HIPAA was adopted in 1996 and since then, Covered Entities (CEs) have been required to protect individuals’ personal health information or face hefty fines for non-compliance. The U.S. Health and Human Services Office for Civil Rights (OCR) enforces HIPAA; the fines they have issued have grown exponentially in recent years.
In 2018, Anthem, one of the nation’s largest health benefits companies, paid what is still the largest HIPAA fine in history of $16 million in for a data breach that exposed the electronic protected health information (ePHI) of 79 million individuals. The next largest settlement was $5.5 million paid by Memorial Healthcare Systems in 2017 for the inappropriate access of PHI of 115,143 individuals. Earlier this year, we learned hackers compromised two employees' email accounts at a Michigan healthcare group which exposed patient data and went undetected for six months.
With increasingly severe HIPAA non-compliance fines on the line, healthcare organizations must exercise extreme diligence in the protection of PHI. But it isn’t an easy task. Compliance requires that CEs adhere to two primary rules: the HIPAA Privacy Rule, which details which data must be protected, and the HIPAA Security Rule which establishes how that data is protected.
The Privacy Rule defines identifiable health information as demographic data that relates to:
The Security Rule outlines three categories of safeguards – administrative safeguards, physical safeguards and technical safeguards – to help you ensure data is protected and standards are followed accordingly.
Achieving and maintaining HIPAA compliance requires both thoughtful security and ongoing initiative. While there is some irony in providing a compliance checklist when we often hear ‘compliance is much more than checking a box,’ there are program elements that can – and should – be checked off. When marked complete, your level of confidence in your organization’s HIPAA adherence will increase.
The below 7 areas have been excerpted from the OCR’s recommended essential elements of an effective HIPAA compliance program.
Complete the following assessments / audits and be able to provide all appropriate documentation that they have been conducted for the past 6 years.
[ ] Security Risk Assessment
[ ] Privacy Assessment
[ ] HITECH Subtitle D Audit
[ ] Security Standards Audit
[ ] Asset and Device Audit
[ ] Physical Site Audit
[ ] Have all staff members undergone annual HIPAA training, and do you have documentation to prove that they have completed annual training?
[ ] Is there a staff member designated as the HIPAA compliance, privacy and/or security officer?
[ ] Have all staff members received security awareness training and do you have documentation to prove they have completed it?
[ ] Do you provide periodic reminders to reinforce security awareness training?
Conduct risk analyses to assess whether encryption of electronic protected health information (ePHI) is appropriate and provide documentation on the decision-making process.
[ ] If encryption is not appropriate, have you implemented alternative and equivalent measures to ensure the confidentiality, integrity, and availability of ePHI?
[ ] Have you implemented controls to guard against unauthorized accessing of ePHI during electronic transmission?
Implement identity management and access controls.
[ ] Have you assigned unique usernames/numbers to all individuals who require access to ePHI?
[ ] Is access to ePHI restricted to individuals that require access to perform essential work duties?
[ ] Have you implemented policies and procedures for assessing whether employees’ access to ePHI is appropriate?
[ ] Have you developed policies and procedures for terminating access to ePHI and recovering all electronic devices when an employee leaves an organization or their role changes?
[ ] Does your system automatically logout a user after a period of inactivity?
Create and monitor ePHI access logs.
[ ] Routinely monitor logs to identify unauthorized accessing of ePHI.
[ ] Implement controls to ensure ePHI may not be altered or destroyed in an unauthorized manner.
Develop policies and procedures for the secure disposal of PHI.
[ ] Develop policies and procedures for rendering PHI unreadable, indecipherable and incapable of being reconstructed.
[ ] Develop policies and procedures for permanently erasing ePHI on electronic devices when they are no longer required.
[ ] Ensure all devices that store PHI are stored securely until they are disposed of in a secure fashion.
Define a clear process for security incidents and data breaches.
[ ] Ensure you have the ability to track and manage all incident investigations.
[ ] Be able to provide the required reporting of minor or meaningful breaches/incidents.
[ ] Implement a procedure by which employees may anonymously report a privacy/security incident or potential HIPAA violation.
Successfully completing this checklist does not guarantee your organization is HIPAA compliant – nor does it ensure that your organization will avoid potential data breaches. However, it will get you off to a very good start. For more information on implementing a successful program, download our whitepaper: Achieving HIPAA Compliance: Your Guide to Avoiding HIPAA and HITECH Penalties.