How to Build HIPAA-Compliant Software: A Clear Guide to Getting It Right

HIPAA-compliant software development isn’t optional when dealing with sensitive health data. Still, even the big players may get it wrong. Welltok’s 2023 MOVEit hack, for example, exposed data from 8.5 million people, which is considered one of the largest breaches ever.

“It takes 20 years to build a reputation and a few minutes of cyber-incident to ruin it,” a landmark quote by Stéphane Nappo, former CISO at Société Général, couldn’t be more true. For Welltok, that "few minutes" meant millions in recovery costs and reputational disaster.

If your business handles Personal Health Information (PHI) through EHR systems, billing software, telemedicine platforms, or other healthcare apps, you should use compliance as a concrete shield against security threats and penalties. The latter, by the way, can cause a hit of $50,000 per violation.

In this comprehensive guide by Overcode, you’ll find everything needed to develop secure, HIPAA-compliant software.

Why is HIPAA important in healthcare?

U.S. officials recently highlighted the importance of HIPAA in healthcare, stressing its role in industry cybersecurity.

Cyberattacks on major players like Ascension and UnitedHealth (data from 5.6 million people was exposed!) demonstrate just how vulnerable the healthcare sector can be. Since 2019, breaches caused by hacking and ransomware have increased by 89% and 102%, respectively.

But that’s not all:

• Healthcare data breaches have steadily surged over the past 14 years.

• 2023 set a harsh record with 725 breaches disclosing over 133 million records in the U.S. only.

• 677 major violations in 2024 alone affected more than 182.4 million individuals in the U.S.

That is why the answer to the logical question: Why is HIPAA important to healthcare? Is: because people demand stronger protection for their data. Threats are on the rise, and the Health Insurance Portability and Accountability Act, which we call HIPAA, remains an effective instrument to ensure healthcare stakeholders pay due attention to the protection of patient data.

What are the benefits of HIPAA in the healthcare field?

Being HIPAA compliant is, first of all, rewarding in terms of financial gain. Beyond protection from costly legal fines, the benefits of HIPAA include client trust, strengthened internal processes, and confident positions in the highly competitive medical software market. Let’s break each statement down.

• Avoided HIPAA violation penalties

  The fines for HIPAA violations can cost you a fortune but will vary based on each offense's severity, extent, and impact. Penalties range from $141 to $2,134,831 per violation, depending on intent, corrective actions, and the harm caused. No need to dwell on this benefit further; numbers speak for themselves.

• Stronger security and market confidence

  HIPAA compliance in software development demands standards that can significantly fortify your system’s resilience. Your business activity becomes more security-focused, making costly cyber attacks less likely and their impact less severe.

  On top of that, HIPAA-compliant encryption, audit controls, data integrity safeguards, and secure data transmission all are important indicators for healthcare professionals and their patients. They prove your commitment and responsibility, which are key to building trust and credibility in business.

• Competitive distinction

  Being HIPAA compliant is another way to showcase your expertise over competitors. Handling sensitive data in this very particular way makes your company a trustworthy choice for complex healthcare projects.

  Moreover, clients appreciate HIPAA compliance because it shows you’re serious about protecting their data. For example, a hospital chain might renew contracts knowing that your efforts keep them safe from audits and penalties.

• Streamlined development

  Following HIPAA guidelines from the start makes it easier to manage PHI, preventing rework and saving time. When features like encryption, authentication, and access control are part of a specific framework to follow, your engineers can focus on building core functionality without reinventing security measures. This way, you get a faster and more reliable development process.

Next, let’s go over the compliance requirements. After all, knowing how to make those benefits work is what really sets you apart.

HIPAA-compliant software requirements

Let’s perceive HIPAA requirements for software as a specific blueprint that lets you evaluate your software development approach from a compliance standpoint. Such requirements will give you clarity on both the technical and functional capabilities required from your software.

HIPAA compliance technical requirements

With technical software safeguards, you cover the “what” and "how" of data security. Below, we outline for you HIPAA compliance software requirements translated into the effective mechanisms to protect electronic protected health information (ePHI):

1. Data encryption: As the HIPAA Privacy Rule provisions dictate, ePHI must be encrypted both at rest and in transit, typically employing:
   - AES 256-bit encryption for data at rest.
   - TLS (Transport Layer Security) for data in transit.
   
   Remember that the least HIPAA-compliance software requirement for encryption is the AES 128-bit standard.

2. Audit and event logging: The system you develop must record every interaction with ePHI and capture important details, such as:
   - Timestamps of access.
   - User IDs of people interacting with ePHI.
   - Actions performed (view, modify, delete, etc.).
   
   Another important criterion in the logging aspect is data integrity. You should design the logs in such a way that they are tamper-proof. For example, you can opt for hash algorithms (e.g. SHA-256) to detect unauthorized changes.
   
   Also, HIPAA-compliant software systems should perform automated audits to meet the required 12-month frequency of log analysis and reporting.

3. User authentication and access management: To prevent unauthorized access to ePHI, health systems should implement the following:

   • Multifactor Authentication (MFA) which is a two-step process that combines something the user knows (password) and something they possess (token or phone-based code).

   • Biometric verification methods such as fingerprint or facial recognition.

   • Token-based authentication (e.g. OAuth, JWT) to certify users without repeated password entry.

   • Role-based access control (RBAC) which restricts access to ePHI based on the specific roles and responsibilities of users within the organization. This includes four key components:

     • Job functions such as physicians, administrative staff, or technical support. These roles range from general categories for therapists, doctors, nurses, etc., to specific roles like medical receptionist, IT support, and so on.

     • Access rights (e.g. read, write, delete) are assigned to the individual roles. The authorizations are tailored to the respective role to restrict access to only necessary data.

     • Users who are assigned based on their work tasks and whose access is regulated by the authorizations tied to their assigned roles.

     • Role hierarchy where higher-level roles (e.g. senior physicians, administrators) can inherit permissions from lower level roles, reflecting the structure of the organization and ensuring that individuals have appropriate access to data.

4. HIPAA screen lock and timeout requirements: As long as HIPAA screen lock requirements apply to organizations and their employees, establish internal policies such as a 10-minute inactivity timeout for the screen lock.

5. Transmission security and electronic transaction standards: You should ensure all data transfers use secure communication channels like HTTPS, SFTP, or VPN; digital certificates will help you authenticate servers and encrypt data exchanges. Choose HIPAA-mandated formats like ASC X12 for healthcare claims and payment processing or NCPDP for pharmacy transactions.

6. Breach response features: According to HIPAA guidelines in the case of theft of software, you have 60 days to report it to the Office for Civil Rights (OCR).
   
   Fully HIPAA-compliant software should automatically generate breach alerts, provide workflows for incident notification, and create detailed breach reports. Such reports should be specific, including the nature of the breach, the affected individuals, the data involved, and the corrective actions to mitigate further risks.

7. Contingency planning: One of the key requirements for digital healthcare systems is the ability to recover within 72 hours, especially for software classified as critical infrastructure. To meet the requirements, you can pay attention to the following architectural and backup strategies:

   • Implement cloud-based backup systems from scalable and secure services (AWS Backup, Azure Backup, or Google Cloud Storage).

   • Schedule incremental or differential backups to reduce recovery time. A pleasant bonus—minimized storage costs.

   • Maintain geographically distributed backups to protect data from localized accidents.

   • Spread workloads across systems to reduce strain and speed up recovery processes.

We’ve covered the requirements for your software, so now, let’s outline the process of building it, from planning to maintenance.

How to become HIPAA compliant?

The actual answer is quite straightforward: make your organization become HIPAA compliant. Here are the steps you can take to get there.

Conduct risk analysis

Every HIPAA-covered entity must practice regular self-audits to assess current compliance, identify risks, and spot areas for improvement. As medical software evolves, you'll need to update these assessments to catch up with the emerging threats. Mitigating risks, however, won't be enough without a clear plan on how to fix compliance gaps. Define how you will replace or modify existing systems to meet data security requirements with clear documentation and monitoring of your compliance progress.

Assign security responsibilities

Businesses operating in regulated sectors, and healthcare is for sure one of them, often face legal requirements to appoint Security Officers. So, a decisive step in how to get HIPAA compliant would be to appoint such a role. Security Officers take care of such HIPAA IT services as:

• Managing firewalls, encryption, and access controls.

• Securing cloud hosting, on-premise servers, and networks.

• Observing systems access and authentication.

• Handling data breaches and compliance reporting.

• Educating staff on security best practices.

• Protecting corporate communication channels.

In general, it’s the role entirely responsible for developing security strategies and policies.

Develop security strategies and policies

While security strategies and policies differ from company to company, depending on its needs and capacities, the overarching goal is the same: protect the confidentiality and integrity of sensitive information its ecosystem handles. The main task in this respect is safeguarding that only authorized users can access defined and approved systems.

You can take HIPAA compliance technical requirements outlined in the chapter above to lay a foundation for your corporate security standards.

Remediate issues

Consider the following measures to take another step in securing your network and systems handling ePHI:

• Use up-to-date anti-malware software to prevent malicious attacks on ePHI.

• Log all the security incidents, track responses, and keep records for compliance audits.

• Uninstall any software you no longer use to minimize potential vulnerabilities.

• Deploy firewalls, intrusion detection or prevention systems, as well as data loss prevention tools to protect ePHI.

• Conduct vulnerability scans every six months and penetration tests annually as HIPAA requires.

• Make sure you separate any systems containing ePHI from general-use networks.

• Ensure alerts notify administrators within 24 hours of unauthorized access or terminated user accounts.

You can also close inactive network ports to reduce the number of unauthorized access points.

Sign Business Associate Agreements (BAAs)

You might and will likely work with third-party vendors with PHI access. Think of cloud providers or independent contractors. Your task is to make sure you have signed Business Associate Agreements (BAAs) with them to put their HIPAA compliance in writing.

Provide employee training

Software can’t handle all the compliance-related staff. Your employees should also follow HIPAA policies with all due respect, mastering such aspects as:

• What is PHI and its importance?

• How to securely handle PHI.

• Recognizing and preventing potential breaches.

• Steps to be taken in case of a security incident.

• Disciplinary actions for non-compliance.

Your software, meanwhile, should help them track training progress. Just be patient and persistent: a culture of compliance and security awareness won’t appear overnight.

Evaluate regularly

Continuously monitor and evaluate your security measures. Update software proactively. Repeat the previous two steps. New regulations shouldn’t catch you off guard, but sometimes they can. The latest HIPAA Notice of Proposed Rulemaking dropped on December 27, 2024—right in the middle of the holiday season. This way, staying prepared is the only constant in a compliance-driven environment.

How to build HIPAA-compliant software

Building HIPAA-compliant software requires translating security, privacy, and operational policies into safe coding and development practices. Let’s talk about how to do it right.

Select HIPAA-compliant technology

Fortunately, HIPAA-compliant healthcare technology offers plenty of appealing options, from secure cloud platforms to development frameworks. Focus on compliant technologies your team knows well and those that fit your budget.

HIPAA compliance early in development

Frameworks like the Secure Development Lifecycle (SDL) are a great way to build security and compliance into every step. You can take them as a basis and continue with the following:

• Peer reviews or automated tools to verify that the code meets HIPAA standards.

• Unit, integration, and system testing at every stage.

• Tracking access to ePHI to immediately detect and stop unauthorized activity.

• Having a response plan in place to quickly detect, log, and report breaches.

• Continuous improvement regarding HIPAA standards, which means risk reviews and security measures updates as the new best practices in this sphere might require.

The technology stack you'll pick for the back end and front end of your system is just as crucial in this compliance-maintaining process.

HIPAA standards on the back end

The major cloud providers already offer HIPAA compliance for software development in their out-of-the-box solutions. What you choose depends on the architecture you’re considering and your specific needs and capacities. Some offerings you may consider:

• AWS: Offers HIPAA-compliant services such as EC2 for compute, S3 for storage, and RDS for databases.

• Google Cloud: Provides Compute Engine and other HIPAA-compliant healthcare services.

• Microsoft Azure: Offers HIPAA-compliant options in its cloud infrastructure.

• Aptible: A platform designed specifically for healthcare.

• Datica: Specializes in healthcare hosting with built-in HIPAA compliance.

Using secure data centers and tools offered by the same providers can also help you stay HIPAA compliant.

Front-end technologies for HIPAA compliance

When developing the front end of your HIPAA-compliant app, ensure that data encryption, user authentication, and secure communication are top priorities. Common HIPAA-compliant front-end technologies include:

• React:
  React is well-known for its reusable UI components. By using React’s virtual DOM, your engineering team ensures that only changed UI parts are re-rendered. It’s a sound solution to optimize the user experience through a minimum of unnecessary updates. Such an approach to re-rendering is quite practical as it guarantees that sensitive data is not exposed unnecessarily.

  In addition, the React architecture helps implement the above-mentioned secure data handling practices—data encryption in transit and at rest, managing authentication processes, and integrating proper input validation to reduce vulnerabilities.

• Next.js:

  As a framework built on React, Next.js shares similar characteristics in terms of HIPAA compliance. You can also make use of such features as server-side rendering (SSR) and secure data fetching to meet HIPAA’s security standards. This way, for HIPAA-compliant web development, frameworks like React or the Next.js tech stack are go-to options as they allow the building of secure and responsive interfaces. Consider combining them with Node.js and Express for back-end development to create scalable and secure systems.

• Angular:

  Angular has built-in protection against common vulnerabilities and supports Content Security Policies (CSP), adding a layer of defense against attacks.

  Similar to React, Angular allows integration with MFA and RBAC, so only authorized users can access PHI—precisely as the HIPAA minimum necessary access principle dictates.

  Moreover, its component-based structure enables reusable, secure components, providing control over data handling.

• Vue.js:

  Vue.js is another JavaScript framework focusing on security, modular architecture, and integration with necessary security protocols. Like React and Angular, it’s not considered HIPAA-compliant out-of-the-box, but it can be made compliant when used with secure back-end systems and best practices such as secure data transmission.

Separate PHI from other app data

To simplify compliance, keep PHI in a dedicated database. This approach prevents unnecessary encryption and decryption of non-sensitive data. You'll also improve app performance this way.

Leverage synthetic data for testing

You can try experimenting with advanced tech solutions to make software HIPAA-compliant. Take synthetic data, for example. It can make a significant difference in your development and testing process.

Synthetic data mimics real-world patterns, replacing PII (Personally Identifiable Information*). It can also be used for de-identification through removing or altering sensitive information to comply with privacy regulations. This approach allows you to test your systems and analyze the data they contain without violating HIPAA.

*PII is not automatically subject to HIPAA, but since PII can overlap with PHI, HIPAA regulations can come into action.

Collaborate with a HIPAA-compliant tech partner

How to make HIPAA-compliant software smoothly? Consider partnering with an experienced software development vendor. When selecting a HIPAA-compliant development company, look for relevant expertise, positive customer feedback, independent reviews, and a solid portfolio of successful projects.

How much does HIPAA compliance cost?

The cost of HIPAA-compliant app development involves several variables, so it ranges widely depending on the following:

• Target platforms (iOS, Android, web)

• Number of screens and design complexity

• Scope of features and functionality

• Third-party integrations

• Quality assurance and testing efforts

• Location and expertise of the development team

• Cooperation model (in-house, outsourcing, or hybrid)

• Further maintenance and updates

Each of these factors shapes the total cost and timeline for your HIPAA app development project. Have a look at the breakdown we’ve made for you in the table below.

The most accurate way to estimate costs is by consulting an experienced software development vendor. As a HIPAA-compliant development company, Overcode can guide you through regulatory requirements while managing your engineering workload.

Looking for cost-efficient HIPAA-compliant software development? Send a request to Overcode

HIPAA compliance checklist for software development

Let’s combine everything we've covered in this article as a convenient “cheat sheet.” Use this software HIPAA compliance checklist to dot the i's and cross the t’s of regulatory standards.

1. User access control

   • Assign unique identifiers to all users accessing ePHI.

   • Implement role-based access control, limiting data access to what's necessary.

   • Deactivate user profiles for inactive or terminated users.

   • Track login attempts and automatically log users out after inactivity.

   • Strong passwords and multi-factor authentication for accessing ePHI must be strictly observed.

2. Data security and privacy

   • Encrypt all medical records and mobile device data during storage and transmission.

   • Store only the minimum necessary data and avoid retaining unnecessary PHI.

   • Back up data regularly, prevent unauthorized deletion, and securely dispose of data that is no longer required.

   • Set rules for portable media transmission (laptops or cell phones).

   • Regulate access to and use of wireless networks.

   • Develop and adhere to session termination procedures for inactive computer systems.

3. Patient rights and access

   • Provide mechanisms for patients to securely access their personal health information.

   • Track and log who accessed ePHI, when, and how.

4. Data sharing and third parties

   • Share only anonymized data with third parties with client consent and log shared data.

   • Have signed BAAs in place.

5. Application security

   • Protect the software from common threats (e.g., SQL injection, XSS) through secure coding practices and a security-oriented tech stack.

6. Incident and risk management

   • Ensure rapid breach-response mechanisms.

   • Conduct HIPAA risk assessment to countercheck potential data security and compliance sensitivity.

   • Ensure corrective actions throughout your development cycle.

7. Employee management

   • Conduct regular security training for your employees and make sure they understand what HIPAA security software development entails.

   • Conduct employee background checks and sign confidentiality agreements.

   • Observe user access rules for new and existing employees.

Voila! Use with confidence, but keep in mind that the nuances of HIPAA compliance can vary depending on the specific healthcare services your business provides and the nature of your product.

HIPAA-compliant solutions: How can Overcode help?

Overcode develops secure, scalable, and HIPAA-compliant web and mobile applications for the healthcare industry. Whether you’re validating your idea or seeking talent to build a full-scale product, we offer a modern tech stack, a team of experienced engineers, and deep domain knowledge. Our expertise allows us to integrate technologies such as SaaS, AI, blockchain, and IoT to make healthcare software reliable and competitive.
Take a closer look at our healthcare solutions to see our work in action:

Telehealth app case study

Overcode cooperated with the U.S.-based clinic network on the development of a telehealth app project. Built with observance of all the HIPAA compliance standards, its key features include:

• Authentication for patients, doctors, and admins with two-factor authentication (2FA).

• Patient ailment tracking and secure doctor-patient communication.

• Dynamic questionnaires supporting text, multi-select, and video responses.

• Doctor dashboards for treatment plans and prescriptions.

• Admin tools for managing medications and order workflows.

The Overcode team used React.js and AWS services for security and scalability and designed the app with rapid expansion in mind. This approach allowed our client to launch new disease modules in three to four hours.

In just 6 months, Overcode delivered a user-friendly telehealth solution for three health conditions with guides to simplify ongoing management for the client’s team.

Threshold’s privacy-first care app for aging loved ones

Threshold uses non-invasive sensors to monitor activity and vitals, keeping caregivers informed without compromising the dignity of older adults.

Threshold tasked Overcode with building a HIPAA-compliant app to manage IoT sensors, track motion, and send alerts—all in time for CES 2024.

Overcode contributions included:

• Comprehensive research and intuitive UI/UX design, completed with prototypes.

• A cross-platform app built with React Native, Expo, SWR, and TypeScript.

• Advanced analytics to monitor motion by time and zone.

• Intuitive onboarding with customizable access for caregivers.

• Development of a custom Bridge in React Native, enabling smooth interaction between JavaScript and Native code.

In just three months, the cooperation resulted in an MVP that debuted at CES 2024, earning a CES 2025 Innovation Award in Accessibility & AgeTech.

Embryonics project: Advancing IVF with AI and ML

Embryonics was a fascinating project with a noble goal: increasing in-vitro fertilization success rates. The Embryonics team developed AI-powered algorithms that can analyze time-lapse embryo imaging and predict implantation chances. This way, clinicians received a reliable basis for life-critical decision-making.

Embryonics partnered with Overcode to develop a HIPAA-compliant web app for visualizing embryo development and tracking patient progress.

We helped our client by delivering:

• A clear and practical interface for grading embryos and managing patient cycles.

• Interactive timelines and video players integrated with AWS infrastructure.

• Scalable back end built using React.js, Redux, TypeScript, and Redux-Saga.

• Detailed documentation for easy handoff to the client’s internal team.

Overcode provided a fast MVP, allowing Embryonics to refine their algorithms and showcase their technology. In 2022, we supported them further by creating the Egg Freezing Calculator app. Following our cooperation, Embryonics shared with us their achievements:

• 6 successful pregnancies in an 11-woman pilot project.

• Got covered on TechCrunch.

• Was acquired by Rhea in 2023.

Got a brilliant idea of your own? Don’t let the complexities of healthcare regulations and compliance hold you back from bringing it to life.

Reach out to Overcode, experts in HIPAA-compliant mobile and web app development. Let’s handle the tech side of your business so you can focus on making an impact.

Send us a request or schedule a call today!