Ultimate Guide to HIPAA Compliant Software Development

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In 2019, the Office of the Secretary of Health and Human Services fined 10 people $12 274 000 for violating the HIPAA procedural standards. With an average financial penalty of $1 227 400 per case, even the smallest act of negligence can result in significant financial damages for healthcare providers.

Privacy protection is more important than ever in the digital age since interconnected information systems are frequently vulnerable to data leakage. It does not imply that healthcare organizations should give up on their aspirations to go digital. Instead, they ought to ensure that their software is very secure and consider the current data privacy laws. The key HIPAA IT rules will be covered in this article, along with instructions on how healthcare providers can make HIPAA compliant software.

What do software firms need to know about HIPAA compliance?

“Covered entities” are those doctors, dentists, clinics, pharmacies, nursing homes, and other healthcare service providers with access to electronic medical data.

“HIPAA standard applies to the software provider if the software company interacts with a solution that collects and analyses personal identifiers of patients.”

Every company that complies with HIPAA requirements is either a covered entity or a business associate. According to HIPAA, a business associate is any individual or organization that provides a covered entity with services that require the disclosure of PHI. This definition states that “any healthcare software companies that maintain, share, or merely have access to individually identifiable health information of patients must be HIPAA compliant.”

Whether or if HIPAA rules will apply to your application depends on three key factors:

The Health Insurance Portability and Accountability Act (HIPAA) is the most important privacy law in US healthcare. The Office introduced it for Civil Rights (OCR) to create federal guidelines for safeguarding certain health information.

Respecting HIPAA’s rules, regulations, and updates constitutes compliance. All medical software must comply with five essential principles set forth by HIPAA.

The Privacy Rule

The goal of the Rule is to decrease fraud and theft while enhancing the flow of health data. It gives patients access rights to their health information, including the ability to inspect, obtain a copy of, and request changes to their data.

Rule of Compliance

According to the Enforcement Rule, the Department of Health and Human Services (HHS) will enforce HIPAA by determining fault and levying penalties for noncompliance. For more Details https://meltedspace.com/

Standard Rule

It lays down the guidelines for healthcare solution interoperability. It modifies several HIPAA Privacy, Security, and Enforcement requirements, making it harder to avoid reporting breaches, extending business partners’ liability for noncompliance, and establishing new privacy restrictions for utilizing PHI.

“Medical software that collects, gathers, stores, transmits, and/or operates PHI must abide by HIPAA’s rules and laws. An application is exempt from HIPAA compliance if it does not deal with protected health information.”

There will be repercussions if the software goes outside any HIPAA compliance rules. Therefore, knowing how to create a HIPAA-compliant healthcare software package.

The following is the software development HIPAA compliance checklist to help you create secure solutions:

Users’ permission

Identity assurance in software applications is divided by the US government into four layers. Only one authentication element is utilized at the most fundamental levels.


Entails using a special data set, accessible only to the authorized person, as a PIN or password.

Inherence: Assume that a biometric scan will verify a user’s unique, innate characteristics.

Place: Only allows access if the user is in a specific place at the time of access.

Possession: gives users more information, like a security code. As a result, the visitor must enter such information to establish legal custody.

A HIPAA-compliant software solution must constantly remind users to acquire patient data without requiring them to go through a laborious process.

Emergency Setting

What should the emergency plan for your HIPAA-compliant healthcare app contain?

A complete list of every team member, including their titles, addresses, and job responsibilities.

Resolution Strategy

The strategy outlines business partners’ actions to secure patient data. As a result, it covers the following safety-related topics in detail:

A strategy for resolving upcoming problems a rundown of all the procedures that will be followed to keep data secure.

As a result, in terms of secure software development practices, the remediation plan is the most crucial document for HIPAA compliance. The main challenge is figuring out exactly what your company must do to comply with security regulations.

Backup of Data

The company must emphasize the following areas to ensure that software complies with HIPAA:

A quicker and easier method of data security is encryption. The apps should use the 256-bit AES protocol and two-factor authentication for the best possible data security.

Monitoring: If the backup system fails, the system must immediately alert the staff of the company.

The fact that the data will be safe even if the original file copy is hacked is a key advantage of frequently backing up data.

  • Monitoring

It’s important for app owners and developers to test the efficiency and security of access algorithms regularly. Therefore, the preventive measures are a crucial component of the thorough HIPAA compliance checklist for software development:

  • Activity logs and audit controls: 

Using an automated risk detection system to spot any suspect attempts to enter the system quickly.

  • Automatic logout: 

Any healthcare software should be designed so that a user logs out of the program after their shift is over.


Healthcare providers and their associates may incur hefty fines for breaking HIPAA requirements. The establishment of numerous technical protections, a thoroughly strategic approach to medical practice management software development, and reliance on reliable partners are all recommended for entities subject to HIPAA rules.

Author Bio

I am Zoya Arya, and I have been working as Content Writer at Rananjay Exports for past 2 years. My expertise lies in researching and writing both technical and fashion content. I have written multiple articles on Gemstone Jewelry like Opal jewelry and other stones over the past years and would love to explore more on the same in future. I hope my work keeps mesmerizing you and helps you in the future.

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