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NASA NTRS2017

The Integrated Medical Model: Outcomes from Independent Review

In 2016, the Integrated Medical Model (IMM) v4.0 underwent an extensive external review in preparation for transition to an operational status. In order to insure impartiality of the review process, the Exploration Medical Capabilities Element of NASA's Human Research Program convened the review through the Systems Review Office at NASA Goddard Space Flight Center (GSFC). The review board convened by GSFC consisted of persons from both NASA and academia with expertise in the fields of statistics, epidemiology, modeling, software development, aerospace medicine, and project management (see Figure 1). The board reviewed software and code standards, as well as evidence pedigree associated with both the input and outcomes information. The board also assesses the models verification, validation, sensitivity to parameters and ability to answer operational questions. This talk will discuss the processes for designing the review, how the review progressed and the findings from the board, as well as summarize the IMM project responses to those findings. Overall, the board found that the IMM is scientifically sound, represents a necessary, comprehensive approach to identifying medical and environmental risks facing astronauts in long duration missions and is an excellent tool for communication between engineers and physicians. The board also found IMM and its customer(s) should convene an additional review of the IMM data sources and to develop a sustainable approach to augment, peer review, and maintain the information utilized in the IMM. The board found this is critically important because medical knowledge continues to evolve. Delivery of IMM v4.0 to the Crew Health and Safety (CHS) Program will occur in the 2017. Once delivered for operational decision support, IMM v4.0 will provide CHS with additional quantitative capability in to assess astronaut medical risks and required medical capabilities to help drive down overall mission risks.

medical equipment↗
NASA NTRS2018

Medical Simulations for Exploration Medicine

Medical simulation is a useful tool that can be used to train personnel, develop medical processes, and assist cross-disciplinary communication. Medical simulations have been used in the past at NASA for these purposes, however they are usually created ad hoc. A stepwise approach to scenario development has not previously been used. The NASA Exploration Medical Capability (ExMC) created a medical scenario development tool to test medical procedures, technologies, concepts of operation and for use in systems engineering (SE) processes.

Reyes, David↗
NASA NTRS2016

Wearable Biosensor Monitor to Support Autonomous Crew Health and Performance

During future human exploration missions, spaceflight crews will encounter adverse health outcomes and decrements in performance during the missions and for long term health. The Psychophysiological Research Lab is currently conducting a technology demonstration of a prototype wearable biosensor system (Astroskin) on astronaut surrogates during 30 day missions within NASAs Human Exploration Research Analog (HERA). HERA, located at Johnson Spaceflight Center, represents a flight analog for simulation of isolation, confinement and remote conditions of mission exploration scenarios. Astroskin, an autonomous medical monitoring system, consists of an intelligent garment for the upper body and a headband fitted with sensors, and associated software and hardware that can measure, transmit and store vital signs (ECG, respiration, blood pressure, etc.), sleep quality and activity level of the wearer. One of the main goals of the technology demonstration is to evaluate the performance of the Astroskin system (i.e., data quality), crew usability and comfort. To validate the Astroskin as a viable option for use during future spaceflight missions, crew data from HERA are sent to Ames researchers for processing and analyses. Crew surveys on usability and comfort will also be evaluated. This work supports the Exploration Medical Capabilities element within NASAs Human Research Program.

space analog↗
NASA NTRS2019

ExMC Approach to Pharmaceutical Stability Research: An Overview

Goals of Stability Studies: Identify medications that are stable under real and simulated space conditions, especially deep space radiation; Identify medications that are potent and safe after their expiration dates; Ultimately provide a safe and effective formulary for exploratory spaceflight missions. ExMC: Exploration Medical Capabilities.

Cory, Wendy↗
NASA NTRSDate not supplied

Developing a Medical System Foundation for Level of Care IV: Short-Duration Lunar Orbit

The Human Research Program (HRP) Exploration Medical Capability (ExMC) element has developed a Medical System Foundation for Level of Care IV, as defined by NASA’s space flight human-system standards, for short-duration lunar orbit missions by employing a systems engineering approach using model-based systems engineering tools. This Foundation includes a concept of operations, medical system architecture, associated functional and non-functional requirements and rationales, and medical conditions, capabilities, and resources. Collectively, these serve as a starting point (“Foundation”) for a medical system that meets the Level of Care IV requirement. The Foundation also includes traces to the current versions of NASA standards documents and lower (e.g., sub-system) and higher (e.g., vehicle system) level requirements. Stakeholders can use the Foundation to analyze the traces between medical capabilities, medical conditions, medical resources, and requirements; identify medical system interfaces with other vehicle systems/subsystems; and as a basis for performing trades on risks vs. medical system mass and volume allocation. To facilitate communication of the Foundation to stakeholders who do not have access to the modeling tools used, an HTML representation of the Foundation was created. This discussion will focus on the processes through which the Medical System Foundation was developed, how the Foundation builds a bridge between the medical and engineering domains and facilitates communication between these communities, and how these processes can be applied more broadly to a crew health and performance system and other system domains.

S. Lumpkins↗
NASA NTRSDate not supplied

Developing A New Medical Condition List for Exploration Spaceflight

For the last decade, the National Aeronautics and Space Administration (NASA) has utilized a probabilistic risk analysis tool called the Integrated Medical Model (IMM), which contains 100 medical conditions, to conduct medical trade-space analyses and risk assessments for International Space Station (ISS) operations. Planning for future missions to the Moon and Mars will require updated tools and evidence that consider the unique features of exploration missions. To address this need, the Exploration Medical Capability (ExMC) Element of the NASA Human Research Program is developing an advanced trade-space analysis tool suite, IMPACT. As a part of this effort, ExMC has produced the IMPACT version 1 Condition List (ICL 1.0) which expands the scope and definition of medical conditions.

Amy Jean Kreykes↗
NASA NTRSDate not supplied

A Model-Based Systems Engineering Journey to Developing a Concept of Operations

Starting in 2017, NASA’s Human Research Program (HRP) Exploration Medical Capability (ExMC) element began a systems engineering transition from traditional, document-centric development to model-centric development when defining its foundation medical systems. These foundation medical systems define a Concept of Operations (ConOps) and identify the generic requirements for a medical system based on assumptions about a generic crew and mission environments and guidance from NASA standards (e.g., Medical “Levels of Care”). By making the transition, ExMC intends to improve communication among stakeholders about foundation medical system requirements and content. In addition, this transition will enable ExMC to lower both development and crew treatment risks for future, mission-specific medical systems. ExMC followed a Model Based Systems Engineering (MBSE) paradigm when developing the foundation medical systems. A model-based approach provides several advantages over a traditional, document-centric approach. First, when Systems Engineers (SE) develop diagrams in a model using a standard modeling language, they produce information dense pictures that facilitate understanding much more efficiently with less room for misinterpretation than text. Second, due to the evolving nature of projects, documentation becomes out of date the minute it is published. This can result in people making decisions based on information that is no longer current, especially if they are referencing a locally-stored copy of a document. A model, on the other hand, is always up to date with the latest approved changes and information. It serves as a single point of truth. Third, a model-centric approach centralizes all important information in one place. Rather than having to flip through separate ConOps documents, design specifications, requirements specifications, and the like to coordinate information, a model captures the content in one, integrated spot. This integration makes tracing information from end-to-end easier with greater reliability. The ExMC Systems Engineering Lifecycle follows a well-defined process. ExMC Systems Engineers perform all major steps of the process, regardless of the development methodology. One of the first steps in the process is developing the ConOps that describes the operation of the system from the point of view of the users. It includes a list of the users and their needs, the goals of the medical system, key assumptions about the system, and definitions of the medical system’s operational environments. For this development effort, ExMC chose to replace the traditional text-based ConOps document with a model. While the decision to change the development workflow was not difficult, implementing the structural and organizational workflows were. It required showing ExMC’s users, most of whom are not Systems Engineers, how the information they require would be presented in the model and to gain their acceptance of this approach. This paper documents key lessons learned during the ConOps transformation by focusing on how the model represents information, the agile workflow used by SEs when developing the model and how it integrates into a project plan, how leadership influenced key users to accept the transformation, and how the users interact with the model information.

Jeffrey Robert Cohen↗
NASA NTRSDate not supplied

ExMC Ground-Based Space Radiation Analog Pilot Drug Stability Studay: Final Data Review

Uncertainty regarding space radiation effects on medication degradation and potency remains high, though early data suggest that space radiation may affect the potency and quality of some pharmaceuticals. In the absence of empirical spaceflight measurements to characterize this risk area for long-duration planetary missions, high-fidelity ground-based targeted radiation analogs could provide valuable insights. The NASA Human Research Program's (HRP) Exploration Medical Capability (ExMC) Element conducted a pilot study to characterize the chemical stability of four selected medications exposed to rapid switching, mixed-species simulated galactic cosmic radiation (GCR) beams at the NASA Space Radiation Laboratory (NSRL), at Brookhaven National Laboratory (BNL). The research objective was to compare the effects of simulated GCR beam exposures on drug stability to those previously observed following spaceflight.

Vernie R Daniels↗
NASA NTRSDate not supplied

Application of Agile for Systems Engineering, Project Management and Modeling and Lessons Learned

The Systems Engineering team within the Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has been transforming its development processes to be more efficient, robust,and responsive to change and to its stakeholders. To these ends, the Systems Engineering team trialed the integration of agile development techniques into existing and new processes. Agile development methods are well understood within the software development community. Outside ofsoftware development, however, how non-software project management (PM) and systems engineering (SE) teams implement agile development techniques is less well understood. In its transformation efforts, the ExMC SE team focused on three main areas: Improving the project communications among subsystem teams and stakeholders by adopting a scrum-like process, Changing the status and reporting mechanisms to improve schedule coordination between the subsystem team, SE leadership, and ExMC Element leadership, and Unifying the model-based SE workflow to improve understanding of Concepts of Operations across projects.This presentation highlights several of these transformations and what the SE team learned while undergoing the transformation.

S Lumpkins↗
NASA NTRSDate not supplied

IMPACT User Experience

NASA Human Research Project (HRP) and Exploration Medical Capabilities (ExMC) team identified a need to implement a human-centered design approach for a computational tool that performs detailed trade space analysis and research prioritization, known as Informing Mission Planning via Analysis of Complex Tradespaces (IMPACT). IMPACT processes numerous parameters such as space vehicle design, mission objectives, evacuation capability, medical events, and mission constraint, including but not limited to; duration, mass, volume, equipment, and medical capability, each with complex and interconnected relationships. The ability for users to navigate through these complexities and provide an intuitive report is critical to aiding stakeholders in the decision-making process of future missions. In this presentation we will discuss how the IMPACT team has applied human-centered design strategies to improve system usability by modelling human-system integration (i.e., task analysis) with the MagicDraw SysML modelling application and performing A/B testing of user interface prototypes.

S Ozbek↗
NASA NTRSDate not supplied

Medical System Foundation Overview for Long-Duration Lunar Orbit and Surface Operations Missions

The Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has developed a Medical System Foundation for Level of Care IV, as defined by NASA’s space flight human-system standards, for long-duration lunar orbit and surface operation missions by employing a systems engineering approach using model-based systems engineering tools. This Foundation model includes a concept of operations; functional decomposition; clinical content (medical conditions, capabilities, and resources); associated functional, interface and non-functional technical requirements; and traces to the current versions of NASA standards documents and parent-level (Program- and Vehicle habitat system level) requirements. Collectively, these components constitute a foundation that serves as a starting point for a medical system that meets the Level of Care IV requirement. The Foundation was developed by a multidisciplinary team consisting of systems engineers, scientists, and clinicians across NASA, and information is presented in an easily accessible format that is understandable across disciplines. Stakeholders can use the Foundation to analyze the traces between medical capabilities, medical conditions, medical resources, and requirements and to identify medical system interfaces with other vehicle systems/subsystems. It can also be used as a basis for performing trades on risks vs. medical system mass and volume allocation. This discussion will focus on the processes through which the Medical System Foundation was developed, how the Foundation builds a bridge between the medical and engineering domains and facilitates communication between these communities, and how these processes can be applied more broadly to a crew health and performance system and other system domains. The presentation also discusses Foundation modifications based on the recently updated versions of the NASA 3001 Standards.

S. Lumpkins↗
NASA NTRSDate not supplied

Lessons Learned from Medical System Foundation Development for Long-Duration Lunar Orbit and Lunar Surface Missions

The Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has been tasked with the development of Medical System Foundations for Level of Care IV for both short-duration lunar orbital missions and, subsequently, long-duration lunar orbital and surface operations missions. These Medical System Foundations serve as a framework to aid in early medical system design and mission planning. The content of both Foundation models is similar, consisting of a concept of operations, functional decomposition, clinical content (medical conditions, capabilities, and resources), technical requirements (interface, non-functional, and functional), and traces between these components and to the NASA standards documents and parent-level (Program- and Vehicle habitat system-level) requirements. Additionally, the development of both Foundations employed systems engineering principles and a model-based systems engineering (MBSE) approach. Throughout the development of these Foundations, ExMC has strived to improve the efficiency and robustness of its processes and to be more responsive to change (i.e., in design reference mission parameters and assumptions) and to stakeholders’ feedback. The most significant improvements made between the short- and long-duration Foundation models during this transformation process are the following: • Replacement of the traditional document-based ConOps with a model-based ConOps according to MBSE principles, which facilitated more efficient understanding of the material and the consolidation of all relevant information into a centralized location. • Utilization of an agile approach with tasks organized into sprints. This approach enabled solicitation of more frequent usability feedback from stakeholders, incorporation of more human factors reviews into the sprints, and more efficient tasking of team members. This presentation will discuss the journey of developing both Foundation models, as well as the lessons learned and resulting improvements made between the Short- and Long-Duration models.

M Kaetzer↗
NASA NTRSDate not supplied

The Evolution of the Impact Evidence Library Methods – What We Learned

During fiscal years 2020-2022 NASA’s Human Research Program, Exploration Medical Capability Element has worked to source this evidence for the model. During the process several lessons learned have been identified and drive recommendations for future efforts. The ICL 1.0: Spaceflight Medical Operational expertise should be consulted regarding the addition of future conditions. A clinician experienced with the nuances of spaceflight is recommended to have a minimum of 20 hours per condition to adequately source the evidence. Condition definitions should be carefully crafted to maintain mutual exclusivity. Common side effects from medications, common and consequential incidental findings in laboratory studies, and consequential side effects of diagnostic and procedural capabilities should be considered for inclusion as unique conditions in future iterations of the ICL 1.0. Incidence: Spaceflight incidence, although based on small population sizes, is the gold standard. Terrestrial incidence should be applied cautiously. Probability of minor vs. severe cases of the condition: Data informing severity probability of the medical condition are nearly always terrestrial. Special attention should be paid to this metric as it drives outcomes in the model and terrestrial data often overestimate severity of expected cases in spaceflight. Condition duration: Three clinical phases currently exist in the model. They represent the time necessary for diagnosis, treatment/convalescence/recurrence, and the remaining duration of the mission after maximal recovery, respectively. Further subdivision of acute and convalescent treatment/recurrence is recommended. Probability of need for evacuation: Surrogates for “Return to Definitive Care” were chosen prior to data collection. In most cases these surrogates were “need for hospitalization” or “need for surgery.” For many conditions these may not be realistic drivers of “Return to Definitive Care” and should be re-examined. Probability of Crew Mortality: Terrestrial mortality data is difficult to apply to astronauts who, invariably, have less comorbidities than terrestrial subjects. It must be applied judiciously. The proportion of mission tasks impaired by the condition: “Task Impairment” was assigned to each condition prior to the condition duration data becoming available. Future efforts should assign Task Impairment as the final step in sourcing the evidence.

A.J. Kreykes↗
NASA NTRSDate not supplied

Medical System Requirements Development for Lunar Operations

The major health hazards of spaceflight include higher levels of damaging radiation, altered gravity, extended periods of isolation and confinement, a closed and potentially hostile living environment, and the stress associated with being a long distance from Earth. As we increase the duration of lunar stays with foreseeable communication latencies and disruptions, there will be a progressive need for crew to maintain their own health and independently respond to critical medical events. The Exploration Medical Capability element of the NASA Human Research Program is developing a set of Medical System requirements for lunar transit and surface operations. These requirements specify the capabilities, processes and procedures of a habitat Medical System needed for a range of conditions known to occur during spaceflight. Requirement text is written so as not to constrain innovative design solutions necessary for a resilient system. The requirement set includes attributes and functions the Medical System imposes on eight additional habitat systems. A key property of the Medical System is the provision of medical knowledge that will be stored, updated, analyzed, and secured within a Habitat Data System. A Task Performance Support System will aid in medical data acquisition and interpretation, crew training, medical condition prevention, diagnosis and treatment, provide interactive procedures, and track medical inventory. A Wellness System will focus on the provision of countermeasures to prevent, mitigate or treat adverse physical and behavioral health effects while the Medical System recommends adjustments to these countermeasures to maintain crew health. An Environmental Monitoring System will share out-of-bounds readings of air and water quality, acoustics, and radiation exposure levels with the Medical System to help identify issues before they affect crew health and performance. A Communications System will provide secured and private consultations between crew and the ground medical team and their loved ones on Earth. The Medical System also imposes requirements on a Research & Testbed System, fostering advanced medical science such as human research. A Waste Management System provides biohazard waste containment and waste disposal options (recycle and reuse). An Extravehicular Activity System supports crew health during lunar surface activities. And finally, a Maintenance Support System ensures that medical equipment is performing as expected. These requirements are being specifically developed for lunar surface operations but could help to identify Medical System requirements for any space habitat (e.g., I-Hab, commercial endeavors, etc.).

technology↗
NASA NTRSDate not supplied

ExMC Systems Engineering Status

The Exploration Medical Capability (ExMC) Element within the Human Research Program (HRP) applies systems engineering principles along with the use of Model-Based Systems Engineering (MBSE) tools to identify and communicate the requirements for medical and crew health and performance (CHP) systems. The MBSE approach to medical system design offers a paradigm shift toward greater integration between the vehicle and a human health and performance system. In addition, the MBSE tools provide a means in which systems engineers can develop different views of the relationships between and among requirements, standards, functions, and capabilities, to name a few, that is best suited for a user’s objectives. Applying these tools, ExMC Systems Engineering (SE) developed three MBSE models in support of multiple projects in fiscal year (FY) 2023. These included the Long-Duration Lunar Orbit and Lunar Surface (LDLOLS) Medical System Foundation, Earth-Independent Medical Operations (EIMO) medical system ConOps, and the 2023 Artemis CHP System model. This talk will provide a high-level overview of what the ExMC SE team has accomplished since the last Investigators’ Workshop, an introduction to upcoming SE talks, and the ongoing systems engineering work.

Systems engineering↗
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 NTRSDate not supplied

ExMC Systems Engineering Status

The Exploration Medical Capability (ExMC) Element within the Human Research Program (HRP) applies systems engineering principles along with the use of Model-Based Systems Engineering (MBSE) tools to identify and communicate the requirements for medical and crew health and performance (CHP) systems. The MBSE approach to medical system design offers a paradigm shift toward greater integration between the vehicle and a human health and performance system. In addition, the MBSE tools provide a means in which systems engineers can develop different views of the relationships between and among requirements, standards, functions, and capabilities, to name a few, that is best suited for a user’s objectives. Applying these tools, ExMC Systems Engineering (SE) developed three MBSE models in support of multiple projects in fiscal year (FY) 2023. These included the Long-Duration Lunar Orbit and Lunar Surface (LDLOLS) Medical System Foundation, Earth-Independent Medical Operations (EIMO) medical system ConOps, and the 2023 Artemis CHP System model. This talk will provide a high-level overview of what the ExMC SE team has accomplished since the last Investigators’ Workshop, an introduction to upcoming SE talks, and the ongoing systems engineering work.

Systems engineering↗
NASA NTRS2024

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

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↗