What is HIPAA Compliance Software? The Fundamental Guide

Posted by Ken Reiher

HIPAA compliance software is a powerful security and compliance resource to protect against a breach. This guide outlines the features you should look for when purchasing a solution, along with potential implementation roadblocks and how to address them.

Imagine trying to find a needle in a haystack. Have you tried to find a piece of due diligence information buried in a host of Excel documents or stuck in a binder somewhere? Managing HIPAA compliance manually is like finding needles in haystacks.

Now… Imagine you had a magnet that could help you easily locate that needle. HIPAA compliance software can be your magnet.

While compliance management software solutions cover a broader range of security and compliance requirements, HIPAA compliance software addresses regulations specific to the HIPAA Rule.

The HIPAA Rule encompasses a series of rules, including (among others):

  • Privacy Rule
    The HIPAA Privacy Rule requires appropriate safeguards to protect the privacy of 18 different personal health information identifiers, such as name, address, birthdate, social security number and visual images.

  • Security Rule
    The HIPAA Security Rule defines standards, procedures and methods for protecting data with attention to how PHI is stored, accessed and transmitted. Three types of security are required: Administrative, Physical and Technical.

  • Breach Notification Rule
    The Breach Notification Rule requires HIPAA-covered entities and their business associates to provide notification following a breach of unsecured PHI.

HIPAA compliance software is designed to help you manage the documentation, auditing, assessments and action planning needed to maintain compliance with the HIPAA Rule.

Benefits of a structured approach

Healthcare is only getting more complex. Constant evolution in technology only adds to this complexity, and increases a healthcare organization’s vulnerability. It’s simply not possible – or at the least, efficient – to manage HIPAA compliance with pen and paper.

Are you performing vendor assessments using Excel? How many hundreds of individual third-party assessments do you manage individually? What about file storage? Is your documentation housed in various departments where you can’t get to it easily?

HIPAA compliance software is a powerful tool to put structure around processes that have traditionally been scattered. What if you could have all your vendor assessments in one place, AND a system to easily identify risks and assign tasks for mitigation?

Must-have features and functions

Fundamental Guide to HIPAA Compliance Software

If you’re looking to make a purchase, you’ll want to make sure the solution offers these features specific to managing compliance around the HIPAA Rule:

  • Task Management
    Manage action plans and tasks across your organization related to HIPAA compliance, with alerts and notifications

  • Event Management
    When a breach occurs, manage incident response with a HIPAA breach questionnaire and guidance on how to respond

  • Audits
    Perform audits in a variety of departments. Look for a solution that includes templates you can use or customize.

  • Assessments
    Perform both internal and external HIPAA compliance risk assessments, including with third-party vendors, medical devices, and ancillary facilities that may not be owned by your organization.



Take your audits digital. A solution that offers mobile auditing will help you streamline your audit process.

  • Regulation Management
    Manage overall compliance with HIPAA regulations.

  • Documentation
    Gather, organize and store evidentiary documentation that shows due diligence of HIPAA compliance, including policies, procedures, plans and other evidence.

  • Contract Management
    Manage business associate agreements (BAAs) in a single place.

Download the infographic.



For a more efficient process, manage all regulations and frameworks – including NIST CSF, HITRUST and PCI – in a single solution.

Implementation challenges and how to work through them

As with any type of purchase, you may be up against some internal roadblocks. Let’s walk through a few of the challenges and how you might be able to address them.

  • Budget constraints
    Budget constraints are typical in healthcare, regardless of the size of organization. New technology purchases are especially scrutinized. Be prepared to make the case for the purchase and implementation of HIPAA compliance software. Thoroughly document where you can achieve time and monetary savings. Also, correlate the purchase expense to insurance. The C-suite will have better transparency and better accountability around HIPAA compliance activity. If you can show an ROI of purchasing a proactive, structured solution that will help avoid a breach, or lessen the impact when a breach does occur, that should help make the case for budgetary ask.

  • Competing priorities
    Competing priorities is another potential roadblock. This can impact budget allocation, but also implementation and adoption throughout the organization. Do some internal expectation setting up front. Getting buy-in from a multi-disciplinary leadership team will help bolster your argument for a software purchase. In addition, it might help to bring in an outside, objective resource to help make the case.

  • Aversion to change
    The age-old aversion to change may also hinder your ability to properly implement a HIPAA compliance software solution. We recommend a crawl-walk-run approach. Start small – for example, implement a service like a third-party risk assessment – and get some traction. As you gather small wins, you’ll also start to collect a team of internal advocates who can help spread the word and lead to improved usage.

Beyond the software

No software solution can guarantee that your organization will be HIPAA compliant. But, a comprehensive solution, along with stringent internal processes, can make it much easier to manage a difficult and complex compliance program.

A functional internal governance structure will help provide overall accountability of your HIPAA compliance program. HIPAA compliance software should give you reports and trending that you can take to a governance committee for more informed decision making. And, empowered with that data, the governance committee can also help with budgeting for future resources.

Look to internal and external resources – including human, physical and technical – to manage your HIPAA compliance program. Software itself only goes so far. You need subject matter experts and other administrative and technical tools to actually mitigate risks.



Consider a virtual CISO to help manage activities that you may not have the capacity to take on.

Additional compliance management software resources from ComplyAssistant

Free tool: Mobile app free trial
Guide: Fundamental Guide to HIPAA Security Risk Assessments
Blog: A Guide to the NIST Cybersecurity Framework
Blog: HIPAA-HITECH Security – Why Pay for “Nothing?”
Blog: HIPAA-HITECH Privacy and Security Reminders for the Workforce