HIPAA Compliance Software

HIPAA Compliance Software

HIPAA compliance software is a SaaS compliance framework that assists Covered Entities and Business Associates in their compliance efforts by providing all the tools and guidance an organization needs to satisfy the requirements of the HIPAA Privacy, Security, and Breach Notification Rules, and Subtitle D of the HITECH Act.

If your organization is subject to the rules of Health Insurance Portability and Accountability Act (HIPAA) you will understand how challenging it is to ensure you have developed policies and procedures that cover every applicable HIPAA standard. The challenge is complicated by some standards applying to some organizations, but not to others, and by some implementation specifications being required, while others are addressable.

The task of navigating the HIPAA standards, finding out which standards apply, and developing policies to comply with applicable standards can be assigned to one person in smaller organizations or to a team of compliance officers in larger organizations. However, regardless of how many people are assigned to compliance duties, there is always the risk of an implementation specification being overlooked due to human error – and human errors can be costly if they result in HIPAA violations.

How to Mitigate the Risk of Human Error

One way to mitigate the risk of human error – and the complexity of complying with HIPAA – is to implement HIPAA compliance software. HIPAA compliance software contains libraries of policies and procedures that can be filtered to be relevant to each organization´s activities. Organizations can then compare their existing policies and procedures against the filtered selection generated by the software to identify where gaps exist in compliance.

Once any gaps have been identified in an organization´s compliance efforts, the software guides compliance officers through the process of eliminating the gaps via risk assessments and analyses. The results of the assessments and analyses help compliance officers determine the content of new policies or the best way to develop new procedures. Once the policies and procedures are finalized, the software simplifies version control and document retention.

Further Benefits of HIPAA Compliance Software

In addition to finding and eliminating gaps in an organization´s compliance efforts, HIPAA compliance software can be used to conduct self-audits on privacy and security standards, create inventories of assets and devices used to access PHI, track employee training, and assess the organization´s preparedness for a data breach so the correct procedures are in place to notify the appropriate individuals and authorities depending on the nature of the breach.


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One of the benefits of self-audits is that it enables organizations to identify when poor compliance practices have developed in the workplace. If poor compliance practices are allowed to evolve into a cultural norm of non-compliance, this can lead to an increase in HIPAA violations. Poor compliance practices can be reversed with refresher HIPAA training, provided they are identified at an early stage – something compliance officers are capable of doing with HIPAA compliance software.

Seek Out Vendors That Provide Additional Support

There are undoubtedly some organizations – both big and small – who will be unable to take full advantage of HIPAA compliance software due to a shortage of resources. These organizations – and others who wish to accelerate their journeys to full HIPAA compliance – should seek out vendors that provide additional compliance support such as training support and audit support, and who are willing to get involved with incident management.

These vendors will be more familiar with the challenges of complying with HIPAA and will have a deeper knowledge of where gaps most commonly appear in organizations´ compliance efforts. Furthermore, they will likely have come across most violation scenarios in their experience and therefore vendors providing additional support will be better positioned to help organizations react, respond, and recover from a HIPAA violation or data breach.

HIPAA Compliance Software FAQs

What is a SaaS HIPAA compliance framework?

A SaaS (Software-as-a-Service) HIPAA compliance framework is a cloud-based framework that can be accessed from any device with an Internet connection. The benefit of being cloud-based is that compliance officers can access the framework from any location at any time of day or night. This can be an advantage if – for example – a Privacy compliance officer works in a different location than a Security compliance officer, or if an incident occurs out of normal working hours.

Is it necessary to have both a Privacy compliance officer and a Security compliance officer?

Under 45 CFR § 164.530 and 45 CFR § 164.308, most Covered Entities and Business Associates are required to designate a Privacy Officer and a Security Officer. In smaller organizations, the roles can be designated to the same person, or a healthcare administrator will be assigned the role of Privacy Officer and a senior member of the IT department the role of Security Officer. In larger organizations and health systems, teams of compliance officers collaborate on HIPAA compliance.

Why do some HIPAA standards apply to some organizations, but not to others?

Exclusions to certain HIPAA standards apply depending on the nature of the organization's operations. For example, six of the ten Administrative Requirements of the Privacy Rule do not apply to Group Health Plans “because Group Health Plans provide health benefits through an insurance contract with a health insurance issuer or Health Maintenance Organization (HMO) and do not create or receive PHI except for summary health information”.

Does HIPAA compliance software help manage Business Associates?

Although most HIPAA compliance software provides some level of help to manage Business Associates, the best HIPAA compliance software provides the tools to assess the status of Business Associates´ privacy standards, security standards, and other areas of compliance – such as the Business Associate´s preparedness for a data breach and ability to notify Covered Entities of the breach as well as appropriate individuals and authorities.

What is the difference between a required implementation specification and an addressable implementation specification?

When an implementation specification is required, it is mandatory and there is no option but to implement it. When an implementation specification is addressable, it must be implemented unless an existing or alternate solution is at least as effective at meeting the objectives of the implementation specification, or there is a justifiable reason why the implementation specification is not reasonable or appropriate. Further information about required and addressable implementation specifications can be found in this FAQ published by the Dept. of Health and Human Services.

About Liam Johnson
Liam Johnson has produced articles about HIPAA for several years. He has extensive experience in healthcare privacy and security. With a deep understanding of the complex legal and regulatory landscape surrounding patient data protection, Liam has dedicated his career to helping organizations navigate the intricacies of HIPAA compliance. Liam focusses on the challenges faced by healthcare providers, insurance companies, and business associates in complying with HIPAA regulations. Liam has been published in leading healthcare publications, including The HIPAA Journal. Liam was appointed Editor-in-Chief of The HIPAA Guide in 2023. Contact Liam via LinkedIn: https://www.linkedin.com/in/liamhipaa/