Network security file format management system and method and medical equipment

Abstract

The invention relates to the technical field of medical instrument product network security, and discloses a network security file format management system and method and medical instrument equipment, and the system comprises a data collection module, a template configuration module, a field filling module and an integration output module; the data acquisition module is respectively connected with the template configuration module and the external software interface; the template configuration module is also connected with the field filling module; and the field filling module is also connected with the integration output module. Medical instrument information and test data are collected and transmitted through the data collection module, and it is ensured that the information basis of follow-up processing is accurate and related; a fixed field configured by the template ensures that basic formats are consistent, and a self-adaptive field can adapt to different conditions; the field filling module is used for automatically filling a template, so that format difference possibly caused by manual filling is avoided; and the integrated output module integrates the filled template into a file conforming to a preset format, so that the problem of inconsistent file formats is solved.

Description

Technical Field

[0001] This application relates to the field of cybersecurity for medical device products, and in particular to a cybersecurity file format management system, method, and medical device equipment. Background Technology

[0002] With the networking and intelligentization of medical devices, apps, PC software, web applications, physical devices, and Bluetooth / WiFi connected devices are widely used in the medical field, such as for remote health monitoring, patient data management, and device control. The U.S. Food and Drug Administration (FDA), in its "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (2025 edition), requires manufacturers to submit detailed cybersecurity documentation before market launch, including vulnerability scans, penetration testing, risk assessments, threat modeling, cybersecurity management records, and source code audits.

[0003] However, existing technologies lack a unified template for medical devices with network connectivity, resulting in inconsistent file formats. Furthermore, the cybersecurity risks vary significantly across different device types and connectivity methods (such as App / Bluetooth), making it difficult for existing templates to provide comprehensive coverage. Manually preparing documents is time-consuming and prone to overlooking crucial information. Therefore, a systematic and standardized cybersecurity document template system is urgently needed to adapt to the diversity of medical device products and improve the efficiency of FDA compliance preparation. Summary of the Invention

[0004] The purpose of this application is to provide a network security file format management system, method, and medical device, aiming to solve the technical problem of inconsistent file formats caused by the lack of a unified template for medical device devices with network connectivity in the prior art.

[0005] To achieve the above objectives, this application proposes a network security file format management system, which is applied to medical device equipment; the network security file format management system includes: a data acquisition module, a template configuration module, a field filling module, and an integration output module;

[0006] The data acquisition module is connected to the template configuration module and the external software interface respectively; the template configuration module is also connected to the field filling module; the field filling module is also connected to the integrated output module.

[0007] The data acquisition module is used to collect medical device information and test data input by the user through the external software interface, and transmit the medical device information and test data to the template configuration module;

[0008] The template configuration module is used to configure corresponding fixed fields and adaptive fields according to the medical device information and the test data, and generate multiple network security file templates;

[0009] The field filling module is used to automatically fill each of the network security file templates according to the file templates pre-configured by the user.

[0010] The integrated output module is used to integrate the filled network security file templates into a network security file that meets the preset format requirements.

[0011] In one embodiment, the plurality of network security document templates include: a management plan template, a vulnerability scan report template, a penetration and fuzzing test template, a source code vulnerability detection template, a risk assessment template, and a management report template; the template configuration module includes: a management plan unit;

[0012] The management planning unit is connected to the data acquisition module;

[0013] The management planning unit is used to perform cybersecurity lifecycle management of the medical device based on the medical device information and test data input by the data acquisition module.

[0014] The management plan unit is also used to generate the periodic plan report based on the network security lifecycle management and transmit it to the field filling module.

[0015] In one embodiment, the management plan template, the vulnerability scan report template, the penetration and fuzz testing template, the source code vulnerability detection template, the risk assessment template, and the management report template all support adaptive field generation and multi-device collaboration scenarios, and support independent and / or integrated use to generate network security files that meet the preset requirements.

[0016] In one embodiment, the template configuration module further includes: a missed scan reporting unit;

[0017] The missed scan reporting unit is connected to the management plan unit;

[0018] The vulnerability reporting unit is used to record the vulnerability scan results of the host, Web, and App of the medical device.

[0019] The vulnerability scanning report unit is also used to generate the vulnerability scanning report template based on the vulnerability scanning results and transmit it to the field filling module.

[0020] In one embodiment, the template configuration module further includes: a penetration and fuzz testing unit;

[0021] The penetration and fuzz testing template is connected to the management plan unit;

[0022] The penetration and fuzzy testing unit is used to record the penetration test results and fuzzy test results of the medical device.

[0023] The penetration and fuzz testing unit is further configured to generate the penetration and fuzz testing template based on the penetration test results and the fuzz test results, and transmit it to the field filling module.

[0024] In one embodiment, the template configuration module further includes: a source code vulnerability detection unit;

[0025] The source code vulnerability detection unit is connected to the management plan unit;

[0026] The source code vulnerability detection unit is used to record the analysis results of the source code of the medical device.

[0027] The source code vulnerability detection unit is also used to generate a source code vulnerability detection template based on the analysis results and transmit it to the field filling module.

[0028] In one embodiment, the template configuration module further includes: a risk assessment unit;

[0029] The risk assessment unit is connected to the vulnerability scanning report unit, the penetration and fuzz testing unit, and the source code vulnerability detection unit, respectively.

[0030] The risk assessment unit is used to record the risk level in the vulnerability scan report template, the penetration and fuzz testing template, and the source code vulnerability detection template;

[0031] The risk assessment unit is also used to generate the risk assessment template according to the risk level and transmit it to the field filling module.

[0032] In one embodiment, the template configuration module further includes: a management report unit;

[0033] The management reporting unit is connected to the risk assessment unit;

[0034] The management report unit is used to review the risk assessment template and generate a management report template from the review results, which is then transmitted to the field filling module.

[0035] In addition, to achieve the above objectives, this application also proposes a medical device that includes the network security file format management system described above.

[0036] Furthermore, to achieve the above objectives, this application also proposes a network security file format management method, which is applied to the medical device described above; the method includes:

[0037] Collect medical device information and test data input by the user through the external software interface;

[0038] Configure corresponding fixed fields and adaptive fields based on the medical device information and the test data, and generate multiple network security file templates;

[0039] Automatically populate each of the aforementioned network security file templates based on the user's pre-configured file templates;

[0040] The filled network security file templates are integrated into a network security file that meets the preset format requirements.

[0041] This application proposes a network security file format management system, method, and medical device. The network security file format management system is applied to a medical device; the system includes: a data acquisition module, a template configuration module, a field filling module, and an integration output module; the data acquisition module is connected to both the template configuration module and an external software interface; the template configuration module is also connected to the field filling module; the field filling module is also connected to the integration output module; the data acquisition module is used to acquire medical device information and test data input by the user through the external software interface, and transmit the medical device information and test data to the template configuration module; the template configuration module is used to configure corresponding fixed fields and adaptive fields according to the medical device information and test data, and generate multiple network security file templates; the field filling module is used to automatically fill each network security file template according to the file template pre-configured by the user; the integration output module is used to integrate the filled network security file templates into a network security file output that meets preset format requirements. The data acquisition module collects and transmits medical device information and test data, ensuring the accuracy and relevance of the information foundation for subsequent processing and providing a prerequisite for unified format processing. The template configuration module generates standardized templates adaptable to multiple scenarios through dynamic configuration of fixed and adaptive fields, solving the technical problem of the lack of unified templates in the field of network-connected medical devices. Fixed fields ensure consistency in the basic format, while adaptive fields flexibly adapt to the personalized needs of different devices. The segment filling module automatically fills the template, avoiding format differences that may occur due to manual filling, further ensuring format uniformity. The integrated output module integrates the filled templates into a file conforming to the preset format, directly solving the problem of inconsistent file formats. Therefore, compared with existing technologies, this system achieves a unified network security file format for medical devices with network connectivity. Attached Figure Description

[0042] Figure 1 This is a schematic diagram of the modules of the first embodiment of the network security file format management system proposed in this application;

[0043] Figure 2 This is a schematic diagram of the modules of the second embodiment of the network security file format management system proposed in this application;

[0044] Figure 3 This is a flowchart illustrating an embodiment of the network security file format management method proposed in this application.

[0045] Explanation of icon numbers:

[0046] label name label name 100 Data acquisition module 220 Missed Scan Reporting Unit 200 Template configuration module 230 Penetration and Fuzzy Testing Unit 300 Field filling module 240 Source code vulnerability detection unit 400 Integrated output module 250 Risk assessment unit 500 External software interface 260 Management Reporting Unit 210 Management Planning Unit Detailed Implementation

[0047] It should be understood that the specific embodiments described herein are merely illustrative of this application and are not intended to limit this application.

[0048] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0049] It should be noted that all directional indicators (such as up, down, left, right, front, back, etc.) in the embodiments of this application are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indicator will also change accordingly.

[0050] Furthermore, the use of terms such as "first" and "second" in this application is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. Additionally, the technical solutions of the various embodiments can be combined with each other, but only on the basis of being achievable by those skilled in the art. When the combination of technical solutions is contradictory or impossible to implement, such a combination of technical solutions should be considered non-existent and not within the scope of protection claimed in this application.

[0051] Reference Figure 1 , Figure 1 This is a schematic diagram of the modules of the first embodiment of the network security file format management system proposed in this application. Figure 1 This application presents a first embodiment of a network security file format management system.

[0052] The network security file format management system is applied to medical device equipment; the network security file format management system includes: a data acquisition module 100, a template configuration module 200, a field filling module 300, and an integrated output module 400.

[0053] It should be noted that this network security file format management system is a comprehensive management system specifically designed for the medical device field. Its core purpose is to efficiently and systematically process medical device-related information and test data, generating files that meet network security requirements to satisfy the U.S. Food and Drug Administration (FDA) needs in data management, security, and compliance with regulations in the medical device industry. The system mainly consists of four key parts: a data acquisition module 100, a template configuration module 200, a field filling module 300, and an integration and output module 400. These modules collaborate to complete the entire process from data acquisition to file output.

[0054] The data acquisition module 100 is connected to the template configuration module 200 and the external software interface 500 respectively; the template configuration module 200 is also connected to the field filling module 300; the field filling module 300 is also connected to the integrated output module 400.

[0055] It should be understood that the data acquisition module 100, as the system's data entry point, has dual connections. On one hand, it connects to the external software interface 500, which is the user's data input interface; on the other hand, it directly connects to the template configuration module 200, transmitting the acquired data to subsequent modules for processing in a timely manner.

[0056] It should be noted that the template configuration module 200 receives data from the data acquisition module 100 and is also connected to the field filling module 300, passing the configured template to the field filling module 300 for subsequent field filling operations.

[0057] It should be understood that the field filling module 300 receives the template generated by the template configuration module 200 and performs field filling according to the user's pre-configuration. After filling is completed, it connects to the integration output module 400 and passes the filled template to the integration output module 400.

[0058] It should be noted that the integration output module 400, as the final stage of the system, receives the filled template from the field filling module 300, integrates it into a cybersecurity file that conforms to preset format requirements, and outputs it. The cybersecurity file conforming to preset format requirements is a cybersecurity file that complies with FDA requirements.

[0059] The data acquisition module 100 is used to collect medical device information and test data input by the user through the external software interface 500, and transmit the medical device information and test data to the template configuration module 200.

[0060] It should be understood that the data acquisition module 100 is the foundation of the entire system, responsible for interacting with the external software interface 500 and collecting various types of information input by the user through this interface. This information mainly covers two aspects: medical device information and test data. Medical device information may include basic information such as device name, model, specifications, manufacturer, production date, and expiration date; test data may include detailed data such as the device's performance indicators, safety indicators, and functional test results under various test environments.

[0061] It should be noted that users input the corresponding medical device information and test data on the external software interface 500 according to the format and requirements prompted by the system. The data acquisition module 100 monitors the interface input in real time. Once it receives the information input by the user, it immediately performs preliminary processing and verification to ensure the integrity and accuracy of the data. Subsequently, the collected medical device information and test data are transmitted to the template configuration module 200 to provide data support for subsequent template generation.

[0062] The template configuration module 200 is used to configure corresponding fixed fields and adaptive fields according to the medical device information and the test data, and generate multiple network security file templates.

[0063] It should be understood that the template configuration module 200 performs in-depth analysis and processing on the medical device information and test data transmitted from the data acquisition module 100, configures corresponding fixed and adaptive fields, and generates multiple cybersecurity file templates. Fixed fields are those that remain unchanged under different medical devices and testing scenarios, such as file number, generation date, and version number; adaptive fields are those that change dynamically based on specific medical device information and test data, such as device-specific parameters and test result values. By properly configuring fixed and adaptive fields, cybersecurity file templates adaptable to different situations and needs can be generated.

[0064] It should be noted that after receiving data from the data acquisition module 100, the template configuration module 200 first performs detailed analysis of the data to identify the key medical device information and test data characteristics contained within. Then, based on preset rules and algorithms, it determines the fixed and adaptive fields that need to be set. For example, for a specific type of medical device, the corresponding fixed field format and content are set according to its industry standards and safety requirements; simultaneously, adaptive fields are dynamically generated based on the characteristics of the device's test data, such as setting different data display formats according to different test items. Finally, the configured fixed and adaptive fields are combined to generate multiple templates that meet the requirements of network security documents, and these templates are transmitted to the field filling module 300.

[0065] The field filling module 300 is used to automatically fill each of the network security file templates according to the file templates pre-configured by the user.

[0066] It should be understood that the primary task of the field population module 300 is to populate various network security file templates with corresponding data according to the user-preconfigured file templates. The user-preconfigured file templates can be understood as a set of data population rules, which specify what data should be filled into each field and the source of that data. By populating fields according to these rules, it is ensured that the generated network security file content is accurate, complete, and conforms to the expected format.

[0067] It should be noted that after receiving multiple network security file templates generated by the template configuration module 200, the field filling module 300 reads the file template information pre-configured by the user. Based on this configuration information, it extracts the corresponding data content from the raw data collected by the data acquisition module 100 and fills the data into the corresponding fields of each network security file template according to the field positions and format requirements defined in the template. During the filling process, the module performs further verification and processing on the data to ensure that the filled data completely matches the template requirements, avoiding data errors or format inconsistencies. After filling is complete, the filled network security file templates are transmitted to the integration output module 400.

[0068] The integrated output module 400 is used to integrate the filled network security file templates into a network security file that meets the preset format requirements.

[0069] It should be understood that the integration output module 400 is the final stage of the system. It is responsible for integrating the filled network security file templates transmitted by the field filling module 300, generating a complete network security file that meets the preset format requirements, and outputting it to the specified location or system. The preset format requirements are usually determined based on the standards and specifications of the medical device industry, the company's internal management requirements, and relevant laws and regulations, and may include aspects such as file structure, layout, encoding format, and file naming rules.

[0070] It should be noted that after receiving the populated network security file templates, the integration output module 400 merges and organizes these templates according to preset integration rules. For example, it arranges relevant content from multiple templates in an orderly manner, adds necessary file headers and footers, and adjusts page layout and formatting to ensure the generated file has a clear structure and complete content. Then, it performs a final format check on the integrated file to verify that it fully conforms to the preset format requirements. If any non-compliance is found, it is promptly adjusted and corrected. Finally, the verified network security file that meets the preset format requirements is output to a designated storage location or transmitted to a relevant system for further user use or archiving.

[0071] In this embodiment, the network security file format management system is applied to medical device equipment. The network security file format management system includes: a data acquisition module 100, a template configuration module 200, a field filling module 300, and an integration output module 400. The data acquisition module 100 is connected to the template configuration module 200 and an external software interface 500. The template configuration module 200 is also connected to the field filling module 300. The field filling module 300 is also connected to the integration output module 400. The data acquisition module 100 is used to acquire medical device information and test data input by the user through the external software interface 500, and transmit the medical device information and test data to the template configuration module 200. The template configuration module 200 is used to configure corresponding fixed fields and adaptive fields according to the medical device information and the test data, and generate multiple network security file templates. The field filling module 300 is used to automatically fill each network security file template according to the file template pre-configured by the user. The integration output module 400 is used to integrate the filled network security file templates into a network security file that meets the preset format requirements. The data acquisition module 100 collects and transmits medical device information and test data, ensuring the accuracy and relevance of the information foundation for subsequent processing and providing a prerequisite for unified format processing. The template configuration module 200 generates standardized templates adaptable to multiple scenarios through dynamic configuration of fixed and adaptive fields, solving the technical problem of the lack of unified templates in the field of network-connected medical devices. Fixed fields ensure the consistency of the basic format, while adaptive fields flexibly adapt to the personalized needs of different devices. The field filling module 300 automatically fills the template, avoiding format differences that may occur due to manual filling, further ensuring format uniformity. The integration and output module 400 integrates the filled templates into a file conforming to the preset format, directly solving the problem of inconsistent file formats. Therefore, compared with existing technologies, this system achieves a unified network security file format for medical devices with network connectivity.

[0072] Reference Figure 2 , Figure 2 This is a schematic diagram of the modules of the second embodiment of the network security file format management system proposed in this application. The second embodiment of the network security file format management system proposed in this application is based on the first embodiment of the network security file format management system described above.

[0073] The multiple network security document templates include: management plan template, vulnerability scan report template, penetration and fuzzing test template, source code vulnerability detection template, risk assessment template, and management report template; the template configuration module 200 includes: management plan unit 210.

[0074] It should be understood that the cybersecurity file format management system includes various cybersecurity file templates, namely management plan templates, vulnerability scan report templates, penetration and fuzz testing templates, source code vulnerability detection templates, risk assessment templates, and management report templates. These templates have the ability to generate adaptive fields and are suitable for multi-device collaborative scenarios. They can be used independently to generate cybersecurity files that meet preset requirements, or they can be used in conjunction with other systems to comprehensively protect the cybersecurity of medical devices from different dimensions and meet FDA security management requirements.

[0075] The management planning unit 210 is connected to the data acquisition module 100.

[0076] It should be understood that the management plan unit 210 is directly connected to the external software interface 500, and is also associated with the vulnerability reporting unit 220, the penetration and fuzzing unit 230, and the source code vulnerability detection unit 240.

[0077] The management planning unit 210 is used to perform cybersecurity lifecycle management of the medical device based on the medical device information and test data input by the data acquisition module 100.

[0078] It should be noted that the management planning unit 210 implements cybersecurity lifecycle management for medical devices based on the medical device information (such as device type, usage environment, importance, etc.) and test data (such as past safety test records, failure frequency, etc.) input by the user through the data acquisition module 100. This covers the entire process from device deployment to decommissioning, including security strategy formulation, security measure implementation, and regular security assessments, ensuring that the device maintains a good cybersecurity status at different stages.

[0079] The management planning unit 210 is also used to generate the periodic plan report based on the network security lifecycle management and transmit it to the field filling module 300.

[0080] It should be understood that, based on the work content and arrangements of network security lifecycle management, the management planning unit 210 generates a periodic plan report. This report details the security tasks, testing plans, and maintenance arrangements for the equipment in various time periods, providing clear guidance for subsequent security work. After generation, the periodic plan report is transmitted to the field filling module 300 for further filling and improvement of the document content.

[0081] The template configuration module 200 further includes a missed scan report unit 220; the missed scan report unit 220 is connected to the management plan unit 210.

[0082] It should be noted that the vulnerability reporting unit 220 is connected to the management planning unit 210, and its function relies on vulnerability scanning at different levels of the medical device, and it has data interaction relationships with the device's host, Web and App systems.

[0083] The vulnerability reporting unit 220 is used to record the vulnerability scan results of the host, Web and App of the medical device.

[0084] It should be understood that the vulnerability reporting unit 220 is responsible for performing a comprehensive vulnerability scan of the medical device's host, web, and app components, and recording detailed information about various vulnerabilities discovered during the scan, such as vulnerability type, severity, and location. This information is crucial for assessing the device's security status.

[0085] The vulnerability scanning reporting unit 220 is also used to generate the vulnerability scanning report template based on the vulnerability scanning results and transmit it to the field filling module 300.

[0086] It should be noted that, based on the recorded vulnerability scan results, the vulnerability scan reporting unit 220 generates a vulnerability scan report template. This template presents vulnerability information in a clear and standardized format, making it easier for relevant personnel to understand the security risks present in the device. After generation, the vulnerability scan report template is transmitted to the field filling module 300 for subsequent field filling and file completion.

[0087] The template configuration module 200 further includes a penetration and fuzz testing unit 230; the penetration and fuzz testing template is connected to the management plan unit 210.

[0088] It should be understood that the penetration and fuzzing test unit 230 is connected to the management plan unit 210 and also has a test interaction relationship with the medical device (testing the device through test interfaces or network connections, etc.).

[0089] The penetration and fuzzy testing unit 230 is used to record the penetration test results and fuzzy test results of the medical device.

[0090] It should be noted that the penetration and fuzzing unit 230 performs penetration testing and fuzzing testing on medical devices. Penetration testing simulates hacker attacks to examine the device's security capabilities; fuzzing, on the other hand, uses abnormal data to test the device's stability and security when handling unusual situations. This unit records the results of both tests in detail, including vulnerabilities discovered during the testing process and any abnormal reactions from the device.

[0091] The penetration and fuzz testing unit 230 is also used to generate the penetration and fuzz testing template based on the penetration test results and the fuzz test results and transmit it to the field filling module 300.

[0092] It should be understood that, based on the recorded penetration test and fuzzing results, the penetration and fuzzing unit 230 generates a penetration and fuzzing template. This template visually demonstrates the device's performance in the face of different types of attacks, providing a reference for evaluating the device's security performance. After generation, the template is transferred to the field filling module 300 to continue the file generation process.

[0093] The template configuration module 200 further includes a source code vulnerability detection unit 240; the source code vulnerability detection unit 240 is connected to the management plan unit 210.

[0094] It should be noted that the source code vulnerability detection unit 240 is connected to the management plan unit 210, and also has a data interaction relationship with the source code storage and management system of the medical device equipment.

[0095] The source code vulnerability detection unit 240 is used to record the analysis results of the source code of the medical device.

[0096] It should be understood that the source code vulnerability detection unit 240 performs in-depth analysis of the source code of medical device equipment to detect existing security vulnerabilities and potential risks, such as code injection vulnerabilities and buffer overflow vulnerabilities. It records in detail the problems found during the analysis process, including the code location of the vulnerability, the type of vulnerability, and its potential impact.

[0097] The source code vulnerability detection unit 240 is also used to generate a source code vulnerability detection template based on the analysis results and transmit it to the field filling module 300.

[0098] It should be noted that, based on the recorded source code analysis results, the source code vulnerability detection unit 240 generates a source code vulnerability detection template. This template presents security issues in the source code in a professional and detailed manner, helping developers and security personnel understand the security status of the code and providing a basis for subsequent code remediation and optimization. After generation, the template is transmitted to the field filling module 300 to proceed with the file generation process.

[0099] The template configuration module 200 further includes a risk assessment unit 250; the risk assessment unit 250 is connected to the vulnerability reporting unit 220, the penetration and fuzz testing unit 230 and the source code vulnerability detection unit 240 respectively.

[0100] It should be understood that the risk assessment unit 250 is connected to the vulnerability reporting unit 220, the penetration and fuzzing unit 230 and the source code vulnerability detection unit 240 respectively, and integrates the information provided by these units to conduct risk assessment.

[0101] The risk assessment unit 250 is used to record the risk level in the vulnerability scan report template, the penetration and fuzzing test template, and the source code vulnerability detection template.

[0102] It should be noted that the risk assessment unit 250 receives information from vulnerability scan report templates, penetration and fuzzing test templates, and source code vulnerability detection templates, comprehensively analyzes the security risks present in the device in various aspects, and determines the corresponding risk level. The risk level is usually classified based on factors such as the severity of the vulnerability and the potential scope of its impact, reflecting the security status of the device in a straightforward manner.

[0103] The risk assessment unit 250 is also used to generate the risk assessment template according to the risk level and transmit it to the field filling module 300.

[0104] It should be understood that, based on the recorded risk level, the risk assessment unit 250 generates a risk assessment template. This template comprehensively assesses the cybersecurity risks of medical devices, providing an important basis for developing security strategies and taking corresponding security measures. After generation, the risk assessment template is transferred to the field filling module 300 to continue the document generation process.

[0105] The template configuration module 200 further includes a management report unit 260; the management report unit 260 is connected to the risk assessment unit 250.

[0106] It should be noted that the management reporting unit 260 is connected to the risk assessment unit 250, and also has an information exchange relationship with the enterprise's safety management department or relevant decision-making level.

[0107] The management report unit 260 is used to review the risk assessment template and generate a management report template from the review results, which is then transmitted to the field filling module 300.

[0108] It should be understood that the management reporting unit 260 reviews the risk assessment template, organizing relevant experts or security management personnel to audit and analyze the results of the risk assessment to ensure the accuracy and reliability of the assessment results. During the review process, discussions and adjustments may be made regarding the determination of risk levels and recommendations for risk response measures. Based on the review results, the management reporting unit 260 generates a management report template. This template summarizes the cybersecurity status of the medical device, proposes targeted security management recommendations and decision-making references, and provides managers with comprehensive security information to enable them to make reasonable security decisions. After generation, the management report template is transmitted to the field filling module 300, completing the entire cybersecurity document generation process.

[0109] It should be noted that the management plan template, the vulnerability scan report template, the penetration and fuzz testing template, the source code vulnerability detection template, the risk assessment template, and the management report template all support adaptive field generation and multi-device collaboration scenarios, and can be used independently and / or integrated to generate cybersecurity documents that comply with FDA requirements.

[0110] In this embodiment, a combination of testing and analysis methods is used to evaluate the cybersecurity status of medical devices from different perspectives. The management planning unit 210 performs overall lifecycle management, ensuring that devices have corresponding security measures at different stages; the vulnerability reporting unit 220, penetration and fuzz testing unit 230, and source code vulnerability detection unit 240 respectively discover potential security issues from the perspectives of vulnerability scanning, attack simulation testing, and code analysis; the risk assessment unit 250 comprehensively evaluates the risk level based on the results of various methods; and the management reporting unit 260 conducts the final review. This comprehensive evaluation system can promptly identify various security risks existing in the devices, providing a basis for taking effective security protection measures, thereby comprehensively ensuring the cybersecurity of medical devices. Each template supports adaptive field generation, automatically adjusting the file content according to different devices and testing conditions, reducing the workload of manual filling and modification, and improving the efficiency of file generation. At the same time, it avoids field omissions or errors caused by human error, ensuring the accuracy and completeness of the file content and improving file quality. It supports multi-device collaborative scenarios, allowing simultaneous security testing and file generation for multiple medical devices, meeting the needs of large-scale device management in medical institutions. Furthermore, the templates can be used independently or integrated, flexibly combined according to actual needs to generate comprehensive and systematic cybersecurity documents, further improving the efficiency and quality of document generation. Each unit generates corresponding report templates, presenting test results, risk assessments, and other information in a clear and standardized format. For example, the periodic planning report clearly defines the security tasks of the device at different stages; the vulnerability scan report template lists vulnerability information in detail; and the risk assessment template visually displays the risk level. The management reporting unit 260 reviews the risk assessment templates and generates management report templates from the review results. This mechanism makes the security decision-making process more scientific and rigorous. Management can make reasonable security decisions based on the comprehensive information and professional advice in the management reports, optimize the allocation of security resources, and improve the effectiveness of cybersecurity management.

[0111] In addition, this application also proposes a medical device that includes the network security file format management system described above.

[0112] Since the medical device adopts all the technical solutions of all the above embodiments, it has at least all the beneficial effects brought about by the technical solutions of the above embodiments, which will not be repeated here.

[0113] Furthermore, this application also proposes a network security file format management method, which is applied to the medical device device described above; see reference Figure 3 , Figure 3 This is a flowchart illustrating an embodiment of the network security file format management method proposed in this application. The method includes:

[0114] Step S10: Collect medical device information and test data input by the user through the external software interface.

[0115] It should be understood that the executing entity of this embodiment can be a computing service device with data processing, network communication, and program execution functions, or an electronic device capable of performing the above functions. For example, the medical device described above. The following uses a medical device as an example to describe this embodiment and the following embodiments.

[0116] It should be noted that step S10 first requires collecting medical device information and test data input by the user through an external software interface. Medical device information may include basic information such as the device's model, specifications, manufacturer, and usage environment; test data may cover various data generated during network security testing, such as vulnerability scan results, penetration test data, and source code analysis data. Using the external software interface as the entry point for user interaction with the system allows users to easily input relevant information and data. This design makes operation more intuitive and convenient, lowering the user's barrier to entry.

[0117] Step S20: Configure corresponding fixed fields and adaptive fields according to the medical device information and the test data, and generate multiple network security file templates.

[0118] It should be understood that after receiving medical device information and test data, the template configuration module configures corresponding fixed and adaptive fields based on this information. Fixed fields are pre-defined fields that remain unchanged across all cybersecurity files, such as file titles, dates, and report numbers. Adaptive fields, on the other hand, are dynamically generated based on different medical device information and test data, such as device-specific vulnerability information and risk levels. The combination of fixed and adaptive fields ensures that the generated cybersecurity files have a unified format while accurately reflecting the personalized information of different devices. Based on the configured fixed and adaptive fields, multiple cybersecurity file templates are generated. These templates correspond to different cybersecurity file types, such as management plan templates, vulnerability scan report templates, penetration and fuzzing templates, source code vulnerability detection templates, risk assessment templates, and management report templates. Each template has its specific structure and content requirements for recording and presenting different aspects of cybersecurity information.

[0119] Step S30: Automatically populate each of the network security file templates according to the file templates pre-configured by the user.

[0120] It's important to note that the system automatically populates various cybersecurity file templates based on user-configured templates. These templates can be understood as rules or mappings that specify which data should be filled into which field of which template. For example, users can configure the system to automatically populate the vulnerability scan results recorded in the vulnerability report unit into the corresponding fields of the vulnerability report template. The system will extract relevant content from the collected medical device information and test data according to the user-defined rules and accurately populate the corresponding cybersecurity file templates. This process automates data processing, improves the efficiency and accuracy of file generation, and reduces errors that may result from manual intervention.

[0121] Step S40: Integrate the filled network security file templates into a network security file that meets the preset format requirements.

[0122] It should be understood that the various network security document templates, after being filled in, are integrated to form a complete network security document that conforms to the preset format requirements. During the integration process, the system will combine the contents of each template according to a certain logical order and format specifications, ensuring that the document structure is clear and hierarchical. The final output network security document must conform to the preset format requirements, which may include specifications for document layout, font, font size, page margins, and other appearance aspects, as well as requirements for the organization and logical relationships of the document content. Network security documents that conform to the preset format requirements are easy for users to read, understand, and use, and also facilitate storage, archiving, and sharing.

[0123] In this embodiment, automated data collection, configuration, population, and integration operations reduce manual processing workload and improve the efficiency of cybersecurity document generation. The automated process minimizes human error and ensures the accuracy and reliability of the generated cybersecurity documents. Adaptive field configuration and user-pre-configured file templates enable this method to adapt to different types of medical devices and diverse testing needs, offering significant flexibility. The generated cybersecurity documents comply with FDA requirements, facilitating standardized document management and enabling users to easily view, audit, and trace the documents.

[0124] The above are only some embodiments of this application and do not limit the scope of implementation of this application. Any equivalent structural or procedural transformations made based on the content of this application specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the protection scope of this application.

Claims

1. A network security file format management system, characterized in that, The network security file format management system is applied to medical device equipment; The network security file format management system includes: a data acquisition module, a template configuration module, a field filling module, and an integrated output module; The data acquisition module is connected to the template configuration module and the external software interface respectively; the template configuration module is also connected to the field filling module; the field filling module is also connected to the integrated output module. The data acquisition module is used to collect medical device information and test data input by the user through the external software interface, and transmit the medical device information and test data to the template configuration module; The template configuration module is used to configure corresponding fixed fields and adaptive fields according to the medical device information and the test data, and generate multiple network security file templates; The field filling module is used to automatically fill each of the network security file templates according to the file templates pre-configured by the user. The integrated output module is used to integrate the filled network security file templates into a network security file that meets the preset format requirements.

2. The network security file format management system as described in claim 1, characterized in that, The multiple network security document templates include: management plan template, vulnerability scan report template, penetration and fuzz testing template, source code vulnerability detection template, risk assessment template, and management report template; the template configuration module includes: a management plan unit; The management planning unit is connected to the data acquisition module; The management planning unit is used to perform cybersecurity lifecycle management of the medical device based on the medical device information and test data input by the data acquisition module. The management plan unit is also used to generate the management plan report based on the network security lifecycle management and transmit it to the field filling module.

3. The network security file format management system as described in claim 2, characterized in that, The management plan template, the vulnerability scan report template, the penetration and fuzz testing template, the source code vulnerability detection template, the risk assessment template, and the management report template all support adaptive field generation and multi-device collaborative scenarios, and can be used independently and / or integrated to generate network security files that meet the preset requirements.

4. The network security file format management system as described in claim 2, characterized in that, The template configuration module also includes: a missed scan reporting unit; The missed scan reporting unit is connected to the management plan unit; The vulnerability reporting unit is used to record the vulnerability scan results of the host, Web, and App of the medical device. The vulnerability scanning report unit is also used to generate the vulnerability scanning report template based on the vulnerability scanning results and transmit it to the field filling module.

5. The network security file format management system as described in claim 4, characterized in that, The template configuration module also includes: a penetration and fuzz testing unit; The penetration and fuzz testing template is connected to the management plan unit; The penetration and fuzzy testing unit is used to record the penetration test results and fuzzy test results of the medical device. The penetration and fuzz testing unit is further configured to generate the penetration and fuzz testing template based on the penetration test results and the fuzz test results, and transmit it to the field filling module.

6. The network security file format management system as described in claim 5, characterized in that, The template configuration module also includes: a source code vulnerability detection unit; The source code vulnerability detection unit is connected to the management plan unit; The source code vulnerability detection unit is used to record the analysis results of the source code of the medical device. The source code vulnerability detection unit is also used to generate a source code vulnerability detection template based on the analysis results and transmit it to the field filling module.

7. The network security file format management system as described in claim 6, characterized in that, The template configuration module also includes: a risk assessment unit; The risk assessment unit is connected to the vulnerability scanning report unit, the penetration and fuzz testing unit, and the source code vulnerability detection unit, respectively. The risk assessment unit is used to record the risk level in the vulnerability scan report template, the penetration and fuzz testing template, and the source code vulnerability detection template; The risk assessment unit is also used to generate the risk assessment template according to the risk level and transmit it to the field filling module.

8. The network security file format management system as described in claim 7, characterized in that, The template configuration module also includes: a management report unit; The management reporting unit is connected to the risk assessment unit; The management report unit is used to review the risk assessment template and generate a management report template from the review results, which is then transmitted to the field filling module.

9. A medical device, characterized in that, The medical device includes a network security file format management system as described in any one of claims 1 to 8.

10. A method for managing network security file formats, characterized in that, The method is applied to the medical device as described in claim 9; the method includes: Collect medical device information and test data input by the user through the external software interface; Configure corresponding fixed fields and adaptive fields based on the medical device information and the test data, and generate multiple network security file templates; Automatically populate each of the aforementioned network security file templates based on the user's pre-configured file templates; The filled network security file templates are integrated into a network security file that meets the preset format requirements.

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