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Medical Data Architecture (MDA) Project Status

The Medical Data Architecture (MDA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the ExMC MDA project addresses the technical limitations identified in ExMC Gap Med 07: We do not have the capability to comprehensively process medically-relevant information to support medical operations during exploration missions. This gap identifies that the current in-flight medical data management includes a combination of data collection and distribution methods that are minimally integrated with on-board medical devices and systems. Furthermore, there are a variety of data sources and methods of data collection. For an exploration mission, the seamless management of such data will enable a more medically autonomous crew than the current paradigm. The medical system requirements are being developed in parallel with the exploration mission architecture and vehicle design. ExMC has recognized that in order to make informed decisions about a medical data architecture framework, current methods for medical data management must not only be understood, but an architecture must also be identified that provides the crew with actionable insight to medical conditions. This medical data architecture will provide the necessary functionality to address the challenges of executing a self-contained medical system that approaches crew health care delivery without assistance from ground support. Hence, the products supported by current prototype development will directly inform exploration medical system requirements.In fiscal year 2018, the MDA project developed Test Bed 2, the second iteration in a series of prototypes with functionality focused on data security through role-based access control and encryption, integration with One Portal exercise software and ingestion of an ultrasound Digital Imaging and Communications in Medicine (DICOM) file and image display. Test Bed 2 advances the medical data system architecture framework by providing these functionalities in a scalable system that maintained a layered, modular design. The architecture framework uses a data services approach with role-based access to data in a customized medical record system suitable for space exploration. These functionalities were demonstrated as part of the Next Space Technologies for Exploration Partnerships (NextSTEP) ground test demonstrated at the NASA Johnson Space Center Integrated Power, Avionics and Software (iPAS) facility. Interfacing to a Core Flight Software (CFS) system, the MDA system, using Consultative Committee for Space Data Systems (CCSDS) protocol, transferred an exercise file from the simulated flight MDA system to a mirrored MDA system on the ground through the CFS system. The selection of data sources and demonstrations enabled the team to address stakeholder concerns throughout the development process. In the next iteration, the MDA team will work with stakeholders to identify additional relevant functionalities to further advance system data models, standards and principles that will inform the medical system requirements development.

medical data architecture↗

Medical Data Architecture Project Status

The Medical Data Architecture (MDA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the ExMC MDA project addresses the technical limitations identified in ExMC Gap Med 07: We do not have the capability to comprehensively process medically-relevant information to support medical operations during exploration missions. This gap identifies that the current in-flight medical data management includes a combination of data collection and distribution methods that are minimally integrated with on-board medical devices and systems. Furthermore, there are a variety of data sources and methods of data collection. For an exploration mission, the seamless management of such data will enable a more medically autonomous crew than the current paradigm. The medical system requirements are being developed in parallel with the exploration mission architecture and vehicle design. ExMC has recognized that in order to make informed decisions about a medical data architecture framework, current methods for medical data management must not only be understood, but an architecture must also be identified that provides the crew with actionable insight to medical conditions. This medical data architecture will provide the necessary functionality to address the challenges of executing a self-contained medical system that approaches crew health care delivery without assistance from ground support. Hence, the products supported by current prototype development will directly inform exploration medical system requirements.

medical data architecture↗

Medical Data Architecture (MDA) Project Status

The Medical Data Architecture (MDA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the ExMC MDA project addresses the technical limitations identified in ExMC Gap Med 07: We do not have the capability to comprehensively process medically-relevant information to support medical operations during exploration missions. This gap identifies that the current in-flight medical data management includes a combination of data collection and distribution methods that are minimally integrated with on-board medical devices and systems. Furthermore, there are a variety of data sources and methods of data collection. For an exploration mission, the seamless management of such data will enable a more medically autonomous crew than the current paradigm. The medical system requirements are being developed in parallel with the exploration mission architecture and vehicle design. ExMC has recognized that in order to make informed decisions about a medical data architecture framework, current methods for medical data management must not only be understood, but an architecture must also be identified that provides the crew with actionable insight to medical conditions. This medical data architecture will provide the necessary functionality to address the challenges of executing a self-contained medical system that approaches crew health care delivery without assistance from ground support. Hence, the products supported by current prototype development will directly inform exploration medical system requirements.

medical data architecture↗

A Strategic Approach to Medical Care for Exploration Missions

Exploration missions will present significant new challenges to crew health, including effects of variable gravity environments, limited communication with Earth-based personnel for diagnosis and consultation for medical events, limited resupply, and limited ability for crew return. Providing health care capabilities for exploration class missions will require system trades be performed to identify a minimum set of requirements and crosscutting capabilities, which can be used in design of exploration medical systems. Medical data, information, and knowledge collected during current space missions must be catalogued and put in formats that facilitate querying and analysis. These data are used to inform the medical research and development program through analysis of risk trade studies between medical care capabilities and system constraints such as mass, power, volume, and training. Medical capability as a quantifiable variable is proposed as a surrogate risk metric and explored for trade space analysis that can improve communication between the medical and engineering approaches to mission design. The resulting medical system design approach selected will inform NASA mission architecture, vehicle, and subsystem design for the next generation of spacecraft.

Canga, Michael A.↗

A Strategic Approach to Medical Care for Exploration Missions

Exploration missions will present significant new challenges to crew health, including effects of variable gravity environments, limited communication with Earth-based personnel for diagnosis and consultation for medical events, limited resupply, and limited ability for crew return. Providing health care capabilities for exploration class missions will require system trades be performed to identify a minimum set of requirements and crosscutting capabilities which can be used in design of exploration medical systems. Current and future medical data, information, and knowledge must be cataloged and put in formats that facilitate querying and analysis. These data may then be used to inform the medical research and development program through analysis of risk trade studies between medical care capabilities and system constraints such as mass, power, volume, and training. These studies will be used to define a Medical Concept of Operations to facilitate stakeholder discussions on expected medical capability for exploration missions. Medical Capability as a quantifiable variable is proposed as a surrogate risk metric and explored for trade space analysis that can improve communication between the medical and engineering approaches to mission design. The resulting medical system approach selected will inform NASA mission architecture, vehicle, and subsystem design for the next generation of spacecraft.

Antonsen, E.↗

Exploration Medical Cap Ability System Engineering Overview

Deep Space Gateway and Transport missions will change the way NASA currently practices medicine. The missions will require more autonomous capability compared to current low Earth orbit operations. For the medical system, lack of consumable resupply, evacuation opportunities, and real-time ground support are key drivers toward greater autonomy. Recognition of the limited mission and vehicle resources available to carry out exploration missions motivates the Exploration Medical Capability (ExMC) Element's approach to enabling the necessary autonomy. The ExMC Systems Engineering team's mission is to "Define, develop, validate, and manage the technical system design needed to implement exploration medical capabilities for Mars and test the design in a progression of proving grounds." The Element's work must integrate with the overall exploration mission and vehicle design efforts to successfully provide exploration medical capabilities. ExMC is using Model-Based System Engineering (MBSE) to accomplish its integrative goals. The MBSE approach to medical system design offers a paradigm shift toward greater integration between vehicle and the medical system, and directly supports the transition of Earth-reliant ISS operations to the Earth-independent operations envisioned for Mars. This talk will discuss how ExMC is using MBSE to define operational needs, decompose requirements and architecture, and identify medical capabilities needed to support human exploration. How MBSE is being used to integrate across disciplines and NASA Centers will also be described. The medical system being discussed in this talk is one system within larger habitat systems. Data generated within the medical system will be inputs to other systems and vice versa. This talk will also describe the next steps in model development that include: modeling the different systems that comprise the larger system and interact with the medical system, understanding how the various systems work together, and developing tools to support trade studies.

McGuire, K.↗

Risk of Adverse Health Outcomes and Decrements in Performance Due to In-flight Medical Conditions

The drive to undertake long-duration space exploration missions at greater distances from Earth gives rise to many challenges concerning human performance under extreme conditions. At NASA, the Human Research Program (HRP) has been established to investigate the specific risks to astronaut health and performance presented by space exploration, in addition to developing necessary countermeasures and technology to reduce risk and facilitate safer, more productive missions in space (NASA Human Research Program 2009). The HRP is divided into five subsections, covering behavioral health, space radiation, habitability, and other areas of interest. Within this structure is the ExMC Element, whose research contributes to the overall development of new technologies to overcome the challenges of expanding human exploration and habitation of space. The risk statement provided by the HRP to the ExMC Element states: "Given that medical conditions/events will occur during human spaceflight missions, there is a possibility of adverse health outcomes and decrements in performance in mission and for long term health" (NASA Human Research Program 2016). Within this risk context, the Exploration Medical Capabilities (ExMC) Element is specifically concerned with establishing evidenced-based methods of monitoring and maintaining astronaut health. Essential to completing this task is the advancement in techniques that identify, prevent, and treat any health threats that may occur during space missions. The ultimate goal of the ExMC Element is to develop and demonstrate a pathway for medical system integration into vehicle and mission design to mitigate the risk of medical issues. Integral to this effort is inclusion of an evidence-based medical and data handling system appropriate for long-duration, exploration-class missions. This requires a clear Concept of Operations, quantitative risk metrics or other tools to address changing risk throughout a mission, and system scoping and system engineering. Because of the novel nature of the risks involved in exploration missions, new and complex ethical challenges are likely to be encountered. This document describes the relevant background and evidence that informs the development of an exploration medical system.

Antonsen,Erik↗

Medical Optimization Network for Space Telemedicine Resources

INTRODUCTION: Long-duration missions beyond low Earth orbit introduce new constraints to the space medical system such as the inability to evacuate to Earth, communication delays, and limitations in clinical skillsets. NASA recognizes the need to improve capabilities for autonomous care on such missions. As the medical system is developed, it is important to have an ability to evaluate the trade space of what resources will be most important. The Medical Optimization Network for Space Telemedicine Resources was developed for this reason, and is now a system to gauge the relative importance of medical resources in addressing medical conditions. METHODS: A list of medical conditions of potential concern for an exploration mission was referenced from the Integrated Medical Model, a probabilistic model designed to quantify in-flight medical risk. The diagnostic and treatment modalities required to address best and worst-case scenarios of each medical condition, at the terrestrial standard of care, were entered into a database. This list included tangible assets (e.g. medications) and intangible assets (e.g. clinical skills to perform a procedure). A team of physicians working within the Exploration Medical Capability Element of NASA's Human Research Program ranked each of the items listed according to its criticality. Data was then obtained from the IMM for the probability of occurrence of the medical conditions, including a breakdown of best case and worst case, during a Mars reference mission. The probability of occurrence information and criticality for each resource were taken into account during analytics performed using Tableau software. RESULTS: A database and weighting system to evaluate all the diagnostic and treatment modalities was created by combining the probability of condition occurrence data with the criticalities assigned by the physician team. DISCUSSION: Exploration Medical Capabilities research at NASA is focused on providing a medical system to support crew medical needs in the context of a Mars mission. MONSTR is a novel approach to performing a quantitative risk analysis that will assess the relative value of individual resources needed for the diagnosis and treatment of various medical conditions. It will provide the operational and research communities at NASA with information to support informed decisions regarding areas of research investment, future crew training, and medical supplies manifested as part of the exploration medical system.

Shah, R. V.↗

Preparation for an Earth Independent Medical Operations Demonstration using the Tempus ALS™ Medical Device

NASA’s exploration-class missions have severe resource constraints, long return trip durations, significant communication delays and limited resupply opportunities. Validation on the International Space Station (ISS) of medical devices that fit within Earth-Independent Medical Operations (EIMO) systems is a necessary preparation step. Key features of an EIMO medical system include: 1) technologies that support the prevention, diagnosis, and treatment of spaceflight medical events; 2) components that meet mass, volume, power and crew time/training constraints; 3) consideration of the medical skill level of the astronaut caregiver; 4) collection, storage and analysis of medical data within a central data architecture; and 5) incorporation of appropriate guidance and support tools that allow crew autonomy. The Human Research Program’s (HRP) Exploration Medical Capability (ExMC) Element and the Exploration Medical Integrated Product Team (XM-IPT) are planning an ISS technology demonstration to determine the feasibility of including a multifunctional medical device into an EIMO medical system. Demonstration Preparations: The Tempus ALS (Remote Diagnostic Technologies, Ltd., Philips Corp., Farnborough, UK) is a commercial-off-the-shelf medical device, with United States Food and Drug Administration clearance and is Conformité Européene marked in Europe. Several thousand units have been sold and are successfully operating in pre-hospital and in remote settings, such as by European Space Agency (ESA) flight surgeons and some of NASA’s commercial partners during post-flight medical operations. The Tempus ALS provides vital sign measurements such as blood pressure, electrocardiograms, heart rate, end tidal CO2, respiration rate, pulse oximetry and temperature. The device has ultrasound imaging and video laryngoscopy capabilities and has automatic or manual defibrillation modes for treating cardiac arrhythmias. It includes procedural guidance capabilities to assist in the collection of the vital sign measurements and it has various data transmission and report generation features. NASA’s HRP ExMC and XM-IPT are partnering with the ESA to demonstrate the Tempus ALS on ISS, with ESA manifesting the Tempus ALS and its accessories. ESA will compare performance of periodic health status exams and medical contingency drills performed nominally and with the Tempus ALS. NASA’s EIMO demonstration will include the use of Tempus ALS to diagnose a complaint of abdominal pain under increasingly independent circumstances. The caregiver must assess the present illness, collect vital sign measurements, and perform an abdominal ultrasound, under one of three communication situations, including real-time, with a several second delay and with a delay on the order of minutes. Expected Outcomes: Information will be gained about the feasibility, benefits, and challenges of using a multifunctional, all-in-one, medical device for medical diagnosis instead of separate devices with singular functionalities. Information will also be collected about performance differences as communication delays increase and available ground support decreases. Gaining this understanding will allow for further development of exploration medical system capabilities which takes the EIMO construct into consideration.

Beth Lewandowski↗

Medical System Concept of Operations for Mars Exploration Mission-11: Exploration Medical Capability (ExMC) Element - Human Research Program

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.

Urbina, Michelle↗

Medical Systems Engineering to Support Mars Mission Crew Autonomy

Human spaceflight missions to Mars face exceptionally challenging resource limitations that far exceed those faced before. Increasing transit times, decreasing opportunity for resupply, communications challenges, and extended time to evacuate a crew to definitive medical care dictate a level of crew autonomy in medical care that is beyond the current medical model. To approach this challenge, a medical systems engineering approach is proposed that relies on a clearly articulated Concept of Operations and risk analysis tools that are in development at NASA. This paper proposes an operational clinical model with key terminology and concepts translated to a controls theory paradigm to frame a common language between clinical and engineering teams. This common language will be used for design and validation of an exploration medical system that is fully integrated into a Mars transit vehicle. This approach merges medical simulation, human factors evaluation techniques, and human-in-the-loop testing in ground based analogs to tie medical hardware and software subsystem performance and overall medical system functionality to metrics of operational medical autonomy. Merging increases in operational clinical autonomy with a more restricted vehicle system resource scenario in interplanetary spaceflight will require an unprecedented level of medical and engineering integration. Full integration of medical capabilities into a Mars vehicle system may require a new approach to integrating medical system design and operations into the vehicle Program structure. Prior to the standing-up of a Mars Mission Program, proof of concept is proposed through the Human Research Program.

Antonsen, Erik↗