Protected health information breaches have impacted over 176 million patients in the United States from 2009 to 2020. Surprisingly, most of these breaches have occurred due to human error and failure to comply with HIPAA rules, as opposed to external threats.
But what exactly is HIPAA, and why does it matter? Since 1996, the Health Insurance Portability and Accountability Act (HIPAA) has protected individuals’ health information by requiring healthcare providers and businesses to obtain consent before disclosing this information to anyone other than a patient and the patient’s authorized representatives. It’s a fundamental piece of legislation that has fostered patient trust and underscored accountability in the healthcare system for decades.
In this article, we’ll explore what HIPAA entails, who must comply, strategies for managing sensitive health data, and more.
Defining the Health Insurance Portability and Accountability Act
What is Protected Health Information?
Before diving into what HIPAA entails, it’s important to understand what types of information the Act protects.
Protected Health Information (PHI) is any health information that can identify an individual, that is in possession of or transmitted by a “covered entity” or its business associates, that relates to a patient’s past, present, or future health.
PHI includes both demographic and geographic identifiers, such as patient names, phone numbers, and emails, as well as biometric information, such as medical records, fingerprints, voiceprints, genetic information, facial images, and more.
PHI can exist in various formats, including electronic PHI (digital formats, also known as ePHI), physical PHI (physical medical files, billing statements, or written notes), and oral communications (conversations in which health information is discussed).
Why is compliance with HIPAA important?
Not only does HIPAA ensure that sensitive health information is kept confidential and handled properly, but it also offers patients control over their health records and the ability to decide who can access their information, which fosters trust in the healthcare system and informed decision-making. For healthcare organizations, compliance with HIPAA is not just a legal obligation, but also an ethical responsibility. It demonstrates a commitment to respecting patients’ rights and maintaining high standards of care.
With cyber threats on the rise, HIPAA also ensures that healthcare providers, insurers, and their business associates implement safeguards like encryption, secure access controls, and regular risk assessments. These measures mitigate the risks of data breaches, which can lead to identity theft, financial loss, and damage to an individual’s reputation.
Who must comply with HIPAA?
Under HIPAA, the two main categories of entities that need to comply with the regulations are Covered Entities and Business Associates.
Covered Entities
Covered Entities are directly involved in providing, handling, or processing health information. They include healthcare providers, health organizations that provide or pay for the cost of medical care, and healthcare clearinghouses that process health information.
Business Associates
Business Associates are individuals or companies that perform functions or provide services on behalf of Covered Entities, which involve the use or disclosure of Protected Health Information (PHI). They include billing and coding services, data storage and cloud providers, IT and software providers, and legal, accounting, and consulting firms.
Covered Entities and Business Associates must comply with HIPAA’s Privacy, Security, and Breach Notification Rules to protect PHI, limit access to authorized personnel, and meet regulatory standards. But what are these requirements?
HIPAA compliance requirements
The Privacy Rule regulates the use and disclosure of PHI, protects patient privacy, grants individuals rights over their health information, and applies to all forms of PHI.
The Security Rule ensures the confidentiality, integrity, and security of ePHI by requiring physical, technical, and administrative safeguards to prevent unauthorized access or breaches.
The Breach Notification Rule requires notifying affected individuals, HHS, and sometimes the media of unsecured PHI breaches, with specific timelines and documentation requirements for compliance.
The Omnibus Rule extends HIPAA obligations to Business Associates, enforces stricter compliance measures, and strengthens penalties while addressing the handling of PHI in marketing and other activities.
Each of these rules plays a vital role in protecting patient information and ensuring that healthcare organizations and their associates manage PHI with the highest standards of security and privacy. You can learn more about implementing HIPAA and its different Rules on the HHS website.
Steps to achieve HIPAA compliance
If you’ve made it this far, you’re probably quite interested in becoming HIPAA-compliant. But where do you start? The steps below are a great starting point for organizations looking to build a comprehensive and sustainable HIPAA compliance program that protects patient data and avoids penalties.
1. Conduct a risk assessment
The first step to achieving HIPAA compliance is identifying risks to PHI and assessing their likelihood and impact. You should also be conducting risk assessments annually or during major changes. Document your findings to understand your current state, address issues, and prioritize improvements.
For more information, read the HHS’s guidance on risk analysis.
2. Implement HIPAA policies and procedures
Next, address key HIPAA areas like access controls, incident response, and data sharing by creating tailored policies and procedures for managing PHI, customized to fit your organization’s size, structure, and operations.
Written policies guide employees in handling PHI, ensure consistency, and include breach protocols. They should be regularly reviewed and updated to align with evolving regulations and organizational changes.
3. Train staff and raise awareness
Employee negligence often causes HIPAA violations, making comprehensive training essential. Train all staff, including role-specific sessions for those handling PHI, using interactive, scenario-based methods to boost engagement. Regular refreshers and tracking participation helps foster a culture of compliance and reduce risks.
4. Secure physical access
Protect physical PHI by leveraging secure storage, shredding unneeded documents, and controlling access to storage areas and devices. Use locks, badge systems, and surveillance. Establish visitor and contractor policies to prevent theft or loss of sensitive information.
5. Implement technical safeguards
Cyber threats and accidental data loss are major risks to PHI. Protect PHI with firewalls, encryption, secure authentication, and role-based access requiring strong passwords. Use audit trails, enable 2FA, and conduct regular penetration testing to defend against breaches, unauthorized access, and accidental data loss.
Regular backups provide peace of mind to organizations, allowing them to restore data quickly in the event of a breach or other event.
6. Conduct regular audits and updates
HIPAA compliance requires ongoing reviews, updated risk assessments, and testing incident response plans. Use compliance software to streamline audits and maintain detailed records of updates and reviews to address new risks, regulations, or technologies effectively.
Consequences of non-compliance
Non-compliance with HIPAA can result in serious consequences, ranging from financial penalties to long-term reputational harm.
Fines are categorized into four tiers: lack of awareness, reasonable cause, willful neglect (corrected), and willful neglect (not corrected). The amount of the fine ranges from $100 to $1.5 million, relative to the severity of the violation and if an effort was made to correct it.
A data breach or HIPAA violation can cause reputational damage, eroding patient trust, attracting negative publicity, and straining business relationships with stakeholders concerned about data security. They can also lead to costly investigations, sometimes requiring corrective actions, and litigation, which can cause significant operational disruptions, increased scrutiny from regulatory agencies, and financial strain. Organizations found non-compliant may also find themselves at a competitive disadvantage, making it difficult to attract new clients or partners. Not to mention, a culture of non-compliance may demoralize staff, leading to increased turnover and difficulty in recruiting talent.
How comprehensive data protection bolsters your HIPAA compliance strategy
As a cloud service provider, we understand the importance of secure and compliant data protection. By leaving your PHI unprotected, you risk non-compliance, data breaches, and potential legal and financial repercussions.
With HIPAA-compliant backups, healthcare organizations can confidently and securely protect and restore critical data, all while ensuring adherence to regulatory standards.
Stay tuned for more on the importance of HIPAA-compliant data backups coming soon! In the meantime, learn how Rewind protects your business-critical data.
Margaret Corcoran">
