HIPAA Compliance Software
The purpose of HIPAA compliance software is to provide a framework to guide a HIPAA-covered entity or business associate through the process of becoming HIPAA-compliant and ensuring continued compliance with HIPAA and HITECH Act Rules.
The software helps compliance officers navigate the nuances of HIPAA and ensure all provisions of the HIPAA Privacy, Security, Breach Notification Rule, and Omnibus Rules are satisfied. The software also proves a company has made a good faith effort to comply with HIPAA by maintaining full documentation of all compliance activities.
That ensures that if a company is audited by the HHS’ Office for Civil Rights (OCR) or is investigated by OCR or state attorneys general over a data breach, the company can demonstrate no aspect of HIPAA has been missed, all policies and procedures are in order, staff have been trained, and appropriate technical, physical, and administrative safeguards have been implemented and are being maintained.
It should be noted that the use of HIPAA compliance software will not absolve companies of liability in the event of an employee violating HIPAA, but regulators do take a covered entity’s or business associate’s good faith efforts to comply with HIPAA into account when deciding whether a financial penalty or other sanction is appropriate.
HIPAA Risk Assessment Software
One of the most important elements of the HIPAA Security Rule is the risk analysis or risk assessment. The purpose of the risk assessment is to identify all risks to the confidentiality, integrity, and availability of protected health information (PHI). If the risk assessment is not performed, healthcare organizations cannot be sure that all risks have been identified, which means it will not be possible to reduce those risks to a reasonable and acceptable level through the HIPAA risk management process.
Even though the risk assessment is foundational element of HIPAA compliance, it is one of the provisions of HIPAA that causes healthcare organizations the most problems. The failure to conduct an organization-wide HIPAA-compliant risk assessment is the single most common HIPAA violation penalized by OCR in its enforcement actions.
The use of HIPAA risk assessment software helps to ensure that the risk assessment is completed to the standard demanded by HIPAA, by guiding organizations through the whole process and ensuring all identified risks are tracked along with the efforts made by the company to remediate those risks.
Self-Assessments of HIPAA Compliance
HIPAA-covered entities and business associates are required by law to complete regular self-audits to ensure continued compliance with HIPAA.
Business associates are required to complete five self-audits each year as a minimum. They are the above-mentioned Security Rule risk assessment, an audit of security standards, an asset and device audit, an audit of physical security, and an audit of compliance with HITECH subtitle D. HIPAA covered entities must also complete these audits, along with an additional privacy risk assessment.
HIPAA compliance software is useful for tracking these audits and ensuring documentation is maintained to demonstrate each self-audit has been completed. If any gaps are identified, the software can be used to prioritize and document remediation efforts to reduce risks and vulnerabilities to a reasonable and acceptable level.
Avoid Taking Shortcuts with HIPAA Compliance Software
Many compliance solutions only address specific elements of HIPAA compliance, such as the risk assessment. While HIPAA risk assessment software is a good place to start, it only covers one required provision of the HIPAA Security Rule.
Software that only covers specific aspects of HIPAA compliance will not help covered entities and business associates assess and demonstrate they are fully compliant. Even if covered entities and business associates are confident about their compliance programs, it is best to use a comprehensive software solution that covers all of the required and addressable provisions of HIPAA Rules, HITECH Act requirements, and even state laws.
A comprehensive compliance software solution may be more expensive in the short-term, but by efficiently guiding covered entities and business associates though the full compliance process, costs can be reduced, all gaps can be identified and addressed, and the risk of regulatory fines for noncompliance can be reduced to a minimal level.
Best HIPAA Compliance Software
The best HIPAA compliance software is a comprehensive compliance solution that walks users through setting up, implementing, and maintaining HIPAA policies and procedures, tracks staff training, and ensures all appropriate safeguards are implemented to meet HIPAA Privacy and Security Rule requirements.
Many HIPAA compliance software solutions include templates for policies and HPAA documents, such as business associate agreements. While these are certainly useful and can save compliance officers a great deal of time, HIPAA requires all policies and procedures to specific and relevant to each organization.
The best HIPAA compliance software solutions make it easy for policies, procedures, and HIPAA documentation to be customized to cover the specific ways that the organization creates, receives, uses, stores, and transmits protected health information.
The top HIPAA compliance solutions also help with the managment of business associates. Business associates can be fined directly for HIPAA violations, but HIPAA covered entities also a responsibility to ensure their vendors are fully compliant. A HIPAA breach at a business associate will have many negative implications for a covered entity.
Some HIPAA compliance software solutions allow covered entities to send self-audits to their business associates, monitor the results of those audits, and track and maintain business associate agreements.
You should also look for a software solution that lets you track employee HIPAA and security awareness training to ensure that every member of the workforce has received and has attested to receiving the required training.
Last but not least, even the best HIPAA compliance software solutions are not guaranteed to resolve all HIPAA compliance issues. If problems are experienced, support staff should be available to guide you through the compliance process and answer any questions you may have about HIPAA. Look for a software provider that offers regular sessions with compliance experts who will be able to answer any HIPAA questions and assess your compliance program and progress.
Assessing Suitable HIPAA Compliance Software Vendors
Finding a suitable vendor of HIPAA compliance software can be a challenge. We suggest the following tips for finding a suitable software vendor to ensure the service provided for you is comprehensive and does not leave any unidentified gaps in your compliance efforts:
- Avoid HIPAA training courses that promise compliance certification within a matter of minutes
- Select vendors that offer compliance solutions tailored to your specific needs
- Ensure somebody is available to answer any questions and guide you through the compliance process
- Check the vendor offers a solution that supports continued compliance rather than simply providing a one-off assessment
- Request verifiable testimonials from the vendor.
HIPAA Compliance Software Vs. HIPAA Compliant Software
The terms “HIPAA compliant software” and “HIPAA compliance software” are frequently used interchangeably by some software vendors, although the two terms mean something quite different.
“HIPAA compliance software” is more often than not an app or service that guides a business through its compliance efforts. This type of software can either help with specific elements of HIPAA compliance (i.e. Security Rule risk assessments) or provide a total solution for every element of HIPAA compliance.
HIPAA compliant software is usually an app or service for healthcare organizations that includes all the necessary privacy and security safeguards to meet the requirements of HIPAA, for instance, secure messaging solutions, hosting services, and secure cloud storage services. HIPAA compliant software does not guarantee compliance. It is the responsibility of users of the software solutions to ensure the software is used in a HIPAA-compliant manner.
HIPAA Compliance Certification for Software
There is no officially recognized HIPAA compliance certification for software, as any certification only confirms a software solution has incorporated all of the required safeguards to meet the requirements of HIPAA Rules. HIPAA compliance certification for software only confirms a solution is compliant at the moment when the compliance certificate is issued.
That said, many training and software companies issue HIPAA compliance certification to companies that have demonstrated compliance through the use of the software. These HIPAA compliance certifications may not be officially recognized by OCR and state attorneys general, but they do serve an important purpose.
They provide assurances that policies and procedures have been introduced in line with HIPAA, demonstrate a company is fully aware of its responsibilities under HIPAA and has provided appropriate training to employees, and confirm that software meets or exceeds the minimum standards for privacy and security demanded by HIPAA.
Vendors looking to break into the healthcare market will need to demonstrate to prospective healthcare clients that they are aware of their responsibilities with respect to HIPAA and provide “reasonable assurances” to the covered entity that they are compliant. This is achieved through the signing of a business associate agreement, but the use of HIPAA compliance software and any accompanying HIPAA compliance certification will help. It can be used to differentiate a company’s products and services and stand out from the competition.
It can be time-consuming finding a suitable vendor with a product to match your specific needs. There is no “one-size-fits-all” solution to HIPAA compliance, but the effort you put into identifying and addressing HIPAA compliance shortfalls is likely to pay dividends in the long run. Ensuring all aspects of HIPAA are satisfied should improve your security posture and help you prevent costly data breaches.
The software will ensure that no provision of HIPAA is overlooked, thus helping the company avoid regulatory fines for noncompliance.