While efforts have been made to address privacy and security in software development, one aspect that is usually ignored is traceability.
What is traceability?
Traceability is the ability to locate and track software artifacts throughout the Software Development Life Cycle (SDLC). As a recent review of software engineering methods applied to HIPAA compliance explains, traceability is a major gap in achieving HIPAA compliant software development.
Generally, this notion is not receiving the attention it deserves, considering the stress on other stages of SDLC, like design and testing.
Designing HIPAA compliant software
Privacy and security predominate in the design phases of HIPAA compliant software development. It builds the foundation for systems that protect sensitive patient information.
For instance, some researchers have pointed out the need for using tools like RIPS (to detect security vulnerabilities in PHP and Java applications) during the testing phase to bridge the gap between HIPAA's technical requirements and potential security vulnerabilities. These include "SQL injection, allowing risky permissions, sharing of data and storing it within third-party entities."
While these tools can help identify gaps and mitigate potential security risks, they don’t ensure that all software artifacts meet HIPAA requirements throughout the SDLC.
The traceability challenge
The complexity of HIPAA Rules often makes it difficult to define and extract software requirements. According to the review, “the requirements extraction process is challenging due to the ambiguity and complexity of specific rules.”
This situation requires clearer regulations and stronger frameworks to easily map HIPAA requirements to software components. Without a clear, traceable path, it becomes difficult to verify if each requirement is properly addressed during the implementation phase.
This issue also reveals a weakness in current development approaches. The implementation phase mainly focuses on understanding how each part of healthcare software works but fails to consider traceability.
Traceability is especially concerning for mobile health (mHealth) apps, which are highly vulnerable to security risks that threaten patient data.
So, how can software developers mitigate these risks?
To manage these risks, developers must use strong testing tools and traceable systems starting from the early stages of development to ensure security throughout the process.
Additionally, future research should prioritize integrating traceability frameworks into the SDLC.
Closing this gap and making traceability a core part of the SDLC can help developers build healthcare software that meets compliance standards and improve patient data protection.
Read also: How cyberattacks threaten patient outcomes
FAQs
How does encryption help HIPAA compliance?
Encryption converts contents into a form only accessible to the authorized recipient, and not any other person or system. It prevents unauthorized access, upholding HIPAA regulations.
What is SQL Injection (SQLi) and why is it a threat to healthcare security?
SQL Injection (SQLi) is a cyberattack where harmful SQL code is inserted into a database query through user input fields. This allows attackers to access, alter, or delete sensitive data. In healthcare, SQLi can expose patient records and medical information, leading to data breaches and unauthorized access.
How does SQLi impact HIPAA compliance in healthcare organizations?
SQLi poses a serious risk to HIPAA compliance because it can expose protected health information (PHI), violating HIPAA Rules. A successful SQLi attack can result in patient data breaches, hefty financial penalties, and legal action against healthcare providers.
