How to Develop a HIPAA Compliant Software

Why is HIPAA compliance for the software so crucial? There are many acronyms that flow through the healthcare industry and it can be hard to keep track of all the requirements, but it is essential to understand them thoroughly since your organization’s reputation depends on it.

From healthcare terminology to regulatory procedures, each stands for a higher purpose. They ensure the safety and protection of both patients and health care providers.

Let’s talk about HIPAA. This stands for the Health Insurance Portability and Accountability Act of 1996 and assures patients’ protected health information (PHI) remains confidential. 

We will discuss who needs to pass HIPAA compliance, how to choose a software partner to develop HIPAA compliant software from scratch or update the existing medical infrastructure with new modules and interfaces. Finally, we will cover six steps for creating HIPAA compliant software:

Who Needs to Obtain HIPAA Compliance?

HIPAA-covered entities are individuals or companies that receive, forward, or update electronically protected health information (ePHI) or electronic health records (EHRs). Based on the U.S. Department of Health & Human Services classification, we can divide them into four main groups:

• Health care providers – doctors, clinics, psychologists, and dentists, who transfer any data in an electronic form along with a transaction for which HHS has selected a standard.
• Health care plans – health insurance companies, HMOs, company health plans, etc.
• Health care clearinghouses – organizations that process nonstandard health data they receive from another facility into a standard electronic format or vice versa.
• Health care business associates – a person or entity that delivers services that involve the use or disclosure of PHI on behalf of a covered entity.

In a nutshell, every business that deals with patient health information should ensure they use HIPAA compliant software and follow procedures to maintain the security of this information. 

6 Steps For Creating HIPAA Compliant Software

The development of new healthcare software and the implementation of software into an electronic health record implies compliance with HIPAA requirements. 

There are two common ways in the healthcare software ecosystem: 

• Software development from scratch 
• Integration of software modules or interfaces into legacy medical infrastructure that requires thorough analysis to make sure that all implementations are embedded properly. 

It’s essential to make sure that your in-house team or software development partner has extensive expertise in developing HIPAA compliant software. This way, you can ensure that software security can both assist in achieving regulatory compliance with HIPAA and is developed and deployed with security as a priority. 

Now let’s talk about steps the software provider should follow when building HIPAA compliant software. 

1. Assure Core HIPAA Security Training

All members of a software development team must receive relevant training on HIPAA compliance to correspond to security basics and recent privacy trends throughout the whole software development process.

Since the software development process incorporates security and privacy considerations, the basic tenets of training are consistent with the HIPAA Security and Privacy Rules. It requires workforce training, including IT staff and engineers, as it relates to securing software to protect PHI. 

From our experience, we conduct security training according to HIPAA compliance requirements for our team members on a regular basis to make sure they know what PHI is, how to protect sensitive data, and are aware of the latest updates and best practices. 

When onboarding new developers on the project, there is a mandatory briefing on security requirements for HIPAA compliant software development ensuring that everyone is on the same page. It allows enhancing the security of our workforce and, more importantly – the client’s customers and their data.

2. Establish Security Requirements

It’s essential to consider security and privacy as a fundamental aspect of secure software development. The team needs to define security requirements for a project during the initial planning stages to identify critical milestones and deliverables and to authorize security and privacy integration to reduce disruption to plans. Establishing security requirements in the very beginning saves time and helps avoid difficulties with HIPAA compliance certification. 

3. Ensure Risk Prevention Activities

Activities mentioned below make it easier for covered entities to acquire, build, integrate, and maintain the software in compliance with the HIPAA Security Rule during the whole security SDLC.

Use of Appropriate Cryptographic Standards

The use of best practice cryptographic standards is the beginning of evaluating whether the software will meet HIPAA Security Rule requirements. 

• Full-Disk or Virtual disk encryption

The full-disk method implies encrypting all the data on a computer’s hard drive along with its operating system. The virtual disk method allows encrypting data containers, which comprise many files and folders. Both approaches comply with HIPAA requirements. Access is guaranteed only after user authentication. 

• File Encryption

This approach allows encrypting specific files and folders with a unique key that mitigates threats involving malware and remote access to protected data. File encryption is necessary for data transfer and exchange to prevent data exchange vulnerabilities.

• Secure Sockets Layer (SSL)

SSL is a safe transfer tunnel that ensures data encryption in transit and protects files transferred between the user’s browser and cloud server or between different parts of the healthcare system. Using SSL allows exchanging of data with trusted internal parties only and prevents any data leaks.

Finding Software Vulnerabilities by Analyzing Attack Surface

Attack surface reduction means reducing risk by giving hackers less opportunity to exploit a potential weak spot or vulnerability. It also may include shutting off or restricting access to system services, applying the policy of least privilege, and layered defenses. All software components must have enough permissions and data access to perform its functions. No more of that. Minimizing attack surfaces and vulnerabilities improves data security to ensure HIPAA compliance of the software product.

Risk Assessment, Analysis, and Measures

It’s better to start with risk analysis by carefully reviewing requirements and expectations to identify security concerns and privacy risks. It’s more professional advice rather than a requirement for the development of HIPAA compliant software. Since almost all medical systems interact with third-party networks, it’s a potential point of data loss or breach of PHI and requires specific consideration. Risk analysis practice provides an organization with a high-level approach for evaluating and understanding how each integrated module affects its protected health information security. Having a big and clear picture of potential risks, respective causes and prevention measures helps address HIPPA compliance requirements for software products.

Threats Modeling

Security threats assessment, testing and modeling help identify the top threats in the physical, software, and operational areas and implement the right controls for HIPAA compliance.

A team cannot build secure HIPAA compliant software unless it understands the assets the project is trying to protect, the threats and potential vulnerabilities introduced by the project, and details of how the project mitigates those threats.

Threat analysis is valuable in identifying systems integration vulnerabilities — for example when integrating your product with hospital electronic healthcare record (EHR) systems.

4. Implementation of HIPAA Compliant Software

The implementation practices of the Security SDLC process are critical to the overall ability of the healthcare software to protect the patient’s PHI, particularly in the case of the new HIPAA compliant software development scenario.

From our experience, when a project is from scratch, implementing security software practices is much easier than when it comes to legacy systems. In legacy projects, the transition to HIPAA requires a more thorough analysis as there are many pitfalls you can face. For example, such cases as insufficient API implementation or decrepit authorization when switching from HTTP to HTTPS.

The common goal is to deliver well-functioning HIPAA-compliant software with minimum defects to avoid potential outbreaks. Implementation is focused on the processes associated with how an organization develops and deploys software elements and their related deficiencies. 

5. Initiate HIPAA Compliance Verification

No less critical is the verification that the security practices are successfully implemented to comply with HIPAA requirements. 

Verification concentrates on the processes and activities related to how an organization checks and tests artifacts produced throughout software development. 

This process usually includes extensive testing using several methods, and an automated or manual code review for security issues to verify the software security complies with HIPAA and provides higher assurance of safety than analysis alone. 

As for our experience, we estimate twice as much time for testing as for development since we understand the importance of sensitive patient information. It’s essential to verify thoroughly huge volumes of HIPAA-related data to ensure that it’s secured.

When working with a legacy project, it becomes more critical – verification of HIPPA compliance goes first, and only then implementation and extension of functionality.

6. Create an Incident Response Plan

Every release of HIPAA-compliant software should include an incident response plan. Even systems with no identified vulnerabilities at the time of release can be exposed to new threats that appear over time. The Incident Response Plan should tell you how to identify and settle the situation, how to contain the situation, how to fix the situation, and how to retrieve anything affected by the incident. These measures ensure the ability of software to maintain HIPAA compliance with each following release and update.

What’s Next

During the COVID-19 pandemic, HIPAA compliance is more crucial than ever. In the age of HIPAA-compliant software, no disease outbreak on this scale has ever been experienced. Thus, health systems give access to care management and self-service applications. Whereas the growth of telehealth offers enhanced efficiency and mobility, it also significantly increases the security risks for healthcare data.

The HIPAA Security and Privacy Rules ensure the security of PHI and restrict the uses and exposures of PHI to those related to treatment, payment, and healthcare services.

HIPAA compliance requirements ensure security and credibility and consequently contribute to a healthcare organization’s growth. No less important is choosing a reliable software partner that knows what security and privacy measures must be in place.