HIPAA Compliance guide

 

What is HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) is a set of regulations that applies to institutions that handle medical records and dictates the proper use and disclosure of protected health information (PHI). HIPAA lays out the control measures that need to be in place for accessing medical records. Specifically, HIPAA is designed to prevent the disclosure of sensitive patient information to any third party without the individual's consent. Additionally, HIPAA also covers electronic protected health information (ePHI), which as the name suggests is information that is transmitted, stored, and accessed electronically.

The major concerns that HIPAA addresses are:

  • Maintaining privacy when it comes to an individual's health details.
  • Protecting a patient's medical records as well as their identifiable personal details.
  • Regulating access to the medical records of an organization.

Who must comply with HIPAA?

HIPAA applies only to those entities and individuals operating within the United States. It does not apply outside the US, even if entities are handling the PHI of US citizens. There are two groups of institutions that are required to be HIPAA-compliant:

  • Covered entities (CEs)
  • Business associates (BAs) who serve the CEs

CEs are those who are directly in contact with patients or have access to their medical information. By HIPAA standards, CEs are individual healthcare providers, organizations providing treatment, and other organizations performing healthcare operations. These include doctors, therapists, dentists, hospitals, healthcare insurance companies, and government programs that pay for healthcare.

HIPAA outlines a BA as being an organization that creates, receives, or maintains the PHI of a CE. Given the wide scope of the providers who manage, transmit, or process PHI, examples include MSPs, IT providers, faxing companies, cloud storage providers, email hosting service providers, and billing companies.

Consequences of noncompliance with HIPAA

The US Department of Health and Human Services' Office for Civil Rights (OCR) is the government body that enforces HIPAA regulations. When HIPAA's rules are violated, OCR may levy civil, monetary, or criminal penalties, including fines and imprisonment. If there is a violation, the individual reserves the right to make a complaint to OCR or the privacy officer of the healthcare provider. When it comes to financial penalties, the final price to be paid is based on a four-tier structure that is categorized based on the severity of the violation.

Yet not all HIPAA violations result in financial penalties. For minor violations that are a consequence of misinterpretation of the rules, OCR expects the organization in question to comply readily. If it does not, OCR may choose to issue penalties. However, even in the absence of financial penalties, noncompliance with HIPAA can result in certain intangible losses, such as reputation damage and loss of customer trust.

HIPAA requirements

In order to be HIPAA-compliant, CEs and BAs should adhere to the rules: the privacy rule, security rule, and data breach notification rule.

The privacy rule

The privacy rule lays down the guidelines for the permitted use and disclosure of PHI. The rule requires CEs to:

  • Appoint a privacy officer to monitor the rule implementation.
  • Create and distribute the notice of privacy practices, ensuring it is available to patients through different media.

The security rule

The security rule defines the standards that aim to protect ePHI that is transmitted and received by organizations. This rule focuses on strengthening the data's integrity and availability. It requires organizations to establish systems and policies that protect ePHI against common security threats and vulnerabilities.

The rule divides the implementation specifications into two categories: required and addressable. The specifications of the required category, such as conducting security and privacy awareness training for all employees, are mandatory. The addressable specifications must be implemented if the right tools and contexts exist, but if they do not, the situation and decisions have to be documented.

The data breach notification rule

The data breach notification rule mandates that the entity involved must notify individuals whose PHI may have been compromised. The breach notification must be made within 60 days of the discovery of the breach. Additionally, media outlets must be notified if the breach involves more than 500 residents of a state or jurisdiction. When the breach is caused by a BA, the BA is required to notify the CE about it.

HIPAA compliance processes

  • Self-evaluation

    All the CEs and BAs are required to periodically identify if there are any administrative or physical gaps in their compliance with HIPAA. This can be done by regularly conducting both technical and non-technical audits of the organization.

  • Remediation

    After identifying the gaps in the organization's HIPAA compliance, remediation plans must be set in order to eradicate HIPAA violations. The remediation plans must be thoroughly documented, including schedules for when the plans will be carried out and completed.

  • Documentation

    All the efforts made by an organization to comply with HIPAA must be documented. Documentation is of great importance during OCR's HIPAA investigations, helping organizations pass HIPAA audits.

  • Incident management

    Like any organization in the event of a data breach, all CEs and BAs must notify the affected individuals that their data has been compromised as well as thoroughly document the data breach, in accordance with the data breach notification rule.

  • BA management

    All CEs and BAs should make a record of all the third-party vendors who have access to PHI. Additionally, secure PHI handling must be prioritized to implement BA agreements (BAAs). BAAs must be reviewed yearly so that all the changes to the organization and vendors are duly noted.

  • Awareness training

    CEs and BAs must develop and implement policies and procedures around PHI in accordance with HIPAA compliance. These policies and procedures must be duly updated to keep up with any changes in the organization. Educating employees on these set policies is essential. Furthermore, a written indication of an employee's participation in training programs must be recorded.

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HIPAA best practices: A checklist

Often, it is possible to prevent HIPAA violations by implementing standard policies and educating the concerned personnel through proper awareness training. Here are a few IT best practices for managing PHI and avoiding noncompliance with HIPAA and subsequent OCR penalties:

  • Enforce passwords and a layered authentication process such as multi-factor authentication on all devices used to access medical records.
  • Implement the Zero Trust security model and keep accessing patients' information to a minimum, such as only when it pertains to work or with permission from the patients themselves. In addition to preventing unauthorized access, the Zero Trust model enhances network monitoring and inventory management.
  • Implement strict rules against sharing credentials between employees.
  • Minimize emailing PHI as much as possible. Emails are vulnerable to being intercepted or accessed by unauthorized parties. In addition, emails can be forwarded or copied without the sender's consent, resulting in the sensitive information being shared with unintended recipients.
  • Conduct HIPAA security assessments, which include ensuring that security policies are updated.
  • Be thorough about updating antivirus software on all the devices in use.
  • Make sure all storage services and apps meet HIPAA security guidelines.
  • In the event of a data breach, notify the incident response team and deploy the incident response plan with the goal of restricting the damage and minimizing recovery time. Investigate, identify the root cause, and eliminate any malware or botnet connections.
  • Check shared documents and ensure that sensitive data is not publicly accessible.

HIPAA: Key rules to consider

HIPAA rule Code definition Compliance recommendations
164.306(a)(1) General requirements Ensure the confidentiality, integrity, and availability of all electronic protected health information the covered entity or business associate creates, receives, maintains, or transmits.
  • The integrity of PHI must be maintained by validating the unique identifiers associated with every patient.
  • Ensure confidentiality by authorizing logins, restricting information access based on user authority, and keeping all systems updated with the latest security patches.
  • Maintain data availability by keeping the systems updated, optimizing data formatting, and removing corrupted files.
164.308(a)(1)(i) Security management process Implement policies and procedures to prevent, detect, contain, and correct security violations.
  • Use access control tools to prevent unauthorized access.
  • A formal risk assessment of the threats and vulnerabilities should be performed, and an action plan must be developed to deal with the most critical threats.
164.308(a)(1)(ii)(D) Information system activity review Implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.
  • Organizations are required to analyze and archive data regarding security activities, like access to applications and documents, the creation and suspension of user accounts, and any security incidents.
164.308(a)(3)(ii)(A) Authorization and/or supervision Implement procedures for the authorization and/or supervision of workforce members who work with electronic protected health information or in locations where it might be accessed.
  • Access to data should be restricted based on the user's credentials and authority.
  • Mitigate the threat of a breach by implementing robust access control mechanisms across all information systems.
164.308(a)(4)(i) Information access management Implement policies and procedures for authorizing access to electronic protected health information.
  • Use a standard system for authorizing user access. For example, the creation or deletion of accounts should require management approval through the submission of a request form.
  • Track and document users accessing ePHI and their access levels.
164.308(a)(5)(ii)(C) Log-in monitoring Implement procedures for monitoring log-in attempts and reporting discrepancies.
  • Consistently monitor and review system activities and login attempts.
  • Periodic log review documentation should be held in an archive.
  • Strictly adhere to the log data retention period based on the log level.
164.308(a)(6)(ii) Response and reporting Identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the covered entity or business associate; and document security incidents and their outcomes.
  • Analyze and document security incidents.
  • Classify incidents based on their severity.
  • The HIPAA security official of the organization must be made aware of all security incidents involving ePHI.

In this day and age, data has become invaluable, especially when it includes personal medical information. HIPAA is a well-established regulation that helps ensure the secure access and use of confidential personal information in healthcare systems. Understanding the importance of HIPAA and being familiar with all its requirements will make compliance at all junctures easier. To maintain a safe environment where patient data is well protected and to preserve the public's trust in the healthcare system, ensuring compliance with HIPAA regulations must be the foremost concern when it comes to individuals, organizations, and third-party associations.

EventLog Analyzer is a web-based IT compliance solution with real-time log management and network defense capabilities. The solution can provide your organization with the ability to dive deep into the machine logs and gain actionable insights. With EventLog Analyzer, your organization will be equipped to face diverse threats and protect critical client PHI while saving valuable time by generating predefined compliance reports. You can schedule a demo today and see for yourself how EventLog Analyzer makes it easy to comply with some of the most important mandates of HIPAA.

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