Industry Regulations

5 automated security scanners

Medical Device Compliance

Purpose: The Medical Device Compliance Scanner is designed to identify and assess various aspects of medical device companies related to compliance with industry regulations such as HIPAA, ISO 14971, and FDA guidelines. This tool scans for the presence of security policies, maturity indicators like SOC 2 and ISO 27001 certifications, documentation of safety features, update management practices, and compliance certifications that are crucial for ensuring robust cybersecurity and regulatory adherence in medical device operations.

What It Detects:

Security Policy Indicators: The scanner identifies the presence of security policies related to data protection, incident response, access control, and other critical areas as mandated by HIPAA and similar regulations.
Maturity Indicators: Evaluates compliance certifications such as SOC 2 and ISO 27001, along with penetration testing and vulnerability assessments that are essential for assessing the maturity of an organization’s cybersecurity practices.
Safety Feature Documentation: Checks for documentation of safety features and risk management practices like Failure Mode Effects Analysis (FMEA), which is crucial for ensuring patient safety in medical devices.
Update Management Practices: Assesses the presence of update policies, procedures, and mechanisms to ensure timely software and firmware updates that are critical for addressing vulnerabilities and enhancing functionality without compromising safety or efficacy.
Compliance Certifications: Verifies the display of compliance certifications on public-facing pages or trust centers, which is vital for transparency and assurance in regulatory compliance.

Inputs Required:

domain (string): The primary domain to analyze, representing the company’s website address that needs evaluation.
company_name (string): The name of the company whose compliance practices are being assessed, used for searching relevant statements on their site.

Business Impact: Ensuring compliance with regulations such as HIPAA and ISO 14971 is not only legally required but also critically important to protect sensitive patient data and maintain trust in medical device operations. Compliance failures can lead to severe penalties, legal repercussions, and damage to the company’s reputation, making this scanner a pivotal tool for maintaining robust cybersecurity posture and regulatory adherence in the healthcare technology sector.

Risk Levels:

Critical: Conditions that directly affect core security policies or significant compliance certifications are critical. These include instances where key compliance statements are absent from public-facing pages.
High: High risk conditions involve missing or inadequate documentation of safety features and update management practices, which can lead to potential vulnerabilities in device functionality and patient safety.
Medium: Medium risk conditions pertain to incomplete or insufficient maturity indicators such as SOC 2 compliance that are essential for demonstrating robust cybersecurity practices but may not be fully met.
Low: Low risk findings include minor infractions like grammatical errors in security policies, which do not significantly impact overall compliance posture but should still be addressed for continuous improvement.
Info: Informational findings provide context on areas where improvements could enhance the scanner’s output without immediate regulatory or operational impacts.

Example Findings:

A company fails to disclose a comprehensive security policy regarding data protection, which is critical under HIPAA regulations but not explicitly mentioned in their public documentation.
Lack of documented risk assessments and FMEA for safety features in medical devices could be identified as high-risk conditions due to potential safety hazards that are inadequately managed.

FedRAMP Compliance

Purpose: The FedRAMP Compliance Scanner is designed to assess and report on the compliance of company security documentation, public policy pages, trust center information, and compliance certifications with the Federal Risk and Authorization Management Program (FedRAMP) standards. It aims to identify the presence of security policies, maturity indicators such as SOC 2 and ISO 27001 compliance, comprehensive security documentation, continuous monitoring practices, and implementation of specific FedRAMP-mandated controls.

What It Detects:

Security Policy Indicators: Detection of mentions of “security policy” in company documents, references to “incident response” procedures, statements related to “data protection” measures, and verification of “access control” policies.
Maturity Indicators: Check for SOC 2 compliance certifications, identification of ISO 27001 standards adherence, detection of penetration test results or references, and location of vulnerability scan or assessment documentation.

Inputs Required:

domain (string): The primary domain to analyze, such as “acme.com,” which helps in searching for relevant documents across the company’s site.
company_name (string): The name of the company, used for statement searching and ensuring that findings are contextually relevant to the organization being assessed.

Business Impact: This scanner is crucial for organizations aiming to meet or exceed FedRAMP compliance requirements, as it helps in identifying gaps in security documentation and practices that could affect regulatory adherence and public trust.

Risk Levels:

Critical: Findings that directly impact critical security controls and are non-compliant with FedRAMP standards.
High: Significant deficiencies in security policies or documentation that pose a high risk to the organization’s security posture.
Medium: Minor issues requiring attention but not immediately critical, which could lead to potential risks if left unaddressed.
Low: Informal findings that do not significantly impact compliance or security but are still recommended for improvement based on best practices.
Info: General information about the company’s security posture without immediate risk implications.

Example Findings:

“Incomplete documentation regarding data handling and protection policies.”
“Lack of evidence for regular penetration testing as required by FedRAMP.”

This structured approach provides a clear understanding of how the FedRAMP Compliance Scanner operates, what it evaluates, and its implications on organizational security.

HIPAA Compliance

Purpose: The HIPAA Compliance Scanner is designed to assess a company’s adherence to HIPAA regulations by evaluating its security controls, privacy policies, and breach notification procedures. This evaluation is crucial as non-compliance can result in substantial financial penalties and damage to reputation.

What It Detects:

Identifies the presence of “security policy” documents.
Checks for “incident response” plans.
Verifies “data protection” measures.
Ensures “access control” protocols are in place.
Looks for SOC 2 certifications.
Searches for ISO 27001 compliance.
Detects penetration testing activities.
Identifies vulnerability scanning or assessment reports.
Analyzes privacy policy documents for adherence to HIPAA requirements.
Checks for data encryption practices.
Verifies patient consent mechanisms.
Ensures secure disposal of protected health information (PHI).
Examines breach notification policies and procedures.
Checks for timely reporting mechanisms.
Verifies communication protocols with affected individuals.
Reviews public-facing policy pages for transparency and completeness.
Validates the presence of trust center information.
Confirms the availability of compliance certifications.

Inputs Required:

domain (string): The primary domain to analyze, such as “acme.com”.
company_name (string): The company name for statement searching, such as “Acme Corporation”.

Business Impact: This scanner is critical for assessing the security posture of healthcare organizations and ensuring compliance with HIPAA regulations, which are essential for protecting sensitive patient data from breaches and unauthorized access. Non-compliance can lead to significant fines and damage to a company’s reputation.

Risk Levels:

Critical: Conditions that directly impact the integrity, confidentiality, and availability of PHI, such as lack of a security policy or breach notification procedures not meeting HIPAA standards.
High: Conditions that significantly increase the risk of a data breach, such as inadequate access controls or encryption practices not aligned with HIPAA requirements.
Medium: Conditions that may lead to less severe but still significant risks, such as incomplete privacy policies or lack of vulnerability assessment reports.
Low: Informative findings that do not directly impact security but can be useful for continuous improvement, such as the presence of trust center information without specific compliance certifications.

Example Findings:

A company does not have a documented security policy despite being required by HIPAA to maintain one.
Patient consent mechanisms are found to be inadequate, posing risks to patient privacy and data protection.

NERC CIP Compliance

Purpose: The NERC CIP Compliance Scanner is designed to identify and assess critical asset protection, access controls, and monitoring compliance issues within organizations in accordance with the North American Electric Reliability Corporation (NERC) Critical Infrastructure Protection (CIP) standards. This tool ensures that companies adhere strictly to regulatory requirements for cybersecurity in the electric grid.

What It Detects:

Security Policy Indicators: The scanner identifies the presence of security policies, incident response plans, data protection measures, and access control protocols within company documentation.
Maturity Indicators: It evaluates compliance with certifications such as SOC 2, ISO 27001, penetration testing, and vulnerability assessments to ensure a robust cybersecurity posture.
Critical Asset Protection: The scanner checks for documentation related to the protection of critical assets as mandated by NERC CIP standards.
Access Control Compliance: It verifies that access controls are properly implemented and documented, including user authentication and authorization mechanisms.
Monitoring and Detection Mechanisms: Ensures that monitoring systems and detection mechanisms are in place to promptly identify and respond to security incidents.

Inputs Required:

domain (string): Primary domain to analyze (e.g., acme.com) - This is necessary for the scanner to gather information from the specified domain.
company_name (string): Company name for statement searching (e.g., “Acme Corporation”) - This helps in identifying relevant documents and statements within the company’s documentation.

Business Impact: Compliance with NERC CIP standards is crucial for ensuring the reliability of the electric grid, which supports critical infrastructure across North America. Non-compliance can lead to severe penalties, operational disruptions, and loss of public trust.

Risk Levels:

Critical: Findings that directly impact security policies, such as missing or inadequate incident response plans, are considered critical.
High: Issues related to data protection, where there is a risk of unauthorized access or exposure of sensitive information, are classified as high severity.
Medium: Compliance gaps in areas like basic access controls without severe consequences but still important for overall security posture are marked as medium.
Low: Informal compliance with general cybersecurity practices that do not pose immediate risks but should be addressed for continuous improvement.
Info: General information about certifications and documented measures that provide minimal to no risk or impact on the organization’s security posture.

Example Findings:

A company lacks a comprehensive security policy document, posing a high risk of unauthorized access and potential data breaches.
The absence of an ISO 27001 certification despite significant critical infrastructure operations indicates a compliance gap that could lead to regulatory non-compliance and financial penalties.

CMMC Compliance

Purpose: The CMMC Compliance Scanner evaluates an organization’s adherence to the Capability Maturity Model for Cybersecurity (CMMC) by assessing practice implementation, maturity levels, and documentation. It helps identify gaps in security policies, compliance certifications, and overall maturity.

What It Detects:

Identifies the presence of comprehensive security policies.
Checks for incident response plans.
Verifies data protection measures.
Ensures access control protocols are documented.
Looks for SOC 2 compliance certifications.
Searches for ISO/IEC 27001 standards adherence.
Detects penetration testing activities.
Identifies vulnerability scanning or assessment reports.
Reviews publicly available security documentation.
Checks policy pages on the company website.
Examines trust center information.
Validates compliance certifications listed.
Analyzes content for specific security-related terms and phrases.
Ensures policies are up-to-date and accessible.
Verifies alignment with CMMC requirements.
Evaluates the presence of detailed trust center information.
Checks for transparency in security practices.
Validates the inclusion of compliance certifications.

Inputs Required:

domain (string): Primary domain to analyze (e.g., acme.com)
company_name (string): Company name for statement searching (e.g., “Acme Corporation”)

Business Impact: This scanner is crucial for organizations aiming to achieve and maintain compliance with the CMMC standards, which are essential for securing critical infrastructure in the defense industrial base. Compliance not only mitigates risks but also enhances trust among stakeholders by demonstrating a commitment to robust cybersecurity practices.

Risk Levels:

Critical: The scanner identifies significant gaps or deficiencies in security policies and practices that directly impact the organization’s ability to comply with CMMC standards, potentially leading to severe penalties or loss of contract capabilities.
High: There are notable shortcomings in at least one critical area of cybersecurity practice, which could lead to substantial risks if not addressed promptly.
Medium: The scanner detects areas where improvements could be beneficial but does not pose immediate risk. These should be prioritized for future enhancement.
Low: The findings are primarily informational and suggest minor enhancements that do not significantly impact the overall security posture of the organization.
Info: The findings pertain to routine or best practice recommendations, contributing to a continuous improvement in cybersecurity practices without raising immediate concerns.

Example Findings:

“The company’s incident response plan lacks specific details and procedures for handling data breaches.”
“There is no evidence of ISO/IEC 27001 compliance despite the presence of several security policies.”