Guide on HIPAA Compliant Software Development: Requirements Checklist for 2023

Guide on HIPAA Compliant Software Development: Requirements Checklist for 2023

29 April 2022 • 14 min read

Many businesses put a priority on lightning-fast app launch speed. It is, of course, reasonable to aim to earn money on their software as soon as possible. However, such an attitude can lead to severe coding mistakes and weaknesses in application security.

Having the app down or partially inoperable is a bad customer experience. But when an organization lets the customers’ data slip away, the end of the company’s reputation is nearing. Data security is particularly relevant in the healthcare industry. It may be hard to believe, but health facilities account for 30% of all data breaches.

How do you prevent such involvement?

Ensure HIPAA compliant app development.

The healthcare industry is one of the most regulated in the USA and worldwide. So, the Health Insurance Portability and Accountability Act should become your manual for conquering the healthcare software development business.

The HIPAA not only protects users’ confidential medical information but defines the rules you have to abide by as a software provider. We don’t want to scare you, but in 2021, HIPAA penalties in the United States totaled about $6 million.

Make an app HIPAA compliant

But how to make an app HIPAA compliant?

We have the answers right here in this article. Moreover, we’ll share information from our expertise as a company that has already produced HIPAA-compliant software like MedRealtime and MediConnect.

At Softermii, we pride ourselves on being a leader and pioneer in healthcare app security. None of our healthcare-related projects have ever been breached or compromised.

  • We strive to reduce costs and deploy secure applications from the start.
  • We recommend starting with an impregnable MVP and building upon it to comply with all security protocols and the need to offer immediate solutions.
  • Our security researchers are operating round the clock monitoring the latest security developments and adding preemptive layers of security to guard your product.
  • We get such outstanding outcomes by combining the most recent technology breakthroughs with the human intelligence of our senior developers.

Who Needs to Comply with HIPAA?

We will tell you right away: if you plan to develop healthcare software, HIPAA compliance is a must. What other organizations must follow those rules? We can distinguish four main groups:

HIPAA-compliant software development

Healthcare Providers

It is both doctors and clinics in general. This law applies to psychologists and dentists as well. Anyone who stores patient data electronically should follow the HIPAA standards.

Read also: Benefits of Therapist App Development

Healthcare Plans

These include health insurance companies, government health programs, health maintenance organizations (HMOs), etc.

Healthcare Clearinghouses

Those companies act as intermediaries between healthcare facilities and insurance payers. They are directly involved in processing medical data; thus, they must protect it.

Healthcare Business Associates

These are individuals or legal entities that provide services to healthcare companies. For example, they could be software developers like you, accounting firms, etc.

To summarize all of the above, anyone who has access to patients’ digital data must follow the Health Insurance Portability and Accountability Act. As a software provider, you should ensure HIPAA compliance application development.

What Are the Requirements for HIPAA Compliance Software Development?

As you may already know, HIPAA contains numerous rules and requirements. But which are the main ones? And how do they influence software development? Let’s discuss them so you can stay on top of PHI or Protected Health Information security.

HIPAA-compliant app development

HIPAA Privacy Rule

The Privacy rule restricts the use and disclosure of PHI to minimize the likelihood of data theft or fraud. It also implies that only the patient has complete control over his medical records.

HIPAA Security Rule

This rule implies that healthcare companies must protect any personal information about the patient. This regulation applies to every organization that has access to confidential patient data.

HIPAA Enforcement Rule

The Enforcement rule regulates all penalties that may apply to those responsible for violations related to patient data.

The Breach Notification Rule

This rule implies that you, a software provider, should inform your patients or users about any data breaches within your digital product. You should also immediately report data breaches to organizations like the Department of Health and Human Services. If the data leak affects more than 500 patients, you need to contact the media.

The Omnibus Rule

This regulation is the most recent update to HIPAA, which elaborates on standards not addressed in previous requirements. The Omnibus Rule strengthens the data privacy policy further, extending HIPAA’s obligations for business associates, updating the breach standard, and prohibiting storage, purchase, or sale of data, even those not containing the user’s date of birth.

Secure Authentication

This requirement insists on the implementation of reliable user authentication. However, the HIPAA does not specify which authentication approach you need to implement in your app, so choose from the available options:

  • 2FA (two-factor authentication)
  • MFA (multi-factor authentication)
  • Password-less (for example, FaceID)


This requirement implies that your software must follow the technical and administrative measures to ensure data integrity. By integrity, HIPAA means that data cannot be modified or damaged unintentionally. Softermii experts recommend you accomplish this by implementing:

  • Authentication
  • Digital signature
  • Encryption
  • Blockchain app architecture
  • Device access control

Storage Encryption

Encryption is another requirement for developing a HIPAA compliant app. According to the Act, ePHI must be encrypted both at rest and in transit.

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8 Steps for Building HIPAA Compliant Software

Now you understand the basic requirements for HIPAA compliant mobile app development. Then it’s time to highlight the main steps to create secure software that follows all regulations.

Step 1. Conduct Analysis and Audit

As a software vendor, you need to review your product’s compliance with HIPAA. You have to do this regularly and report on the outcomes to your partner organization: a healthcare company for which you are developing this software. This way, you protect yourself from the risks of data leakage and HIPAA penalties. Growing medical practices can also benefit from checking out the existing HIPAA-compliant software products and how they operate.

Step 2. Create and Implement Remediation Plans

Once you have done the analysis and self-audit, you are more likely to see the gaps in your HIPAA compliance. Since you have identified such vulnerabilities, you can develop a plan to address them.

Step 3. Hire a HIPAA Compliance and Security Specialist

HIPAA regulations require you to hire a data security expert. This employee will find ways to reduce all the risks associated with patients’ personal information and will be able to train your team in this regard.

Step 4. Provide Secure Documentation Management

If you want your software to meet HIPAA requirements, make sure it has structured documentation. This documentation should be stored in a safe repository and be available to you at any time.

Step 5. Develop an Incident Management System

Your software should be able to analyze and manage incidents. What does it mean? In case of an incident, the system should identify the problem and take appropriate measures to protect sensitive data. To do this, you must identify errors in advance to avoid data leaking situations.

Step 6. Use the .NET Framework to Ensure HIPAA Compliance and Provide Code Access Security

To ensure complete HIPAA compliance and data security, use the .NET Framework. It is a set of class libraries and a runtime to provide rapid creation and efficient operation of web services and apps. The .NET Framework vision is to offer simple programming coupled with scalable free-to-use Internet protocols.

Using the .NET Framework is also a step forward to guarantee software security. It lets you provide a fine-grained and evidence-based security system around your app. The .NET Framework can ensure system administrators and users do not have access to the data they are not supposed to see via numerous granular permissions.

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Step 7. Sign a Business Associate Agreement

Signing a business associate agreement with any healthcare organization is another step towards full HIPAA compliance for web applications and mobile apps. Since you supply software to your partner like a healthcare facility, such an agreement is a must.

HIPAA Compliance Checklist for Medical Software Development

At this point, you are already aware of the fundamental HIPAA regulations for patient data protection. They include adhering to relevant privacy, security, and data leak rules. But what about software development? Are there any particular pitfalls or milestones to think about? To answer this, we will go through the main features of the HIPAA compliance checklist for information technology.

User Authorization

The administrator must strictly control user access to the healthcare app. Be sure to integrate the identity verification feature and the appropriate password requirements into your software.

Access Control

Determine in advance what features of your app will be available to specific users. For example, a doctor may access more advanced application functionality than his patients.

Remediation Plan

As we have already said, this is a plan that you develop to avoid all possible risks related to data security. In addition to creating such a plan, you need to integrate it into your software.

Data Backup

Think carefully about what types of patient data you are going to store. You may not even need to know your user’s address or ZIP code. Before creating a healthcare app, you have to think about such matters in advance and develop a privacy policy for data backup.

Emergency Mode

Access to all patient data is sometimes critical in emergencies. Therefore, add an emergency mode feature to your software so that a doctor can quickly retrieve information about his patient.

Automatic Logout

It is another efficient data security measure. Implement the automatic logout feature if the user has not been active in your program in a while.

Data Encryption

Make your network secure for patient data with robust encryption protocols.

Softermii Experience with HIPAA Compliant Software Development

Our company has extensive experience developing medical software, so we are used to satisfying legal requirements. And if you decide to build a HIPAA compliant app, you can always contact us for help. For our part, we provide the following benefits of cooperation:

Governance & Compliance

Our application security team ensures that we offer apps in strict compliance with HIPAA and PCI US government regulations through ongoing code assessments, reporting, and remediation advice to healthcare companies.

Continuous Assessment of Risks

We provide services to continually assess your web and mobile apps risks from the start of the project to ongoing app support and upgrades without slowing down the development processes.

Code Visibility for Developers

We ensure that our developers, along with your on-site development team, have full and constant access to the code to identify and fix malicious vulnerabilities at any point to safeguard your clients and the development process.

Support of Coding Best Practices

Rest assured that our development team ensures the use of the best industry practices in secure application design. Also, we are ready to provide your team with remediation guidance and support for your ongoing projects.

Our HIPAA Privacy Measures

Privacy measures have no hierarchy as to the HIPAA regulations. Each point of access should still fully adhere to HIPAA if you plan that your app and organization, in general, fully comply with HIPAA.

How to make an app HIPAA-compliant

Data Protection for Healthcare Organizations

With the ever-growing need for advanced apps with high UX and low development cost, the issue of data security is pushed to the margins.

But as the electronic patient databases expand, the demand for additional security grows. High-quality care in the digital age requires healthcare organizations to embrace the need for on-demand data access fully compliant with HIPAA standards and PHI protection.

Our team can implement the data protection solutions for your particular project. For example, we have successfully done this in the HIPAA Telmed product. As the name suggests, it is a platform for telemedicine that fully complies with HIPAA standards. Learn more about this case by following this link.

The Best Data Protection Solutions Offered by Softermii

We offer solutions that recognize and protect patient data in all forms, either structured or unstructured, such as emails, documents, and scans. We do this through a web or mobile app that allows healthcare providers to share data securely and effectively.

When patients entrust you with their healthcare, your organization needs to prioritize taking care of their private health-related and personal information. Let’s look at some Softermii cases to see how we help take care of users’ personal information through our products.


HIPAA compliance application development

It is advanced medical software that we have developed in the form of web and mHealth platforms for booking doctor appointments and conducting telehealth visits.Since MedRealtime allows patients to receive care remotely, it was significant for us to ensure high data security. Here’s how we accomplished our HIPAA mobile app development:

  • Secure video and messaging room with built-in NAT, firewall, and encrypted security according to healthcare regulations
  • PIN access to the video room for users
  • Confidential way to send patient data over EHR networks running over HTTPS protocol
  • Secure payment gateway

Let’s look at another medical app we have created.


Building HIPAA-compliant software

It is a mobile app that connects doctors and healthcare product companies. This application does not store patient personal data, but it contains numerous doctor accounts and a list of medical product companies along with their offers. As a result, physicians may now conveniently search for the medical software or apps they need and connect the sellers directly.

Final Thoughts on Building HIPAA Compliant Software

Ensuring HIPAA compliance for mobile apps or other software means making your users’ data security a top priority. And that, in turn, means satisfied customers: healthcare facilities, doctors, and patients.

Once you have an idea for an app, for example, HIPAA compliant video conferencing software, feel free to contact us and have it checked for your target healthcare market. We will guarantee to meet all specifications, HIPAA regulations, and best practices. It is always helpful to work with someone who knows the tricks of the trade and can ensure a safe and smooth development process based on strategic insights, advice, and lessons learned.

Frequently Asked Questions

What does the HIPAA IT compliance checklist consist of?

Consider the following technical aspects: secure authentication, integrity, encryption, user authorization, access control, remediation plan, automatic logout, etc. Furthermore, this checklist consists of HIPAA Privacy Rule, HIPAA Security Rule, HIPAA Enforcement Rule, the Breach Notification Rule, and the Omnibus Rule.

What are HIPAA Security Rules?

The HIPAA Security Rule consists of standards created to protect patients’ electronic personal health information. This regulation also requires the use of appropriate measures to guarantee the security, confidentiality, and integrity of such information.

What are the main steps to building HIPAA compliant software?

The primary steps to making your software HIPAA compliant are conducting analysis and audit, implementing remediation plans, hiring a data security specialist, developing an incident management system, and providing secure documentation control.

Can software be HIPAA compliant?

Yes, it can. To achieve this result, you need to follow the HIPAA requirements and ensure data protection best practices.

How long does it take to become HIPAA compliant?

It will take up to six months if you hire full-time employees or longer in the case of part-time work.

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