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For clients 6 min read

A Guide to Ensuring HIPAA Compliance for Your Software Product

The 1996 US Health Insurance Portability and Accountability Act (HIPAA) has grown into a pivotal legal framework governing the functionality of medical software. Enacted to address the growing need for standardised regulations in the healthcare sector, HIPAA not only transformed the way medical data is handled but also became a cornerstone in safeguarding patient privacy and promoting the seamless exchange of health information

Understanding HIPAA:

HIPAA was conceived to establish clear-cut regulations regarding the handling of medical data by healthcare entities and other entities with access to such information. While mandatory within the United States, the protective umbrella of HIPAA doesn’t stretch beyond its national borders. Adhering to HIPAA is critical for shielding patient information and empowering individuals in their healthcare decision-making

Key Concepts in HIPAA:

HIPAA chiefly revolves around Protected Health Information (PHI) or electronic Protected Health Information (ePHI). Covered entities, encompassing healthcare professionals, and business associates, including IT specialists and legal professionals, play pivotal roles in ensuring compliance.

Key HIPAA Rules:

  • HIPAA Privacy Rule

Establishes a national standard for safeguarding medical records and personal healthcare information, granting individuals control over their private information

  • HIPAA Security Rule

Enacted in 2005, this rule sets standards for the treatment of electronic personal health information by covered entities

  • HIPAA Omnibus Rule

Broadens the definition of business associates to include all third-party contractors, compelling them to comply with privacy, security, and breach notification rules when dealing with PHI

HIPAA Compliance Checklist for Software

To attain HIPAA compliance for your software product, consider the following key steps:

  • Control Access Strictly

Enforce role-based access control to restrict data access to what’s necessary for each user. Identify all specialists, encompassing doctors, nurses, administrators, and technical staff, and customize their access accordingly.

  • Limit Session Times

Bolster security by automatically logging out users after a designated period of inactivity. Adjust session times based on user roles and job requirements.

  • Encrypt Data

While HIPAA permits alternative security approaches, encryption remains a reliable and expeditious method to safeguard medical information. Utilize the most secure encryption protocols endorsed by the National Institute of Standards and Technology.

  • Implement an Activity Tracking System

Monitor users’ activities to detect patterns and pinpoint suspicious actions. Amplify incident investigation capabilities by logging all actions and user IDs.

  • Back Up Data

Regularly back up data and securely store it on a third-party server. Ensure frequent backups for added confidence in data recovery.

  • Ensure Secure Authentication

Choose from diverse authentication approaches, such as multi-factor authentication, biometrics, expiring passwords, or risk-based authentication. Tailor authentication methods based on the security needs of your software.

  • Ensure Secure Data Transfer and Storage

Opt for cloud storage, ensuring compliance with HIPAA regulations. Select a HIPAA-compliant cloud service provider, such as Dropbox or Google Drive.

  • Protect Correspondence

Encrypt external email correspondence using secure protocols like AES, OpenPGP, or S/MIME. Contemplate integrating a secure chat feature for regular correspondence between covered entities and patients.


While the array of HIPAA requirements for software security may seem expansive, numerous contemporary software products across various industries employ akin strategies to fortify themselves against potential threats. By conscientiously adhering to this HIPAA compliance checklist, you not only shield your software but also contribute to upholding the privacy and security of delicate healthcare information. Gotoinc team has 7 years of experience working with Healthcare projects, fill free to contact us and discuss your project 

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