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Home › Robotic Medicine › Protocol library › RMP-BEH-004

CONCEPTUAL · DRAFT v0.2 · NOT FOR CLINICAL USE. An educational thought experiment about how a care robot could follow an auditable protocol. It is not a medical procedure, has not been validated, and must not be used to care for anyone. Thresholds marked <set by …> are deliberately left for clinical leads and validation to set. Disclaimer
Robotic Medicine · Protocol library

RMP-BEH-004 Sleep and lighting schedule support: shows the schedule the flight surgeon set, silent on-screen light-mode prompts and a private log (the robot never wakes anyone)

AI-assisted Reviewed (AI-assisted) AI-assisted clinical and source review by the Medical Research Assistant, Oct 21, 2026 (batch 12 review: 15 required corrections, R1 to R15; 11 optional suggestions not applied in this version), then a verification pass (Oct 21, 2026) that found every required correction for this protocol applied (PASS). No named human clinician has reviewed it. Not for clinical use.

Fixed rules (same in every protocol)

1 · Identity and scope

On a crewmember's command, the robot loads the sleep and lighting schedule that the flight surgeon and behavioral health team set (sleep window, and the times for the general, pre-sleep and phase-shift light modes) and shows it on screen. At each scheduled light time it shows a silent on-screen prompt outside sleep stations, which the crewmember can act on or dismiss; the crewmember changes the light themselves. After the crewmember accepts a post-wake prompt, it runs a short private check-in and logs what they state. It never wakes anyone, never enters a sleep station, never changes a light and never advises on sleep. The log is shared only with the crewmember, the flight surgeon and the behavioral health team (the CMO only if the crewmember agrees or a red flag fires).

Why this protocol was chosen. The ISS solid-state lights have general, pre-sleep and phase-shift modes for day-to-day light, the end of the work day and shifting sleep patterns (Maida 2016); NASA-STD-3001 requires lighting that supports alertness, pre-sleep and circadian shifting (V2 8055) and private sleep accommodation (V2 7070). ISS crew slept about 6 hours a night by wrist monitor (Barger 2014), and astronauts sleep less in flight than on Earth (NASA sleep evidence report 2016). Advice on sleep, light and the work schedule belongs to the flight surgeon and behavioral health team, as in RMP-NEURO-006, so the robot only shows their schedule and logs what the crewmember states. Silent prompts, the check-in wording and the log rules are design judgment. Open question for review: whether the robot should ever change a light mode on the crewmember's spoken command, or leave all light control to the crew.

Autonomy: Max rung 2 for showing the sleep and lighting schedule the flight surgeon and behavioral health team set, silent on-screen prompts outside sleep stations, and a private log. The crewmember changes every light themselves; the robot never changes a light, never sounds a tone and never wakes anyone, as in RMP-NEURO-006.

Covers

  • Showing the sleep and lighting schedule the flight surgeon set
  • Silent on-screen light-mode prompts outside sleep stations
  • A private post-wake check-in with its own log (the RMP-NEURO-006 sleep log is separate, and shared with the CMO)
  • Low mood or stress: RMP-BEH-002

Locked out (never done by the robot under this protocol)

  • Diagnosis or naming a cause
  • Any medicine, fluid or oxygen advice; starting, stopping or adjusting oxygen
  • Touching the crewmember
  • Handing over any medicine outside RMP-PHARM-001, or after a MISMATCH or CANNOT VERIFY (the item stays quarantined; only the CMO can ask for it, through the RMP-PHARM-001 logged two-step override)
  • Waking a crewmember for a check-in, or entering a sleep station unless invited
  • Advising on sleep habits, light, caffeine, exercise or the work schedule (the flight surgeon and behavioral health team decide)
  • Saying whether a crewmember is rested, fit for a task, or past the effect of a medicine
  • Clearing or stopping anyone from a task
  • Recording in a sleep station, or using a camera during the check-in
  • Changing any light, light mode or brightness itself
  • Sounding any alarm, tone or voice to wake a crewmember, or prompting inside a sleep station or during a sleep window
  • Changing or suggesting changes to the schedule
  • Scoring or rating sleep or how well the schedule was followed
  • Sharing the log with anyone but the crewmember, the flight surgeon and the behavioral health team (the CMO only with agreement or on a red flag)
  • Suggesting, choosing, fetching or dosing any sleep medicine or other medicine, or saying when to take it (a human order and RMP-PHARM-001 are needed)
  • Dose-interval cues (any reminder, tone, colour, countdown or spoken cue tied to when a medicine was last taken)

Related: RMP-NEURO-006 · RMP-BEH-002 · RMP-BEH-001 · RMP-NEURO-002

2 · Roles

Medical authority
Flight surgeon (ground). Holds medical authority for every run.
Onboard lead
Crew medical officer (CMO), acting under delegated care; uses the pre-approved onboard checklist when there is no link.
Others
  • Second trained CMO: receives every alert and takes over if the CMO is the patient
  • Vehicle commander: leads any cabin emergency procedure
  • Other crew: help as the CMO or commander directs
  • Behavioral health team (ground): sets the sleep and lighting schedule with the flight surgeon
Commercial flights
On commercial flights, 'flight surgeon' and 'CMO' mean the operator's designated medical authority and trained onboard responder. If no trained responder is aboard, this protocol is not used. (NASA-STD-3001 requires two CMOs per vehicle for NASA programs [V1 3006]; FAA rules set no medical standards for spaceflight participants.) [12]

Robot may

  • Load and show the schedule the flight surgeon set
  • Show silent on-screen light-mode prompts outside sleep stations
  • Run a private check-in after the crewmember accepts a post-wake prompt
  • Keep a private log

Robot may not

  • Wake anyone or enter a sleep station uninvited
  • Change a light or the schedule
  • Advise on sleep, light, caffeine or work
  • Score sleep or schedule adherence

3 · Preconditions and consent

Consent
The crewmember agrees to schedule prompts and the private log. The log goes only to the crewmember, the flight surgeon and the behavioral health team; the CMO is told only if the crewmember agrees or a red flag fires. Before flight, each crewmember was told that skipped check-ins are flagged under RMP-BEH-002 (not by this protocol), that an urgent alert and the words that triggered it are kept and cannot be withdrawn, that records are stored encrypted and never used to train or tune software, and that this robot can miss things or raise false alarms. A pre-flight plan exists for securing medicines and other means of self-harm, and each crewmember who wanted one has a safety plan written with the behavioral health team.
Emergency consent
A red flag sends an alert as listed; the robot still never wakes anyone (the CMO or commander decides).
Withdrawal
The crewmember can turn prompts off or stop the log at any time.

4 · Required sensor inputs

IDInputSourceRequiredIf missing
IN-1Sleep and lighting schedule (sleep window and light-mode times), set by the flight surgeon and behavioral health teamFlight surgeon / behavioral health teamYesThe robot shows "schedule not loaded" and gives no prompts.
IN-2Sleep and light times in the crewmember's wordsCrewmemberOptionalLog "not stated".
IN-3Answers to the red-flag questionsCrewmemberOptionalLog "no response"; D2 applies.
IN-4Link status and delayCommunications systemYesTreat as link down; the log is queued.

5–6 · Steps and decision points

Each step names who acts. Decision points sit after the step they follow and say who decides: Robot Crew Ground. Any stop rule in section 7 can interrupt any step.

  1. S1RobotRung 2

    On the crewmember's command, load the schedule the flight surgeon and behavioral health team set and show it on screen; send a "schedule support started" note to the flight surgeon (queued if the link is down). The CMO is told only if the crewmember agrees or a red flag fires. Every URGENT alert goes to the CMO and the flight surgeon at the same time (queued for the flight surgeon if the link is down). If the CMO is the patient, is busy treating, or does not answer, the alert goes to the second trained CMO, or the crewmember named before flight [V1 3006]. An URGENT alert that is not acknowledged within <set by validation> seconds is repeated and sent to the next named crewmember.

    Done when: Schedule shown; note sent or queued.

    V1 3006V2 10174

  2. S2RobotRung 2

    At each scheduled light-mode time, show a silent on-screen prompt outside sleep stations (for example "Schedule: pre-sleep light from 21:00, as set by the flight surgeon"). The crewmember changes the light themselves or dismisses the prompt; the robot never changes a light, never sounds a tone and never prompts inside a sleep station or during a sleep window.

    Done when: Prompt shown; "acted on" or "prompt dismissed" logged as stated.

    V2 8055V2 7070

  3. S3RobotRung 2

    After the crewmember accepts the post-wake prompt (never by waking them), run a short private check-in by voice or on screen, camera off: first say: "This robot listens for certain words and can miss things or raise false alarms. It is not a safety monitor. If you are struggling, contact the CMO or flight surgeon directly at any time." Then red-flag questions first (including any talk of self-harm), then sleep and light times as they state. Log the answers word for word in this protocol's own private log, under its sharing rule. If RMP-NEURO-006 is running, ask the crewmember first whether to add them to that sleep log, and say that the RMP-NEURO-006 log is shared with the CMO; add them only on a clear yes.

    Done when: Answers logged or "no response".

    V1 6003

    D1DecisionRobot decides

    Checked after every answer and at any point in the run (even mid-question or mid-step): does any answer, reading or observation meet a red flag, including any talk of self-harm or suicide?

    • Yes → Stop the current question or step at once and apply the action listed for each matching red flag (URGENT alert, flag, or stop), with the answer or reading itself, never a cause. Every URGENT alert goes to the CMO and the flight surgeon at the same time (queued for the flight surgeon if the link is down). If the CMO is the patient, is busy treating, or does not answer, the alert goes to the second trained CMO, or the crewmember named before flight [V1 3006]. An URGENT alert that is not acknowledged within <set by validation> seconds is repeated and sent to the next named crewmember.
    • No → Continue.
    D2DecisionRobot decides

    Did the crewmember answer the check-in after accepting it, or say they want to skip a question?

    • Yes → Continue.
    • Declined explicitly (the crewmember says no to a question) → Log "declined" for that question only; the alert already sent stands.
    • No response, or the answer does not make sense → URGENT: log "no response" (never "declined"); the CMO, or the second trained CMO if the CMO is the patient, checks the crewmember in person at once.
  4. S4RobotRung 2

    Show the crewmember the schedule next to their own logged times as a clock-time timeline, with no words about whether it is good or bad.

    Done when: Timeline shown.

    V1 6003

  5. S5Crew

    The crewmember follows or changes their own routine; the commander and the CMO decide any wake-up for a critical task, by their own means.

    Done when: As decided by the crew.

    V2 7070

    D3DecisionRobot decides

    Is a crewmember asleep when a task needs them?

    • Yes → The robot never wakes them: it tells the commander and the CMO on screen, and they decide by their own means.
    • No → Continue.
  6. S6RobotRung 2

    After any URGENT alert: After an URGENT alert the robot does not leave on its own: it stays at its rest position in the module, with its screen and voice link available, until a human has taken over or tells it to go. It never follows, blocks or touches anyone. It keeps time-stamping what humans say they did, and repeats the alert if it is not acknowledged.

    Done when: Robot at rest in the module until a human releases it; alert acknowledged or escalated.

    V2 10173V1 3006

  7. S7Ground

    The flight surgeon and behavioral health team (or the CMO under the onboard checklist when there is no link) review the log and decide on any schedule change; the robot loads only a schedule they send.

    Done when: Decision logged.

    V1 3004

    D4DecisionGround decides

    Does the schedule change?

    • Link live → Flight surgeon decides; robot logs.
    • Link down or delay too long → The CMO decides under the pre-approved onboard checklist; the flight surgeon reviews the log at the next contact.
  8. S8RobotRung 2

    Send the flight surgeon and the behavioral health team the private log: schedule shown, prompts acted on or dismissed as stated, answers and alerts.

    Done when: Log delivered or queued.

    V1 6003V1 7003

7 · Stop and escalate rules, red flags

IDTriggerWhat happensLevel
X1The patient (or the crewmember being examined) says stop, or withdraws consentRobot stops all motion at once, backs away to its rest position and tells the CMO. Recording stops unless the patient agrees to keep it running.V2 10165stop
X2Any crewmember presses stop or takes over controlProtective stop; robot holds its stopped position; only a human may restart it.V2 10165V2 10168V2 10174safe-state
X3Robot fault, sensor fault, or a force, speed or reach limit is reachedProtective stop and hand control to the CMO; log the fault.V2 10172V2 10168safe-state
X4CMO is asked to take over and does not respond (for example, the CMO is the patient)Robot stays stopped; the next named crewmember is called.V2 10173V2 7045safe-state
X5Loss of link, or delay longer than the limit for live guidanceOnly the robot pauses: before it holds, it moves to a position clear of a hatch route or a crewmember's route (it never pauses in one), and tells the CMO. This pauses robot movement only: crew sleep, care already under way and all other care continue under the onboard checklist and never wait for the link or the robot. The CMO decides whether the robot continues offline under the pre-approved onboard checklist; it resumes only on the CMO's confirmation.V2 10172V2 10173pause
X6An URGENT alert is not acknowledged within the set timeRobot repeats the alert and sends it to the next named crewmember (the second trained CMO first if the CMO is the patient), and keeps repeating at the set interval. It stays where it is: it does not leave on its own.V1 3006V2 10173urgent
X7The crewmember stops responding, or seems confused or drowsy, at any pointURGENT alert at once, even mid-question or mid-step; the robot stops its current task, stays at its rest position and does not continue the run; a crewmember checks in person.urgent
X8A crewmember asks the robot what is wrong, or for medicine, fluid or treatment advice, including about a sleep medicineRobot declines, says it cannot assess or advise, and routes the question to the CMO or flight surgeon.stop
X9The robot is at a sleep station, or a prompt would show inside one or during a sleep windowRobot moves away without sound, shows nothing there, and logs the prompt as "not shown – sleep window".V2 7070safe-state
X10Someone needs the space or route the robot is inRobot moves clear at once without contact and holds; it never pauses in a hatch route.V2 10172safe-state

Red flags

The robot reports the sign or value only, never what it means. Numeric thresholds are placeholders for the clinical lead.

IDSignThresholdAction
RF1Talk of self-harm or suicide, or of not wanting to be alive [4]any (if not sure, treat as yes)URGENT private alert to the flight surgeon now, mid-question if need be; the CMO if the link is down or delayed (the second CMO if the CMO is the person concerned), as agreed before flight; repeated and escalated if not acknowledged. No risk rating. See RMP-BEH-002 and RMP-BEH-001.
RF2A sudden severe headache, or a headache with fever, weakness, confusion or a change in vision [5]anyURGENT alert; see RMP-NEURO-002
RF3Short sleep, as logged [2]less than <set by clinical lead> hours a night for <set by flight surgeon> nights in a row (for context, ISS crew averaged about 6.1 hours a night by wrist monitor)Flag to the flight surgeon
RF4Trouble sleeping that goes on, or that the crewmember says affects their work or mood [3]beyond <set by flight surgeon> nights, or any report that it affects work or moodFlag to the flight surgeon; see RMP-BEH-002
RF5Feeling very drowsy before a critical task, as stated (design judgment) (general clinical red flag; no source cited)anyFlag to the CMO and flight surgeon at once; the robot never clears or stops anyone from the task
RF6A light stuck in one mode, or one that will not dim or turn off, as stated (design judgment) (general clinical red flag; no source cited)anyFlag to the commander
RF7Any mention of taking, wanting or reacting to a sleep medicine, as stated [2]anyFlag privately to the flight surgeon; see RMP-NEURO-006, whose sleep-medicine red flags (RF1, RF3, RF4, RF8) apply; the robot gives no advice

8 · Safety limits

IDLimitValueHow enforced
L1Contact with the crewmembernot allowedKeep-out zone in the robot controllerV2 10172
L2Sound or light from the robot in a sleep station or during a sleep windownot allowedSleep-window and sleep-station map in the robot controllerV2 7070
L3Changing a light, light mode or brightnessnot allowedNo lighting command is loadedV2 8055
L4Robot speed near the crewmember<set by validation>Hard limit in the controllerV2 10172

9 · Logs and audit

10 · Links to NASA-STD-3001

RequirementTopic (paraphrased)How this protocol uses it
[V1 3004]In-mission medical care capabilities (including inventory, vital signs, imaging and ECG, procedures, restraints, medications, private data transmission)In-mission medical care capabilities, including inventory monitoring and the flight surgeon's decisions on care.
[V1 3006]Crew medical officers: two per vehicleTwo trained CMOs per vehicle for NASA programs; the second trained CMO receives alerts when the CMO is the patient (see the commercial-flight note).
[V1 6003]Private medical communicationsLogs and alerts sent to the ground are private medical communications.
[V1 7001]Medical records kept permanently and retrievable for trend analysisRecords kept so the flight surgeon can see trends.
[V1 7003]Security of medical recordsSecure handling of medical records.
[V2 7045]Medical equipment usable by non-physician crewUsable by non-physician crew, including when the CMO is the patient.
[V2 7046]Restraint of patient, care provider and suppliesPatient, caregiver and supplies restrained.
[V2 7059]Inventory management: track locations and quantitiesKit inventory and seal status are tracked.
[V2 7070]Private sleep accommodation; the robot never prompts in a sleep station.
[V2 8055]Lighting supports the physiological effects of light; the flight surgeon sets the light schedule.
[V2 10161]Automated system status shown to the operatorRobot shows its status and health.
[V2 10162]Mode changes announcedMode changes are announced to the operator.
[V2 10163]Data recording and sharingRobot records and shares its data.
[V2 10164]Clear allocation of responsibility (human or system)Shows whether the human or the robot is expected to act.
[V2 10165]Human override and shutdownHuman can override and shut down the robot.
[V2 10168]Failure recovery: safe human takeoverHuman can take over.
[V2 10172]Protective stop when limits are exceededProtective stop when a limit is exceeded.
[V2 10173]Safety DefaultRobot stays stopped if no one takes over.
[V2 10174]Only a human initiates or restartsOnly a human starts or restarts the robot.

IDs as published in Volume 1 Revision C [7] and Volume 2 Revision F [8]. NASA-STD-3001 binds NASA programs; it is not a regulation for commercial flights. Its robot rules are general automation requirements, not medical-device rules.

11 · Validation

  1. Simulation. Scripted days with a prompt due in a sleep window, a crewmember asleep before a critical task, self-harm talk at check-in, lost link. Pass: Zero wakings; zero light changes; every red flag raised.
  2. Training model. Prompt display drills across modules. Pass: Zero prompts inside sleep stations.
  3. Parabolic or station demonstration. Silent movement near sleep stations. Pass: Noise limit held.
  4. Flight use under flight surgeon supervision. First week of schedule support. Pass: No safety or privacy events.

No stage has been run. Pass and fail criteria must be fixed in advance by the clinical lead and safety board.

12 · Human sign-off

Before any use
  • Clinical lead for the specialty (sets every clinical threshold marked <set by clinical lead>)
  • Flight surgeon, as medical authority
  • Robotics and medical-device safety board
  • Program approval for the mission
Each run
Started by the crewmember. The flight surgeon and behavioral health team set every schedule; the crew control every light.
Restart after a stop
Human only. After any emergency or protective stop, a crewmember must restart the robot; the robot never restarts itself.

None of these sign-offs has happened. This is a Draft v0.2.

13 · Change control for learning

Change-plan model: FDA guidance [11].

Loss of signal and Mars delay

Live link
Low Earth orbit: the log reaches the flight surgeon and behavioral health team when the link allows.
Loss of signal
  • Only the robot pauses non-essential motion, at a position clear of hatch routes and crew routes, and tells the CMO; it resumes offline only on the CMO's confirmation.
  • Crew sleep, care already under way and all other care continue under the onboard checklist and never wait for the link or the robot.
  • The loaded schedule keeps showing; the log is queued.
Mars-class delay
  • Mars: schedules are set before and during flight with delay; the crew decide on their routine.
[10]
Corrections and updates

Oct 21, 2026, version 0.2. Batch 12 AI-assisted clinical review (Medical Research Assistant), Oct 21, 2026; no named human clinician. Changes:

  • R10: the sleep-medicine and dose-interval lockouts from RMP-NEURO-006 are copied in; never-words "sleeping pill", "melatonin", "take something"; new RF7 routes any sleep-medicine mention to RMP-NEURO-006 and its red flags; X8 covers sleep-medicine questions. Sources: RMP-NEURO-006; Barger (hypnotic use).
  • R11: check-in answers stay in this protocol's own log under its sharing rule; they are added to the RMP-NEURO-006 sleep log only if the crewmember agrees after being told that log is shared with the CMO. Design judgment.
  • Batch 12 protocols now record the review as AI-assisted (Medical Research Assistant, Oct 21, 2026); no named human clinician.

Earlier version: Draft v0.1, Oct 21, 2026. Download the current YAML above.

Sources

  1. Maida JC. Introduction to the Solid State Based Interior Lighting System for ISS (NASA Technical Reports Server 20160005080, 2016). ntrs.nasa.gov/citations/20160005080 Supports: The ISS solid-state light assemblies have three modes: general (4500 K, the default for day-to-day operations), pre-sleep (2700 K, for the end of the work day, to remove as much melatonin suppression as possible) and phase-shift (6500 K, to suppress melatonin and increase alertness when the circadian rhythm needs to be shifted); each light has its own mode, dimming and on-off buttons. Read Oct 21, 2026 (saved copy in src/b12).
  2. Barger LK, Flynn-Evans EE, Kubey A, et al. Prevalence of sleep deficiency and use of hypnotic drugs in astronauts before, during, and after spaceflight: an observational study. Lancet Neurol. 2014;13(9):904-912. PMID 25127232. doi:10.1016/S1474-4422(14)70122-X Supports: By wrist actigraphy, ISS crew obtained about 6.1 hours of sleep a night in flight and Shuttle crew about 6.0 hours; 12 of 16 ISS crew (75%) and 61 of 78 Shuttle crew (78%) reported using sleep-promoting drugs.
  3. NASA Human Research Program. Evidence Report: Risk of Performance Decrements and Adverse Health Outcomes Resulting from Sleep Loss, Circadian Desynchronization, and Work Overload (2016). humanresearchroadmap.nasa.gov/evidence/reports/Sleep.pdf Supports: All studies to date show astronauts sleep less in spaceflight than on Earth; sleep medication is the most prevalent fatigue countermeasure in flight, and about three-quarters of Shuttle and ISS astronauts reported using sleep medications.
  4. National Institute for Health and Care Excellence. Self-harm: assessment, management and preventing recurrence. NICE guideline NG225 (2022). www.nice.org.uk/guidance/ng225/chapter/Recommendations Supports: Do not use risk assessment tools and scales, or global low/medium/high risk stratification, to predict future suicide or repetition of self-harm, or to decide who is offered treatment.
  5. National Institute for Health and Care Excellence. Headaches in over 12s: diagnosis and management. Clinical guideline CG150. www.nice.org.uk/guidance/cg150/chapter/Recommendations Supports: Headache features that need further investigation or referral include worsening headache with fever, sudden-onset headache reaching maximum intensity within 5 minutes, new-onset neurological deficit, and impaired level of consciousness.
  6. NASA OCHMO. Behavioral Health and Performance. Technical Brief OCHMO-TB-016 Rev B (Oct 24, 2023). www.nasa.gov/wp-content/uploads/2023/12/ochmo-tb-016-behavio… Supports: Behavioral health concerns in spaceflight include stress, depression, anxiety, relationship problems and grief; contributing factors include sleep, workload, medicine side effects and medical conditions; 2 of 7 NASA Shuttle-Mir astronauts reported depressive symptoms; past events include reported possible hallucinations and withdrawal after delayed news of a family death; support includes private psychological conferences, and missions beyond 6 months or beyond low Earth orbit should add minimally obtrusive monitoring.
  7. NASA. NASA-STD-3001, Space Flight Human-System Standard, Volume 1: Crew Health, Revision C (2023). www.nasa.gov/wp-content/uploads/2023/11/nasa-std-3001-vol-1-… Supports: NASA-STD-3001 Vol 1 Rev C: V1 3004, V1 3006, V1 6003, V1 7003.
  8. NASA. NASA-STD-3001, Volume 2: Human Factors, Habitability, and Environmental Health (Rev F, 2026), including Section 10.6 Automated and Robotic Systems. standards.nasa.gov/standard/NASA/NASA-STD-3001_VOL_2 Supports: NASA-STD-3001 Vol 2 Rev F: V2 7070, V2 8055, and Section 10.6 automated and robotic systems.
  9. NASA OCHMO. Medical Operations. Technical Brief OCHMO-TB-044 (2025). www.nasa.gov/wp-content/uploads/2025/08/ochmo-tb-044-medical… Supports: The crew surgeon keeps medical authority when care is delegated; crew medical officers train on the JSC 48522 medical checklist.
  10. NASA. Mars communications disruption and delay (fact sheet, 2023 Moon to Mars Architecture Concept Review). www.nasa.gov/wp-content/uploads/2024/01/mars-communications-… Supports: One-way Earth-Mars delay up to about 21-23 minutes, plus blackouts of about 2-3 weeks near solar conjunction.
  11. U.S. Food and Drug Administration. Marketing submission recommendations for a predetermined change control plan for artificial intelligence-enabled device software functions (guidance). www.fda.gov/regulatory-information/search-fda-guidance-docum… Supports: A model for planning, validating and rolling back software updates.
  12. U.S. Code of Federal Regulations, Title 14, Part 460: Human space flight requirements. www.ecfr.gov/current/title-14/chapter-III/subchapter-C/part-… Supports: Federal rules for crew and spaceflight participants on licensed commercial flights; they set no medical standards for spaceflight participants.

Checked on 2026-10-20: links opened (HTTP 200 or publisher redirect), DOIs and PubMed IDs matched, NASA documents read in full text. The framework comes from Part 1.

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