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What is HIPAA compliance?
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If you’ve interacted with any health-related service in the last 20-plus years, you’ve heard of HIPAA and the need to be HIPAA compliant. For companies working in or with the healthcare industry, HIPAA compliance is the cornerstone of a strong security posture.
Are you in tune with what it takes to gain and maintain HIPAA compliance? Why is HIPAA compliance so important, and who needs to be HIPAA compliant? And what happens if an organization isn’t HIPAA compliant? Read on for answers to all these questions about HIPAA compliance and becoming compliant.
Let’s start from the top: When did HIPAA compliance start?
HIPAA stands for the Healthcare Insurance Portability and Accountability Act, which was signed into law on August 21, 1996. HIPAA’s high-level goal is to keep patients’ protected health information (PHI) — any individually identifiable health information — safe and secure, whether it exists in a physical or electronic form.
HIPAA was passed to improve the portability and accountability of health insurance coverage for employees moving between jobs. An additional goal of HIPAA include providing coverage for employees with pre-existing medical conditions and simplifying the administration of health insurance.
If your company works in the healthcare industry or is considering working with healthcare clients, it is important to have an understanding of HIPAA. It's also crucial you understand how to become HIPAA compliant and how to stay up to date on compliance.
HIPAA applies to organizations known as covered entities and business associates. Covered entities HIPAA applies to include health care providers like:
- Doctors
- Clinics
- Psychologists
- Health plans
- Health insurance companies
- Government healthcare programs
- Health care clearinghouses
Business associates are people or entities performing activities that involve the use or disclosure of protected health information on behalf of or in service to a covered entity. Business associates could include third party administrators assisting a health plan with claims processing, SaaS healthcare solutions such as telemedicine technologies and mobile health apps, and more.
Why is HIPAA compliance so important?
Before HIPAA was instituted, there was not a common set of accepted security standards or requirements for the protection of health information in the healthcare industry. HIPAA put in place requirements to ensure that healthcare organizations are actively safeguarding patient data — and also instituted repercussions for those organizations that fail to be HIPAA compliant.
Technologies have evolved — and continue to evolve — in the years since HIPAA took effect and HIPAA compliance was put in place. Over time, the healthcare industry as a whole has been moving away from keeping and collecting data and information on paper, moving instead toward using electronic information systems to conduct a wide range of industry functions. These functions include both in the clinical delivery of care and in its administration.
With more and more protected health information flowing through the many computerized systems and processes of covered entities and their business associates — from electronic health records and pharmacy and laboratory information, to computerized physician order entry (CPOE), by which healthcare providers use computers to directly enter medical orders — HIPAA compliance and the diligent protection of patient PHI only continues to increase in importance. New technology is always coming into play to manage and secure data in the healthcare industry; companies must be able to integrate and work with new technologies while maintaining the safety and security of patient PHI.
In order to ensure that your company is in compliance with HIPAA, your organization should build and implement a holistic data protection strategy that encompasses all areas of HIPAA compliance while ensuring the security and availability of PHI, and maintaining the trust of patients and those people and organizations with whom you do business.
So, What is HIPAA compliance?
There are a number of HIPAA rules that must be adhered to in order to ensure HIPAA compliance. The HIPAA Security Rule, instituted in 2005, is key among these rules. HIPAA Security Rules specify safeguards to protect the confidentiality, integrity, and availability of electronic protected health information (ePHI).
The Security Rule articulates three types of security safeguards:
- Administrative
- Physical
- Technical
Security safeguards are required for a company to be in HIPAA compliance.
- Administrative safeguards include a company’s performance of risk analysis as a part of their security management processes.
Examples include:
- Evaluating the likelihood and impact of potential risks to ePHI
- Implementing security measures to address identified risks
- Documenting security measures to be taken
- Maintaining continuous and appropriate security protections
Administrative safeguards also include:
- Designation of an official representative or team responsible for HIPAA security policies and procedures
- Implementing role-based access to ePHI
- Providing employee training
- Regularly evaluating how a company’s policies and procedures are meeting the Security Rule
- Physical safeguards include limiting and managing physical access to facilities while enabling authorized access, and implementing policies and procedures for access to and use of workstations and electronic media. Physical safeguards to become HIPAA compliant also include regarding transfer, removal, disposal, and reuse of electronic media, in order to protect ePHI.
- Technical safeguards include the implementation of ePHI access control policies, audit control mechanisms for the recording and examination of access and activity in systems interacting with ePHI.
To be HIPPA compliant, you'll also need integrity controls to ensure and confirm that ePHI is not improperly altered or destroyed, and transmission security measures protecting against unauthorized ePHI access while ePHI is in transmission over a network.
In addition to implementing these safeguards for the protection of sensitive patient information, organizations working or interacting with patient PHI must now complete annual self-audits assessing their privacy and security practices to ensure that they are in line with current HIPAA standards, and should vet the vendors with whom they work.
Who needs to maintain compliance with HIPAA? And what happens if an organization is not in compliance with HIPAA?
The U.S. government passed the HITECH (Health Information Technology for Economic and Clinical Health) Act in 2009 to further encourage use of electronic health records. The HITECH Act also increased penalties for organizations in violation of HIPAA, and introduced the Breach Notification Rule.
The Breach Notification Rule requires that breaches of unsecured protected health information must be communicated to affected individuals, the U.S. Department of Health and Human Services (HHS). In some cases breaches may even need to be reported to the media.
As of 2020, HIPAA requires that breaches affecting fewer than 500 people, known as Minor Breaches, must be reported by the end of the calendar year to HHS and the affected individuals. Breaches affecting more than 500 people, known as Meaningful Breaches, must be reported within 60 days to HHS, the affected individuals, and the media. Meaningful Breaches reported to HHS are added to its Breach Notification Portal, a permanent archive and searchable database of HIPAA violations going back to 2009.
A data breach is not automatically a HIPAA violation HIPAA violation is defined as a failure to comply with HIPAA standards and provisions. If an organization’s compliance program compromises the security and integrity of PHI or ePHI, then the organization is in violation of HIPAA.
Thus a data breach resulting from an incomplete or ineffective HIPAA compliance program becomes a HIPAA violation. Organizations in violation of HIPAA risk compromising sensitive patient information — and facing financial and other penalties as a result.
Violations and data breaches can be extremely costly, from steep monetary fines to the costs of communicating breach notifications and mitigating subsequent damages, to the possibility of criminal prosecution.
How can my organization sustain our HIPAA compliance?
One of the top challenges in HIPAA compliance is finding a way to continuously stay compliant despite changes to your systems and staff. To prevent costly compliance gaps, follow these top tips.
- Maintain Thorough Activity Logs - Have protocols and processes in place to make sure your IT staff has a detailed log of anything pertaining to PHI and where it goes. Along with this, find a way to monitor those logs and keep an eye out for security risks among this activity.
- Lock Down Log-Ins - Maintain strict rules and requirements for passwords organization-wide and enforce these policies for every employee or contractor.
- Layer Your Security - The best security takes a multi-layered approach to keep breaches at bay and make it easier to detect threats before they become problems. Layer security strategies like log-ins, multi-factor authentication, encryption, and more.
Other recent HIPAA compliance updates to be aware of:
New laws and amendments to laws can happen at any time and it’s up to your organization to keep track and make sure you’re following the current HIPAA and privacy laws. Just in the past few years, there have been multiple changes and new laws, such as:
- 2020 CARES Act
- 2021 HIPAA Safe Harbor Law
- 21st Century Cures Act
- HIPAA Civil Monetary Penalty Overturned
Recent HIPAA updates under consideration have included potential changes to HIPAA compliance and related regulations with the goal of protecting the privacy of patients seeking treatment for substance abuse disorders. In the context of the opioid epidemic, there have been calls to make changes that would enable clinicians to view full medical records, including records related to substance abuse disorders.
Access to these medical records would allow for treatment decisions to be informed by a patient’s full health history. With the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act in 2020, healthcare providers’ ability to share records of individuals with substance abuse disorders has been expanded. At the same time, the CARES Act has tightened requirements around confidentiality breaches.
Vanta is here to help your company build a holistic security compliance program that will support your ongoing HIPAA compliance. Vanta provides a set of security and compliance tools that scan, verify, and secure a company’s IT systems and processes.
Vanta also offers a suite of tools streamlining the non-technical components of security tracking and audit preparation, so that gathering, maintaining, and consolidating audit evidence is easier for both your company and your auditor. Vanta is “security in a box” for technology companies, trusted by hundreds for automated security and compliance.
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Determine if you need to comply with GDPR
Not all organizations are legally required to comply with the GDPR, so it’s important to know how this law applies to your organization. Consider the following:
Do you sell goods or services in the EU or UK?
Do you sell goods or services to EU businesses, consumers, or both?
Do you have employees in the EU or UK?
Do persons from the EU or UK visit your website?
Do you monitor the behavior of persons within the EU?
If any of the above statements apply to your business, you’ll need to be GDPR compliant.
Document the personal data you process
Because GDPR hinges on the data you collect from consumers and what your business does with that data, you’ll need to get a complete picture of the personal data you’re collecting, processing, or otherwise interacting with. Follow these items to scope out your data practices:
Identify and document every system (i.e. database, application, or vendor) that stores or processes EU- or UK-based personally identifiable information (PII).
Document the retention periods for PII in each system.
Determine whether you collect, store, or process “special categories” of data, including:
Racial or ethnic origins
Religious or philosophical beliefs
Genetic data
Health, sex life, or sexual orientation data
Political opinions
Trade union membership
Biometric data that could uniquely identify someone
Determine whether your documentation meets the GDPR requirements for Records of Processing Activities, that include information on:
The name and contact details of the controller
The purpose behind the processing of data
A description of the categories of data that will be processed
Who will receive the data
Documentation of suitable safeguards for data transfers to a third country or an international organization
The retention period of the different categories of data
A general description of the technical and organizational security measures
Determine whether your documentation includes the following information about processing activities carried out by vendors on your behalf:
The name and contact details of the processor(s) and of each controller on behalf of which the processor is acting, and, where applicable, of the controller’s or the processor’s representative, and the data protection officer
The categories of processing carried out on behalf of each controller
Documentation of suitable safeguards for data transfers to a third country or an international organization
A general description of the technical and organizational security measures
Determine your legal grounds for processing data
GDPR establishes conditions that must be met before you can legally collect or process personal data. Make sure your organization is meeting the conditions listed below:
For each category of data and system/application, determine the lawful basis for processing based on one of the following conditions:
Consent of the data subject
Contract with the data subject
Necessary for compliance with a legal obligation
Necessary in order to protect the vital interests of the data subject or a third party
Necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller
Necessary for the purposes of the legitimate interests pursued by the controller or by a third party, except where such interests are overridden by the rights of the data subject
Review and update current customer and vendor contracts
For your organization to be fully GDPR compliant, the vendors you use must also maintain the privacy rights of your users’ and those rights should be reflected in your contracts with customers:
Review all customer and in-scope vendor contracts to determine that they have appropriate contract language (i.e. Data Protection Addendums with Standard Contractual Clauses).
Determine if you need a Data Protection Impact Assessment
A Data Protection Impact Assessment (DPIA) is an assessment to determine what risks may arise from your data processing and steps to take to minimize them. Not all organizations need a DPIA, the following items will help you determine if you do:
Identify if your data processing is likely to create high risk to the rights and freedoms of natural persons. Considering if your processing involves any of the following:
Automated processing, including profiling, and on which decisions are based that produce legal effects
Special categories of data or data related to criminal convictions and offenses
Monitor any publicly accessible area on a large scale
If any of the above are true, you may need to conduct a data protection impact assessment for existing and new data projects.
Clearly communicate privacy and marketing consent practices
A fundamental element of GDPR compliance is informing consumers of their data privacy rights and requesting consent to collect or process their data. Ensure your website features the following:
A public-facing privacy policy which covers the use of all your products, services, and websites.
Notice to the data subject that include the essential details listed in GDPR Article 13.
Have a clear process for persons to change or withdraw consent.
Update internal privacy policies
Ensure that you have privacy policies that are up to the standards of GDPR:
Update internal privacy notices for EU employees.
Have an employee privacy policy that governs the collection and use of EU and UK employee data.
Determine if you need a data protection officer (DPO) based on one of the following conditions:
The data processing is carried out by a public authority
The core activities of the controller or processor require regular and systematic monitoring of data subjects on a large scale
Review compliance measures for external data transfers
Under GDPR, you’re responsible for protecting the data that you collect and if that data is transferred. Make your transfer process compliant by following these steps:
If you transfer, store, or process data outside the EU or UK, identify your legal basis for the data transfer. This is most likely covered by the standard contractual clauses.
Perform and document a transfer impact assessment (TIA).
Confirm you comply with additional data subject rights
Ensure you’re complying with the following data subject rights by considering the following questions:
Do you have a process for timely responding to requests for information, modifications, or deletion of PII?
Can you provide the subject information in a concise, transparent, intelligible, and easily accessible form, using clear and plain language?
Do you have a process for correcting or deleting data when requested?
Do you have an internal policy regarding a Compelled Disclosure from Law Enforcement?
Determine if you need an EU-based representative
Depending on how and where your organization is based, you may need a representative for your organization within the European Union. Take these steps to determine if this is necessary:
Determine whether an EU representative is needed. You may not need an EU-rep if the following conditions apply to your organization:
Data processing is occasional
Data processing is not done on a large scale
Data processing doesn’t include special categories or data related to criminal convictions and offenses
Doesn’t risk to the rights and freedoms of data subjects
A public authority or body
If the above conditions do not apply to you, appoint an EU-based representative.
Identify a lead data protection authority (DPA) if needed
GDPR compliance is supervised by the government of whatever EU member-state you’re operating in. If you’re operating in multiple member-states, you may need to determine who your lead data protection authority is:
Determine if you operate in more than one EU state.
If so, designate the supervisory authority of the main establishment to act as your DPA.
Implement employee training
Every employee in your organization provides a window for hackers to gain access to your systems and data. This is why it's important to train your employees on how to prevent security breaches and maintain data privacy:
Provide appropriate security awareness and privacy training to your staff.
Integrate data breach response requirements
GDPR requires you to create a plan for notifying users and minimizing the impact of a data breach. Examine your data breach response plan, by doing the following:
Create and implement an incident response plan which includes procedures for reporting a breach to EU and UK data subjects as well as appropriate data authorities.
Establish breach reporting policies that comply with all prescribed timelines and include all recipients (i.e. authorities, controllers, and data subjects).
Implement appropriate security measures
GDPR requires you to take measures to minimize the risk of a data breach. This includes security practices such as pseudonymization/encryption, maintaining confidentiality, restoration of access following physical/technical incidents, and regular testing of measures. Consider the following:
Have you implemented encryption of PII at rest and in transit?
Have you implemented pseudonymization?
Have you implemented appropriate physical security controls?
Have you implemented information security policies and procedures?
Can you access EU or UK PII data in the clear?
Do your technical and organizational measures ensure that, by default, only personal data that are necessary for each specific purpose of the processing are processed?
Streamline GDPR compliance with automation
GDPR compliance is an ongoing project that requires consistent upkeep with your system, vendors, and other factors that could break your compliance. Automation can help you stay on top of your ongoing GDPR compliance. The following items can help you streamline and organize your continuous compliance:
Explore tools for automating security and compliance.
Transform manual data collection and observation processes via continuous monitoring.
Download this checklist for easy reference
GDPR compliance FAQs
In this section, we’ve answered some of the most common questions about GDPR compliance:
What are the seven GDPR requirements?
The requirements for GDPR compliance are based on a set of seven key principles:
- Lawfulness, fairness, and transparency
- Purpose limitation
- Data minimization
- Accuracy
- Storage limitations
- Integrity and confidentiality
- Accountability
These are the seven requirements you must uphold to be GDPR compliant.
Is GDPR compliance required in the US?
GDPR compliance is mandatory for some US companies. GDPR compliance is not based on where your organization is located but whose data you collect, store, or process. Regardless of where your organization is based, you must comply with GDPR if you are collecting or processing data from EU residents.
What are the four key components of GDPR?
The four components of GDPR include:
- Data protection principles
- Rights of data subjects
- Legal bases for data processing
- Responsibilities and obligations of data controllers and processors
Safeguard your business with GDPR compliance
If your organization collects data from EU residents, GDPR compliance is mandatory for you. It’s important to follow the steps listed above to protect your business from heavy fines and to respect the data privacy rights of consumers.
Vanta provides compliance automation tools and continuous monitoring capabilities that can help you get and stay GDPR compliant. Learn more about getting GDPR compliance with Vanta.
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
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.
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
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.
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.
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.
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
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.
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.
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.
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 NowDetermine 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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Choosing the right HITRUST certification level and streamlining implementation
As an authorized reseller, Vanta’s pre-built HITRUST solution natively includes the necessary controls, documents, and policies - eliminating the manual “do-it-yourself” approach that other platforms require. Curious to see this in action? Join Vanta and HITRUST for a live session!
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