If you’re developing an app, a patient portal, or any digital health tool, getting compliance right from the start is non-negotiable. Here, the Health Insurance Portability and Accountability Act (HIPAA) serves as the foundation of patient trust.
​But where do you even begin? It can feel overwhelming. As a team that specializes in developing secure software for the healthcare industry, we’ve guided many companies through this exact process. That’s why we’ve created a straightforward HIPAA compliance software checklist—so you have clear, practical steps to build and maintain a solid compliance program.
What Is HIPAA Compliance?
HIPAA is a U.S. law that sets a national standard for protecting patient health information. HIPAA compliance means following the rules in the Health Insurance Portability and Accountability Act.
As a U.S. law, HIPAA mainly applies to organizations in the United States. However, it also covers foreign companies working with U.S. healthcare groups. For example, if a company from another country provides online storage or assists with drug testing for U.S. patients, it must follow HIPAA regulations when handling patient health information, regardless of location.
Who needs to be HIPAA compliant?
Two main groups are required to comply with HIPAA regulations:
- Covered Entities: These are the primary healthcare providers, health plans, and healthcare clearinghouses. This includes doctors’ offices, hospitals, clinics, dentists, pharmacies, insurance companies, and government programs like Medicare and Medicaid.
- Business Associates: These are individuals or organizations that perform work on behalf of a covered entity and have access to Protected Health Information (PHI). This can include billing companies, IT providers, cloud storage services, lawyers, and accountants who work with healthcare clients.
What data must be protected?
When talking about HIPAA compliance checklist for software development, we’re primarily focused on protecting electronic Protected Health Information (ePHI)—any identifiable health data that you create, receive, maintain, or transmit electronically, such as names, addresses, dates, social security numbers, medical records, and so on.
HIPAA lists 18 identifiers. If any of these are present in health information, that information is considered “individually identifiable” and is treated as PHI.
It means that organizations that handle protected health information (PHI) must have physical, technical, and administrative safeguards in place to ensure the privacy and security of this sensitive data.
Keep in mind that AI in healthcare often relies on large data sets for training. These datasets typically contain personal information, health data, or protected health information (PHI). Since AI uses this kind of data, privacy laws and regulations will affect how the data can be used. For example, if the AI handles a lot of PHI, HIPAA rules will apply, whether the AI is used by a Covered Entity or its Business Associates.
The Core HIPAA Compliance Rules
Before diving into code, you need to understand the main components of HIPAA that apply to software. There are five key HIPAA regulations to know:
- The Privacy Rule: This rule defines who may access and use ePHI. For software, you must implement controls that guarantee only authorized users view data (e.g., a doctor accesses only their patients’ records, not others).
- The Security Rule: This is the most critical rule for software development. It dictates how you must protect ePHI. It’s broken down into three categories of safeguards, which we’ll explore in detail below.
- The Breach Notification Rule: This rule obliges you to alert patients and authorities if a data breach occurs. Your software’s design and logging mechanisms are critical for detecting and managing breaches effectively.
- The Omnibus Rule: This is a final rule that strengthened and expanded HIPAA regulations. It officially extended HIPAA’s requirements to business associates, who are any third-party vendors that handle PHI on behalf of a covered entity.
- The Enforcement Rule: This rule deals with the “what happens if” scenario. It outlines the procedures for investigations into potential HIPAA violations and details the civil money penalties that can be imposed for non-compliance.
Step-by-Step HIPAA Compliance Checklist
Becoming HIPAA compliant requires a structured approach to protect patient data and avoid penalties. It’s not a one-time task but an ongoing commitment to handling sensitive health information. This HIPAA compliance requirements checklist simplifies the process into key steps, followed by an explanation of the core rules.
The Privacy Rule
The Privacy Rule is all about patient rights and the proper use of their health information. It governs who is allowed to view, use, and share ePHI. When building software, you’re essentially creating a digital environment where these rights are either protected or violated.
Key HIPAA Compliance Steps:
- Identify all forms of PHI (written, electronic, verbal)
- Develop and implement policies for how PHI is used and disclosed
- Provide patients with a Notice of Privacy Practices (NPP)
- Train staff on permitted uses/disclosures and minimum necessary standards
- Put safeguards in place to prevent unauthorized access
- Establish procedures for handling patient access requests and amendments
The Security Rule
The Security Rule is your technical blueprint. Think of it as the specific list of locks, alarms, and security protocols for your digital house. It’s broken down into three types of safeguards.
1. Administrative Safeguards
These are the policies and procedures that form your security strategy. They are about how your organization manages security, not just the tech itself.
- Conduct a Risk Analysis: Identify where ePHI is located within your system and assess the potential risks to its confidentiality, integrity, and availability.
- Assign a Security Officer: Designate a specific person (or team) responsible for developing and implementing your HIPAA security policies.
- Implement Staff Training: Everyone on your team who interacts with ePHI—from developers to support staff—needs regular training on security policies and procedures.
- Manage Security Incidents: Have a clear plan for how to identify, respond to, and report security incidents.
2. Physical Safeguards
These controls focus on protecting the physical hardware and infrastructure that stores and accesses ePHI.
- Control Facility Access: If you have on-premise servers, ensure only authorized personnel can access them.
- Secure Workstations: Implement policies for workstations that access ePHI, whether they’re in an office or remote. This includes things like screen locks, password protection, and proper data handling on personal devices.
- Manage Devices and Media: Have strict procedures for the use and disposal of devices that contain ePHI, such as laptops, hard drives, or USB sticks.
3. Technical Safeguards
This is where the code meets compliance. These are the technology-based controls you build directly into your software and systems to protect ePHI. At Redwerk, we have extensive hands-on experience, from conducting detailed security code reviews for IT support providers to performing full-fledged SDLC audits for AML/KYC companies.
- Implement Access Control: Ensure users can only access the minimum necessary information to do their jobs. A great way to achieve this is through role-based access control (RBAC), where permissions are assigned based on a user’s role (e.g., doctor, nurse, admin, patient).
- Use Unique User Identification: Every user must have their own unique login (no shared accounts!). This is fundamental for tracking activity.
- Establish Audit Controls: Your software must be able to record and examine activity. This means logging who accessed what ePHI and when. These logs are essential for detecting and investigating potential breaches.
- Ensure Data Integrity: You need mechanisms to prevent the unauthorized alteration or destruction of ePHI. This often involves using checksums or other cryptographic methods.
- Encrypt, Encrypt, Encrypt: All ePHI must be encrypted both when it’s “at rest” (stored on a server or database) and “in transit” (being sent over a network). Using end-to-end encryption is the gold standard here.
The Breach Notification Rule
A data breach is one of the biggest fears in healthcare tech. This rule provides a clear playbook for what to do in the event of the worst-case scenario. Having a plan is great, but knowing how to execute it is even better.
Key HIPAA Compliance Steps:
- Develop a clear incident response plan
- Identify what qualifies as a breach under HIPAA
- Notify affected individuals within 60 days of discovering a breach
- Notify the U.S. Department of Health and Human Services (HHS)—immediately for breaches affecting 500+ individuals, annually for smaller breaches
- Document breach investigation, notifications, and corrective actions
The Omnibus Rule
This rule was created to modernize the regulations and close loopholes that had emerged with the rise of digital health records and cloud computing. For any company developing healthcare software today, the Omnibus Rule is especially important because it directly addresses the role of technology partners. It expands obligations to business associates and subcontractors.
Key HIPAA Compliance Steps:
- Update Business Associate Agreements (BAAs) to include HIPAA requirements
- Extend HIPAA compliance obligations to subcontractors handling PHI
- Ensure patient rights include access to electronic copies of their PHI
- Restrict marketing, fundraising, and sale of PHI without patient authorization
- Revise policies and procedures to align with Omnibus updates.
The Enforcement Rule
The Enforcement Rule gives the government, specifically the Office for Civil Rights (OCR), the power to investigate complaints and conduct audits. It also outlines the significant financial penalties for non-compliance.
Key HIPAA Compliance Steps:
- Implement internal monitoring and auditing for compliance
- Document all HIPAA policies, procedures, and employee training
- Promptly address violations and apply corrective actions
- Maintain evidence of compliance efforts (risk assessments, training logs, incident reports)
- Prepare for potential audits and investigations by HHS OCR
Achieve HIPAA Compliance with a Trusted Tech Partner
A software development agency can be a crucial partner in achieving healthcare HIPAA compliance. The key is working with someone who understands both cutting-edge software development and the complex landscape of healthcare regulations. At Redwerk, our multi-disciplinary team has deep expertise in project management, business analysis, solution architecture, software development, and regulatory consulting to guide you through the entire process.
How We Can Help
- Concept Design & Architecture: We design your software’s architecture for HIPAA compliance from day one, selecting the right HIPAA-compliant technology stack and integrations.
- Development & Testing: By building your solution with essential technical safeguards, such as encryption and audit controls, we ensure your telehealth platform or medical diagnosis software is secure from the outset. Our process includes rigorous security testing to identify and eliminate vulnerabilities.
- Comprehensive SDLC Audits: We embed compliance directly into your software development lifecycle (SDLC). We can audit your entire development process—from project management and QA to DevOps—to ensure security and compliance are maintained at every stage.
- Audit-Ready Documentation: We create all the necessary documentation required for a formal audit, saving you significant time and resources. Having a clear HIPAA compliance requirements checklist and supporting documents is crucial for demonstrating HIPAA compliance in healthcare.
Why Choose Redwerk for Your HIPAA Compliance
Achieving HIPAA compliance in healthcare can seem daunting, but it becomes entirely manageable when integrated into your SDLC from day one. By following this HIPAA checklist for software development, you lay the foundation for a secure, trustworthy, and successful healthcare application.
However, if you’re looking for a HIPAA compliance requirements checklist tailored to your business needs, feel free to reach out. We’ll provide an actionable plan that is clear for both technical and non-technical team members. We also offer hands-on implementation support and comprehensive guidance to ensure you succeed.
Proven Experience in High-Stakes Industries
Since 2005, we’ve delivered complex software solutions for clients in government, healthcare, and fintech. For example, we partnered with a US-based healthcare cloud provider, ClearDATA, to support their legacy .NET product, ensuring strict adherence to HIPAA-compliant standards.
We also developed Current, an ADA-compliant e-government SaaS that simplifies the delivery of welfare programs in over 12 U.S. states and counties. Our experience demonstrates that we understand how to handle sensitive data and comply with the most stringent industry regulations.
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Deep Technical & Cybersecurity Expertise
Our team possesses deep expertise in secure software architecture, data encryption, and access control mechanisms. We are skilled at conducting comprehensive security risk analyses and penetration testing to identify and neutralize threats before they impact your business. This is a core part of our service, not an afterthought.
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Practical, Hands-On Experience
We aren’t just auditors; we’re practitioners who have built complex solutions from the ground up for over 170 businesses across North America, Europe, and Australia. This real-world experience means we know how to fix actual problems, not just check boxes on a HIPAA compliance sheet. For instance, when we helped Complete Network conduct a comprehensive software audit of their network mapping app, we not only verified its security but also increased its code maintainability by 90%.
Contact us today for a free, no-obligation consultation on your HIPAA strategy. Let’s build a solution that patients and providers can trust.
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