Written by Luis Paradela|Posted on May 31, 2022
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.
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:
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.
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:
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.
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