HIPAA Compliance in Medical Software Development

Written by Luis Paradela|Posted on May 31, 2022

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When it comes to developing medical software and apps, developers and software engineers must ensure that the resulting application is HIPAA-compliant. This means that the application meets the technical and physical safeguards of the HIPAA Security Rule.

What Is HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) was passed by congress in 1996 with the goal of establishing national rules and standards to protect the privacy of patient health information.

The law’s intention is to restrict access to patient records to authorized healthcare providers while keeping the same data secure from potential abuse. In 2013, HIPAA was extended to include the recording, storage, transmission, and retrieval of digital data.

In today’s digital world, data privacy and security are more important than ever. The HIPAA Journal reported 642 data breaches within the healthcare industry in 2020, a 25% increase over the previous year.

This is where HIPAA comes in. HIPAA regulates the flow of patient health data to protect it from fraud, theft, and breach.

The rules and standards enforced by HIPAA include the following requirements:

  • Privacy: Patients’ rights to PHI (protected health information). Any use or access to the information requires patient authorization.
  • Security: Physical, technical, and administrative security measures. This includes a number of measures, such as data backups, encryption, avoiding storing data in local storage of user devices, and all typical infrastructure security measures (activity tracking monitoring, firewalls, and any other strong protection against breaches and attacks).
  • Monitoring: All the platform services must be monitored for any change and access, in order to find out if there is any breach at any point in time.
  • Breach Notification: If a security breach is discovered, the authorities should be notified.

What Does This Mean for Healthcare Software Developers?

If you are looking to build an eHealth or mHealth app that collects patient data, then your app will be subject to HIPAA regulatory compliance for medical software applications if that personal data will be shared with a medical professional or other HIPAA-covered entity (e.g., doctors or health insurance companies).

The US Department of Health and Human Services’ Office for Civil Rights can impose fines to punish breaches of PHI, Even if no breach of PHI occurs, non-HIPAA-compliant software could be still subject to a penalty.

To avoid potential fines and penalties, it makes sense to employ experienced development teams that understand the ins and outs of HIPAA compliance, as the process can be complicated. For example, even if you are hosting an application in a HIPAA-compliant environment, that does not automatically make the application HIPAA-compliant. This means that the whole software solution and cloud architecture must meet HIPAA standards. In the case of any SaaS product, it is highly recommended that it should also be SOC2 (Systems and Organization Controls 2) compliant to guarantee data security to a high standard.

Developing HIPAA-compliant medical software

Because generic software does not meet HIPAA’s exacting standards, medical software must be built from the ground up to transmit, receive, and store PHI securely and privately. To protect from data breaches or losses, software must be carefully tested for any vulnerabilities or exploits, both during development and during its lifetime deployment.

The following functionalities are essential to HIPAA-compliant software and must be included by developers:

  • Secure data encryption and decryption: All data must be encrypted at all stages – prior to transmission, the transmission channel itself, and at the end storage location.
  • Restricted access: User authorization and authorization monitoring functions to ensure that only authorized persons can access patient records. This also extends to system administrators, to protect the software from being altered. Users must be automatically logged out after a set period.
  • Data storage: The storage systems must be able to safely store PHI.
  • Safe and secure backup: To safeguard against data loss, software should be designed to recover and restore lost data in an encrypted form.
  • Emergency mode: The software should be able to protect the data in case of power outage or system failure.
  • Documentation processing: consistent with the standards of formatting and secure storage used in healthcare.
  • Oversight: HIPAA requires healthcare providers to conduct regular audits to ensure compliance and monitor potential vulnerabilities. The software should be able to analyze audits, assess compliance, and provide risk assessments/recommendations for improvement.
  • Remediation plan: this is required to allow providers to correct errors and enable data recovery.
  • Disposability: PHI that is no longer needed should be permanently deleted.

As a major solutions provider for one of the most important pediatric hospitals in the US, AccelOne has years of expertise and development experience when it comes to developing medical software that must take into account HIPAA regulations and the safeguarding of protected health information (PHI).

To learn more about how nearshore software development team can help you achieve HIPAA compliance with your healthcare software, contact us online or call 800.863.6814.

Luis Paradela

Luis Paradela

Chief Development Officer


Buenos Aires

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