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DESIGN FRAMEWORK · v1.0 DRAFT

MGCIS Integrated Design

One system, thirty modules — parallel coding and the international approval roadmap

Mythozoesis Global Care Integration System · Mythozoesis Research Institute · September 2026 · English edition (한국어판)

Notice — This page describes the design and plans of MGCIS. It does not currently provide insurance claims or reimbursement, and it is not diagnosis or treatment. Decisions on diagnosis, treatment and billing rest with licensed professionals in each country. It is not used for psychotic disorders such as schizophrenia, manic episodes, or acute suicidal crisis.

At a Glance

  • What it is: MGCIS is a universal healing system that parallel-codes myth-based narrative and narrative-music healing alongside each country's diagnostic and billing systems. It is designed to run on one engine and 30 modules.
  • What is different: It is designed to measure each of 22 limitations of existing systems (diagnostic reliability, 19.7% dropout, the treatment gap, and others) with a dedicated verification indicator.
  • How it is used: A cycle of scope screening → grade assessment → narrative and music prescription → outcome measurement → international sharing → recommendation update.
  • Who pays: Insurance (10 modules) is one of four funding channels; the remaining 20 modules can run now on public budgets, institutional contracts, and self-care.
  • Where it is heading: Toward registration as a WHO-FIC related classification over about four years, building evidence in the order of reliability studies → pilots → randomized controlled trials.
  • What is needed now: First clinical data. A classification reliability study and a first pilot are the next steps (Section 6).

ICMZ is a complementary healing layer that is coded in parallel alongside each country's diagnostic and billing systems without changing them. This document fills gaps in the earlier five-stage document design, and sets out an evidence-building pathway aimed at registration as a WHO related classification, together with a sharing and feedback system through which user countries pool data to improve healing outcomes jointly.

Vision: A Universal Healing System for All Humanity

MGCIS is not a system of any single country or culture. It aims to be a universal healing system through which every person can name their own suffering and find a path to recovery. Universality is built in three layers.

LayerMeaningMechanism in this document
Universal structureStories of loss, betrayal, power, descent, and rebirth appear in the myths of every civilizationICMZ concepts and the seven stages of the Kyklos (Sections 0 and 2)
Local expressionEach person meets the same structure through their own myths, language, and music10 cultural spheres, 8 languages, client choice of cultural sphere, fairness principles (Section 5)
Shared verificationUniversality is not asserted but demonstrated by measuring together across many countriesICMZ Outcome Set, international sharing and feedback, outcome comparison by cultural sphere (Sections 0, 5, and 7)

Universal structure, local expression, shared verification. Every person heals through the stories of their own culture, and every healing becomes wisdom for all of humanity.

"Narro ergo fluo atque sum nos" — I narrate, therefore I flow, and indeed I am we. Every design in this document is an effort to extend the "I am we" of this motto to all of humanity.

0. Identity and Strengths of ICMZ: A Myth-Based Narrative Clinical Healing System

ICMZ is a third category, neither narrative medicine nor a diagnostic classification. It is a myth-based narrative clinical healing system that names suffering through mythic archetypes and sets out a healing pathway through a seven-stage cycle.

AspectNarrative medicine (Rita Charon, Columbia University)DSM-5-TR / ICDICMZ
Starting questionHow do clinicians listen and respond to patients' stories?What disease or disorder is present?What mythic structure does this suffering have, and how does it flow toward recovery?
Core focusClinicians' narrative competence (attention, representation, affiliation; close reading)Disease and disorder categoriesThe archetypal structure of suffering and the healing pathway
Language resourcesLiterary works and patients' storiesSymptom criteria53,580 concepts drawn from myths of 10 cultural spheres, world literature, historical figures, and war decision-makers
Classification systemNone (a method of education and practice)Diagnostic codesSix-pillar ICMZ codes
Healing pathwayNo stage modelNone (treatment is in separate guidelines)Seven stages of the Kyklos + Pharmakon
Outcome measurementMainly qualitativeWhether diagnostic criteria are metMovement across the seven stages + standard scales coded in parallel
Relationship to existing systemsComplement to medical education and practiceStandardComplementary layer coded in parallel alongside billing systems

In all submissions and papers, ICMZ is not introduced as "a branch of narrative medicine" or "a new diagnostic system"; it is defined by the fourth column of this table. Narrative medicine is respected as an adjacent field and cited separately in the references.

ICMZ Design Responses to the Limitations of Existing Systems

The strength of ICMZ lies in directly addressing 22 limitations already identified in existing U.S. and WHO systems. Strengths are measured, not asserted. Each response has a verification indicator, and these indicators become the outcome indicators of the trials in Section 6 and the sharing network in Section 7.

#Limitation of existing systemsEstablished factsICMZ design responseVerification indicator
1Some categories have low diagnostic reliabilityIn the DSM-5 field trials, kappa was about 0.3 for major depressive disorder and about 0.2 for generalized anxiety disorderInter-rater agreement for concept assignment measured and published from the outset; deterministic mapping engineKappa of 0.6 or higher
2Heterogeneity within a single diagnosis; high comorbidityDifferent symptom combinations are grouped under the same diagnostic labelNaming by the structure (archetype) of suffering rather than a symptom list; individual structure expressed as a combination of 1 primary + 2 secondary conceptsDifferences in outcomes by concept type within the same diagnosis
3Diagnosis does not indicate a recovery pathwayDiagnostic categories classify only the current stateSeven stages of the Kyklos + Pharmakon = current position and next taskCorrelation between stage movement and scale improvement
4Dropout from psychotherapyAdult psychotherapy dropout rate of 19.7% (meta-analysis of 669 studies), about 1 in 5A 6–8 page report in the client's language, myths that sound like one's own story, narrative music between sessionsDropout rate (parallel-coding group vs. control group)
5Stigma of diagnostic labelsThe label "disorder" can readily lead to self-stigmaNaming by universal experiences that heroes and gods also went through (universalizing suffering)Change on an internalized stigma scale
6Western-centered categoriesCultural concepts of distress remain at the level of appendices and interview toolsConcepts from 10 cultural spheres, link to the CFI, client choice of cultural sphereCultural fit ratings, dropout rate by cultural sphere
7Treatment gapTreatment rates below 10% in low-income countries and above 50% in high-income countries. Median workforce of 13 per 100,000 population (WHO 2025)Stepped care, free multilingual dictionary and textbooks, self-care musicPeople reached, cost per person
8Diagnosis, intervention, and outcomes recorded separatelyICD, procedure codes, and scales are not linked to one anotherLinked in a single record through three-layer parallel codingRecord completeness
9Only the individual is considered; perpetration and power structures lie outside classificationClassification addresses only the victim's symptomsCallisto Dilemma (secondary victimization), Angelostrophe (anger directed at those who tell the truth), Kratopatheia (pathology of power)Reduction in "my fault" attributions
10Prevention gapThose below diagnostic thresholds fall outside servicesStepped-care level 1 self-care, education and music, intervention at formative stages (Genesis, Auxesis)Rate of deterioration in the below-threshold group
11Insurers find it difficult to predict treatment duration and costDiagnoses have no progression stagesStage-based expected pathways. Duration and cost estimation models published only after data have accumulatedPrediction error

Additional limitations (12–22): meaning of recovery, relationships, groups, and practice

#Limitation of existing systemsEstablished factsICMZ design responseVerification indicator
12Medicalization of normal sufferingAfter DSM-5 removed the bereavement exclusion for depressive disorders, debate over the pathologizing of grief has continuedLoss and grief addressed through the Demeter and Orpheus narratives and positioned as a stage in the cycle rather than as pathologyRate of unnecessary diagnosis and medication referral
13Difference between symptom remission and personal recoveryRecovery research treats connectedness, hope, identity, meaning, and empowerment (CHIME) as coreKyklos mapped to CHIME (Anagnorisis = identity and meaning; Palingenesis = hope and empowerment)Recovery process scale (QPR)
14Absence of the dimension of meaning and existenceDiagnostic criteria count only symptomsA meaning structure for every concept; the HAG "meaning structure" itemMeaning in Life Questionnaire (MLQ)
15The client is merely the object of diagnosisClinicians assign classifications and clients receive themClients choose their own myth and rewrite their story through re-storying (co-authorship)Shared decision-making ratings, therapeutic alliance scale
16Lack of follow-up tools for relapseRelapse after recovery is common in depression and other conditionsSelf-maintenance after Palingenesis: My Myth Card, narrative music, follow-up at 3, 6, and 12 months12-month relapse rate
17Intergenerational transmission and family systems lie outside classificationDiagnosis at the individual levelFamily narratives analyzed through divine genealogies and the Epigonoi (intergenerational revenge); family sessionsFamily functioning scale
18Insufficient response to collective trauma (war, disaster)Classification centers on individual illness. WHO emphasizes expanding mental health support in disaster responseGroup narrative and music programs using Kratopatheia and war myths (stepped-care level 2)Pre- and post-program scales for group programs
19Therapist burnout and secondary traumaCare for counselors lies outside classification and billing systemsMyths for counselors (Chiron, the wounded healer), supervision narrativesProfessional Quality of Life Scale (ProQOL)
20Low engagement among adolescents and the digital generationText-centered therapy feels distant to younger generationsThe same myths delivered through music, games, and video (outputs of the five departments of the Mytho-Humanities School)Engagement and retention rates by age group
21Underuse of measurement-based careOnly a minority of clinicians use standard scales regularlyScale entry made a condition for report generation: an incentive structure in which entering data produces the documentScale entry rate per session
22Research takes a long time to reach practiceThe time for evidence to be reflected in care is often cited as 17 yearsThe feedback cycle in Section 7 distributes reviewed recommendations directly as versions (a learning system)Time from discovery to adoption in practice

These 22 indicators are grouped as the ICMZ Outcome Set. To insurers, WHO, and investors, the message is not "ICMZ is better" but "this limitation of existing systems is being measured with this indicator." Measured strengths cannot be refuted.

ICMZ Integrated Operating Flow

ICMZ integrated operating flow: a six-stage cycle of screening, three-layer parallel coding, narrative and music intervention, outcome measurement, international sharing, and recommendation update
ICMZ integrated operating flow · six-stage cycle

The six stages from screening to recommendation update form a single cycle; each stage is described in detail in Section 5 (screening), Section 2 (parallel coding and narrative music), Section 0 (outcome indicators), and Section 7 (sharing and updating).

1. Basic Principle: Parallel Coding, Not Replacement

Because a system that conflicts with the existing systems of the United States and WHO member states would be rejected, ICMZ does not change a single character of existing diagnostic and billing codes; it records the healing pathway alongside them in parallel.

ICMZ does not replace DSM-5-TR or ICD. It leaves each country's existing diagnostic and billing systems unchanged and adds a parallel healing pathway built on myth narrative and narrative music to improve therapeutic outcomes.

Parallel coding has four meanings.

2. Three-Layer Parallel Coding Structure

A single session record lists the diagnosis, intervention and outcome layers side by side, and in each layer the field used for billing is kept separate from the ICMZ parallel-coding field.

LayerCode used for billing (existing system)ICMZ parallel coding (clinical record)Corresponding WHO classification
Diagnosis layerNational diagnosis codes (ICD-10-CM in the United States, KCD in Korea, ICD-11 in adopting countries)One primary ICMZ concept code + up to two secondary codesICD
Intervention layerProcedure codes (CPT psychotherapy codes in the United States, national counseling fee schedules)Narrative intervention applied (myth presentation, re-storying, Pharmakon task) + narrative music matched to the same stageICHI
Outcome layerValidated scale scores (PHQ-9, GAD-7, PCL-5, WHODAS 2.0)Position in the seven Kyklos stages, HAG (research use), Pyros grade (research use)ICF (WHODAS 2.0 is ICF-based)

The most important design point for international approval is that the three layers correspond respectively to WHO's three reference classifications (ICD, ICHI and ICF).

Integration of Narrative Healing and Narrative-Music Healing

As a principle, ICMZ interventions apply narrative and music together in a single context. Mythoiasis narrative music, matched to the myth concept and Kyklos stage addressed in the session, carries the same story forward in sound.

  1. Pairing: A piece of music is assigned to each concept and stage. For example, Katabasis (descent) is paired with a slow piece that helps endure the descent, Catharsis (purification) with a releasing piece, and Palingenesis (rebirth) with a piece about rising again.
  2. Within the session: The sequence is myth narrative presentation → narrative-music listening → sharing responses → re-storying.
  3. Between sessions: The client listens to the same piece as self-care and records responses in the Pharmakon journal.
  4. Recording: The track number, stage, listening context (in or out of session) and pre- and post-listening emotional self-ratings are recorded together in the intervention layer.
  5. Safety: The exclusion criteria (Section 5) apply equally to music. Pieces that may trigger traumatic memories are checked in advance, and the client can stop at any time.
  6. Billing: Music is recorded as a technique within an existing psychotherapy session. Billing music therapy separately requires a music therapist qualified in that country.

Information on which pieces drew good responses at which stages and in which cultural spheres is also gathered through the sharing and feedback cycle in Section 7, and music recommendations are updated accordingly.

Grade-Based Assignment of Narrative and Music Prescriptions

Once a client's grade is determined, the system assigns candidate narratives to read and narrative music to listen to, and these are delivered to the client after clinician approval. The higher the grade, the greater the share of short, more distant narratives, stabilization-focused music, and clinician accompaniment.

Grade determination: The Pyros four grades (Grade 1 mild to Grade 4 very severe, each with a, b, c and a direction of worsening, improving or plateau) are used, but the grade is always set by the clinician together with standard scales. For example, PHQ-9 has established bands of 5–9 mild, 10–14 moderate, 15–19 moderately severe and 20–27 severe, which serve as reference points for the grade. Because the Pyros grade is still being validated, it is not used on its own.

Prescription table by grade (initial standard, to be adjusted with data):

GradeStepped-care levelReading prescription (narrative)Listening prescription (narrative music)Amount and frequencyAssignment and accompaniment
Grade 1 mild1 Self-care or 2 guided helpMyth narrative for the primary concept + a 10-stanza, 40-line poem, and the relevant chapter of the textbookMythoiasis piece for the current Kyklos stage + a piece for the next stage3–5 times per week, 15–20 minutes eachSystem assignment, checked by facilitator or counselor
Grade 2 moderate3 Specialist counselingBegin with more distant myths (other cultural spheres, symbol-centered); read together in session, then self-readingCurrent-stage piece + Deep Calm relaxation and sleep pieces2–3 times per week, 10–15 minutes eachDelivered after counselor approval
Grade 3 severe3–4 Specialist counseling with concurrent psychiatric careIn session only; short symbolic narratives (half a page or less)Mainly Deep Calm relaxation and sleep; narrative music in session onlyOne piece per session; self-directed tasks limited to musicCounselor accompaniment required; shared with treating physician
Grade 4 very severe4 Psychiatric treatmentNot assignedNot assigned (treating physician may allow relaxation music only)—Re-screen after stabilization

Conditions subject to exclusion (Section 5) receive no assignment regardless of grade.

Assignment procedure:

  1. Screening passed: Proceed only if scope screening and crisis screening have been passed.
  2. Grade determination: Grades 1–4 are set using standard scales + HAG + clinician judgment.
  3. Concept and stage decision: The mapping engine proposes one primary and two secondary concepts and the current Kyklos stage.
  4. Culture and preferences: The cultural sphere, language (of eight) and reading/listening preferences chosen by the client are applied.
  5. Candidate selection: Three narratives and three pieces of music with matching concept × stage × cultural sphere × grade tags are selected from the content library.
  6. Safety filter: Content whose trigger tags overlap with the client's trauma type is excluded. For example, a survivor of sexual violence is not initially assigned a direct version of the Medusa narrative.
  7. Clinician approval: The counselor selects from or replaces the candidates. Only Grade 1 self-care is delivered automatically, with later review by a facilitator.
  8. Delivery: "My myth of the week" and "My music of the week" are provided via app, website or print.
  9. Response recording: Before and after reading or listening, the client rates their state of mind from 0 to 10 and writes a one-line reflection in the Pharmakon journal.
  10. Re-evaluation: Prescriptions are adjusted every two weeks, and the grade is reassessed with standard scales every four weeks.

Automatic adjustment rules based on response:

SignalAction
State of mind worsens by 2 points or more after reading or listening, twiceSwitch to more distant narratives or to music only, and notify the counselor
Crisis signal enteredStop prescriptions immediately and switch to the crisis protocol
No reading or listening for two weeksSwitch to a shorter format (one stanza of a poem, one piece of music) and ask why
Steady improvement in state of mind + scale improvementProceed to the narratives and music of the next Kyklos stage
Grade increaseSwitch immediately to the corresponding grade row of the prescription table above, and raise the stepped-care level

Content library tags: All narratives, poems and music carry the following tags so that the assignment engine can select them.

TagExample
Type and sourceMyth narrative (glossary ‘Narrative’ entry), 10-stanza, 40-line poem (Mythopaideia), textbook chapter, Mythoiasis and Deep Calm pieces
ICMZ concept and Kyklos stageMedousastrophe / Katabasis
Cultural sphere and languageOne of 10 cultural spheres; 8 languages
LengthReading minutes, track minutes
Narrative distance1 distant symbol · 2 close story · 3 re-storying of one's own story
Trigger warningViolence, sexual violence, suicide, loss, war
Recommended gradeGrade 1 · Grade 2 · Grade 3

All assigned content and responses are gathered through the sharing and feedback cycle in Section 7 to learn which narratives and pieces were effective at which grades and in which cultural spheres. The amounts and frequencies in the prescription table are initial standards and will be revised annually using these data.

Record example (United States, post-traumatic stress, hypothetical case):

[Billing field — submitted to the insurer]
Diagnosis: F43.10 (ICD-10-CM)
Procedure: 90837 Psychotherapy, 60 minutes (CPT)

[Clinical record field — kept in the counseling record]
Treatment technique: Integrative narrative therapy, with ICMZ framework parallel coding
ICMZ concepts: Medousastrophe (primary), Callisto Dilemma (secondary)
Kyklos: transitioning from Katabasis → Anagnorisis
Outcome: PCL-5 58 → 41 (entered measured values)

The existing INS-ICMZ codes are not placed on claims; they are used only as internal reference numbers within the clinical record field above.

3. National Billing Code Conversion Table

For parallel coding to work, the ICD-11 codes in the 330 mappings must be converted once more into the codes each country actually uses for billing. ICD-11 came into effect in January 2022, but as of May 2024, 14 countries were actually reporting in ICD-11, and more countries are in transition.

RegionDiagnosis billing codeProcedure and fee codesConversion priority
United StatesICD-10-CM (ICD-11 transition timeline not yet set)CPT: 90791 initial evaluation, 90832·90834·90837 individual 30·45·60 minutes, 90846·90847 family, 90853 groupPriority 1
GermanyICD-10-GMNational fee schedule (EBM)Priority 2
United KingdomICD-10OPCS-4 (hospital procedures)Priority 2
JapanICD-10-based disease namesMedical fee point schedulePriority 2
Greece and other EUICD-10 or national modificationNational fee schedulesPriority 3
ICD-11 reporting countriesICD-11 (330 mappings used as is)Country-specificAlready complete

Conversion is based on official correspondence tables (WHO's ICD-10↔ICD-11 mapping tables, the US GEMs, etc.), and results are shown in documents only after review by local coding experts in each country. Conversion to the Korean KCD is kept for internal reference only, maintaining the existing principle of not submitting to domestic institutions.

4. Redesign of the Five-Stage Documents

The stages and page counts remain unchanged, and the 64-page Stage 5 document is changed from "insurance evidence material" to a **"Clinical Documentation Support document for parallel coding (Clinical Documentation Support)"**.

StageDocumentLengthReaderAdditions
1Counseling briefing1–2 pagesCounselorAdd scope screening (Section 5), a validated-scale baseline field and a crisis-screening result field
2Interim report7–8 pagesCounselorScale score trends recorded alongside HAG
3In-depth counseling and final evaluationRecordsCounselorThree-layer parallel-coding record for each session
4Client report6–8 pagesClientNo change (strongest document)
5Clinical Documentation Support document64 pagesClinicians, reviewers, researchersRestructured according to the table of contents below

Table of contents of the 64-page document (64 pages in total):

SectionContentPagesData source
1Cover and summary2Input data
2Billing information summary (diagnosis and procedure codes, sessions, period)2Clinician input
3Statement of medical necessity4Written by clinician; AI drafts only
4Initial assessment (validated scales + HAG)6Measured scores
5Treatment plan (goals, frequency, duration)4Clinician input
6Session-by-session progress notes (based on 12 sessions)20Session records
7Outcome trends (scale score tables and graphs)6Measured scores
8ICMZ parallel-coding record (concepts, Kyklos movement, narrative music, Pharmakon)8Mapping engine + session records
9Risk assessment and safety plan4Clinician input
10Termination and follow-up plan3Clinician input
11Appendix (methodology, scale descriptions, notices, signature fields)5Fixed text

Number sourcing rules (rules to be built into the generator):

5. Safety, Ethics, Fairness and Privacy

Because international organizations and insurers check safety before effectiveness, five items are fixed in writing.

Scope of Application and Advance Notice

Conditions that ICMZ cannot address are screened before counseling begins, and the client is informed in advance. For these conditions psychiatric treatment takes priority, and myth and symbolic narratives may instead reinforce symptoms.

ConditionICMZ applicationReason
Psychotic disorders such as schizophrenia and schizoaffective disorderNot applied. Not applied even in the stable phase without the treating physician's consentRisk that myths and symbols become mixed with delusions and hallucinations and reinforce symptoms. Antipsychotic treatment takes priority
Manic or hypomanic episodes of bipolar disorderNot applied during an episodeRisk of reinforcing grandiose thinking and a sense of mission
Acute suicide risk or self-harm crisisStop immediately and switch to crisis interventionSafety comes first
Severe cognitive impairment such as delirium or dementiaNot appliedNarrative work itself is difficult
Acute phase of substance intoxication or withdrawalAfter detoxification and stabilizationMedical risk takes priority
Eating disorders with high physical riskAdjunctive only, after medical stabilization and with the specialist team's consentPhysical risk takes priority
Children and adolescentsOnly with guardian consent and the involvement of child and adolescent specialistsAppropriateness by developmental stage not yet validated

Advance notice (included in the consent form):

Mythozoesis (ICMZ) is a complementary approach that adds myth-based narrative and narrative-music healing to existing care. It is not used for psychotic disorders such as schizophrenia, manic episodes, acute suicidal crisis, severe cognitive impairment, or acute intoxication or withdrawal; in these cases psychiatric treatment comes first. If such a condition is identified during sessions, ICMZ sessions stop and the client is referred to specialist care.

Screening is the first field of the Stage 1 briefing document; if a condition applies, no further documents are generated and only referral guidance is output.

Objective Fairness Across Ethnicities, Cultures, Regions and Histories

Because MGCIS is intended for people worldwide, it is designed with a structure that shows in numbers, rather than merely declares, that no ethnicity, culture, region or history is placed above others or pathologized.

Six principles:

  1. Equality of the 10 cultural spheres: No cultural sphere serves as the standard or the center of the archetypes. Ancient Greek naming is a shared scholarly nomenclature, like Latin scientific names in biology, and every concept carries names in eight languages together with corresponding stories from each cultural sphere.
  2. The client chooses: Cultural spheres are not assigned automatically by ethnicity or nationality. Giving Korean myths to someone of Korean descent or African myths to someone of African descent is a stereotype; the client's choices and responses decide.
  3. Name phenomena, not groups: Concepts are named after mythological figures and phenomena of suffering, not after ethnic, national or religious groups. No ethnicity becomes the name of a concept.
  4. History from multiple perspectives: Content dealing with war, colonialism and conflict, such as Kratopatheia and Historiopaideia, uses sources from both sides and addresses the psychological phenomena of power rather than blaming individuals.
  5. Respect for living faiths: Content dealing with gods and saints who are still worshipped today (e.g. Hindu and Shinto deities) is reviewed in consultation with the relevant tradition, and clients may choose to exclude it.
  6. Acknowledging the limits of grouping: Where a single cultural sphere contains many peoples, such as "Africa" or "the Americas", it will be divided into sub-spheres as usage data accumulate.

Measurable fairness audit (published annually):

Audit itemWhat is measuredStandard
RepresentationNumber of concepts, content items and narrative-music pieces by cultural sphere, region and languageIf coverage is skewed toward one cultural sphere, a reinforcement plan is drawn up
Outcome equityRecovery, improvement and deterioration rates compared by cultural sphere, region, language, sex, age and incomeIf differences between groups recur, causes are investigated and addressed. Published only when each group meets a minimum size
Recommendation fairnessWhether the assignment engine gives certain groups shorter or less effective contentEthnicity and nationality are not used as recommendation inputs. If differences appear, the engine is corrected
Scale validityWhether standard scales are versions validated in that language and cultureOnly validated translations are used. If none exists, forward translation, back-translation and local validation are completed before introduction
Sensitive expressionsDerogatory, stereotyping or colonial-perspective expressions in concepts and contentReviewed by cultural-sphere advisors; reports answered within 30 days

Data sovereignty of Indigenous and minority cultures: Stories and data of the Ainu, Ryukyu, Indigenous peoples of the Americas and others follow the CARE Principles for Indigenous Data Governance (Collective benefit, Authority to control, Responsibility, Ethics). The Institute works in partnership with the communities concerned, and the means of returning part of the benefit derived from their stories to the community is set out by agreement.

Equity of access:

International Fairness Committee: Members are drawn evenly from WHO's six regions (Africa, the Americas, South-East Asia, Europe, Eastern Mediterranean and Western Pacific), and the chair rotates among regions. The committee reviews the audit above, operates a public channel for objections, and issues an annual fairness report together with the outcomes report.

6. Evidence-Building Plan

International approval requires two kinds of evidence: that "the classification is applied consistently" and that "parallel coding produces better outcomes." Work on the first can begin now.

  1. Classification reliability study (possible now): Two or more clinicians independently assign ICMZ concepts to the same set of hypothetical cases, and agreement (kappa coefficient) is measured. No patients are needed, and the study demonstrates the "mutually exclusive categories" that WHO-FIC requires.
  2. Reanalysis of existing cases (possible now): Applying ICMZ to published DSM and ICD cases can serve as evidence of "classification fit." However, it is not evidence of treatment effect, and papers and investment documents will state this distinction clearly.
  3. Clinical trial registration: Before recruiting participants, the plan is first registered with ClinicalTrials.gov or a registry linked to WHO ICTRP. The registration date becomes the official record of priority.
  4. Pilot (overseas partner institution): After ethics committee (IRB) approval, licensed clinicians code ICMZ in parallel with existing treatment and measure validated scales before and after. The aim is to confirm feasibility, safety and client acceptability; no claims of effect are made.
  5. Randomized controlled trial: "Existing treatment + ICMZ parallel coding" is compared with "existing treatment alone." As an add-on design fully consistent with the parallel-coding principle, it is also favorable for ethics review. Outcome measures are specified in advance from the ICMZ Outcome Set in Section 0 (scale change, dropout rate, stigma, cultural fit, etc.).
  6. Publications: Results are published in peer-reviewed English-language journals in the order reliability study → pilot → RCT. An application for US CPT Category III also requires these papers or an IRB-approved protocol.

First Pilot Design (Draft)

The aim is not to prove effect but to show that the approach is feasible and safe; these results will form the design basis for a randomized controlled trial.

ItemDesign
Study typeSingle-arm pre-post feasibility study, pre-registered, IRB-approved
SiteOne overseas partner clinical institution (with licensed clinicians on staff)
ParticipantsAdults with Grade 1–2 (mild to moderate) depression, anxiety or grief. Those meeting exclusion criteria (Section 5) are excluded
ModulesMCLIS and MGRIS profiles (or MHWIS clinician burnout)
Sample size30–50 participants (a size commonly used in feasibility studies)
InterventionExisting treatment + 8–12 sessions of ICMZ parallel coding + grade-specific narrative and music prescriptions (Section 2)
Primary outcomesRecruitment rate, completion rate (dropout rate), scale entry rate, client acceptability, number of adverse events and deteriorations
Secondary outcomesPre-post change in PHQ-9, GAD-7, WHODAS 2.0 and MLQ; Kyklos movement; response by content item
Duration2 months recruitment + 3 months intervention + 3 months follow-up after termination
SafetyIndependent safety monitor, crisis protocol, stopping criteria defined in advance
ReportingAll results made public, favorable or not (including deterioration rate)

Use and Ongoing Expansion of the 330 Clinical Mappings

The 330 mappings submitted to WHO (code, concept, clinical description, DSM-5, ICD-11; 19 DSM categories) have a case structure close to actual counseling content, making them the largest asset for building evidence now, without patients. However, because they are expert-constructed cases, they are used not as evidence of healing effect but as evidence of content validity and classification reliability.

Four uses:

UseMethodEvidence produced
Reference table for the mapping engineAlready in operation. The same case always yields the same resultDeterministic consistency
Content validity studySix or more licensed clinicians rate the clinical appropriateness of each mapping on a 1–4 scaleContent Validity Index (CVI). Commonly used threshold: 0.78 or higher
Classification reliability study (Section 6, item 1)Two or more clinicians independently map a sample of the 330 cases and compare results with each other and with the reference tableInter-rater agreement (kappa)
Counselor training and certificationPractice casebook for the Mytho-Humanities School psychology department; certification exam itemsConsistent application across counselors

Ongoing entry and expansion method:

  1. Standardized entry form: All new mappings are entered using the same fields: mapping number, de-identified case summary, core symptom keywords (8 languages), ICMZ 1 primary and 2 secondary concepts, DSM-5-TR, ICD-11, ICD-10-CM, Kyklos stage, differentiation rule (why it is not a similar alternative concept), recommended grade, linked narrative and music, trigger tags, module, cultural region, validation status, and version and author.
  2. Codes only from the master registry: Codes are never created ad hoc during mapping. Concepts not in the registry are registered first. Mismatched codes would break the billing chain.
  3. Listing after review: The sequence is draft → review by two experts → differentiation rule finalized → incorporation into the engine. Validation status is shown in three levels: draft / expert-reviewed / field-confirmed.
  4. Regression testing: Each time a new mapping is added, the system automatically checks that existing standard cases (e.g., a man in his 50s whose son has died → G009 Niobeia Petrification/309.81/6B41) still return the same answer. If an answer changes, it is deployed only after review confirms the change was intended.
  5. Fill gaps first: Of the current 330, Kyklos stages are concentrated in Katabasis (about 150), while Acme has only about 10. Gaps by stage, by module (30) and by cultural region (10) are tabulated and filled first.
  6. Real counseling mappings flagged separately: Once the pilot begins, mappings of real cases obtained with consent are accumulated separately as "field cases." The rate of agreement between the engine's suggestion and the clinician's final choice becomes the engine's accuracy, and discordant cases become material for refining differentiation rules.

Expansion target (proposed): Adding 30 cases per month to reach about 700 within one year, with the number of mappings, category coverage, stage balance, content validity and engine–clinician agreement rate published quarterly. These figures serve as direct evidence of "quality and stability," a WHO-FIC registration criterion.

7. International Sharing and Feedback System

This is a federated structure in which each user country keeps its raw data within its borders and shares only pseudonymized, aggregated results. As more countries participate, the narrative recommendations received by clinicians in every country become more accurate.

Feedback cycle (returns to step 1 on completion):

  1. Recording: Clinicians in each country create three-layer parallel-coding records using a common data model.
  2. In-country storage: Raw data are kept only on servers in that country. This complies with cross-border transfer restrictions such as the EU GDPR.
  3. Aggregate sharing: Only pseudonymized aggregate statistics (or federated analysis results) are sent to the ICMZ Learning Network hub. Small cells with fewer than 10 cases are not disclosed.
  4. Analysis: The analysis examines which concepts and narratives appeared together with scale improvement in which diagnoses and cultural regions.
  5. Feedback: Results are reflected in the "next-session narrative recommendations" on clinicians' screens in each country. Changes to recommendations are reviewed by an expert committee and released with a version number.
  6. Expansion: New distress structures discovered in the field are submitted as Layer 2 (open extension layer) proposals and listed after review.

Common data model (all user countries record the same fields):

FieldContentSharing scope
Case numberCountry-specific pseudonymous IDIn-country only
Diagnostic codeNational billing code + ICD-11 equivalentShared as aggregate
ICMZ concepts1 primary + 2 secondary, cultural regionShared as aggregate
Kyklos stagePosition among 7 stages per sessionShared as aggregate
Validated scalesPHQ-9, GAD-7, PCL-5, WHODAS 2.0 scoresShared as aggregate
Intervention recordNarratives used, narrative music (track number, response), Pharmakon assignmentsShared as aggregate
BackgroundAge group, language, number of sessionsShared as aggregate
Verbatim counseling contentClient statements and notesNot shared

Governance:

Associations seen in observational data are not causal, so promising concept–narrative combinations are confirmed through the trials in Section 6 before being adopted as standard recommendations. The network itself serves as evidence of "use in multiple countries" and "ongoing maintenance and revision," both WHO-FIC registration criteria.

Client-Participatory Measurement and Sharing

Healing effect, ICMZ's greatest strength, is designed to be measured not by clinicians alone but together with clients, with results shared among clients to help the next person heal. One person's recovery becomes the next person's map.

Measurement points:

TimingWhatWhoTime required
BaselineStandard scales (PHQ-9, GAD-7 or PCL-5 as applicable) + WHODAS 2.0 + HAG + meaning (MLQ)Client, confirmed by clinician15 minutes
Every sessionUltra-brief scales (ORS, 4 items on life status; SRS, 4 items on session satisfaction) + Kyklos stageClient2 minutes
After each reading or listeningState of mind before and after (0–10), whether it "helped," one-line commentClient30 seconds
Every 4 weeksStandard scales re-administered, grade reassessedClient and clinician10 minutes
TerminationSame set as baseline + recovery process (QPR)Client20 minutes
At 3, 6 and 12 monthsStandard scales + relapse statusClient (app notification)10 minutes

Outcome determination (same yardstick for every client):

My Healing Map (client screen): Clients view their own measurement results as follows.

Seeing one's own change is itself a source of continuing motivation and serves as a mechanism to reduce dropout (Limitation 4).

Client-to-client feedback and sharing (all optional):

MethodContentWhat reaches other clients
Content ratingClients record whether a myth or track they read or heard "helped" and their before-and-after changeRecommendations of "narratives that helped people at a similar stage and in a similar cultural region" (only aggregates of 10 or more people)
Recovery-story donationAt termination, clients anonymously donate their own re-storying narrativeAfter clinician review and de-identification, listed in the library as "narrative distance 2" (close narrative) content
Peer groupsGroups of people passing through the same concept or stage (e.g., "People passing through Katabasis")Led under supervision by peer supporters with lived experience trained at the Mytho-Humanities School
Lived-experience advisory panelRecovered clients jointly review recommendation changes, new content and screensDesign aligned with the client's perspective

When a new distress structure appears repeatedly in donated recovery stories, it is submitted as a Layer 2 new-concept proposal. Clients become co-creators of the system.

Safeguards:

The results of this measurement and sharing are published in an annual outcomes report covering recovery, improvement and deterioration rates, which becomes the actual evidence of ICMZ's healing effect to present to insurers, WHO and investors.

Open Innovation Operations: Rapid Adoption of New Healing Methods

When a new healing method is identified, anyone can propose it; it is piloted quickly according to its risk grade and adopted as standard once its effect is confirmed. "Immediate" applies in two cases: low-risk content is added within a few weeks, and anything found to cause harm is removed within 24 hours.

Entry points for proposals (all through a single public proposal channel):

Adoption pathways by risk grade:

GradeExamplesPathwayTarget timeframe
Low riskNew narrative music tracks, new myth versions and translations, donated recovery storiesReview → tagging → library listing → response monitoring2–4 weeks
Medium riskNew intervention techniques, prescription table changes, new module profilesSafety review → pilot with consenting institutions and clients → comparison on outcome measures → adoption3–6 months
High riskMethods affecting crisis intervention, medication or physical medical careOutside ICMZ scope. Left to the judgment of the medical system under the parallel-coding principleNot adopted
Safety correctionContent or rules with confirmed signals of harm or deteriorationImmediate removal → post-hoc investigation → notification to user countries24 hours

Step-by-step flow: Proposal received (public; first response within 2 weeks) → risk-grade classification → pilot adoption → evaluation using the ICMZ Outcome Set (including deterioration rate) → standard adoption and versioned release → ongoing monitoring and withdrawal if needed.

What is open, and to what extent:

LayerDegree of opennessReason
Layer 1 core concepts (50,092)Fixed. Corrected only in the annual stable releaseClassification stability required by WHO-FIC
Layer 2 extension conceptsAlways open. Listed after reviewNew distress structures arising from the field and from clients
Prescription tables, protocols and module profilesRevised quarterlyReflect shared data and trial results
Content library (narrative and music)Continuously addedLow-risk pathway
Engine access (API, FHIR) and tag specificationOpen specificationExternal researchers, developers and partner institutions contribute in the same format

Governance: An Open Innovation Committee (clinicians, researchers, people with lived experience, cultural-region advisors and ethics experts) makes decisions, and all proposals, decisions and reasons are kept as a public record. Members' conflicts of interest are disclosed in advance. Adopted methods are reflected in the same version in textbooks and counselor certification courses, so the field always works to the latest standard. Contributors are credited by name, and the Institute manages the system's standards and trademarks.

8. Future-Oriented Design

Over the next 5–10 years, mental health insurance and regulation are expected to move toward "paying for outcomes, connecting digitally, keeping AI under human oversight, and adapting to culture." By building these into the design before the changes arrive, ICMZ will already be a prepared system when they do.

Coming changeDesign to build in nowBenefit
Outcome-based payment: expansion of contracts that pay for results rather than number of sessionsOutcome reports that automatically combine Kyklos stage and standard scale changeICMZ records serve directly as evidence in outcome-based contracts
Health record standard integration (HL7 FHIR); planned US transition to ICD-11Publish ICMZ as a FHIR code system, scales in LOINC, diagnoses dual-mapped to ICD-10-CM and ICD-11Fits into hospital electronic records like a plug-in. No rework at transition
Insurance coverage of digital therapeutic apps (Germany's DiGA: risk class I and IIa medical devices, 12-month provisional listing, proof of effect within a maximum of 24 months)Combine mythocare self-reflection and Mythoiasis narrative music into a single self-care app and prepare a low-risk medical device pathwayFirst pathway to insurance reimbursement without a counselor
Medical AI regulation (EU AI Act: AI in medical devices is high-risk, with human oversight and logging obligations)Keep mapping in the deterministic engine; AI drafts only; final judgment by the clinician; rationale and version recorded for every recommendationNo design change needed even as regulation tightens
Clinical workforce shortages and task-sharing (use of trained non-specialists, as in WHO mhGAP and PM+)The stepped-care model belowLower cost and greater access. The Mytho-Humanities School as a workforce source
Demand for culturally adapted care (DSM-5-TR Cultural Formulation Interview, CFI)Link CFI results to concept selection across the 10 cultural regionsA place as a "culturally adapted tool" even within the US system
Growing acceptance of real-world evidence (RWE)Design the Section 7 ICMZ Learning Network as a registry study from the outsetThe network itself becomes an evidence-generating mechanism

Stepped-Care Model

The same ICMZ concepts and narrative music are provided at different intensities according to the level of distress, and a client is moved up a level when signs of deterioration appear.

LevelTarget groupProviderICMZ delivery formatPayer
1 Self-careMild difficulties, preventionSelf (app and website)Self-reflection + narrative music + textbooksIndividual, employer benefits, future digital therapeutic app reimbursement
2 Guided helpMildFacilitators certified by the Mytho-Humanities School (under licensed supervision)Group narrative and music programsInstitutions, employers, communities
3 Professional counselingModerateLicensed counselorFive-step documentation + three-layer parallel codingInsurance (existing fee schedules)
4 Psychiatric treatmentSevere; exclusion conditionsPsychiatryNot applied, or adjunctive with the treating physician's consentInsurance

Anticipated Risks and Responses

RiskResponse
Criticism of cultural appropriation in using minority-culture myths (Ainu, Ryukyu, Indigenous peoples, etc.)Review by cultural-region advisors, attribution of sources, collaboration with the relevant communities
Religious objectionsClients can change cultural region or turn off parallel coding (Section 5)
AI errors and fabricated contentDeterministic mapping, numeric sourcing rules (Section 4), final clinician approval
Data breachesIn-country storage, pseudonymization, minimal collection (Section 7)
Dependence on the founderDocumented classification standards, International Steering Committee, annual stable release (e.g., ICMZ 2027.1) with published change history
Exaggerated promotionPublic communication principles

9. MGCIS Integrated Design: One System, Thirty Modules

The 30 platforms are unified into a single system, MGCIS, and the existing platforms become its 30 modules. This translates the book's (Chapters 39–47) "one mirror, thirty rooms" into a system structure, so it does not contradict existing materials.

Confirmed Terms

TermConfirmedReason
Integrated systemMGCIS — Mythozoesis Global Care Integration SystemKeeps the abbreviation investors and WHO already know. C is broadened from Clinical to Care to cover organizational, educational and public domains
Unit of compositionPlatform → ModuleA component of one system, not a separate system
Module codeExisting abbreviations kept (MNFSIS…MHRIS)Continuity with the book and IR materials. The trailing IS is kept as a historical code
Clinical moduleExisting platform MGCIS (clinical healing) → MCLISAvoids overlap with the umbrella name MGCIS
Standard listVersion in Chapters 40–46 of the bookThe publication is the most official record
Domain7 domains = Chapters 40–46 of the bookUses the book's chapter divisions as they are
Core EngineICMZ engine (Core Engine)Screening, three-layer parallel coding, narrative music, outcome indicators, Learning Network
Parallel codingParallel CodingRecording alongside, not replacement
Narrative musicNarrative Music (Mythoiasis)Linked to Mythoiasis music
ICMZ Outcome SetICMZ Outcome Set (22)The 22 indicators in Section 0
Scope screeningScope ScreeningSection 5
Clinical Documentation Support documentClinical Documentation SupportThe 64-page document in Section 4
ICMZ Learning NetworkICMZ Learning NetworkSection 7

Four-Layer Structure

  1. ICMZ engine: Concepts, screening, documentation, music, measurement and sharing used in common by all modules.
  2. 7 domains: Groupings of Chapters 40–46 of the book.
  3. 30 modules: Profiles within each domain (target population, additional screening, concept set, music set, outcome indicators, funding channel, referral pathway).
  4. 4 funding channels: Insurance billing / public and international budgets / institutional and corporate contracts / self-care and digital.
The four main funding channels of the MGCIS Core Engine and 30 modules
MGCIS · Core Engine and main funding channels of the 30 modules

Even without insurance approval, 20 modules can operate now through public budgets, institutional contracts and self-care, and their usage record becomes the basis for insurance and WHO approval.

7 Domains × 30 Modules (Standard List)

A data grade of "protected" indicates a module whose data is legally stored separately with segregated access rights (see data partitioning below).

Domain (book chapter)ModuleTargetMain funding channelData grade
Clinical and public safety (40)MCLISClinical healing (referral hub for all modules)InsuranceStandard
Clinical and public safety (40)MNFSISNarrative forensics and public safetyPublicProtected
Clinical and public safety (40)MMDISMilitary and veteransPublicProtected
Society and organizations (41)MOLISOrganizations and leadership (corporate EAP)Institutional/corporateStandard
Society and organizations (41)MEISEducation and schoolsInstitutional/corporateStandard
Society and organizations (41)MASISSportsInstitutional/corporateStandard
Crisis and displacement (42)MDCISDisaster and crisisPublicStandard
Crisis and displacement (42)MMRISMigrants and refugeesPublicProtected
Crisis and displacement (42)MHWISHealth workers and caregiversInstitutional/corporateStandard
Crisis and displacement (42)MRPISReligion and pastoral careInstitutional/corporateStandard
Identity and relationships (43)MLGISSexual and gender minoritiesSelf-careProtected
Identity and relationships (43)MDAISDisability and accessibilityInsuranceStandard
Identity and relationships (43)MADISAdoption and identitySelf-careStandard
Identity and relationships (43)MFPISFamilies of incarcerated peoplePublicProtected
Identity and relationships (43)MACISArts and creative workInstitutional/corporateStandard
Life course and loss (44)MAGISAging and older adultsInsuranceStandard
Life course and loss (44)MGRISGrief and bereavementInsuranceStandard
Life course and loss (44)MPPISPerinatal care and parentingInsuranceStandard
Life course and loss (44)MECISEnd of life and palliative careInsuranceStandard
Life course and loss (44)MCHISChildren and adolescentsInsuranceProtected
Social suffering (45)MAPISAddiction recoveryInsuranceProtected
Social suffering (45)MDVISDomestic violenceInsuranceProtected
Social suffering (45)MSVISSexual violenceInsuranceProtected
Social suffering (45)MIISIncarcerationPublicProtected
Social suffering (45)MESISEconomic hardship and povertyPublicStandard
New human suffering (46)MTDISTechnology and digital lifeSelf-careStandard
New human suffering (46)MENVISEnvironmental and climate anxietySelf-careStandard
New human suffering (46)MFAISCelebrities and public figuresInstitutional/corporateStandard
New human suffering (46)MHRISHuman rightsPublicProtected
New human suffering (46)MIPISInternational peacePublicStandard

Inter-Module Referral Chains (Linkage Effects)

Because a person's record sits within one system, the same myth carries the story forward as the person moves between modules. Client consent is obtained again at each move between modules.

ChainFlowLinkage effect
DisasterMDCIS → MCLIS trauma healing, MGRIS bereavement for families of the deceased, MHWIS care for rescuersVictims, bereaved families and caregivers addressed together
End of lifeMAGIS → MECIS → MGRISContinuous from before death through the family's grieving
ViolenceMDVIS ↔ MSVIS ↔ MCHIS ↔ MPPISIntervention to break intergenerational transmission (Limitation 17)
IncarcerationMIIS ↔ MFPIS ↔ MNFSISSocial reintegration and harm to families addressed together
MigrationMMRIS ↔ MHRIS ↔ MDCISTailored with myths from the culture of origin (Limitation 6)
WarMMDIS → MCLIS, MIPISThrough Kratopatheia, down to the causes of the wound (Limitation 9)
GenerationsMEIS ↔ MCHIS ↔ MTDISFrom the prevention stage through music and games (Limitations 10 and 20)
CaregiversMOLIS ↔ MHWIS ↔ MFAISBurnout prevention through the Chiron myth (Limitation 19)
AddictionMAPIS ↔ MESIS ↔ MIISAddresses together the vicious cycle of addiction entangled with poverty and incarceration

Data Partitioning and Operating Principles

Launch Sequence

  1. MCLIS (clinical): The hub to which all modules refer. Already in operation.
  2. MHWIS (health workers): Employers pay, effects are easy to measure with a burnout scale (ProQOL), and risk is low.
  3. MGRIS (grief and bereavement): Has the highest fit with myth and directly answers Limitation 12 (medicalization).
  4. MOLIS (corporate EAP): Generates both revenue and a usage record without insurance approval.
  5. Protected-tier modules are opened one at a time after safety has been confirmed in the four modules above.

10. International Approval Pathway

The realistic route by which WHO formally recognizes an external classification is registration as a "Related Classification" in the WHO Family of International Classifications (WHO-FIC). The nursing classification (ICNP) and the primary care classification (ICPC-2) are included in this capacity, and it fits exactly the parallel coding principle of standing alongside ICD without altering it.

Related Classification registration criteria and ICMZ status:

WHO-FIC criterionICMZ statusActions required
Purpose: health information not covered by existing classificationsHealing pathways and narrative structure are absent from ICD, ICF and ICHIA proposal that describes the gap precisely
Quality: hierarchical structure, mutually exclusive categories, stabilitySix-pillar hierarchy and coding system in place; Layer 1 fixedDemonstrate exclusivity through a reliability study (Section 6, item 1)
Accessibility: free, multilingual publicationGlossary free, in 8 languagesThe classification itself remains free. Revenue comes from software, training and publishing
Sustainability: body responsible for maintenance and revisionThe Institute existsPublish the revision cycle and committee in writing
Use record: actual use in one or more countriesNo clinical use record yetUsage records from pilot institutions (Section 6, item 4)
Collaboration: willingness to align with the WHO-FIC NetworkWHO dev11 #357P submittedPrior consultation with one Collaborating Centre

Registration procedure: The proposing institution submits to the WHO-FIC Family Development Committee (FDC) → committee evaluation → presentation and approval at the WHO-FIC Network annual meeting → recommendation by the WHO-FIC Council → publication by WHO. A World Health Assembly resolution is not required.

Parallel pathways:

11. Phased Roadmap

About four years to Related Classification registration is proposed, and each phase must meet its passing criteria before moving to the next (durations are estimates).

  1. Phase 0 · Document preparation (now to 3 months): Revision of the 64-page generator, US billing code conversion table, parallel coding of validated scales, safety and consent documents, cleanup of the English edition, draft ICMZ FHIR code system.
    • Passing criteria: zero fabricated numbers in generated documents; billing codes reviewed by local coding specialists.
  2. Phase 1 · Reliability and collaboration (3–9 months): Classification reliability study, securing one overseas partner clinical institution, clinical trial registration, prior consultation with a WHO-FIC Collaborating Centre, feasibility review of a digital therapeutic app pathway (DiGA, etc.) for the self-care app.
    • Passing criteria: inter-rater agreement (kappa) of 0.6 or higher; IRB approval.
  3. Phase 2 · Pilot and first paper (9–24 months): Parallel coding pilot, submission of reliability and pilot papers, strengthening of #357P, ICHI mapping table.
    • Passing criteria: no serious adverse events; pilot completed; at least one paper published or under review.
  4. Phase 3 · Application for approval (24–48 months): Randomized controlled trial, launch of the sharing and feedback network among user countries (Section 7), application for WHO-FIC Related Classification registration, application for US CPT Category III.
    • Passing criteria: actual usage records from one or more countries; peer-reviewed papers; documentation of the revision and maintenance system.

Expert Review List

Before actual application, written confirmation will be obtained from experts in each of the areas below. The legal and regulatory content of this document is a design direction based on public sources and is not legal advice.

AreaReviewerItems to confirmTiming
Personal dataUS and EU privacy lawyersHIPAA and GDPR compliance, cross-border transfer, protected-tier modulesPhase 0
Medical device and AI regulationDigital health regulatory consultantWhether the engine and apps are medical devices; EU AI Act and DiGA pathwaysPhases 0–1
Billing codesCertified medical coding specialists in each countryCountry-specific code conversion of 330 itemsPhase 0
Clinical safetyPsychiatrists and clinical psychologistsExclusion criteria, crisis protocols, grade assessmentPhase 0
Research designClinical trial methodology and statistics expertsPilot and RCT design, methods for determining effectsPhase 1
EthicsPartner institution IRBConsent forms, data usePhase 1
CultureCultural advisory committee membersContent review, sensitive expressionsOngoing
Classification standardsWHO-FIC Collaborating CentreWhether Related Classification criteria are metPhase 1

Sources

CPT psychotherapy codes and national diagnostic coding systems are generally known information and must be verified against each country's latest edition before actual application.