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NASA NTRS2011

Technology Development to Support Human Health and Performance in Exploration Beyond Low Earth Orbit

In the course of defining the level of risks and mitigating the risks for exploration missions beyond low Earth orbit, NASA s Human Research Program (HRP) has identified the need for technology development in several areas. Long duration missions increase the risk of serious medical conditions due to limited options for return to Earth; no resupply; highly limited mass, power, volume; and communication delays. New space flight compatible medical capabilities required include: diagnostic imaging, oxygen concentrator, ventilator, laboratory analysis (saliva, blood, urine), kidney stone diagnosis & treatment, IV solution preparation and delivery. Maintenance of behavioral health in such an isolated, confined and extreme environment requires new sensory stimulation (e.g., virtual reality) technology. Unobtrusive monitoring of behavioral health and treatment methods are also required. Prolonged exposure to weightlessness deconditions bone, muscle, and the cardiovascular system. Novel exercise equipment or artificial gravity are necessary to prevent deconditioning. Monitoring of the degree of deconditioning is required to ensure that countermeasures are effective. New technologies are required in all the habitable volumes (e.g., suit, capsule, habitat, exploration vehicle, lander) to provide an adequate food system, and to meet human environmental standards for air, water, and surface contamination. Communication delays require the crew to be more autonomous. Onboard decision support tools that assist crew with real-time detection and diagnosis of vehicle and habitat operational anomalies will enable greater autonomy. Multi-use shield systems are required to provide shielding from solar particle events. The HRP is pursuing the development of these technologies in laboratories, flight analog environments and the ISS so that the human health and performance risks will be acceptable with the available resources.

Kundrot, C.E.↗

NASA NTRS2012

The NASA Human Research Wiki - An Online Collaboration Tool

The Exploration Medical Capability (ExMC) element is one of six elements of the Human Research Program (HRP). ExMC is charged with decreasing the risk of: "Inability to adequately recognize or treat an ill or injured crew member" for exploration-class missions In preparation for exploration-class missions, ExMC has compiled a large evidence base, previously available only to persons within the NASA community. ExMC has developed the "NASA Human Research Wiki" in an effort to make the ExMC information available to the general public and increase collaboration within and outside of NASA. The ExMC evidence base is comprised of several types of data, including: (1)Information on more than 80 medical conditions which could occur during space flight (a)Derived from several sources (b)Including data on incidence and potential outcomes, as captured in the Integrated Medical Model s (IMM) Clinical Finding Forms (CliFFs). (2)Approximately 25 gap reports (a)Identify any "gaps" in knowledge and/or technology that would need to be addressed in order to provide adequate medical support for these novel missions.

Barr, Yael↗

NASA NTRSDate not supplied

Bringing the Flight Surgeon Console Into the Artemis Era: Constructing A Quick Reference Guide for the Orion Vehicle

BACKGROUND: Historically, NASA flight surgeons working on control console have had access to a quick reference guide that provides tailored clinical information for a variety of medical conditions, symptoms, and events that crew members may experience on the International Space Station (ISS). With the development of the Orion vehicle and its new medical system intended for the Artemis missions, a new quick reference guide is required to reflect the capabilities of this new medical system. OVERVIEW: The Flight Surgeon Quick Reference Guide(FSQRG)offers a variety of information to flight surgeons. For each condition/symptom/event, the guide describes what actions and procedures crew members will perform either automatically or at the instruction of the flight surgeon. The guide describes what further information should be collected, lists potential diagnoses, and further actions available to be taken by the Flight Surgeon or crew. The guide also describes what medications are available to the crew, common clinical decision-making tools, and other terrestrial practices. Due to the significant differences between the ISS and the Orion vehicle in both structure and mission scope, Orion’s medical system is significantly smaller than the ISS’s. When constructing the new guide for the Orion vehicle we began with the ISS version of the guide as a template. We then replaced ISS crew procedure references with their Orion counterpart if one existed. We also added new Orion crew procedure references where clinically appropriate. Reductions or additions to the medical equipment/medication references were made until they were consistent with resources available on Orion. Finally, we constructed a resource matrix that allows flight surgeons to easily identify the location of medications and equipment required for crew procedures. DISCUSSION: The information provided in the updated FSQRG allows flight surgeons to make quick and clinically accurate decisions that can be accomplished within the scope of the Orion vehicle medical system. This timely and accurate decision making becomes more important as missions go beyond low earth orbit and communication becomes more delayed. Such quick reference guides also have the potential to reflect medical systems on future vehicles, missions, and partner vehicles.

Anderson carter↗

NASA NTRS2006

Operational and Research Musculoskeletal Summit: Summit Recommendations

The Medical Informatics and Health Care Systems group in the Office of Space Medicine at NASA Johnson Space Center (JSC) has been tasked by NASA with improving overall medical care on the International Space Station (ISS) and providing insights for medical care for future exploration missions. To accomplish this task, a three day Operational and Research Musculoskeletal Summit was held on August 23-25th, 2005 at Space Center Houston. The purpose of the summit was to review NASA#s a) current strategy for preflight health maintenance and injury screening, b) current treatment methods in-flight, and c) risk mitigation strategy for musculoskeletal injuries or syndromes that could occur or impact the mission. Additionally, summit participants provided a list of research topics NASA should consider to mitigate risks to astronaut health. Prior to the summit, participants participated in a web-based pre-summit forum to review the NASA Space Medical Conditions List (SMCL) of musculoskeletal conditions that may occur on ISS as well as the resources currently available to treat them. Data from the participants were compiled and integrated with the summit proceedings. Summit participants included experts from the extramural physician and researcher communities, and representatives from NASA Headquarters, the astronaut corps, JSC Medical Operations and Human Adaptations and Countermeasures Offices, Glenn Research Center Human Research Office, and the Astronaut Strength, Conditioning, and Reconditioning (ASCR) group. The recommendations in this document are based on a summary of summit discussions and the best possible evidence-based recommendations for musculoskeletal care for astronauts while on the ISS, and include recommendati ons for exploration class missions.

Scheuring, Richard A.↗

NASA NTRS2011

Telemedicine in Space Flight - Summary of a NASA Workshop

The Exploration Medical Capability Element of the Human Research Program at NASA Johnson Space Center hosted the Telemedicine Workshop in January 2011 to discuss the medical operational concept for a crewed mission to a near-Earth asteroid (NEA) and to identify areas for future work and collaboration. With the increased likelihood of a medical incident on a long duration exploration mission to a near-Earth asteroid, as well as the fact that there will likely be limited medical capabilities and resources available to diagnose and treat medical conditions, it is anticipated that a more structured use of telemedicine will become highly desirable. The workshop was convened to solicit expert opinion on current telemedicine practices and on medical care in remote environments. Workshop Objectives: The workshop brought together leaders in telemedicine and remote medicine from The University of Texas Medical Branch, Henry Ford Hospital, Ontario Telemedicine Network, U.S. Army Institute of Surgical Research, University of Miami, American Telemedicine Association, Doctors Without Borders, and the Pan American Health Organization. The primary objectives of the workshop were to document the medical operations concept for a crewed mission to a NEA, to determine gaps between current capabilities and the capabilities outlined in the operations concept, to identify research required to close these gaps, and to discuss potential collaborations with external-to-NASA organizations with similar challenges. Summary of Discussions and Conclusions: The discussions held during the workshop and the conclusions reached by the workshop participants were grouped into seven categories: Crew Medical Officers, Patient Area in Spacecraft, Training, Electronic Medical Records, Intelligent Care Systems, Consultation Protocols, Prophylactic Surgical Procedures, and Data Prioritization. The key points discussed under each category will be presented.

Barsten, K. N.↗

NASA NTRS2013

Probabilistic Modeling of the Renal Stone Formation Module

The Integrated Medical Model (IMM) is a probabilistic tool, used in mission planning decision making and medical systems risk assessments. The IMM project maintains a database of over 80 medical conditions that could occur during a spaceflight, documenting an incidence rate and end case scenarios for each. In some cases, where observational data are insufficient to adequately define the inflight medical risk, the IMM utilizes external probabilistic modules to model and estimate the event likelihoods. One such medical event of interest is an unpassed renal stone. Due to a high salt diet and high concentrations of calcium in the blood (due to bone depletion caused by unloading in the microgravity environment) astronauts are at a considerable elevated risk for developing renal calculi (nephrolithiasis) while in space. Lack of observed incidences of nephrolithiasis has led HRP to initiate the development of the Renal Stone Formation Module (RSFM) to create a probabilistic simulator capable of estimating the likelihood of symptomatic renal stone presentation in astronauts on exploration missions. The model consists of two major parts. The first is the probabilistic component, which utilizes probability distributions to assess the range of urine electrolyte parameters and a multivariate regression to transform estimated crystal density and size distributions to the likelihood of the presentation of nephrolithiasis symptoms. The second is a deterministic physical and chemical model of renal stone growth in the kidney developed by Kassemi et al. The probabilistic component of the renal stone model couples the input probability distributions describing the urine chemistry, astronaut physiology, and system parameters with the physical and chemical outputs and inputs to the deterministic stone growth model. These two parts of the model are necessary to capture the uncertainty in the likelihood estimate. The model will be driven by Monte Carlo simulations, continuously randomly sampling the probability distributions of the electrolyte concentrations and system parameters that are inputs into the deterministic model. The total urine chemistry concentrations are used to determine the urine chemistry activity using the Joint Expert Speciation System (JESS), a biochemistry model. Information used from JESS is then fed into the deterministic growth model. Outputs from JESS and the deterministic model are passed back to the probabilistic model where a multivariate regression is used to assess the likelihood of a stone forming and the likelihood of a stone requiring clinical intervention. The parameters used to determine to quantify these risks include: relative supersaturation (RS) of calcium oxalate, citrate/calcium ratio, crystal number density, total urine volume, pH, magnesium excretion, maximum stone width, and ureteral location. Methods and Validation: The RSFM is designed to perform a Monte Carlo simulation to generate probability distributions of clinically significant renal stones, as well as provide an associated uncertainty in the estimate. Initially, early versions will be used to test integration of the components and assess component validation and verification (V&V), with later versions used to address questions regarding design reference mission scenarios. Once integrated with the deterministic component, the credibility assessment of the integrated model will follow NASA STD 7009 requirements.

kidney stones↗

NASA NTRS2016

Conceptual Drivers for an Exploration Medical System

Interplanetary spaceflight provides unique challenges that have not been encountered in prior spaceflight experience. Extended distance and timeframes introduce new challenges such as an inability to resupply medications and consumables, inability to evacuate injured or ill crew, and communication delays that introduce a requirement for some level of autonomous medical capability. Because of these challenges the approaches used in prior programs have limited application to a proposed three year Mars mission. This paper proposes a paradigm shift in the approach to medical risk mitigation for crew health and mission objectives threatened by inadequate medical capabilities in the setting of severely limited resources. A conceptual approach is outlined to derive medical system and vehicle needs from an integrated vision of how medical care will be provided within this new paradigm. Using NASA Design Reference Missions this process assesses each mission phase to deconstruct medical needs at any point during a mission. Two operational categories are proposed, nominal operations (pre-planned activities) and contingency operations (medical conditions requiring evaluation) that meld clinical needs and research needs into a single system. These definitions are used to derive a task level analysis to support quantifiable studies into a medical capabilities trade. This trade allows system design to proceed from both a mission centric and ethics-based approach to medical limitations in an exploration class mission.

Antonsen, E.↗

NASA NTRS2020

Enabling Space Exploration Medical System Development Using a Tool Ecosystem

The NASA Human Research Program’s (HRP) Exploration Medical Capability (ExMC) Element is utilizing a Model Based Systems Engineering (MBSE) approach to enhance the development of systems engineering products that will be used to advance medical system designs for exploration missions beyond Low Earth Orbit. In support of future missions, the team is capturing content such as system behaviors, functional decompositions, architecture, system requirements and interfaces, and recommendations for clinical capabilities and resources in Systems Modeling Language (SysML) models. As these products mature, SysML models provide a way for ExMC to capture relationships among the various products, which includes supporting more integrated and multi-faceted views of future medical systems. In addition to using SysML models, HRP and ExMC are developing supplementary tools to support two key functions: 1) prioritizing current and future research activities for exploration missions in an objective manner; and 2) enabling risk-informed and evidence-based trade space analysis for future space vehicles, missions, and systems. This paper will discuss the long-term HRP and ExMC vision for the larger ecosystem of tools, which include dynamic Probabilistic Risk Assessment (PRA) capabilities, additional SysML models, a database of system component options, and data visualizations. It also includes a review of an initial Pilot Project focused on enabling medical system trade studies utilizing data that is coordinated across tools for consistent outputs (e.g., mission risk metrics that are associated with medical system mass values and medical conditions addressed). This first Pilot Project demonstrated successful operating procedures and integration across tools. Finally, the paper will also cover a second Pilot Project that utilizes tool enhancements such as medical system optimization capabilities, post-processing, and visualization of generated data for subject matter expert review, and increased integration amongst the tools themselves.

Amador, Jennifer R.↗

NASA NTRS2020

Enabling Space Exploration Medical System Development Using a Tool Ecosystem

The NASA Human Research Program's (HRP) Exploration Medical Capability (ExMC) Element is utilizing a Model Based Systems Engineering (MBSE) approach to enhance the development of systems engineering products that will be used to advance medical system designs for exploration missions beyond Low Earth Orbit. In support of future missions, the team is capturing content such as system behaviors, functional decompositions, architecture, system requirements and interfaces, and recommendations for clinical capabilities and resources in Systems Modeling Language (SysML) models. As these products mature, SysML models provide a way for ExMC to capture relationships among the various products, which includes supporting more integrated and multi-faceted views of future medical systems. In addition to using SysML models, HRP and ExMC are developing supplementary tools to support two key functions: 1) prioritizing current and future research activities for exploration missions in an objective manner; and 2) enabling risk-informed and evidence-based trade space analysis for future space vehicles, missions, and systems. This paper will discuss the long-term HRP and ExMC vision for the larger ecosystem of tools, which include dynamic Probabilistic Risk Assessment (PRA) capabilities, additional SysML models, a database of system component options, and data visualizations. It also includes a review of an initial Pilot Project focused on enabling medical system trade studies utilizing data that is coordinated across tools for consistent outputs (e.g., mission risk metrics that are associated with medical system mass values and medical conditions addressed). This first Pilot Project demonstrated successful operating procedures and integration across tools. Finally, the paper will also cover a second Pilot Project that utilizes tool enhancements such as medical system optimization capabilities, post-processing, and visualization of generated data for subject matter expert review, and increased integration amongst the tools themselves.

Amador, Jennifer R.↗

NASA NTRSDate not supplied

Developing Mission Segment-Specific Clinical Data for Impact

Space exploration missions represent a significant future objective for NASA’s human spaceflight operations for the near and long term. By operating missions during longer periods and over further distances, NASA’s mission planning models, hardware systems, and medical capabilities will be stretched beyond their original design constraints. The necessity of medical training and medical supply manifesting for such missions is likely to become incredibly intricate as trade-space analysis is performed over varying mission profiles. For this purpose, IMPACT was created to extend and improve the Integrated Medical Model (IMM) which is used for International Space Station (ISS) medical predications and consists of a probabilistic risk assessment tool that simulates missions to calculate risks given the constraints on crew complement, mission duration and activity (such as Extravehicular Activities), power, communication, mass, volume, and evacuation consideration as well as to predict mission outcomes. Currently, the medical evidence used to support IMPACT remains static, addressing risks of a medical condition and the impacts of the condition during spaceflight only, but is only calculated for a small number of mission parameters. Extended missions will consist of new and varied living environments, changing gravitational loads, and dynamic working requirements. Medical risks are not typically constant but will change depending upon the physical and physiological environment of the body during all phases of a mission. Risks are likely to shift during different mission segments, and understanding how components of a mission profile change risks will assist mission planners to increase chances for mission success.

Christopher Zahner↗

NASA NTRS2003

An Independent Human Factors Analysis and Evaluation of the Emergency Medical Protocol Checklist for the International Space Station

Emergency medical capabilities aboard the ISS include a Crew Medical Officer (CMO) (not necessarily a physician), and back-up, resuscitation equipment, and a medical checklist. It is essential that CMOs have reliable, usable and informative medical protocols that can be carried out independently in flight. The study evaluates the existing ISS Medical Checklist layout against a checklist updated to reflect a human factors approach to structure and organization. Method: The ISS Medical checklist was divided into non-emergency and emergency sections, and re-organized based on alphabetical and a body systems approach. A desk-top evaluation examined the ability of subjects to navigate to specific medical problems identified as representative of likely non-emergency events. A second evaluation aims to focus on the emergency section of the Medical Checklist, based on the preliminary findings of the first. The final evaluation will use Astronaut CMOs as subjects comparing the original checklist against the updated layout in the task of caring for a "downed crewmember" using a Human Patient Simulator [Medical Education Technologies, Inc.]. Results: Initial results have demonstrated a clear improvement of the re-organized sections to determine the solution to the medical problems. There was no distinct advantage for either alternative, although subjects stated having a preference for the body systems approach. In the second evaluation, subjects will be asked to identify emergency medical conditions, with measures including correct diagnosis, time to completion and solution strategy. The third evaluation will compare the original and fully updated checklists in clinical situations. Conclusions: Initial findings indicate that the ISS Medical Checklist will benefit from a reorganization. The present structure of the checklist has evolved over recent years without systematic testing of crewmember ability to diagnose medical problems. The improvements are expected to enable ISS Crewmembers to more speedily and accurately respond to medical situations on the ISS.

Marshburn, Thomas↗

NASA NTRSDate not supplied

Earth-Independent Medical Operations (EIMO) Concept of Operations

In contrast to the current crew health paradigm for low-Earth orbit and Lunar missions, which depends on real-time communication with Mission Control, deep-space exploration missions will require a significant shift in medical operations. This shift is driven by the constraints of operating at a considerable distance from Earth, such as resource limitations—lack of resupply, restricted mass, power, volume, and data—as well as communication delays and the inability to evacuate back to Earth during emergencies. To move toward a more self-reliant medical model, a strategy is needed to gradually increase space-based crew autonomy and reduce risks to mission success in the challenging environment of deep space. This transformative change, known as "Earth-Independent Medical Operations" (EIMO), explores the gradual transfer of medical care and decision-making from Earth-based support to space-based systems. The goal of this transition is to enhance astronaut health and performance while minimizing mission risks. EIMO requires the development of a medical system that integrates seamlessly with mission planning, vehicle and spacesuit design, and data architecture. This integration is crucial for building a robust medical infrastructure that not only safeguards astronaut well-being but also ensures overall mission success. The Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has revised the EIMO model-based Concept of Operations (ConOps) which outlines an initial vision for EIMO. The ConOps, which is built on the stakeholders’ need, system goals, and objectives (NGOs), presents an array of in-mission scenarios that span a wide range of medical conditions demonstrating the system’s capabilities from basic to complex events. Developed by a multidisciplinary team of systems engineers, scientists, and clinicians within ExMC, the ConOps revision includes two new scenarios(Barotrauma and Self-Medical Management and Behavioral Health and Chronic Medical Care), and implementation of findings from EIMO technical interchange meetings that focused on data and training. The envisioned EIMO Medical System (MS) operates as a system of systems, gathering data from various sources such as reference databases, real-time wearable sensors, point-of-care diagnostics, and environmental controls. The MS also incorporates advanced training tools to support autonomous medical care, assisting the Crew Medical Officer (CMO) during medical events where Ground Support is either unavailable or communication-delayed beyond practicality. Furthermore, MS functions and capabilities were decomposed from the scenarios to establish foundational requirements for EIMO and traced to the NASA Spaceflight Human-System Standard(NASA-STD-3001, Volumes 1 and 2). These traces were performed to gain insights on the alignment of EIMO requirements with the NASA standard. This work serves as an initial recommendation to increase crew autonomy gradually and safely for Mars missions and future deep-space exploration.

medical system↗

NASA NTRSDate not supplied

How Environment and Operational Considerations Guide Requirements Development for Clinical Decision Support Beyond Low Earth Orbit

The Aerospace Medical community is acutely aware of the need for automated cognitive systems to support astronauts in responding to and making critical decisions about assessing – and treating - medical conditions and assuring wellness during exploration spaceflight missions. Such systems will be critically important to mission success as we venture farther from terrestrial settings (particularly low-earth orbit platforms) and encounter increasingly Earth-independent medical decision-making scenarios and requirements. This need would likely be met through the development of a Clinical Decision Support System (CDSS) that assimilates information from various sources (e.g., vehicle environmental control system, blood pressure cuff, and heart rate monitor) integrated with medical and wellness data to provide detailed guidance tailored to individual crew member needs. This presentation will address some of the fundamental considerations and their implications that must be fully understood by CDSS requirement developers early in the system lifecycle.

B Burian↗

NASA NTRSDate not supplied

Earth-Independent Medical Operations (EIMO) Concept of Operations

Compared to the current paradigm for crew health in low-Earth orbit and Lunar missions that rely on constant communication with Mission Control, there is an anticipated shift in medical operations for deep-space exploration missions. This shift stems from mission constraints imposed by the considerable distance from Earth, which include resource limitations due to a lack of resupply, mass, power, volume, and data limitations, challenges imposed by communication latency and the inability to evacuate in case of emergencies. To transition towards a more self-reliant medical approach, a comprehensive strategy is essential to progressively enable crew autonomy and mitigate mission success risks in the challenging environment of space. This transformative shift is collectively referred to as "Earth-Independent Medical Operations" (EIMO), signifying the gradual transfer of medical care and decision-making from terrestrial resources to space-based assets. This transition is aimed at bolstering astronaut health and performance while simultaneously reducing the overall risks associated with space missions. The constraints related to EIMO necessitate an integrated development of medical systems, featuring interoperability with mission planning, vehicle design, spacesuit design, and data architecture. This integration is vital in establishing a robust medical infrastructure that not only supports the well-being of astronauts but also ensures the success of the mission as a whole. The Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has developed a model-based Concept of Operations (ConOps) outlining an initial vision for EIMO. Within this ConOps, a comprehensive view is presented, encompassing stakeholder needs, system objectives, and system goals associated with EIMO. Additionally, it provides illustrative examples of the various activities (scenarios) for which the system will be employed during missions. The selection of these activities has been meticulous, aiming to encompass a wide spectrum of medical conditions, including those falling under different risk categories, such as low-likelihood-low-consequence, low-likelihood-high-consequence, and high-likelihood-low-consequence. The selection of these activities (scenarios) effectively encompasses the wide range of medical events situated within an assumed probability-consequence bell curve. In each scenario, at least one of the five main EIMO components identified is captured. Those EIMO components are: Pre-mission Planning, Acute and Emergent Management Decision Making, Prolonged Medical Management Decision Making, Supplies and Resource Management, and Task Load Management. The ConOps was developed by a multidisciplinary team consisting of systems engineers, scientists, and clinicians across NASA and aims to serve as an initial recommendation to gradually and safely enabling crew autonomy for Mars missions and beyond.

Earth Independent Medical Operations↗

NASA NTRS2024

Earth-Independent Medical Operations (EIMO) Concept of Operations (ConOps)

Earth Independent Medical Operations↗

NASA NTRS2015

Human System Risk Management for Space Flight

This brief abstract reviews the development of the current day approach to human system risk management for space flight and the development of the critical components of this process over the past few years. The human system risk management process now provides a comprehensive assessment of each human system risk by design reference mission (DRM) and is evaluated not only for mission success but also for long‐term health impacts for the astronauts. The discipline of bioastronautics is the study of the biological and medical effects of space flight on humans. In 1997, the Space Life Sciences Directorate (SLSD) initiated the Bioastronautics Roadmap (Roadmap) as the "Critical Path Roadmap", and in 1998 participation in the roadmap was expanded to include the National Space Biomedical Research Institute (NSBRI) and the external community. A total of 55 risks and 250 questions were identified and prioritized and in 2000, the Roadmap was base-lined and put under configuration control. The Roadmap took into account several major advisory committee reviews including the Institute of Medicine (IOM) "Safe Passage: Astronaut care for Exploration Missions", 2001. Subsequently, three collaborating organizations at NASA HQ (Chief Health and Medical Officer, Office of Space Flight and Office of Biological & Physical Research), published the Bioastronautics Strategy in 2003, that identified the human as a "critical subsystem of space flight" and noted that "tolerance limits and safe operating bands must be established" to enable human space flight. These offices also requested a review by the IOM of the Roadmap and that review was published in October 2005 as "A Risk Reduction Strategy for Human Exploration of Space: A Review of NASA's Bioastronautics Roadmap", that noted several strengths and weaknesses of the Roadmap and made several recommendations. In parallel with the development of the Roadmap, the Office of the Chief Health and Medical Officer (OCHMO) began a process in 2004 of evaluating the tolerance limits and safe operating bands called for in the Bioastronautics Strategy. Over the next several years, the concept of the "operating bands" were turned into Space Flight Human System Standards (SFHSS), developed by the technical resources of the SLSD at the NASA Johnson Space Center (JSC). These standards were developed and reviewed at the SLSD and then presented to the OCHMO for acceptance. The first set of standards was published in 2007 as the NASA‐STD‐3001, Volume 1, Crew Health that elaborated standards for several physiological areas such as cardiovascular, musculoskeletal, radiation exposure and nutrition. Volume 2, Human Factors, Habitability and Human Health was published in 2011, along with development guidance in the Human Integration Design Handbook (HIDH). Taken together, the SFHSS Volumes 1 and 2, and the HIDH replaced the NASA‐STD‐3000 with new standards and revisions of the older document. Three other changes were also taking place that facilitated the development of the human system risk management approach. In 2005, the life sciences research and development portfolio underwent a comprehensive review through the Exploration Systems Architecture Study (ESAS) that resulted in the reformulation of the Bioastronautics Program into Human Research Program (HRP) that was focused on appropriate mitigation results for high priority human health risks. The baseline HRP budget was established in August 2005. In addition, the OCHMO formulated the Health and Medical Technical Authority (HMTA) in 2006 that established the position of the Chief Medical Officer (CMO) at the NASA JSC along with other key technical disciplines, and the OCHMO became the responsible office for the SFHSS as noted above. The final change was the establishment in 2008 of the Human System Risk Board (HSRB), chaired by the CMO with representation from the HRP, SLSD management and technical experts. The HSRB then began to review all human system risks, established a comprehensive risk management and configuration management plan and data sharing policy. These major developments of standards, the HRP, the HMTA and a forum for review of human system risks (HSRB) facilitated the integration of human research, medical operations, systems engineering and many other disciplines in the comprehensive review of human system risks. The HSRB began a comprehensive review of all potential inflight medical conditions and events and over the course of several reviews consolidated the number of human system risks to 30 where the greatest emphasis is placed for investing program dollars for risk mitigation. The HSRB considers all available evidence from human research, medical operations and occupational surveillance in assessing the risks for appropriate mitigation and future work. All applicable DRMs (low earth orbit 6 and 12 months, deep space sortie for 30 days and 1 year, a one year lunar mission, and a planetary mission for 3 years) are considered as human system risks are modified by the hazards associated with space flight such as microgravity, exposure to radiation, distance from the earth, isolation and a closed environment. Each risk has a summary assessment representing the state of knowledge/evidence base for that risk, the available risk mitigations, traceability to the SFHSS and program requirements, and future work required. These data then can drive coordinated budgets across the HRP, the International Space Station, Crew Health and Safety and Advanced Exploration System budgets. These risk assessments were completed for 6 DRMs in December of 2014 and serve as the baseline for which subsequent research and technology development and crew health care portfolios can be assessed. The HSRB will review each risk at least annually and especially when new information is available that must be considered for effective risk mitigation. The current status of each risk can be reported to program management for operations, budget reviews and general oversight of the human system risk management program.

Davis, Jeffrey↗

NASA NTRS2017

Personalized Risk Assesment for Adverse Drug Reactions and Treatment Failures

As NASA and other space agencies prepare for future long-term space missions beyond the LEO, the cumulative impact of risk factors encountered in space increases substantially rising concerns about astronauts health. Application of on-board medications to mitigate clinical symptoms associated with certain medical conditions and illnesses is the first line of response to ensure sustainable health and performance of crew. Unfortunately, very limited research has been conducted to determine efficacy of the earth-based pharmaceuticals in a microgravity environment. In some instances, orally administered medications taken during flight were reported to be less effective than expected. Evaluation of series of experiments involving astronauts from shuttle flights shows notable individual variability to several pharmaceuticals during flight. These data provide reasonable assumption of perturbation in CYP450 enzymes during spaceflight, which contribute to the hepatic metabolism of the majority of drugs and therefore may have significant effects on therapeutic efficacy and increase treatment-related toxicity. The genes encoding the CYP450 enzymes are highly variable in humans. Inheritable variations of CYP450 hepatic metabolizer enzymes and transport proteins play a crucial role in the inter-individual variability of drug efficiency and risks of adverse drug reactions. Additionally, there are some reports that document changes in the levels of production of drug-metabolizing enzymes in microgravity. Therefore, in order to provide a safe and effective pharmaceutical treatment in space, medications selection should be based not only on the specific efficacy of medications but also on the individual drug sensitivity and flight-induced changes in metabolism of astronauts chosen for a particular mission. To our knowledge, there was no pre-flight drug sensitivity testing on a genetic level for any of the previous manned NASA space missions. Therefore, technologies capable of predicting and managing medication efficacy, side effects, and toxicity of drugs based on individual genetic variability of crew members are increasingly needed. In this report, we present results of testing the market available Personalized Prescribing System (PPS), a comprehensive, non-invasive solution for safer, targeted medication management for every crew member. Statistical accuracy and simplicity of non-invasive sample analysis demonstrate the feasibility of drug sensitivity assessment and record-keeping tool for flight surgeons and astronauts in applying the recommended medications for situations arising in flight. The information on individual drug sensitivity will translate into personalized risk assessment for adverse drug reactions and treatment failures for each drug from the medication kit as well as predefined outcome. This will address the HHC’s raised “Concern of Clinically Relevant Unpredicted Effects of Medication” as recently updated.

medications↗

NASA NTRSDate not supplied

A Strategy for Advancing Earth Independent Medical Operations

Exploration medical operations to the Moon and Mars present unprecedented challenges for providing in-mission medical care. The greater distance from Earth is the primary hazard that drives the need for a medical operations paradigm shift from low earth orbit mission. Increasingly complex long duration and long distance missions will have resource constraints (ex: mass, power, volume, data), a paucity of resupply or evacuation opportunities, and disruptions in real-time communications. In order to advance a more autonomous medical approach, a multi-faceted strategy will need to optimize all aspects of human health and performance in space. This strategy will include: increasing onboard medical autonomy through the development of novel crew health and performance systems; decision support capabilities to augment astronauts’ abilities in preventing, diagnosing, and treating medical conditions; creating new procedures and training tools for skill maintenance and just-in-time training; and enabling rapid crew access to data from all on-board systems, leading to better-informed, real-time, autonomous decisions. Collectively, this approach can be referred to as “Earth Independent Medical Operations” (EIMO). The Exploration Medical Capability Element of NASA’s Human Research Program has undertaken a longitudinal planning process to consensus around EIMO. Technical interchange meetings will occur with key constituents in late 2022 and again in early 2023 to define EIMO in practical terms and identify key elements of an EIMO system, with greater conceptual articulation and dissemination planned for the second half of 2023. We will share insights into the strategy for internal and external consensus building around EIMO, with a particular focus on the approach to partner stakeholders within NASA as well as commercial agencies.

Jay Lemery↗