Tablo Medical Informatics System

Certificate

Approved Algorithms (48)

Derived Review-Risk Graph (review prompts, not findings)

flowchart LR
  %% Deterministic review-risk graph for Tablo Medical Informatics System
  %% Review prompts and evidence gaps, NOT vulnerability findings.
  subgraph CMVP["CMVP-disclosed clues"]
    C2["[low] Firmware update / recovery<br/>/ rollback (referenced in<br/>text)<br/><i>upgrade</i>"]
    C3["[low] Self-test / status surface<br/>(referenced in text)<br/><i>Self-Test<br/>Status Output</i>"]
    C5["[low] Protocol / secure-channel<br/>references (may be KDF<br/>names, not a live channel)<br/><i>TLS<br/>SSH<br/>HTTPS</i>"]
    C6["[low] Operating system / runtime<br/>referenced (boundary<br/>membership not asserted)<br/><i>operating system<br/>linux<br/>application</i>"]
  end
  subgraph Inference["Derived inference"]
    I2["Possible only, trusted<br/>code is reachable through<br/>update and recovery paths."]
    I3["Possible only, some<br/>services may process input<br/>before, or without,<br/>operator authentication."]
    I5["Possible only, a protocol<br/>is referenced, but whether<br/>it is a live channel or<br/>only a KDF/algorithm name<br/>is unconfirmed."]
    I6["Possible only, a<br/>runtime/OS is referenced,<br/>but its membership in the<br/>cryptographic boundary is<br/>not established."]
  end
  subgraph Risk["Reviewer question"]
    R2["Are update images<br/>authenticated before<br/>parsing, and are<br/>downgrade/rollback paths<br/>constrained?"]
    R3["Can unauthenticated<br/>services leak state,<br/>consume resources, or<br/>transition security state?"]
    R5["If a live TLS/SSH/IKE<br/>channel exists, could<br/>library CVEs apply, or is<br/>this only a<br/>KDF/documentation name?"]
    R6["If the OS/runtime is<br/>in-boundary, could its<br/>CVEs be hidden by<br/>firmware-only versioning?"]
  end
  subgraph Evidence["Evidence needed to close"]
    E2["confirm the disclosure<br/>itself (keyword hit,<br/>context unverified) ·<br/>update image format ·<br/>signature-before-parse<br/>proof · anti-rollback /<br/>downgrade policy"]
    E3["confirm the disclosure<br/>itself (keyword hit,<br/>context unverified) ·<br/>pre-auth reachability<br/>matrix · rate limits and<br/>output redaction ·<br/>abuse-case tests"]
    E5["confirm the disclosure<br/>itself (keyword hit,<br/>context unverified) ·<br/>library identity and<br/>version ·<br/>certificate-validation<br/>behaviour · protocol-CVE<br/>disposition"]
    E6["confirm the disclosure<br/>itself (keyword hit,<br/>context unverified) ·<br/>runtime identity and<br/>config · kernel/runtime<br/>hardening profile ·<br/>patch/backport manifest"]
  end
  C2 --> I2 --> R2 --> E2
  C3 --> I3 --> R3 --> E3
  C5 --> I5 --> R5 --> E5
  C6 --> I6 --> R6 --> E6
  classDef clue fill:#eef3f9,stroke:#6f7f91,color:#1f3a5f;
  classDef infer fill:#fff7e6,stroke:#b98500,color:#6b4e00;
  classDef risk fill:#fbe9e9,stroke:#b02a2a,color:#7a1f1f;
  classDef evidence fill:#e6f4ea,stroke:#1e7d34,color:#14532d;
  class C2,C3,C5,C6 clue;
  class I2,I3,I5,I6 infer;
  class R2,R3,R5,R6 risk;
  class E2,E3,E5,E6 evidence;

flowchart LR
  %% Deterministic clue tier for Tablo Medical Informatics System
  %% confidence: high = structured record field; medium = structured but soft; low (dashed) = bare keyword hit, context unverified
  subgraph CMVP["CMVP-disclosed clues (deterministic)"]
    C2["[low] Firmware update / recovery / rollback (referenced in text)<br/><i>upgrade</i><br/>src: text:keyword"]
    C3["[low] Self-test / status surface (referenced in text)<br/><i>Self-Test<br/>Status Output</i><br/>src: text:keyword"]
    C5["[low] Protocol / secure-channel references (may be KDF names, not a live channel)<br/><i>TLS<br/>SSH<br/>HTTPS</i><br/>src: text:keyword"]
    C6["[low] Operating system / runtime referenced (boundary membership not asserted)<br/><i>operating system<br/>linux<br/>application</i><br/>src: text:keyword"]
  end
  classDef clueHigh fill:#eef3f9,stroke:#2f6fb0,stroke-width:2px,color:#1f3a5f;
  classDef clueMedium fill:#eef3f9,stroke:#6f7f91,color:#1f3a5f;
  classDef clueLow fill:#f7f7f7,stroke:#999,stroke-dasharray:4 4,color:#444;
  class C2,C3,C5,C6 clueLow;

Security Policy, page by page

Outset Medical, Inc. Tablo Medical Informatics System Hardware Version: 1.0 Hardware Part Number: PN-0002824 Firmware Version: MIES 4.9.12.6269 FIPS Security Level: 1 Document Version: 1.2 Prepared for: Prepared by: Outset Medical, Inc. Corsec Security, Inc.

3052 Orchard Drive 12600 Fair Lakes Circle, Suite 210

San Jose, CA 95134 Fairfax, VA 22033 United States of America United States of America Phone: +1 669 231-8200 Phone: +1 703 267 6050 www.outsetmedical.com www.corsec.com

Abstract This is a non-proprietary Cryptographic Module Security Policy for Tablo Medical Informatics System (firmware version: MIES 4.9.12.6269) from Outset Medical, Inc. (Outset). This Security Policy describes how Tablo Medical Informatics System meets the security requirements of Federal Information Processing Standards (FIPS) Publication 140-3, which details the U.S. and Canadian government requirements for cryptographic modules. More information about the FIPS 140-3 standard and validation program is available on the Cryptographic Module Validation Program (CMVP) website, which is maintained by the National Institute of Standards and Technology (NIST) and the Canadian Centre for Cyber Security (CCCS). This document also describes how to run the module in a secure Approved mode of operation. This policy was prepared as part of the Level 1 FIPS 140-3 validation of the module. Tablo Medical Informatics System is referred to in this document as Medical Informatics System or the module. References This document deals only with operations and capabilities of the module in the technical terms of a FIPS 140-3 cryptographic module security policy. More information is available on the module from the following sources:

• The Outset website (www.outsetmedical.com) contains information on Tablo from Outset.
• The search page on the CMVP website (https://csrc.nist.gov/Projects/cryptographic-module-validationprogram/Validated-Modules/Search) can be used to locate and obtain vendor contact information for technical or sales-related questions about the module. Document Organization ISO/IEC 19790 Annex B uses the same section naming convention as ISO/IEC 19790 section 7 - Security requirements. For example, Annex B section B.2.1 is named “General” and B.2.2 is named “Cryptographic module specification,” which is the same as ISO/IEC 19790 section 7.1 and section 7.2, respectively. Therefore, the format of this Security Policy is presented in the same order as indicated in Annex B, starting with “General” and ending with “Mitigation of other attacks.” If sections are not applicable, they have been marked as such in this document. Tablo Medical Informatics System ©2024 Outset Medical, Inc.

1. General The Outset Tablo is a dialysis machine designed from the inside out to offer a better and easier experience for patients and providers. The Outset Tablo machine creates an all-in-one solution that reduces care and infrastructure costs, expands the variety of eligible users, and enables new care delivery models. The Tablo Hemodialysis System is an automated machine designed to filtrate blood and offers multiple automated maintenance functions. It consists of a water purification system, Tablo cartridge, Non-invasive blood pressure cuff, and a two-way data communication. The Tablo Hemodialysis System is a mobile indoor unit that establishes a two-way data communication that automatically sends treatment data as well as machine performance to the Outset Tablo Cloud. The Tablo machine includes touchscreen guidance that contains animations and conversational instructions. Figure 1

• Tablo Hemodialysis System Functions below shows the main functions of the Tablo system. Figure 1
• Tablo Hemodialysis System Functions Tablo Medical Informatics System ©2024 Outset Medical, Inc.

The Tablo machine feature set includes inexpensive operations, direct connection to the Tablo Cloud, automated functions, and effective hemodialysis features:

• Blood flow rate of up to 400 mL/min
• Extracorporeal Circuit volume of 140 mL
• Maximum Ultrafiltration Rate of 2,000 mL/hour
• Dialysate Flow Rate of up to 300 mL/min
• Automated daily heat disinfection and weekly chemical disinfection
• Automatic Saline Bolus tracking
• Automated water purification system The module is the Tablo Medical Informatics System, which is an internal component of the Outset Tablo and provides secure storage and transmission of patient data. Tablo Medical Informatics System is validated at the FIPS 140-3 section levels shown in Table 1. Table 1
• Security Levels The module has an overall security level of 1.

1 N/A – Not Applicable

Tablo Medical Informatics System ©2024 Outset Medical, Inc.

2. Cryptographic Module Specification Tablo Medical Informatics System is a hardware module with a multi-chip embedded embodiment. The module is a single board computer (embedded within the Tablo dialysis machine) that securely protects and transmits patient data.

Table 2 below lists the module configuration(s) used for validation testing. Table 2 – Cryptographic Module Tested Configuration

Table 3 lists the cryptographic algorithm sources employed by the module. Table 3 – Cryptographic Algorithm Sources Validation certificates for each approved security function are listed in Table 4. ©2024 Outset Medical, Inc.

Table 4 – Approved Algorithms Validation Certificates

2 This table includes vendor-affirmed algorithms that are approved but CAVP testing is not yet available.

No part of the TLS protocol, other than the KDF, has been tested by the CAVP and CMVP.

4 The methods of shared secret computation are approved per FIPS 140-3 IG D.F

The vendor affirms the following cryptographic security methods:

• Cryptographic key generation
• The module implements cryptographic key generation (CKG) compliant to NIST SP 800-133rev2 section 4. The module uses unmodified output from its Approved DRBGs (both

5 ECC CDH – Elliptic Curve Cryptography Cofactor Diffie-Hellman

No part of the TLS protocol, other than the KDF, has been tested by the CAVP and CMVP.

7 No part of the SSH protocol, other than the KDF, has been tested by the CAVP and CMVP.

OpenSSL DRBG cert. A2701 and Bouncy Castle DRBG cert. A2699) as both symmetric keys and seeds for generating asymmetric key pairs. The module’s DRBGs are seeded via entropy generated from the module’s internal entropy mechanism. The module implements the non-Approved but allowed algorithms shown in Table 5 below, in both the Tablo Medical Informatics System OpenSSL Cryptographic Library and Tablo Medical Informatics System Bouncy Castle Cryptographic Library. Table 5

• Non-Approved Algorithms Allowed in the Approved Mode of Operation The module employs the non-Approved algorithms with no security claimed shown in Table 6 below. Table 6
• Non-Approved Algorithms Allowed in the Approved Mode of Operation with No Security Claimed

The cryptographic boundary of the module is defined by the physical perimeter of the Tablo Medical Informatics System (shown in Figure 2). A logical block diagram of the module’s hardware components is provided in Figure 3 below. Figure 2 – Tablo Medical Informatics System PN-0002824 Tablo Medical Informatics System ©2024 Outset Medical, Inc.

Figure 3 – Module Block Diagram (with Cryptographic Boundary)

There are no excluded hardware or firmware components.

The module supports an Approved mode of operation only. When installed, configured, and operated according to this Security Policy, the module does not support a non-Approved mode of operation. Tablo Medical Informatics System ©2024 Outset Medical, Inc.

3. Cryptographic Module Interfaces The module supports the following logical interfaces: A mapping of the physical ports to the module’s logical interfaces can be found in Table
4. Note that the module does not output control information, and thus has no specified control output interface. Table 7 – Ports and Interfaces RS – Recommended Standard

9 USB – Universal Serial Bus

10 DC – Direct Current

11 GPIO – General Purpose Input/Output

12 USB OTG – Universal Serial Bus On-The-Go

SD/MMC – Secure Digital Multi-Media Card

14 SIM – Subscriber Identity Module

Tablo Medical Informatics System ©2024 Outset Medical, Inc.

Physical Port SATA15 I2C16 I2S17 SPI18 CAN19 HDMI20 VGA21 Audio

Logical Interface (Not in Use) (Not in Use) (Not in Use) (Not in Use) (Not in Use) (Not in Use) (Not in Use) (Not in Use)

Data That Passes Over Port/Interface

Table 8

• LED Indicator SATA
• Serial ATA

16 I2C – Inter-Integrated Circuit

17 I2S – Inter-IC Sound

18 SPI – Serial Peripheral Interface

19 CAN – Controller Area Network

HDMI – High-Definition Multimedia Interface

21 VGA – Video Graphics Array

Tablo Medical Informatics System ©2024 Outset Medical, Inc.

4. Roles, Services, and Authentication The sections below describe the module’s authorized roles, services, and operator authentication methods.

The module supports a Crypto Officer (CO) role and a User role. The CO role performs cryptographic initialization or management functions and general security services. The User role performs general security services, including cryptographic operations and other approved security functions. The operator assumed a Crypto Officer role implicitly by invoking a service allocated to the Crypto Officer and assumes a User role implicitly by invoking a service allocated to the User. The module does not support multiple concurrent operators. Table 9 – Roles, Service Commands, Input and Output Tablo Medical Informatics System ©2024 Outset Medical, Inc.

Descriptions of the services available to the authorized roles are provided in Table 10 below. Please note that the keys and Sensitive Security Parameters (SSPs) listed in the table indicate the type of access required using the following notation:

• G = Generate: The module generates or derives the SSP.
• R = Read: The SSP is read from the module (e.g., the SSP is output).
• W = Write: The SSP is updated, imported, or written to the module.
• E = Execute: The module uses the SSP in performing a cryptographic operation. Table 10
• Approved Services Note that the Show Status, Perform Zeroization, and Show Module Version services do not require an Approved security service indicator per FIPS 140-3 Implementation Guidance 2.4.C. ©2024 Outset Medical, Inc.

The operator can verify the module firmware version on the Tablo Status Screen: Figure 4 – Status/Show Version Screen

The module does not support authentication mechanisms; roles are implicitly selected based on the service invoked. Refer to Table 10 above for a listing of the services associated with each authorized role. ©2024 Outset Medical, Inc.

5. Software/Firmware Security All firmware components within the cryptographic boundary are verified using an integrity technique implemented within the cryptographic module itself. The module implements a CRC-32 integrity test of the module firmware. Failure of the integrity check for the module will cause the module to enter a critical error state. Tablo Medical Informatics System is not delivered to end-users as a standalone offering and is only used in conjunction with the Outset Tablo. The CO can initiate the pre-operational tests on demand by power-cycling the Outset Tablo. The module does not support firmware upgrade. In order to provision the module, the CO must first invoke the “Import Provision File” service and obtain the specified indicator that the service was executed successfully (note this step is not required to operate the module in Approved mode). ©2024 Outset Medical, Inc.

6. Operational Environment The operational environment of the module does not provide access to a general-purpose operating system (OS). The module employs a non-modifiable operational environment. The operating system offers no mechanism whereby the operator can modify software/firmware components, nor can the operator load and execute software or firmware that was not included as part of the validation of the module. The module’s operating system is Linux 4.1.15 LTS23. LTS – Long Term Support ©2024 Outset Medical, Inc.

7. Physical Security As a multi-chip embedded module, the module is composed of production-grade components necessary to meet FIPS 140-3 level 1 physical security requirements. All components of the hardware are coated with commercial standard passivation. ©2024 Outset Medical, Inc.

8. Non-Invasive Security There are currently no approved non-invasive mitigation techniques referenced in ISO/IEC 19790:2021 Annex F. ©2024 Outset Medical, Inc.

9. Sensitive Security Parameter Management The module supports the keys and other SSPs listed in Table 11

• SSPs below. Table 11
• SSPs ©2024 Outset Medical, Inc.

24 The IV generation method complies with technique #1 (for TLS 1.2 GCM Cipher Suites) in FIPS 140-3 IG C.H. RFC 5246 defines the TLS 1.2 protocol; RFC

25 The IV generation method complies with technique #1 (for SSHv2 protocol) in FIPS 140-3 IG C.H. Each IV is generated and used only within each

protocol’s implementation. ©2024 Outset Medical, Inc.

The AES-GCM IV is used in the following protocols:

• TLS
• The AES-GCM IV is used in the TLS protocol. The TLS AES-GCM IV is generated in compliance with TLS v1.2 GCM cipher suites as specified in RFC26 5288 and section 3.3.1 of NIST SP 800-52rev1. Per RFC 5246, when the nonce_explicit part of the IV exhausts the maximum number of possible values for a given session key, the module will trigger a handshake to establish a new encryption key. The AES-GCM IV is a random 96-bit value generated with available entropy provided by the available entropy source.
• SSH
• The module’s SSHv2 implementation is compliant with RFCs 4252, 4253 and 5647. The AES GCM IV generation is in compliance with RFC 5647 and is only used for the SSHv2. When an SSH session gets terminated for any reason, all keying material will be re-negotiated by the module.

The module performs all applicable key assurances for its DH and ECDH implementations as specified in section 9 of NIST SP 800-56Arev3. These tests are performed as conditional tests. In order to zeroize all keys and CSPs present within the module, the operator shall decommission the module by performing the following steps:

1. Upload patient log files to the cloud and clear from MI board
2. Erase volatile storage in MIES unit
3. Clear log files from black box USB For further detailed information on each step please refer to the “Tablo X Hemodialysis System De-Installation Procedure”, steps 4, 5, and
4. For the zeroization of keys in volatile memory, module operators can power-cycle the Tablo machine.

Table 12 below specifies the module’s entropy sources. RFC – Request For Comment ©2024 Outset Medical, Inc.

Table 12 – Non-Deterministic Random Number Generation Specification ©2024 Outset Medical, Inc.

10. Self-Tests Both pre-operational and conditional self-tests are performed by the module. Pre-operational tests are performed between the time a cryptographic module is powered on or instantiated (after being powered off, reset, rebooted, cold-start, power interruption, etc.) and before the module transitions to the operational state. Conditional selftests are performed by the module during module operation when certain conditions exist. The following sections list the self-tests performed by the module, their expected error status, and the error resolutions.

The module performs the following pre-operational self-test(s): • Firmware integrity test (using CRC-32)

The module performs the following conditional cryptographic algorithm self-tests (CASTs):

• Tablo Medical Informatics System CPU Jitter Library:
• SHA-3 Known Answer Test
• Stuck test on entropy source
• Repetition Count Test on entropy source
• Adaptive Proportion Test on entropy source
• Tablo Medical Informatics System OpenSSL Cryptographic Library:
• AES ECB encrypt and decrypt KATs27 (128-bit)
• AES CCM encrypt and decrypt KATs (192-bit)
• AES GCM encrypt and decrypt KATs (128-bit)
• CTR_DRBG KAT (256-bit AES-CTR with derivation function)
• CTR_DRBG Health Tests (Instantiate, Generate, Reseed)
• DSA Digital Signature Verification KAT (2048-bit; SHA2-256)
• ECDSA Digital Signature Verification KAT (P-224 and K-233 curve, SHA2-256)
• HMAC KATs (SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512)
• RSA Digital Signature Verification KAT (2048-bit; SHA2-256; PKCS#1.5 scheme)
• SHA KATs (SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512)
• ECC CDH Shared Secret “Z” Computation KAT (P-224 curve)
• Tablo Medical Informatics System Bouncy Castle Cryptographic Library:
• AES ECB encrypt and decrypt KATs (128-bit)
• AES CCM encrypt and decrypt KATs (128-bit)
• AES GCM encrypt and decrypt KATs (128-bit)
• CTR_DRBG KAT
• CTR_DRBG Health Tests (Instantiate, Generate, Reseed)
• DSA Digital Signature Verification KAT (2048-bit) KAT
• Known Answer Test ©2024 Outset Medical, Inc.

• ECDSA Digital Signature Verification KAT (P-256)
• HMAC KATs (SHA2-256, SHA2-512)
• RSA Digital Signature Verification KAT (2048-bit)
• SHA KATs (SHA-1, SHA2-256, SHA2-512)
• FFC Shared Secret “Z” Computation KAT (Parameter Sets/Key sizes: FB)
• ECC CDH Shared Secret “Z” Computation KAT (P-256) The module performs the following conditional pair-wise consistency tests (PCTs):
• Tablo Medical Informatics System OpenSSL Cryptographic Library:
• ECDH key generation PCT
• Tablo Medical Informatics System Bouncy Castle Cryptographic Library):
• DH key generation PCT
• ECDH key generation PCT

The CO can initiate the pre-operational self-test (as well as the conditional CASTS) on demand for periodic testing of the module by power-cycling the Tablo machine. The LED will blink 2 times to indicate that self-tests are running.

Upon failure of any self-test, the module will set an internal flag and enter a critical error state. In this state, the module will no longer perform cryptographic services or output data over the data output interfaces. For any subsequent request for cryptographic services, the module will return a failure indicator. To recover, the module must be reinitialized by power-cycle of the Tablo machine. If the pre-operational self-tests complete successfully, then the module can resume normal operations. If the module continues to experience self-test failures after reinitializing, then the module will not be able to resume normal operations, and the CO should contact Outset Medical, Inc. for assistance. ©2024 Outset Medical, Inc.

11. Life-Cycle Assurance The sections below describe how to ensure the module is operating in its validated configuration. Module operators shall follow all guidance provided guidance in this section to ensure the module is operating in a compliant manner. Operating the module without following this guidance (including the use of undocumented services) will result in non-compliant behavior and is outside the scope of this Security Policy.

The Medical Informatics System is delivered to the end user contained within the larger Outset Tablo machine, and there are no further installation procedures required by the operator.

No initialization steps are required to be performed by end-users.

No setup steps are required to be performed by end-users.

There are no specific management activities required of the CO role to ensure that the module runs securely. However, if any irregular activity is noticed or the module is consistently reporting errors, then Outset Customer Support should be contacted. Module operators can view the module’s operational status via the Tablo machine GUI.

The following list provides guidance for the User role: • In case the module’s power is lost and then restored, the key used for the AES GCM encryption or decryption shall be re-established.

There are no known CVEs associated with the cryptographic module. ©2024 Outset Medical, Inc.

12. Mitigation of Other Attacks This section is not applicable. The module does not claim to mitigate any attacks beyond the FIPS 140-3 Level 1 requirements for this validation. ©2024 Outset Medical, Inc.

13. Acronyms and Abbreviations Table 13 provides definitions for the acronyms and abbreviations used in this document. Table 13 – Acronyms ©2024 Outset Medical, Inc.

Prepared by: Corsec Security, Inc.

2600 Fair Lakes Circle, Suite 210

Fairfax, VA 22033 United States of America Phone: +1 703 267 6050 Email: info@corsec.com http://www.corsec.com