The HIPAA compliance software market is full of confusing and misleading promises and guarantees. To cut through the noise, it helps to begin with this question: What does HIPAA compliance mean for small- and mid-size health care organizations?
The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) routinely releases updates to HIPAA regulation through official guidance on their website. The changing face of HIPAA regulation means that a one-time fix isn’t going to cut it–that’s why you need a HIPAA compliance software that can adapt to your organization’s day-to-day challenges.
In addition, the regulation is extensive. Even with routine guidance and a helpful FAQ, the real work of becoming compliant needs to come from within your organization.
HIPAA compliance software might be exactly what you need to help you manage your compliance. There are a number of options available, and depending on the size and scope of your organization you might find that you have different needs that you want your software to accomplish.
Regardless of the idiosyncrasies of your organization, though, it’s important to remember that all health care organizations are beholden to the same HIPAA regulatory requirements. Whether you’re an optometrist or an anesthesiologist, you need to uphold the same rigorous privacy and security standards within your practice in order to protect patients’ sensitive health info.
The Seven Elements
A few years ago, the HHS Office of Inspector General (OIG) published “The Seven Fundamental Elements of an Effective Compliance Program.” It’s become the golden rule of HIPAA compliance.
The Seven Fundamental Elements is by no means exhaustive. But it’s a powerful resource that can benefit all health care professionals. The Seven Elements are the essential framework that all good compliance plans should be built upon, and you should use them as your guide while you navigate the complex world of HIPAA regulation.
If you take away one thing from this article it should be this: Before deciding on a HIPAA compliance software for your company, make sure you vet it against the Seven Elements. If the software you’re considering doesn’t have mechanisms to address everything on this list, it’s not a total solution and it will not fully protect you from OCR audits and fines.
Below, we discuss the most important features that a good HIPAA compliance software should include. Keep the Seven Elements handy as you read along so you know what to look for during your search.
Here are the six features your HIPAA compliance software really must have:
HIPAA regulation calls for a series of mandatory audits that health care professionals need to execute within their organizations. These audits should span your organization’s privacy and security infrastructure and are meant to help identify risk areas.
A good HIPAA compliance software will use these audits to give you to get a complete picture of the current status of your organization’s compliance. They’re an excellent starting point that should act as your guide through creating the rest of your compliance plan.
You’ll want to make sure that these self-audits take the form of assessments or questionnaires that give you the opportunity to demonstrate the current state of your organization’s compliance measures.
Most software solutions differ from hiring a consultant because they are more DIY. HIPAA compliance software will usually require that you conduct these audits manually and should include a mechanism for “self-audits.” Self-audits are a cost-effective alternative to hiring a consultant and will produce the same data as long as you conduct them properly.
2. Remediation Plans
Your self-audits will reveal the ‘gaps’ or ‘deficiencies’ in your HIPAA compliance. Filling these gaps will form the basis of your remediation plans.
Remediation plans are unique to your company and should specifically lay out how you plan on patching up gaps your compliance. Depending on the nature and the volume of the gaps you’ve discovered, remediation plans will be actionable, multi-step plans with explicit designations for how and when gaps are going to be closed.
An effective HIPAA compliance software should handle creating and executing your remediation plans. The data you’ve entered into your self-audits will directly populate the necessary remediation plans in order to remedy the gaps you’ve uncovered. Another important element is documenting how and when these plans will be fulfilled. We’ll discuss documentation in more detail later, but for now: if your HIPAA compliance software doesn’t include a documentation mechanism for remediation plans, it’s not doing what it needs to.
3. Policies, Procedures, and Employee Training
Once you’ve identified and remedied the gaps in your organization, you need a tool to ensure that they won’t become recurring areas of risk. That’s where policies and procedures come into play.
There are many different solutions available that companies can turn to for policies and procedures, but most of the time they fall short of the regulatory requirements and will leave your organization exposed in the event of an OCR audit.
Policies and procedures need to be specific to the needs of your organization. That’s why purchasing binders with generic policies and procedures is so dangerous. If your policies and procedures aren’t specifically addressing the gaps you’ve discovered through your self-audits and remediation plans, they aren’t offering what you need. Your HIPAA compliance software should have some means of creating policies and procedures that you can implement in your own practice. Often, these will manifest as basic templates that you can fill in and tailor to the specific needs of your own practice.
Once you’ve implemented these policies and procedures, your HIPAA compliance software should include a means of training your employees. This training is usually found in a module within the software. Employees will read over documents and view training decks that establish common practices and standards for keeping health data safe and secure.
Employees must attest that they’ve understood the training they’ve received in order to protect your organization from liability in the event of a breach. Again: a good compliance software will document employee training and attestation so that you can illustrate your compliance to an auditor in the event of an OCR investigation.
Documentation is the most important element when considering a HIPAA compliance software. Not only is it mandated by federal regulation, but it’s also essential to actually being able to prove that you’ve done the work toward becoming compliant.
Documentation is probably the strongest benefit of adopting a HIPAA compliance software in your organization. Your software should build your plan and document the process year after year so that you’re prepared for an audit with all of your resources in one place.
5. Business Associate Management
Another important element of HIPAA compliance is managing your relationships with business associates. A business associate can be loosely defined as any organization that you’ve hired to handle PHI.
A HIPAA compliance software should allow you to manage and track your relationships with business associates, including the execution of business associate agreements (BAAs). These agreements are mandated by the HIPAA Omnibus Rule and must be reviewed every year to ensure that the terms of the agreements are still being met.
Business associate agreements have become a chief area of concern for OCR. In the aftermath of a $750,000 settlement in April 2016, OCR director Jocelyn Samuels commented that “HIPAA’s obligation on covered entities to obtain business associate agreements is more than a mere check-the-box paperwork exercise.” She continued, “It is critical for entities to know to whom they are handing PHI and to obtain assurances that the information will be protected.” An effective HIPAA compliance software will give you the tools necessary to manage these relationships.
6. Incident Management
Finally, there’s the issue of incident management. Even with the most effective compliance program imaginable, PHI breaches are always possible. Something as simple as a misplaced laptop or an unshredded document can lead to major fines in the event of an OCR investigation.
That’s why you need a HIPAA compliance software that can help monitor and manage breaches as they occur. In the event of a breach, your software should allow you to document and report the breach to OCR. And so long as your software has all of the capabilities we’ve discussed in this article, you should have no problem illustrating your organization’s compliance to auditors.
That’s the real value of a HIPAA compliance software: the peace of mind you get knowing that your entire compliance plan is stored in one central location.
It’s an important step you can take toward protecting your patients’ data and defending your hard-fought reputation.
HIPAA compliance software can provide a simple solution to a complex problem. The time and money your practice can save with the implementation of a compliance program is well worth minimizing the risk of HIPAA breaches and fines.
Finding a HIPAA compliance software that’s right for your practice gives you the peace of mind that your patients’ data is being kept safe and secure.