What your compliance, security, and clinical teams will ask — answered upfront.

The platform's session structure is mapped to the three canonical attention networks in cognitive neuroscience: alerting, executive, and the default mode network.

• Posner, M. I. & Petersen, S. E. (1990). The attention system of the human brain. Annu. Rev. Neurosci.
• Petersen, S. E. & Posner, M. I. (2012). The attention system of the human brain: 20 years after. Annu. Rev. Neurosci.
• Raichle, M. E. et al. (2001). A default mode of brain function. PNAS.
• Buckner, R. L., Andrews-Hanna, J. R. & Schacter, D. L. (2008). The brain's default network: anatomy, function, and relevance to disease. Ann. NY Acad. Sci.

The optional pre-session settling protocol uses cyclic sighing — a brief structured respiration practice shown to reduce physiological arousal and improve mood.

• Balban, M. Y., Neri, E., Kogon, M. M., Weed, L., Nouriani, B., Jo, B., Holl, G., Zeitzer, J. M., Spiegel, D. & Huberman, A. D. (2023). Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Reports Medicine, 4(1), 100895.

Brain Fuel — the nutritional-rehabilitation module — is grounded in the published nutritional psychiatry literature.

• Sarris, J. et al. (2015). Nutritional medicine as mainstream in psychiatry. Lancet Psychiatry.
• Marx, W. et al. (2017). Nutritional psychiatry: the present state of the evidence. Proc. Nutr. Soc.
• Jacka, F. N. et al. (2017). A randomised controlled trial of dietary improvement for adults with major depression (the SMILES trial). BMC Medicine.
• Cryan, J. F. & Dinan, T. G. (2012). Mind-altering microorganisms: gut microbiota in behaviour. Nat. Rev. Neurosci.

Face Flex (V1, V2, V3) follows established neurorehabilitation standards for facial paralysis assessment and mirror-therapy-based motor recovery.

• House, J. W. & Brackmann, D. E. (1985). Facial nerve grading system. Otolaryngol. Head Neck Surg.
• Ramachandran, V. S. & Altschuler, E. L. (2009). The use of visual feedback, in particular mirror visual feedback, in restoring brain function. Brain.
• Beurskens, C. H. G. & Heymans, P. G. (2003). Positive Effects of Mime Therapy on Sequelae of Facial Paralysis. Otology & Neurotology, 24(4), 677–681.

Every module declares a minimum Rancho Los Amigos level (1–10) and a per-level difficulty cap, derived from clinical consensus. Exercises above the clinician-set access band are surfaced with rationale for clinician review — never silently dropped.

Sessions follow a three-phase rhythm mapped to the canonical attention networks in cognitive neuroscience — alerting, executive engagement, and default-mode recovery (Posner & Petersen, 1990; Petersen & Posner, 2012; Raichle et al., 2001). Cognitive sets can begin with a brief optional settling protocol cited to Balban et al. (2023), followed by focused practice and a recovery break at the end. Ratios and durations are configurable under clinician supervision.

In-session difficulty adapts within the clinician-prescribed tier — never across it. Focus Forge uses static stimulus-ratio tiers (Foundational / Intermediate / Advanced); the engine adapts duration, ISI, and distractor complexity inside those bounds only.

BrainMeBack is designed for use under clinician supervision with patients whose cognitive capacity may be impaired by injury, stroke, or disease. The platform does not make treatment recommendations directly to the patient — every prescription, severity assessment, and protocol change remains the responsibility of the supervising clinician. Capacity to consent should be assessed by the supervising clinician per institutional policy; legally authorized representative (LAR) workflows are supported.

The platform supports — but does not replace — the supervising clinician's decisions about exclusion and escalation. Screening considerations the prescribing clinician owns include:

• Photosensitivity / seizure history for modules with rapid visual contrast or alternating stimuli
• Vestibular or oculomotor symptoms for modules with sustained gaze tracking
• Post-concussion exercise intolerance prior to motor-cortex modules (Finger Flow family)
• Behavioral-health escalation pathway for Mood Mind and any module that surfaces emotional content
• Family / caregiver involvement per Safe Steps ADL caregiver-mode and per institutional discharge protocol

These are considerations for the supervising clinician — not platform-level medical determinations. BrainMeBack does not screen or exclude on its own.

BrainMeBack is designed to support clinician-reviewed workflows consistent with the Clinical Decision Support framework in FD&C Act §520(o)(1)(E), as added by §3060 of the 21st Century Cures Act, and FDA's September 2022 CDS Final Guidance:

1. The platform does not acquire, process, or analyze a medical image, an in-vitro diagnostic signal, or a pattern from a signal-acquisition system.
2. It displays, organizes, and supports review of structured cognitive-rehabilitation information about a patient.
3. It presents clinician-facing protocol and configuration options for non-time-critical rehabilitation support.
4. Each option is designed to surface its basis so the supervising clinician can independently review that basis before acting.

The platform is not intended for time-critical clinical decision-making and is not a substitute for clinical judgment. Regulatory positioning should be reviewed with counsel for each deployment context.

Not a digital therapeutic. Not a Class II device. Not a diagnostic tool. We do not refer to the platform as “DTx” and we don't market against device-cleared peers. Clinician-supervised cognitive exercises is the core category language used in our materials.

Hash-chained audit log of PHI access, prescription changes, and overrides, exportable to CSV in formats designed for survey reviewers (TJC, CARF) and internal audit teams. Off-platform integrity attestation (daily signed root digest) is on the post-seed roadmap.

Patient identifiers, clinical notes, and free-text fields are designed to be encrypted at the field level using the platform cryptographic boundary. Encryption coverage and key-management practices are detailed in the security overview, available under NDA.

15-minute idle session timeout. 2-minute background lock on the patient app. Optional biometric re-auth (Face ID / Touch ID). For deployments that connect to an EHR via SMART on FHIR, OAuth tokens are designed to be encrypted at rest with AES-256-GCM in __Host- prefixed cookies.

Postgres Row-Level Security is designed to enforce per-clinician patient isolation server-side. A signed-in clinician sees only their assigned caseload — even a misbehaving client query should not cross the boundary.

HIPAA authorization, data usage, research participation, clinician data sharing, and third-party integration consents are authored in English, Spanish, French, Portuguese, Mandarin, Arabic, Hindi, and Filipino. Per-locale legal review status is surfaced in the dashboard.