HIPAA compliance involves protecting patient health information through the key regulations: the Privacy Rule, the Security Rule, and the Breach Notification Rule. Additional steps for maintaining HIPAA compliance include conducting risk assessments, training employees, implementing business associate agreements (BAAs), and ensuring robust physical and technical safeguards.
The HIPAA Privacy Rule establishes national standards for protecting patient information. According to the Department of Health and Human Services, "A major purpose of the Privacy Rule is to define and limit the circumstances in which an individual's protected health information may be used or disclosed by covered entities. A covered entity may not use or disclose protected health information, except either: (1) as the Privacy Rule permits or requires; or (2) as the individual who is the subject of the information (or the individual's personal representative) authorizes in writing."
Permitted uses and disclosures:
Read more: What are the permitted uses and disclosures of PHI?
Patient rights:
Read more: FAQs: Patient rights under HIPAA
The HIPAA Security Rule focuses on protecting electronic PHI. The HHS states that "The Security Rule requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards for protecting e-PHI.".
Administrative safeguards:
Read more: A deep dive into HIPAA's administrative safeguards
Physical safeguards:
Read more: A deep dive into HIPAA's physical safeguards
Technical safeguards:
Read more: A deep dive into HIPAA's technical safeguards
According to the HHS, "A breach is, generally, an impermissible use or disclosure under the Privacy Rule that compromises the security or privacy of the protected health information. " The Breach Notification Rule requires covered entities to notify affected individuals and the Department of Health and Human Services (HHS) in case of a data breach involving unsecured PHI.
Affected individuals must be notified without unreasonable delay and no later than 60 days following the discovery of the breach. The HHS must be notified if the breach involves 500 or more individuals. Healthcare organizations may also need to inform the media if the breach involves more than 500 individuals in a particular state or jurisdiction.
A comprehensive risk assessment helps identify vulnerabilities in an organization's systems and processes.
Related: How to perform a risk assessment
Employee training ensures that all staff members understand HIPAA regulations and their responsibilities. An effective HIPAA training program should cover several key elements. First, provide an overview of HIPAA regulations and their importance, emphasizing the necessity of protecting patient information. Role-specific training should be included, ensuring employees understand how HIPAA applies to their specific job functions. Educate staff on security best practices, including procedures for safeguarding PHI. Teach them the steps for incident reporting so they know how to report potential breaches promptly. Lastly, educate employees on HIPAA updates and best practices to keep everyone informed and compliant.
Covered entities must have contracts in place with business associates who handle PHI. A business associate is any entity that performs activities involving the use or disclosure of PHI on behalf of a covered entity.
Key components of a BAA include a description of permitted uses and disclosures of PHI, safeguards to protect PHI, and reporting requirements for breaches. Regular audits and reviews ensure that business associates adhere to HIPAA requirements.
Read more: FAQs: Business associate agreements (BAAs)
Effective physical and technical safeguards are necessary to protect PHI.
Examples of physical safeguards:
Examples of technical safeguards:
The HIPAA Omnibus Rule, enacted in 2013, introduced significant changes and expansions to HIPAA regulations.
Key changes and additions:
The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted in 2009, introduced new HIPAA requirements and incentives for adopting electronic health records (EHR). The HITECH Act encourages the adoption and meaningful use of EHR technology to improve healthcare delivery. Key provisions related to HIPAA include expanded breach notification requirements, which ensure that patients are informed about any potential compromises to their PHI. Additionally, the Act provided financial incentives for healthcare organizations to adopt EHR technology, promoting a more efficient, secure, and interoperable healthcare system.
Related: The basics of HITECH and how it works with HIPAA
Regular compliance checks help maintain HIPAA compliance by ensuring ongoing adherence to requirements and identifying areas for improvement. Review policies and procedures to ensure they are up-to-date and compliant with HIPAA regulations when conducting internal audits. Assess security measures, evaluating the effectiveness of physical, administrative, and technical safeguards. Identify and address gaps by implementing corrective actions to rectify any vulnerabilities or non-compliance issues found during the audit.
Developing an incident response plan helps effectively manage security breaches. Components of the plan should include procedures for identifying, reporting, and responding to security incidents. In case of a breach, the steps to take are to contain it, assess its impact, notify affected individuals and authorities, and implement measures to prevent future breaches. This structured approach ensures that breaches are handled promptly and efficiently, minimizing damage and maintaining compliance.
Read more: Developing a HIPAA compliant incident response plan for data breaches
Informing patients of their rights and providing clear information on privacy practices maintains trust and compliance. Ensure patients know their rights under HIPAA, such as access to their medical records and the ability to request amendments. Additionally, provide clear and accessible information on privacy practices by distributing the notice of privacy practices and ensuring it is readily available to patients. Transparency helps promote trust and ensures patients are informed about how their information is protected.
Yes, but only if the use is approved by an Institutional Review Board (IRB) and proper de-identification or patient consent is obtained per HIPAA regulations.
HIPAA requires that mobile devices used to access or store ePHI be secured with strong passwords, encryption, and remote wipe capabilities to protect against unauthorized access and data breaches.
HIPAA prohibits the posting of any PHI on social media, including patient details or images. Healthcare professionals must ensure that their social media activities do not violate patient privacy or disclose sensitive information.
Read more: FAQs: All about HIPAA and social media