HIPAA Compliant Software Development: Principles and Best Practices

What Is HIPAA Compliance?

HIPAA, the Health Insurance Portability and Accountability Act, was enacted in 1996 by the U.S. Congress, with the goal of modernizing the flow of healthcare information. It was aimed at protecting the information of patients while allowing the transfer of health data required to provide high-quality health care. The HIPAA rules are designed to protect the privacy and security of certain health information. For software developers, it means that any software used to store, collect, process, or transmit protected health information (PHI) must be designed in such a way that it meets the requirements of HIPAA.

In this article, we’ll briefly review HIPAA compliance requirements, cover the key principles of HIPAA-compliant development, and provide three best practices that can help your software comply with HIPAA: risk assessments, a modern development paradigm called GitOps, and backup and recovery practices.

What Are HIPAA Compliance Requirements?

Here is a brief overview of the key requirements of the HIPAA regulation.

HIPAA Privacy Rule

The HIPAA Privacy Rule establishes national standards for the protection of individuals’ medical records and other personal health information (PHI). It applies to health plans, healthcare clearinghouses, and healthcare providers that conduct certain healthcare transactions electronically.

The rule requires appropriate safeguards to protect the privacy of personal health information and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. It also gives patients rights over their health information, including rights to examine and obtain a copy of their health records and to request corrections.

HIPAA Security Rule

The HIPAA Security Rule sets standards for protecting the confidentiality, integrity, and availability of electronic protected health information (ePHI). Covered entities and their business associates must implement technical, physical, and administrative safeguards to secure ePHI.

This includes measures like access control, data encryption, and the use of secure communication channels. The Security Rule is flexible, allowing organizations to tailor their security measures to their size, capabilities, and the potential risks to ePHI.

HIPAA Enforcement Rule

The HIPAA Enforcement Rule provides guidelines for investigations into HIPAA compliance violations, compliance reviews, and hearings. It establishes procedures for imposing civil money penalties on covered entities and their business associates that fail to comply with the HIPAA rules.

The Enforcement Rule also outlines the process for entities to respond to complaints, the factors considered in determining penalties, and the rights to an administrative hearing.

Breach Notification Rule

The HIPAA Breach Notification Rule requires covered entities and their business associates to notify affected individuals, the Secretary of Health and Human Services, and in some cases, the media, of a breach of unsecured PHI.

Notifications must be provided without unreasonable delay and in no case later than 60 days following the discovery of a breach. This rule aims to ensure that individuals are aware of breaches so they can take steps to protect themselves from potential harm.

Omnibus Rule

The HIPAA Omnibus Rule, enacted in 2013, strengthens the privacy and security protections established under HIPAA for individual health information. It expands the obligations of business associates of healthcare providers, plans, and clearinghouses, making them directly liable for compliance with certain HIPAA Privacy and Security Rule requirements.

The Omnibus Rule also enhances limitations on the use and disclosure of PHI for marketing and fundraising purposes and prohibits the sale of PHI without individual authorization.

4 Principles of HIPAA-Compliant Software Development

Here are the key principles of HIPAA-compliant software development.

1. Data Minimization: Only Collect Necessary Information

In HIPAA-compliant software development, data minimization is a critical principle. It emphasizes collecting only the information necessary to fulfill a specific purpose, thereby reducing the risk of unauthorized access or disclosure.

This approach not only aligns with privacy best practices but also minimizes potential damage in the event of a data breach. Developers must evaluate the necessity of each piece of PHI they intend to collect and process, ensuring that only essential data is handled.

2. Data Encryption at Rest and in Transit

Encrypting data at rest and in transit is fundamental to safeguarding PHI. Encryption transforms readable data into an unreadable format that can only be decrypted with a specific key, significantly reducing the risk of data breaches.

For HIPAA compliance, developers must ensure that PHI stored in databases, files, or transmitted over networks is encrypted using strong, industry-standard algorithms. This protects information from unauthorized access, whether it’s stored on a server or transmitted to another entity.

3. Access Control: Authorization and Authentication Mechanisms

Implementing robust access control measures is essential for HIPAA compliance. This involves creating mechanisms for authentication, ensuring that only authorized individuals can access ePHI, and authorization, defining what authorized users can do with the data.

Techniques such as multi-factor authentication, role-based access controls, and secure password policies help prevent unauthorized access to sensitive information. Regularly reviewing and updating access privileges is also crucial to accommodate changes in roles or employment status.

4. Audit Controls: Tracking Access and Changes to PHI

Audit controls are critical for tracking access to and modifications of PHI. They help in identifying and investigating unauthorized activities or potential breaches by maintaining records of who accessed information, what changes were made, and when these activities occurred.

Implementing comprehensive audit trails and monitoring systems enables organizations to detect anomalies in system use, ensuring accountability and facilitating the investigation of incidents. This principle is pivotal in maintaining the integrity and confidentiality of PHI.

HIPAA Compliance Best Practices For Software Development

Conduct a HIPAA Risk Assessment

The first step in ensuring HIPAA compliance in your software development process is conducting a thorough risk assessment. This involves identifying potential threats and vulnerabilities that could affect the confidentiality, integrity, and availability of electronic protected health information (ePHI).

Once these threats and vulnerabilities are identified, the next step is to assess the current security measures in place to protect against these risks. This involves evaluating your software’s security features, your team’s security practices, and your organization’s security policies and procedures.

Lastly, the risk assessment process involves determining the potential impact of these threats and vulnerabilities on your organization and taking appropriate actions to mitigate these risks. This could involve implementing additional security measures, updating your software, or revising your security policies and procedures.

Utilize GitOps for Configuration and Infrastructure Management

GitOps, a modern development paradigm, leverages Git as a single source of truth for declarative infrastructure and applications. By utilizing GitOps, teams can enhance their ability to audit code changes and demonstrate adherence to safe coding practices, crucial for the protection of electronic protected health information (ePHI). The GitOps model automates the deployment process by using Git pull requests to initiate changes in the infrastructure, which then triggers automated pipelines to test, validate, and deploy those changes. This automation ensures that any change to the infrastructure or applications that handle ePHI is peer-reviewed, recorded, and traceable.

In addition, GitOps offers an additional layer of security by facilitating rapid rollbacks and recovery from incidents, minimizing the impact of any breach or failure. With its emphasis on version control, immutability, and support for automated compliance checks, GitOps is an invaluable methodology for maintaining the integrity, confidentiality, and availability of ePHI in a HIPAA-compliant environment.

Implement Data Backup and Disaster Recovery

A data backup and disaster recovery plan is another essential component of HIPAA compliance in software development. This involves regularly backing up your ePHI, and implementing procedures to restore your ePHI in the event of a data loss or system failure.

Your data backup plan should include details on how frequently your data is backed up, where your backups are stored, and how long your backups are retained. Your disaster recovery plan should include details on how your ePHI is restored, how quickly it can be restored, and what steps are taken to ensure the integrity and confidentiality of your ePHI during the recovery process.

In conclusion, ensuring HIPAA compliance in your software development process involves implementing robust security measures, conducting regular risk assessments, and developing a comprehensive data backup and disaster recovery plan. By following these principles and best practices, you can protect your ePHI, comply with HIPAA requirements, and build trust with your patients and customers. Remember, when it comes to HIPAA compliance, it’s always better to be safe than sorry.

Author Bio: Gilad David Maayan

Gilad David Maayan is a technology writer who has worked with over 150 technology companies including SAP, Imperva, Samsung NEXT, NetApp and Check Point, producing technical and thought leadership content that elucidates technical solutions for developers and IT leadership. Today he heads Agile SEO, the leading marketing agency in the technology industry.

LinkedIn: https://www.linkedin.com/in/giladdavidmaayan/