Is there an expiry date to HIPAA compliance?

HIPAA compliance itself does not have a fixed or formal expiry date. Instead, compliance is an ongoing obligation for covered entities and business associates. While specific projects or data access requests related to health information research may have expiration dates, these are operational or administrative deadlines rather than expiration of HIPAA compliance itself. 

In the context of HIPAA, covered entities and business associates must regularly update their policies, conduct risk assessments, train staff, and implement safeguards to ensure ongoing protection of protected health information (PHI). Failure to renew or update compliance measures can lead to lapses in compliance, but the legal requirements of HIPAA remain indefinite. 

There have been many instances where organizations have allowed compliance to lapse. In fact, as illustrated in the Innovations in Clinical Neuroscience case study ‘Top Five HIPAA Lessons Learned: A Review of HHS Resolution Agreements,’ lapses in compliance are one of the most common issues. For example, the article stated that “North Memorial failed to conduct an accurate and thorough risk analysis that took into account all of North Memorial’s IT equipment, applications, and data systems using ePHI.” Therefore, HIPAA compliance is a continuous, dynamic process without a formal expiry date

A brief overview of HIPAA 

HIPAA serves multiple purposes centered on improving the efficiency of healthcare delivery and protecting individuals’ health information privacy. StatPearls Health Insurance Portability and Accountability Act (HIPAA) Compliance discusses the purpose of the legislation, “HIPAA sets strict standards for managing, transmitting, and storing protected health information…uphold patients' rights to confidentiality and empower them to control the disclosure of their health information, fostering trust in healthcare systems.” 

Central to HIPAA is the Privacy Rule, which sets detailed regulations for the use and disclosure of PHI by covered entities. The Privacy Rule aims to safeguard individuals’ health information while allowing the flow of data necessary for high-quality healthcare and health research. HIPAA also includes the Security Rule, which requires administrative, physical, and technical safeguards to protect electronic PHI (ePHI).

Who does it apply to

According to StatPearls ‘Patient Confidentiality’, “HIPAA applies to all healthcare institutions and healthcare workers who submit claims electronically.” 

Covered entities include healthcare providers, health plans, and healthcare clearinghouses that electronically transmit health information connected to HIPAA-covered transactions. Business associates are individuals or organizations that perform functions or activities on behalf of covered entities involving the use or disclosure of PHI, such as billing companies, contractors, and cloud service providers. 

The HIPAA Omnibus Rule expanded the definition of business associates to include subcontractors who create, receive, maintain, or transmit PHI, making them directly subject to HIPAA’s Security and Privacy Rules. HIPAA also applies to all individuals working within healthcare settings who handle PHI, including clinical staff, administrative personnel, interns, volunteers, and contractors. The law governs how these entities and individuals use, disclose, and safeguard PHI.

HIPAA compliance is not a one-and-done 

HIPAA compliance is not a one-time event but a continuous, changing process because healthcare environments, technologies, and threats are evolving. The HIPAA Security Rule requires covered entities to conduct thorough risk assessments that identify vulnerabilities and threats to PHI. 

These assessments must be updated regularly to address new risks, such as emerging cybersecurity threats or changes in technology infrastructure. Enforcement actions by the Office for Civil Rights (OCR) have demonstrated that failure to maintain ongoing compliance can result in penalties and corrective action plans. 

According to the above-mentioned study, Top Five HIPAA Lessons Learned: A Review of HHS Resolution Agreements, “When investigating covered entities for potential HIPAA violations, OCR has often found that the covered entity failed to conduct a ‘thorough and accurate’ risk assessment.” HIPAA policies that were reasonable at one point may become inadequate over time due to changes in healthcare delivery models, regulatory updates, or technological advances.

Technological change and the soft expiry of compliance

According to the 2024 Cluster Computers journal article ‘Data breaches in healthcare: security mechanisms for attack mitigation,’ “Healthcare services have been integrating electronic health records (EHRs) and the Internet of Medical Things (IoMT), which represent a shift towards a more connected and data-driven approach to healthcare. This transformation offers unprecedented opportunities to improve patient care and operational efficiency and, on the other hand, liability to healthcare cybersecurity threats.” Mobile devices and cloud storage require encryption, access controls, and secure data disposal policies to comply with HIPAA’s Security Rule. 

The concept of soft expiry refers to the idea that while HIPAA regulations themselves do not expire, the effectiveness of compliance measures can diminish over time if they are not updated to reflect technological advancements and emerging threats. This necessitates ongoing re-evaluation and certification of health IT products and security protocols to ensure continued protection of PHI. Certification programs, such as those by the Certification Commission for Healthcare Information Technology (CCHIT), help ensure that EHR systems meet current privacy and security standards.

External factors that expire compliance over time

External factors continuously alter the landscape of privacy risks, regulatory requirements, and operational contexts in healthcare. One major external factor that can impact compliance “expiration” is the rapid change in cybersecurity threats, including ransomware, phishing, and malware attacks, which constantly introduce new vulnerabilities to PHI. 

As attackers develop more sophisticated methods, previously adequate security measures can become outdated, requiring healthcare entities to adapt quickly or face noncompliance and data breaches. Regulatory changes also contribute to this dynamic environment; updates or new guidance from the Department of Health and Human Services (HHS) can modify HIPAA requirements, compelling covered entities and business associates to revise policies, procedures, and safeguards to remain compliant. 

During public health emergencies such as the COVID-19 pandemic, HIPAA enforcement was temporarily relaxed to facilitate telehealth and data sharing. At this time, it took the form of the Notification of Enforcement Discretion for Telehealth Remote Communications During COVID-19 Nationwide Public Health Emergency, noting, “According to the Notification, covered healthcare providers can use telehealth to provide all services that, in their professional judgment, can be provided through telehealth.” 

Best practices to ensure compliance remain continuous 

• Perform thorough and periodic risk analyses to identify vulnerabilities and threats to PHI. Use these assessments to update safeguards and address emerging risks.
• Apply appropriate controls such as access controls, encryption, secure storage, and audit trails to protect PHI.
• To reduce human error and insider risks, all employees, including leadership and new hires, should be trained annually on HIPAA requirements, privacy practices, and security awareness.
• Ensure contracts with all business associates, like HIPAA compliant email platforms, clearly define their HIPAA compliance responsibilities and require them to safeguard PHI accordingly.
• Implement continuous monitoring systems to detect unauthorized access or breaches in real-time and maintain channels for reporting concerns or violations.
• Periodically audit HIPAA compliance efforts internally to verify adherence to policies and identify gaps before external audits.
• Keep thorough records of all compliance-related activities, including risk assessments, training sessions, audits, policies, and incident responses, for at least six years as required.
• Collect and retain only the minimum necessary PHI required for healthcare operations and restrict access based on job roles and need-to-know principles.
• Facilitate patient access to their health information promptly and securely, complying with the HIPAA Privacy Rule and related initiatives.
• Monitor and incorporate new HIPAA regulations, guidance, and enforcement trends to keep compliance measures current.

FAQs

What are the legal exceptions to HIPAA privacy rules?

Certain situations allow healthcare professionals to disclose PHI without patient authorization, such as reporting gunshot wounds, abuse cases, infectious diseases, or injuries related to criminal acts, when required by law.

What are the consequences of HIPAA violations?

Violations can lead to civil and criminal penalties, including fines and imprisonment. Penalties vary based on the severity of the violation and whether it was due to willful neglect or negligence.

What rights do patients have under HIPAA?

Patients have the right to access their medical records, request corrections, obtain an accounting of disclosures, and receive notifications of breaches affecting their PHI.

How does HIPAA address electronic health records (EHRs)?

HIPAA’s Security Rule sets standards for protecting electronic PHI, requiring encryption, access controls, audit controls, and secure transmission methods for EHRs and other electronic systems.