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:
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.
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.
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
HIPAA compliance processes
Self-evaluationAll 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.
RemediationAfter 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.
DocumentationAll 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 managementLike 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 managementAll 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 trainingCEs 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.
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:
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.||
|164.308(a)(1)(i) Security management process||Implement policies and procedures to prevent, detect, contain, and correct security violations.||
|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.||
|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.||
|164.308(a)(4)(i) Information access management||Implement policies and procedures for authorizing access to electronic protected health information.||
|164.308(a)(5)(ii)(C) Log-in monitoring||Implement procedures for monitoring log-in attempts and reporting discrepancies.|
|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.||
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.
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