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HIPAA Software Compliance: Considerations & Requirements

by | October 26, 2023

HIPAA compliance in software development is not merely a box to check. It’s a commitment to patient privacy and data security. 

However, as technology continues transforming the healthcare landscape, ensuring HIPAA compliance for software development becomes more challenging.  

For example, did you know that between 2009 and 2022, there were 5,150 data breaches in the healthcare sector? Additionally, in 2018, these breaches were reported at a rate of approximately 1 per day. In 2022, this rate more than doubled, with an average of 1.94 healthcare data breaches of 500 or more records reported daily. 

So, how can you ensure your healthcare systems and software are bulletproof to security vulnerabilities? 

Let’s cover everything related to HIPAA, including the HIPAA compliance software checklist, apps that are subject to HIPAA, best practices in the field, and some other HIPAA-compliant software examples. 

What is HIPAA and Why is it Important? 

HIPAA (also known as the Health Insurance Portability and Accountability Act) is a federal law enacted in 1996. It was designed to address several critical aspects of healthcare, including data privacy and security, as well as patient rights.  

HIPAA is of paramount importance because it: 

  • Establishes a framework for safeguarding sensitive patient data 
  • Ensures the confidentiality and integrity of healthcare information 
  • Aims to prevent healthcare fraud and abuse  
  • Grants patients greater control over their health information 

Compliance with HIPAA for software developers is not just a legal requirement but an ethical commitment to protect individuals’ sensitive healthcare data. 

Apps and Software That are Subject to the Health Insurance Portability and Accountability Act (HIPAA) 

HIPAA compliance applies to various types of healthcare-related apps and medical software, including:  

  • Electronic Health Record systems: EHR systems are digital versions of a patient’s paper chart. They store patients’ medical histories, diagnoses, medications, and treatment plans. The best EHR software development practices apply robust security measures and provide controlled access to patient records to ensure 100% compliance with HIPAA. 
  • Health Information Exchange platforms: HIE platforms facilitate the secure exchange of patient data among healthcare providers. HIPAA compliance ensures that sensitive patient information shared through these platforms remains confidential.  
  • Picture Archiving and Communication Systems: PACS software stores and manages medical images, such as X-rays and MRIs. HIPAA mandates strict controls on access to these images and encryption for secure transmission.  
  • Laboratory Information Systems: LIS software manages and tracks laboratory test orders and results. HIPAA compliance in LIS ensures the confidentiality of patient data, particularly sensitive test results.  
  • Radiology Information Systems: RIS software is used in radiology departments to manage patient scheduling, reporting, and image tracking. Compliant RIS systems prioritize data security and access control.  
  • Telemedicine/telehealth platforms: Telehealth technology enables remote medical consultations, while telemedicine solutions allow the exchange of healthcare information between patients and healthcare providers. HIPAA requires these platforms to implement encryption and stringent privacy controls to protect patient information during virtual visits and information exchange.  
  • Patient portals: Patient portal software allows individuals to access their health records, schedule appointments, and communicate with healthcare providers. HIPAA-compliant portals ensure secure access to patient data.  
  • Clinical Decision Support Systems: CDSS software assists healthcare professionals in making clinical decisions. HIPAA compliance ensures that these systems maintain the confidentiality and integrity of patient data.  
  • Mobile health apps: Mobile health apps cover a broad spectrum, from fitness trackers to apps that manage chronic conditions. If they handle protected health information (PHI), they must adhere to strict data protection standards. 

What Are the HIPAA Compliance Software Requirements

HIPAA establishes stringent guidelines to safeguard patients’ PHI. The HIPAA compliance checklist for software development includes: 

  • Patient consent: Software applications must obtain patient consent before collecting, using, or disclosing their PHI. Consent should be clear and informed, with patients fully aware of how their data will be utilized. 
  • Security safeguards: Software must implement robust security measures to protect PHI from unauthorized access or breaches. This includes encryption, access controls, and audit logs to track data access. 
  • Minimum necessary rule: Software should only use or disclose only the most necessary PHI needed to accomplish the intended purpose. Unnecessary exposure of patient data is discouraged.  
  • Data integrity: Software applications must ensure the accuracy and integrity of PHI. Any modifications or corrections to patient records should be properly documented.  
  • Access control: Access to PHI should be limited to authorized personnel who require the information for legitimate healthcare purposes. Role-based access control is commonly used to enforce these restrictions. 
  • Data transmission security: When PHI is transmitted electronically, software must use secure methods such as encryption to protect it from interception or unauthorized access during transmission.  
  • Breach notification: In the event of a data breach affecting PHI, software developers and healthcare entities must adhere to HIPAA’s breach notification requirements. Patients and relevant authorities should be informed promptly.  
  • Training and awareness: Personnel handling PHI must receive training on HIPAA compliance. Software providers should promote awareness of HIPAA regulations among their users. 
HIPAA compliance software checklist

The Software Development Life Cycle (SDLC) and HIPAA 

To ensure that your healthcare software adheres to HIPAA regulations, you first must understand the Security in the Software Development Life Cycle (SSDLC) within the context of HIPAA compliance.  

First, let’s get a brief overview of the software development life cycle: 

Overview of SDLC 

SDLC is a structured process used for designing, developing, and maintaining high-quality software.  

When it comes to HIPAA compliance, SDLC plays a crucial role in ensuring that healthcare software meets the rigorous standards of data security and privacy mandated by the Health Insurance Portability and Accountability Act. Each stage of the SDLC process is carefully orchestrated to integrate HIPAA compliance measures, safeguarding patient information from inception to deployment. 

Let’s see how this is one at each stage of SDLC. 

Integration of HIPAA Considerations at Each Stage 

If you follow all HIPPA-related regulations and requirements, you can qualify for HIPAA compliance certification for your software solution.  

But how exactly can you incorporate all HIPAA regulations in your solution?  

Here’s how HIPAA compliance is integrated into SDLC, ensuring full compliance: 

Requirement Analysis

At this initial stage, developers work closely with healthcare providers and stakeholders to identify the specific HIPAA requirements and constraints of the project. They analyze the types of data to be handled, access controls, and encryption protocols needed to protect patient information. 


In the design phase, HIPAA compliance considerations influence architectural decisions. Developers ensure that the software’s structure allows for secure data transmission, storage, and access. They also plan for audit trails and user authentication methods. 

Development and Coding

During coding, developers write code with an emphasis on security. They implement encryption algorithms, authentication processes, and secure APIs to protect patient data. Regular code reviews and testing help catch vulnerabilities early. 


This involves rigorous security testing, including penetration testing and vulnerability assessments. This stage ensures that the software withstands potential threats and adheres to HIPAA standards. 


Before deployment, a final HIPAA compliance check is conducted. This includes verifying that data encryption and access controls are correctly configured. Only after this thorough examination is the software ready for release. 


Ongoing maintenance includes constant monitoring and addressing any emerging threats. HIPAA compliance is continually assessed to adapt to evolving security challenges and regulations. 

Best Practices for HIPAA-Compliant Software Development 

To achieve HIPAA compliance, software vendors need to adopt a set of best practices that safeguard patient information while creating innovative healthcare solutions.  

Let’s delve into some of these best practices for developing software that meets HIPAA standards. 

  • Data encryption at all times: Ensure that sensitive patient data is encrypted both when it’s stored (at rest) and when it’s transmitted between systems (in transit). This safeguards patient information from unauthorized access. 
  • Regular security audits and risk assessments: Conduct frequent security audits and risk assessments to identify vulnerabilities in your software. This proactive approach helps you stay ahead of potential threats and ensures ongoing compliance. 
  • Role-based access control: Implement role-based access control to restrict system access based on the roles and responsibilities of users. This ensures that only authorized personnel can view or modify patient data. 
  • Secure coding practices: Train your development team in secure coding practices. Enforce secure coding standards and conduct regular code reviews to identify and fix security flaws early in the development process. 
  • Data backup and disaster recovery: Regularly back up patient data and create a robust disaster recovery plan. This ensures that patient information can be quickly restored in case of data loss due to unforeseen events. 
HIPAA compliance for software development

Examples of HIPAA-Compliant Software 

Scopic builds various HIPAA-compliant software solutions, catering to the diverse healthcare needs of our clients. Here are some of the HIPAA-compliant software solutions we developed:  


Accurate shade matching is paramount in dental restoration, yet it is often a challenging and inefficient process that involves lots of back-and-forths between dentists, patients, and labs.  

Shadewave envisioned a solution to enhance this process and Scopic’s healthcare software development experts brought this vision to life. The shade matching tool employs advanced image processing algorithms to calculate tooth shade, translucency, and value with remarkable precision.  

Approved as HIPAA compliant, Shadewave’s cloud-based software simplifies the entire process, benefiting practitioners, patients, lab teams, and ceramists alike.  


Nautilus Medical aimed to simplify the exchange of medical images, reports, and EMR data. They collaborated with Scopic to develop AutoRay+, a comprehensive DICOM distribution system.  

This system allows for the automatic exchange of medical data between users, specialists, and patients. It features:  

  • Merge and edit of patient demographics 
  • PACS query/retrieve 
  • Auto-burning of CDs/DVDs 
  • A DICOM viewer 
  • Peer-to-peer exchange services 

The result: efficient and secure data exchange built with HIPAA compliance in mind. 


Mediphany, developed in partnership with Scopic, tackles the intricacies of medical image interpretation. This radiology imaging software simplifies MRI and CT scan analysis with high-quality 3D models and expert guidance, all within a secure and HIPAA-compliant environment 

Users can obtain professional insights remotely, eliminating the time and cost constraints of traditional radiology consultations.  

Mediphany also ensures that all patient data is safe at all times, making radiology image sharing efficient and safe. 

ECS Clinical

Clinical professionals work in a fast-paced and high-stress environment. This requires them to have real-time collaboration channels where they can exchange real-time updates, regardless of their physical locations. 

Enter ECS Clinical Messenger – an app that facilitates consultations and collaborations across healthcare enterprises.  

Scopic’s seasoned developers brought ECS Clinical Messenger to life, enabling healthcare professionals to connect effortlessly via chat, voice, SMS, or video. The solution also adheres to HIPAA compliance standards, ensuring that sensitive healthcare information remains secure and private. 

Ready to build your own HIPAA-compliant software?

 We offer expert custom healthcare software development services that can help you build a cutting-edge solution while prioritizing data security and user-friendliness.


HIPAA compliance is an ongoing commitment. As technology evolves, so do cyber threats. Regular security audits, strong data encryption, role-based access control, secure coding, and data backups are foundational.  

Protect patient data and deliver excellence in healthcare. Choose Scopic for HIPAA-compliant software that exceeds expectations. Contact us today to start your journey to secure, compliant healthcare software. Your patients and business will thank you. 


About Creating HIPAA Software Compliance Guide

This guide was authored by Veselina Lezginov, and reviewed by Nhat Bui, a Solution Architect with experience in leading and delivering complex software projects.

Scopic provides quality and informative content, powered by our deep-rooted expertise in software development. Our team of content writers and experts have great knowledge in the latest software technologies, allowing them to break down even the most complex topics in the field. They also know how to tackle topics from a wide range of industries, capture their essence, and deliver valuable content across all digital platforms.

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