1. Introduction

Currently, we are experiencing the Fourth Industrial Revolution (4IR), also referred to as Industry 4.0. This revolution differs from all previous industrial revolutions as it blurs the lines between the digital, physical, and biological spheres, ushering in transformations of entire systems across governments, businesses, industries, and society as a whole, through the use of emerging technologies^[1]. One of the sectors impacted is the healthcare sector, as it is exposed to technological evolution, being affected by digitization, revolutionizing the entire way healthcare is delivered, from the interaction between patients and healthcare providers to governments and stakeholders^[1].

Through 4.0 technologies, changes are occurring in the organization and structure of healthcare systems. It is important to understand them as they enable new methods of treatment, diagnosis, and monitoring of patients' health status, changes in the management of healthcare institutions, and the way healthcare is accessed^[2]. There is no consensus in the literature on a definition of healthcare systems; these are clusters of complex elements that interact together to form an even more complex system, whose interactions affect the achievement of health system objectives. Regardless of these objectives varying between countries, in essence, they are similar, as the objective of any healthcare system is to improve the health of the population^[3].

2. Materials and Methods

The main objective of the present study focused on understanding the perception of a set of qualified stakeholders regarding the implementation of 4.0 technologies and the subsequent necessary government actions and benefits for citizens.

We established the following specific objectives: to ascertain the influence of Industry 4.0 on governmental action impacting healthcare and to understand the benefit of implementing 4.0 technologies in healthcare systems for citizens (Table 1).

We opted for an exploratory descriptive study with a qualitative approach, and semi-structured interviews were conducted with 70 national and international personalities and stakeholders in the healthcare sector from 33 different countries, covering all 7 continents, including healthcare professionals in leadership positions and managers (Table 2 and Table 3). The interview guide was based on the specific objectives of the study. The interviews took place from March 27, 2020, to November 2, 2020 (Figure 1).

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Figure 1. Framework for finding interviewees for the study.

One of the major limitations of the study was the difficulty in finding experts with sufficient knowledge about the impact of Industry 4.0 in the healthcare context at the time of data collection. This challenge potentially introduced a sampling bias that could affect the generalizability of our findings. To mitigate this, two approaches were taken with the interviewees. In the first approach, many respondents indicated that they did not have enough knowledge about Industry 4.0 to participate in the study. Therefore, in the second approach, we selected 70 respondents from 33 different countries who had sufficient knowledge about the impacts of Industry 4.0 in the healthcare sector (Figure 2).

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Figure 2. Framework for conducting interviews and data processing.

The diversity of participants across various countries was intended to enhance the generalizability of the results by incorporating a wide range of perspectives and experiences. During data analysis, we acknowledged the potential sampling bias by critically examining how the specific backgrounds and regions of our participants might influence the findings, and we interpreted the results within the context of this diverse yet specialized sample. Additionally, data saturation was considered when no new insights emerged from additional data, indicating that the sample size of 70 interviewees was sufficient for the scope of this study.

3. Results and Discussion

3.1 Results

Through the content analysis methodology from Bardin's perspective, categories were created for each of the questions in the script representing the respondents' perceptions, where the percentage values obtained are cumulative, as in some questions, the interviewees responded to multiple categories simultaneously (Table 4 and Figure 3).

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Figure 3. Government response and citizen benefits form Industry 4.0 in healthcare systems.

Regarding question one, it was possible to create two categories through content analysis:

3.1.1 Category (a) Governments are slowly keeping up with the rapid evolution of the industry 4.0 landscape in healthcare systems

Interviewees mention that governments are slowly keeping up with the rapid evolution of the industry 4.0 landscape in healthcare systems for several reasons. Many refer to a lack of strategic vision from the governments, as many of these governments are still in a 2.0 mindset concerning the implementation of technologies in healthcare systems, lagging behind technological changes.

Another frequently mentioned reason is the lack of investment in 4.0 technologies by governments in healthcare systems. It is unanimously concluded that although the initial costs are higher, the investment is substantially profitable in the long run. For this to happen, governments must initially fund 4.0 technologies, which can be somewhat problematic. Another reason interviewees mention is that governments still take overly conservative positions, preventing the alteration of the status quo of implementing 4.0 technologies in healthcare systems. According to the interviewees, this is mainly because laws and regulations created by governments do not follow or keep up with the introduction of innovation, and astute tech companies move faster than legislative and judicial systems can react.

3.1.2 Category (b) Governments are keeping up with the rapid evolution of the industry 4.0 landscape in healthcare systems

Interviewees mention that governments are keeping up with the rapid evolution of the industry 4.0 landscape in healthcare systems by encouraging the implementation of 4.0 technologies and modernizing governmental operations. The interviewees state that governments are adapting regulations to keep up with the change, supporting research funding, and allowing tech startups to facilitate collaboration with healthcare system institutions, aiding the introduction of 4.0 technologies. Interviewees also note that governments are modifying and adapting laws and regulations to keep up with changes, making them more flexible to test and implement various technological innovations. They also have a strategic 4.0 vision where these technologies are already part of the short and medium-term strategic plans to be implemented in healthcare systems. According to the interviewees, governments are aware of the importance and positive impact that the introduction and implementation of these technologies have on healthcare systems and are thus driving their introduction and implementation through strategies, legislation, and funding.

Regarding question two, it was also possible to create two categories through content analysis:

3.1.3 Category (a) More accessibility

Interviewees mention that the introduction of 4.0 technologies in healthcare systems brings greater accessibility to citizens. 4.0 technologies are changing the way citizens interact with healthcare systems, offering more efficient means, such as applications, chatbots, Big Data, and Blockchain, which enable faster contact and greater information exchange, exemplified by remote access to their health records. Interviewees mention that using technologies like devices and wearables connected through the Internet of Things (IoT) also facilitates access to healthcare for patients, as they can receive alerts, and professionals can get instant updates on their health status, allowing 24/7 remote monitoring and avoiding unnecessary trips to healthcare institutions. Interviewees state that with telemedicine, citizens' access to healthcare systems is also facilitated, reducing waiting lists and wait times for appointments at healthcare institutions, thus signaling emergency and non-emergency situations, alleviating hospitals, and breaking down many existing barriers to citizens' access to healthcare systems.

3.1.4 Category (b) More empowerment

Interviewees report that citizens are becoming more empowered through 4.0 technologies. Technologies like devices, wearables, and IoT allow citizens to have real-time and more accurate knowledge of their health status, making them integral parts of the healthcare delivery process. Through 4.0 technologies, data and information will be shared more quickly, allowing citizens to better manage their clinical information, improving their understanding of their health status, and aiding in decision-making processes. 4.0 technologies are also promoting health literacy among citizens. Interviewees mention that technologies like Artificial Intelligence (AI) and Machine Learning will allow citizens to self-diagnose through algorithm interpretation and interaction with these technologies. Generally, interviewees state that the Fourth Industrial Revolution is increasingly empowering citizens regarding their health status, leading to a better quality of life and making citizens happier and more productive in society.

3.2 Discussion

3.2.1 Government action

From the results of this study, it was observed that several governments are keeping up with the evolution of the Fourth Industrial Revolution (4IR) in their healthcare systems. Many governments are actively supporting the implementation of 4.0 technologies by modernizing operations and introducing policies that facilitate these advancements in healthcare. They are also fostering relationships with new stakeholders in the health and technology sectors, who previously held less influence in healthcare. These stakeholders now operate autonomously or in partnership with existing suppliers, creating value chains and strengthening government efforts in healthcare's digital transformation^[4-8].

The advent of 4.0 technologies is reshaping consumer interactions and altering traditional business models. These changes present fundamental challenges for regulators, such as balancing citizen protection, ensuring fair markets, and implementing regulations that also support the adoption of 4.0 technologies^[6-9]. The rapid development of these technologies has challenged the conventional approach of drafting regulations slowly and deliberately, which then remain in place for extended periods. Many existing regulatory frameworks are slow to adapt to socio-economic changes, and regulatory bodies often exhibit risk aversion. This need for quick adaptation creates substantial challenges for technology industries, where innovation happens at a fast pace^[8-11].

Numerous authors have noted various challenges that emerging technologies pose to traditional regulatory models. These challenges include coordination issues, regulatory silos, and an abundance of outdated rules^[8,11]. The swift pace of technological advancements has intensified the urgency for regulators to keep up, as digital products, services, and industries can expand rapidly. However, political cycles typically require five to twenty years to adjust to new developments, exacerbating the gap-often called the "pace problem"-between technological progress and regulatory frameworks^[12].

This gap is evident in healthcare, where the digital health dilemma is creating significant obstacles for regulators aiming to keep pace with technological innovation^[12].

From a regulatory standpoint, a major issue with emerging technologies is data ownership, given the vast amounts of data they generate. Without a unified global agreement on data protection, regulators worldwide have adopted different stances. Approximately 30% of nations lack data protection laws, and those that do often implement conflicting regulations. The European Union's General Data Protection Regulation (GDPR) prioritizes privacy, enforcing strict controls on cross-border data flows and granting citizens the right to "be forgotten." In contrast, the United States takes a sector-specific approach, relying on state laws that typically target industries such as healthcare^[13].

The healthcare sector is particularly affected by data regulation, as large-scale data and clinical information sharing enabled by 4.0 technologies demands a unique regulatory approach to ensure safe and effective implementation^[10,12]. Another significant regulatory challenge posed by 4.0 technologies is cybersecurity. Cyber threats are increasingly targeting healthcare, which is among the sectors most vulnerable to cyberattacks^[7-9]. Regulators must implement protective measures, as 4.0 technologies in healthcare continuously collect and analyze medical images, physiological data, lab results, and other sensitive information, raising critical concerns about patient data security^[6,14].

According to Eggers et al.(2018), policymakers and government regulators facing these regulatory challenges posed by 4.0 technologies should address four fundamental questions^[6] (Table 5).

Figure 4 represents how the four questions suggested by Eggers et al. (2018) regarding how regulators and policymakers should respond to the rapid changes brought by 4IR technologies at the regulatory level and their respective implementation phases^[6].

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Figure 4. Regulatory implementation phases regarding 4.0 technologies^[6].

3.2.2 Benefits of implementing 4.0 technologies in healthcare for citizens

The study results indicate that technologies from the Fourth Industrial Revolution are enhancing healthcare access and empowering citizens to manage their health.

Access can be defined as the ability or opportunity to reach or use a service^[15,16]. In healthcare, access typically refers to the opportunity or ease with which patients or communities can utilize appropriate services according to their needs^[9,15,16]. Thus, it encompasses the opportunity to obtain suitable health services, when necessary, shaped by individuals' characteristics, social and physical environments, and healthcare system features^[10,17,18].

4.0 technologies are expanding the reach of diagnostic, treatment, and follow-up interventions, thereby improving healthcare access^[7-9,19]. One of the significant challenges faced by healthcare systems is providing quality care to populations who lack access to specialized doctors due to geographic or socio-economic barriers^[20]. Remote healthcare enabled by 4.0 technologies has proven effective in overcoming these barriers, particularly for rural and remote communities, helping to close gaps for underserved populations and alleviate the shortage of specialty providers^[8,20].

Additionally, 4.0 technologies are enabling a new model of care: home hospitalization. In this model, patient homes are transformed into "smart homes" equipped with technology to monitor daily activities, collect health data, and share it with healthcare providers^[7-10,21]. These homes incorporate sensors and devices that enhance their functionality, adding intelligence, automation, and adaptability, ultimately improving residents' health and well-being and decentralizing healthcare^[9,22]. This approach is particularly important given the aging population, as it improves access to healthcare for older adults, reduces hospital admissions, and reserves hospital resources for emergencies^[8,21].

4.0 technologies also facilitate real-time sharing of clinical information and biodata between patients and providers, allowing information to be exchanged almost instantaneously. This real-time sharing supports immediate healthcare decisions and introduces an innovative way for patients to access healthcare, significantly reducing waiting lists^[8,9,22].

Modern healthcare systems are becoming more community-oriented, transcending organizational boundaries to facilitate knowledge sharing among clinicians, patients, and other stakeholders. While these technologies introduce challenges, they also present opportunities to strengthen connections across all aspects of healthcare operations from service delivery to management and patient relations ultimately enhancing communication and access^[8,9,23,24].

Patient empowerment is a growing concept, describing situations where patients are encouraged to take an active role in managing their health. This shift transforms the traditional patient-healthcare relationship, granting patients management capabilities that are now recognized as essential for improving healthcare quality^[8,25,26]. Gibson (1991) defines patient empowerment as helping citizens control factors affecting their health. Similarly, Calvillo et al. (2013) describe it as an ongoing partnership process between patients and healthcare systems^[27-29]. Laverack (2006) and Monteagudo and Gil (2009) emphasize that empowerment revolves around power. However, Anderson and Funnell (2010) and Page and Czuba (1999) argue that empowerment is more about responsibility, confidence, and control, as mere knowledge without application can leave individuals feeling powerless^[30,31].

Patient empowerment, as outlined in scientific literature, reflects patients' control over their health and their active involvement in healthcare^[26]. The World Health Organization (WHO) (2009) describes it as "a process through which people gain greater control over decisions and actions that affect their health." WHO emphasizes four key components of empowerment, which include patients understanding their role, gaining knowledge and skills from healthcare providers, participating in culturally responsive environments, and engaging actively^[30] (Table 6).

4.0 technologies play a fundamental role in promoting patient empowerment by supporting these WHO components. They provide mechanisms for citizens to access their clinical information, enabling informed decision-making about their health^[31]. These technologies also foster new connections between patients, users, and healthcare providers, facilitating virtual communities where users share information with peers. This peer-sharing promotes knowledge acquisition, enabling citizens to engage with each other and healthcare providers effectively^[7-9,32,33].

Finally, 4.0 technologies support tools and solutions for maintaining healthy habits, health education, chronic disease self-management, and the use of patient-controlled Personal Health Records. This fosters an empowering environment for patients^[7-9,25]. Infrastructure based on 4.0 technologies such as IoT integrated with devices, communication services, and delivery services offers an opportunity to promote active citizen participation in health management. These systems maximize information flow, facilitate personalized healthcare services, and empower citizens to participate in healthcare production. They create a network and service infrastructure that supports personalized, flexible, and secure services within a holistic ecosystem^[10,34,35].

4. Conclusion

This study highlights the crucial role that Industry 4.0 technologies play in transforming healthcare systems and empowering patients. Through a comprehensive analysis, two key categories emerged: the pace at which governments are adapting to the industry 4.0 landscape in healthcare systems, and the benefits these technologies bring to accessibility and patient empowerment.

The study reveals a dichotomy in governmental responses to the rapid evolution of Industry 4.0 technologies in healthcare systems. On one hand, some governments are lagging, hindered by outdated strategic visions, insufficient investment, and conservative regulatory stances. These governments remain entrenched in a 2.0 mindset, struggling to keep pace with technological advancements. On the other hand, several governments are proactively modernizing operations, adapting regulations, and supporting research and innovation. These forward-thinking governments recognize the substantial long-term benefits of investing in 4.0 technologies and are supporting integration through strategic planning, legislation, and funding.

The introduction of 4.0 technologies is significantly enhancing healthcare accessibility for citizens. Technologies such as IoT, wearables, telemedicine, and blockchain are revolutionizing the way citizens interact with healthcare systems, offering efficient and real-time access to health information and services. These advancements reduce barriers to care, particularly for remote and underserved populations, and alleviate pressures on healthcare institutions by enabling remote monitoring and telehealth services.

Furthermore, 4.0 technologies are empowering citizens by providing them with the tools and knowledge needed to actively participate in their health management. Real-time data sharing, health literacy through AI and machine learning, and the development of personal health records empower patients to make informed decisions about their health. This empowerment fosters a more collaborative relationship between patients and healthcare providers, leading to improved health outcomes and a higher quality of life.

The rapid development of 4.0 technologies presents significant challenges for traditional regulatory frameworks. The study highlights the need for agile and adaptive regulations that can keep pace with technological innovations. Issues such as data ownership, privacy, and cybersecurity are paramount, requiring coordinated global efforts to develop consistent and effective regulatory standards.

The integration of Industry 4.0 technologies into healthcare systems offers transformative opportunities to enhance accessibility, empower patients, and improve overall health outcomes. Governments that proactively adopt these technologies and modernize their regulatory frameworks will be better positioned to harness the full potential of the Fourth Industrial Revolution in healthcare. Future research could build on these findings by exploring specific strategies that governments, especially those lagging behind, can implement to overcome regulatory challenges. For instance, further investigation into how governments can establish adaptive regulatory frameworks that address data ownership, privacy, and cybersecurity concerns could provide valuable insights. Additionally, studies could focus on how emerging technologies like AI, blockchain, and IoT can be more seamlessly integrated into healthcare systems to ensure equity in access and empower patients globally.

By continuing to explore these areas, researchers and policymakers can ensure that the benefits of Industry 4.0 are maximized, driving innovation and improving healthcare outcomes worldwide.

Authors contribution

Melo e Castro JAGM: Article conception, design, analysis and interpretation of data.

Monteiro MHGCF: Article orientation and supervision.

Both authors wrote and approved the final manuscript.

Conflicts of interest

The authors declare no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Funding

None.

Copyright

© The Author(s) 2024.