22-Step HIPAA Compliant Software Development Checklist

The HIPAA compliance software development landscape is known for its nuances and complexities, but it doesn’t necessarily have to be this way. Explore Riseapps’ decade of expertise in developing HIPAA-compliant software for healthcare, detailed in this article.

From understanding the key components and requirements for HIPAA-compliant software development and detailing a HIPAA compliance checklist to real-life HIPAA software development use cases.

Understanding HIPAA compliance for software development

Why HIPAA Compliance Matters

The Health Insurance Portability and Accountability Act (HIPAA) has come a long way since 1996.

Introduced with the aim to enhance health insurance portability, reduce healthcare fraud, and streamline insurance administration, HIPAA was heavily driven primarily by the rapid digitization of the healthcare industry. As technology advanced, HIPAA regulations expanded to cover more types of electronic health information and introduced stricter data privacy standards to manage risks in EHRs, mobile health apps, telemedicine, IoT, cloud computing, and other areas.

Consequences of Non-Compliance

Non-compliance with HIPAA can lead to severe financial and reputational damage, such as:

• Civil monetary penalties reaching up to $68,928 per violation or above, depending on the level of culpability.

Example:  In 2020, Children’s Hospital & Medical Center (CHMC) of Omaha had to pay $80,000 to the Office for Civil Rights (OCR) for failing to provide timely access to medical records to a patient’s parent.

• Fines imposed by the Department of Health and Human Services (HHS) of up to $1.5 million per year for each violation.

Example: In 2018, Cottage Health was obliged to a $3 million settlement for such HIPAA violations as HIPAA Security and Breach Notification Rules, as a result of the two breaches that put the data of 62,500 individuals at risk.

• Criminal penalties, including fines and imprisonment.

Example: In 2019, a former employee of Alliance Health and Human Services was sentenced to 3 years in federal prison for HIPAA Privacy Rule violations, stolen health data, and identity theft.

• Loss of license or accreditation

Example: In 2019, a nursing home in Tennessee lost its license and was shut down after an investigation found numerous instances of neglect and failure to protect residents’ health information.

Essential HIPAA Rules for HIPAA-Compliant Software Development

HIPAA Privacy Rule

HIPAA Privacy regulations ensure confidentiality by giving patients control over who accesses and corrects their medical records. According to it, HIPAA-covered entities must follow strict protocols for disclosing protected health information (PHI). For example, a covered entity like a hospital must provide patients with a Notice of Privacy Practices outlining how sensitive health data is handled, who can access it, and how they can request corrections.

HIPAA Security Rule

The HIPAA Security Rule establishes a robust framework to safeguard electronic protected health information (ePHI) across healthcare organizations. The security rule is designed to ensure the confidentiality, integrity, and availability of ePHI through a comprehensive framework of physical safeguards, technical safeguards, and administrative safeguards.

HIPAA Enforcement Rule

The Enforcement Rule oversees compliance, empowering regulators to hold entities accountable as they investigate breaches and impose penalties for violations. If a clinic fails to secure patient records and a breach occurs, the Office for Civil Rights (OCR) can investigate and fine the clinic to uphold HIPAA standards.

Breach Notification Rule

The Breach Notification Rule mandates prompt disclosure of breaches to affected individuals, authorities, and business associates. If a healthcare provider discovers a breach, they must notify affected patients and the OCR, detailing the steps they are taking to mitigate the damage.

Business Associate Agreement

Business Associate Agreements (BAAs) are an integral part of the HIPAA rules. They mandate that covered entities, such as healthcare providers, health plans, and healthcare clearinghouses, must have a BAA in place with any business associate that handles Protected Health Information (PHI) on their behalf.

HIPAA-Compliant Software Requirements

Data Encryption

HIPAA-compliant software must implement robust encryption measures to protect ePHIs, both at rest and in transit. Efficient encryption practices not only ensure compliance with HIPAA’s security requirements but also mitigate risks of unauthorized access and data breaches, thereby maintaining patient confidentiality and the integrity of healthcare data.

Access Controls

Just like keys and ID scanners safeguard physical access, access controls play the role of limiting access to sensitive electronic health information to authorized personnel only. This includes implementing unique login credentials and role-based access, as well as leveraging emergency access procedures and automatic logoff features help maintain the availability and confidentiality of PHI.

User Authentication

User authentication is a cornerstone of HIPAA compliance, verifying the identity of users accessing the system and thus safeguarding patient confidentiality and privacy. Strong password policies, regular updates to authentication mechanisms, and user education on best practices are all efficient practices to mitigate risks associated with unauthorized access and potential data breaches.

Audit and Integrity Controls

By implementing robust control systems within HIPAA-compliant software, organizations can establish normal access patterns and quickly identify discrepancies. Audit controls are critical for tracking access to PHI and leveraging the ability to identify unauthorized access, while integrity controls ensure the accuracy and consistency of electronically protected health information (ePHI). These control systems involve mechanisms that record and examine activity in information systems containing sensitive data.

Transmission Security

To protect data integrity and confidentiality during transmission, HIPAA mandates the use of secure communication channels. Using SSL and TLS certificates ensures data remains encrypted and secure, even if intercepted.

Data Backup and Recovery

Regular data backups are mandatory under HIPAA to ensure that protected health information (PHI) can be recovered in the event of data loss. Covered entities must implement procedures to create retrievable exact copies of PHI and ensure that backups are encrypted and stored securely, preferably offsite. Regular testing of backup systems is also crucial.

HIPAA Compliance Software vs HIPAA-Compliant Software

Organizations often combine the benefits of HIPAA compliance solutions with HIPAA-compliant software. Yet, there’s a clear distinction between them.

The main difference between ‘HIPAA compliance software’ and ‘HIPAA-compliant software’ is that the former includes features to meet HIPAA regulations, while HIPAA compliance software (the latter) includes features to meet HIPAA regulations.

Noteworthy, using HIPAA compliance software alone cannot fully ensure HIPAA compliance. Achieving HIPAA-compliant software recognition requires comprehensive measures: strong policies, ongoing staff training, regular risk assessment, secure data handling, cloud storage security, adherence to technical safeguards, and many more. Therefore, organizations aiming for HIPAA compliance must implement technical security measures that incorporate both appropriate HIPAA compliance software tools and robust organizational practices.

Proven Ways To Build a HIPAA-Compliant App

As a healthcare software development partner, the Riseapps team is well-versed in HIPAA compliance regulations. By prioritizing data security, privacy, and protection guidelines throughout their development processes, Riseapps consistently delivers HIPAA-compliant solutions that safeguard patient information and adhere to industry standards. Check out some of them below.

HIPAA-Compliant EHR/EMR

The Wound Pros, the AI-driven wound care management services company and an accredited DMEPOS supplier with $5M revenue requested Riseapps create and deploy a HIPAA-compliant EHR/EMR platform. The client wanted to replace their existing technology with a feature-rich, automated, and flexible architecture to support operational efficiency and growth.

Addressing HIPAA compliance for this project, Riseapps embraced the project’s complexity. Thanks to comprehensive planning of patient data workflows and alignment with HIPAA rules, we guaranteed security and privacy. Besides, the implementation of access controls for the facility management module significantly enhanced compliance by ensuring that only authorized users could access sensitive information.

Within the project scope, Riseapps developed 120+ wound care management modules and delivered a fully-fledged EHR/EMR platform from scratch to easily facilitate the organization’s workflows for consultants, facilities, warehouses, and management teams. This enabled the client to cut patient care delivery costs by 65%, grow wound healing rates by 34%, and invest up to 3 times less time on day-to-day tasks — all while maintaining 100% compliance.

HIPAA-Compliant Telehealth

Kego is a profitable US-based virtual urgent care clinic that partnered with Riseapps to leverage a robust, HIPAA-compliant platform that connects healthcare providers and patients via a videoconferencing platform.

Throughout the project, Riseapps ensured all data generated by Kego app is securely stored in designated HIPAA-compliant cloud data storage, ensuring encryption and access controls were strictly maintained. Meantime, patients enjoy continuous access to their appointment history, medical charts, and payment records, with robust authentication measures in place to safeguard their data.

HIPAA-Compliant Diagnostic App

InteliWound is a California-based healthtech company passionate about improving wound care delivery and tackling the challenge of controlling high costs through efficient healthcare software solutions.

The company approached Riseapps for a trusted partnership in developing HIPAA-compliant wound management software to assist physicians in clinical assessment, effective treatment, order supply management, and more.

Riseapps created a highly scalable platform built on Amazon Web Services. With an open flow of communication between authorized users, patients’ sensitive health information stored and managed in InteliWound remains strictly protected, adhering to HIPAA Security Rules and other HIPAA compliance standards.

HIPAA-Compliant RPM

Carehalo is a leading-edge SAAS healthcare software solutions provider that empowers next-level chronic disease management through a complex ecosystem of tools. But they needed to cover one missing piece — remote patient monitoring.

Riseapps developed a robust RPM tool that serves as an integral part of CareHalo’s chronic disease management platform. This healthcare app uses the collected data to predict and prevent events that would otherwise require medical intervention.

As a result, Riseapps helped CareHalo create the leading health monitoring tool that improves health outcomes and generates profit, all while being HIPAA compliant. The solution leverages role-based access and sophisticated algorithms to prioritize patient care needs while safeguarding patient data.

HIPAA Compliance Checklist For Software Development

HIPAA compliance is a complex process that incorporates multiple stages throughout the project lifecycle. Follow the checklist of best practices and technical security measures by Riseapps that helped numerous healthcare organizations deploy efficient HIPAA-compliant healthcare software solutions.

Step 1. Requirement Gathering and Design

The first step towards achieving software HIPAA compliance is thoroughly documenting and understanding all requirements pertaining to ePHI. This includes identifying specific HIPAA regulations, conducting comprehensive risk assessments to pinpoint vulnerabilities, designing robust security controls, and capturing user requirements related to data handling and privacy.

Explore the list of action steps below to guide yourself through this stage toward HIPAA-compliant healthcare software.

Stakeholder Collaboration

• Conduct meetings with healthcare providers and stakeholders.
• Identify specific HIPAA requirements and constraints.
• Ensure clear communication of compliance needs to the development team.

💡Pro Tip: Establish a dedicated compliance team to ensure continuous alignment with HIPAA requirements.

Data Analysis

• Analyze the types of data to be handled.
• Determine necessary access controls and encryption protocols.
• Evaluate the need for data anonymization or de-identification where applicable.

💡Pro Tip: Use data flow diagrams to visualize how data moves through your system, making it easier to identify potential compliance issues.

Architectural Decisions

• Design the software architecture with HIPAA compliance in mind.
• Ensure secure data transmission, storage, and access mechanisms.
• Plan for data segregation to prevent unauthorized access.

💡Pro Tip: Leverage microservices architecture to isolate and secure different components of your healthcare app, enhancing overall security.

Audit Trails Planning

• Plan for implementing comprehensive audit trails.
• Define requirements for logging and monitoring access to ePHI.
• Establish procedures for regular review of audit logs.

💡Pro Tip: Implement automated log analysis tools to proactively monitor audit trails for suspicious activities.

User Authentication

• Design robust user authentication methods.
• Include two factor authentication or multi-factor one if necessary.
• Implement session management and timeout features.

💡Pro Tip: Incorporate biometric authentication methods for enhanced security.

Documentation

• Document all HIPAA requirements and design decisions.
• Create a comprehensive compliance plan.
• Maintain records of all design reviews and decisions.

💡Pro Tip: Use version control systems to manage and track changes to documentation.

Risk Assessment

• Conduct a thorough risk assessment to identify potential vulnerabilities.
• Develop mitigation strategies for identified risks.

💡Pro Tip: Conduct risk assessments periodically, especially at times of significant system changes.

Compliance Training

• Train the development team on HIPAA requirements and best practices.
• Ensure ongoing education about regulatory changes and updates.

💡Pro Tip: Develop interactive training modules and quizzes to reinforce HIPAA compliance knowledge among team members and business associates.

Step 2. Development and Testing

During the development and testing stage of the HIPAA-compliant software project, the focus shifts to implementing the documented data privacy and security requirements from the previous stage. This involves secure coding practices, robust authentication and access controls, proper encryption protocols, and rigorous code reviews to validate security features and ensure they meet HIPAA standards.

Secure Coding Practices

• Write code with a strong emphasis on security.
• Incorporate encryption algorithms and secure APIs.
• Follow secure coding guidelines and best practices.

💡Pro Tip: Adopt a “shift-left” approach by integrating security testing early in the development lifecycle.

Authentication and Authorization

• Implement robust authentication processes.
• Set up role-based access controls.
• Ensure minimal privilege access for users.

💡Pro Tip: Use OAuth 2.0 and OpenID Connect for secure, scalable user authentication and authorization.

Code Reviews

• Conduct regular code reviews focusing on security.
• Guarantee compliance with HIPAA security rule and other HIPAA requirements.
• Utilize automated code review tools to enhance accuracy.

💡Pro Tip: Utilize automated code review tools like SonarQube to catch security issues early.

Security Testing

• Perform penetration testing and vulnerability assessments.
• Conduct static and dynamic code analysis.
• Use threat modeling to anticipate potential security issues.

💡Pro Tip: Employ CI/CD pipelines that include automated security testing tools.

Encryption

• Encrypt data at rest and in transit using best practices for the healthcare sector.
• Regularly update encryption algorithms to stay current.

💡Pro Tip: Regularly review and update your encryption standards to align with the latest security protocols.

Compliance Verification

• Regularly verify that the software remains HIPAA compliant.
• Document all testing procedures and outcomes.
• Create a compliance matrix to track adherence to requirements.

💡Pro Tip: Maintain a dashboard that provides real-time insights into the status of various compliance measures.

Automated Testing

• Implement automated testing for security and compliance.
• Use tools that can continuously monitor code for vulnerabilities.

💡Pro Tip: Use tools like Selenium and JUnit for automated testing to ensure consistent test results.

Performance Testing

• Test the software’s performance under various conditions.
• Ensure that security measures do not degrade performance.

💡Pro Tip: Conduct load testing to ensure your security measures do not impact system performance under high demand.

Step 3. Implementation and Deployment

While it might seem like a finish line, a range of steps should be performed before the software deployment. A final HIPAA compliance check is crucial to verify that encryption and access controls are correctly configured. Only after this thorough examination is the software deemed ready for release. See the list of actions required to perform at this stage.

Final Compliance Check

• Conduct a thorough HIPAA compliance check.
• Verify data encryption and access controls.
• Perform a final risk assessment before deployment.

💡Pro Tip: Conduct a mock audit to ensure all compliance measures are in place before final deployment.

Deployment Planning

• Plan deployment to integrate seamlessly with existing systems.
• Ensure minimal disruption to ongoing operations.
• Prepare rollback procedures in case of deployment issues.

💡Pro Tip: Use blue-green deployment strategies to minimize downtime and reduce risk during deployment.

User Training

• Provide training for users on HIPAA-compliant software usage.
• Ensure users understand data protection protocols.
• Offer ongoing support and refresher training sessions.

💡Pro Tip: Create detailed user manuals and video tutorials to support end-users in adopting the new system securely.

Monitoring Setup

• Set up monitoring for security threats and compliance issues.
• Implement automated alerts for suspicious activities.
• Use intrusion detection and prevention systems (IDPS).

💡Pro Tip: Implement real-time monitoring solutions like Splunk or ELK Stack for continuous visibility into system performance and security.

Documentation

• Document deployment procedures and configurations.
• Ensure all compliance checks are recorded.
• Maintain an up-to-date inventory of all systems and components.

💡Pro Tip: Use documentation generators like Swagger for APIs for greater efficiency.

Business Continuity Planning

• Develop and test a business continuity plan.
• Ensure the plan includes procedures for maintaining HIPAA compliance during emergencies.

💡Pro Tip: Regularly test your business continuity plan with disaster recovery drills.

Step 4. Ongoing Maintenance and Auditing

Maintaining HIPAA compliance is an ongoing effort that includes constant monitoring of the software to address any emerging threats. This holistic approach ensures that healthcare organizations and their business associates remain HIPAA-compliant and secure in the evolving digital landscape. In doing so, incorporate the following strategies:

• regular monitoring to detect and address security vulnerabilities promptly;
• security audits ensuring efficient security measures;
• integration of new features that enhance security and compliance;
• compliance checks for regular HIPAA compliance monitoring;
• incident response planning to mitigate breaches efficiently;
• vendor compliance monitoring;
• backup and recovery in case of data breach or system failure;
• policy revisions to reflect regulation change;
• security patch management;
• ongoing training to leverage new best practices for maintaining compliance.

HIPAA-Compliant App Development vs Software Development: Key Differences

HIPAA-compliant software development ensures that a wide range of software solutions used in healthcare comply with strict HIPAA regulations. This includes complex systems like databases, cloud storage services, and communication platforms, all of which require robust security measures and adherence to healthcare data protection standards throughout their development and deployment.

In contrast, HIPAA-compliant app development focuses on creating standalone applications tailored for healthcare use: for example, EHR systems, telemedicine platforms, and mobile health apps. Developers in this realm embed specific security features directly into these applications, including encryption, authentication controls, and strict access management, to ensure the final version of healthcare software is HIPAA compliant.

HIPAA Compliance Application Development Bottlenecks

Complex Regulatory Requirements

Understanding and interpreting the intricate details of HIPAA regulations can be difficult and require specialized knowledge and continuous updates as laws evolve. Meantime, failure to accurately interpret and implement these HIPAA compliance requirements can lead to significant risks and consequences.

Solution: Involve legal experts or business associates who are well-versed in the nuances of HIPAA rules for extra guidance.

Scalability and Performance

Balancing the need for robust security measures while maintaining application performance and scalability can be challenging. Third-party integrations can add complexity, requiring thorough vetting of vendors for their security practices, implementing secure APIs and data exchanges, and ensuring continuous monitoring of third-party systems.

Solution: Implement a layered security approach that integrates lightweight yet effective security measures, such as optimized encryption algorithms and efficient access controls.

Cost and Resource Allocation

Allocating sufficient budget and resources while managing costs effectively is a common bottleneck for many healthcare providers, especially when developing and maintaining HIPAA-compliant software.

Solution: Find a trusted healthcare software development partner who can help you optimize essential security features, leverage cost-effective scalability and compliance tools, and establish clear budgetary controls.

FAQ