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What is HIPAA compliance?
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.
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.
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
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
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?
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.
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?
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
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)?
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?
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
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?
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?
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?
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?
Consider streamlining GDPR compliance with automation
Transform manual data collection and observation processes into continuous monitoring
Download this checklist for easy reference
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
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
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
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
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
Develop a risk register
Record and manage your organization’s risks
Summarize each identified risk
Indicate the impact and likelihood of each risk
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
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
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
Assemble required documents and records
Review ISO 27001 Required Documents and Records list
Customize policy templates with organization-specific policies, process, and language
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
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
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
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
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
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
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
Download this checklist for easy reference
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