies the contribution of each feature to individual predictions, allowing us to determine the relative importance of various demographic-, personality-, and technology-related factors and their interactions in shaping participants’ trust in and acceptance of AI in health care. RESULTS Consumer attitudes toward technology, technology use, and personality traits were the primary drivers of trust and intention to use AI in health care. Use cases were ranked by acceptance, with noninvasive monitors being the most preferred. However, the specific use case had less impact in general than expected. Nonlinear dependencies were observed, including an inverted <i>U</i>-shaped pattern in positivity toward AI based on self-reported AI knowledge. Certain personality traits, such as being more disorganized and careless, were associated with more positive attitudes toward AI in health care. Women seemed more cautious about AI applications in health care than men. CONCLUSIONS The findings highlight the complex interplay of factors influencing trust and acceptance of AI in health care. Consumer trust and intention to use AI in health care are driven by technology attitudes and use rather than specific use cases. AI service providers should consider demographic factors, personality traits, and technology attitudes when designing and implementing AI systems in health care. The study demonstrates the potential of using predictive AI models as decision-making tools for implementing and interacting with clients in health care AI applications.

The successful implementation of artificial intelligence (AI) in health care depends on its acceptance by key stakeholders, particularly patients, who are the primary beneficiaries of AI-driven outcomes. To survey hospital patients to investigate their trust, concerns, and preferences toward the use of AI in health care and diagnostics and to assess the sociodemographic factors associated with patient attitudes. This cross-sectional study developed and implemented an anonymous quantitative survey between February 1 and November 1, 2023, using a nonprobability sample at 74 hospitals in 43 countries. Participants included hospital patients 18 years of age or older who agreed with voluntary participation in the survey presented in 1 of 26 languages. Information sheets and paper surveys handed out by hospital staff and posted in conspicuous hospital locations. The primary outcome was participant responses to a 26-item instrument containing a general data section (8 items) and 3 dimensions (trust in AI, AI and diagnosis, preferences and concerns toward AI) with 6 items each. Subgroup analyses used cumulative link mixed and binary mixed-effects models. In total, 13 806 patients participated, including 8951 (64.8%) in the Global North and 4855 (35.2%) in the Global South. Their median (IQR) age was 48 (34-62) years, and 6973 (50.5%) were male. The survey results indicated a predominantly favorable general view of AI in health care, with 57.6% of respondents (7775 of 13 502) expressing a positive attitude. However, attitudes exhibited notable variation based on demographic characteristics, health status, and technological literacy. Female respondents (3511 of 6318 [55.6%]) exhibited fewer positive attitudes toward AI use in medicine than male respondents (4057 of 6864 [59.1%]), and participants with poorer health status exhibited fewer positive attitudes toward AI use in medicine (eg, 58 of 199 [29.2%] with rather negative views) than patients with very good health (eg, 134 of 2538 [5.3%] with rather negative views). Conversely, higher levels of AI knowledge and frequent use of technology devices were associated with more positive attitudes. Notably, fewer than half of the participants expressed positive attitudes regarding all items pertaining to trust in AI. The lowest level of trust was observed for the accuracy of AI in providing information regarding treatment responses (5637 of 13 480 respondents [41.8%] trusted AI). Patients preferred explainable AI (8816 of 12 563 [70.2%]) and physician-led decision-making (9222 of 12 652 [72.9%]), even if it meant slightly compromised accuracy. In this cross-sectional study of patient attitudes toward AI use in health care across 6 continents, findings indicated that tailored AI implementation strategies should take patient demographics, health status, and preferences for explainable AI and physician oversight into account.