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This paper provides an overview and status of Gateway, humanity’s first space station to orbit the Moon providing vital support for a sustained, long-term human return to the lunar surface and a steppingstone to Mars as part of the Artemis missions. As a lunar outpost, Gateway is a destination for deep space crew expeditions and science investigations, a port for deep space transportation, including landers transiting to the lunar surface or spacecraft embarking to deep space destinations beyond the Earth-Moon system. The National Aeronautics and Space Administration (NASA) leads the Program and is the integrator of the spaceflight capabilities and contributions of U.S. commercial partners and international partners to develop Gateway. This paper will provide an overview of Gateway’s major components in various stages of development. The entire Gateway spacecraft is at preliminary design level of maturity, with some components at or near critical design review. Gateway’s major components are the Power and Propulsion Element; the Habitation and Logistics Outpost; Deep Space Logistics; the International Habitation module; Gateway External Robotics System; European System Providing Refueling, Infrastructure and Telecommunications; and an Airlock. This paper will also provide an update on the status of the integration activities necessary to fly and operate this complex, next-generation integrated spacecraft for a minimum 15-year design life, including systems engineering integrated analysis cycles, the autonomous Vehicle System Manager software, verification and validation labs, and common vehicle equipment. Expanding on the successful partnership that has provided over 20 years of continuous crew operations in low-Earth orbit on the International Space Station, Gateway is an evolution of this extraordinary partnership leveraging the capabilities of each contributor to expand humankind’s sustained exploration deeper into the cosmos. Highlighting the international program with participation from multiple space agencies, this paper will also provide a status of Gateway multilateral governance structure and international agreements.

Background NASA’s human exploration spaceflight missions to the Moon and Mars present unprecedented challenges for in-mission medical care. The distance from Earth will mean increased mission durations, communication delays, limited to no resupply opportunities, and constraints on the medical evacuation of astronauts. Mass, volume, power, and data will be limited while higher demands will be placed on the crew to manage medical care. NASA’s Moon to Mars exploration strategy lays out increasingly complex Artemis missions both in terms of duration and operations. In these more challenging deep space missions, it is important to quantitatively estimate the human medical risk to inform a traditional heuristic approach to medical risk. Prior tools have been developed for missions in low Earth orbit, but a new tool is required to plan for future exploration missions. Methods IMPACT (Informing Mission Planning via Analysis of Complex Tradespaces) is a risk assessment tool developed by NASA to advance exploration mission medical system design by quantitatively estimating mission medical risk. IMPACT v1.0 includes a novel evidence library baselined to exploration environments; an expanded list of 119 medical conditions; the addition of medical resources; and the ability for rapid and iterative analysis. Medical system risk estimates include loss of crew life, consideration of the need for return to definitive care (medical evacuation), and an estimate of crew time affected due to medical conditions. A notional long duration lunar orbit and lunar surface design reference mission (DRM) was chosen with a 4-astronaut crew to represent a sustained exploration Artemis mission. Results/Discussion Overall, IMPACT successfully quantified medical risk and derived an optimized medical system to support crew on a long duration lunar mission. In this DRM, the calculated loss of crew life from a medical event was 0.008 events per mission, risk of potential need for evacuation was 0.30 events per mission, and cumulative crew time affected by medical conditions was 103 days. The medical conditions that most contributed to overall medical risk were decompression sickness, trauma conditions, and respiratory failure. The conditions that had the largest effects on crew performance included musculoskeletal injuries and lunar dust exposure. The IMPACT-generated medical system included resources that target the most common and highest risk conditions. This systematic analysis demonstrates the value of the IMPACT tool in medical system design for human exploration spaceflight missions.

BACKGROUND NASA’s human exploration spaceflight missions to the Moon and Mars present unprecedented challenges for in-mission medical care. A greater distance from Earth will mean increased mission durations, communication delays, limited to no resupply opportunities, and constraints on the evacuation of ill or injured crew. Mass, volume, and power will be limited while higher demands will be placed on the crews to manage medical events. NASA’s Moon to Mars exploration strategy outlines increasingly complex Artemis missions both in terms of duration and operations. In these more challenging deep space missions, it is important to quantitatively estimate the human system risk attributable to medical conditions and use these estimates to advance medical system design. METHODS IMPACT (Informing Mission Planning via Analysis of Complex Tradespaces) is a probabilistic risk assessment (PRA) and tradespace analysis tool developed by NASA to advance exploration mission medical system design. IMPACT v1.0 includes a novel evidence library baselined to exploration environments; an expanded list of 119 medical conditions; a large increase in the number of medical resources and the flexibility of their use; and the ability for rapid and iterative analysis. Medical system risk estimates include loss of crew life, consideration of the need for return to definitive care (medical evacuation), and an estimate of crew time affected due to medical conditions. A notional long duration lunar orbit and lunar surface design reference mission (DRM) was chosen with a 4-astronaut crew to mimic a foundational exploration Artemis mission. The DRM profile includes outbound transit on Orion, Gateway space station rendezvous in lunar orbit, 6 months on the Lunar surface with extravehicular activity (EVA), return rendezvous with Gateway, and transit back to Earth. RESULTS/DISCUSSION: Overall, IMPACT successfully quantified medical risk and derived an optimal medical system to support crew on a long duration lunar mission. In this DRM, the calculated loss of crew life from a medical event was 0.008 events per mission, risk of potential need for evacuation was 0.30 events per mission, and cumulative crew time affected by medical conditions was 103 days. The medical conditions that most contributed to medical risk were decompression sickness, trauma, and respiratory failure. The conditions that had the largest effects on crew performance included musculoskeletal injuries and lunar dust exposure. The IMPACT-generated medical system included resources that target the most common and highest risk conditions and performed as expected. This demonstrates the value of the IMPACT tool in medical system design for human exploration spaceflight missions.

Throughout the history of human spaceflight, crewmembers have experienced various in-flight medical conditions including illness and injury. Planned missions to the Moon and Mars will require capabilities to maintain the health of future space travelers. Mass, power, and volume available in the vehicles and habitats for these missions will be severely constrained; resupply of resources will be limited or non-existent, as will opportunities for evacuation to Earth. Furthermore, ground-based support will be hampered by communication latencies and blackouts. These vehicle and mission constraints will necessitate a medical system that has been efficiently planned, providing on-board procedural guidance in addition to a variety of medical devices and consumable resources. Medical capabilities required for the diagnosis and treatment of potential medical conditions during future spaceflight missions may include real-time health monitoring, medical imaging, and biomarker analyses ( e.g., blood or urine). Terrestrial medicine shares these needs, thus many of these medical capabilities could likely be satisfied by Commercial-Off-The-Shelf (COTS) devices and methodologies; however, in some cases the unique space environment and increased mission duration will drive the need to modify technologies and the way care is provided. NASA’s Human Research Program (HRP) Exploration Medical Capability (ExMC) Element and Mars Campaign Office’s Exploration Medical Integrated Product Team (XMIPT) are working together to decrease medical risk during exploration missions. Flight-tested medical diagnostic and treatment technologies are necessary to effectively manage medical conditions relevant to exploration missions while meeting vehicle constraints, integrating with medical decision-support tools, and enabling increasingly Earth-independent operations. Several projects have leveraged the ISS as a testbed for exploration, including 1) i n- situ blood analysis, 2) medical inventory, 3) intravenous fluid generation, and 4) autonomous medical procedure guidance. Management of several in-flight medical conditions, such as bacterial and viral infections and acute radiation syndrome, is dramatically improved with ability to assess blood cell populations, electrolytes, and metabolites. I n December 2020 and January 2021 ExMC performed an ISS technology demonstration (Tech Demo) of the HemoCue® WBC DIFF analyzer (HemoCue, Brea, CA), a COTS device that was modified to enable functionality in a spaceflight environment. This Tech Demo marked the first time that hematology measurements were successfully performed real-time in microgravity. Also modified and demonstrated was the reusable Handheld Electrolytes and Lab Technology for Humans (rHEALTH) ONE analyzer (rHEALTH, Bedford, MA), which uses flow cytometry and sheath-based hydrodynamic focusing methodologies. The rHEALTH ONE ISS Tech Demo in May 2022 demonstrated test results obtained in-flight matched those on the ground. NASA currently relies on crew self-reporting to manage and maintain medical inventory on ISS.The ability to maintain an accurate inventory becomes more critical during long duration missions since the crew will need to be increasingly autonomous in finding and utilizing medical items, including those scenarios when alternative treatments need to be considered due to limited or no resupply. HRP’s Medical Consumables Tracking (MCT) project was developed by ZIN Technologies, Inc. (Cleveland, OH), and demonstrated real-time tracking of medical supplies aboard the ISS between December 2016 and July 2018. The MCT system design utilized Radio Frequency Identification Device (RFID) technology to perform automated inventory and was installed in the Crew Health Care System (CHeCS) Resupply Stowage Rack (RSR). The challenge of limited shelf life, exacerbated by the lack of resupply opportunities, affects a plethora of medical system components including consumables, pharmaceuticals, and intravenous (IV) fluid. In 2010, ExMC funded ZIN Technologies, Inc. (Cleveland, OH), to develop the Intravenous Fluid Generation (IVGEN) system. IV fluids were successfully generated with IVGEN using the potable water supply on ISS during ISS Expedition 23. The XMIPT is in the process of developing a miniaturized version of the original IVGEN hardware for a future Tech Demo aboard the ISS. Current ISS medical operations rely heavily on preflight training and real-time remote guidance, both of which become impractical or impossible for exploration missions. The primary goal of the Autonomous Medical Officer Support (AMOS) Software Tech Demos on ISS was to confirm telemedical proof-of-concept for autonomous medical imaging in an operational setting. This novel software tool shifts emphasis from preflight training and real-time remote guidance to in-flight just-in-time instruction, a new and necessary paradigm for crew medical autonomy. AMOS introduces a novel, streamlined skill management concept for exploration missions featuring comprehensive training and guidance modules for ultrasound examinations using the ISS Ultrasound 2 (a modified GE Vivid-q™; General Electric HealthCare, Chicago, IL). With no prior crew training or remote guidance, two Tech Demos on the ISS (April 2020 and June 2022) resulted in high quality, clinically useful image sets. We will provide a review of historical, current, and planned medical devices and technologies considered for inclusion within future spaceflight medical systems and summarize hardware development activities and medical device tech demos conducted on the ISS.

Data flows and storage/retrieval capacity are severely constrained during missions in space and challenges will become even greater during exploration class missions. There is a need for an artificial intelligence (AI)-based clinical decision support system (CDSS) to monitor and analyze data to provide real-time consultative support for crew medical officer (CMO) decision-making. EIMO is defined as the gradual transition of medical care and decision making from terrestrial to space-based assets, enabling support of astronaut health and performance and reducing overall mission risk. While a hallmark of this paradigm shift from low-earth orbit is that on-board care will increasingly become the responsibility of the astronauts for primary management and decision making, terrestrial assets will continue to be paramount in pre-mission screening and planning, as well as prevention, health maintenance and long-term care contingencies. New capabilities and systems that enable progressively more robust and resilient systems and crews will be necessary to reduce risk and increase probability of deep space exploration mission success. An aspiration for EIMO is to develop AI-enhanced solutions for analysis of crew health & performance data and to facilitate clinical decision support for autonomous medical operations. A “system of systems” approach is envisioned whereby EIMO will deploy AI-supported natural language processing and machine learning (ML) techniques to utilize embedded reference databases and real-time data streams [input vectors] from multiple data sources. Constituent input vectors may include environmental controls, countermeasures data, behavioral data, physiologic wearables, point-of-care laboratory tests, personalized medical records, inventory trade space risk assessments, COTS medical databases, and ground support inputs. An ideal AI capability would possess trained fusion algorithms to cross reference input vectors with medical ‘knowledge’ [cultivated database] to stratify relevant data streams for predictive and actionable capabilities. In addition, EIMO will feature mobility, in that it can be accessed and can push/pull data within and between multiple vehicles/habitats. Large amounts and variable sources of data can be leveraged to diagnose, inform treatment strategies, and potentially predict medical events and performance decrements. Inclusion of advanced training tools using extended reality will enable increasingly autonomous medical care to aid a CMO when ground support is unavailable or time-delayed beyond required action window, e.g., emergent medical situations. EIMO CDSS would require very large datasets to train pre-flight and significant amounts of data are needed to support ML via in-flight CDSS operations. An additional challenge will be to find sufficient data to train a model relevant to astronaut demographics. The rapid, accelerating evolution of this field creates a propitious solution space to leverage multi-modal AI through public-private partnership(s). The status of multi-modal AI systems today would preclude their use for long duration missions as they remain unreliable and are subject to “digital hallucinations” and other errors that could pose operational risk. A federated labs structure is being considered to test and optimize data flow from the multiple input vectors leading to field testing in suitable ground/flight analogs. Critical to the success of an EIMO CDSS will be integration and interoperability and success will be defined by a system that can serve as an in-flight medical consult for the CMO providing critical support during medical contingencies. Benefits to terrestrial medicine may be significant as an outflow of the EIMO medical system, particularly for remote areas and communities lacking significant infrastructure, personnel and resources.

The scope of this report is limited to evaluating drug stability with respect to spaceflight. The effects of spaceflight on drug pharmacokinetics (PK) or drug pharmacodynamics (PD) are not addressed in this report: these topics will be reviewed in future reports. This is the first report of the available evidence pertaining to the chemical and physical stability of drugs in the context of drug impurity, drug repackaging, and exposure to ionizing space radiation. Previous studies are discussed within this report and, where possible, the data are interpreted and contextualized with regards to drug stability.

On 26th October 2023, ExMC convened a panel of Subject Matter Experts (SMEs) from NASA, broadly representing Headquarters, the Human Research Program, Medical Operations, the Human Health and Performance Directorate at JSC, the Health and Medical Technical Authority, the Flight Operations Directorate, and representation from other Centers including: Ames Research Center (ARC), and Glenn Research Center (GRC). Representatives from the Canadian Space Agency also participated in this TIM. In addition, SMEs from industry included representation from the following entities: Axiom Space, Space Exploration Technologies Corporation, Level Ex, Shiny Box Interactive. Additional SMEs from academia included: University of Houston, Touro University, Weill Cornell Medical College and the Translational Research Institute for Space Health at Baylor College of Medicine. This group of stakeholders discussed the training issues related to facilitating EIMO. Sub-topics for this discussion included the following: - Pre-launch medical curriculum development - Ground-based training on medical hardware - Dental health - Behavioral health - Telemedicine - Just-in-time training - Simulation-based training (extended reality)

Background: Following the success of Artemis I, NASA is preparing for human extended duration missions. Ongoing efforts are focused on mitigating mission-related risks, including those affecting crew health and performance. Communication latency, logistics of resupply and time frame of medical evacuation are barriers to provision of healthcare for these missions, especially with respect to constraints in mass, volume, and crew training. An in-depth assessment of medical risks, capabilities and resources for a specific mission design is necessary to determine an optimal balance that maximizes likelihood of mission success. Overview: IMPACT (Informed Mission Planning via Analysis of Complex Tradespaces) is a dynamic tool designed to estimate medical risk and outcomes for a specific mission design. In its current iteration, a list of medical conditions selected based on likelihood of occurrence and/or consequence was linked to a set of clinical capabilities and resources necessary for diagnosis and management. A probabilistic risk analysis tool was then used to identify and estimate the likelihood and consequence of risks through the following outcome metrics: loss of crew life (inflight mortality due to medical conditions), need for medical evacuation (return to definitive care), and crew disability (task time affected based on how medical conditions influence the ability to perform specific exploration mission crew tasks). Finally, the model’s optimization algorithm provides recommendations for medical capabilities that maximize risk mitigation relative to mass and volume constraints. In the Spring of 2023, IMPACT was utilized to estimate outcome metrics for a design reference mission that would be representative of an extended duration Artemis mission. Notional data generated were then used to determine a recommended set of medical capabilities and resources relative to user-defined mass and volume constraints. A multidisciplinary team has also been updating IMPACT to strengthen the model’s fidelity. Figure 1 shows how updates to outcome metric inputs for the conditions resulted in different capability and resource allocation recommendations. Discussion: This presentation will discuss the IMPACT tool and share the latest data generated for a representative extended duration Artemis mission. Efforts to improve the fidelity of data generated by the model’s algorithm will also be discussed.