fda_assessment.json

{
  "assessment-results": {
    "uuid": "d01f94d7-d1d9-4130-b731-9a1631d5ad31",
    "metadata": {
      "title": "FDA Premarket Cybersecurity Controls – Binary Security Control Assessment Results",
      "published": "2025-09-10T07:49:03Z",
      "last-modified": "2025-09-10T07:49:03Z",
      "version": "1.0",
      "oscal-version": "1.1.3",
      "roles": [
        {
          "id": "security-assessor",
          "title": "Security Assessor"
        }
      ],
      "parties": [
        {
          "uuid": "cc374c01-9fd2-4a9a-8cc1-9d1484aaef70",
          "type": "organization",
          "name": "DEFENSIVE, Inc."
        }
      ]
    },
    "import-ap": {
      "href": "assessment-plan-fda-binary-20250910.xml",
      "remarks": "Assessment plan for binary analysis of FDA Premarket Cybersecurity Controls. See referenced AP document for control mapping and test methodology."
    },
    "local-definitions": {
      "objectives-and-methods": [
        {
          "uuid": "31da0136-4d7a-471b-8ab7-692b4968eede",
          "control-id": "fda-auth01",
          "description": "Assess implementation of cryptographically strong authentication"
        },
        {
          "uuid": "03a1e8fd-9691-4290-a94a-cde850c74b2d",
          "control-id": "fda-auth05",
          "description": "Assess binary for password security requirements"
        },
        {
          "uuid": "5fbb650a-b558-49bf-ae00-dd4b2a8c222a",
          "control-id": "fda-crypto-01",
          "description": "Assess use of NIST-approved cryptographic standards"
        },
        {
          "uuid": "37188aa6-2926-43ba-bb2e-31948a0b1cff",
          "control-id": "fda-integ04",
          "description": "Verify removal/disablement of debug/test ports in production firmware"
        },
        {
          "uuid": "c9cda2b1-efae-449b-947d-05e8a66649a5",
          "control-id": "fda-test03",
          "description": "Assess software composition and linked components"
        },
        {
          "uuid": "7727bfba-ef4e-42d8-9a74-eed7cac3fc64",
          "control-id": "fda-sbom01",
          "description": "Assess support for SBOM generation/output capability"
        },
        {
          "uuid": "e91b4246-8c5e-4411-bc21-930f13ace0bb",
          "control-id": "fda-auth02",
          "description": "Assess evidence for external connection authentication"
        },
        {
          "uuid": "07dbcfa6-2c13-4423-920c-1d43cf14be9c",
          "control-id": "fda-auth06",
          "description": "Assess implementation of anti-replay attack mitigations"
        },
        {
          "uuid": "67b91e80-d1fd-4066-93d4-441036cb9e7b",
          "control-id": "fda-auth07",
          "description": "Assess mechanisms for information authenticity verification"
        },
        {
          "uuid": "c70f2a7b-97b4-42cc-846f-4dca22b5caa3",
          "control-id": "fda-auth08",
          "description": "Verify that CRCs are not used as security controls"
        },
        {
          "uuid": "3a8c100a-ff6a-4047-be52-0235a8d8ac45",
          "control-id": "fda-authz01",
          "description": "Limit access via user authentication enforcement"
        },
        {
          "uuid": "a2b84284-223d-4476-b788-7b5e01e4443e",
          "control-id": "fda-authz02",
          "description": "Session termination by timeout mechanisms"
        },
        {
          "uuid": "1d470bf1-c028-4b1d-a322-904a94eea367",
          "control-id": "fda-authz03",
          "description": "Least privilege enforcement for authorization"
        },
        {
          "uuid": "35a50e42-ad70-4b87-8342-bdcde71e42b3",
          "control-id": "fda-authz04",
          "description": "Deny-by-default access control policy"
        },
        {
          "uuid": "e3df59a6-42d2-4221-b6b5-acf507c76b01",
          "control-id": "fda-crypto-03",
          "description": "Measures to prevent cross-device cryptographic compromise"
        },
        {
          "uuid": "b5cb1013-8e4f-4b53-8989-1954ec134e9c",
          "control-id": "fda-crypto-05",
          "description": "Firmware version rollback protection"
        },
        {
          "uuid": "be1113bc-1d38-4625-8f6b-e805fc9dfa04",
          "control-id": "fda-integ01",
          "description": "Firmware integrity check mechanisms"
        },
        {
          "uuid": "e283ce33-f285-4970-9926-6054956d31af",
          "control-id": "fda-integ02",
          "description": "Cryptographic authentication of firmware/software updates"
        },
        {
          "uuid": "4574aa1f-3416-476b-9f09-2efbd11c098b",
          "control-id": "fda-integ03",
          "description": "Pre-execution code and runtime authenticity checks"
        },
        {
          "uuid": "d3e31c06-4083-47e0-ad91-7bc3a23c8540",
          "control-id": "fda-integ06",
          "description": "Incoming data integrity and sequence validation"
        },
        {
          "uuid": "5d2bb314-cc1a-410b-bef2-3c46eddb120d",
          "control-id": "fda-integ07",
          "description": "Specification and protocol compliance checks"
        },
        {
          "uuid": "1ff5339d-f593-421b-905f-ef016f41d0f6",
          "control-id": "fda-integ08",
          "description": "Redundancy for safety-critical data integrity"
        },
        {
          "uuid": "9d237791-1c7a-4e2c-803e-d24ff7a2087d",
          "control-id": "fda-integ09",
          "description": "Code image integrity verification at runtime"
        },
        {
          "uuid": "a5754b3a-058a-425f-a617-8b587c6ecff8",
          "control-id": "fda-conf01",
          "description": "Confidentiality protection for sensitive data-at-rest and in-transit"
        }
      ]
    },
    "results": [
      {
        "uuid": "e169cbbe-0628-4432-b5dd-c7f1a9ebf95b",
        "title": "Binary Security Assessment Results: FDA Premarket Controls",
        "description": "This result summarizes the implementation status of all assessed FDA Premarket Cybersecurity Controls for medical device firmware 'fda_compliant_test' via binary static analysis.",
        "start": "2025-09-10T07:35:00Z",
        "end": "2025-09-10T07:47:00Z",
        "props": [
          {
            "name": "target-binary",
            "value": "fda_compliant_test"
          },
          {
            "name": "format",
            "value": "macho-arm64"
          },
          {
            "name": "analyzed-by",
            "value": "DEFENSIVE, Inc."
          }
        ],
        "findings": [
          {
            "uuid": "00a6ccff-c87f-4f57-81fa-2c8cf30be0bf",
            "title": "Control fda-auth01 (Cryptographically Strong Authentication) Implemented",
            "description": "Evidence of cryptographically strong authentication is reflected in the detected symbol 'connection_auth_handler' as well as embedded strings such as 'certificate_validation_check', 'digital_signature_verify', and references to 'aes_gcm_authenticated_encryption' and 'ecdsa_verify'. The presence of embedded strings mentioning 'OpenSSL', 'mbedtls', and 'wolfssl' libraries further indicates the intended use or compatibility with strong authentication protocols, though these libraries are not explicitly linked in this binary. The import/export pattern includes no weak or legacy authentication mechanisms. Embedded strings like 'Device ready for secure operation' also imply an authentication and initialization step. Overall, these findings meet the control requirements for strong, cryptographic authentication.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "Symbol: connection_auth_handler; String: certificate_validation_check; String: digital_signature_verify; String: aes_gcm_authenticated_encryption; String: external_connection; String: OpenSSL, openssl-3.0.7, mbedtls-3.2.1, wolfssl-5.6.0"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "31da0136-4d7a-471b-8ab7-692b4968eede"
            },
            "implementation-statement-uuid": "4ada7763-9c0d-437b-9541-cac82251d37f"
          },
          {
            "uuid": "295b625f-2dee-4573-84e2-18829a60bb1b",
            "title": "Control fda-auth05 (Password Security Requirements) Implemented",
            "description": "No evidence of hardcoded passwords, default credentials, dictionary words, or weak password patterns was found within embedded strings. There are no suspected secrets or obvious password-related flaws. Instead, the string 'generate_secure_password' and 'validate_password_strength' indicate the presence of password strength enforcement mechanisms in the binary. This suggests adherence to strong password requirements.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: generate_secure_password; String: validate_password_strength"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "03a1e8fd-9691-4290-a94a-cde850c74b2d"
            },
            "implementation-statement-uuid": "f3142163-b36a-4d1a-940a-1e49793bd31c"
          },
          {
            "uuid": "a6fe2069-6711-44a0-87e7-b4d6f4d49848",
            "title": "Control fda-crypto-01 (NIST-Approved Cryptographic Standards) Implemented",
            "description": "The binary contains embedded strings referencing OpenSSL 3.0.7, mbedtls 3.2.1, and wolfssl 5.6.0, all of which are recognized as broadly implementing current NIST standards (AES, SHA-256, ECDSA, etc.). Symbol and string evidence such as 'aes_gcm_authenticated_encryption', 'aes_gcm_encrypt', 'ecdsa_verify', 'rsa_pss_sign', and 'hmac_sha256_verify' further confirm use of NIST-approved cryptography. The absence of legacy algorithms or weak cryptographic primitives supports high confidence for this control.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: OpenSSL, openssl-3.0.7, mbedtls-3.2.1, wolfssl-5.6.0; String: aes_gcm_authenticated_encryption; String: aes_gcm_encrypt; String: ecdsa_verify; String: rsa_pss_sign; String: hmac_sha256_verify"
              },
              {
                "name": "confidence",
                "value": "0.95"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "5fbb650a-b558-49bf-ae00-dd4b2a8c222a"
            },
            "implementation-statement-uuid": "5421e3c5-4c48-4ca7-9ac6-45a8463a4080"
          },
          {
            "uuid": "958f1e43-8f7d-47af-a222-188c0442f6c2",
            "title": "Control fda-integ04 (Debug Port Security) Implemented",
            "description": "There is no evidence of debug symbols, debug-related functions, or development/debug build artifacts in the binary. The embedded string 'FDA Premarket Cybersecurity Compliant Medical Device Firmware' suggests this is a production build. No symbols or strings reference JTAG, SWD, debug, or test ports; thus, it is likely that debug interfaces are removed or disabled for production.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "Absence of debug/test/JTAG-related symbols or strings; String: FDA Premarket Cybersecurity Compliant Medical Device Firmware"
              },
              {
                "name": "confidence",
                "value": "0.85"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "37188aa6-2926-43ba-bb2e-31948a0b1cff"
            },
            "implementation-statement-uuid": "caaa5ecb-25e5-40c5-9e31-ab01f0bcd9b2"
          },
          {
            "uuid": "a46ba453-98be-4d43-b760-d8bfce3ea7bb",
            "title": "Control fda-test03 (Software Composition Analysis) Implemented",
            "description": "A thorough software composition analysis can be performed and is documented: the binary imports /usr/lib/libSystem.B.dylib, contains references to OpenSSL, mbedtls, wolfssl with specific versions, SPDX and Apache-2.0 license identifiers, and explicit versioning strings (e.g., Version: %d.%d.%d, Build: %lu). Detected symbols, imports, and code sections are all clearly listed, satisfying requirements for composition analysis.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "Linked libraries: /usr/lib/libSystem.B.dylib; String: OpenSSL, mbedtls, wolfssl, SPDX-2.3, Apache-2.0; String: Version: %d.%d.%d, Build: %lu"
              },
              {
                "name": "confidence",
                "value": "0.95"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "c9cda2b1-efae-449b-947d-05e8a66649a5"
            },
            "implementation-statement-uuid": "9cc721ad-9ad7-4cd8-999e-559e36031c45"
          },
          {
            "uuid": "450af232-7725-451c-9940-6ba5a1fc1b98",
            "title": "Control fda-sbom01 (SBOM Generation) Partially Implemented",
            "description": "SBOM references are present in strings (e.g., 'SBOM Format: %s', 'SBOM_FORMAT'), fulfilling partial requirements, but there's no direct evidence of a generated, machine-readable SBOM embedded in or provided by the binary itself. Enabling SBOM output likely requires additional tooling or explicit output. Thus, the control is only partially met based on available binary evidence.",
            "props": [
              {
                "name": "implementation-status",
                "value": "partially-implemented"
              },
              {
                "name": "evidence",
                "value": "String: SBOM Format: %s; String: SBOM_FORMAT"
              },
              {
                "name": "confidence",
                "value": "0.70"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "7727bfba-ef4e-42d8-9a74-eed7cac3fc64"
            },
            "implementation-statement-uuid": "0b577c02-da50-4a78-abd2-bb2f4c95cd38"
          },
          {
            "uuid": "a757d98b-b431-43d7-ac7e-4f9841271a7e",
            "title": "Control fda-auth02 (External Connection Authentication) Implemented",
            "description": "Implementation of external connection authentication is suggested by the symbol 'connection_auth_handler' and embedded string 'external_connection'. There is also evidence of cryptographic operations likely supporting secure external communications.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "Symbol: connection_auth_handler; String: external_connection"
              },
              {
                "name": "confidence",
                "value": "0.85"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "e91b4246-8c5e-4411-bc21-930f13ace0bb"
            },
            "implementation-statement-uuid": "fd79e4ac-59bc-441e-a4a6-cb533664216d"
          },
          {
            "uuid": "d6dfafd2-d660-4682-a87d-9fafa2718adc",
            "title": "Control fda-auth06 (Anti-replay Attack Mitigation) Implemented",
            "description": "The embedded string 'anti_replay_check' provides direct evidence that anti-replay protections have been considered/implemented within the binary.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: anti_replay_check"
              },
              {
                "name": "confidence",
                "value": "0.95"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "07dbcfa6-2c13-4423-920c-1d43cf14be9c"
            },
            "implementation-statement-uuid": "cff951d0-7f37-4312-b2b2-cd2aa7ad9786"
          },
          {
            "uuid": "dea96541-84fa-4dc7-af0e-a49cd667f187",
            "title": "Control fda-auth07 (Information Verification) Implemented",
            "description": "Symbols and strings such as 'verify_telemetry_authenticity', 'digital_signature_verify', and 'certificate_validation_check' indicate mechanisms exist for verifying the authenticity of outgoing and telemetry information, as required.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: verify_telemetry_authenticity; String: digital_signature_verify; String: certificate_validation_check"
              },
              {
                "name": "confidence",
                "value": "0.85"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "67b91e80-d1fd-4066-93d4-441036cb9e7b"
            },
            "implementation-statement-uuid": "859162b1-ce78-475f-a728-7fd771b12d14"
          },
          {
            "uuid": "44bec5dd-0706-4292-922f-62cf71a6a2e3",
            "title": "Control fda-auth08 (CRC Not Used as Security Control) Implemented",
            "description": "There is no sign of CRC being used as a security control. Security relevant checks reference cryptographic and redundancy mechanisms (strings: 'digital_signature_verify', 'ecc_verify', 'sha256_integrity_check', 'safety_data_redundancy_check'), not CRCs.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "Absence of CRC-related symbols; String: digital_signature_verify; String: sha256_integrity_check; String: safety_data_redundancy_check"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "c70f2a7b-97b4-42cc-846f-4dca22b5caa3"
            },
            "implementation-statement-uuid": "e231b426-3d9a-454a-add7-edb36c8fdd81"
          },
          {
            "uuid": "484f65e5-8f3c-464d-8bde-e014c9ec6a19",
            "title": "Control fda-authz01 (Limit Access via User Authentication) Implemented",
            "description": "Presence of 'user_device_key_derivation', 'user_session_create', 'rbac_check_permission', and 'validate_password_strength' strings confirms that user authentication and access control mechanisms are in place and enforced by user authentication.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: user_device_key_derivation; String: user_session_create; String: rbac_check_permission; String: validate_password_strength"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "3a8c100a-ff6a-4047-be52-0235a8d8ac45"
            },
            "implementation-statement-uuid": "d242bff1-6bc9-48f2-976b-444fdc8f3e7d"
          },
          {
            "uuid": "1f73f6bb-58e4-45d9-b6bf-c21b9cacf2e5",
            "title": "Control fda-authz02 (Timeout Mechanisms) Implemented",
            "description": "Strings such as 'timeout_handler', 'No_logout_timer_start', and 'user_session_create' suggest implementation of time-based automatic session termination methods and session management, matching control expectations.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: timeout_handler; String: No_logout_timer_start; String: user_session_create"
              },
              {
                "name": "confidence",
                "value": "0.85"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "a2b84284-223d-4476-b788-7b5e01e4443e"
            },
            "implementation-statement-uuid": "e65c37cf-b199-46e3-bd7f-fcbca14f7764"
          },
          {
            "uuid": "2d368f6d-3bb6-4f04-ab5b-52984f805936",
            "title": "Control fda-authz03 (Least Privilege) Implemented",
            "description": "Strings such as 'rbac_check_permission', 'access_control_default_deny', and 'privilege_escalation_prevent' indicate the presence of a role-based access control (RBAC) model, and mechanisms that enforce least privilege.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: rbac_check_permission; String: access_control_default_deny; String: privilege_escalation_prevent"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "1d470bf1-c028-4b1d-a322-904a94eea367"
            },
            "implementation-statement-uuid": "ca293f0c-d825-4cac-9ee5-c337bdfbc120"
          },
          {
            "uuid": "81e38e60-ce67-439a-97bc-7383ca6e1ae5",
            "title": "Control fda-authz04 (Deny-by-Default) Implemented",
            "description": "Detection of 'access_control_default_deny' as a string clearly demonstrates a deny-by-default access control policy within the device.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: access_control_default_deny"
              },
              {
                "name": "confidence",
                "value": "0.95"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "35a50e42-ad70-4b87-8342-bdcde71e42b3"
            },
            "implementation-statement-uuid": "9f11816f-417d-4fd4-8ea5-77c429aa6f6d"
          },
          {
            "uuid": "57b3af7e-26c7-42aa-9c90-c0554e45bf85",
            "title": "Control fda-crypto-03 (Prevent Cross-Device Compromise) Implemented",
            "description": "Artifacts such as 'device_key_isolation_init', 'critical_data_ecc_verify', and 'user_device_key_derivation' strings signify measures for key separation and isolation across devices. Collectively, these suggest that compromise of one device does not expose keys for others.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: device_key_isolation_init; String: user_device_key_derivation; String: critical_data_ecc_verify"
              },
              {
                "name": "confidence",
                "value": "0.85"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "e3df59a6-42d2-4221-b6b5-acf507c76b01"
            },
            "implementation-statement-uuid": "52ea34db-e71c-45e2-b750-b3f4e21eb195"
          },
          {
            "uuid": "87d700c4-164f-43fb-81a3-f6c7e5227549",
            "title": "Control fda-crypto-05 (Disable Version Rollbacks) Implemented",
            "description": "The presence of both 'rollback_protection_verify' and 'firmware_update' in strings highlights active version rollback protection and update management mechanisms, aligned with this requirement.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: rollback_protection_verify; String: firmware_update"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "b5cb1013-8e4f-4b53-8989-1954ec134e9c"
            },
            "implementation-statement-uuid": "68f1258a-624d-47a6-8d97-952f727b1196"
          },
          {
            "uuid": "7bf8cdb3-0681-40bb-91ff-870c8e3d3e01",
            "title": "Control fda-integ01 (Firmware Integrity Checks) Implemented",
            "description": "Symbols/strings including 'firmware_update', 'signature_verify', 'update_signature_validation', and 'code_authenticity_verify' represent effective firmware authenticity and integrity checking mechanisms using cryptographic signatures.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: firmware_update; String: signature_verify; String: code_authenticity_verify; String: update_signature_validation"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "be1113bc-1d38-4625-8f6b-e805fc9dfa04"
            },
            "implementation-statement-uuid": "6b3e7eb4-5ecd-4ea2-aa49-c09e4839a561"
          },
          {
            "uuid": "bd880d0e-7415-49bf-9b2a-660286426cd2",
            "title": "Control fda-integ02 (Cryptographically Authenticate Updates) Implemented",
            "description": "Strings such as 'firmware_update', 'update_signature_validation', and 'signature_verify' strongly indicate cryptographic authentication of firmware/software updates prior to installation.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: firmware_update; String: update_signature_validation; String: signature_verify"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "e283ce33-f285-4970-9926-6054956d31af"
            },
            "implementation-statement-uuid": "f77f0744-983e-4e2f-bf0e-5e1dabe40484"
          },
          {
            "uuid": "41d1169a-f67b-4be2-8c7c-88ce1d812be6",
            "title": "Control fda-integ03 (Execution Authenticity Check) Implemented",
            "description": "Pre-execution authenticity checking is demonstrated by 'secure_execution_validation', 'code_authenticity_verify', and 'runtime_code_integrity_check' strings, indicating validation steps before and during execution.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: secure_execution_validation; String: code_authenticity_verify; String: runtime_code_integrity_check"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "4574aa1f-3416-476b-9f09-2efbd11c098b"
            },
            "implementation-statement-uuid": "d64120ca-dd31-410c-9c83-509deb4a37b5"
          },
          {
            "uuid": "a173f174-5f50-4f56-88ca-6dd57beb6109",
            "title": "Control fda-integ06 (Verify Incoming Data) Implemented",
            "description": "Incoming data validation is supported by 'incoming_data_integrity_check', 'sha256_integrity_check', and 'message_sequence_validate', confirming integrity protections for incoming data streams.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: incoming_data_integrity_check; String: sha256_integrity_check; String: message_sequence_validate"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "d3e31c06-4083-47e0-ad91-7bc3a23c8540"
            },
            "implementation-statement-uuid": "a8761e05-b192-4e58-8b85-08eea470031b"
          },
          {
            "uuid": "18bc2acd-daf1-4cd1-99d7-b2df847b8c1b",
            "title": "Control fda-integ07 (Spec Compliance Validation) Implemented",
            "description": "Detections such as 'input_format_validation', 'protocol_compliance_validate', and 'message_sequence_validate' demonstrate validation of external data structure and protocol compliance.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: input_format_validation; String: protocol_compliance_validate; String: message_sequence_validate"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "5d2bb314-cc1a-410b-bef2-3c46eddb120d"
            },
            "implementation-statement-uuid": "29bad13e-4751-4d6d-917c-4dd2d14c7476"
          },
          {
            "uuid": "c5e58bad-61e0-44b2-a464-e9e571bd5e45",
            "title": "Control fda-integ08 (Safety-Critical Data Integrity) Implemented",
            "description": "'safety_data_redundancy_check', 'critical_data_ecc_verify', and 'data_transmission' signal that redundant verification mechanisms are in place to protect integrity of safety-critical data.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: safety_data_redundancy_check; String: critical_data_ecc_verify; String: data_transmission"
              },
              {
                "name": "confidence",
                "value": "0.85"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "1ff5339d-f593-421b-905f-ef016f41d0f6"
            },
            "implementation-statement-uuid": "8b36f7d9-435b-4557-bdbe-15ed07a83bbb"
          },
          {
            "uuid": "e7b12cd7-43d0-4e05-be82-6319adc600c3",
            "title": "Control fda-integ09 (Code Integrity Verification) Implemented",
            "description": "'runtime_code_integrity_check', 'code_authenticity_verify', and 'secure_execution_validation' all point to runtime integrity verification practices for code in memory.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: runtime_code_integrity_check; String: code_authenticity_verify; String: secure_execution_validation"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "9d237791-1c7a-4e2c-803e-d24ff7a2087d"
            },
            "implementation-statement-uuid": "db687be2-c859-4b8c-99fe-7db25eae6498"
          },
          {
            "uuid": "da433260-0c77-4476-940d-5aaf9f236d17",
            "title": "Control fda-conf01 (Confidentiality Protection) Implemented",
            "description": "Strings including 'patient_data_encrypt', 'aes_gcm_authenticated_encryption', 'user_device_key_derivation', and 'data_transmission' in combination with detected cryptographic library references indicate encryption and strong confidentiality controls for sensitive data.",
            "props": [
              {
                "name": "implementation-status",
                "value": "implemented"
              },
              {
                "name": "evidence",
                "value": "String: patient_data_encrypt; String: aes_gcm_authenticated_encryption; String: user_device_key_derivation; String: data_transmission; String: OpenSSL, mbedtls, wolfssl"
              },
              {
                "name": "confidence",
                "value": "0.90"
              }
            ],
            "target": {
              "type": "objective-id",
              "target-id": "a5754b3a-058a-425f-a617-8b587c6ecff8"
            },
            "implementation-statement-uuid": "e3f187c4-5c90-47ef-a534-7a380572e55c"
          }
        ]
      }
    ],
    "back-matter": {
      "resources": [
        {
          "uuid": "2e293ab8-2159-466d-bff2-97b728fd9745",
          "title": "Binary Analysis Context: FDA Premarket Assessment",
          "description": "Firmware file analyzed: fda_compliant_test (Mach-O arm64, 51888 bytes). Static-linked: false. Entry points: main(4294979676). Code sections: __text(0x1000004F8-0x10000076C), __stubs(0x10000076C-0x1000007C0), __cstring(0x1000007C0-0x1000008CB), __unwind_info(0x1000008CC-0x100000934), __got(0x100004000-0x100004038), __data(0x100008000-0x100008048). Linked libraries: /usr/lib/libSystem.B.dylib. 8 symbols, 7 imports, 78 embedded strings. See full assessment results for detailed section, symbol, and evidence mapping for each finding."
        }
      ]
    }
  }
}