Cybersecurity Plan (Investigational Build)

Status: Draft v0.1
Owner: BionicLoop engineering

1. Scope

This plan covers cybersecurity controls for:

• mobile app runtime
• connected-device communications (CGM + pump)
• telemetry data handling (local and future cloud path)

2. Security Objectives

• Preserve safety-critical command integrity.
• Protect confidentiality of participant data.
• Maintain availability of safety-relevant status and logs.

3. Security Baseline Controls

• Transport security for all cloud telemetry endpoints (future primary path).
• Minimize persistent local sensitive data; debug exports are temporary.
• Principle of least privilege for iOS entitlements and background modes.
• Dependency and package version tracking (SBOM-ready inventory).
• Logging controls: avoid secrets and unnecessary identifiers in clear text.
• Explicit failure handling for unavailable/unknown device states.

4. Threat Scenarios (Initial)

• BLE disruption or spoofed/disrupted communication causing stale status.
• Unauthorized access to exported local telemetry files.
• Data exfiltration via insecure cloud upload path (future risk).
• Dependency vulnerability introducing runtime compromise.

5. Planned Evidence Artifacts

• threat model worksheet (data flow + trust boundaries)
• SBOM/dependency inventory snapshots
• static analysis/dependency scan results
• penetration/resilience test notes for network upload path (when implemented)
• incident-response drill notes

6. Incident Handling (Seed)

• Define severity levels (Critical, High, Medium, Low).
• Create response SLAs by severity.
• For Critical/High findings:
• triage immediately
• patch and verify
• update risk register + traceability matrix
• communicate impact to study/clinical stakeholders

7. Regulatory Alignment

See Docs/Quality/RegulatoryReferences.md for FDA cybersecurity guidance links and applicability notes.