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Aerospace medical and bioengineering considerations in M-2 lifting body research vehicle, discussing protective equipment, escape and medical monitoring systems
Now, more than ever before, NASA is realizing the value and importance of their intellectual assets. Principles of knowledge management-the systematic use and reuse of information, experience, and expertise to achieve a specific goal-are being applied throughout the agency. LSDA is also applying these solutions, which rely on a combination of content and collaboration technologies, to enable research teams to create, capture, share, and harness knowledge to do the things they do well, even better. In the early days of spaceflight, space life sciences data were collected and stored in numerous databases, formats, media-types and geographical locations. These data were largely unknown/unavailable to the research community. The Biomedical Informatics and Health Care Systems Branch of the Space Life Sciences Directorate at JSC and the Data Archive Project at ARC, with funding from the Human Research Program through the Exploration Medical Capability Element, are fulfilling these requirements through the systematic population of the Life Sciences Data Archive. This project constitutes a formal system for the acquisition, archival and distribution of data for HRP-related experiments and investigations. The general goal of the archive is to acquire, preserve, and distribute these data and be responsive to inquiries for the science communities. Information about experiments and data, as well as non-attributable human data and data from other species' are available on our public Web site http://lsda.jsc.nasa.gov. The Web site also includes a repository for biospecimens, and a utilization process. NASA has undertaken an initiative to develop a Shuttle Data Archive repository. The Shuttle program is nearing its end in 2010 and it is critical that the medical and research data related to the Shuttle program be captured, retained, and usable for research, lessons learned, and future mission planning. Communities of practice are groups of people who share a concern or a passion for something they do, and learn how to do it better as they interact regularly. LSDA works with the HRP community of practice to ensure that we are preserving the relevant research and data they need in the LSDA repository. An evidence-based approach to risk management is required in space life sciences. Evidence changes over time. LSDA has a pilot project with Collexis, a new type of Web-based search engine. Collexis differentiates itself from full-text search engines by making use of thesauri for information retrieval. The high-quality search is based on semantics that have been defined in a life sciences ontology. Additionally, Collexis' matching technology is unique, allowing discovery of partially matching dicuments. Users do not have to construct a complicated (Boolean) search query, but can simply enter a free text search without the risk of getting "no results". Collexis may address these issues by virtue of its retrieval and discovery capabilities across multiple repositories.
As NASA transitions its focus to travel back to the moon and on to new destinations, the need to ensure the capture, analysis, and application of research and medical data is of greater urgency than at any other previous time. In this era of limited resources and challenging schedules, the Human Research Program (HRP), based at NASA’s Johnson Space Center (JSC), recognizes the need to extract the greatest possible amount of information from the data already captured. To this end, the HRP Chief Scientist Office (CSO), HRP Program Planning and Control (PP&C) Office, and the Space Medicine Operations Division have been working together to make reuse of both research data and medical monitoring data more accessible to the user community through the Life Science Data Archive (LSDA) and the Lifetime Surveillance of Astronaut Health (LSAH) Repositories. The task of both LSDA and LSAH repositories is to acquire, preserve, and distribute retrospective research (LSDA) and medical (LSAH) data and information both within the NASA community and to the science community at large, for knowledge discovery, retrospective analysis, and planning of future research studies. An additional goal is to encourage collaboration with non-NASA institutions also faced with enhancing human performance in extreme environments. In September 2022, the LSDA website and its contents transitioned to a new NASA Life Sciences Portal (https://nlsp.nasa.gov/explore/lsdahome). This site continues to feature publicly releasable information such as non-attributable datasets, experiment descriptions (from Project Mercury to ISS, as well as from multiple flight analog missions), descriptions of medical monitoring data, and LSAH newsletters (1992 - 2022). The website also provides an updated portal to request additional research and medical data not accessible from the public website. This presentation will provide an in-depth look at the new system as it relates to finding and requesting retrospective data. We will also detail processes from making a request to delivering data for different types of data requests (i.e., attributable, or non-attributable). This includes descriptions of various approval boards, what information and actions the requestor is responsible for, and key milestones in making data available for reuse.
The NASA Johnson Space Center s (NASA JSC) Committee for the Protection of Human Subjects (CPHS) recently approved the formation of two human data repositories: the Lifetime Surveillance of Astronaut Health Repository (LSAH-R) for clinical data and the Life Sciences Data Archive Repository (LSDA-R) for research data. The establishment of these repositories forms the foundation for the release of data and information beyond the scope for which the data was originally collected. The release of clinical and research data and information is primarily managed by two NASA groups: the Evidence Base Working Group (EBWG), consisting of members of both repositories, and the LSAH Policy Board. The goal of unifying these repositories and their processes is to provide a mutually supportive approach to handling medical and research data, to enhance the use of medical and research data to reduce risk, and to promote the understanding of space physiology, countermeasures and other mitigation strategies. Over the past year, both repositories have received over 100 data and information requests from a wide variety of requesters. The disposition of these requests has highlighted the challenges faced when attempting to make data collected on a unique set of subjects available beyond the original intent for which the data were collected. As the EBWG works through each request, many considerations must be factored into account when deciding what data can be shared and how - from the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act (HIPAA), to NASA s Health Information Management System (10HIMS) and Human Experimental and Research Data Records (10HERD) access requirements. Additional considerations include the presence of the data in the repositories and vetting requesters for legitimacy of their use of the data. Additionally, fair access must be ensured for intramural, as well as extramural investigators. All of this must be considered in the formulation of the charters, policies and workflows for the human data repositories at NASA.
The current health maintenance program for ISS is adequate; however the future of medical care and research in space requires a change where crew time efficiency and autonomy are emphasized. NASA s medical personnel are currently refining their ability to monitor and provide remote health care in such a manner. The proposed plan would evaluate health and fitness of the on orbit crew to; perform on orbit operations, and readiness to return to a terrestrial environment. A two tiered approach will utilize exercise and medical equipment, as well as periodic medical conferences with the flight surgeon, to provide a quantitative and clinical picture of the crew s health and fitness. Any off nominal health and fitness issues that could arise will be evaluated by providing an "armamentarium" of devices both medical and exercise specific to the on orbit crew to use. The ability for the crew to provide autonomous health care, with decreasing earth support, will become increasingly more important for exploration missions. This new plan of health care and maintenance will allow us to, development such efforts while continuing to monitor and provide the best possible health, care and medical research through the microgravity environment on board ISS.
Life support system recommendations, and human reaction to medical experiments for orbital research laboratory
The SRP believes strongly that regularly performed in-flight crew assessments are needed in order to identify a change in health status before a medical condition becomes clinically apparent. It is this early recognition in change that constitutes the foundation of the "occupational health model" expounded in the HRP Requirements Document as a key component of the HRP risk mitigation strategy that will enable its objective of "prevention and mitigation of human health and performance risks". A regular crew status examination of physiological and clinical performance is needed. This can be accomplished through instrumented monitoring of routine embedded tasks. The SRP recommends addition of a new gap to address this action under Category 3.0 Mitigate the Risk. This new gap is closely associated with Task 4.19 which addresses the lack of adequate biomedical monitoring capabilities for performing periodic clinical status evaluations and contingency medical monitoring. A corollary to these gaps is the critical emphasis on preventive medicine, not only during pre- and post-flight phases of a mission as is the current practice, but continued into the in-flight phases of exploration class missions.
This report presents the findings from market research conducted for NASA’s Aerial Aid Convergent Aeronautics Solutions (CAS) exploration project, which aims to assess the current state of the market and technological readiness for Uncrewed Aerial Systems (UAS) for medical emergency first response. The research reveals a robust and rapidly growing market for UAS, with a notable emerging sector for Drones as First Responders (DFR). Despite this growth, DFR applications are currently limited by regulatory, technical, and other challenges, which restrict their use primarily to manned remote video surveillance, and therefore are primarily employed by police units. To our knowledge, there is no evidence of UAS being utilized by medical first responders for scene assessment. Limited evidence exists for closely related applications; however, these are mostly confined to pilot programs for the delivery of medical supplies or equipment. Although there has been discussion around fully autonomous DFR applications for medical purposes such as UAS ambulances or patient transport drones, these applications are generally not yet operational in practice. The technology for full autonomy, especially in guidance and control, has seen significant advancements, and recent Federal Aviation Administration (FAA)regulations are likely to accelerate adoption. Computer vision algorithms for fully autonomous medical emergency response scene surveillance are primed for advancement and deployment. A notable gap likely exists between advancements in computer vision research and what is being integrated in the commercial DFR sector. This gap is primarily due to challenges such as quality assurance for autonomous systems, the availability of application-specific training datasets for computer vision algorithms, regulatory constraints, and public perception and privacy concerns.
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)
This project has demonstrated the possibility of using membrane probes in rodents to monitor physiological variables for extended periods of time. The utility of these probes in physiological studies of microgravity has been demonstrated. The feasibility of developing on-line sensors has also been demonstrated and allows for the possibility of developing real-time automated monitoring systems which can be used in ground-base physiological research as well as in research and medical monitoring in space. In addition to space applications these techniques can be extended to medical monitoring in critical care situations on earth as well as facilitating research in many human and animal diseases.
NASA has long used Probabilistic Risk Assessment (PRA) when high-stakes decisions need to be made about complex systems. For spaceflight medical risk, the Human Research Program’s Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT) is a significant step towards robustly quantifying the risk to crew health during exploration missions. However, there remains a significant gap in the ability to comprehensively characterize and assess risk across the disparate functionalities and capabilities which comprise the entire Crew Health and Performance (CHP) system. To fill this gap, the Crew Health and Performance – Probabilistic Risk Assessment (CHP-PRA) project aims to perform risk characterization for the CHP system by assessing performance risk in addition to medical risk. This effort also includes quantifying Long-Term Health (LTH) risk in addition to in-mission risk outcomes within the CHP-PRA results. LTH risk encompasses the timeframe from immediately post-flight, through the rest of an astronaut’s career, through retirement, and until death. A proof-of-concept LTH risk metric is based on medical condition end-state, as defined by the Evidence Library, capturing the spaceflight specific medical impacts persisting into post-flight[1]. Condition outcomes in the Evidence Library progress through three Clinical Phases (CP): the diagnostic phase (CP1), the treatment/convalescent phase (CP2), and the end-state phase (CP3) which represents the detrimental effects of the condition after the crew member has recovered to the maximal extent. Each CP has an associated Task Impairment (TI), defined as the degree of crew incapacity due to experiencing the condition, and is quantified with a 0-1 range. Conditions with an associated CP3 (e.g. Sepsis, Traumatic Hypovolemic Shock, Sudden Cardiac Arrest, etc.) typically have serious consequences that can cause an astronaut to be fully or partially debilitated throughout the remainder of the mission. Consequently, the Cumulative CP3 TI End-of-Mission Health Status Metric is developed by CHP-PRA to quantify the cumulative effects of all conditions which progressed to the CP3 state throughout the entirety of the mission. Hence, this End-of-Mission Health Status Metric attempts to serve as an indicator of an astronaut’s health state at the time of landing. The severity of the lingering effects of in-mission medical events are dependent on mission activities and the level of available in-mission medical care. This allows the associated cumulative TI metric to be used in comparison with the crew’s end of mission health status for different levels of in-mission resources. This presentation provides the strategy for using CP3 as an LTH metric component, as well as a proof-of-concept demonstration of LTH risk characterization using this component.
While a private individual with a chronic medical condition could perhaps justifiably claim the right to become a "space tourist" through informed consent, NASA and other International crew members are national assets, trained at government expense to fulfill a mission considered essential to national goals. The medical requirements/policy for selection and certification of crewmembers for long duration missions to the International Space Station (ISS) should address: (1) Crewmembers with chronic conditions that require regular dosing of life-sustaining medication for the purposes of secondary or tertiary prevention (i.e. tumor suppression therapy or anticoagulation). (2) Crew members with conditions that will be worsened by spaceflight exposure, placing them at additional personal health risk though not necessarily increasing mission risk (i.e. previous radiation exposure or preflight osteopenia/osteoporosis) The following policies are recommended. A crewmember should not be assigned to an International Space Station mission who: (3) Requires medications to sustain life or who has a disease, which requires medical procedures or diagnostics to monitor and treat same. (4) Has medical condition, which would prevent participation as a candidate in many scientific and medical operational research studies, as their underlying condition would confound the collected data. (5) Requires specialized medical devices for monitoring or treatment of a medical condition, including conditions that require special provisions to conduct routine required countermeasure activities. (6) Who has a disease or requires treatment for same, and for which the effects of space travel may be deleterious to the short or long term health of the individual, An evidence-based approach will be used to provide rationale for policy recommendations under these scenarios. Operational impacts of allowing these medical conditions to fly on the ISS will also be presented.
Ultrasound examinations represent one of the major diagnostic modalities of future healthcare. They are currently used to support medical space research but require a high skilled operator for both probe positioning on the patient's skin and image interpretation. TERESA is a tele-echography project that proposes a solution to bring astronauts and remotely located patients on ground quality ultrasound examinations despite the lack of a specialist at the location of the wanted medical act.
As NASA transitions from the Space Shuttle era into the next phase of space exploration, the need to ensure the capture, analysis, and application of its research and medical data is of greater urgency than at any other previous time. In this era of limited resources and challenging schedules, the Human Research Program (HRP) based at NASA s Johnson Space Center (JSC) recognizes the need to extract the greatest possible amount of information from the data already captured, as well as focus current and future research funding on addressing the HRP goal to provide human health and performance countermeasures, knowledge, technologies, and tools to enable safe, reliable, and productive human space exploration. To this end, the Science Management Office and the Medical Informatics and Health Care Systems Branch within the HRP and the Space Medicine Division have been working to make both research data and clinical data more accessible to the user community. The Life Sciences Data Archive (LSDA), the research repository housing data and information regarding the physiologic effects of microgravity, and the Lifetime Surveillance of Astronaut Health Repository (LSAH-R), the clinical repository housing astronaut data, have joined forces to achieve this goal. The task of both repositories is to acquire, preserve, and distribute data and information both within the NASA community and to the science community at large. This is accomplished via the LSDA s public website (http://lsda.jsc.nasa.gov), which allows access to experiment descriptions including hardware, datasets, key personnel, mission descriptions and a mechanism for researchers to request additional data, research and clinical, that is not accessible from the public website. This will result in making the work of NASA and its partners available to the wider sciences community, both domestic and international. The desired outcome is the use of these data for knowledge discovery, retrospective analysis, and planning of future research studies.
As NASA transitions from the Space Shuttle era into the next phase of space exploration, the need to ensure the capture, analysis, and application of its research and medical data is of greater urgency than at any other previous time. In this era of limited resources and challenging schedules, the Human Research Program (HRP) based at NASA s Johnson Space Center (JSC) recognizes the need to extract the greatest possible amount of information from the data already captured, as well as focus current and future research funding on addressing the HRP goal to provide human health and performance countermeasures, knowledge, technologies, and tools to enable safe, reliable, and productive human space exploration. To this end, the Science Management Office and the Medical Informatics and Health Care Systems Branch within the HRP and the Space Medicine Division have been working to make both research data and clinical data more accessible to the user community. The Life Sciences Data Archive (LSDA), the research repository housing data and information regarding the physiologic effects of microgravity, and the Lifetime Surveillance of Astronaut Health (LSAH-R), the clinical repository housing astronaut data, have joined forces to achieve this goal. The task of both repositories is to acquire, preserve, and distribute data and information both within the NASA community and to the science community at large. This is accomplished via the LSDA s public website (http://lsda.jsc.nasa.gov), which allows access to experiment descriptions including hardware, datasets, key personnel, mission descriptions and a mechanism for researchers to request additional data, research and clinical, that is not accessible from the public website. This will result in making the work of NASA and its partners available to the wider sciences community, both domestic and international. The desired outcome is the use of these data for knowledge discovery, retrospective analysis, and planning of future research studies.
The One Year Mission (1YM) by two astronauts on the International Space Station (ISS), starting in March 2015, offers a unique opportunity to expand multilateral collaboration by sharing data and resources among the partner agencies in preparation for planned space exploration missions beyond low Earth orbit. Agreements and protocols will be established for the collection, distribution, analysis and reporting of both research and clinical data. Data will be shared between the agencies sponsoring the investigators, and between the research and clinical medicine communities where common interests are identified. The assignment of only two astronauts, one Russian and the other American, to the 1YM necessitated creativity in bilateral efforts to maximize the biomedical return from the opportunity. Addition of Canadian, European and Japanese investigations make the effort even more integrative. There will be three types of investigations: joint, cross‐participation and data‐exchange. The joint investigations have US and Russian coprincipal investigators, and the data acquired will be their common responsibility. The other two types must develop data sharing agreements and processes specific to their needs. A multilateral panel of ISS partner space agencies will develop policies for international exchange of scientific information to meet their science objectives and priorities. They will promote archiving of space flight data and will inform each other and the scientific community at large about the results obtained from space life sciences studies. Integration tasks for the 1YM are based on current experience from the ISS and previous efforts on the Russian space station Mir. Closer coordination between international partners requires more common approaches to remove barriers to multilateral resource utilization on the ISS. Greater integration in implementation should increase utilization efficiency to benefit all participants in spaceflight human research. This presentation will describe the overarching principles for multilateral data collection, analysis and sharing and for data security for medical and research data shared between ISS partners prior to release in public forums.
NASA’s exploration missions to Mars will have durations of 2-3 years and will take humans farther away from Earth than ever before. This will result in a paradigm shift for mission planning, spacecraft design, human systems integration, and in-flight medical care. Constraints on real-time communication, resupply, and medical evacuation are major architectural drivers. These constraints require medical system development to be tightly integrated with mission and vehicle design to provide crew autonomy and enable mission success. This concept of operations provides a common vision of medical care for developing a medical system for Mars exploration missions. It documents an overview of the stakeholder needs and goals of a medical system and provides examples of the types of activities the system will be used for during the mission. Development of the concept of operations considers mission variables such as distance from Earth, duration of mission, time to definitive medical care, communication protocols between crewmembers and ground support, personnel capabilities and skill sets, medical hardware and software, and medical data management. The information provided in this document informs the ExMC Systems Engineering effort to define the functions to be provided by the medical system. In addition, this concept of operations will inform the subsequent systems engineering process of developing technical requirements, system architectures, interfaces, and verification and validation approaches for the medical system. This document supports the closure of ExMC Gap Med01: We do not have a concept of operations for medical care during exploration missions, corresponding to the ExMC-managed human system risk: Risk of Adverse Health Outcomes & Decrements in Performance due to Inflight Medical Conditions. This document is applicable to the ExMC Element Systems Engineering process and may be used for collaboration within the Human Research Program.
The research mission is the development of computer assisted diagnostic (CAD) methods for improved diagnosis of medical images including digital x-ray sensors and tomographic imaging modalities. The CAD algorithms include advanced methods for adaptive nonlinear filters for image noise suppression, hybrid wavelet methods for feature segmentation and enhancement, and high convergence neural networks for feature detection and VLSI implementation of neural networks for real time analysis. Other missions include (1) implementation of CAD methods on hospital based picture archiving computer systems (PACS) and information networks for central and remote diagnosis and (2) collaboration with defense and medical industry, NASA, and federal laboratories in the area of dual use technology conversion from defense or aerospace to medicine.