The Health Insurance Portability and Accountability Act (HIPAA) of 1996 establishes the basis for patient privacy and data security in the U.S. healthcare system. Today, the top 5 HIPAA violations remain common among organizations subject to HIPAA regulations.

Its regulations, although sometimes complicated, aim to ensure that individuals’ sensitive health information stays private and is managed with the highest level of care. Despite its vital role, HIPAA violations still occur frequently, resulting in severe penalties, reputational damage, and a loss of patient trust. Recognizing these common mistakes is the first step toward effective compliance and protecting patient information.

This blog highlights the five most common HIPAA violations, sharing real-world impacts and practical strategies that covered entities and business associates can implement to prevent them.

Disclosing Protected Health Information Without Authorization

The unauthorized disclosure of Protected Health Information (PHI) is consistently the most common HIPAA violation. PHI includes a wide range of individually identifiable health details, such as medical records, billing information, demographic data, and even appointment schedules. Sharing or accessing this information without a patient’s explicit authorization (or a legally recognized exception) is considered a breach.

Why it’s so common:

• Human Error and Negligence: This is often the leading cause. A busy receptionist might accidentally give a patient’s information to the wrong person over the phone, a nurse might discuss a patient’s condition in a public area, or a provider might post patient testimonials on the website without authorization.
• Lack of Training and Awareness: Employees who are not adequately trained on HIPAA protocols may unknowingly disclose PHI. They might not understand what constitutes PHI or the specific circumstances under which it can be shared.
• Gossiping and Social Media: Unfortunately, some disclosures are malicious or simply careless. Staff sharing patient stories with friends or posting about a patient’s condition on social media platforms are egregious violations.
• Third-Party Access: Unauthorized access by individuals who are not part of the covered entity’s workforce, such as vendors or unvetted contractors, can also lead to disclosures.

Real-world implications:

The consequences of unauthorized PHI disclosure can be serious. For the patient, it may cause emotional distress, discrimination, identity theft, and financial loss. For the healthcare organization, it can lead to:

• Hefty Fines: The Office for Civil Rights (OCR), which enforces HIPAA, levies substantial fines ranging from thousands to millions of dollars, depending on the severity and culpability of the violation.
• Reputational Damage: News of a data breach can severely damage an organization’s reputation, eroding patient trust and potentially leading to a decline in patient numbers.
• Legal Action: Patients whose PHI has been disclosed without authorization may pursue civil lawsuits against the responsible parties for breach of privacy under state law.
• Corrective Action Plans: The OCR will often mandate a corrective action plan, requiring organizations to invest significant resources in improving their security and privacy practices.

Prevention strategies:

• Robust Employee Training: Implement comprehensive and ongoing HIPAA training for all employees, emphasizing what PHI is, permissible disclosures, and the importance of patient privacy.
• Strict Access Controls: Limit access to PHI to only those who need it to perform their job duties. Implement role-based access controls for electronic health records (EHRs).
• Secure Communication Channels: Mandate the use of secure, encrypted channels for transmitting PHI, avoiding unencrypted email or public messaging apps.
• Clear Policies and Procedures: Establish and enforce clear policies regarding PHI disclosure, including specific guidelines for phone calls, faxes, emails, and in-person discussions.
• Regular Audits: Conduct regular internal audits to monitor access to PHI and identify any unusual activity.
• Shredding and Secure Disposal: Ensure all paper documents containing PHI are securely shredded when no longer needed, and electronic devices are wiped clean before disposal.

Failing to Perform an Accurate or Thorough Risk Analysis

A core requirement of HIPAA is that covered entities and business associates perform a thorough and precise risk analysis. However, it remains one of the least compliant areas for all regulated entities. Nearly all OCR enforcement actions against regulated entities have involved incomplete or missing risk analyses.

A HIPAA risk analysis is an inventory of locations and threats to protected health information, both electronic and non-electronic.

The risk analysis is not a one-time event but an ongoing process designed to identify potential security risks and vulnerabilities to PHI. The findings of the risk analysis inform the risk management actions required to reduce these risks. Failing to perform risk analysis and risk management leaves an organization blind to its weaknesses, making it vulnerable to breaches.

Why it’s so common:

• Lack of Understanding: The task appears too complicated or too time-consuming so organizations put it off, or only partially complete it.
• Underestimation of Scope: Organizations might underestimate the breadth of systems and processes that handle electronic protected health information (ePHI), leading to an incomplete analysis.
• Time and Resource Constraints: A proper risk analysis is a time-consuming and resource-intensive endeavor, which can be challenging for organizations with limited budgets or staff.
• “Check-the-Box” Mentality: Some organizations may treat the risk analysis as a mere compliance formality, performing a superficial review rather than a deep dive into actual vulnerabilities.
• Failure to Update: Technology and threats evolve rapidly. A risk analysis that is not updated regularly quickly becomes obsolete. It should be completed at least once a year.

Real-world implications:

• Undiscovered Vulnerabilities: Without a proper risk analysis, organizations remain unaware of critical vulnerabilities that could be exploited by malicious actors.
• Increased Breach Likelihood: Hidden weaknesses dramatically increase the chances of a data breach, leading to all the associated penalties and damages.
• OCR Penalties: The OCR views a lack of a comprehensive risk analysis as a serious violation itself, regardless of whether a breach has occurred. Fines can be imposed for non-compliance with this specific requirement.
• Ineffective Security Measures: Any security measures implemented without a proper understanding of the actual risks are likely to be ineffective or misdirected, wasting resources.

Prevention strategies:

• Dedicated Resources: Allocate sufficient time, budget, and personnel to conduct a thorough risk analysis.
• Holistic Approach: The risk analysis should encompass all systems, applications, networks, and physical locations where PHI is created, received, maintained, or transmitted.
• Identify Assets: Clearly identify all assets that store, process, or transmit ePHI, including servers, workstations, mobile devices, cloud services, and medical equipment.
• Threat and Vulnerability Assessment: Systematically identify potential threats (e.g., malware, insider threats, natural disasters) and vulnerabilities (e.g., unpatched software, weak passwords, lack of encryption).
• Likelihood and Impact Assessment: For each identified risk, assess the likelihood of it occurring and the potential impact if it does.
• Regular Review and Updates: Conduct risk analyses annually or whenever there are significant changes to the organization’s IT environment or business operations.
• Documentation: Maintain comprehensive documentation of the risk analysis process, findings, and remediation plans.

The HIPAA E-Tool^® provides step-by-step guidance on completing a risk analysis and implementing a risk management plan. Its risk management module features interactive forms that let you input data and answer questions, helping to identify vulnerabilities and support assessments. The module also stores the documented results.

Insufficient Safeguards to Address Security Risks

After a thorough risk analysis, the next crucial step is to put safeguards in place to reduce the identified security risks. Many organizations struggle here. Recognizing risks is only part of the process; the rest involves actively implementing measures to protect ePHI from those risks. Insufficient safeguards can leave an organization vulnerable, even if they have identified their weaknesses.

Why it’s so common:

• Budgetary Constraints: Implementing robust security safeguards can be expensive, leading some organizations to cut corners or prioritize cheaper, less effective solutions.
• Complexity of Modern IT Environments: Healthcare IT environments are increasingly complex, involving cloud services, mobile devices, interconnected systems, and remote access, making comprehensive safeguard implementation challenging.
• Lack of Prioritization: Security might not be a top priority until a breach occurs, leading to delayed or inadequate implementation of necessary controls.
• Failure to Keep Pace with Threats: Cyber threats are constantly evolving. Safeguards that were adequate five years ago may be easily bypassed by today’s sophisticated attacks.
• Over-reliance on “Off-the-Shelf” Solutions: While commercial security products are valuable, they must be properly configured and integrated into the organization’s unique environment. A “set it and forget it” approach is inadequate.

Real-world implications:

• Successful Cyberattacks: Insufficient safeguards are a direct invitation for cybercriminals, leading to ransomware attacks, data exfiltration, and system disruptions.
• Data Breaches: When safeguards fail, ePHI can be compromised, resulting in loss of data, reputational damage, legal action and fines.
• Operational Disruptions: Security incidents can bring healthcare operations to a halt, affecting patient care and revenue.
• Difficulty in Recovery: Without proper safeguards like regular backups and incident response plans, recovering from a security incident can be prolonged and costly.

Prevention strategies:

• Technical Safeguards:
  • Access Controls: Implement unique user IDs, automatic logoffs, and robust password policies.
  • Encryption: Encrypt ePHI both at rest (on servers, hard drives, mobile devices) and in transit (during transmission over networks).
  • Firewalls and Intrusion Detection/Prevention Systems (IDPS): Deploy and regularly update these systems to protect network perimeters.
  • Antivirus/Anti-Malware: Install and keep updated endpoint protection on all devices.
  • Patch Management: Implement a rigorous system for applying security patches and updates to all software and operating systems.
  • Data Backup and Disaster Recovery: Regularly back up ePHI and test disaster recovery plans to ensure business continuity.
• Administrative Safeguards:
  • Security Management Process: Appoint a Security Officer and establish clear security policies and procedures.
  • Workforce Training: Continue regular security awareness training for all staff.
  • Incident Response Plan: Develop and regularly test a comprehensive plan for responding to security incidents and breaches.
  • Contingency Planning: Plan for emergencies that could affect the availability of ePHI.
• Physical Safeguards:
  • Facility Access Controls: Secure physical access to facilities and areas where ePHI is located (e.g., locked server rooms, restricted access to filing cabinets).
  • Workstation Security: Implement policies for securing workstations when unattended (e.g., screen locks) and ensuring secure placement.
  • Device and Media Controls: Manage the movement and disposal of hardware and electronic media containing ePHI.

The Security Rule Checklist in The HIPAA E-Tool^® contains all the questions you need to answer to ensure you have the appropriate safeguards to protect patient data.

Denying Patients Timely Access to Their Medical Records

While HIPAA primarily aims to protect patient privacy from unauthorized disclosures, it also grants patients important rights regarding their own health information. The most notable of these is the right to access their medical records promptly. The OCR has increasingly emphasized this area, making it a key enforcement focus. Denying or unjustifiably delaying a patient’s access to their records is a clear HIPAA violation.

Why it’s so common:

• Administrative Hurdles: Some organizations have overly complex or bureaucratic processes for requesting and obtaining records, leading to delays.
• Lack of Staff Training: Staff members may be unaware of the specific timelines and permissible fees for providing access, or they might mistakenly believe certain information cannot be shared.
• System Inefficiencies: Outdated record-keeping systems or a lack of interoperability can make it difficult to quickly retrieve and provide records.
• Fear of Litigation: Some providers mistakenly believe that withholding certain information (e.g., sensitive notes) can protect them from litigation, which is generally not the case and violates HIPAA.
• Charging Excessive Fees: HIPAA allows for “reasonable, cost-based fees” for copies, but some organizations charge excessive amounts, effectively creating a barrier to access.
• Ignoring Patient Preferences: Patients have the right to receive their records in a format they request (if readily producible), but organizations sometimes push their preferred format.

Real-world implications:

• OCR Penalties: Under the right of access initiative, the OCR has been actively fining organizations for right of access violations, even when no breach has occurred. Fines can be substantial.
• Patient Dissatisfaction: Denying access erodes patient trust and satisfaction.
• Delayed Care: Patients may need their records to seek second opinions, coordinate care with other providers, or apply for benefits, and delays can negatively impact their health outcomes.
• Legal Challenges: Patients may file complaints with the OCR or their State attorney general, or pursue a civil lawsuit if their access to records is denied or delayed.

Prevention strategies:

• Streamlined Access Process: Develop clear, simple, and efficient procedures for patients to request and receive copies of their medical records.
• Employee Training on Patient Rights: Educate all staff involved in record requests about patient access rights, permissible timelines (generally 30 days, with one 30-day extension possible), and acceptable fees. Note: In California if a patient requests to see their records, the provider must permit inspection during business hours within 5 working days of request. Requests for electronic records must be met within 15 days.
• Reasonable and Cost-Based Fees: Only charge reasonable, cost-based fees as permitted by HIPAA for copies of records. Be transparent about these fees.
• Offer Electronic Access: Encourage and facilitate electronic access to records (e.g., via patient portals) where possible, as this is often faster and more cost-effective.
• Respond to All Requests: Acknowledge all record requests promptly, even if an extension is needed.
• Patient Choice of Format: Provide records in the format requested by the patient, if it is readily producible by your systems.
• Educate Patients: Inform patients about their right to access their records through notices and readily available information.

Failing to Enter into a Business Associate Agreement

The HIPAA regulations acknowledge that covered entities often work with third-party vendors who handle PHI on their behalf. These vendors are called business associates (BAs). A critical and often overlooked HIPAA requirement is the need for a Business Associate Agreement (BAA) between a covered entity and any business associate. A BAA is a legally binding contract that specifies how the business associate will protect PHI and ensures compliance with HIPAA regulations.

Why it’s so common:

• Lack of Awareness: Organizations, especially smaller ones, may not fully understand the concept of a business associate or the requirement for a BAA.
• Informal Relationships: Relationships with vendors might develop informally, without the proper legal documentation being put in place.
• Underestimating Vendor Access: Covered entities might not realize the extent to which a vendor (e.g., IT support, billing services, cloud providers, shredding companies) has access to or handles PHI.
• Overlooking “Niche” BAs: It’s easy to identify major BAs like EHR vendors, but smaller, less obvious ones (e.g., email service providers, mail houses, lawyers, accountants who handle PHI) are often missed.
• Failure to Renew/Update: BAAs are not static documents. They need to be reviewed and updated periodically, especially as relationships or services change.
• Vendor Resistance: Some vendors may be reluctant to sign a BAA or may push for less stringent terms.

Real-world implications:

• Chain of Responsibility Broken: Without a BAA, there’s no legally enforceable agreement obligating the business associate to protect PHI. If a BA causes a breach, the covered entity can be held liable.
• Direct Fines for Covered Entities: The OCR will fine covered entities for failing to have a BAA in place with their business associates.
• Lack of Recourse: If a business associate breaches PHI and there’s no BAA, the covered entity has limited legal recourse against the BA, further compounding the financial and reputational damage.
• Increased Breach Risk: Unvetted and unregulated business associates pose a significant security risk, as they may not have adequate safeguards in place.

Prevention strategies:

• Identify All Business Associates: Perform a comprehensive review of all third-party vendors that create, receive, store, or transmit PHI on your behalf. This includes cloud storage providers, IT support, billing services, shredding companies, data analytics firms, and others.
• Mandatory BAA Requirement: Establish it as a strict policy that no business associate will be engaged or granted access to PHI without a fully executed BAA.
• Review and Negotiate BAAs: Don’t just accept a vendor’s standard BAA without review. Ensure it adequately protects your interests and complies with HIPAA. Legal counsel should review these agreements.
• Due Diligence on Business Associates: Before engaging a business associate, perform due diligence to assess their security practices and HIPAA compliance. A BAA is only as good as the BA’s actual security posture.
• Regular Monitoring: Periodically review your relationships with business associates and ensure their compliance with the BAA.
• Update BAAs: Ensure BAAs are updated when services change or when there are updates to HIPAA regulations.

The HIPAA E-Tool^® Helps You Stay Compliant

HIPAA compliance is not just a legal requirement; it is an ethical duty that supports patient trust and the integrity of the healthcare system.

The five violations discussed above highlight critical risk areas that, when addressed proactively, can significantly enhance an organization’s security posture and lower its risk of penalties.

By prioritizing thorough training, performing detailed risk assessments, implementing strong safeguards, respecting patient access rights, and carefully managing business associate relationships, healthcare organizations can strengthen their defenses against breaches and fulfill their core responsibility to safeguard patient privacy. Remaining vigilant and fostering a culture of compliance is the most effective way to handle the complexities of HIPAA and keep sensitive health information secure.

Remember, preventing issues costs much less than dealing with a breach. Invest in HIPAA compliance, and you are investing in your patients, your reputation, and your organization’s future.