The importance of HIPAA and what it can mean for your business

For most people, HIPAA is merely a regulation that they are vaguely familiar with from the paperwork they have to sign at their doctors’ offices. For businesses that are in or related to the healthcare industry, however, HIPAA is a crucial concern that could threaten an organization’s survival if it isn't kept up with properly.


Does your organization need to be HIPAA compliant? Why is HIPAA compliance so vital in the first place, and what could it mean for your business? Our security compliance specialists are answering all your top questions.

Does your business need to comply with HIPAA?

While this is often misunderstood, it’s important to know that HIPAA doesn’t apply to any and all health-related information. The regulation only applies to specific types of organizations based on how you do business and what contact you have with private health information.


Namely, HIPAA laws apply to specific types of organizations that HIPAA outlines as “covered entities,” including:


  • Health plans, such as health insurance companies and HMOs
  • Healthcare providers that conduct any business electronically, including billing insurance companies electronically, which is nearly all healthcare providers
  • Healthcare clearinghouses, which are organizations that receive healthcare data from other organizations and translate it into a different format


To a lesser extent, anyone who serves as a “business associate” of a covered entity also needs to be HIPAA-compliant. A business associate is typically a contractor or subcontractor that a covered entity hires who has access to private health information. A business associate doesn’t have to follow all of the HIPAA regulations, only a limited portion of them.

Why is HIPAA critical for your business?

If you fall under the categories outlined above as “covered entities” in HIPAA, then HIPAA compliance is a vital necessity for your business. There are regulatory reasons and practical reasons why your compliance needs to be a priority.

Avoid serious penalties

HIPAA is not a security standard that is well-advised, yet voluntary. It is a strict US law that must be followed by any organization that qualifies as a covered entity. If you are not compliant, you risk severe penalties issued by the Department of Health and Human Services’ Office for Civil Rights.


There are four tiers of HIPAA penalties, with Tier 1 being the least severe and Tier 4 being the most severe. The OCR can determine which tier your HIPAA violation fits into based on factors like the severity of the violation, how reasonably avoidable the violation was, how much knowledge you had of the problem, and whether you tried to correct the violation.


Each tier has maximum and minimum fines per violation. Those fines are adjusted each year to align with inflation. The current fine amounts took effect in November 2021. For the lowest three tiers, you could be fined up to more than $60,000 per violation and up to over $1.8 million per year. For Tier 4 violations, the minimum fine per violation is over $60,000 and you may be fined more than $1.8 million per violation.

Enhance overall security

HIPAA regulations are not mere formalities. They exist to make your health data more secure and protect it from both intentional and unintentional access by people who shouldn’t have access to it. This involves a variety of information security strategies that are designed to secure your network and beyond.


This means that when you implement HIPAA, you’ll be making your data more secure so you lower your chances for a data breach. Data breaches are costly of their own accord, so HIPAA regulations carry benefits beyond just avoiding legal penalties.

Preserve the trust of your patients

The healthcare industry is a highly trust-based industry. If you lose the trust of your patients or customers, they’re likely to look for a new provider or insurance carrier in a heartbeat because they don’t want to put their health at risk. HIPAA violations are a fast way to lose that essential trust, so becoming and remaining compliant is essential for keeping your patients or customers.

What could HIPAA non-compliance mean for your business?

Ultimately, all of this boils down to the fact that HIPAA non-compliance could be enough of a problem to close your business entirely. You might find yourself with penalty fines so high they could bankrupt your business. You could also quickly lose your patients or customers if the word gets out that you aren’t keeping their private health information safe. All told, not complying with HIPAA could spell the end of your business.

How to protect your business with HIPAA compliance

Can you say with certainty that your business is fully compliant with HIPAA? If not, it’s time to make your HIPAA compliance a top priority.


Getting started is simple when you use an automated compliance platform like Vanta. Vanta will conduct an in-depth scan of your system against HIPAA requirements, providing you with a clear and precise checklist of the regulations you may not comply with and giving you documentation of the regulations you do meet. Along with templates and tools to use in your compliance engineering, Vanta makes HIPAA compliance simpler so you can keep your business and your patients safe.

Get HIPAA compliant


Vanta HIPAA compliance software

Your HIPAA compliance checklist

The ultimate HIPAA guide

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

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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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