Document ID: RISK-REGISTER-2026-04-21
Classification: Internal — Confidential
Owner: Harnoor Singh, Founder
Review Cadence: Monthly (HERALD automated scan) · Quarterly (Founder decision review) · Annual (legal + clinical + insurer)
Last Updated: 2026-04-21
Framework: ISO 31000:2018 + NIST AI RMF 1.0 overlay
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Silent Infinity's risk management practice is built on ISO 31000:2018, the international standard for risk management principles, frameworks, and processes. ISO 31000 frames risk as "the effect of uncertainty on objectives" — a definition deliberately broad enough to capture the full spectrum of threats and opportunities facing an early-stage AI wellness company. The standard requires that risk management be integrated into organizational governance, be structured yet dynamic, and be continually improved as the organization learns. For an AI-native product operating in a mental health-adjacent space, this is not a compliance exercise — it is a survival discipline.
Overlaid on ISO 31000 is the NIST AI Risk Management Framework 1.0 (NIST AI RMF), published January 2023. The NIST AI RMF introduces four core functions — Govern, Map, Measure, Manage — specifically designed for sociotechnical AI systems. Silent Infinity applies the Map function to identify where AI-specific risks surface (model drift, hallucination, harmful output, user manipulation), the Measure function to score and track those risks, and the Manage function to assign mitigations and owners. The Govern function is instantiated through this document and its scheduled review cadence.
Scoring methodology. Every risk is assigned two independent scores on a 1–5 integer scale. Likelihood reflects the probability of the risk materializing within a 12-month horizon: 1 = rare (less than 5% chance), 2 = unlikely (5–20%), 3 = possible (20–50%), 4 = likely (50–80%), 5 = almost certain (greater than 80%). Impact reflects the magnitude of consequence if the risk does materialize: 1 = negligible (no user harm, minimal cost, recoverable in hours), 2 = minor (limited user frustration, small cost, recoverable in days), 3 = moderate (measurable user harm or business disruption, recoverable in weeks), 4 = major (serious user harm, regulatory attention, or significant financial loss), 5 = catastrophic (severe user harm, existential business threat, or irreversible reputational damage). The risk score is the product of these two values, ranging from 1 (low) to 25 (critical).
Risk categories. This register tracks eight categories: Clinical/Safety (risks of direct or indirect harm to users), Technical (infrastructure, reliability, and software supply-chain risks), Legal/Regulatory (compliance obligations and enforcement exposure), Financial (runway, pricing, and revenue risks), Reputational (brand and public perception risks), Operational (internal process and dependency risks), Strategic (competitive and ecosystem risks), and Data/Privacy (data handling, re-identification, and consent risks).
Review cadence. HERALD performs a monthly automated scan of risk indicators — Bedrock error rates, dependency vulnerability advisories, regulatory news feeds, and user feedback signals — and flags any risk whose score has changed by two or more points. The founder reviews all active risks quarterly, updates ownership, closes resolved risks, and formally accepts any risks where mitigation cost exceeds expected value. Annual reviews include external legal counsel specializing in health tech, a licensed clinical advisor, and the company's insurance broker. Ad-hoc reviews are triggered immediately when a new risk with an estimated score of 15 or higher is identified.
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| ID | Category | Description | Likelihood (1-5) | Impact (1-5) | Score | Owner | Current Mitigations | Target Residual Score | Status |
|----|----------|-------------|-----------------|--------------|-------|-------|--------------------|-----------------------|--------|
| R-001 | Clinical/Safety | Crisis detection false negative. A user expressing suicidal ideation or imminent self-harm intent is not flagged by the AI, and no escalation pathway is triggered. The user receives a standard wellness response with no crisis resource surfacing. This is the highest-consequence failure mode in the product. | 3 | 5 | 15 | Founder + Clinical Advisor | Mandatory crisis keyword + semantic intent layer in every prompt pipeline; SafeMessaging-aligned response templates; hardcoded escalation to 988 Lifeline and Crisis Text Line on detection; prompt regression test suite covering 50+ edge cases; human-in-the-loop review of flagged sessions | 6 | Active |
| R-002 | Clinical/Safety | Crisis detection false positive. The AI flags a user who is not in crisis — for example, a user discussing a sad film or describing a past event — causing intrusive crisis prompts, eroding trust, and potentially driving users to disengage or leave negative reviews. Repeated false positives damage both the user relationship and the clinical credibility of the product. | 4 | 2 | 8 | Founder | Tiered escalation (soft check-in before hard crisis prompt); user-controlled sensitivity setting; A/B testing of threshold calibration; feedback loop allowing users to dismiss false alerts; monitoring of false-positive rate in session analytics | 4 | Active |
| R-003 | Clinical/Safety | AI output contributes to user harm. A user acts on AI-generated content that, while not maliciously intended, provides emotionally harmful, medically inaccurate, or contraindicated guidance. This creates direct liability exposure and reputational damage. The harm need not be catastrophic to generate legal action — a user claiming the AI discouraged them from seeking professional help is sufficient. | 2 | 5 | 10 | Founder + Legal Counsel | "Not a therapist" disclaimer on every session initiation; output filtering for medical advice, medication references, and diagnostic language; Terms of Service with clear scope limitation; clinical advisor review of response templates; output audit log retained for 90 days | 5 | Active |
| R-004 | Clinical/Safety | User over-reliance on Silent Infinity instead of human care. A user with a serious mental health condition substitutes the app for professional therapy or psychiatry, delaying or forgoing treatment that could prevent deterioration. This risk is structurally inherent to any AI wellness product and cannot be fully eliminated, only mitigated. | 4 | 4 | 16 | Founder + Clinical Advisor | Onboarding screen explicitly states product is a wellness companion, not clinical care; periodic in-session prompts encouraging professional support; screening question at signup for current therapy engagement; outbound referral integration to BetterHelp / Psychology Today for users who disclose no current professional support | 8 | Active |
| R-005 | Clinical/Safety | Vulnerable population misuse — minors aged 13–17. A minor in this age bracket uses the product in a context for which it was not designed, potentially without parental awareness, and encounters content or escalation pathways inappropriate for their developmental stage. State-level minor protection laws add compounding regulatory risk (see R-015). | 3 | 4 | 12 | Founder + Legal Counsel | Age gate at signup (13+ with parental consent flow); COPPA compliance for under-13 hard block; separate terms for 13–17 cohort; clinical advisor review of minor-appropriate response templates; CSAM detection layer; age-specific session monitoring flag | 6 | Active |
| R-006 | Technical | AWS Bedrock regional outage in us-east-1. Silent Infinity's inference pipeline is currently single-region. A partial or full us-east-1 outage renders all AI features unavailable. Historical AWS data shows us-east-1 experiences roughly 2–3 significant degradation events per year, not all of which affect Bedrock specifically. | 3 | 3 | 9 | Founder (DevOps) | CloudWatch alarms on Bedrock API error rate; graceful degradation UX ("AI is temporarily unavailable, here are static resources"); AWS status page integration for status banner; multi-region failover is on the roadmap post-10k DAU | 4 | Active |
| R-007 | Technical | Lambda cold-start latency spike. Under low-traffic periods or after deployment, Lambda function cold starts introduce 1–3 second latency on first user interactions. For a conversational AI product where responsiveness is core to the emotional experience, perceived sluggishness degrades user satisfaction and increases abandonment. | 4 | 2 | 8 | Founder (DevOps) | Provisioned Concurrency on critical path Lambdas; Lambda warm-up ping every 5 minutes via EventBridge; response streaming to reduce perceived latency; Lighthouse performance budget tracking in CI | 4 | Active |
| R-008 | Technical | DynamoDB throttling under load. Sudden traffic spikes (e.g., following press coverage or a viral social moment) could cause DynamoDB read/write throttling, resulting in session data loss or API errors. On-demand capacity mode mitigates but does not eliminate this risk under extreme spike conditions. | 2 | 3 | 6 | Founder (DevOps) | DynamoDB on-demand capacity mode; CloudWatch alarms on ConsumedWriteCapacityUnits; exponential backoff in all DB clients; SQS buffer in front of write-heavy paths; load test covering 10× current peak traffic | 3 | Active |
| R-009 | Technical | CloudFront distribution misconfiguration. An incorrect cache policy, origin header, or WAF rule could expose unauthenticated endpoints, serve stale content to users, or block legitimate traffic. Misconfiguration is most likely during infrastructure changes or post-deployment. | 2 | 3 | 6 | Founder (DevOps) | Infrastructure-as-code (CDK/Terraform) for all CloudFront config; automated integration tests against staging distribution; WAF rule audit checklist in deployment runbook; no manual console changes to production distribution | 3 | Active |
| R-010 | Technical | Anthropic model version drift changing behavior. When Anthropic updates a model in place (e.g., claude-sonnet-4-x minor update), output behavior, tone, or safety thresholds may shift without a version change in our prompt config. This can silently degrade crisis detection accuracy or response quality. | 3 | 3 | 9 | Founder | Pinned model IDs in all production prompts; automated golden-set regression tests run nightly against production model; alert on any unexpected output distribution shift; changelog monitoring for Anthropic model update announcements | 4 | Active |
| R-011 | Technical | Deprecated model ID in production prompts. Anthropic retires model versions on rolling schedules. If a deprecated model ID remains in production config, API calls begin failing with a 404/400 error, taking down all AI features. This is a known operational risk for all Bedrock customers. | 2 | 4 | 8 | Founder | Model deprecation calendar tracked in TITAN; HERALD monitors Anthropic deprecation announcements; automated alert 60 days before known deprecation dates; model ID audited in every quarterly review | 4 | Active |
| R-012 | Technical | Supply-chain vulnerability in Python dependencies. A malicious or vulnerably backdoored package in the Lambda dependency tree (e.g., a compromised boto3, pydantic, or FastAPI release) could introduce data exfiltration, code execution, or integrity issues. The Python ecosystem's history of typosquatting and compromised maintainer accounts makes this a credible threat. | 2 | 4 | 8 | Founder | Dependabot alerts enabled on all repos; pinned dependency versions in requirements.txt; AWS CodeGuru or Snyk scan in CI pipeline; monthly manual audit of direct dependencies; no use of packages with fewer than 500 weekly downloads without review | 4 | Active |
| R-013 | Legal/Regulatory | FDA Software as a Medical Device (SaMD) reclassification. If Silent Infinity's marketing, clinical advisor endorsements, or in-app language begins to imply clinical efficacy for a specific diagnosis, the FDA could determine the product meets the SaMD definition under 21 CFR Part 880. This would require 510(k) clearance or De Novo authorization before continued operation. | 2 | 5 | 10 | Founder + Legal Counsel | Strict prohibition on diagnostic language, clinical claims, and condition-specific efficacy statements in all copy; clinical advisor review of all marketing materials; legal counsel sign-off before any new feature description referencing mental health conditions; annual FDA guidance monitoring | 4 | Active |
| R-014 | Legal/Regulatory | EU AI Act Article 5 prohibited uses scope expansion. The EU AI Act Article 5 prohibits AI systems that exploit psychological vulnerabilities or use subliminal techniques. While Silent Infinity's current architecture does not engage in these practices, future regulatory guidance could interpret emotional AI companions more broadly. EU market entry would require full compliance assessment. | 2 | 4 | 8 | Founder + Legal Counsel | No EU user acquisition currently; EU AI Act Article 5 compliance checklist prepared for when EU launch is considered; legal counsel briefed on prohibited uses list; product design avoids variable reinforcement schedules or manipulative engagement patterns | 4 | Active |
| R-015 | Legal/Regulatory | State-level minor protection law variance. Multiple US states (California, Texas, Florida, Virginia, Utah) have enacted or are enacting distinct minor protection laws with varying age thresholds, parental consent requirements, and data handling obligations. A single national policy may not satisfy all state requirements simultaneously. | 3 | 3 | 9 | Founder + Legal Counsel | State law tracker maintained by HERALD (quarterly update); most restrictive standard applied nationally as baseline; geofenced policy adjustments where technically feasible; legal counsel review of minor-related features before launch in new states | 5 | Active |
| R-016 | Legal/Regulatory | Data Subject Access and Deletion Request (DSAR) volume exceeds operational capacity. If Silent Infinity scales to tens of thousands of users, even a 0.1% monthly DSAR rate generates dozens of requests requiring human review and response within statutory timeframes (30 days under GDPR, 45 under CCPA). A solo founder cannot process this at scale without automation. | 2 | 3 | 6 | Founder | In-app self-service data export and deletion flow (target: reduces 80% of requests to zero-touch); DSAR response SOP documented; legal counsel template letters for complex cases; DSAR SLA tracked in HERALD | 3 | Active |
| R-017 | Legal/Regulatory | GDPR 72-hour breach notification non-compliance. Under GDPR Article 33, a data breach affecting EU residents must be reported to the supervisory authority within 72 hours of discovery. A solo founder without a dedicated security incident response process could easily miss this window, triggering fines of up to €10 million or 2% of annual turnover. | 2 | 4 | 8 | Founder + Legal Counsel | Incident response playbook documented and accessible offline; legal counsel on retainer with 4-hour breach response SLA; GuardDuty + CloudTrail enabled for anomaly detection; breach notification template pre-drafted; no EU data collection until GDPR compliance is fully certified | 4 | Active |
| R-018 | Legal/Regulatory | CCPA/CPRA enforcement action by California AG or CPPA. California's Consumer Privacy Rights Act (effective 2023) introduced new requirements around sensitive personal information (which includes mental-health-related data), opt-out of sharing, and data minimization. A complaint-driven enforcement action could result in per-violation penalties of $7,500 for intentional violations. | 3 | 3 | 9 | Founder + Legal Counsel | Privacy policy reviewed by legal counsel with explicit CCPA/CPRA compliance section; no sale or sharing of personal data with third parties; sensitive data category classification applied to all session content; annual CPRA audit | 4 | Active |
| R-019 | Legal/Regulatory | California SB 243 companion chatbot enforcement. SB 243 (effective 2025) requires AI companion chatbots to disclose AI nature, prohibit certain manipulative practices, and provide crisis intervention resources. Silent Infinity operates in this regulatory space and must comply. Enforcement by the AG could result in injunctive relief or penalties. | 3 | 3 | 9 | Founder + Legal Counsel | AI nature disclosed at every session start ("You are speaking with an AI"); crisis resources hardcoded in every session; SB 243 compliance checklist reviewed by legal counsel; product reviewed against full statutory text | 4 | Active |
| R-020 | Legal/Regulatory | Unintentional HIPAA applicability due to health data classification. If Silent Infinity forms a business relationship with a healthcare entity (employer health plan, clinical practice, health system) or if session data is determined by a court or regulator to constitute Protected Health Information (PHI), HIPAA compliance obligations could attach retroactively. | 2 | 4 | 8 | Founder + Legal Counsel | No enterprise contracts with covered entities until HIPAA compliance architecture is in place; legal counsel advises on each new enterprise deal type; session data classified as general wellness data, not medical records; no integration with EHR systems | 4 | Active |
| R-021 | Financial | AWS Bedrock pricing changes eroding margin. Amazon has revised Bedrock pricing multiple times. If per-token costs increase significantly, the unit economics of AI-heavy session formats (long-context, voice, multi-turn) deteriorate, potentially requiring price increases, feature restrictions, or infrastructure migration to remain viable. | 3 | 3 | 9 | Founder | Session token budget caps enforced per user tier; cost-per-session tracked in real time via HERALD; model-switching capability maintained (can route to cheaper models for non-critical paths); pricing change monitoring with 30-day response budget | 5 | Active |
| R-022 | Financial | Runway shortened by founder burnout or bandwidth constraints. Silent Infinity is currently sole-founder. The founder's attention and energy are the binding constraint on all progress. Extended illness, personal crisis, or simply unsustainable work pace could materially slow development, delay revenue milestones, and shorten effective runway without any change in bank balance. | 3 | 4 | 12 | Founder | Async-first development workflow; TITAN automation reducing manual operational burden; documented processes for all recurring tasks; advisory relationship with a mentor or peer founder for accountability; explicit weekly capacity ceiling enforced | 6 | Active |
| R-023 | Financial | Stripe account restriction or termination. Stripe has a known pattern of preemptively restricting accounts in "high-risk" verticals including mental health, adult content, and financial services. If Stripe flags Silent Infinity's business category and restricts the account, subscription revenue collection halts immediately with no advance notice. | 2 | 4 | 8 | Founder | Secondary payment processor (Paddle or Braintree) evaluated and approved as backup; Stripe account opened with accurate business category disclosure; no misleading business description; legal entity and purpose clearly documented to Stripe | 4 | Active |
| R-024 | Financial | Enterprise (Org tier) deal gestation exceeding 12 months. B2B enterprise deals in health-adjacent software routinely take 9–18 months to close due to legal review, security assessments, and multi-stakeholder approval chains. If Silent Infinity's financial model depends on enterprise revenue arriving by a specific date, any deal slip materially affects runway calculations. | 3 | 3 | 9 | Founder | Enterprise pipeline tracked with explicit expected close dates and confidence levels; financial model run at P50 and P90 deal timelines; consumer revenue treated as primary; enterprise treated as upside until signed MSA in hand | 5 | Active |
| R-025 | Reputational | Viral negative review or press story. A single high-profile negative account — whether in a major publication, a viral Reddit thread, or a popular mental health podcast — can permanently shape public perception of a product before it has the scale to counter the narrative. For a solo-founder wellness AI, one story about a harmful interaction could define the brand. | 3 | 4 | 12 | Founder | Rapid response playbook documented with pre-approved messaging for most likely incident types; clinical advisor available for on-record commentary; no dark patterns, no misleading claims in any public-facing copy; direct founder responsiveness to user complaints before they escalate | 5 | Active |
| R-026 | Reputational | Character.AI-style minor harm incident. Character.AI faced intense public and regulatory scrutiny in 2024–2025 following reported incidents involving minors and harmful AI interactions. A similar incident at Silent Infinity — regardless of actual causal attribution — could trigger congressional attention, platform removal, and irreversible brand damage. | 2 | 5 | 10 | Founder + Clinical Advisor | Under-18 usage restrictions and monitoring; crisis detection hardened specifically for minor-appropriate signals; clinical advisor co-owns the minor safety protocol; founder prepared to engage proactively with media and regulators in any such event; product designed with safety-first, not engagement-first, philosophy | 4 | Active |
| R-027 | Reputational | Wellness community boycott due to perceived corporate capture. Wellness communities — particularly those around mindfulness, somatic healing, and trauma-informed care — are deeply skeptical of corporate AI products. A perception that Silent Infinity prioritizes engagement metrics over user wellbeing, or that it has taken funding from sources viewed as predatory, could trigger organized boycott. | 2 | 3 | 6 | Founder | Public commitment to no engagement dark patterns; open about business model in all investor-facing and public communications; founder participates genuinely in wellness communities; advisory board includes practitioners, not only technologists | 3 | Active |
| R-028 | Reputational | Social media pile-on due to misunderstood product decision. A product decision that is rational in business context (price change, feature removal, partnership announcement) can be misread publicly and trigger disproportionate social media backlash. For a mental health product, the threshold for public anger is lower than for typical SaaS. | 3 | 2 | 6 | Founder | All major product and policy changes drafted with public communication in mind before execution; founder has a trusted external reviewer read sensitive announcements before posting; community feedback channel monitored proactively | 3 | Active |
| R-029 | Reputational | Founder personal statements creating PR risk. As the public face of a mental health AI, the founder's personal social media statements, interviews, and public positions are held to a higher standard. Off-hand comments about mental health, AI ethics, or competitor products could create disproportionate blowback. | 2 | 3 | 6 | Founder | Personal social media reviewed against brand values before posting on sensitive topics; media training with a communications advisor before major press engagement; clear distinction maintained between founder personal views and company positions | 3 | Active |
| R-030 | Operational | Solo founder single-point-of-failure. If the founder is incapacitated for any reason — medical emergency, family crisis, legal hold — all product decisions, customer communications, infrastructure access, and financial operations halt simultaneously. There is no second authorized person. | 3 | 4 | 12 | Founder | Emergency access documentation stored in encrypted vault (1Password with emergency contact access); trusted technical advisor identified who could maintain critical infrastructure in acute emergency; all credentials documented and accessible to a designated emergency contact | 6 | Active |
| R-031 | Operational | Documentation gaps preventing handoff. If Silent Infinity needs to bring on a contractor, co-founder, or investor-required technical hire, undocumented architecture decisions, implicit prompt engineering rationale, and tribal knowledge create a significant onboarding barrier and increase risk of harmful changes. | 3 | 2 | 6 | Founder | TITAN knowledge base maintained with architecture decision records (ADRs); all prompt templates version-controlled with rationale comments; runbooks for all deployment and incident response procedures; quarterly documentation audit | 3 | Active |
| R-032 | Operational | TITAN agent framework corruption or data loss. TITAN is the founder's AI operating system and is deeply integrated into development, memory, and decision workflows. Corruption of the memory system, accidental deletion of key agent configurations, or a breaking change in the underlying Claude API could significantly degrade development velocity. | 2 | 3 | 6 | Founder | TITAN memory backed up to F:/TITAN with automated sync; version-controlled agent configurations in git; restoration runbook documented; TITAN treated as a critical system with the same backup discipline as production | 3 | Active |
| R-033 | Operational | Third-party MCP tool breaking change. TITAN integrates with external MCP servers (Gmail, filesystem, browser). An upstream breaking change — API deprecation, authentication change, schema update — can silently break automated workflows that the founder depends on for daily operations. | 3 | 2 | 6 | Founder | Pinned MCP server versions; HERALD monitors MCP tool health daily; fallback manual workflows documented for each critical MCP integration; breaking changes surfaced in weekly health check | 3 | Active |
| R-034 | Strategic | Incumbent wellness app acquires open-source crisis module and out-markets us. A well-funded competitor (Calm, Headspace, BetterHelp, Woebot) could integrate a similar AI companion feature — potentially using open-source components — at a speed and marketing budget that drowns out Silent Infinity's market entry before it achieves meaningful traction. | 3 | 3 | 9 | Founder | Competitive differentiation built on depth of personalization and clinical rigor, not feature parity; community and clinical advisor network as moat; first-mover in specific positioning (not another meditation app); monitoring competitor feature releases quarterly | 5 | Active |
| R-035 | Strategic | Anthropic or AWS pricing or policy change altering product viability. Silent Infinity's core product is built on Anthropic models via AWS Bedrock. If Anthropic changes its usage policies (e.g., prohibits mental health applications), revokes API access, or AWS Bedrock is discontinued, the entire inference layer requires emergency migration. | 2 | 5 | 10 | Founder | Model-agnostic abstraction layer in inference code (swap Anthropic for another provider without prompt rewriting); relationship with Anthropic startup program for policy change advance notice; evaluated Google Vertex AI and Azure OpenAI as fallback | 4 | Active |
| R-036 | Strategic | Superior model (e.g., Claude Opus 5 or equivalent) makes current cost model untenable. A step-change improvement in model capability may require migrating to a significantly more expensive model to remain competitive, eroding the per-session economics that underpin the current pricing model. | 3 | 2 | 6 | Founder | Session cost tracked per-model in HERALD; pricing model built with 3× cost headroom before margin turns negative; model upgrade decisions made on explicit ROI analysis, not reflexive adoption | 3 | Active |
| R-037 | Data/Privacy | User data re-identification risk despite anonymization. Session data anonymized for analytics or model evaluation may be re-identifiable via quasi-identifier combinations (device type + session timing + unusual vocabulary patterns). Mental health context makes re-identification significantly more harmful than in typical SaaS products. | 2 | 4 | 8 | Founder | k-anonymity standard applied to any exported analytics data; no analytics export without DSAR review; session content never used in external analytics pipelines without explicit consent and full anonymization review; legal counsel consulted before any data sharing | 4 | Active |
| R-038 | Data/Privacy | Voice biometric data retained longer than consented. If Silent Infinity introduces voice features (planned), raw audio recordings constitute biometric data under Illinois BIPA, Texas CUBI, and Washington My Health MY Data Act. Retention beyond the consented period creates statutory liability with per-violation damages. | 2 | 4 | 8 | Founder + Legal Counsel | Voice feature not yet launched; retention policy pre-drafted with legal counsel before any voice launch; biometric data classified separately from general session data; automatic deletion enforcement at consented retention boundary; BIPA compliance checklist required before voice GA | 4 | Active |
| R-039 | Data/Privacy | Third-party analytics SDK data leak (future risk). Silent Infinity currently uses no third-party analytics SDKs. Future growth pressure may introduce a request to add Mixpanel, Amplitude, or similar. These SDKs can inadvertently capture sensitive session content, violating GDPR, CCPA, and the product's core privacy promise. | 2 | 3 | 6 | Founder | Formal policy: no third-party analytics SDK without explicit DPA, legal review, and privacy impact assessment; if introduced, all SDK calls must exclude session content fields; founder must personally approve any third-party data processor addition | 3 | Active |
| R-040 | Data/Privacy | Training-data contamination from fine-tuning (future). If Silent Infinity proceeds with model fine-tuning on user session data, improper data hygiene could result in fine-tuned model outputs that leak identifiable user content — a catastrophic privacy failure. This risk is future-state but must be designed against now. | 1 | 5 | 5 | Founder + Legal Counsel | Fine-tuning not currently in roadmap; if it enters roadmap, requires: explicit opt-in consent, full legal review, IRB-equivalent ethics review, data anonymization audit, and legal counsel sign-off before any training run; classified as high-scrutiny future initiative | 4 | Active |
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The following ten risks carry the highest composite risk scores and represent the areas of greatest strategic concern for Silent Infinity as of April 2026.
R-004 — User Over-Reliance (Score: 16). This risk ranks highest because it combines high likelihood (users seeking connection from AI wellness products is the entire market thesis) with major impact (a user deferring professional care and suffering a preventable mental health crisis creates both human harm and catastrophic legal liability). The single most important mitigation is the onboarding screen that explicitly states Silent Infinity is not a substitute for clinical care, delivered not as fine print but as an acknowledged step in the registration flow.
R-001 — Crisis Detection False Negative (Score: 15). A false negative in crisis detection is the product failure that ends companies in this space. The impact is unambiguously catastrophic. The single most important mitigation is the multi-layer crisis detection architecture — keyword matching, semantic intent classification, and SafeMessaging-aligned escalation — tested against a curated regression suite of at least 50 edge-case prompts before every production deployment.
R-022 — Founder Burnout / Bandwidth (Score: 12). A solo founder is simultaneously the product's greatest asset and its greatest single point of failure. Unlike technical risks that can be patched, founder incapacity is silent and progressive. The single most important mitigation is an explicit weekly capacity ceiling — no more than a defined number of working hours — enforced through TITAN scheduling, not willpower.
R-030 — Solo Founder Single-Point-of-Failure (Score: 12). Structurally similar to R-022 but distinct: this risk covers acute incapacitation (medical emergency, legal hold) rather than chronic burnout. The single most important mitigation is the emergency access vault — a documented, tested procedure by which a designated trusted contact can access critical infrastructure and maintain operations for a minimum of 72 hours without the founder.
R-025 — Viral Negative Review or Press Story (Score: 12). In the mental health tech space, the asymmetry between positive and negative press is extreme. A single credible negative incident story can require months to counter. The single most important mitigation is the rapid response playbook — a pre-approved set of statements, contact escalation paths, and clinical advisor talking points that can be activated within two hours of any adverse media event.
R-003 — AI Output Contributing to User Harm (Score: 10). Even without malicious intent, an AI that provides emotionally harmful or medically inaccurate content to a vulnerable user creates real liability. The single most important mitigation is the output audit log — every session's AI output retained for 90 days, enabling post-incident review, legal defense, and model improvement.
R-013 — FDA SaMD Reclassification (Score: 10). If the product's language drifts into clinical territory — through a well-meaning clinical advisor endorsement, a press interview, or an ambitious feature description — the FDA's SaMD classification could attach without warning. The single most important mitigation is legal counsel sign-off on any copy, feature, or marketing claim that references a specific mental health condition.
R-026 — Character.AI-Style Minor Harm Incident (Score: 10). The Character.AI incidents of 2024–2025 demonstrated that a single incident involving a minor can trigger congressional scrutiny, app store removal, and class action litigation within weeks. The single most important mitigation is the clinical advisor co-ownership of the minor safety protocol — crisis detection tuned for developmental stage, parental consent flows, and proactive engagement with app store safety review teams.
R-035 — Anthropic/AWS Policy Change (Score: 10). Complete dependency on a single model provider is an existential risk for any AI-native product. The single most important mitigation is the model-agnostic abstraction layer in the inference code — an architectural decision that should be non-negotiable, allowing migration to a different provider within days rather than months.
R-005 — Minor Misuse (Score: 12). The 13–17 cohort combines elevated vulnerability with complex legal obligations across multiple state jurisdictions. The single most important mitigation is the tiered consent flow — not a checkbox, but a verified parental consent process for users who self-report as minors, with session monitoring flags activated automatically.
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The following risks have been reviewed and consciously accepted at their current scores, with documented rationale and trigger conditions for revisiting the decision.
Single-region deployment (R-006 underlying). Silent Infinity currently operates exclusively in AWS us-east-1. The cost and operational complexity of multi-region active-active deployment is not justified at current scale. This is accepted until Daily Active Users exceed 10,000, at which point the cost of a regional outage (in lost sessions and reputational impact) justifies the investment in failover architecture. Trigger: DAU crosses 10,000 for two consecutive weeks.
No dedicated security engineer (affects R-012, R-017, R-037). Security is currently owned by the founder, supported by automated tooling (Dependabot, GuardDuty, Snyk). A dedicated security hire or retainer is not currently cost-justified. This is accepted until either a security incident occurs or annual revenue exceeds $500,000. Trigger: any security incident of any severity, or ARR crossing $500k.
No EU user acquisition (affects R-014, R-017). Silent Infinity does not currently market to or accept users in the European Union. GDPR and EU AI Act compliance architecture is not yet in place. This is accepted until a deliberate EU market entry decision is made. Trigger: board or founder decision to enter EU market.
Voice biometric features not yet launched (R-038). Voice features are on the product roadmap but will not launch until all BIPA/CUBI compliance obligations are fully documented and implemented. The risk is accepted in its pre-launch form. Trigger: voice feature entering beta.
No cyber insurance in place (Insurance Posture section). Cyber insurance is being evaluated (see Section 5). The gap is accepted for a period not to exceed 90 days from the date of this document. Trigger: 2026-07-21 hard deadline.
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Silent Infinity currently operates without a formal insurance policy in place. This is a gap that is explicitly acknowledged and targeted for closure within 90 days of this document's date. The following coverage types are under evaluation.
Technology Errors & Omissions (Tech E&O) with AI Endorsement. This is the most critical policy for an AI-native product. Tech E&O covers claims arising from errors, omissions, or failures in the product — including AI output that causes user harm. Given Silent Infinity's mental health context, an AI endorsement that specifically covers generative AI output liability is required. Preferred carriers are Embroker (which launched an AI-specific policy in 2024) and Counterpart. Target: quote solicited by 2026-05-15, bound by 2026-06-30.
Cyber Liability (Data Breach). A cyber liability policy covers costs arising from a data breach — including breach notification, credit monitoring for affected users, legal defense, regulatory fines (where insurable), and PR crisis management. Given that Silent Infinity processes sensitive mental health session data, the per-incident exposure without this coverage is potentially existential. Coverage limit of at least $1 million is the target for this stage. Target: quote solicited alongside Tech E&O by 2026-05-15.
General Liability. Standard commercial general liability coverage is required for any enterprise or institutional partnership discussions. Minimum $1 million per occurrence / $2 million aggregate is the standard threshold required by most enterprise procurement teams. This is relatively low-cost and should be bound early. Target: bound by 2026-05-31 via an online business insurance provider (Hiscox, Next Insurance, or Embroker bundle).
Directors & Officers (D&O). D&O coverage is not currently required as Silent Infinity has not yet incorporated as a C-corporation with an external board. This coverage becomes relevant at the point of institutional fundraising or formal board formation. It is logged here for the record and will be added to the insurance posture review at that milestone.
The founder's primary broker contact for this process is TBD. The target is to engage at least two brokers for competitive quoting. HERALD will track quote request status and flag if the 2026-05-15 deadline is at risk.
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Monthly automated review (HERALD). HERALD performs a continuous background scan of risk indicators and produces a monthly risk digest. This includes: AWS Bedrock error rate trends, Lambda cold-start percentile tracking, dependency vulnerability advisory count, regulatory news feed monitoring (FDA, FTC, California AG, EU AI Office), and user feedback sentiment signals. Any risk whose composite score increases by two or more points since the last review is flagged for immediate founder attention. New risks that score 12 or higher on initial assessment are treated as immediate escalations.
Quarterly founder review. The founder reviews the full risk register quarterly (target dates: January 15, April 15, July 15, October 15). This review covers: score updates for all active risks, formal acceptance or closure decisions on borderline risks, ownership reassignment where relevant, and an explicit check of the accepted-risk trigger conditions. The output of each quarterly review is a dated version of this document committed to the TITAN plans directory.
Annual external review. Once per calendar year, this register is reviewed with three external parties: (1) legal counsel specializing in health tech and AI regulation, who reviews all Legal/Regulatory risks and flags any new regulatory developments; (2) the clinical advisor, who reviews all Clinical/Safety risks and validates the crisis detection protocol against current clinical guidance; (3) the insurance broker, who reviews the Insurance Posture section and advises on coverage gaps relative to the current risk register scores.
Ad-hoc escalation triggers. Any of the following events triggers an immediate out-of-cycle risk review: a security incident of any severity; a user-reported harmful AI output; any media inquiry about product safety; a regulatory inquiry or subpoena; a Bedrock or AWS service disruption lasting more than 2 hours; or any new law, regulation, or enforcement action that plausibly affects any risk in the Clinical/Safety or Legal/Regulatory categories.
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ISO 31000:2018 — Risk Management: Guidelines. International Organization for Standardization. Provides the foundational framework, principles, and vocabulary for organizational risk management applied throughout this document. Available at iso.org.
NIST AI Risk Management Framework 1.0 (2023) — National Institute of Standards and Technology. Provides the four-function (Govern, Map, Measure, Manage) structure for AI-specific risk identification, measurement, and mitigation. Available at nist.gov/system/files/documents/2023/01/26/AI RMF 1.0.pdf.
OWASP LLM Top 10 (2023) — Open Web Application Security Project. Enumerates the top ten security and safety vulnerabilities specific to large language model applications. Informs technical risk entries R-010 through R-012. Available at owasp.org.
MIT AI Risk Repository (2024) — Massachusetts Institute of Technology. A comprehensive taxonomy of AI-related risks across domains including safety, fairness, privacy, and systemic risk. Used as a cross-reference for completeness of this register's risk enumeration. Available at airisk.mit.edu.
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End of document. Next scheduled review: 2026-07-15 (Quarterly Founder Review).