Updated April 12, 2025
Penetration testing is a proactive way to assess your cybersecurity practices and identify vulnerabilities to remedy. Businesses engage firms to conduct these to understand exploitable weaknesses so they can fix them before hackers exploit them.
While it’s a best practice for organizations in their cybersecurity strategy, compliance with regulations is another reason companies request pen tests. Many laws regulate the collection, use, and sharing of data. As such, remaining compliant with these rules requires regular auditing and testing.
So, what regulations require penetration testing? We’ll review the most common ones and what they say about pen testing.
What Is Penetration Testing?
A penetration test is a simulated cyberattack performed by ethical (white hat) hackers. You hire a firm that specializes in this service to conduct it. There are many types of pen tests that focus on different areas of your IT ecosystem, including:
- Web application pen tests: This exercise assesses the architecture, design, and configuration of web applications, which include everything delivered over the Internet via a browser interface.
- Network security pen tests: These tests identify exploitable issues on different networks associated with routers, switches, or network hosts. It often uses weak assets or misconfigured assets to breach.
- Cloud security pen tests: This option validates your cloud deployment security accuracy. It evaluates overall risk and the potential for a breach to occur in cloud properties. You can request them for public, private, and hybrid clouds.
- IoT security pen tests: In this test, a layered methodology analyzes devices and their interactions. As IoT devices are a popular option for cybercriminals to gain network entry, these issues are critical to correct.
- Social engineering pen tests: These tests work differently than others. They use phishing techniques in emails to determine your network’s ability to defend, detect, and react to them. They also provide insight into whether your security training is effective.
For pen tests and regulations, most will focus on web applications, networks, and clouds.
Regulations and Pen Tests
The regulations and laws below have components that either require or suggest pen testing:
HIPAA
HIPAA is one of the most detailed laws regarding the use of data, specifically PHI (protected health information). As such, there are many rules about data security. While HIPAA doesn’t explicitly require pen testing, there is language that addresses it.
HIPAA Evaluation Standard § 164.308(a)(8) applies to penetration testing, stating that a covered entity or business associate is required to “perform a periodic technical and nontechnical evaluation.”
A technical evaluation typically refers to performing a penetration test.
Information Access Management: § 164.308(a)(4)27 references the need to assess “security measures related to access control” and confirm how effective authentication processes are in preventing unauthorized access to PHI and other assets that contain protected information.
Additionally, NIST 800-66 for HIPAA includes this recommendation: “Conduct penetration testing (where trusted insiders attempt to compromise system security for the sole purpose of testing the effectiveness of security controls), if reasonable and appropriate.”
These mentions within HIPAA around evaluations and assessing certainly align with what a pen test is able to do. By conducting them often, they support your compliance with the HIPAA Security Rule, HIPAA Privacy Rule, and Breach Notification Rule.
HIPAA Security Rule
The HIPAA Security Rule declares that healthcare organizations and their partners must ensure that PHI remains confidential, accessible, and secure.
HHS (Health and Human Services) OCR (Office for Civil Rights), the agency with the authority to enforce HIPAA, presents five points to consider in this rule:
- Assess risks and vulnerabilities related to ePHI’s confidentiality, integrity, and availability.
- Commit regular reviews of HIPAA compliance.
- Identify how you create, maintain, receive, and transmit ePHI.
- Determine how third parties, partners, and vendors with access to ePHI will create, receive, maintain, and transmit it.
- Define data security threats related to risk in three categories: human (internal and external), natural (disaster events like hurricanes or tornadoes), and environmental (physical and cyber).
HIPAA Privacy Rule
The HIPAA Privacy Rule outlines the standards for protecting PHI. The focus is data privacy and what you’ll do using or disclosing it. Pen testing allows you to demonstrate compliance by finding issues that could cause a data breach. Knowing these weaknesses enables you to avoid this risk and remediate any problems.
Breach Notification Rule
The Breach Notification Rule of HIPAA relates to what should happen if a breach occurs, including notifications you must send. Your policy on this would be part of an incident response strategy. Since pen tests emulate an attack, you’ll be able to discern if your defenses are working properly.
PCI-DSS: Payment Card Industry Data Security Standard
PCI-DSS, the Payment Card Industry Data Security Standard, is an information security standard for handling credit card information. The Payment Card Industry Security Standards Council (PCI SSC) administers it, and card brands mandate it. The PCI SSC, however, doesn’t have the legal authority to compel compliance.
The standard has four levels of compliance, depending on the dollar amount of transactions you handle. Level 1 is at the top. All require a PCI scan, and Level 1 organizations must go through internal audits and a scan by an approved scan vendor.
PCI certification also entails using a firewall, encryption, and anti-virus installations. You also have to qualify audits and scans, which pen tests can help do. It’s not an official requirement, but it supports compliance.
SOC 2 Type 2
SOC 2 Type 2 is a System and Organization Control (SOC) framework that provides a report to organizations about security, confidentiality, integrity, privacy, processing, and availability of data controls. Any company storing, using, or transmitting protected data should undergo a SOC 2 Type 2 pen test. It applies to any SaaS or tech company holding customer data.
This type of pen test has five areas: security, availability, processing integrity, confidentiality, and privacy, known as the Trust Service Principles (TSP). The report from your SOC 2 Type 2 pen test will include:
- The IP addresses, URLs, mobile apps, and APIs tested
- Vulnerabilities found
- The assessment steps
- Exploitable area determinations
- Recommendations to remediate, prioritized from most urgent to least
These pen tests ensure you comply with the scheme and have the right security controls to protect data.
ISO 27001: International Organization for Standards 27001
The ISO 27001 compliance scheme standardizes adequate and controlled measures to ensure information security. It involves legal, technical, and physical aspects of a company’s information security management process. ISO 27001 is an umbrella covering every component of security and business continuity.
You must have a pen test each year to comply with ISO 27001.
Medical Device Pen Tests
Manufacturers must meet cybersecurity requirements for medical device approval by the FDA (Food and Drug Administration), including the Premarket Notification 510(k) and Postmarket Submissions. Additionally, a new rule began on October 1, 2023, relating to regulatory submissions of medical devices and cybersecurity. Those requirements include:
- Submitting plans on how the company will track and address cybersecurity issues that occur after the device is on the market
- Implementation of internal procedures regarding medical device security to verify that patches and updates commence after identifying vulnerabilities
- Developing a “software bill of materials” as part of their FDA filings to define all software components in the device
- Compliance with yet-to-be-created rules about being cyber-secure
Pen-testing medical devices can satisfy these requirements. The framework used to do this should include the following:
- The Open Source Security Testing Methodology Manual
- U.S. NIST SP 800-115: Technical Guide to Information Security Testing and Assessment
- FDA Premarket Notification 510(k)
- FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2018 Draft)
- EU Medical Devices Regulation (MDR)
- UL 2900 set of standards (UL’s Cybersecurity Assurance Program)
Financial Industry Regulatory Authority (FINRA)
FINRA establishes cybersecurity protocols for financial organizations and securities firms. The organization assists businesses in meeting the Securities Exchange Act of 1933 (17 CFR §240.17a-4(f)). This law dictates that companies must preserve the electronic records in a non-rewriteable, non-erasable format. FINRA expects its members to use pen testing to ensure they take a risk-based approach to identifying vulnerabilities and assessing security.
More Reasons Why Pen Testing Keeps Your Organization Secure
In addition to the compliance piece, there are many benefits you’ll realize from pen tests. They are one of the most impactful things you can do to be proactive. Working with an experienced team yields many other advantages, such as:
- Removing the blind spots you have about your network: Ethical hackers will “see” the things you don’t.
- Evaluating how robust and effective your controls are: Learn if your controls are really working.
- Locating gaps in your security assurance practices upstream: Examples include automated tools, coding standards, and configurations.
- Identifying unknown flaws in software: You’ll have visibility on those that are both high and low risk.
- Determining quantitative and qualitative examples relating to current security processes: This will help you understand what areas need more attention.
Pen testing is a smart move for any company for compliance and many other reasons. Talk to our experts to learn more about how they work and what you can expect. Contact us today to set up a consultation.
Penetration Testing FAQs
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Penetration testing, also known as security testing, should be conducted on a regular basis to ensure the protection of organizations' digital assets. It is generally recommended that all organizations schedule security testing at least once a year. However, it is essential to conduct additional assessments in the event of significant infrastructure changes, prior to important events such as product launches, mergers, or acquisitions.
For organizations with large IT estates, high volumes of personal and financial data processing, or strict compliance requirements, more frequent pen tests are strongly encouraged. Such organizations should consider conducting penetration testing with a higher frequency to continually assess and strengthen their security measures.
To further enhance security practices, organizations can adopt agile pen testing or continuous pen testing. Unlike traditional pen testing, which occurs at specific intervals, agile pen testing integrates regular testing into the software development lifecycle (SDLC). This approach ensures that security assessments are conducted consistently throughout the development process, aligning with the release schedule of new features. By doing so, organizations can proactively address any vulnerabilities and mitigate risks to customers, without significantly impacting product release cycles.
Penetration Testing as a Service (PTaaS) is a dynamic approach to cybersecurity where regular and systematic penetration tests are conducted to assess the security of an organization's IT infrastructure. Unlike traditional penetration testing, which is typically performed as a one-time assessment, PTaaS offers ongoing testing and monitoring, allowing for continuous identification and remediation of vulnerabilities.
Key aspects of PTaaS include:
Regular Testing Cycles: PTaaS involves conducting penetration tests at predetermined intervals, such as monthly or quarterly. This regularity ensures that new or previously undetected vulnerabilities are identified and addressed promptly.
Updated Threat Intelligence: As cyber threats evolve rapidly, PTaaS providers stay abreast of the latest threat landscapes. This ensures that each test is relevant and effective against the most current types of attacks.
Continuous Improvement: By receiving regular feedback and insights from these tests, organizations can continually improve their security postures. This process includes patching vulnerabilities, updating security policies, and enhancing defense mechanisms.
Comprehensive Reporting and Support: PTaaS typically includes detailed reporting on the findings of each test, along with expert recommendations for remediation. Ongoing support and consultation are often part of the service to help organizations respond effectively to identified issues.
Cost-Effectiveness and Budget Predictability: With an annual contract and monthly payment options, PTaaS allows organizations to budget more effectively for their cybersecurity needs, avoiding the potentially higher costs of one-off penetration tests.
Cloud penetration testing is a specialized and crucial process involving comprehensive security assessments on cloud and hybrid environments. It is crucial to address organizations' shared responsibility challenges while using cloud services. Identifying and addressing vulnerabilities ensures that critical assets are protected and not left exposed to potential threats.
Cloud penetration testing involves simulating real-world attacks to identify and exploit vulnerabilities within the cloud infrastructure, applications, or configurations. It goes beyond traditional security measures by specifically targeting cloud-specific risks and assessing the effectiveness of an organization's security controls in a cloud environment.
The importance of cloud penetration testing lies in its ability to uncover security weaknesses that might be overlooked during regular security audits. As organizations increasingly adopt cloud services, they share the responsibility of ensuring the security of their data and assets with the cloud service provider. This shared responsibility model often poses challenges regarding who is accountable for various security aspects.
Cloud penetration testing not only helps in understanding the level of security provided by the cloud service provider but also provides insights into potential weaknesses within an organization's configurations or applications. By proactively identifying these vulnerabilities, organizations can take necessary steps to mitigate risks and strengthen their security posture.
These terms refer to the amount of information shared with the testers beforehand. Black box testing is like a real-world hacker attack where the tester has no prior knowledge of the system. It's a true test of how an actual attack might unfold. Gray box testing is a mix, where some information is given - this can lead to a more focused testing process. White box testing is the most thorough, where testers have full knowledge of the infrastructure. It's like giving someone the blueprint of a building and asking them to find every possible way in. Each type offers different insights and is chosen based on the specific testing objectives.
When choosing a pen test provider, you'll want to consider several important factors to ensure your organization's highest level of cybersecurity.
Selecting the right pen test provider is crucial for your organization's security. It's about identifying vulnerabilities and having a partner who can help you remediate them effectively. To make an informed decision, here's what you should look for:
Expertise and Certifications: One of the key factors to consider is the expertise of the pen testers. Look for providers with a team of experts holding certifications such as CISSP (Certified Information Systems Security Professional), CSSLP (Certified Secure Software Life Cycle Professional), OSWE (Offensive Security Web Expert), OSCP (Offensive Security Certified Professional), CRTE (Certified Red Team Expert), CBBH (Certified Bug Bounty Hunter), CRTL (Certified Red Team Lead), and CARTP (Certified Azure Red Team Professional). These certifications demonstrate a high level of knowledge and competence in the field.
Comprehensive Testing Services: The cybersecurity landscape constantly evolves, and threats are becoming more sophisticated. To stay ahead, you need a provider with expertise and resources to test your systems comprehensively. Look for a pen test provider like Blue Goat Cyber that offers testing across various areas, including internal and external infrastructure, wireless networks, web applications, mobile applications, network builds, and configurations. This ensures a holistic evaluation of your organization's security posture.
Post-Test Care and Guidance: Identifying vulnerabilities is not enough; you need a partner who can help you address them effectively. Consider what happens after the testing phase. A reputable pen test provider should offer comprehensive post-test care, including actionable outputs, prioritized remediation guidance, and strategic security advice. This support is crucial for making long-term improvements to your cybersecurity posture.
Tangible Benefits: By choosing a pen test provider like Blue Goat Cyber, you ensure that you receive a comprehensive evaluation of your security posture. This extends to various areas, including internal and external infrastructure, wireless networks, web and mobile applications, network configurations, and more. The expertise and certifications of their team guarantee a thorough assessment.
We follow a seven phase methodology designed to maximize our efficiency, minimize risk, and provide complete and accurate results. The overarching seven phases of the methodology are:
- Planning and Preparation
- Reconnaissance / Discovery
- Vulnerability Enumeration / Analysis
- Initial Exploitation
- Expanding Foothold / Post-Exploitation
- Cleanup
- Report Generation
An External Black-Box Penetration Test, also known as a Black Box Test, primarily focuses on identifying vulnerabilities in external IT systems that external attackers could exploit. This testing approach aims to simulate real-world attack scenarios, mimicking the actions of adversaries without actual threats or risks.
During an External Black-Box Pen Test, ethical hackers attempt to exploit weaknesses in network security from an external perspective. This form of testing does not involve internal assessments, which means it may provide a limited scope of insights. However, it is crucial to note that the absence of identified external vulnerabilities does not guarantee complete security.
To gain a comprehensive understanding of the network's resilience, it is recommended to complement the External Black-Box Pen Test with an Internal Black-Box Penetration Test. By combining both approaches, organizations can evaluate the effectiveness of their security measures from both external and internal perspectives.
It is important to acknowledge that external-facing devices and services, such as email, web, VPN, cloud authentication, and cloud storage, are constantly exposed to potential attacks. Therefore, conducting an External Black-Box Pen Test becomes imperative to identify any weaknesses that could compromise the network's confidentiality, availability, or integrity.
Organizations should consider performing External and Internal Black-Box Penetration Tests to ensure a robust security posture. This comprehensive approach allows for a thorough assessment of external vulnerabilities while uncovering potential internal risks. Organizations can strengthen their security defenses by leveraging these testing methodologies and proactively addressing identified weaknesses.
Blue Goat Cyber employs a comprehensive approach to gather intelligence for a penetration test. We begin by actively seeking out relevant information about the targets. This includes identifying the devices, services, and applications the targets utilize. In addition, Blue Goat Cyber meticulously explores potential valid user accounts and executes various actions to uncover valuable data. By conducting this meticulous information-gathering process, Blue Goat Cyber ensures we comprehensively understand the target's infrastructure and potential vulnerabilities for a successful penetration test.
Compliance penetration testing is specially designed to meet the requirements of various regulatory standards. For SOC 2, it's about ensuring that a company's information security measures are in line with the principles set forth by the American Institute of CPAs. In the case of PCI DSS, it's specifically for businesses that handle cardholder information, where regular pen testing is mandated to protect against data breaches. For medical devices regulated by the FDA, pen testing ensures that the devices and their associated software are safe from cyber threats. This type of testing is crucial not just for meeting legal requirements but also for maintaining the trust of customers and stakeholders in industries where data sensitivity is paramount.
