How Space Operations Drive Innovation In Human Healthcare

Appropriate healthcare during human spaceflight necessitates adequate capabilities throughout the mission. This paper aims to raise awareness about how operations impact healthcare innovation. Future missions beyond low-Earth orbit will fundamentally alter healthcare, and advancements in space medicine will drive innovation in the field. Space agencies rely on evidence-based approaches to maximise the impact of innovation and make it safe for use in space. However, a lack of human readiness levels delays the inclusion of humans in the technology development process and can prevent the identification of human health hazards. This creates difficulties for the commercial space sector when attempting to apply the government's evidence-based approaches. As a result, medical capabilities for spaceflight could be developed independently of operations and vehicle/system design. Creating a safety framework necessitates alignment between these domains and may promote improved technology transfer of spaceflight medical capability to terrestrial medical needs.


I. INTRODUCTION
M ISSION design studies are conducted by space agencies to determine the mission objectives and systems required to conduct space missions [1]. Operations refer to the coordination of flight and ground systems to achieve mission objectives [1], which are affected by factors such as distance from Earth, mission duration, space weather, changing gravity, and communication delays. Future crewed missions beyond Low Earth Orbit (LEO) will be more complex and risky than those currently aboard the International Space Station (ISS). This paper aims to raise awareness about how operations affect healthcare innovation. The goal is to identify emerging themes that may have a long-term impact on innovation. The objectives are to demonstrate critical differences in healthcare and innovation in ISS operations and future missions and provide insight into the regulatory processes associated with these developments.

II. MEDICAL CARE
The discipline of preventive medicine has historically dominated space medicine [2]. The use of astronaut selection criteria and medical standards is one preventive strategy for reducing the severity of potential medical events in space [3]. The demand for acute care intervention capabilities in spaceflight is expected to rise as commercial space companies transition from a heavily screened and healthy astronaut corps to one that is less vetted. Space medicine practices aim to restore health and performance during and after a mission, regardless of the type of spaceflight participant. This section describes the medical care associated with recent and future operations.

A. Medical Care in ISS Operations
The ISS medical system, intended for close-in Earth-centric missions, benefits from real-time communications and consumable replenishment and, when necessary, relies on crew re-entry. Telehealth and telemedicine are enabling technologies for monitoring and prevention in this context. Medical training gives the crew the knowledge to stabilise and transport an incapacitated crew member back to Earth, but it may not allow for advanced care. Few astronauts are also physicians, and not all missions on the ISS include a medically trained specialist. However, NASA regulations require that designated medical personnel be included on the crew. Regardless of professional experience, any crew member can be assigned the Crew Medical Officer (CMO) role by the Crew Commander. CMOs receive more extensive medical training than other crew members, including approximately 40 hours of specialised training in the use of onboard medical equipment and hardware [4]. Such an officer provides immediate care and compliance with orders from medical ground crews, especially flight surgeons.

B. Medical Care in New Operations
As the distance from Earth increases, communication delays prevent real-time telehealth and telemedicine services from being provided. The mission architecture, orbital dynamics, and space infrastructure (from telecommunications to payloads) significantly impact the selection of medical capabilities. The in-flight crew's relationship with ground healthcare personnel is mostly delayed (or offline) and heavily filtered by technology. In this setting, medical care is no longer based on the previously mentioned paradigm of stabilising and transporting incapacitated crew members [5]. Risk analysis is a quantitative  VOLUME 4, 2023 Authorized licensed use limited to the terms of the applicable license agreement with IEEE. Restrictions apply. method for determining onboard technology in this context. NASA evaluates the operation and engineering of vehicles and onboard systems using evidence-based human health hazard assessment methods. This approach aims to reduce medical events' likelihood and severity, specifically unacceptable health and mission outcomes [6], and to assist in identifying the need to engineer new medical capabilities.
Future missions to the Moon and Mars will necessitate unprecedented crew independence from Earth. Intelligent systems onboard vehicles and habitats are likely to make this possible. An autonomous medical care system onboard the vehicle is desired to ensure the crew can be self-reliant for their health [7]. Developing this advanced technology is thought to be the best way to counteract known and unknown human health hazards, and it goes beyond space medicine's preventive approach to mature acute care capabilities.
The health provider of incoming missions will be a designated officer trained at the physician level who will provide medical decision-making and treatment for various medical events that could occur during the mission [8]. Such a level of training can bridge the gap between limited onboard resources and the potential need for higher medical capability [8]. Then, having two CMOs for each vehicle/platform and mission phase is critical to ensure that a backup is available for medical treatment [8].
However, historically, preventive practices are based on evidence from the professional astronaut population that has flown and the LEO experience almost exclusively. Uncertainty becomes significant when attempting to generalise this evidence base to future missions with different mission parameters [4].

III. DRIVERS OF INNOVATION
Market demands and technological advancements are the two key innovation drivers in the healthcare segment for ground applications (business-driven innovation). Initially, technology drove space sector innovation to encourage progress and collaboration between government and non-government organisations. Today, technological advancement is less important than it once was, and mission goals and risks drive innovation, also known as purpose-driven innovation. This section elaborates on the drivers of space medical capability innovation.

A. Telemedicine and Ultrasound
Human spaceflight begins with unsophisticated engineering and a lack of knowledge about how the space environment affects human health. Despite this, medical research outside of remote health monitoring has remained a secondary factor in achieving the technology's goals. The White House Domestic Council asked NASA in 1971 to spread the development costs across multiple units [9]. NASA used the opportunity to develop medical capabilities that would benefit people other than astronauts. The Space Technology Applied to Rural Papago Advanced Health Care program aimed to connect physicians in hospitals with those in remote and mobile clinics to improve healthcare quality on Earth. A program like this demonstrates how the dissemination of advances in space technology to populations on the ground can spread technological progress and how the use of terrestrial resources contributes to the space sector's development.
In-flight diagnostics are now required to sustain human space activity decades later. The National Institute of Space Biomedicine provided funding for developing a lightweight, portable ultrasound device capable of high-resolution ultrasound imaging in flight. Ultrasound is non-invasive and can be used for diagnosis in conjunction with telemedicine technology. It also provides in-flight data obtained on the ground using a costly technology incompatible with space travel, such as computed tomography or magnetic resonance imaging [10]. Several Earth-based ultrasound tests are used to treat new conditions such as soft and hard tissue injuries, sinuses, and eyes. Because the proper use and interpretation of ultrasound are highly userdependent, space agencies are investing in remote training and guidance of non-medical operators [11].

B. Humanised Intelligence
Numerous discoveries are being made as a result of new medical technology, and an interest in individual differences among spaceflight participants is paving the way for personalised space medicine [12], [13]. Because acute care knowledge and skills drive the design of medical systems to meet future missions' in-flight medical needs, technological advancement advances by focusing on operational and user needs [13], [14]. Algorithm advancement may facilitate striking the proper balance between technological progress and the provision of more specialised applications.
Artificial Intelligence (AI) techniques (such as machine learning, artificial neural networks, and deep learning, among others) provide technology with human-like intelligence by analysing a massive amount of data. Onboard AI could potentially contribute to crews becoming self-sufficient in a space mission because it requires fewer land-based resources to operate, such as science labs and personnel. AI-based technologies lay the groundwork for autonomous systems capable of achieving goals based on their knowledge and awareness, sensing their surroundings, making decisions, and communicating individually or collectively. In the long run, AI will enable machines to match or outperform critical aspects of human intelligence, allowing them to adapt to unexpected and changing situations regardless of human intervention. In many operational scenarios, such as the military [15], autonomous intelligent agents and humans are used concurrently to achieve common goals, implying that they are expected to make decisions together. Coordination between agents and humans is found to be more important than providing independent functions in operations [15]. Agents work in uncertain areas when information is lacking, and errors undermine human trust. The human component of autonomous intelligent agents is critical to establishing a long-term collaborative relationship between humans and technology. Humans and agents become interdependent when agents are used as teammates rather than tools, and tailored agent communication determines the evolution of human trust in intelligent agents [15].
Although AI is useful in many fields of medicine, it has not yet reached the optimal level for assisting crew members in making health decisions. Before being integrated into space-based medical systems, AI must be clinically robust for monitoring, diagnosis, treatment, and guidance [4]. The precision space health system [13] or other potential space health applications [14], [16] are examples showing the expected level of intelligence. The next step in healthcare technology development is to incorporate human factors and performance in multi-agent systems to ensure trust and cooperation in critical scenarios. The humanisation of human-agent relationships enables adaptability to human and multi-agent scenarios, which may be useful in future operations for assisting or advising CMOs. Using the ground, as in telemedicine, saves time while allowing for early technology transfer. Terrestrial applications can provide less risky development scenarios than space applications. Also, intelligent agents have the potential to improve global healthcare by empowering patients and decentralising hospital care. Humanising intelligent agents will shake the foundations of medical education, medicine, and healthcare, removing barriers to where patients can receive quality care. Several aspects of medical regulation are likely to become transnational, and patients' relationships with their health may become less personal and used to shape the healthcare sector. However, the use of intelligent agents in ground healthcare is progressing slowly due to the need to advance local infrastructure and resources [17] and ethical and legal implications in critical applications such as operating theatres [18]. The development of humanised intelligence for healthcare applications may branch out to meet the needs of the context when developed for use in space or on the ground.

IV. MEDICAL CAPABILITIES
Flying a new technology in space requires several engineering tests to investigate hazards, and their quantification is essential for conducting a rigorous risk assessment to meet space safety requirements.

A. Human Readiness Levels
In the '90 s, NASA formulated a nine Technology Readiness Levels (TRL) scale, with nine being the most mature technology. The European Space Agency [12] and the European Commission [13] adopted similar levels in the following years. Levels inform how close a specific technology component, system or subsystem is to becoming operational within a particular context and help mitigate risks early on in technology development.
The TRL scale does not consider the readiness of the technology when a human is involved, and it lacks a method for evaluating human performance, usability, and user satisfaction [19]. In addition, the scale does not account for safety considerations. A suggested alternative scale is called Human Readiness Levels or HRLs. This scale focuses on developing technology that considers the needs of intended users in an operational environment and helps to include the human element, making development human-centric rather than technology-centric [19].
However, no official HRLs exist for space technology. NASA's Human Research Program (HRP) contributes to technology development by developing countermeasures [22]. The Countermeasure Readiness Levels (CRLs) relate partly to HRLs.
A countermeasure refers to "any procedures, medications, devices, and other strategies designed to keep astronauts healthy and productive" [23]. CRLs mirror TRLs in the rating. The involvement of the HRP typically begins at CRL-4 and continues until CRL-7 or -8 [22].
The U.S. Army Medical Research and Materiel Command (USAMRMC) has established medically-related TRLs or biomedical TRLs for drugs, vaccines, medical devices, and medical information management/information technology and medical informatics in the context of military medical research and development [24]. Biomedical TRLs reduce technical risk and ensure clinical phase compliance with the U.S. Food and Drug Administration (FDA) regulatory process. According to the USAMRMC, risk mitigation for critical biomedical technology elements during the transition from technology to product development is not linear across TRLs, implying that progression through the FDA phase could result in significantly higher TRL [24].

B. Human-Systems Integration's Limitations
Adequate levels of integration designed to accommodate real human needs and capabilities are an essential and frequently overlooked component of system design. NASA has developed a Human-Systems Integration (HSI) approach that shares principles with HRLs in involving humans in system development to ensure mission success [20]. The HIS architecture in place benefits from LEO advantages and real-time access to Mission Control expertise for problem-solving and decision-making in complex and safety-critical situations, such as when anomalies occur. Anomalies are unintended or off-nominal functions of vehicle systems that, if not addressed promptly, can have life-threatening consequences [21]. The frequency of anomalies increases with mission duration and is proportional to the complexity of mission operations [21]. Because future missions beyond LEO will be so different from ISS operations, it is unlikely that the HSI developed for ISS operations will result in mission success [21]. There is awareness of the risks associated with inadequate HSI evolution; however, estimating them is difficult due to a lack of evidence about safe human expeditions without real-time operational and engineering support [21].

C. Liability Games
The expansion of the commercial space sector and commercial human activities in space are paving the way for advancements in healthcare. Commercial suborbital, orbital, and interplanetary flights are available from space companies. These are business-oriented activities that require an operational framework to run successfully. However, operations, mission objectives, structure, and duration differ from activities led by the government. Because of the lack of consistent standards of care across organisations, an evidence-based approach may not be feasible, resulting in variable screening, selection, and training criteria for space passengers [25]. In the dynamic legal and ethical framework of commercial space travel, aspects of risk assessment, such as the development of appropriate medical capabilities, may be beyond the responsibility of companies [25].
A reference framework for ensuring safety is risk assessment for government-operated flights. There is a need to improve safety by regulating the engineering of in-flight medical capabilities that are created independently of vehicle operations and onboard systems. The FDA's regulatory process can be used to develop appropriate guidance, but it is not sufficient. There are several limitations to flying medical capabilities, and stakeholders may underestimate the challenges of protecting human health in space due to a lack of proper regulatory processes.

V. CONCLUSION
Future operations will face new constraints, and advances in space medicine will drive healthcare innovation through an evidence-based approach. However, technological development maturity is not centred on humans, and human risk assessment may occur later in the development process. Commercial space companies can develop new preventive measures; however, compatibility and robustness are critical to ensuring the continuation of space operations. The following are the main highlights of this work: r There is a need to establish readiness levels for incorporating the human element early in technological development. It is a strategy for promoting human-centred development in space technology, strengthening the link between innovation and a specific operational environment, and improving safety.
r Regulatory processes must account for medical capabilities developed independently of the vehicle's operational and engineering environment and onboard systems.