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Cybersecurity Plan (Investigational Build)

Status: Frozen-baseline cybersecurity scope and controls approved for IDE submission Version: 1.03 Owner: BionicLoop engineering
Prepared by: BionicLoop engineering Approval reference: Edward R. Damiano, PhD, cybersecurity scope/control acceptance and final software-package approval, controlled email dated 2026-09-07 EDT Baseline freeze SHA: 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e Last updated: 2026-09-08

Revision History

Version Date Author Summary of Changes
0.1 2026-03-27 Engineering Initial cybersecurity draft baseline
0.9 2026-04-06 BionicLoop engineering Added controlled-document metadata and expanded the cybersecurity package with trust boundaries, inherited-control mapping, local-control mapping, and explicit artifact gaps.
0.91 2026-07-09 BionicLoop engineering Added threat scenarios for persisted fallback/issued-dose recovery state and clinical-unlock verifier material; added update/patch-delivery, end-of-support, and vulnerability-cadence rows to open cybersecurity gaps.
0.92 2026-07-10 BionicLoop engineering Added Algo2015 and Algo2015Safety to the trust-boundary SOUP statement, supplier matrix, SBOM scope, threat scenarios, and planned evidence; recorded separately controlled source custody and build-identity evidence; aligned the investigational export posture with RA-009.
0.93 2026-07-14 BionicLoop engineering Added the unlock-gated, dual-confirmed New Participant Reset as the between-participant local-data lifecycle control and aligned the related threat scenario.
0.94 2026-07-18 BionicLoop engineering Documentation truth-sync for the sponsor-approved RA-009 closure: removed superseded claims that Files sharing and an unprotected Documents CSV remain enabled; recorded the gated Application Support export, absent sharing/open-in-place keys, protected and backup-excluded local artifacts, sequenced retained telemetry, and remaining freeze-time verification gates.
0.95 2026-07-20 BionicLoop engineering Recorded the pre-freeze cybersecurity rehearsal: seven focused TV-SEC-001 regressions passed as working evidence, tracked-source credential-pattern scan found no matches in reviewed scope, both algorithm binaries and current dependency pins/checksums are now inventoried, and formal/live/scanner/supplier closure boundaries remain explicit.
0.96 2026-08-21 BionicLoop engineering Aligned the local-control baseline with update-safe telemetry migration, the uncapped protected clinical ledger, bounded batch recovery, complete active-session step evidence, and the clinical-gated combined CSV/Algo2015 recovery ZIP with epoch-session isolation and protected staging.
0.97 2026-08-21 BionicLoop engineering Recorded the exact-freeze 68/68 local-control pass and the freeze-time composition/manual-advisory companion; captured current algorithm-binary hashes and safety identity; and opened CYBER-DEV-001 because ignored Package.resolved state allowed archive 826 and the formal run to use CryptoSwift 1.9.0 and 1.10.0 respectively.
0.98 2026-08-21 BionicLoop engineering Bound the plan to the three-layer FDA package, removed a workstation-specific internal link, and explicitly escalated the conflict between deferred cloud verification and the statement that Scout is a primary study transport. No cybersecurity control or product behavior changed.
0.99 2026-08-21 BionicLoop engineering Recorded the controlled-source candidate that requires CryptoSwift 1.10.0 exactly, tracks the app-workspace resolution, and passes dependency, crypto/session, core, app, and scoped-security verification. Preserved archive 826 and exact-freeze evidence as immutable history and kept CYBER-DEV-001 open pending a designated archive, physical transport check, evidence disposition, and sponsor approval.
1.00 2026-08-27 BionicLoop engineering Recorded the approved supportive BionicScout scope and replaced internal review labels with direct descriptions of the affected cybersecurity controls and evidence. No cybersecurity control or product behavior changed.
1.01 2026-08-27 BionicLoop engineering Added the Build 843 CycloneDX SBOM, dated advisory/license review, and IDE cybersecurity closure matrix; aligned Scout sequence evidence with its approved corroborating role. No product behavior changed.
1.02 2026-08-28 Software Developer Separated available cybersecurity evidence from still-open additions, removed stale planned-evidence wording, and clarified the historical archive-826 dependency deviation relative to Build 843. No cybersecurity control, test result, or product behavior changed.
1.03 2026-09-03 Software Developer Recorded the 2026-09-03 Build 843 IDE-submission designation and closure of CYBER-DEV-001, reconciled the completed permission and RTM evidence, and replaced placeholder incident-response tasks with controlled governance references. No cybersecurity control, test result, or product behavior changed.

1. Scope

This plan covers cybersecurity controls for:

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

Current submission scope boundary:

  • In the current software package:
  • local/device-resident telemetry handling and export controls
  • software design statements for secure telemetry architecture
  • documentation of implemented auth/session code paths where they affect software understanding
  • Deferred from the current software package:
  • formal closure of cloud-upload verification
  • protected API access, onboarding-provider, authorization-role, password-recovery, session-restore, and auth-failure continuity claims represented by SRS-SEC-003..009

2. Security Objectives

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

3. System Trust Boundary Summary

Primary trust-boundary elements for the current software package:

  • iPhone-resident BionicLoop application
  • Dexcom G7 sensor communication path and supporting official Dexcom application
  • Omnipod DASH pod communication path
  • local persistence (UserDefaults, protected Application Support/app-container files, and Keychain)
  • local alerting and notification surfaces
  • cloud telemetry upload and retained-record delivery path

Current boundary statement:

  • BionicLoop owns the controller-app software behavior, local persistence choices, local export behavior, alerting behavior, and cloud-client code it ships.
  • Dexcom and Insulet own the cleared device firmware, proprietary radio/device behavior, and primary CGM/pump safety/security controls of their respective products.
  • Local package code (OmniBLE, G7SensorKit, LoopKit) is treated as software of unknown provenance / inherited open-source software that requires version, provenance, and delta tracking by BionicLoop.
  • The embedded dosing-algorithm binaries (Algo2015.xcframework and the symbol-isolated Algo2015Safety.xcframework) are built locally from the separately controlled Algo2015 C++ reference source through the controlled primary and safety build processes; provenance is anchored by algorithm-source custody plus the safety build's identity report (byte-identical object except exactly three renamed entry symbols).

4. Supplier / Inherited Control Matrix

Component Security Property Relied Upon Current Controlled Evidence Additional Artifact Needed for Submission Closure BionicLoop Ownership Boundary
Omnipod DASH pod / radio session Device-side command/session security and encrypted command transport Local OmniBLE implementation uses LTK-backed encrypted DASH transport with nonce sequencing and AES-CCM handling in OmniBLE/OmniBLE/Bluetooth/EnDecrypt/EnDecrypt.swift, OmniBLE/OmniBLE/PumpManager/MessageTransport.swift, and OmniBLE/OmniBLE/PumpManager/PodComms.swift. Insulet / FDA-cleared product cybersecurity and interoperability artifact or approved supplier summary identifying the relied-upon control. BionicLoop may rely on the pod/session security model but does not claim original ownership of DASH firmware/radio security.
Dexcom G7 sensor / radio session Device-side authenticated CGM session behavior Local G7 integration exposes a dedicated authentication characteristic and authenticated service boundary in G7SensorKit/G7SensorKit/BluetoothServices.swift; the plugin README also requires use of the official G7 app in G7SensorKit/README.md. Dexcom / FDA-cleared product cybersecurity and interoperability artifact or approved supplier summary identifying the relied-upon control. BionicLoop may rely on the G7 session model and official Dexcom app requirement but does not claim original ownership of Dexcom device/app security.
Official Dexcom application Primary CGM alarm and safety alerting Current BionicLoop requirements and IFU explicitly state Dexcom remains the source of truth for CGM alarming. Formal citation package for Dexcom alarm/security behavior used by the study / submission team. BionicLoop owns only its supplemental in-app CGM status/review presentation.
OmniBLE local package Pump communication implementation Controlled local source and tests are available; the provenance review records the likely public upstream source, likely import commit basis, shipped local delta summary, and classification of reviewed transport changes as connection/pairing recovery rather than cryptographic weakening. Any available upstream tag/release mapping for the identified import basis. BionicLoop owns the chosen version and any local modifications it ships.
G7SensorKit local package CGM communication implementation Controlled local source is available; the package README documents the official G7 app dependency; the provenance review records the likely public upstream source, likely initial import and later synchronization basis, shipped local delta summary, and no security-semantic local delta in the reviewed BLE/auth/logging surfaces. Any available upstream tag/release mapping for the identified import/sync basis. BionicLoop owns the chosen version and any local modifications it ships.
LoopKit local package Shared data storage / platform helper library behavior Controlled local source and license are available; the provenance review records the likely public upstream source, likely import commit basis, shipped local delta summary, and no security-semantic local delta in the reviewed auth/keychain/logging surfaces. Any available upstream tag/release mapping for the identified import basis. BionicLoop owns the chosen version and any local modifications it ships.
Algo2015 / Algo2015Safety binary targets Dosing-algorithm computation integrity (unmodified reference algorithm; per-instance state isolation for the safety track) The controlled primary and safety build processes produce a safety-build identity report proving byte identity to the primary compilation except three renamed entry symbols, with all other globals localized; isolation is regression-tested (Algo2015DualInstanceIsolationTests). Algorithm C++ source is controlled separately under a no-modification rule. Freeze-time SBOM/dependency-inventory rows for both binaries plus the archived identity report at the freeze SHA. BionicLoop owns the hosting, build, and isolation of the binaries; the algorithm's clinical logic is the sponsor-controlled reference source and is never modified.

5. BionicLoop-Owned Local Security Controls

Control Area Current Implementation / Observation Controlled Evidence Current Limitation / Residual Gap
Token and credential storage Auth tokens and stored credentials are persisted in iOS Keychain with kSecAttrAccessibleAfterFirstUnlockThisDeviceOnly. BionicLoop/App/AuthSessionNetworking.swift Applies only to auth/session data, not to all local telemetry artifacts.
Authenticated API requests Protected requests carry Authorization: Bearer <token> and retry once after 401 using refreshed token. BionicLoop/App/AuthenticatedAPIClient.swift, BionicLoop/App/AuthSessionNetworking.swift Formal closure for protected cloud/API scope remains deferred in this software package.
Local telemetry outbox persistence Telemetry uses update-safe incremental migration into a protected SQLite ledger. Retained clinical records are not count-capped, receive monotonic sequence numbers, and drain through bounded batch requests with backward-compatible single-record fallback; retryable and permanent failures remain durable. BionicLoop/App/CloudTelemetryReporter.swift, BionicLoop/App/CloudTelemetryOutbox.swift, BionicLoop/App/SQLiteCloudTelemetryOutboxLedger.swift Exact-freeze local-control evidence is complete. Available sequence-correlated phone-to-Scout observations are corroborating operational evidence; local capacity remains bounded by device storage and iOS app-container availability.
Between-participant local-data lifecycle New Participant Reset (2026-07-14) wipes every participant-scoped store on a reused study phone - clinical configuration, local step telemetry and CSV export, cloud outbox queue, alert history, stored pump/CGM manager state, subject-scoped Keychain unlock material including burned counters, onboarding claim - then signs out; unlock-gated, dual-confirmed, refused with an active pod (RA-013/RA-019, SRS-CLIN-014, TV-CLIN-015). BionicLoop/Runtime/LoopRuntimeEngineNewParticipantResetSupport.swift Supports the RA-009 local-data posture between participants; formal promotion follows the clinical-settings lane
Export minimization boundary A bounded complete active-session step CSV is snapshotted into protected staging and can leave the app only through the clinical-gated Recent Dose Steps share flow. The same ZIP may include byte-faithful copies of only the matching/current epoch-session Algo2015 artifacts; missing or mismatched artifacts yield disclosed partial or CSV-only output, never cross-session mixing. No participant-build Files sharing/open-in-place path exposes the source files. BionicLoop/Runtime/LoopTelemetryStore.swift, BionicLoop/App/LegacyAlgorithmArtifactExport.swift, BionicLoop/Features/Home/HomeRecentDoseStepsView.swift, BionicLoop/Resources/Info.plist Exact-freeze TV-SEC-001 and Build 843 recovery-ZIP observations cover protection, backup exclusion, session isolation, gated sharing, ZIP contents, and absence of sharing keys; evidence acceptance is recorded under D08 and D09.
File-access surface The sponsor-approved RA-009 closure removes UIFileSharingEnabled / LSSupportsOpeningDocumentsInPlace; the step archive, telemetry ledger, and staged recovery ZIP use protected, backup-excluded app-container storage. Algo2015 inspection artifacts remain in the app container because the C++ engine owns their location, but the app applies protection and backup exclusion when it enumerates or snapshots them. BionicLoop/Resources/Info.plist, LoopTelemetryStore.swift, CloudTelemetryOutbox.swift, LegacyAlgorithmArtifactExport.swift, Algo2015ArtifactTailSupport.swift Exact-freeze local-control evidence covers the app-owned paths. Protection remains best-effort for C++-created live artifacts; no ungated external file surface is claimed.
Retained telemetry delivery integrity Safety-relevant retained records use the durable protected ledger and monotonic retained-record sequence numbers so the server can detect loss without normal diagnostic chatter creating false gaps. A separate protected complete active-session step archive preserves local clinical step evidence independently from the bounded Home display cache. BionicLoop/App/SQLiteCloudTelemetryOutboxLedger.swift, BionicLoop/App/CloudTelemetryReporter.swift, BionicLoop/Runtime/LoopTelemetryStore.swift, cloud telemetry contract tests Local freeze evidence is complete. Sequence-correlated Scout data is corroborating and supports material-gap investigation; it is not required to establish local dosing/session reconstruction. Storage-pressure operational disposition remains open.
Logging discipline Debug/API/telemetry logging redacts request query strings and avoids dumping bearer tokens directly. BionicLoop/App/AuthenticatedAPIClient.swift, BionicLoop/App/CloudTelemetryReporter.swift, BionicLoop/App/AuthSessionNetworking.swift, Docs/Quality/Cybersecurity_Logging_and_Secret_Review.md Reviewed for the current software package, but debug-response-snippet behavior and console observability remain a residual development-risk consideration if auth/cloud scope is later reopened.
Platform permissions Current app declares Bluetooth-central background use and Bluetooth usage descriptions. BionicLoop/Resources/Info.plist; Cybersecurity_Local_File_and_Permission_Review.md The controlled least-privilege review is complete for Build 843. Any future permission, background mode, or entitlement change requires a new review.

6. Security Baseline Controls

  • Transport security for all cloud telemetry endpoints.
  • Minimize external exposure of persistent local sensitive data; keep retained telemetry, the active-session step archive, and recovery staging protected and backup-excluded, and expose a bounded recovery ZIP solely through the clinical-gated in-app share flow.
  • Principle of least privilege for iOS permissions and background modes; participant builds omit Files sharing and open-in-place capabilities.
  • Dependency and package version tracking (SBOM-ready inventory), including the locally built Algo2015 / Algo2015Safety binary targets.
  • Logging controls: avoid secrets and unnecessary identifiers in clear text.
  • Explicit failure handling for unavailable/unknown device states.
  • Identity and access control implementation exists in development builds, but formal closure for protected auth/provider/role flows is deferred from the current software package.

7. Threat Scenarios (Current Focus)

  • BLE disruption or spoofed/disrupted communication causing stale status.
  • Unauthorized use of the clinical-gated telemetry share flow or access to local app-container telemetry.
  • Residual prior-participant data on a reused study phone (mitigated by the New Participant Reset wipe, 2026-07-14; between-participant lifecycle control in section 5).
  • Data exfiltration via a compromised or misconfigured cloud upload path.
  • Dependency vulnerability introducing runtime compromise.
  • Account takeover or unauthorized API access via weak/misconfigured auth flows.
  • Privilege escalation from incorrect role/scope mapping.
  • Regression that restores Files sharing/open-in-place keys, weakens local file protection, or leaves a legacy Documents export behind after upgrade.
  • Security-relevant behavior drift between local forks of OmniBLE / G7SensorKit / LoopKit and their upstream source without explicit provenance tracking.
  • Tampering with locally persisted runtime recovery state (pod identity, delivery baselines, pending issued-dose attributions, fallback reconciliation records in UserDefaults) to distort masked-fallback or issued-dose replay accounting on the next launch (added 2026-07-09; behavior introduced by the 2026-06/07 fallback/replay/assumed-delivered feature set, RA-006/RA-008/RA-017).
  • Divergence or tampering between the reviewed Algo2015 C++ source and the locally built Algo2015 / Algo2015Safety xcframeworks the app ships - bounded by the build scripts' identity report (safety binary byte-identical to the primary except three renamed entry symbols), differential-replay characterization discipline for any input change, and dual-instance isolation regression tests.
  • Tampering with or replaying provisioned clinical-unlock verifier material or its local single-use counter to gain clinical-settings access (added 2026-07-09; bounded by HMAC verification, counter burn before unlock, expiry, and lockout - see SRS-CLIN-*).

8. Cybersecurity Evidence Artifacts

Available controlled evidence:

  • trust-boundary and threat-scenario analysis in sections 3, 5, and 7 of this plan
  • supplier/inherited-control matrix in section 4 and the current provenance, embedded-package delta, dependency inventory, and supplier-request records
  • local file/permission, logging/secret, and export/file-sharing reviews
  • Build 843 CycloneDX SBOM and dated manual license/advisory review
  • exact-freeze TV-SEC-001 execution and composition/manual-advisory companion
  • Build 843 dependency verification, archive identity, and retained release artifacts
  • IDE cybersecurity closure matrix distinguishing complete, open, and deferred controls

Controlled source locators include:

  • Docs/Quality/Cybersecurity_SOUP_Provenance_Review.md
  • Docs/Quality/Cybersecurity_Embedded_Package_Delta_Review.md
  • Docs/Quality/Cybersecurity_Local_File_and_Permission_Review.md
  • Docs/Quality/Cybersecurity_Dependency_Inventory.md
  • Docs/Quality/Cybersecurity_SBOM_and_Advisory_Process.md
  • Docs/Quality/Cybersecurity_Logging_and_Secret_Review.md
  • Docs/Quality/Cybersecurity_Supplier_Artifact_Request_List.md
  • Docs/Quality/Cybersecurity_Baseline_Acceptability_Recommendation.md
  • Docs/Quality/Cybersecurity_TV_SEC_001_Freeze_Execution_Checklist.md
  • exact-freeze composition/manual-advisory companion: Docs/Quality/Evidence/Formal/STR-SEC-001/2026-08-21-ide-freeze-sbom-advisory-manual/README.md
  • archive-826 matching CryptoSwift 1.9 impact companion retained as historical evidence: Docs/Quality/Evidence/Formal/STR-SEC-001/2026-08-21-ide-freeze-cryptoswift-1.9-companion/README.md
  • controlled Build 843 CryptoSwift 1.10 verification: Docs/Quality/Cybersecurity_CryptoSwift_1_10_Candidate_Verification.md
  • Build 843 CycloneDX SBOM and dated review: Docs/Quality/Cybersecurity_SBOM_Build_843.cdx.json and Docs/Quality/IDE_Software_Packet/IDE_Build_843_SBOM_and_Advisory_Review.md
  • IDE cybersecurity closure matrix: Docs/Quality/IDE_Software_Packet/IDE_Cybersecurity_Closure_Matrix.md

Evidence still needed only if its associated scope or claim is retained:

  • approved supplier/FDA support for relied-upon DASH and G7 security properties
  • an approved automated dependency scanner output if the controlled manual SBOM/advisory method is not accepted
  • penetration/resilience, identity-provider, and authentication negative-test evidence if the deferred cloud/authentication scope is brought into the IDE software claim
  • incident-response drill evidence, update/patch governance, end-of-support, and vulnerability-monitoring records identified in section 10

9. Current Control and Evidence Matrix

Security Area Related IDs Current Submission Scope Current Control / Design Statement Verification / Evidence Position
Inherited DASH and G7 link security RA-003, RA-009 Supporting inherited control context Current code shows encrypted DASH transport and G7 authentication surfaces; BionicLoop relies on supplier/device security rather than re-implementing device firmware controls. Supplier/FDA artifact linkage remains needed before submission closure can rely on the inherited controls.
Local telemetry export and file handling SRS-SEC-001..002, SRS-LOG-015, TV-SEC-001, TV-LOG-015, RA-009, RA-024 In scope The participant build omits Files sharing/open-in-place keys; retained telemetry, complete active-session step evidence, source Algo2015 artifacts, and recovery staging receive app-container protection/backup exclusion. A clinical-gated ZIP carries a bounded step CSV plus only matching/current epoch-session algorithm files. Sponsor disposition is closed Low for RA-009. Exact-freeze TV-SEC-001 passed 68/68 scoped local-control tests. Any retained physical ZIP claim remains subject to the defined evidence-promotion process.
Secure cloud upload and study-data transport SRS-SEC-001, TV-SEC-002, RA-009 Supportive function; broader formal verification deferred The implementation supports secure cloud telemetry and a protected, clinical-gated local recovery export. Scout is supportive for monitoring, troubleshooting, corroborating software evidence, and sequence/gap review; local dosing does not depend on Scout availability. Official study sources are Dexcom Clarity for CGM, the BionicLoop exported CSV for insulin delivery, and staff-entered electronic case-report forms for adverse events and other safety information. Commercial cloud, Part 11, and broader provider/authentication closure remain deferred.
Protected API access, onboarding providers, role authorization, password recovery, session restore, auth-failure continuity SRS-SEC-003..009, TV-SEC-003..008, RA-009 Deferred from the current software package Existing implementation remains documented for software understanding. No closure is claimed in this package; re-open only if the relied-upon study scope is widened.
SOUP / local-package provenance RA-009 supporting control In scope as documentation/process requirement Controlled OmniBLE, G7SensorKit, and LoopKit sources have recorded provenance, local-delta, dependency-inventory, and SBOM/advisory notes. The Algo2015 binaries are built from separately controlled algorithm source; provenance is anchored by algorithm-source custody, controlled build scripts, and the safety-build identity report. Build 843 requires CryptoSwift 1.10.0 exactly and fail-closed checks its source URL, version, and revision. Exact-freeze and Build 843 companion records preserve the resolved dependencies, algorithm slice hashes, safety identity, advisory review, compatibility tests, archive identity, and physical transport observations. Build 843 was designated as the IDE submission build on 2026-09-03, closing CYBER-DEV-001; evidence and cybersecurity acceptance were recorded under D08 and D09.

10. Current Missing Artifacts / Open Cyber Gaps

  • Approved supplier or FDA-cited cybersecurity/interoperability artifacts for the exact Dexcom G7 and Omnipod DASH security properties being relied upon
  • Any available upstream tag/release mapping for the identified OmniBLE, G7SensorKit, and LoopKit import/sync baselines
  • Sponsor acceptance of the controlled manual SBOM/advisory method or execution of an approved scanner if the manual method is not accepted
  • Continued retention of the Build 843 archive, installation, transport, and recovery-ZIP evidence accepted under D08 and D09
  • Sponsor-approved software update and patch-delivery procedure for the investigational fleet, including authorization, installation, and re-verification triggers
  • End-of-support statement for the investigational baseline (what happens to devices/data when the study build is superseded) (added 2026-07-09)
  • Vulnerability-response cadence for the study window (monitoring source, triage SLA, and criteria for notifying the sponsor/IRB) beyond the incident-handling requirements in section 12 (added 2026-07-09)

11. Deferred Authentication Scope Note

For the current software package:

  • SRS-SEC-003..009 are not claimed as closed software scope
  • TV-SEC-003..008 are not claimed as submission evidence in this package
  • SDD-AUTH-001, SDD-AUTH-002, SDD-POL-015, and SDD-POL-016 remain documented because the implementation exists, but they should be treated as documented implementation context rather than accepted closure claims for this package

BionicScout is approved as a supportive monitoring and corroborating evidence tool, not an authoritative dosing or study-outcome source. The approved scope, authoritative data sources, and deferred commercial cloud controls are recorded in IDE_Cloud_Telemetry_Submission_Scope_Decision.md.

12. Incident Response Requirements

The controlled post-approval software change procedure defines the required engineering assessment, risk and traceability updates, regression evidence, deployment authorization, study communication assessment, and sponsor-owned regulatory classification for a software incident or corrective change. The IDE Cybersecurity Closure Matrix retains the still-open sponsor decisions for named contacts, severity criteria, response timing, containment, recovery, vulnerability-monitoring cadence, and reporting responsibilities. Until those decisions are approved, this plan does not claim a completed incident-response SLA.

13. Regulatory Alignment

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