Producing and maintaining quality security documentation is critical to the continuity of internal security best practices, and for ensuring the successful outcome of any regulatory interaction. Harbor Labs has produced extensive sets of security documentation for clients, including cybersecurity analyses, security policy documents, threat models, attacker models, and penetration test plans, among many others. These documents serve as the foundation for our clients’ internal security policies and procedures, and meet the requirements necessary for industry certifications and regulatory approvals.
The first stage in any Harbor Labs consulting engagement typically begins with a thorough security review of all existing design documentation associated with the client system’s firmware, communication protocols, topology, patch models, interfaces, access controls and cryptographic systems. Where documentation is missing or requires modification, Harbor Labs staff will produce the security materials and documentation necessary to meet the client’s objectives. All documentation is produced according to the client’s internal formatting standards, or templated to meet the requirements of the regulatory body or certification authority to which the documentation will be submitted.
Harbor Labs conducts an exhaustive series of exploits against the attack surface of the target system using a combination of Harbor Labs’ proprietary analytic tool set and select open-source tools, to determine any flaws, misconfigurations, weaknesses or vulnerabilities that might disqualify it from regulatory certification. The resulting report highlights those issues with the highest probability of impacting patient safety, along with a CVSS 3.0 score and recommendations for remediation.
FirmwareIQ provides the foundation for clinical device continuous threat monitoring. Employing a system of patented analytic engines, FirmwareIQ performs thousands of separate automated inspections of the target device software, identifying vulnerabilities and potential areas of weakness. The output is a comprehensive analytic report that categorizes, prioritizes and scores every area of weakness, misconfiguration and exploitable vulnerability within the device. The output is displayed in a graphically-intuitive report that is sortable, searchable and navigable, allowing users to quickly pinpoint the areas of greatest security concern.
FirmwareIQ generates a comprehensive record of the device, identifying each of the key attributes and technical characteristics that could serve as the basis for a future postmarket exploit. These attributes include the operating system(s), executables, libraries, chip set(s), cryptography and networking components, among other device characteristics. Once compiled, this record serves as the device’s attack surface and is the basis for Harbor Labs continuous threat landscape monitoring service.Software Bill of Materials (BOM)
Using only the software binary, FirmwareIQ can unpack the device firmware and produce a high-fidelity reconstruction of the target file system. The SBOM is provided in tabular format as part of the FirmwareIQ security report, formatted for regulatory submission. The SBOM is sortable and searchable for quick reference and research by the end user, and serves as one of the inputs for Harbor Labs Postmarket Surveillance.
With a long-standing corporate resume in the medical security market and an equally strong reputation in the legal and federal justice community, Harbor Labs is able to combine its expertise in healthcare, information security and litigation to provide clients with an unmatched level of support in EHR and healthcare IT cases.