How To Ensure HIPAA-Compliant Software Development

With the world shifting into a digital era, and our increasing connectivity and reliance on technology, the importance of safeguarding an individual’s personal information has become one of the biggest issues in modern times. As the use of health-tech devices and medical software in the health care industry increases, every patient’s health information is taking on heightened value since it often contains all of an individual’s personally identifiable information.

Thanks to the recent pandemic, more people than ever are talking about HIPAA. What is HIPAA? What does it mean for software to be HIPAA-compliant? What information is protected by HIPAA? At Cardinal Peak, we recognize that protecting sensitive data and staying HIPAA-compliant has never been more crucial, and our engineers are here to assist you in making the IoT health care product development process worry-free.

This blog post will answer those aforementioned questions and walk you through the process of ensuring your software is HIPAA-compliant.

What is HIPAA?

The Health Insurance Portability and Accountability Act, or HIPAA, was a bill that was first introduced in 1996, and it revolutionized the medical industry’s informational organization. The federal law requires the use of code sets that have to be coupled with patient identifiers in their files, which reduces the paperwork burden by streamlining the transfer and storage of patient files and electronic medical records (EMR) between health organizations. HIPAA also enforces the requirements for group health insurance policies to protect patient data, standardizes how much can be saved in a pretaxed medical savings account and prohibits tax deductions on interest for life insurance loans.

Addressing the use and disclosure of individuals’ health information, the HIPAA Privacy Rule helps make sure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high-quality health care, as well as protect the public’s health and well-being.

The following types of individuals and organizations are subject to the Privacy Rule:

  • Health care providers
  • Health plans
  • Health care clearinghouses
  • Business associates, including contractors

Health information such as diagnoses, treatment information, medical test results and prescription information are protected under HIPAA — as are national identification numbers and demographic information such as birth dates, gender, ethnicity, and contact and emergency contact information.

There are additional rules for securing protected health information (PHI) that is created, received, used or maintained by a covered entity; establishing how the Department of Health and Human Services enforces HIPAA; and requiring HIPAA-covered entities and their business associates to provide notification of a breach of unsecured PHI, whether paper-based or electronic.

Additionally, the most recent addition to HIPAA, the Omnibus Rule, adjusted several previously established HIPAA rules to strengthen HIPAA’s privacy and security protections for health information by extending noncompliance liability to business associates and instituting new privacy restrictions for the use of PHI.

Armed with that background information, HIPAA-compliant software can then be defined as programs and other operating information that helps ensure health care organizations effectively protect patients’ data by complying with all the necessary security and privacy provisions. Additionally, HIPAA-compliant software solutions provide a compliance framework that guides health care providers along the path for ensuring the safety of patients’ protected health information.

Necessary Components to Ensure HIPAA-Compliant Software Development

When trying to make sure your software is following the proper guidelines, compliance can certainly feel overwhelming. There are various elements that must be present for a software solution to be considered HIPAA-compliant.

Risk Assessment

The first step in this process is a risk assessment to figure out all of the necessary changes or systems that would need to be implemented to ensure compliance. Identifying and prioritizing such concerns as early as possible helps minimize risk so that your project avoids as much potential danger as possible.


The security of the software has to be tested, and there needs to be a minimum level of access control and monitoring – password security with two-factor or multifactor authentication or another layer of verification, the ability to automatically log out whenever a specific amount of time has passed, and detection systems for potential security breaches. Exploits taking advantage of unpatched software, data sent over email and phishing attacks are all made possible by human error. Consequently, implementing training protocols for all employees who would be handling these systems is important. User authorization/permissions, vendor management and access control are other necessary security features for HIPAA-compliant software.

Remediation Plans

If there is a compliance issue that arises, then there also needs to be a remediation plan in place to minimize damage, implement changes to the software and inform any affected individuals as quickly as possible. These plans aren’t something that can be successful if they are cookie cutter, and our engineers at Cardinal Peak are experts at tailoring programs to meet these unique needs.

Data Storage and Backup

The software also needs protections and systems in place to ensure information integrity by tracking the systems that are storing and transmitting the data. This refers to authentication issues, such as having two-factor authentication, and making sure that any sent information is encrypted. It is also important to ensure any push notifications for apps or other software do not contain any PHI.

Patient information is on a need-to-know basis, so it is important that HIPAA-compliant software stores as little personal information as possible and has specific guidelines on who and when this data can be accessed. PHI should not be stored on a backup or in a highly vulnerable file. Before these guidelines were in place, people were being targeted for identity theft, and there were few tools available to protect their personal information.

Disaster Recovery and Data Disposal

In the event of a disaster, the HIPAA Security Rule established robust backup and disaster recovery plans. HIPAA-compliant software solutions, therefore, require a policy for when and where to back up PHI and other essential data — ideally in an offsite or mirrored cloud facility to maintain uptime. HIPAA requires adequate disposal of PHI. When the PHI is electronic, health care software must be able to completely overwrite or purge data or physically destroy the data or data device including backup. Finally, a disaster recovery plan adequately outlines how organizations should respond during a threat or attack.

Organization-Specific Policies and Procedures

Usually identified through self-audits and remediation plans, your organization’s unique compliance policies and procedures should be implemented across business functions to set expectations for how PHI should be handled, guide daily work operations and ensure consistent patient care.

Benefits of HIPAA-Compliant Software

While HIPAA compliance is mandated for organizations working in health care, there are also benefits to ensuring your software is HIPAA-compliant. In addition to the abilities to both ensure regulatory compliance and to remain up to date with any compliance changes, HIPAA-compliant software also delivers increased loyalty, profitability and differentiation.

First, when patients or prospective patients are confident that you’re serious about protecting their sensitive data, you’re building trust with them. Since PHI is one of the most vulnerable data sets, companies that implement safeguards to ensure the confidentiality, integrity and availability of PHI tend to be more trusted — and with trust comes loyalty. When a patient trusts you, they are more likely to continue to turn to you when in need. With more patients being retained due to improved loyalty, your profitability increases. Finally, HIPAA compliance can differentiate your business from the competition. Some organizations will even offer a “seal of compliance” that can be displayed on websites or in email signatures to signal a deep dedication to compliance.


Our right to privacy is something that we should never take for granted. Thanks to policies like HIPAA, protections have been put in place to make sure our private information isn’t easily shared. While this process can create extra work in the product design and development phase, we at Cardinal Peak are here to help at every step along the way. Quality assurance is our passion, so you’ll know that your HIPAA-compliant product is being built on schedule and on budget.

Whatever application your medical software serves, our talented team of expert engineers ensures your project has everything it needs from end to end. Please reach out if you’re curious about our HIPAA-compliant software development services.