What is HIPAA Compliance Software?

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HIPAA compliance software provides a range of tools to help organizations achieve compliance with the Health Insurance Portability and Accountability Act (HIPAA) and maintain compliance thereafter. However, because of the complexity of HIPAA, organizations are advised to select a software solution from a vendor who also provides support, training, and guidance.

Most HIPAA Covered Entities and Business Associates are required to designate a Privacy Officer and a Security Officer whose role it is to develop policies and procedures to safeguard Protected Health Information (PHI) from unauthorized uses and disclosures. The compliance officers must ensure the policies and procedures are implemented and adhered to in order to prevent HIPAA violations.

Even in large organizations that have the resources to dedicate whole teams to HIPAA compliance, this is a massive task. HIPAA is exceptionally complex and – because it was written to accommodate many different types of organization – some Privacy Rule and Security Rule standards only apply to certain types of organization, while exceptions exist for other types of organization.

In addition, some Security Rule standards have both “required” and “addressable” implementation specifications – the latter being a source of confusion for many compliance officers who have to determine whether existing safeguards are at least as effective as those required by the Security Rule, or whether the safeguards are necessary at all if the standard is unnecessary or unreasonable.

How HIPAA Compliance Software can Help

The complexity of HIPAA can result in oversights and omissions – notwithstanding that human error can also be a factor in organizations being less than 100% compliant. Therefore, many organizations take advantage of HIPAA compliance software – a web-based platform that includes tools, forms, and guidance for compliance officers to help avoid oversights, omissions, and human error.

Among the software´s tools is a library of policies and procedures that can be filtered in order to be relevant to the organization´s requirements. This enables compliance officers to compare the organization´s existing level of compliance with the optimum state in order to identify gaps in compliance that could lead to avoidable HIPAA violations and data breaches.

The guidance pages of the HIPAA compliance software help compliance officers fill the gaps via risk assessments and analyses, and then compliance officers can confirm 100% compliance via privacy and security standard audits. The software also enables organizations to create an inventory of devices used to access PHI, track employee training, and assess their data breach preparedness.

The Importance of Support, Training, and Guidance

As with any software, users of HIPAA software are not going to become experts the first time they access the web-based platform. Vendor support is going to be necessary to help compliance officers navigate the software and use the tools to identify gaps in compliance. Vendor support may also be necessary to ensure any new policies implemented as a result of a risk assessment or audit are suitable to meet the requirements of HIPAA.

Any new policies or procedures implemented by a Covered Entity are subject to the “material change” training standard in 45 CFR § 164.530, so vendor support may also be required with training members of the workforce affected by the new policies and procedures. Thereafter, compliance officers may need assistance using the software to manage document retention, employee attestations (that they have received training), and policy version control.

Some vendors will also provide support and guidance if – despite the best efforts of the organization – a HIPAA violation or data breach occurs. Although HIPAA compliance software can guide compliance officers through the appropriate actions, it can help to have a human expert on hand to answer questions and support incident management, so the organization is able to react, respond, and recover from a HIPAA violation or data breach quicker.

HIPAA Compliance Software FAQs

How can compliance officers ensure HIPAA policies are adhered to?

It is not possible for compliance officers to ensure HIPAA policies are adhered to 100%, but there are many policies that are managed by technical safeguards and these technical safeguards enforce adherence. In situations where adherence is dependent on the actions or inactions of an employee, effective training and a sanctions policy contribute towards adherence – although it is impossible to foresee errors in human judgement or malicious actions that can result in a violation.

How do smaller organizations with limited resources cope with HIPAA compliance?

Smaller organizations with limited resources cope with HIPAA compliance better than many people imagine. Because of their size or the nature of their activities, smaller organizations may not have the same volume of standards to comply with as larger organizations. In addition, training and monitoring employee compliance can be much simpler, mitigating the possibility of poor compliance practices developing into a cultural norm – an issue more likely to affect larger organizations.

What is the advantage of HIPAA compliance software being web-based?

The advantage of HIPAA compliance software being web-based is that the software can be accessed by compliance officers from any Internet-connected device, from any location, at any time. This can be advantageous if (for example) compliance officers work remotely, or if a HIPAA violation occurs outside normal working hours and the software needs to be accessed from a remote device.

Why might a HIPAA violation or data breach occur if an organization is 100% compliant?

A HIPAA violation or data breach might occur if an organization is 100% compliant and has implemented all the necessary policies, procedures, and safeguards because an oversight, omission, or human error by an employee could result in a HIPAA violation or data breach which would require the Covered Entity or Business Associate to commence incident management.

Where can I find further information about HIPAA compliance software?

To find further information about HIPAA compliance software, the best option is to contact a software vendor in order to discuss your requirements, the current level of your organization’s compliance, and the challenges you are experiencing. You should also ask for a no-obligation demonstration of the HIPAA compliance software and use the opportunity to find out more about the vendor´s support, training, and guidance services.

What is the difference between HIPAA-compliant software and HIPAA compliance software?

The difference between HIPAA-compliant software and HIPAA compliance software is that HIPAA compliance software helps a covered entity or business associate become – and remain – HIPAA compliant. HIPAA-compliant software, by contrast, is usually an app or service that has been developed to meet the minimum security safeguards stipulated by the HIPAA Security Rule. This can include email services, cloud-based storage, or payment services. However, despite being called HIPAA-compliant software, compliance often depends on how the software is configured and used.

Does the use of HIPAA compliance software prove HIPAA compliance?

The use of HIPAA compliance software does not prove HIPAA compliance. HIPAA violations can still occur despite the use of compliance software. However, if a violation does occur, the Office for Civil Rights (the body that enforces HIPAA) may take the use of such software as a demonstration of the commitment a covered entity has to be HIPAA compliant.

How can HIPAA compliance software help in self-audits?

HIPAA compliance software can help in self-audits to assess the implementation of security protocols and the efficacy of their training programs, etc. HIPAA compliance software can also be used to document these audits, as well as help covered entities and business associates address any shortcomings identified in the audit.

Is the use of HIPAA compliance software required by the Department for Health and Human Services?

The use of HIPAA compliance software is not required by the Department of Health and Human Services (HHS). However, its use may result in more favorable outcomes if a HIPAA violation occurs that is then investigated by HHS’ Office for Civil Rights. The goal of compliance software is to mitigate the risk of violations, so even if it is not directly endorsed by HHS, compliance software can be beneficial to covered entities and business associates.

James Keogh

James Keogh has been writing about the healthcare sector in the United States for several years and is currently the editor of HIPAAnswers. He has a particular interest in HIPAA and the intersection of healthcare privacy and information technology. He has developed specialized knowledge in HIPAA-related issues, including compliance, patient privacy, and data breaches. You can follow James on Twitter https://x.com/JamesKeoghHIPAA and contact James on LinkedIn https://www.linkedin.com/in/james-keogh-89023681 or email directly at [email protected]