The ultimate HIPAA compliance guide and checklist

Organizations working in and with the healthcare industry must confront a certain amount of complexity to stay on top of the technology and practices necessary to achieve HIPAA compliance. Vanta helps you establish policies, procedures, and ongoing practices that will position you for a successful HIPAA compliance review and audit — and to showcase your comprehensive commitment to healthcare data security.

Our guide will walk you through the key points of HIPAA and critical additions since its introduction, discuss what it means to comply with HIPAA (and outline the risks of non-compliance), and help you take important next steps on your HIPAA compliance journey.


HIPAA basics and terminology you need to know

Let’s start with a HIPAA overview. What is HIPAA and what is its purpose? HIPAA, the Healthcare Insurance Portability and Accountability Act, was signed into law on August 21, 1996. HIPAA’s overarching goal is to keep patients’ protected health information (PHI) safe and secure, whether it exists in a physical or electronic form. HIPAA was created to improve the portability and accountability of health insurance coverage for employees moving between jobs. HIPAA was also created to deal with waste, fraud, and abuse in health insurance and delivery of healthcare, as well as to promote the use of medical savings accounts, provide coverage for employees with pre-existing medical conditions, and simplify the administration of health insurance.

To achieve this administrative simplification in particular, the healthcare industry was encouraged to computerize patients’ medical records — an effort that has both improved patient healthcare and communication, and introduced increased risk to patient data privacy through the possibility of identity theft and patient privacy violations.


HIPAA compliance checklist

Attaining HIPAA compliance can be a complex and time-consuming process, and the work to maintain your compliance never ends. However, a clear to-do list will help you simplify this and plan the project accordingly. Download our HIPAA compliance checklist to keep you on track toward compliance. To begin assessing and planning your compliance process, though, start with these steps:

1. Determine what you need; which annual audits and assessments are required for your organization?

2. Get a starting point by conducting initial audits and assessments to see which requirements you don’t yet meet.

3. Create a plan for meeting any missing criteria and put it into action.

4. Delegate your compliance by appointing a HIPAA Compliance Officer.

5. Plan HIPAA training for all your staff, conducted by the HIPAA Compliance Officer, and make sure your HIPAA Compliance Officer conducts these training sessions every year.

6. Get a completed attestation of HIPAA policies and procedures from all members of staff.

7. Ensure that your business associates are HIPAA compliant as well by conducting your own audits and assessments of them, and conduct these reviews every year.

8. Create policies and protocols for potential data breaches, review these policies with your staff, and make sure you have a plan for reporting these breaches to the HHS OCR.

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HIPAA compliance requirements

There have been a number of additions to HIPAA since its initial passage that require the critical attention and compliance of covered entities and business associates, such as healthcare providers and plans, and vendors or subcontractors who have access to protected health information. These HIPAA additions include the HIPAA Privacy Rule, Security Rule, Enforcement Rule, the HITECH (Health Information Technology for Economic and Clinical Health) Act, the Breach Notification Rule, and the Final Omnibus Rule.

  • The HIPAA Privacy Rule (2003) sets national standards to safeguard individuals’ medical records and other protected health information, and establishes when PHI may be used and disclosed.
  • The HIPAA Security Rule (2005) specifies safeguards to protect the confidentiality, integrity, and availability of electronic protected health information (ePHI), and articulates three types of security safeguards — administrative, physical, and technical — that must be adhered to in order to ensure HIPAA compliance.
  • The HIPAA Enforcement Rule (2006) was introduced to give the U.S. Department of Health and Human Services the ability to investigate complaints against covered entities not operating in compliance with the Privacy and Security Rules, and to enact penalties.
  • The Health Information Technology for Economic and Clinical Health Act (HITECH) was introduced in 2009; its primary goal was to urge healthcare authorities to implement the use of electronic health records (EHRs), as well as to incentivize healthcare organizations to maintain patient protected health information in electronic format as opposed to paper files. This led to the extension of the HIPAA Rules to business associates and third-party healthcare industry suppliers, so that any organizations interacting with protected health information were bound to comply with HIPAA.
  • The HIPAA Breach Notification Rule (2009) was also introduced in conjunction with the HITECH Act’s changes, requiring that in the event of a breach of unsecured PHI, notification of the breach is communicated to affected individuals, the U.S. Department of Health and Human Services, and in some cases, the media.
  • The Final Omnibus Rule (2013) clarified gray areas and fleshed out necessary details in existing HIPAA and HITECH regulations, while also establishing new penalties for HIPAA noncompliance.

The encouragement to use electronic health records and to maintain patient PHI in electronic form led to the wider development of technology and platforms for digital health data storage and distribution — which in turn increased the need for healthcare and related organizations to effectively manage and monitor access to sensitive healthcare information.

Organizations working in and with the healthcare industry must have a range of clear policies and procedures in place to ensure the safety of patient data, to ensure their compliance with the various rules and components of HIPAA, and to track and document their compliance for audit and verification purposes.


What does it mean to be HIPAA compliant — and how can my company get started? 


Achieving HIPAA compliance isn’t a matter of proving your company’s adherence to a single static standard. HIPAA’s rules and requirements are intentionally broad and flexible to accommodate the range of types and sizes of covered entities and business associates that create, access, process, or store protected health information (PHI), and that must thus comply with HIPAA.

HIPAA compliance is an evolving process; your organization is responsible for proving in an ongoing way that you are abiding by all the rules of HIPAA. Your company’s compliance with HIPAA involves fulfilling the requirements of the initial act of 1996, its subsequent amendments and additions, and any related legislation.

Who needs to be HIPAA compliant?

Covered entities and business associates with access to PHI are obligated to ensure that administrative, physical, and technical safeguards are in place to maintain the security of patient data; that they are in compliance with the HIPAA Privacy Rule; and that they have procedures in place to comply with the Breach Notification Rule should a data breach occur. An individual or a team within your organization must be identified as the responsible party for ensuring your organization’s HIPAA compliance. They should lead the charge in managing HIPAA compliance and assume the business risk to your company.

Your company will want to develop and implement a system for tracking policies, processes, procedures, documents, and related compliance materials. Your goal is to maintain compliance with HIPAA’s various component elements, to track any changes in ongoing HIPAA regulations, and to establish and maintain organizational processes for gathering compliance metrics, such that the status of your compliance with HIPAA is evident at any time.

HIPAA’s recommendations for how organizations can go about achieving compliance are technology-neutral, in that there are no expectations of use of certain prescribed systems or services; the expectation is that organizations and entities are advancing a serious approach to achieve compliance with HIPAA’s data protection regulations.

Understanding the penalties for non compliance with HIPAA

The creation of the HIPAA Enforcement Rule introduced the ability of the U.S. Department of Health and Human Services (HHS) to fine organizations for avoidable ePHI breaches. HHS’s Office for Civil Rights (OCR) is responsible for this enforcement, which it achieves through conducting compliance reviews, conducting outreach to encourage compliance, and investigating complaints.

The financial and other penalties incurred as a result of HIPAA violations and data breaches can be extraordinarily costly — from steep fines that vary by violation, to the organizational costs of issuing breach notifications and mitigating the damages following breaches, to the further possibility of criminal prosecution.

Fines may be levied against an organization whether a violation was unintentional or deliberate. Civil violations tend to involve situations where a covered entity fails to resolve a breach violation, and civil money penalties are subsequently levied to compensate for the violation. The Office for Civil Rights separates civil money penalties into four categories that range from a Tier 1 violation committed without an entity having reasonably known (incurring a possible fine of $100 – $50,000 per violation, with an annual maximum of $25,000 for repeat violations) to a Tier 4 violation in which a breach has occurred due to willful neglect and the cause of the violation has not been remedied (incurring a fine of $50,000 per violation, and capped at $1.5 million per year). A recently revised interpretation of the HITECH Act implemented restructured caps, with annual maximums increasing with the severity of the violation tier — a change intended to acknowledge an entity’s level of culpability in a breach and set maximum fines accordingly.

By managing and monitoring your organization’s compliance with the rules and regulations of HIPAA on an ongoing basis, you will be best positioned to identify any potential data security risks or threats and to mitigate those risks before they turn into larger and much costlier problems.



How can your company begin its HIPAA compliance journey?


Vanta streamlines your HIPAA and SOC 2 audit prep and support you as you prepare for a smooth and thorough evaluation and reporting process. As there is no official HIPAA compliance reporting mechanism, leveraging the SOC 2+ HIPAA report allows you to demonstrate your compliance using an industry standard report structure in the SOC 2 audit and to save on both time and cost.

Vanta includes HIPAA compliance support, and we’re able to offer guidance and information on preparing for your HIPAA audit — helping you track how ePHI flows through your systems and access points, helping you develop a breach notification policy and template, building a statement of applicability that describes how your organization controls for each of the HIPAA safeguards, and more. As part of Vanta’s HIPAA support package, we include features for tracking resources on your inventory list that store or process ePHI, as well as tracking Business Associate Agreements for vendors with whom you share ePHI. Vanta also offers HIPAA addendum policy templates to help you get started with your HIPAA policy language. We can help you utilize Vanta’s feature set to help track a range of HIPAA tasks, such as employee training, and to further customize your HIPAA compliance approach.

About Vanta


Vanta provides a set of security and compliance tools that scan, verify, and secure a company’s IT systems and processes. Our cloud-based technology identifies security flaws and privacy gaps in a company’s security posture, providing a comprehensive view across cloud infrastructure, endpoints, corporate procedures, enterprise risk, and employee accounts. Vanta also offers a suite of tools streamlining the non-technical components of security tracking and audit preparation, so gathering 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 their SOC 2 preparation and more.

1

Determine whether the GDPR applies to you and if so, if you are a processor or controller (or both)

Do you sell goods or service 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 apply to your business, you’ll need to get GDPR compliant.
2

Create a Data Map by taking the following actions

Identify and document every system (i.e. database, application, or vendor) which 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

racial or ethnic origins
genetic data
political opinions
biometric data that can uniquely identifying someone
religious or philosophical beliefs
health, sex life or sexual orientation data
trade union membership

Determine whether your Data Map meets the requirements for Records of Processing Activities (Art. 30)

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 including 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 Data Map includes the following information about processing activities carried out by vendors on your behalf

the name and contact details of the processor or processors 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
3

Determine your grounds for processing data

For each category of data and system/application have you determined 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 data subject
4

Take inventory of current customer and vendor contracts to confirm new GDPR-required flow-down provisions are included

Review all customer contracts to determine that they have appropriate contract language (i.e. Data Protection Addendums with Standard Contractual Clauses)

Review all in-scope vendor contracts to determine that they have appropriate contract language (i.e. Data Protection Addendums with Standard Contractual Clauses)

Do your agreements cover the following items?
vendor shall process the personal data only on documented instructions (including when making an international transfer of personal data) unless it is required to do otherwise by EU or member state law
vendor ensures that persons authorized to process the personal data are subject to confidentiality undertakings or professional or statutory obligations of confidentiality.
vendor have adequate information security in place, technical and organizational measures to be met to support data subject requests or breaches
vendor shall not appoint or disclose any personal data to any sub-processor unless required or authorized
vendor shall delete or return all the personal data after the end of the provision of services relating to processing, and deletes existing copies unless Union or Member State law requires storage of the personal data;
vendor makes available all information necessary to demonstrate compliance and allow for and contribute to audits, including inspections

Have you performed a risk assessment on vendors who are processing your PII?

5

Determine if you need to do a Data Protection Impact Assessment

Is your data processing taking into account the nature, scope, context, and purposes of the processing, likely to result in a high risk to the rights and freedoms of natural persons?

Does your processing involve 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 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.
6

Review product and service design (including your website or app) to ensure privacy notice links, marketing consents, and other requirements are integrated

Do you have a public-facing Privacy Policy which covers the use of all your products,  services and websites?

Does the notice to the data subject include the following items?

the identity and the contact details of the organization and its representative
the contact details of the data protection officer, if applicable
the purposes to process personal data and its legal basis for the processing
the recipients or categories of recipients of the personal data, if any
the details regarding any transfer of personal data to a third country and the safeguards taken applicable

Does the notice also include the following items?

the retention period, or if that is not possible, the criteria used to determine that period
the existence of the data subject rights (i.e. requests for information, modification or deletion of PII)
the right to withdraw consent at any time
the right to lodge a complaint with a supervisory authority
whether the provision of personal data is a statutory or contractual requirement, or a requirement necessary to enter into a contract, as well as whether the data subject is obliged to provide the personal data and of the possible consequences of failure to provide such data
the existence of automated decision-making, including profiling, and meaningful information about the logic involved, as well as the significance and the consequences

Do you have a mechanism for persons to change or withdraw consent?

7

Update internal privacy policies to comply with notification obligations

Update internal privacy notices for EU employees

Do you have an Employee Privacy Policy governing the collection and use of EU and UK employee data?

Determine if you need to appoint a Data Protection Officer, and appoint one if needed

Have you determined whether or not you must designate a Data Protection Officer (DPO) based on one of the following conditions (Art. 37)?

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
8

If you export data from the EU, consider if you need a compliance mechanism to cover the data transfer, such as model clauses

If you transfer, store, or process data outside the EU or UK, have you identified your legal basis for the data transfer (note: most likely covered by the Standard Contractual Clauses)

Have you performed and documented a Transfer Impact Assessment (TIA)?

9

Confirm you are complying with other data subject rights (i.e. aside from notification)

Do you have a defined process for timely response to Data Subject Access Requests (DSAR) (i.e. requests for information, modification or deletion of PII)?

Are you able to 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?

10

Determine if you need to appoint an EU-based representative, and appoint one if needed

Have you appointed an EU Representative or determined that an EU Representative is not needed based on one of the following conditions?

data processing is occasional
data processing is not 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
11

If operating in more than one EU state, identify a lead Data Protection Authority (DPA)

Do you operate in more than one EU state?

If so, have you designated the Supervisory Authority of the main establishment to act as your Lead Supervisory Authority?

12

Implement Employee Trainings to Demonstrate Compliance with GDPR Principles and Data Subject Rights

Have you provided appropriate Security Awareness and Privacy training to your staff?

13

Update internal procedures and policies to ensure you can comply with data breach response requirements

Have you created and implemented an Incident Response Plan which included procedures for reporting a breach to EU and UK Data Subjects as well as appropriate Data Authorities?

Do breach reporting policies comply with all prescribed timelines and include all recipients i.e. authorities, controllers, and data subjects?

14

Implement appropriate technical and organizational measures to ensure a level of security appropriate to the risk

This includes pseudonymization/ encryption, maintaining confidentiality, restoration of access following physical/technical incidents and regular testing of measures

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 measure ensure that, by default, only personal data which are necessary for each specific purpose of the processing are processed?

15

Consider streamlining GDPR compliance with automation

Transform manual data collection and observation processes into continuous monitoring

Download this checklist for easy reference

Download now
1

Develop a roadmap for successful implementation of an ISMS and ISO 27001 certification

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

Consider ISO 27001 certification costs relative to org size and number of employees

Clearly define scope of work to plan certification time to completion

Select an ISO 27001 auditor

2

Set the scope of your organization’s ISMS

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

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

Inform stakeholders regarding scope of the ISMS

3

Establish an ISMS governing body

Build a governance team with management oversight

Incorporate key members of top management, e.g. senior leadership and executive management with responsibility for strategy and resource allocation

4

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

5

Execute 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

6

Develop a risk register

Record and manage your organization’s risks

Summarize each identified risk

Indicate the impact and likelihood of each risk

7

Document a risk treatment plan

Design a response for each risk (Risk Treatment)

Assign an accountable owner to each identified risk

Assign risk mitigation activity owners

Establish target dates for completion of risk treatment activities

8

Complete the Statement of Applicability worksheet

Review 114 controls of Annex A of ISO 27001 standard

Select controls to address identified risks

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

9

Continuously assess and manage risk

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
10

Assemble required documents and records

Review ISO 27001 Required Documents and Records list

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

11

Establish employee training and awareness programs

Conduct regular trainings to ensure awareness of new policies and procedures

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

12

Perform an internal audit

Allocate internal resources with necessary competencies who are independent of ISMS development and maintenance, or engage an independent third party 

Verify conformance with requirements from Annex A deemed applicable in your ISMS's Statement of Applicability

Share internal audit results, including nonconformities, with the ISMS governing body and senior management

Address identified issues before proceeding with the external audit

13

Undergo external audit of ISMS to obtain ISO 27001 certification

Engage an independent ISO 27001 auditor

Conduct Stage 1 Audit consisting of an extensive documentation review; obtain feedback regarding readiness to move to Stage 2 Audit

Conduct 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

14

Address any nonconformities

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

Ensure org is following processes that it has specified and documented

Ensure org 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

15

Conduct regular management reviews

Plan reviews at least once per year; consider a quarterly review cycle 

Ensure the ISMS and its objectives continue to remain appropriate and effective

Ensure that senior management remains informed

Ensure adjustments to address risks or deficiencies can be promptly implemented

16

Calendar ISO 27001 audit schedule and surveillance audit schedules

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

17

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

18

Learn more about achieving ISO 27001 certification with Vanta

Book an ISO 27001 demo with Vanta

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1

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

2

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

3

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

4

Appoint a security and compliance point person in your company

Designate an employee as your HIPAA Compliance Officer

5

Schedule annual HIPAA training for all employees

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

6

Document employee trainings and other compliance activities

Thoroughly document employee training processes, activities, and attestations

7

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

8

Institute an annual review process

Annually assess compliance activities against theHIPAA Rules and updates to HIPAA

9

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

Download this checklist for easy reference

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