What Is HIPAA Compliance?

HIPAA compliance means meeting the requirements of HIPAA (the Health Insurance Portability and Accountability Act), a law regulated by the US Department of Health and Human Services (HHS). Practically speaking, HIPAA compliance involves adherence to the physical, administrative, and technical safeguards outlined in HIPAA, which covered entities and business associates must uphold to protect the integrity of Protected Health Information (PHI).

Brief Overview of HIPAA’s Four Rules

To achieve HIPAA compliance, you need to thoroughly understand the rules set forth by the HIPAA regulation. These rules are divided into four key areas:

  • The Privacy Rule outlines how PHI can be used and disclosed, giving patients rights over their health information.
  • The Security Rule sets standards for safeguarding electronic PHI (ePHI) through administrative, physical, and technical safeguards.
  • The Breach Notification Rule requires covered entities and business associates to notify affected individuals, the HHS, and in some cases, the media, in the event of a breach of unsecured PHI.
  • The Final Omnibus Rule made several amendments to the previous rules, enhancing patients’ privacy protections and strengthening the ability of the HHS to enforce compliance.

Beginner’s Guide to HIPAA Compliance

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Ultimate 9-Step HIPAA Compliance Checklist

1. Dedicate Responsible Personnel

HIPAA compliance requires assigning specific roles within your organization to ensure that all aspects of the regulations are met. This involves appointing a HIPAA Privacy Officer and a HIPAA Security Officer:

  • The Privacy Officer is responsible for developing and implementing privacy policies and procedures that comply with the HIPAA Privacy Rule. This includes handling complaints and ensuring that all employees are trained on the organization’s privacy practices.
  • The Security Officer is tasked with the implementation and management of the security measures necessary to protect ePHI. This role involves conducting risk assessments, overseeing the technical safeguards, and ensuring that security measures are updated to address new threats.

2. Develop a HIPAA Compliance Administration Plan

A comprehensive HIPAA compliance administration plan is essential for managing all aspects of HIPAA compliance within your organization. This plan should outline the policies and procedures that your organization will follow to comply with HIPAA.

Key components of this plan include:

  • Risk assessments to identify potential vulnerabilities in your handling of PHI and ePHI.
  • Incident response procedures for managing potential breaches or non-compliance issues.
  • Regular audits to ensure that all departments are adhering to HIPAA policies and procedures.
  • Documentation protocols to track compliance efforts and demonstrate adherence to HIPAA rules.

3. Implement Physical Safeguards

Physical safeguards are necessary to protect the integrity of PHI and ePHI by preventing unauthorized physical access to your facilities and systems.

Important measures include:

  • Controlled access to facilities where PHI and ePHI are stored, using secure locks, access control systems, or even security personnel.
  • Workstation security to ensure that devices used to access ePHI are secured against unauthorized access. This can include locking screens when not in use and ensuring workstations are not accessible to unauthorized personnel.
  • Proper disposal of PHI and ePHI, ensuring that paper records are shredded and electronic data is securely deleted or degaussed.

4. Implement Technical Safeguards to Protect Access to ePHI

Technical safeguards are crucial for protecting ePHI from unauthorized access or breaches. These measures include:

  • Access controls such as unique user IDs and passwords to ensure that only authorized individuals can access ePHI.
  • Encryption of ePHI both at rest and in transit, to protect data from being accessed by unauthorized individuals if it is intercepted or stolen.
  • Audit controls that track access and activity related to ePHI, allowing you to monitor who accessed the data and when.
  • Automatic logoff mechanisms that terminate sessions after a period of inactivity, reducing the risk of unauthorized access.

5. Train Employees on HIPAA Procedures

Training your employees on HIPAA procedures is a fundamental part of achieving and maintaining compliance. Every employee who has access to PHI or ePHI should be regularly trained on HIPAA regulations and your organization’s specific policies.

Training should cover:

  • Understanding HIPAA rules including the Privacy, Security, and Breach Notification Rules.
  • Proper handling of PHI and ePHI, ensuring that employees know how to securely access, transmit, and dispose of this information.
  • Recognizing potential threats such as phishing emails, which could lead to a breach.
  • Reporting suspicious activity or potential breaches to the designated HIPAA officers.

6. Plan for Emergencies

Your HIPAA compliance strategy should include contingency planning to ensure that PHI and ePHI remain secure during emergencies, such as natural disasters, system failures, or cyberattacks.

An effective emergency plan includes:

  • Data backup procedures to ensure that all ePHI is regularly backed up and can be restored in the event of data loss.
  • Disaster recovery plans that outline how your organization will continue to operate and protect PHI and ePHI during and after an emergency.
  • Testing and revision of plans to ensure that they are effective and up to date with current threats and technologies.

7. Set Up Breach Notifications in Case Data is Lost

Under the Breach Notification Rule, covered entities and business associates must have procedures in place for notifying affected individuals, the HHS, and in some cases, the media, when a breach of unsecured PHI occurs.

Your breach notification procedures should include:

  • Immediate internal reporting of any potential breach to the designated HIPAA Security Officer.
  • Evaluation of the breach to determine its severity and the number of individuals affected.
  • Notification of affected individuals as soon as possible, but no later than 60 days after discovering the breach. Notifications should include a description of the breach, the type of information involved, and the steps affected individuals should take to protect themselves.
  • Reporting the breach to the HHS using the appropriate online portal. For breaches involving more than 500 individuals, the media must also be notified.

8. Document HIPAA Activity

Documentation is a critical part of HIPAA compliance, serving as evidence that your organization is meeting the requirements of the law.

Key areas to document include:

  • HIPAA policies and procedures that your organization has implemented.
  • Risk assessments conducted to identify and mitigate vulnerabilities.
  • Training records showing that employees have been educated on HIPAA compliance.
  • Incident reports detailing any breaches or potential breaches and the steps taken to address them.

9. Continually Monitor and Update Compliance Policies

HIPAA compliance is not a one-time effort but requires ongoing monitoring and updates as your organization grows and as new regulations or threats emerge.

Ongoing compliance efforts should include:

  • Regular audits of your HIPAA compliance program to identify areas that need improvement.
  • Updating policies and procedures in response to changes in your organization’s operations, the introduction of new technology, or updates to HIPAA regulations.
  • Continuous training for employees to ensure they are aware of any new procedures or risks.

Top Tips for HIPAA Compliance

HIPAA expert Raj Chaudhary, who leads the security and privacy teams at consultancy group Crowe Horwath, suggested these tips for more effective HIPAA compliance:

  • Keep data in the appropriate hands by strengthening security with logins. Ensure that only the people that need access to ePHI have a user ID or a user account, and policies are in place to change default passwords and increase password complexity.
  • Monitor controls and ensure logging is working correctly. A key aspect of complying with the HIPAA Security Rule is that you pay close attention to access to PHI. Simply put, you want to log everything. IT personnel should make sure that the logging feature is active within all systems around the clock. In addition to logging, you want to directly monitor via a system of rules, so you can examine your data accumulation process and be certain that everything is continually meeting your access controls.
  • Assess your access controls at all layers, including the network and your software. At the level of the network, you should have user IDs and strong passwords. This level of security is usually less problematic because it’s managed directly by IT. The other critical layer, though, is the software. You need to maintain control of that layer. Plus, although it’s annoying to users to get locked out of their accounts, Chaudhary noted that it’s a lesser evil to get hacked. “[A]s an example, if somebody externally breaks in through your firewall to get to your systems and is now trying to guess the password, you’ve got to make sure that you have some sort of a lock-out after a few of these attempts,” he said. “I typically recommend that after 10 failed attempts, one should be locked out.”

Pay careful attention to business associates who are handling any PHI, aka protected health information. Chaudhury recommended carefully reviewing your business associate agreement (BAA) that controls your data relationship with each vendor that is handling your data. Since the introduction of the Final Omnibus Rule, business associates are directly responsible for meeting the parameters of HIPAA compliance –in other words, you are now less exposed by the law since the vendors carry some of the burdens. Nonetheless, due diligence is still necessary.

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This article was updated with the latest information on September 3, 2024.