Robot Assisted Surgery in the U.S.

Submitted on 4/11/2019 for SPM9239 – Responsible Innovation. Grade: 8/10.

Co-written with Angginta Ramdani Ibrahim and Bhavana Hulivahana.

Word count: 4900

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Abstract

The technological developments of surgical robots have enabled the implementation of Robot Assisted Surgery (RAS) that offers minimally invasive procedures to patients. Although it offers benefits such as lower blood loss and faster recovery time, RAS costs significantly higher compared to laparoscopy and conventional open surgery. The added robotic interface between the surgeon and the patient triggers social and ethical issues that calls for a more responsible approach to the development and implementation of the technology. The paper will delve on the responsible innovation challenges in the US: the current healthcare system, the interconnectedness of the actors, and future development of the technology. We use four dimensions of responsible innovation to analyze the responsibility of the surgical robots technology: anticipation, reflexivity, inclusiveness, and responsiveness. The relevant responsible innovation initiatives are identified and assessed according to the life cycle of medical devices introduced by KNAW. We found that responsible initiatives are present in all four phases, but improvements are still needed. In order to deliver the right care, hospital as the problem owner needs to implement a set of strategy. However, due to the limited power of hospital, other actors within the healthcare network also have to contribute to the improvement of the implementation of RAS and ensure its status as a responsible innovation.

1. Introduction

1.1 The case of Robot Assisted Surgery (RAS)

In general, there are three distinct surgical interventions: open surgery, laparoscopy, and Robot Assisted Surgery (RAS). Open surgery is a traditional type of surgery which is done by making a large open cut on the skin. It is more suitable for patients that are not healthy enough to be under anesthesia for long (Beaumont, n.d.). In 1989, laparoscopic cholecystectomy was introduced to the general surgery world (Kelly, 2008). Laparoscopic surgery is a minimally invasive surgery that uses small cuts in the skin to access the surgical region on the body (NHS, 2018). It has a number of benefits such as smaller scars, shorter recovery time, less discomfort, and lower risk of complications (Buia et al., 2015). The development of surgical robots started to address the increasing demand for greater precisionand safety in minimally invasive procedures (Ashrafian et al., 2017). In essence, a RAS involves one surgeon working behind seated robotic console and one surgeon/assistant that is responsible to position robotic ports, suture up incisions, and apply anaesthetic (Randell et al., 2017).

In 2000, Da Vinci, which is a RAS system developed by Intuitive, was approved by the Food and Drug Administration (FDA) for general laparoscopic surgery and made commercially available in the U.S.. The number of RASs performed worldwide by Da Vinci system has surpassed five million surgeries, with a 32% use of increase of use between 2017 and 2018 in the U.S. alone (Intuitive Inc., 2018). According to Lee et al. (2017), there was a decrease of 35.4% in open surgeries, a 3.5 fold increase in laparoscopic surgeries, and a 41.3 fold increase in robotic surgeries between 2004-2012. The study also found that robotic surgery was associated with the highest costs, without substantial outcome benefits over laparoscopic that provides better outcomes and lower costs than open surgery. The increasing adoption of robotics in healthcare has triggered ethical questions and ignited an attempt to incorporate the framework of responsible innovation into the development of the technology (Stahl & Coeckelbergh, 2016). It is particularly important to ensure that the implementation and further development of RAS can be sustained as a responsible innovation.

In this paper, we attempt to answer the following questions:

Main research question:How can Robot Assisted Surgeries in the U.S. be conducted more responsibly by integrating the four dimensions of Responsible Innovation?

Sub research question 1:What are the responsible innovation challenges associated with RAS in regards to the system, stakeholders, and technological development?

Sub research question 2: What strategies can be implemented to improve aspects related to RAS? 

1.2 Responsible Innovation

Innovation holds an important role in society by providing solutions. On the other hand, we have to acknowledge that innovation will not only result in intended outcome but also negative implications that can create more problems that will subsequently demand for additional innovation – resulting in an unending loop. This situation creates responsibilityfor scientists and engineers, where they are not only expected to develop innovation in a closed environment, but to open it and to exercise their train-of-thoughts about the ripple effects that can impact society: to conduct and develop responsible innovation.

Multiple studies have attempted to provide definitions for Responsible Innovation. Von Schomberg (2013) proposed a definition that highlighted the interactions between actors throughout the innovation process, whereas Stilgoe et al. (2013) offered a far more concise definition that focused on ‘collective stewardship’ of innovation. The two definitions emphasized the need to conduct the innovation process in such a way that involves stakeholders in order to achieve the intended outcome.  However, we find the need to acknowledge the innovation process as a clear example of the problem of many hands, where the gap in the distribution of responsibility may be considered as morally problematic (van de Poel et al., 2012). For instance, the medical innovations that are developed and deployed in society demands the government to create new regulations and pushes healthcare providers to change its routine. The interconnectedness of the actor throughout the development and implementation of the technology might create problems in ascribing responsibility over medical incidents. Therefore, we propose the following definition of responsible innovation:

Responsible innovation is a continuous process that iterates throughout the life stages of the innovation and demands all stakeholders to be alert to the implications of technology and act according to their capacity in order to ensure the achievement of the intended outcome of an innovation.

2. Responsible Innovation Challenges

In this section, we identified the responsible innovation challenges that relate to the development of surgical robots in the U.S.: the current condition of the U.S. healthcare system, the interconnectedness of actors within the healthcare network, and the future development of the technology.

2.1 The U.S. Healthcare System

The U.S. ranks last in healthcare performance when being compared to other 10 high-income countries, and it is the only country among the developed nations without universal health insurance coverage (Schneider et al., 2017). High healthcare costs and inadequate healthcare insurance are cited as the reasons behind 66.5% of Americans filing for personal bankruptcy (Himmelstein et al., 2019). On top of that, about one-third of all healthcare spending goes to waste due to the fragmented system that delivers unnecessary care (IOM, 2013). Considering the existing problems within the U.S. healthcare system, the introduction of an expensive state-of-the-art technology such as RAS will pose additional challenges to the government’s responsibility in ensuring quality healthcare for its citizens.

2.2 Stakeholders within the healthcare system

Before analyzing the stakeholders involved within the healthcare system, it is important to acknowledge the fundamental purpose of healthcare: enhancing the quality of life by enhancing health. Elshaug et al. (2017) highlighted the importance of achieving the right care, which is defined as “care that is tailored for optimizing health and wellbeing by delivering what is needed, wanted, clinically effective, affordable, equitable, and responsible in its use of resources” (p. 192). The healthcare system consists of various actors, and in regards to the analysis of RAS, we classify them based on their roles when interacting with the technology: technology users, technology developers, technology regulators, and others (Quist, 2018).

As a healthcare provider, the hospital is responsiblein delivering theright careto patients through the sensible use of treatments. The interdependencies between hospitals, surgeons, and patients is apparent in the case of RAS. The decision to adopt surgical robotic system is largely led by surgeons (Randell et al., 2017). Owning a surgical robot is also seen as a way for hospitals to attract surgeons (Murphy et al., 2009; Bennett, 2012) and patients (Lee, 2014). However, the decision to adopt the expensive surgical robotic system might harm the hospital’s financial performance in the long term: with an initial cost of investment between $1.5 to $2.5 million, it is estimated that the hospital needs to perform 150-310 procedures within six years to offset capital and operational costs (Scott, 2016). This might lead to circumstances where RAS is performed as an unnecessary treatment (Barbash & Glied, 2010) that deviates from the pursuance of the right care.

The technology developers (e.g. Intuitive) interact closely with technology users in the development and implementation of the surgical robot. For instance, the development of haptic feedback in a surgical robots was done to address surgeons’ concerns (Okamura, 2009). The manufacturers also encourage surgeons to participate in trainings and provide certifications (FDA, 2013). However, the system has only been approved for a limited set of low-risk surgeries (Robotic Oncology, n.d.), and FDA (2019) has strictly warned against the U.S. of surgical robots for cancer treatment. The policy guidelines and regulations for RAS are set by the government and must be abided by manufacturers and hospitals.

In this analysis, we classified health insurers as ‘other’actor that holds a crucial role as the financier for RAS procedures. In the U.S., there are two health insurance providers: the government and private insurers (DFPE, 2016). RAS is categorized as a minimally invasive surgery that is covered by any insurance company. However, the coverage depends on the patient’s plans and benefits package (Gwinnett Medical Center, n.d.). As the diffusion of RAS continues, the higher hospital costs will be harder to bear, and will eventually be transferred to patients in the form of higher insurance premiums (Sheetz & Dimic, 2019). This highlights the issue of affordabilityandaccessibilityof RAS to the patients, which subsequently creates another challenge within the U.S. healthcare system.

 2.2.1 Problem Owner

Based on the stakeholder analysis, we recognized the hospital as the problem owner in the case of RAS. The hospital is at the center of the healthcare network since it is linked to all the other stakeholders. The adoption of RAS is perceived as a new marketing tool for the hospital and a strategy to retain surgeons and patients, which shows deviance from its main objective in the delivery of care. Nevertheless, cost is a major issue for the hospitals. Apart from the high investment costs, hospitals must also manage subsequent operational costs related to the implementation of the technology. The conflicts put the hospital in a problematic situation, because it is not only responsible to overcome the financial issues that comes along with making major decisions concerning the adoption of RAS, but also to abide to the government and the regulators, provide feedback to manufacturers, make arrangements with insurers, and simultaneously ensure the goodwillof the patients.

2.3 Future development of technology

Fig 1. Level of robot autonomy in RAS

Robot autonomy refers to the level of automation in surgical tasks completed by robots (Yip et al., 2017). There are four levels of robot autonomy: direct control, shared control, supervised autonomy, and full autonomy (Yip et al., 2017). Currently, RAS performs semi-automatically and needs direct control from the surgeons by teleoperating the robotic manipulators. Shared control is the next level of the surgical procedure in which the tools are operated by both human and robot, followed by supervised autonomy, in which robots execute the tasks under supervision of the surgeons (Yip et al., 2017). The ultimate future goal is to allow robots to perform full autonomy without surgeons (Yip et al., 2017). This can be used, for instance, to allow robotic surgeon to perform tele-surgery and more complex surgery. This automation can be done by using Artificial Intelligence (AI) that can help reduce variations of surgeons’ skills and improve patient outcomes with its accuracy and data monitoring (Britt, 2018). In 2018, there were early trials to incorporate AI with RAS which are expected to be more developed in the coming future (Britt, 2018). It was argued that AI automation in RAS can expose patients to higher riskbecause the variability in human autonomymakes it really difficult to completely automate without a surgeon (Orady, 2017). The stakeholders need to take future technological development into account in order to ensure the responsibility of the innovation.

3. Analysis

To analyse the responsibility of RAS, we use the four dimensions of responsible innovation: anticipation, reflexivity, inclusiveness, and responsiveness,as the basis to dig deeper on the values as well as the corresponding social and ethical issues related to the development of RAS.

3.1 Four dimensions of responsible innovation

3.1.1 Anticipation

In Responsible Innovation,anticipationdimension explores epistemological possibilities of future impacts and risks of the innovation into the design process, so that the innovation can be more receptiveand robust(Stilgoe et al, 2013). The most important ethical consideration that needs to be anticipated before implementing any kind of technology, including surgical technology, is the safety of the users (Strong et al., 2019).

In the U.S., between 2000-2013, there were 8,061 cases of device malfunction, which contributes to 75.9% of all RAS procedures (10,624 occurrences) (Alemzadeh et al, 2016). Together with other causes, device malfunction leads to 1,391 injuries or 13.1% of all RAS procedures (Alemzadeh et al., 2016). Comparing the number of deaths, open and laparoscopic surgery have lower rate of deaths, 0.82% and 0.22% respectively, compared to RAS that is 1.4% (Rausa et al., 2016). These conditions call for the emphasize of anticipationin the implementation of RAS. The mistakes made by surgical team such as the failure in manipulating the tools, inadequate coordination between hand and foot, incorrect connections of port and cable, and inadequate troubleshooting for technical problems (Alemzadeh et al., 2016), were caused by unclear communicationwithin the team and the inadequate trainingfor the surgeons. This fact does not satisfy FDA’s encouragement for the surgeons to have appropriate credentials in performing different robotic procedures by ensuring proper training (FDA, 2019). These issues show the failure to recognize and anticipate the possible riskslinked to RAS, which could be prevented if the actors adopt a more anticipatory attitude.

3.1.2 Reflexivity

Responsible innovation has to reflect on the value systems by taking into account the actors and institutions (Stilgoe et al, 2013). Reflexivity, in terms of institutional practice, means reflecting on activities and commitments while being awareof the knowledge limitation (Stilgoe et al., 2013). Since RAS is categorized as a biomedical technology,we will depart from Beauchamp & Childress (2001) principlismto assess reflexivity.This principlism is a popular approach in the commitments of biomedical ethics that refers to four basic moral values: autonomy, beneficence, non-maleficence,andjustice.

• Autonomy

In the field of healthcare, autonomyis translated into the principle of informed consent, where the patient has the right to decide what to do with his/her body after being fully informed with all the risks and uncertainty associated with the procedure. Obtaining a valid informed consentin the medical procedure is needed to ensure that the patients have sufficient understanding of the procedure. However, acquiring the correct informed consentin RAS is complicated due to the difficulty in explaining the complex procedure in a comprehensive way to the patients (Ferrarese et al., 2016). Informed consentfor RAS is very different from informed consentin other areas in medical care as it requires a high level of trustfrom the patients, not only to the surgeons (Angelos, 2014), but also to the robot.Ferrarese (2016) argued the procedure of RAS’informed consent needs to be improved by integrating the information already present in the informed consent (e.g. type of disease, causes, consequences, proposed techniques, and related risks) with the data of the experience of the surgical team in performing RAS (e.g. the number of procedures and expertise regional map).

• Beneficence

In the context of RAS,beneficenceprinciple can be defined as an act to serve the patients in such a way that givebenefits.To realize this, the actors should ensure the quality of the healthcare systems. Currently, a RAS procedure requires at least two surgeons: one sitting behind the console and is in charge of controlling the robotic arms, and one surgeon as a bedside assistant that is responsible in assisting the surgeon throughout the operation (Randell et al., 2017). For hospitals with limited human resources, this setting underutilized a surgeon that could actually perform another surgery on another patient. From a utilitarian point of view, this could mean that the implementation of the technology fails to create a greater benefit to a greater number of people.

• Nonmaleficence

Nonmaleficence principle can be defined as an act to avoid error-induced harm and undesirable consequences in serving the patients. Due to the fact that there were still some cases in which the surgeons failed to perform RAS because of technical malfunctions and/or human mistakes, it is clear that this principle has not been fully realized. Moreover, due to the degree of innovativeness of RAS, the entirerisk and uncertaintyof the procedures are not yet known, which create conflicts where the harms and benefits have to be thoroughly informed to the patient.

• Justice

In the case of RAS, justicecan be observed in the non-equal distribution of “power”between healthcare providers and patients: the discrepancy of medical knowledge that will affect the decision-making process. Currently, the FDA is concerned that the patients may have limited knowledge and may not be aware of thesafety and effectivenessof RAS devices (FDA, 2019). Complications could happen when the patients are not properly equipped with the knowledge and they just agreed with the doctor’s advice, which could lead to injuries during robotic surgery. For instance, there was the case of Featherstone, a patient who followed her doctor’s advice and put all her faith in the doctor without being critical of the RAS procedure (Siegel et al., 2018). The procedure was performed and it resulted in both colon and ureter injuries (Siegel et al., 2018). Thus, the educational process of the patients needs to be improved so that they can fully understand RAS and have the power to decide the best medical treatment for them.

In addition, the equal andfair distribution of benefits, risks, and costs among the actors also represent the value ofjustice.Yip et al. (2017) identified an extended set of entities that are culpable in the case of surgical errors, including technology developers and insurers. Thus, accountabilityneeds to be fairly distributed. In the case of surgeons’ failure in performing RAS, it is not only the first operator who is being held accountable,but also the expert surgeon who teaches the less-expert colleague about the procedure (Ferrarese et al., 2016). The ambiguityand complexityof RAS procedure blurs the line between the surgeons and the robots, which might result in avoidance of admitting the errors, and instead ascribing the responsibility to other entities.

3.1.3 Inclusiveness

Theinclusiveness dimension of responsible innovation is about listening continuously to diverse stakeholders and deliberating over their concerns and desiresabout the innovation (Stilgoe et al, 2013). The continuous technological development of surgical robot stems from the feedback from surgeons as the main users (Lee et al., 2005; Kanji et al., 2011; Alasari & Min, 2012, Kirschniak, 2016). However, in the implementation stage, we still found issues related to affordabilityandaccessibility.

The utilization of robots in surgery results in significantly higher cost of procedures. For instance, RAS in gynecologic procedures resulted in cost increase that ranges from $1446 to $2667 when compared to laparoscopy and open surgery (van Dam et al., 2011). It is important to note that high cost is the primary reason why Americans have problems in accessing healthcare (DPE, 2016). When we combine this with the problematic U.S. healthcare landscape, it is natural to question and whether public can really afford RAS or not. This shows a lack of inclusiveness as RAS can only be afforded exclusively by high-income people. This brings us to the second social issue: accessibility. If RAS will be available only to a small portion of the population that can afford it, then it would raise questions about the government’s ability in ensuring equal accessto safe and qualitycarethat can benefit the entire population. However, we should again look at the price tag that will come with an ensured accessibility of RAS. In the U.S., RAS is projected to generate additional annual healthcare cost of $2.5 billion when being fully substituted for conventional surgery (Barbash & Glied, 2010).

3.1.4 Responsiveness

Responsivenessis about how to react to respond to stakeholders, public values, and changing circumstances (Stilgoe et al., 2013). The implementation of RAS can improvehuman welfarebecause it provides thedynamicsolution to deal with challenges and needs in the medical field, which could improve public health. It answers the increasing demand for greaterprecisionandsafety(Ashrafian et al., 2017) that cannot be done by limitedhuman capability. It also provides faster recovery and shorter hospital stays (Lawinjury, 2017). The current technological development of RAS (e.g., the implementation of AI, autonomous robot, etc.) can be seen as a response to answer social needs by utilizing new insights and development of the latest technology. For instance, the development of tele-surgery or Trauma Pod using robotic system enables surgeons to remotely help patients in different geographical places. Although this advanced development is very risky, it is useful for the patients in the remote, extreme, and dangerous areas (George et al., 2018).

3.2 Relevant responsible innovation initiatives

In order to assess the existing responsible initiatives surrounding RAS in the U.S., we will use the four phases in the medical device life cycle as introduced by KNAW (2014): (1) from idea to product, (2) experimental use in practice, (3) uptake in regular care, and (4) long-term implementation and reimbursement. The four discrete phases help us to figure out which stakeholders are involved in which stage and to assess the relevant initiatives. We intend to take a step back from the problem of many hands and utilize a consequentialist view that is suited for distributing responsibilities in a technology development (Doorn, 2012).

3.2.1 From idea to product

It is important for the stakeholders to apply the consequentialist perspective in order to develop the “right” technology during the design phase (Doorn, 2012). The most crucial stakeholders in this phase are the technology developers and health care providers as the co-developer of the technology. Intuitive, as a technology developer, exhibits inclusivenessthrough the arrangement of collaborative research initiatives with hospitals, clinicians, and surgical societies in order to support high-quality clinical evidence showing the values of the technology. The inclusion of technology users is able to improve the level of anticipation that subsequently translates into the development of features that can better accommodate the procedures and prevent adverse events.

3.2.2 Experimental use in practice

The transition between the first and second phase is a certification that allows for market access (KNAW, 2014). In the U.S., a new medical technology requires Pre-Market Approval (PMA) from the FDA. However, in practice, PMA is often replaced by the more flexible 510(k) procedure that grants approval based on the principle of equivalence to existing medical devices in the market (Britton, 2016). In fact, Intuitive’s surgical robot was approved by the FDA in 2000 through the 510(k) procedure by proving equivalency with laparoscopy (Jones, 2000). In contrast to PMA, human-subject clinical trials for safety and effectiveness are typically not required (Johnson, 2012). This raises concern in regards to the safety of the technology and question whether or not FDA has adequately embed anticipation and fully exercise its forward-looking responsibility.

3.2.3 Uptake in regular care

The transition between the second and third phase is the gradual dissemination of devices into regular care, the activity that mostly relies on the hospitals and healthcare professionals (KNAW, 2014). The technology users hold a vital role in the uptake of RAS in regular care through the decision-making chain. The Hospital decides on the acquisition of the technology, surgeon decides on introducing RAS to the patient, and the patient makes the final call of opting for the procedure. However, we should acknowledge that Intuitive plays an important role behind the rapid diffusion of surgical robots in the U.S. The company implements extensive marketing efforts that target all three technology users: hospitals, surgeons, and patients (Greenberg, 2013). This situation calls for the involvement of technology regulators to monitor the interdependencies of the actors within the healthcare system and intervene when necessary. It is also important for each actor to exercise reflexivityin order to ensure its contribution to the delivery of the right care to the society.

3.2.4 Long-term implementation and reimbursement

The long-term implementation of RAS is facilitated by hospitals, which need certainty of the reimbursement of the procedure. One example of relevant initiative is the Health Technology Assessment (HTA), which is useful in informing reimbursement and coverage decisions by insurers (Whyte & Hall, 2013). Currently, the U.S. is the only industrialized nation without an organized national HTA program, which can be attributed to the lack of a national healthcare system (Haas & Moskowitz, 2007). This condition is far from ideal as this would hinder the efficiency of the evaluation of healthcare system, where redundant studies might be conducted as HTAs are performed in a decentralized and privatized manner (Garrison, 2011). The U.S. government needs to overhaul the entire healthcare system and develop a national HTA program to increase the transparency and accountability of the system. Other than that, in this phase, the FDA also requires manufacturers to conduct postmarket surveillance (PMS) and report the safety level of a medical device.

4. Conclusions and recommendations

The framework of responsible innovation is used to analyze the current RAS procedure that is implemented in the U.S. and to structure the recommendations in order to conduct RAS more responsibly. According to the analysis, we have identified relevant values for each of the responsible innovation dimensions: safety (anticipation), autonomy, beneficence, non-maleficence, justice (reflexivity), affordabilityand accessibility(inclusiveness), and human welfare (responsiveness). We have also analyzed the responsible innovation challenges of RAS in the U.S.: the non-ideal U.S. healthcare system, the interconnectedness of the actors within the healthcare system, and the future technological development of the surgical robots.

After analyzing RAS, according to the medical device life cycle phases, we found that responsible innovation initiatives exist in each of the phases. However, the initiatives need to be further improved. As the problem owner, the hospital is present in all of the phases. We identify several strategies for the hospital to ensure the responsibility of RAS in each phase. In the first phase (from idea to product), the hospital should interact closely with the technology developers during the technology development to prevent undesirable consequences related to safety. In the second phase (experimental use in health practice), the hospital should be involved with the FDA in assessing the technology before it can receive market approval. In the third phase (uptake in regular care), the hospital needs to ensure proper training for the surgeon to guarantee the appropriate credentials to perform different RAS procedures. In addition tosafety, it should ensure the qualityof the services to give benefits (beneficence) and avoid harm (non-maleficence) to the patients. For instance, by ensuring that the facilities and infrastructures needed to perform RAS are working well to avoid technical malfunctions. The lack of knowledgeof the patients regarding the procedure of RAS needs to be improved by providing complete information throughinformed consent, so that the patients have adequate knowledge power (justice) and make the treatment decision under full autonomy. The patients can also beincludedin the open discussion regarding technical procedure of the robotic surgery system to ensure the inclusivenessof the procedure. In the fourth phase (long term implementation and reimbursement), the hospital needs to utilize its position power as the actor that connects all the stakeholders within the healthcare system. In order to ensureaffordabilityand accessibilityof the procedure, the hospital needs to make arrangements with both technology developers and health insurers. However, this could only be made possible by the involvement of the technology regulators: the U.S. government and FDA.

On its own, the hospital cannot improve the current condition of RAS because it is dependent on other actors. It is crucial for the U.S. government to improve the U.S. healthcare system, develop a national HTA program, and guarantee the affordability of RAS for anyone who needs it as the necessary treatment. For example, by creating a system that allows the insurance companies to cover RAS treatment or fostering competition in the field of robotic surgery to avoid monopoly so the price can be driven down. Other than that, the government should make the innovation process more participatory by including public opinions and facilitating discussions between developers, insurers, and the users (including the public), so the technology could be moreinclusive to improve public health and human welfare. The U.S. government should also impose regulations and demand technology developers to acknowledge its culpability of a surgical error caused by technical malfunctions. The FDA needs to also exercise itsblocking powerto monitor the implementation of RAS and hinder the use of RAS if negative consequences that could threaten the ethical values happen in an unacceptable level. These two regulators (the U.S. government and the FDA) have to consider the long-term implications of technological developments and establish boundaries to avoid harm and to benefit the wider public (beneficenceandnon-maleficence).

 

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