Working with all different type of healthcare organizations and business associates, I frequently hear the following phrases:
“We have a process for that, it is just not documented”
“We did some items that would qualify to meet those requirements, but we didn’t know we had to document”
“We have a high level of HIPAA compliance, but just don’t have documented policies and procedures”
While all these statements may be true – the issue is HIPAA requires documentation and proof that you are complying with the regulations. As we enter 2015 and are looking at 1) Increased enforcement of HIPAA, 2) Next phase of HIPAA Audits, 3) Data Breaches Increasing and 4) Continued Meaningful Use Audits – organizations need to make the time to assure proper documentation exists in order to comply with the HIPAA regulations.
Policies and Procedures – They are a Requirement
If you look at the detail of the HIPAA Privacy, Security, and Breach Notifications Rule – they all have a section that requirements documentation to exist to support the regulations.
- Privacy Rule Documentation – 164.530(i) – A covered entity must develop and implement written privacy policies and procedures that are consistent with the Privacy Rule
- Security Rule Documentation – 164.316(b)(1) – Maintain the policies and procedures implemented to comply with the regulations in written (which may be electronic) form; and (ii) if an action, activity or assessment is required by this subpart to be documented, maintain a written (which may be electronic) record of the action, activity, or assessment
- Breach Notification Rule Documentation – 164.316(b)(1) – A covered entity must comply with the administrative requirements as defined under the HIPAA rule documentation. Additionally, in the event of an unauthorized use or disclosure, the covered entity or business associate shall have the burden of demonstrating that all notifications were made as required by this subpart or that the use or disclosure did not constitute a breach
In addition to supporting compliance with policies and procedures, organizations should also ensure that they are supporting what they are doing to comply with appropriate documentation. Some examples of documentation to review to ensure it exists per your policy is:
- Proof of Information System Activity Review – what, what, when, where, outcomes
- Workforce Sanctions Applications – when have you applied sanctions and why
- Workforce Training Proof – regular training documentation as well we periodic updates
- Compliant Received and Proof of Resolution – all complaints regarding privacy and security, the investigation and outcomes
- Breach Notification Investigations (including 4 required questions) – all information regarding the investigation as well as the outcome documentation and assurance of the burden of proof
- Business Associate Contracts – do you have business associates contracts signed for the third party vendors you use
- Notice of Privacy Practices Acknowledgement – are you getting proper signatures as required and defined in your policy
This is not an all-inclusive list, but rather a sample to start thinking about how to verify that documentation exists. It is EXTREMELY important that you don’t assume proper documentation is happening – ask and look to verify that proper documentation is happening. Each of the above sample areas should be reviewed to see if what is defined in the policy and procedure that you have is truly being followed appropriately.
Don’t sit back and assume you are ok because you have a process – make sure you have proper documentation to support your compliance with HIPAA regulations. You can always conduct mock audits or hire an organization to analyze this for you. It is best to be prepared!
Final Word on HIPAA Compliance and Documentation – Take initiative, review, analyze, and verify. Your compliance level is only as good as the documentation you have to support it. Be diligent, dig through documentation, and feel confident with your compliance with HIPAA.