the guide to HIPAA Compliant software development

The Guide to HIPAA-Compliant Software Development with Checklist

The Health Insurance Portability and Accountability Act (HIPAA) is straightforward in that it is designed to protect private patient information across healthcare settings. In practice however, especially for software, HIPAA compliance can be more challenging. This post provides a comprehensive overview of steps to take to ensure your software development is HIPAA compliant.  

By complying with HIPAA requirements, software developers can contribute to a safe and trustworthy healthcare environment for patients.

To create a HIPAA-compliant database, download our free checklist!

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Why Is HIPAA Compliance Important in Software?

In 1996, Congress created HIPAA to protect individuals from losing healthcare if they were in between jobs. Shortly after its signing into law, the US Department of Health and Human (HHS) Services enacted rules that defined the proper and improper (illegal) use of patient information.

The privacy rule was needed to prevent:

  • Healthcare fraud
  • Employers using it to discriminate against someone
  • Extortion of sensitive or potentially embarrassing information
what does protected health information include

Protected Health Information (PHI) includes:

  • Names, dates, and addresses
  • Contact information, including biometric identities
  • Emails, website links, and URLs
  • Social Security, medical records, account and certificate numbers
  • Vehicle and device identifiers and serial numbers
  • Full-face photographic images

HIPAA is essential protection for patient information, meaning healthcare software engineering projects must maintain absolute compliance with all HIPAA rules or guidelines.  

Noncompliance with HIPAA software development guidelines can result in fines up to $50,000 per violation for an initial offense. Subsequent violation fines can exceed $1 million. By complying with HIPAA requirements, software developers can contribute to a safe and trustworthy healthcare environment for patients.

How Do I Make My Application HIPAA Compliant?

HIPAA regulations cover the following for software development or any IT function that stores, transmits, or safeguards protected health information. Data security safeguards cover:

  • Physical
  • Administrative 
  • Technical

All software development must ensure that these three areas comply with HIPAA standards and security best practices. Here is a rundown of each category.

Physical

Physical security covers access to servers and other communications equipment that might contain Protected Health Information (PHI) or allow the sharing of patient data. In addition, physical security also includes firewalls and antivirus software as well as physical backups and backups to third-party management entities.

Technical

Technical security includes point-to-point encryption, secure connections, and protocols. It also consists of security standards, best practices, and quality assurance testing required to verify that patient data has protection from unauthorized access or use.

Administrative

Administrative security covers paperwork, policies, guidelines, training, and personnel management. These mostly pertain to the employees that will have access to PHI. Examples of these types of employees include doctors, nurses, social workers, front office administrators, etc. Any employee with access to patient data must undergo annual training and certification to ensure they understand the law and how to handle data in a compliant manner.

For software development, the technical and physical safeguards directly apply. Some physical safeguards focus on IT infrastructure and physical data security measures. Any software you develop must safeguard the PHI listed above.

What Is Health Information Technology Policy?

Health information technology policy covers two distinct areas of procedure and protocol development. First, the US federal government manages healthcare information policy at a national level. Additionally, individual companies monitor internal healthcare information policies that are relevant to their specific business.

The Health Information Technology for Economic and Clinical Health Act of 2009 authorized HHS to create and implement programs designed to:

  • Improve healthcare quality, safety, and efficiency
  • Promote health IT, including electronic health records
  • Ensure a private and secure exchange of authorized healthcare information

Your company or your client’s company will have policies that comply with those programs and ensure that all software is HIPAA compliant. An internal policy aims to ensure that all software, IT, paper, and electronic records management adhere to HIPAA protocols, standards, procedures, and prohibitions.

How Do I Ensure My Software Is Secure?

Does your risk management plan appropriately check all the boxes when it comes to custom softwares and software services? The only way to ensure your software is secure is to perform a HIPAA audit, address any findings, and then constantly test it to verify that the data, policies, and protocols you have put in place maintain full compliance. 

That degree of vigilance requires working with someone that knows HIPAA compliance and how to develop IT programs, software, and tools to verify and ensure compliance.

What Is ePHI?

ePHI refers to electronic Protected Health Information. All ePHI must be encrypted before it is transmitted electronically, in any capacity. 

Software storing ePHI must meet all HIPAA technology requirements, including a HIPAA-compliant web application if the web application interacts with any database or software that stores, secures, manages, or transmits patient data.

How Do I Perform a HIPAA Audit on My Software?

There are three ways to conduct a HIPAA audit on your software:

Buy Audit Software

Audit software can be expensive and requires a lot of research to ensure you get the best audit package available. It is very challenging to find HIPAA compliance software that will cover all provisions of HIPAA Rules, HITECH Act, and state laws. You will need to do your due diligence on which provisions the software encompasses.

Perform an Internal Audit

If you wish to perform your own internal HIPAA audit, you will need to appoint a HIPAA Privacy Office and a HIPAA Security Officer. Your security officer will be responsible for conducting risk assessments and identifying threats and vulnerabilities found throughout your current work practices, the physical security on your premise, and the virtual security of your software and networks. Several online sources can help you set up your own audit, although it will not be official. You will likely need to Additionally, you would still be on the hook for any penalties or fines if something gets overlooked.

Hire HIPAA Software Development Professionals

You always have the option to hire an organization that works with HIPAA ePHI to develop compliant software for you. Finding a software vendor that follows comprehensive guidelines in their development practices can be challenging, so here are some questions to ask:

  • Does the vendor offer compliance solutions that fit your specific business needs?
  • Can the vendor provide verifiable testimonials from previous clients?
  • Does the vendor offer continual compliance support rather than one-off assessments?
  • Does the vendor have someone on staff who is a business associate, or do they work with a business associate?

These questions will help you ensure that at the end of the development project, you will have compliant software. 

Final Thoughts

HIPAA compliance software development is vital for anyone who stores, safeguards, transmits, or works with PHI or ePHI. Noncompliance can be extremely costly, even if no breach has occurred. Pleading ignorance of HIPAA guidelines is not accepted as a justifiable argument for non-compliance, so it’s vital to be educated and follow current standards. After reading this guide you can make informed decisions on how to build HIPAA-compliant software for your business.

At Nomadic, HIPAA-compliant software is what we do best. If you are wondering how to make your software HIPAA-compliant software, contact us today!

Jordan Choquette

Software Product Manager
Jordan is a dynamic product manager who loves to help customers bridge the gap between business ideas and technology solutions. He loves traveling, playing and listening to music, cooking, and being in nature. You can find him tending to his farm with his wife and two dogs.