Understanding Germany's IT Security Act 2.0

Written by

Herman Errico

Reviewed by

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The IT Security Act 2.0, which was passed by the German Bundestag and Bundesrat in spring 2021, came into effect at the end of May 2023.

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Due to the increased IT security obligations and higher fines, the numerous changes to the central German IT Security Act, specifically the Law on the Federal Office for Information Security (BSI-Gesetz), are particularly relevant for operators of critical infrastructures already covered by the BSI-Gesetz, as well as for companies in the municipal waste disposal sector, manufacturers of IT products used in critical infrastructures, and companies of special public interest.

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The IT Security Act 2.0 and the second KRITIS regulation have far-reaching consequences. While there was previously a transition period for implementing the new requirements, companies must now comply with the requirements of the Federal Act on the Security of Information Technology (BSIG) from the first working day on which they meet the threshold values of the second KRITIS regulation.

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This means that from the first day after the IT Security Act 2.0 and the second KRITIS regulation come into effect, potential operators of critical infrastructures must adhere to the requirements of the IT Security Act 2.0. Failure to comply with the requirements can result in significant fines of up to 20 million euros imposed by the Federal Office for Information Security (BSI).

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This post will cover the scope and applicability of the Act, exploring the new definitions and audit and security requirements for both critical infrastructure operators and digital service providers. Additionally, we will explore the voluntary IT security label, the reporting requirements and new regime for the administrative fines associated with non-compliance to the new Act.

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Additionally, this post aims at providing an overview of the requirements for both critical infrastructure operators and digital service providers so that organizations can be in a better position to understand what aspects they will need to prioritize as part of their security programme should their business be in scope for the new IT Security Act.

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Should you require support in determining if this new law applied to you, feel free to engage with one of our experts at Vanta.

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Scope and applicability

The IT Security Act 2.0 applies to operators of critical infrastructure (KRITIS-Betreiber), which includes sectors such as energy, information technology, telecommunications, transportation, healthcare, finance, water supply, waste management and more.

Operators are identified based on predefined criteria, such as their significance for the functioning of society and the potential consequences of IT security incidents.

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Key terms and definitions

The Act identifies a number of definitions to support an easier application of the requirements including concepts such as information technology, security in information technology, federal communications technology, harmful software, security gaps, certification, protocol data, data traffic, IT products, systems for attack detection, critical infrastructures, digital services, provider of digital services, critical components, and companies in the special public interest.

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These definitions aim to provide clarity and common understanding of the terms used within the context of the law. By clearly defining these terms, it helps ensure consistent interpretation and application of the law's provisions. The definitions cover various aspects of information technology, security, infrastructure, and services, providing a comprehensive framework for the implementation and enforcement of the law.

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Overall, these definitions play a crucial role in establishing a common language and understanding for all stakeholders involved in the protection of critical infrastructures and the security of information technology. They lay the foundation for effective communication, compliance, and enforcement efforts, helping to safeguard the integrity, availability, and confidentiality of information and IT systems.

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Audits and inspections

The BSI is empowered to conduct audits and inspections to verify compliance with the law's requirements. Audits may include reviewing documentation, conducting on-site inspections, and assessing the effectiveness of security measures implemented by operators. Non-compliance with the law can result in penalties, including fines.

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Authority of the Federal Office

The Federal Office is responsible for gathering and evaluating information to prevent threats to information technology security. This includes identifying security gaps, malware, successful or attempted attacks, and the methods used. It promptly informs federal authorities about relevant information and facts related to IT security. Overall, Section 4 establishes the Federal Office as a central hub for information sharing and coordination among federal authorities, ensuring a proactive approach to information technology security and facilitating effective response measures.

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Other federal authorities are required to inform the Federal Office without delay if they become aware of significant information related to IT security. However, there are exceptions for information that is confidential or protected by constitutional status. The Federal Office has the authority to monitor the security of federal communications technology and can request information, access data processing systems, and examine devices used for federal communications technology.

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Additionally, the Federal Office serves as the general registration office for security in information technology. It receives information from third parties about security risks and evaluates this information. The reported information is used to inform the public, federal authorities, operators of critical infrastructures, and companies in the public interest. However, the disclosure of reported information may be limited if it contains trade secrets or business secrets.

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Section 7a of the Act establishes the authority of the Federal Office to examine the security of information technology products and systems. The Federal Office can request manufacturers to provide necessary information for the examination, including technical details. The obtained information is promptly shared with relevant supervisory authorities, and the findings may be shared and published if necessary for fulfilling the Federal Office's tasks. Non-compliance by manufacturers with information requests can result in public disclosure of the non-compliance, including the manufacturer's name and details of the affected product or system. However, manufacturers are given an opportunity to comment before any disclosure occurs. This section ensures that information technology products and systems undergo rigorous security examinations, promotes information sharing, and holds manufacturers accountable for complying with security requirements.

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In summary, Section 7a grants the Federal Office the power to examine the security of information technology products and systems. It requires manufacturers to provide necessary information for the examination and mandates the prompt sharing of findings with relevant authorities. The section also establishes the possibility of public disclosure in cases of non-compliance by manufacturers. By enforcing stringent security examinations and promoting transparency, this section contributes to enhancing the overall security of information technology systems.

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Requirements for operators of critical infrastructures

Under the legislation, operators of critical infrastructures are required to implement appropriate measures to protect the security of their information technology systems. These measures should prevent disruptions and ensure the availability, integrity, authenticity, and confidentiality of the systems.

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Operators must use systems for attack detection and develop incident response plans. They can propose industry-specific security standards, which will be assessed by the Federal Office. Compliance with the requirements must be demonstrated every two years through security audits, reviews, or certifications. The Federal Office has the authority to review compliance and may involve independent third parties. Operators must provide access and support during these reviews. The Federal Office can define requirements for security audits and certifications in consultation with industry representatives. Additionally, The operators must ensure that they can be reached at any time via the contact point named or specified by the Federal Office

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The operators of critical infrastructures shall appropriately prove compliance with the requirements at least every two years. This evidence may be provided by means of security audits, reviews or certifications. The operators shall provide the Federal Office with the results of the audits, reviews or certifications performed including any security deficiencies identified. The Federal Office may request the provision of the documentation on which the assessment was based. In the event of security deficiencies, the Federal Office may request remedy of the security deficiencies.

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Special requirements for providers of digital services

Section 8c of the legislation introduces special requirements for providers of digital services. These providers are obligated to implement suitable technical and organizational measures to manage risks to the security of their network and information systems used for providing services within the European Union. These measures aim to prevent or minimize the effects of security incidents. The detailed requirements for these measures are defined by implementing acts of the Commission.

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Providers of digital services must immediately report any security incidents that materially affect the provision of their services within the European Union to the Federal Office. The determination of material effect and the content of the reports are specified by implementing acts of the Commission. If the provider lacks sufficient access to the necessary information to evaluate the impact of the incident, the reporting obligation does not apply. In cases where the reported security incidents affect another EU Member State, the Federal Office informs the competent authority of that Member State.

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If there are indications that a provider of digital services is not meeting the requirements, the Federal Office can request certain measures from the provider. These measures may include transferring information for security evaluation, providing evidence of security measures taken, and rectifying any non-compliance. The Federal Office cooperates with the competent authority of another EU Member State if the provider is based there, in fulfilling these tasks and requesting measures if necessary.

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Security in information technology in companies in the special public interest

This section of the IT Security law imposes obligations on companies in the special public interest regarding IT security. Here are the key points:

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Companies must submit a self-declaration on IT security to the Federal Office, providing information about certifications, security audits, or protection measures implemented in the last two years.
The Federal Office can provide guidance on organizational and technical precautions based on the self-declaration.
Companies have specific deadlines for submitting self-declarations based on their classification.
Companies must register with the Federal Office and provide contact information.
Optional registration is available for companies not falling under the first two categories.
Companies must promptly report disruptions that affect the availability, integrity, authenticity, and confidentiality of their IT systems.
By November 1, 2021, companies falling under a different category must report disruptions as per the Major Incidents Ordinance.
The Federal Office can verify a company's status by requesting information on domestic added value or confirmation from an auditing firm.
These provisions ensure that companies in the special public interest comply with IT security requirements through self-declarations, reporting of disruptions, and registration with the Federal Office.

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Critical components prohibitions

Under Section 9b of the legislation, the use of critical components in critical infrastructures is subject to certain prohibitions and requirements. Here are the key points:

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Notification Requirement: Operators of critical infrastructures must notify the Federal Ministry of the Interior, Building and Community in advance about the planned deployment of a critical component, specifying the component and its intended use. This requirement does not apply if the operator has already reported the use of another critical component of the same type and use that has not been prohibited.

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Prohibition and Orders: The Ministry, in consultation with relevant departments and the Federal Foreign Office, has the authority to prohibit the deployment of a critical component or issue orders to the operator if the deployment could compromise public order or security in Germany. Factors considered include the manufacturer's control by a foreign government, involvement in activities impacting security, and alignment with security policy goals.

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Guarantee Declaration: Critical components can only be used if the manufacturer provides a guarantee declaration to the operator. This declaration demonstrates that the component does not have features that could be exploited for malicious purposes. The Federal Ministry, in agreement with relevant departments and the Federal Foreign Office, sets the minimum requirements for the guarantee declaration.

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Prohibition of Continued Use: If indications of manufacturer untrustworthiness arise, such as violations of obligations or technical risks, the Ministry can prohibit the continued use of the critical component or issue orders to the operator. In severe cases, a prohibition may be issued.

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Impact on Other Components: If the further use of a critical component is prohibited, the Ministry can also prohibit the planned use of other components of the same type and manufacturer, as well as the continued use of existing components, with a reasonable compliance period provided.

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Voluntary IT security label

The legislation introduces a voluntary IT security label to inform consumers about product security. The label consists of a manufacturer's declaration and security information provided by the Federal Office. Manufacturers must meet specific IT security requirements and obtain approval. The label is attached to the product or published online, directing consumers to access relevant information. The Federal Office ensures compliance and can take action if discrepancies or security gaps are identified.

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Reporting obligations

Section 13 of the legislation outlines reporting obligations of the Federal Office. The office must inform the Federal Ministry of the Interior about its activities, which are used to inform the public about IT security risks through an annual report.

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The Federal Office also shares information with the Commission regarding critical infrastructure operators, sectors, and services, while ensuring confidentiality. Consultations are initiated with other EU Member States regarding critical services in shared sectors.

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Additionally, the Federal Office submits a summary report to the cooperation group on reported security incidents, measures taken, and anonymized data. Operators are obligated to report significant IT security incidents to the BSI. The law specifies the types of incidents that need to be reported, including incidents that could have a significant impact on critical infrastructure or public safety. Reporting timelines and procedures are defined to ensure prompt communication and response to incidents.

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Fines for administrative offenses

Section 14 of the legislation outlines regulations on fines for administrative offenses. It specifies various actions that are considered offenses, including failure to comply with precautionary measures, violation of enforceable orders, failure to provide required information or reports, and non-compliance with registration or documentation requirements.

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The fines for these offenses range from up to EUR 50,000 to up to EUR 2 million, depending on the specific violation and intentionality. Negligent acts are also considered offenses. Violations related to ENISA and cybersecurity certification can result in fines of up to EUR 1 million or up to EUR 2 million, depending on the offense.

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Pre-work for your SOC 2 compliance

Choose the right type of SOC 2 report:

A SOC 2 Type 1 report assesses how your organization aligns with the security controls and policies outlined in SOC 2

A SOC 2 Type 2 report has all the components of a Type 1 report with the addition of testing your controls over a period of time

The correct report will depend on the requirements or requests of the client or partner that has requested a SOC 2 report  
from you

Determine the framework for your SOC 2 report. Of the five Trust Service Criteria in SOC 2, every organization needs to comply with the first criteria (security), but you only need to assess and document the other criteria that apply. Determining your framework involves deciding which Trust Service Criteria and controls are applicable to your business using our Trust Service Criteria Guide.

Estimate the resources you expect to need. This will vary depending on how closely you already align with SOC 2 security controls, but it can include several costs such as:

Compliance software

Engineers and potentially consultants

Security tools, such as access control systems

Administrative resources to draft security policies

Auditing for your compliance certification

Obtain buy in from your organization leadership to provide the resources your SOC 2 compliance will need.

Work toward SOC 2 compliance

Begin with an initial assessment of your system using compliance automation software to determine which necessary controls and practices you have already implemented and which you still need to put in place.

Review your Vanta report to determine any controls and protocols within the “Security” Trust Service Criteria that you do not yet meet and implement these one by one. These are multi-tiered controls across several categories of security, including:

CC1: Control Environment

CC2: Communication and Information

CC3: Risk Assessment

CC4: Monitoring Activities

CC5: Control Activities

CC6: Logical and Physical Access Controls

CC7: System Operations

CC8: Change Management

CC9: Risk Mitigation

Using Vanta’s initial assessment report as a to-do list, address each of the applicable controls in the other Trust Services Criteria that you identified in your initial framework, but that you have not yet implemented.

Using Vanta’s initial assessment report, draft security policies and protocols that adhere to the standards outlined in SOC 2.  

Vanta’s tool includes thorough and user-friendly templates to make this simpler and save time for your team.

Run Vanta’s automated compliance software again to determine if you have met all the necessary criteria and controls for your SOC 2 report and to document your compliance with these controls.

Complete a SOC 2 report audit

Select and hire an auditor affiliated with the American Institute of Certified Public Accountants (AICPA), the organization that developed and supports SOC 2.

Complete a readiness assessment with this auditor to determine if you have met the minimum standards to undergo a full audit.

If your readiness assessment indicates that there are SOC 2 controls you need to address before your audit, complete these requirements. However, if you have automated compliance software to guide your preparations and your SOC 2 compliance, this is unlikely.

Undergo a full audit with your SOC 2 report auditor. This may involve weeks or longer of working with your auditor to provide the documentation they need. Vanta simplifies your audit, however, by compiling your compliance evidence and documentation into one platform your auditor can access directly.

When you pass your audit, the auditor will present you with your SOC 2 report to document and verify your compliance.

Maintain your SOC 2 compliance annually

Establish a system or protocol to regularly monitor your SOC 2 compliance and identify any breaches of your compliance, as this can happen with system updates and changes.

Promptly address any gaps in your compliance that arise, rather than waiting until your next audit.

Undergo a SOC 2 re-certification audit each year with your chosen SOC 2 auditor to renew your certification.

Download this checklist for easy reference

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Prioritizing Your Security and Opening Doors with SOC 2 Compliance

Information security is a vital priority for any business today from an ethical standpoint and from a business standpoint. Not only could a data breach jeopardize your revenue but many of your future clients and partners may require a SOC 2 report before they consider your organization. Achieving and maintaining your SOC 2 compliance can open countless doors, and you can simplify the process with the help of the checklist above and Vanta s compliance automation software. Request a demo today to learn more about how we can help you protect and grow your organization.

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Request a demo

Pre-work for your ISO 42001 compliance

Understand ISO 42001 requirements

Decide on what is the scope of the AIMS

Familiarize yourself with key AI concepts, principles, and lifecycle based on ISO frameworks

Determine if you are a provider, developer, or user of AI systems

Perform initial gap analysis

Using Vanta, asses your in-scope ISO 42001 controls

Identify areas of requirement, development, or adjustment

Secure top management support

Present a business case highlighting the benefits of ISO 42001 certification

Define roles and responsibilities for top management in AIMS implementation

Involve various department heads in the analysis to ensure comprehensive coverage

Work for your ISO 42001 compliance

Appoint a Project Manager

Designate an owner for the ISO 42001 implementation project

Develop a project plan

Outline steps, timelines, and resources needed for AIMS implementation

Integrate the AIMS implementation project within existing organizational processes

Establish the AIMS framework

Define the scope and objectives of the AIMS within the organization

Develop and document AI policies and risk management processes

Based on gap analysis, implement necessary controls for AIMS

Ensure integration of AIMS with other management systems and requirements

Create an AIMS statement of applicability (SOA)

Promote competence and awareness

Conduct training for stakeholders on AI concepts and ISO 42001 requirements

Raise awareness about the importance and benefits of AIMS

Implement AIMS controls

Create an AI policy

Define the process for reporting concerns about AI systems

Identify, document, and manage resources for AI systems

Ensure tooling and computing resources for AI systems are adequately documented

Conduct an AI system impact assessment exercise

Ensure that objectives are documented for the design and development of AI systems

Create a process for responsible design and development of AI systems

Ensure that AI system deployment, operation, and monitoring are documented and executed according to your AIMS

Define and implement data management processes for AI systems

Assess and document the quality of data for AI systems

Ensure that system documentation and information for users is provided and accessible

Document and follow the processes for the responsible use of AI systems

Clearly allocate and document responsibilities with third parties

Conduct internal audits

Regularly assess compliance with ISO 42001 and the effectiveness of AIMS

Management review

Review AIMS performance and compliance with top management

Address any non conformities and areas for improvement

Prepare for your external audit

Work with A-LIGN as your ISO 42001 certification body

Engage A-LIGN, a leading ISO certification body, to conduct your audit

Prepare documentation

Ensure all AIMS documentation is up to date and accessible

Pre-audit meeting

Prepare a list of questions and clarifications regarding the audit process

Initial sales process

Discuss the scope of the audit in detail to ensure full preparedness

Conduct a pre-certification audit (optional)

Consider a pre-certification audit to identify any remaining gaps

The ISO 42001 audit

Engage in the certification audit

Collaborate with A-LIGN auditors, providing necessary information and access

Designate a team member as the point of contact for auditors to streamline communication

Organize walkthroughs to discuss your AIMS processes and procedures, including facilities (if applicable)

Address audit findings

Plan for immediate, short-term, and long-term corrective actions based on the audit report

Celebrate the audit success with your team and publicly promote your certification

Continuous improvement

Establish a continuous improvement team to oversee progress post-certification

Continuously improve the AIMS, leveraging lessons learned and feedback

Integrate ISO 42001 compliance metrics into regular management reviews

Keys to success

Leverage Vanta s readiness capabilities and A-LIGN s expertise for an efficient and high-quality audit experience from  
readiness to report

Incorporate AIMS within the business strategy and daily operations

Apply continuous improvement to enhance AIMS over time

Avoid integrating new technologies during the initial AIMS implementation

Engage interested parties and maintain their support throughout

Highlight the completion of the audit to demonstrate trust with customers, partners, and other key stakeholders

Download this checklist for easy reference

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Demonstrating secure AI practices with ISO 42001

The rapid adoption of AI has driven innovation and opportunities for growth — and with it, new risks for the companies that manage the data that power these technologies. These companies have not had a way to demonstrate trust to their customers and show that they are deploying AI securely and safely. Achieving ISO 42001 compliance helps to demonstrate this trust through a third-party verifiable way and opens the doors to time-savings, more deals, and expedited sales processes. The above checklist simplifies the process of becoming ISO 42001 compliant by leveraging the power of Vanta's continuous compliance software. Request a demo today to learn more about how Vanta can help you streamline the path to ISO 42001.

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Request a demo

Develop a roadmap for your ISMS implementation and ISO 27001 certification

Implement Plan, Do, Check, Act (PDCA) process to recognize challenges and identify gaps for remediation

Consider the costs of ISO 27001 certification relative to your organization’s size and number of employees.

Use project planning tools like project management software, Gantt charts, or Kanban boards.

Define the scope of work from planning to completion.

Determine the scope of your organization’s ISMS

Decide which business areas are covered by your ISMS and which ones are out of scope

Consider additional security controls for processes that are required to pass ISMS-protected information across the trust boundary.

Communicate the scope of your ISMS to stakeholders.

Establish an ISMS team and assign roles

Select engineers and technical staff with experience in information security to construct and implement the security controls needed for ISO 27001.

Build a governance team with management oversight.

Incorporate key members of top management (senior leadership and executive management) and assign responsibility for strategy and resource allocation.

If you have a large team, consider assigning a dedicated project manager to track progress and expedite implementation.

Align the team on the following:

The planning steps you’ve already taken

The scope of the ISMS

Which team members are responsible for which aspects of the project

Conduct an inventory of information assets

Consider all assets where information is stored, processed, and accessible

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Record information assets: data and people
Record physical assets: laptops, servers, and physical building locations
Record intangible assets: intellectual property, brand, and reputation

Assign to each asset a classification and owner responsible for ensuring the asset is appropriately inventoried, classified, protected, and handled

Meet with your team to discuss this inventory and ensure that everyone is aligned.

Perform a risk assessment

Establish and document a risk-management framework to ensure consistency

Identify scenarios in which information, systems, or services could be compromised

Determine likelihood or frequency with which these scenarios could occur

Evaluate potential impact of each scenario on confidentiality, integrity, or availability of information, systems, and services

Rank risk scenarios based on overall risk to the organization’s objectives

Develop a risk register

Record and manage your organization’s risks that you identified during your risk assessment.

Summarize each identified risk

Indicate the impact and likelihood of each risk.

Rank risk scenarios based on overall risk to the organization’s objectives.

Document a risk treatment plan

Design a response for each risk, known as a risk treatment.

Assign an owner to each identified risk and each risk mitigation activity.

Establish target timelines for completion of risk treatment activities.

Implement your risk mitigation treatment plan and track the progress of each task.

Complete the Statement of Applicability

Review the 93 controls listed in Annex A.

Select the controls that are relevant to the risks you identified in your risk assessment.

Complete the Statement of Applicability listing all Annex A controls, justifying inclusion or exclusion of each control in your ISMS implementation.

Implement ISMS policies, controls and continuously assess risk

Assign owners to each of the security controls to be implemented.

Figure out a way to track the progress and goals for each control.

Build a framework for establishing, implementing, maintaining, and continually improving the ISMS.

Include information or references to supporting documentation regarding:

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Information Security Objectives
Leadership and Commitment
Roles, Responsibilities, and Authorities
Approach to Assessing and Treating Risk
Control of Documented Information
Communication
Internal Audit
Management Review
Corrective Action and Continual Improvement
Policy Violations
All of the Annex A controls that you have selected

Establish employee training and awareness programs

Define expectations for personnel regarding their role in ISMS maintenance.

Train personnel on common threats facing your organization and how to respond.

Establish disciplinary or sanctions policies or processes for personnel found out of compliance with information security requirements.

Make security training part of the onboarding process for new employees.

Conduct regular training to ensure awareness of new policies and procedures.

Conduct regular management reviews

Plan reviews at least once per year. Consider a quarterly review cycle if your organization is large or if your infrastructure is changing frequently.

Ensure the ISMS and its objectives continue to be effective.

Verify that senior management stays informed.

Ensure risks or deficiencies can be promptly addressed.

Assemble ISO 27001 required documents

Review the ISO 27001 Required Documents and Records list.

Customize policy templates with organization-specific policies, process, and language.

Perform an ISO 27001 internal audit.

Examine each of the requirements from Annex A that you deemed applicable in your ISMS' Statement of Applicability and verify that you have each in place.

Assign in-house employees to conduct the internal audit, specifically employees who were not involved in the ISMS development and maintenance or hire an independent third party.

Share internal audit results, including nonconformities, with the ISMS team and senior management.

Address any issues your internal audit identified before proceeding with the external audit.

Verify compliance with the requirements from Annex A deemed applicable in your ISMS' Statement of Applicability.

Undergo external audit of ISMS to obtain ISO 27001 certification.

Select an independent ISO 27001 auditor.

Complete the Stage 1 Audit consisting of an extensive documentation review; obtain the auditor’s feedback regarding your readiness to move to the Stage 2 Audit.

Complete the Stage 2 Audit consisting of tests performed on the ISMS to ensure proper design, implementation, and ongoing functionality; evaluate fairness, suitability, and effective implementation and operation of controls.

Address any nonconformities.

Ensure that all requirements of the ISO 27001 standard are addressed.

Ensure your organization is following the processes that it has specified and documented.

Ensure your organization is upholding contractual requirements with third parties.

Address specific nonconformities identified by the ISO 27001 auditor.

Receive auditor’s formal validation following resolution of nonconformities.

Plan for subsequent ISO 27001 audits and surveillance audits.

Perform a full ISO 27001 audit once every three years

Prepare to perform surveillance audits in the second and third years of the Certification Cycle

Consider streamlining ISO 27001 certification with automation.

Explore tools for automating security and compliance

Transform manual data collection and observation processes into automated and continuous system monitoring

Identify and close any gaps in ISMS implementation in a timely manner

Learn more about achieving ISO 27001 certification with Vanta

Book an ISO 27001 demo with Vanta

Download this checklist for easy reference

Download now

Prioritizing your security and opening doors with ISO 27001 compliance

Information security is a vital priority for any business today from an ethical standpoint and from a business standpoint. Not only could a data breach jeopardize your revenue, but many of your future clients and partners may require an ISO 27001 report before they consider your organization. Achieving and maintaining your ISO 27001 compliance can open countless doors, and you can simplify the process with the help of the checklist above and Vanta’s compliance automation software.

‍

Request a demo today to learn more about how we can help you protect and grow your organization.

‍

Request a demo

Develop a roadmap for your ISMS implementation and ISO 27001 certification

Implement Plan, Do, Check, Act (PDCA) process to recognize challenges and identify gaps for remediation

Consider the costs of ISO 27001 certification relative to your organization’s size and number of employees.

Use project planning tools like project management software, Gantt charts, or Kanban boards.

Define the scope of work from planning to completion.

Determine the scope of your organization’s ISMS

Decide which business areas are covered by your ISMS and which ones are out of scope

Consider additional security controls for processes that are required to pass ISMS-protected information across the trust boundary.

Communicate the scope of your ISMS to stakeholders.

Establish an ISMS team and assign roles

Select engineers and technical staff with experience in information security to construct and implement the security controls needed for ISO 27001.

Build a governance team with management oversight.

Incorporate key members of top management (senior leadership and executive management) and assign responsibility for strategy and resource allocation.

If you have a large team, consider assigning a dedicated project manager to track progress and expedite implementation.

Align the team on the following:

The planning steps you’ve already taken

The scope of the ISMS

Which team members are responsible for which aspects of the project

Conduct an inventory of information assets

Consider all assets where information is stored, processed, and accessible

‍

Record information assets: data and people
Record physical assets: laptops, servers, and physical building locations
Record intangible assets: intellectual property, brand, and reputation

Assign to each asset a classification and owner responsible for ensuring the asset is appropriately inventoried, classified, protected, and handled

Meet with your team to discuss this inventory and ensure that everyone is aligned.

Perform a risk assessment

Establish and document a risk-management framework to ensure consistency

Identify scenarios in which information, systems, or services could be compromised

Determine likelihood or frequency with which these scenarios could occur

Evaluate potential impact of each scenario on confidentiality, integrity, or availability of information, systems, and services

Rank risk scenarios based on overall risk to the organization’s objectives

Develop a risk register

Record and manage your organization’s risks that you identified during your risk assessment.

Summarize each identified risk

Indicate the impact and likelihood of each risk.

Rank risk scenarios based on overall risk to the organization’s objectives.

Document a risk treatment plan

Design a response for each risk, known as a risk treatment.

Assign an owner to each identified risk and each risk mitigation activity.

Establish target timelines for completion of risk treatment activities.

Implement your risk mitigation treatment plan and track the progress of each task.

Complete the Statement of Applicability

Review the 93 controls listed in Annex A.

Select the controls that are relevant to the risks you identified in your risk assessment.

Complete the Statement of Applicability listing all Annex A controls, justifying inclusion or exclusion of each control in your ISMS implementation.

Implement ISMS policies, controls and continuously assess risk

Assign owners to each of the security controls to be implemented.

Figure out a way to track the progress and goals for each control.

Build a framework for establishing, implementing, maintaining, and continually improving the ISMS.

Include information or references to supporting documentation regarding:

‍

Information Security Objectives
Leadership and Commitment
Roles, Responsibilities, and Authorities
Approach to Assessing and Treating Risk
Control of Documented Information
Communication
Internal Audit
Management Review
Corrective Action and Continual Improvement
Policy Violations
All of the Annex A controls that you have selected

Establish employee training and awareness programs

Define expectations for personnel regarding their role in ISMS maintenance.

Train personnel on common threats facing your organization and how to respond.

Establish disciplinary or sanctions policies or processes for personnel found out of compliance with information security requirements.

Make security training part of the onboarding process for new employees.

Conduct regular training to ensure awareness of new policies and procedures.

Conduct regular management reviews

Plan reviews at least once per year. Consider a quarterly review cycle if your organization is large or if your infrastructure is changing frequently.

Ensure the ISMS and its objectives continue to be effective.

Verify that senior management stays informed.

Ensure risks or deficiencies can be promptly addressed.

Assemble ISO 27001 required documents

Review the ISO 27001 Required Documents and Records list.

Customize policy templates with organization-specific policies, process, and language.

Perform an ISO 27001 internal audit.

Examine each of the requirements from Annex A that you deemed applicable in your ISMS' Statement of Applicability and verify that you have each in place.

Assign in-house employees to conduct the internal audit, specifically employees who were not involved in the ISMS development and maintenance or hire an independent third party.

Share internal audit results, including nonconformities, with the ISMS team and senior management.

Address any issues your internal audit identified before proceeding with the external audit.

Verify compliance with the requirements from Annex A deemed applicable in your ISMS' Statement of Applicability.

Undergo external audit of ISMS to obtain ISO 27001 certification.

Select an independent ISO 27001 auditor.

Complete the Stage 1 Audit consisting of an extensive documentation review; obtain the auditor’s feedback regarding your readiness to move to the Stage 2 Audit.

Address any nonconformities.

Ensure that all requirements of the ISO 27001 standard are addressed.

Ensure your organization is following the processes that it has specified and documented.

Ensure your organization is upholding contractual requirements with third parties.

Address specific nonconformities identified by the ISO 27001 auditor.

Receive auditor’s formal validation following resolution of nonconformities.

Plan for subsequent ISO 27001 audits and surveillance audits.

Perform a full ISO 27001 audit once every three years

Prepare to perform surveillance audits in the second and third years of the Certification Cycle

Consider streamlining ISO 27001 certification with automation.

Explore tools for automating security and compliance

Transform manual data collection and observation processes into automated and continuous system monitoring

Identify and close any gaps in ISMS implementation in a timely manner

Learn more about achieving ISO 27001 certification with Vanta

Book an ISO 27001 demo with Vanta

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Plan strategically when scheduling and timing your audit

Sometimes, the biggest roadblock to scheduling an audit is knowing where to start. Here are a few tips for taking your first big step in the audit process.

Check into your chosen firm’s availability. Small auditing firms tend to have more limited time and need more advance notice, while larger firms have more resources and, therefore, more availability. However, larger firms can cost more to hire.

Give yourself enough time before the audit. In many cases, audits don’t just check to see if you’ve done an activity once; they look for evidence of continuous controls. Plan to collect consistent evidence over at least three months to demonstrate this.

Choose a dedicated team or team member who will be available throughout the audit. Your auditor will need a go-to person to provide all the proper information and be available for any follow-up questions. Check calendars of others stakeholders involved with the audit controls to ensure they’ll be present when you schedule your audit on-site or live sessions.

Be aware of commitments and deadlines. You will likely sign a statement of work (SOW) when you schedule an audit. Your team is responsible for meeting all the deadlines outlined in this SOW. The auditor will need the correct information from your team in a timely manner to do their job.

Pro tip: Make sure your team understands the difference between the “audit window” or “review period” and the length of the audit itself. The “audit window” is the timeframe the auditors will use to gauge if you’ve been consistent with your controls. Typically, they require three months or more. This time period is different from the 1-4 weeks that the auditor will be inside your organization, conducting the audit itself.

Prepare your team in advance

Once you’ve scheduled your audit, it’s time to work with your team and assign tasks to the appropriate owners. An audit requires participation from several teams, from engineering to IT to sales. Here are a few ways to prepare these teams for audit-related activities:

Know which framework(s) you’re working towards and communicate the requirements to your team. If you’re going to work towards multiple frameworks simultaneously, identify overlaps so you don’t duplicate work. A tool like Vanta helps break down requirements and map them to action items.

Understand which evidence each team needs to provide. Next, communicate requirements and deadlines to each department. It’s a good idea to use a central hub that can show all preparation activities and who is responsible for each one.

Inform your team why this is an important activity so they understand that the time and commitment are worthwhile for them. Connect it to outcomes and KPIs that matter to their teams whenever possible. Audits ultimately prove your company’s commitment to security and trust, and meeting a framework can be the difference between growing your business and missing out on opportunities.

Communicate to your team that the goal is progress, not perfection. If it’s your first time getting audited against a particular framework, you probably won’t get a perfect score, and that’s okay! Instead, make it your goal to set a baseline for meeting the framework, then find ways to improve your controls over time.

Pro tip: As you and your team prepare for the audit, remember to do your due diligence before the auditor even arrives. Get to know exactly how your controls align with the framework and be realistic about which shortcomings you expect the auditor will likely find. That way, you won’t be surprised by the audit’s findings.

Manage your evidence

As your team prepares for an audit, collecting evidence of your activities is just as important as completing the activities themselves. For example, you will likely need to draft formal security policies and protocols (for example, this is one of the requirements for SOC 2). But you can’t just say, “We have the required security policies.” You’ll need to provide your auditor with a hard copy of your policies. And this is just one of the many controls they will require you to prove with documentation.

Managing evidence gets complicated quickly, considering how many documents your auditor will require. So, it’s your job to make sure that evidence is organized and ready as soon as the auditor asks for it. Here are a few tips for compiling the proper evidence to be fully prepared when the auditor arrives:

Ensure your evidence shows consistency —not just point-in-time or static documentation. You should be able to prove that you’ve maintained the proper controls throughout your audit window. A tool like Vanta that supports continuous controls monitoring can help with this.

Compile and store your documentation in a way that simplifies sharing the relevant evidence with the auditor. You want to spend as little time as possible chasing down specific documents or screenshots during the audit. Getting organized beforehand means far less stress for your team when the auditor begins their assessment. Vanta can help you stay on top of your documentation by storing all documents in a centralized location and automatically updating data with real-time changes.

Get to know your evidence inside and out. You shouldn’t be surprised by anything that your auditor finds. It helps to use a governance, risk, and compliance (GRC) automation tool to parse through the documentation and summarize findings. This way, you have a consolidated view of evidence rather than a bunch of disparate documents and files that are hard to consume at once.

Be transparent and upfront with your evidence. Don’t try to shape a specific story or alter the truth by showing more or less documents to an auditor. Honesty is always the best policy in these cases, especially considering the potential consequences of lying in an audit. Altering the truth can significantly impact the integrity of your company, or even prevent you from requesting audits in the future.

Pro tip: Be transparent without embellishing the truth when the auditor arrives. Let your evidence speak for itself. You might think this goes without saying, but the temptation to overshare or embellish can get the best of anyone when the audit actually begins.

Work closely with your auditor

Many organizations enter the auditing process with concerns about their relationship with the auditor. Fortunately, in most cases, the process will be less like a test proctored by an intimidating professor and more of a back-and-forth conversation with an industry expert who knows best how to get you to your goals.

Here’s some advice for working with your auditor and making it a better experience for both of you:

Look for specialization. Find an auditor specializing in the framework(s) you’re working toward. You can start by asking for recommendations within your industry—Vanta’s network of trusted auditors is a great place to start.

Help your auditor understand your business. You will need to guide them through the ins and outs of your organization, including where your controls reside and which insights they provide to your business. They won't know where to start assessing your controls if they don’t understand your organization or GRC processes and tools.

Treat the audit like a conversation. In most cases, your auditor will be inside your organization for a few weeks to months, and during that time, it should become a back-and-forth working relationship. The auditor will likely ask you for specific evidence over time, and you will work with them directly to provide each piece of information they need, and so on.

Maintain the relationship with your auditor afterward. They can serve as a helpful resource as you build out your GRC initiatives and continuously maintain and improve compliance over time. While auditors can’t give direct advice on how to do something, most are more than willing to help wherever they can. For example, if you plan to change your tech stack, employee policies, etc., consider asking your auditor how these changes will impact future audits before committing to the change.

Pro tip: Keep in mind that it’s common practice to switch your auditor every few years to avoid bias. But once you’ve found a firm and auditor you like, you can always ask them for recommendations and referrals to find your next auditor.

Take your audit results to the next level

An audit isn’t just a one-and-done activity—it’s the beginning of a journey toward a stronger security posture over time. To get the most out of your audit findings, prepare your team to work on the following initiatives after the audit is done:

Share your new compliance status with the right audiences. Many businesses rely use a public-facing site (like Vanta Trust Center) to display their real-time GRC efforts. Your prospective customers can then use this data to expedite security questionnaires and provide proof points to key decision-makers.

Track KPIs that show your response to the gaps that your auditor finds. The specifics of these KPIs will depend on your particular business, priorities, etc. In general, they should center around risk reduction and remediation efforts. For instance, if you have any findings, opportunities for improvement (OFI), or nonconformities listed in your report, track the response to these insights over time. How are you changing processes? What new tools have you implemented?

Consider conducting a readiness assessment between formal external audits. Businesses will typically either hire a third party or pick a team member who isn’t involved in any GRC activities to perform this type of audit. The best way to incorporate readiness assessments into your processes without causing business disruption is to use continuous monitoring to get an instant snapshot of all existing controls.

Treat your audit like a jumping-off point for security initiatives. Meeting a particular framework doesn’t necessarily equate to bulletproof security. For example, a compliance framework often doesn’t account for emerging threats. Still, consistently meeting the controls listed in a framework is a great starting point for establishing a strong security culture throughout your organization.

Foster a strong security culture. As you respond to your audit findings and implement stronger GRC controls, your team members need to understand why specific controls exist and how to play a role in meeting them. Ultimately, this is all about fostering a strong security and risk management culture throughout your organization. Consider rolling out security training and tracking KPIs such as phishing drill click-through rates and training completion rates. This will help demonstrate progress for future audits as well as improving your organization’s security posture.

Anatomy of an audit report

Knowing what to expect when you finally get that audit report can help you set expectations for internal and external stakeholders ahead of time. Here’s what the typical audit report should contain:

Executive summary: A high-level recap of the report’s purpose, the standard/framework in question, etc.
Scope: An in-depth description of the scope that the audit covered. For example, was it a corporate-wide evaluation, a test on a specific application, or something else?
Testing information: A detailed list of all tests the auditor ran, such as policy reviews, artifact evaluations, and on-site observations.
Testing results: A report on the results of these tests, including any exceptions.
Management responses: The management team’s explanations as to why an exception exists and how they will respond to it in the future.
Conclusion: The auditor’s opinion on the assessment. Keep in mind that this area of the report will rank the company by maturity, not as a pass or fail.

While compliance audits can feel overwhelming because of the time and resources that they require, they offer your team the unique opportunity to start a journey toward stronger security and deeper customer trust. Plus, tasks like scheduling, managing evidence, and working with your auditor don’t have to feel so daunting if you go into your next audit with the right expectations and preparation.

Confirm which CMMC level your business needs

The first step of the CMMC program and becoming CMMC certified is confirming what CMMC level you’re on. Here are a few ways you can confirm what level your business needs.

Determine the type of data you handle. If you handle FCI, you’ll likely fall under level 1, whereas if you handle CUI, you will be under level 2 or 3. If you handle a variety of FCI and CUI information, you must be certified at the level encompassing all the information you handle.

Check your contract. If you currently have a contract, reach out to your contracting officer. They can help determine your level and the requirements to remain compliant. As you bid on future contracts, the DoD will specify the required CMMC level and assessment type for eligibility in the solicitation and resulting contract.

Perform a self-assessment. If you don’t currently have a contract, but hope to in the future, the best thing you can do is perform a self-assessment of your systems. This ensures you meet the necessary security requirements and have implemented proper controls to protect sensitive information. It will also give you an idea of what level you’re at.

Establish your FCI and CUI boundaries

Once you confirm what level of certification you need, your next step is to figure out what systems, processes, and data—referred to as assets—fall under CMMC requirements. The DoD refers to this process as establishing your boundaries for FCI and CUI.

Review boundaries and assessment scope guidelines for your CMMC level. Each level has set boundaries and assets based on the information that’s handled. Once you know your level, you can review general guidelines for assessment scope.

Identify in-scope assets. For each level, there will be set assets that are considered in scope. Depending on the certification you’re seeking, you’ll need to identify all assets that process, store, or transmit FCI or CUI data. This includes all people, technology, facilities, and external service providers. For levels 2 and 3, this also includes specialized assets, security protection assets, and contractor risk managed assets.

Document in-scope assets. Once you’ve identified all assets in scope, you’ll need to document them. Documentation includes creating an asset inventory and providing a network diagram, which will be a part of your official assessment.

Pro tip: At each level, any asset that isn’t in scope is considered out-of-scope, meaning it doesn’t need to be documented during an assessment. For more information on what assets are considered in and out of scope, the DoD has scoping guidelines for each level.

Perform a gap assessment

Once you’ve established your CUI and FCI boundaries and your organization’s current status, you’ll want to conduct a gap assessment, also known as a CMMC gap analysis, to identify areas where your organization is falling short. A good gap assessment helps reduce the stress of prepping for CMMC certification since it’ll show you any areas or processes you need to focus on to pass level assessments and get certified. To perform a gap assessment, you’ll want to:

Identify and document existing controls. Map your current security controls to the objectives outlined in the CMMC framework. This includes documenting asset treatment in a system security plan (SSP).

Identify and document controls not yet satisfied. Identify and review controls that you haven’t yet satisfied. You’ll want to pay close attention to this step as these controls need to be addressed and satisfied to pass certification during an official assessment.

Pro tip: As you complete your gap assessment, you’ll likely need to collaborate with stakeholders across the business to ensure you have up-to-date information. Improper documentation or oversight of required controls could result in your organization not meeting CMMC certification requirements.

Create and execute a plan of action and milestones

As you work through the steps of planning and preparing for CMMC certification, you’ll also need a Plan of Action and Milestones (POA&M).

Create a POA&M. A POA&M allows companies to create a roadmap for improvement with details on what to prioritize, steps for action, who’s responsible for them, resources needed, and deadlines. Any company seeking CMMC certification can complete a POA&M after their gap assessment.

Execute your POA&M. The actions and steps outlined in your POA&M should make the process easier. But, take it step by step. Attempting to remediate every action at once makes it hard to track progress. It could also result in accidentally overlooking important steps, security gaps, or unresolved issues, which can impact your official assessment.

Regularly monitor progress and gather evidence. As you begin implementing new controls, document and monitor progress. This includes validating control design and regularly reviewing your progress against milestones. You’ll also want to gather evidence surrounding them. Evidence should include steps you’ve taken to implement controls and any results from it. If controls result in new policies and procedures, document those as well.

Pro tip: Along with completing a POA&M, you should document your Supplier Performance Risk System (SPRS) score. An SPRS score ranges from -230 to +110 and helps the DoD understand how well a contractor is protecting sensitive data and government information. Determining your SPRS score can ensure you focus on the right areas when working towards CMMC certification.

Conduct assessment

If you’ve completed steps one through six, conducting the assessment should go smoothly. Ideally, you’ve addressed all security gaps and areas of improvement in your POA&M, so there shouldn’t be any surprises during the official assessment. Like most of the CMMC certification process, the type of assessment you conduct will depend on your level.

Level 1

Conduct a self-assessment against level 1 security requirements. Level 1 only requires a self-assessment.

Gather and prepare evidence. A self-assessment requires the submission of documents and evidence, such as policy and process documents, training materials, and planning documents. It also requires interviews with employees and testing to ensure processes are followed.

Ensure all level 1 security requirements are met or marked as “not applicable.” To achieve level 1, all security requirements must be met or not applicable, with results entered into the SPRS.

Level 2

Determine which assessment is required. Level 2 has two types of assessments, a self-assessment or a certification assessment. Self-assessments for level 2 are the same as level 1. For a certification assessment, a C3PAO must complete it.

Gather and prepare evidence. The documents, interviews, and testing laid out in level 1 are required for level 2 certification.

Determine if you’re eligible for a conditional or final level 2. A level 2 assessment can result in a conditional or final level 2. A conditional level 2 will require a POA&M. To achieve level 2, all security requirements must be met or not applicable.

Update your POA&M for final certification if you receive a conditional level 2. To achieve a final level 2, you must complete or close out your POA&M within 180 days.

Level 3

Achieve final level 2 certification with a C3PAO. Level 3 requires two assessments. Both must be completed to achieve level 3 certification. The first assessment is achieving final level 2 with a C3PAO.

Complete an assessment with the Defense Contract Management Agency (DCMA) DIBCAC. This assessment is based on level 3 requirements. The DCMA DIBCAC assessment can result in a conditional or final certification.

Update your POA&M for final certification if you receive a conditional level 3. To achieve final level 3, you must complete or close out your POA&M in 180 days.

Maintain certification

After putting in the work to officially become CMMC certified, you’ll need to maintain your certification. Due to the quickly evolving nature of cybersecurity, the DoD requires CMMC-certified organizations to review their controls and affirm compliance annually. Depending on your level, assessments take place annually or every three years.

Level 1

Complete a self-assessment annually. Similar to initial certification, you must complete the self-assessment and enter it into the SPRS every year.

Complete an annual affirmation. The annual affirmation verifies compliance with the 15 basic safeguarding requirements in FAR clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems.

Level 2

Complete an annual affirmation. For both self and C3PAO certifications, an annual affirmation verifying compliance with the 110 security requirements in NIST SP 800-171 Revision 2, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations needs to be completed and entered into the SPRS.

Complete a self- or C3PAO assessment every three years. Results of a self assessment must be entered into the SPRS. C3PAO results must be entered into the CMMC Enterprise Mission Assurance Support Service (eMASS).

Level 3

Complete an affirmation annually. An annual affirmation must be completed to verify compliance with the 24 identified requirements from NIST SP 800-172 and entered into the SPRS.

Complete a DIBCAC assessment every three years. Results of a DIBCAC assessment must be entered into CMMC eMASS.

How Vanta makes CMMC certification easier

While CMMC certification can feel overwhelming, having tools to help you prepare for and maintain certification is key.

‍Vanta makes it easier to meet CMMC requirements across all three levels. Through a centralized platform, Vanta can guide you through the step-by-step process of obtaining and monitoring your CMMC implementation.

Additionally, Vanta’s extended partner network offers hands-on support to ensure you can successfully implement CMMC and conduct assessments to renew contracts and win new business.

‍A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Starting your healthcare compliance program

Starting a healthcare compliance program may seem complex, particularly if you’re new to security and compliance. But with the right approach, it can become a clear and manageable process. Investing in building a strong foundation now will set your organization up for future scale and success.

Evaluate your business needs: Start by assessing your organization’s compliance drivers including the following questions:

Do you collect or process PHI? If yes, HIPAA compliance is mandatory.
Have clients or prospects ever asked you about compliance with HIPAA or other industry security standards?
Do your competitors maintain HIPAA compliance or other security standards such as SOC 2, ISO 27001, or HITRUST?

Confirm your PHI scope and data flows: Map out how PHI is collected, processed, transmitted, and stored. You’ll want to minimize PHI exposure across systems and vendors and implement the principle of least privilege and minimum necessary use, in alignment with both HIPAA and broader information security best practices to help reduce risk.

Engage legal counsel and define key roles: As noted above, HIPAA compliance is a legal obligation if your organization handles PHI in any way. You’ll want to review and define your role as a Covered Entity or Business Associate and involve legal counsel early in the process to help guide your regulatory compliance scope and strategy.

Get HIPAA-ready: To prepare for HIPAA compliance, start by implementing baseline technical and administrative safeguards, such as enabling automatic session timeouts and screen locks, encryption at rest and in transit, multi-factor authentication (MFA) enforcement, and least privilege access configurations. Next, establish policies covering various domains such as access control, incident response, breach notification, mobile device management, as well as patient privacy, rights, and related disclosures. From a third-party perspective, ensure you sign Business Associate Agreements (BAAs) with all third parties that handle PHI, and conduct vendor risk assessments to validate their HIPAA compliance posture.

Layer additional frameworks for audit assurance: To strengthen your healthcare compliance program and meet growing customer expectations, consider additional frameworks such as SOC 2 or ISO 27001/27017. These standards provide a more structured and auditable foundation for your compliance practices, and when paired with HIPAA, they enhance your security and privacy posture while also signaling to customers and prospects that you’re prepared to meet their expectations for trust.

Accelerate compliance with the right technology: Instead of relying on manual processes and spreadsheets, choose a platform that streamlines and automates your path to audit readiness—especially if you're working with a lean team. To accelerate sales conversations, build an external-facing trust center to proactively showcase your security posture and healthcare compliance to prospects. You can enhance your trust center by automating security questionnaires with AI-powered responses.

Pro tip: Vanta simplifies your healthcare compliance journey by outlining exactly what’s needed to get audit-ready. Vanta identifies gaps, shows you how to fix them, and automates the process.

Scaling your healthcare program

As your business grows, your compliance program needs to scale with it. Whether you're expanding your team, adding new systems, or selling to larger customers, complexity increases—and so does the need for a more mature and efficient approach to security and compliance. This phase is about operationalizing your program with the right frameworks, tools, and processes to stay ahead of risk while maintaining velocity.

Identify efficiency gaps: Growth introduces new challenges: more people, more tools, and more moving parts. As your business scales, your current compliance processes may not be able to keep up with the additional complexity and operational overhead. Assess your maturity needs by asking the following questions:

Is your company expanding rapidly or pursuing enterprise clients?
Are you adding more tools or systems to your environment?
Is it becoming harder to track compliance status across teams or frameworks?

If you answered yes to any of these questions, then it's time to shift from a foundational program to a scalable and more integrated model.

Mature your program with more prescriptive frameworks: While HIPAA is a necessary baseline, it’s not designed to provide the depth of guidance needed for large-scale or highly regulated operations. As expectations increase, consider layering in additional frameworks that provide further structure, auditability, and credibility.

HITRUST: Offers tiered, prescriptive certification paths (e1, i1, r2) tailored to healthcare use cases and often required by enterprise customers, such as large health providers.
NIST CSF: Helps align with cybersecurity risk management best practices, especially if you plan to work in the public sector.
NIST AI RMF or ISO 42001: If you're incorporating AI, these frameworks support responsible AI governance and risk management.

Centralize and automate compliance workflows: As complexity grows, fragmented workflows and manual tracking break down. Implementing a trust management platform can help you reduce operational overhead and improve visibility by:

Enabling cross-mapping of controls, so you only have to test once across multiple frameworks, such as between HIPAA, SOC 2, HITRUST, ISO 27001, etc.
Running automated tests to continuously monitor your controls for failure risks and streamline year-round audit readiness.
Sending alerts when gaps are identified, and providing clear remediation steps.

Strengthen vendor risk management: Your risk surface grows with every third-party vendor you add. Taking a proactive approach to vendor management not only protects your sensitive data, such as PHI, but also signals maturity to your customers and partners. This includes:

Building a centralized inventory of all vendors that handle PHI or your sensitive and critical systems.
Tracking BAAs, SOC 2 reports, and other security and privacy documentation
Automating vendor risk reviews and renewal cycles to ensure continuous oversight.

Stay ahead of emerging regulation: The healthcare regulatory environment continues to evolve, especially with the rise of AI and ongoing threats to PHI. To stay compliant over time, keep an eye on:

Updates to regulations, such as HIPAA. Examples include the upcoming Security Rule update.
New laws such as Healthcare Cybersecurity Act, which may introduce new federal expectations for providers and vendors.

Additionally, build time into your roadmap for regular gap assessments and policy reviews. Staying proactive helps you reduce risk, avoid fire drills, and respond to change with confidence.

Build trust and drive growth with Vanta

Vanta automates HIPAA, HITRUST, SOC 2, and 35+ other frameworks to help you simplify compliance, strengthen security, and boost efficiency—all in one place. Reduce manual work and monitor compliance continuously, reducing the hassle of screenshots and spreadsheets. And as your business grows, Vanta scales with you, helping you save time on evidence collection with 375+ integrations and automatic cross-mapping between frameworks.

‍Learn more about Vanta for Healthcare. ‍

‍A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Understand your risk level

The first step to becoming AI Act compliant is to understand your risk level. The AI Act specifies four categories to determine this:

Unacceptable: This class of AI is considered a clear threat to those who use it, with harmful features aimed at manipulation and exploitation. It is prohibited as a result.

High: High-risk AI poses serious safety and health risks, and potentially interferes with people’s fundamental rights. However, these cases can reach the market if they meet strict security obligations.

Limited: This category covers AI with specific transparency requirements, e.g. chatbots that must inform users that they are interacting with AI.

Minimal (no risk): This AI poses minimal or no risk to people with the majority of AI use cases across Europe falling into this category.

Understanding your risk level isn’t just about your organisation though – it’s about those you work with. You should therefore extend your AI risk categorisation to the third-party vendors you work with.

Understand the AI risk level of your third-party vendors and the AI they’re using.

Understand the AI risk level AI of your AI-driven vendors, such as LLM providers

Meet regulation requirements and establish AI risk management

The next step is to work on the AI Act regulation requirements as per your risk level to ensure you are compliant. You must ensure this covers best practices around:

User research
System architecture related to your AI system
Data collection and model training to insure integrity and quality of your AI systems are maintained
Documentation to be able to explain your AI risk management system
Feedback mechanisms

Comply with the NIST AI RMF: Regardless of your risk level, you should establish and maintain an AI risk management system–one that includes mitigation strategies. An effective method of doing this is to follow the NIST AI Risk Management Framework. As part of this, you should leverage technical measures for risk mitigation and human-performed activities such as risk management software, automation and even AI itself. But you should also establish human oversight mechanisms for risk management to ensure you are bringing human oversight and accountability.

Obtain the right technical documentation

It is important to obtain the right documentation to support compliance assessment. A good place to start is with an Information Security Management System (ISMS). This establishes a systematic approach to managing your organization’s information security, and a structured approach to integrating information security into your business processes.

Helping to manage and minimise risks to acceptable levels will increase your organization’s resiliency against evolving security threats and ensures the confidentiality, integrity, and availability of organizational and customer information. The scope of an organization’s ISMS can be as small or as large as is necessary. The ISO 27001 standard defines which documents must exist at a minimum.

Plan your ISMS: Put a team and a roadmap together to implement ISMS policies and controls, and continuously assess risk.

Meet the ISO 27001 standard: ISO 27001 is a go-to standard that aligns with global and EU-specific data protection regulations like the GDPR. You can find our ISO 27001 Compliance Checklist here.

To become AI Act compliant, you should establish an Artificial Intelligence Management System (AIMS). ISO 42001 is a great place to start as it is the international standard for establishing, implementing and maintaining an effective AIMS:

Plan your AIMS: Assign a project leader and put a team and roadmap together to implement your AIMS. Our ISO 42001 checklist is a great place to kick this off in the right way.

Earn ISO 42001 certification: ISO 42001 certification demonstrates to customers, partners and regulators that you’re using AI responsibly, ethically and transparently.

To truly demonstrate trust, companies should go beyond the standard. For fintechs, and other financial institutions, this might look like compliance with the Digital Operational Resilience Act (DORA) framework.

Comply with the DORA framework: Not strictly part of the AI Act, the DORA is a relatively new EU framework for ensuring enhanced cybersecurity and operational resilience of financial entities operating in the Union.

Pro tip: You can find out more about DORA and how Vanta can help fintechs scale trust in our free guide–Fortifying Fintech: Security must-haves for Europe’s trailblazers.

Establish data governance

Data governance is essential to maintaining trust and companies must ensure the confidentiality, availability and integrity of the information they handle.

The data used by AI is not just about quality, however–it is about the transparency surrounding how you use it. More and more organisations are training AI models on a mix of customer and synthetic data. What’s more, without a formal data processing agreement (DPA) that prohibits vendors from using customer data to train their AI models, companies risk threats coming from third-parties too.

Ensure you have a formal DPA with your third-party vendors.

Ensure the quality of your data for training, validation, and testing of AI systems.

Ensure your data is accurate, representative and complete.

Ensure customers are given an opt-out option for training AI with their customer data.

Build with trust and transparency

In the AI era, trust and transparency are essential. Customers must have easy access to appropriate information about your company and products, e.g. characteristics, capabilities, limitations, potential risks.

This can be an all-consuming process for security teams, which is why we launched Trust Center – a hassle-free way for companies to demonstrate trust in real-time. Because earning security credentials is only half of the job–to demonstrate trust, you have to communicate them too.

Set up a process to collect evidence to demonstrate compliance: Demonstrating compliance can come with a lot of chaos. But Vanta can help you to automatically gather the evidence you need – taking the strain off your security team.

Communicate security credentials: Use Vanta’s Trust Center to communicate your security credentials to customers, demonstrate trust and turn good security into good business.

Embrace continuous compliance

Forward-thinking organisations won’t stop at the AI Act. They’ll go beyond point-in-time checks towards a holistic and continuous approach to monitoring. This is the practice of ensuring that you’re properly meeting compliance standards you’ve committed to on an ongoing basis – not just at the time of an audit. This approach is integral to establishing appropriate levels of cybersecurity, accuracy and robustness.

Embrace continuous compliance: The path to continuously monitoring your systems looks like checking for compliance gaps on a daily basis – and relying on automation to cut the amount of manual work this involves.

Continuous compliance will ensure you are in a good position to monitor for updates from the European Commission and that you remain agile to the broader risk landscape. But it will also bring reputational benefits and a welcome boost to your bottom line.

Streamline your EU AI Act compliance with Vanta

Vanta is the fastest way to become AI Act compliant, strengthen your cybersecurity posture, and build trust. Vanta’s trust management platform provides organisations with the capabilities and guidance required to efficiently and effectively achieve AI Act compliance. It provides a centralised view of your compliance and security posture by continuously monitoring the critical tools and services your business runs on. Get in touch with our team today.

Pre-work for your Cyber Essentials certification

Evaluate your need for Cyber Essentials. You can assess whether you need a Cyber Essentials certification based on the following criteria:

Do you collect or process sensitive or personal data from UK residents?

Have you ever been asked about Cyber Essentials by clients or prospects?

Do your competitors have Cyber Essentials certification?

Are you working with companies that provide public services in the UK?

Choose the right Cyber Essentials certification. Although both versions of the Cyber Essentials frameworks have the same requirements, Cyber Essentials Plus involves a third-party audit and technical testing. As a result, Cyber Essentials Plus provides an extra layer of security validation beyond the self-assessment in the standard Cyber Essentials certification.

Do you need Cyber Essentials or Cyber Essentials Plus?

Here are some helpful considerations for deciding whether to pursue the Cyber Essentials certification or Cyber Essentials Plus:

Determine your budget. Cyber Essentials Plus is more expensive than Cyber Essentials because of the external audit and higher security assurance. Pricing for Cyber Essentials ranges from £320 to £600 (plus VAT). Cyber Essentials Plus does not have a fixed pricing structure, but estimates start at £1,499 (plus VAT) and increase based on your organisation’s size and complexity. Learn more about Cyber Essentials costs.

Assess your time and team resources. Cyber Essentials Plus requires more time and bandwidth and takes longer to complete, especially for smaller companies (or security teams) with limited internal resources.

Understand your stakeholders’ concerns. The Cyber Essentials Plus third-party audit requirement enables you to demonstrate your commitment to enterprise-wide data security and assure stakeholders who may have security concerns.

Define customer requirements. Cyber Essentials Plus is required to win UK government contracts. It may also be required to conduct business with certain companies in the UK, such as those looking to prevent potential supply chain-related cyber threats from impacting their operations.

Evaluate your infrastructure size and complexity. Larger, more complex entities whose interconnected assets and operations are at high risk of being disrupted by cyber threats may benefit from Cyber Essentials Plus. Its rigour ensures reliable safeguards protect this infrastructure.

Estimate the volume and sensitivity of stored data. Companies that handle vast amounts of sensitive data (such as PHI in healthcare) may gain higher assurance with Cyber Essentials Plus.

Prepare for your Cyber Essentials certification

First, identify your Cyber Essentials requirements.

Obtaining a Cyber Essentials certification requires you to implement controls across five categories:

Firewalls: All firewalls deployed to system boundaries, endpoints, servers, cloud services, and other critical infrastructure entry points should have the correct security configurations, access controls, and security rules.

Secure configurations: All configurations applied to endpoints and networked services should reduce exploitable vulnerabilities while enabling the completion of business-critical services.

User access controls: Access to all user accounts should require authorisation, and only the people who need access to specific endpoints, services, or applications to complete business tasks should have access. Consider using time-bound or just-in-time access and implementing the principle of least privilege (PoLP) to tighten user access controls.

Malware protection: Administrators should establish the appropriate security mechanisms to prevent malware intrusion via known and unknown sources. They should also educate employees and third parties on the risks of malware and ransomware and how to avoid social engineering scams.

Security updates: All devices and software at risk for security flaws should be updated regularly to ensure their configurations are secure and in alignment with recommended industry/manufacturer security standards.

Gap analysis and remediation

Conduct a gap analysis. Evaluate IT infrastructure for gaps in the above control categories.

Document gaps and develop a remediation plan. Documenting the gaps identified and proposing actionable steps to rectify them is critical.

Address gaps that could lead to security vulnerabilities. Following a gap analysis, you may need to remediate sources of exploitable vulnerabilities.

Examples of remediation steps include:

Changing default administrative passwords into stronger, unique ones

Deactivating unnecessary user accounts that are not currently in use

Scheduling automatic system and network security updates

Implementing multi-factor authentication for all user accounts

Installing anti-malware software on all devices

Test all applicable controls. It’s critical to monitor devices and networks to verify the effectiveness of implemented controls in preparation for assessment. Test your controls and make sure they are functioning properly.

Document findings from system monitoring. It’s also helpful to record all the information from monitoring in an organised, shareable report format to keep track of it. Doing so manually is a challenge for any organisation, which is where automation solutions, like Vanta, help reduce these burdens and enable organisations to scale their security monitoring capabilities as they grow.

Complete the self-assessment (for Cyber Essentials)

After you’ve identified the Cyber Essentials requirements that apply to your organisation and remediated any security gaps, the next step towards becoming Cyber Essentials certified is to complete the self-assessment, which is required even when you’re aiming for the Cyber Essentials Plus certification. Here are the steps our team of compliance experts recommend taking:

Prepare for the Cyber Essentials self-assessment. Train all parties involved in the certification process so they are on the same page regarding Cyber Essentials documentation. Building and maintaining a security awareness culture is crucial for your organisation to fully comply with Cyber Essential security guidelines during its day-to-day operations beyond preparing for the Cyber Essentials self-assessment (or audit, if you choose to pursue Cyber Essentials Plus).

Conduct the self-assessment questionnaire. (SAQ). When ready, you can complete an online SAQ and have a senior team member validate it to get the Cyber Essentials certificate. It’s essential to be accurate and truthful when answering questions to ensure alignment with the necessary standards for obtaining the certificate.

Use online readiness tools to prepare for the test. Tools like the IASME Cyber Essentials Readiness Tool provide free questions to help you assess the posture of your company’s controls and their impact on your business operations. These questions are designed to inform you about your current readiness so you can develop a tailored action plan for the Cyber Essentials audit.

Decide whether you need the Cyber Essentials Plus audit. You can choose to obtain the Cyber Essentials Plus certification immediately after the Cyber Essentials self-assessment or in the following months. While you must complete just the self-assessment to obtain the Cyber Essentials certification, you’ll also need to complete and pass an external audit to receive the Cyber Essentials Plus certification.

Complete the external audit for Cyber Essentials Plus

Prepare for the Cyber Essentials Plus audit. If you want to obtain a Cyber Essentials Plus certification, you should ensure your SAQ was certified within three months of applying for the Cyber Essentials Plus.

Identify an independent assessor: Work with a highly-trained assessor to verify that all currently implemented controls align with the Cyber Essentials Plus requirements.

Review audit findings and implement remedial actions (if any): Address any gaps identified during the independent assessment within a set period.

Obtain Cyber Essentials Plus certification: A successful Cyber Essentials Plus certification provides a certificate valid for 12 months following the assessment pass date. Then, you can become designated as a CE-certified company, opening new business opportunities in the private sector or with the UK government.

Maintain ongoing Cyber Essentials or Cyber Essentials Plus certification

Monitor your IT infrastructure regularly. Organisations need continuous internal assessments to verify adherence to the Cyber Essentials security guidelines. As systems and networks age, they are exposed to more vulnerabilities. So, you need to review your existing security configurations and ensure they still match the rigorous standards of the Cyber Essentials or Cyber Essentials Plus program.

Renew your Cyber Essentials certification.The Cyber Essentials and Cyber Essentials Plus certifications expire after 12 months and must be renewed yearly. Renewing these certifications helps you maintain your designation as a Cyber Essentials-certified company and provides assurance to current and future stakeholders.

Implement zero-trust principles. As the cyber risk environment becomes more complex, consider implementing zero trust across systems and networks to keep your data safe. New technologies are constantly emerging, meaning cybercriminals are also looking for the easiest gaps to exploit to access sensitive data for malicious gain.

Streamline Cyber Essentials certification with Vanta

A strong security posture will enable organisations to build customer trust and expand business to or within the UK. However, it’s cumbersome to manually keep track of all the processes necessary to obtain Cyber Essentials or Cyber Essentials Plus certification.

Fortunately, Vanta automates up to 70% of the UK Cyber Essentials process (including evidence collection), dramatically simplifying the compliance process. This enables teams to focus on strengthening their security programs without redundancy.

Plus, with Vanta, you don’t need to duplicate your compliance efforts across multiple frameworks. UK Cyber Essentials has significant overlap with frameworks like ISO 27001. If you’re already compliant with ISO 27001, you don’t need to reinvent the wheel; Vanta automatically cross-references other frameworks and surfaces any overlapping controls that you already have in place.

Vanta’s trust management expertise can help startups and early-stage companies in the UK build and optimise their security programs to obtain the Cyber Essentials certification. Thousands of global customers rely on Vanta’s real-time, transparent trust management platform to demonstrate their focus on security and privacy to stakeholders.

Learn more about how Vanta automates Cyber Essentials compliance.

Pre-work for your HITRUST certification

Align your goals: Ensure that pursuing a HITRUST certification aligns with your business goals and programs

Find internal stakeholders: Identify key stakeholders within your organization, such as champions who can drive internal buy-in, and a project owner to drive the certification process

Educate leadership: Educate your team, executives, and the board on the HITRUST process, implied changes, and the added value to your organization of attaining certification

Work for your HITRUST certification

Understand the HITRUST CSF: Familiarize yourself with the control requirements of the HITRUST CSF

Identify compliance needs: Determine your organization's specific compliance requirements

Select appropriate HITRUST assessment type: Choose between e1, i1, or r2 assessment, according to needs of your business and your risk profile

Use Vanta to streamline the assessment: Use Vanta to identify and remediate gaps in your compliance program

Find an external assessor: Work with Vanta to select a HITRUST Validated Assessor—A-LIGN, Prescient Assurance, or Insight Assurance—to guide you through and to conduct your Readiness assessment

Purchase MyCSF subscription: Work with Vanta to initiate the procurement process for your Validated Assessor, MyCSF subscription, and report credit (if required)

Attend the HITRUST course: Gain insights and guidance through HITRUST’s New Customer Orientation

Readiness assessment

Define assessment scope: Identify the areas and systems to be included in the assessment and communicate the intended timeline of certification to your chosen Validated Assessor

Perform initial assessment: Work with your external assessor to identify gaps using Vanta

Initiate inheritance plans: Create plans for internal or external inheritance of controls

Make inheritance requests: Submit inheritance requests via the MyCSF platform

Secure QA date: Schedule a date for post-submission HITRUST QA review

Remediation

Resolve gaps: Use Vanta to identify and remediate any evidence gaps identified during the readiness assessment

The Validated Assessment

Validated assessment

Provide evidence: Collect and submit necessary evidence to your external assessor

Finalize inheritance: Confirm all inheritance plans

Support External Assessor: Be available for any additional validation requests

Address issues: Resolve any issues noted during the pre-submission QA

Submission and Review

Submit assessment: Submit the relevant evidence to your chosen Validated Assessor to input into MyCSF for HITRUST to review

Support QA process: Be available to assist your external assessor with any QA queries

Certification

Review certification report: Check and approve the draft certification report

Ensuring compliance over time and beyond

Ongoing Monitoring

Remediate gaps: Use Vanta to continue to monitor your state of compliance and continue to close gaps

Plan for the next assessment

Future planning: Prepare for your next HITRUST assessment to maintain compliance, manage risks, and enhance security —
leveraging inheritance where appropriate

Advancing your assessment: Consider expanding your security posture by exploring the different levels within the HITRUSTecosystem — from e1 to i1 and i1 to r2

Leverage the business benefits of HITRUST certification, including

Commercial compliance: Satisfy customer, contractual requirements or preferences for HITRUST certification

Market access: Gain access to new or additional markets that require or prefer HITRUST certification

Market differentiator: Demonstrate the highest level of security posture as a vendor or partner

Risk mitigation: Adopt proven, repeatable, and measurable methods ensure significant risk reduction in certified environments
(only 0.64% of experienced breaches over two years)

Value creation: Improve potential valuation with investors and shareholders

Liability reduction: Protect yourself and your organization by using a prescriptive, complete, and proven framework to plan,  
build, execute, and validate your cybersecurity program instead of building your own

Regulatory compliance: Reuse and restate HITRUST validated controls using HIPAA, SOC 2, ISO 27001, GDRP, and others to  reduce compliance efforts

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Determine which annual audits and assessments are required for your company

Perform a readiness assessment and evaluate your security against HIPAA requirements

Review the U.S. Dept of Health and Human Services Office for Civil Rights Audit Protocol

Conduct required HIPAA compliance audits and assessments

Perform and document ongoing technical and non-technical evaluations, internally or in partnership with a third-party security and compliance team like Vanta

Document your plans and put them into action

Document every step of building, implementing, and assessing your compliance program

Vanta’s automated compliance reporting can streamline planning and documentation

Appoint a security and compliance point person in your company

Designate an employee as your HIPAA Compliance Officer

Schedule annual HIPAA training for all employees

Distribute HIPAA policies and procedures and ensure staff read and attest to their review

Document employee trainings and other compliance activities

Thoroughly document employee training processes, activities, and attestations

Establish and communicate clear breach report processes
to all employees

Ensure that staff understand what constitutes a HIPAA breach, and how to report a breach

Implement systems to track security incidents, and to document and report all breaches

Institute an annual review process

Annually assess compliance activities against theHIPAA Rules and updates to HIPAA

Continuously assess and manage risk

Build a year-round risk management program and integrate continuous monitoring

Understand the ins and outs of HIPAA compliance— and the costs of noncompliance

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Access Review Stage	Content / Functionality
Across all stages	Easily create and save a new access review at a point in time View detailed audit evidence of historical access reviews
Setup access review procedures	Define a global access review procedure that stakeholders can follow, ensuring consistency and mitigation of human error in reviews Set your access review frequency (monthly, quarterly, etc.) and working period/deadlines
Consolidate account access data from systems	Integrate systems using dozens of pre-built integrations, or “connectors”. System account and HRIS data is pulled into Vanta. Upcoming integrations include Zoom and Intercom (account access), and Personio (HRIS) Upload access files from non-integrated systems View and select systems in-scope for the review
Review, approve, and deny user access	Select the appropriate systems reviewer and due date Get automatic notifications and reminders to systems reviewer of deadlines Automatic flagging of “risky” employee accounts that have been terminated or switched departments Intuitive interface to see all accounts with access, account accept/deny buttons, and notes section Track progress of individual systems access reviews and see accounts that need to be removed or have access modified Bulk sort, filter, and alter accounts based on account roles and employee title
Assign remediation tasks to system owners	Built-in remediation workflow for reviewers to request access changes and for admin to view and manage requests Optional task tracker integration to create tickets for any access changes and provide visibility to the status of tickets and remediation
Verify changes to access	Focused view of accounts flagged for access changes for easy tracking and management Automated evidence of remediation completion displayed for integrated systems Manual evidence of remediation can be uploaded for non-integrated systems
Report and re-evaluate results	Auditor can log into Vanta to see history of all completed access reviews Internals can see status of reviews in progress and also historical review detail