Requirements Engineering for Regulatory Compliance in Software Systems: A Systematic Mapping Study

Core Concepts

Software requirements engineering practices must evolve to systematically address the increasing complexity and diversity of regulations impacting software-intensive products and services.

Abstract

• Bibliographic Information: Kosenkov, O., Elahidoost, P., Gorschek, T., Fischbach, J., Mendeza, D., Unterkalmsteiner, M., ... & Mohananic, R. (2024). Systematic Mapping Study on Requirements Engineering for Regulatory Compliance of Software Systems. arXiv preprint arXiv:2411.01940v1.
• Research Objective: This systematic mapping study aims to analyze and synthesize the existing research on requirements engineering (RE) for regulatory compliance in software-intensive products and services (SIPS). The study focuses on identifying challenges, principles, practices, stakeholder involvement, and relevant software development lifecycle (SDLC) processes.
• Methodology: The researchers conducted a systematic mapping study following established guidelines. They searched four academic databases (ACM Digital Library, IEEE Xplore, Scopus, and Elsevier/ScienceDirect) using a predefined search string. After removing duplicates and applying inclusion and exclusion criteria, they selected 280 primary studies published between January 2017 and December 2023 for data extraction and analysis.
• Key Findings: The study identified 14 categories of RE-related challenges in achieving regulatory compliance for SIPS. These challenges are addressed by six main types of principles and practices, with varying levels of stakeholder involvement. The research highlights the connection between RE and other SDLC process areas, emphasizing the need for a holistic approach to compliance. Furthermore, the study reveals that most research focuses on specific regulation fields (e.g., privacy, quality) and application domains (e.g., healthcare, software development, avionics), suggesting potential differences in challenges and stakeholder engagement across various contexts.
• Main Conclusions: The authors conclude that a deeper understanding of stakeholder roles, relationships between SDLC process areas, and specific challenges within distinct regulatory fields is crucial to guide future research and improve practical approaches to regulatory compliance in SIPS.
• Significance: This study provides a comprehensive overview of the current research landscape on RE for regulatory compliance in SIPS. It offers valuable insights for researchers and practitioners by identifying key challenges, principles, practices, and areas requiring further investigation.
• Limitations and Future Research: The study acknowledges the limitations of its broad scope and encourages future research to delve deeper into specific aspects of regulatory RE, such as the development of tailored methodologies for different regulation fields and application domains. Further investigation into the role of stakeholders and the integration of compliance practices throughout the entire SDLC is also recommended.

Stats

The study analyzed 280 primary studies.
About 13.6% of the primary studies considered the involvement of both software engineers and legal experts in developing principles and practices for regulatory compliance.
About 20.7% of primary studies considered RE in connection to other SDLC process areas.

Quotes

"Software engineers are facing an increasing amount of regulations that affect software-intensive products and services (SIPS)."
"A well-structured approach to implementing and adhering to regulations in software engineering is essential to achieve regulatory compliance and provide evidence of that compliance."
"Our findings highlight the need for an in-depth investigation of stakeholders’ roles, relationships between process areas, and specific challenges for distinct regulatory fields to guide research and practice."

Key Insights Distilled From

Systematic Mapping Study on Requirements Engineering for Regulatory Compliance of Software Systems

by Oleksandr Ko... at arxiv.org 11-05-2024

https://arxiv.org/pdf/2411.01940.pdf

Deeper Inquiries

How can the development of standardized frameworks and tools facilitate the implementation of regulatory compliance measures throughout the SDLC of SIPS?

Standardized frameworks and tools can significantly ease the implementation of regulatory compliance measures throughout the Software Development Life Cycle (SDLC) of Software-Intensive Products and Services (SIPS) in several ways:

Common Language and Understanding: Standardized frameworks provide a common vocabulary and set of best practices for addressing regulatory requirements. This shared understanding between stakeholders (including software engineers, legal experts, and regulators) reduces ambiguity and ensures everyone is working towards the same goal.
Early Detection of Compliance Issues: Tools integrated into the SDLC can automatically check for compliance violations during various phases, from Requirements Engineering (RE) and design to development and testing. This early detection allows for timely remediation, preventing costly rework later in the SDLC.
Reduced Complexity and Effort: Frameworks offer templates, checklists, and pre-configured components specifically designed to address common regulatory requirements. This reduces the complexity of compliance tasks and minimizes the effort required from development teams.
Automated Compliance Verification: Tools can automate many aspects of compliance verification, such as generating audit trails, documenting compliance evidence, and running automated tests against regulatory standards. This automation saves time and resources while ensuring a higher degree of accuracy.
Continuous Compliance Monitoring: Frameworks and tools can facilitate continuous compliance monitoring even after SIPS deployment. This proactive approach helps organizations adapt to evolving regulations and maintain compliance throughout the SIPS lifecycle.
Examples of standardized frameworks and tools that can facilitate regulatory compliance include:

Security frameworks: NIST Cybersecurity Framework, ISO 27001, OWASP SAMM
Privacy frameworks: GDPR, CCPA, HIPAA
Industry-specific standards: PCI DSS for payment card industry, FDA regulations for medical devices
Compliance automation tools: Security information and event management (SIEM) systems, vulnerability scanners, data loss prevention (DLP) solutions
By providing a structured and consistent approach to regulatory compliance, standardized frameworks and tools empower organizations to build compliant SIPS efficiently while minimizing risks and costs.

Could focusing on regulatory compliance during the RE phase stifle innovation by limiting design choices and increasing development costs for SIPS?

While focusing on regulatory compliance during the Requirements Engineering (RE) phase is crucial for building compliant SIPS, it's essential to strike a balance between compliance and innovation. Overemphasizing compliance during RE could potentially stifle innovation in the following ways:

Limited Design Space: Early and rigid adherence to specific compliance solutions might narrow down the design space, potentially excluding innovative approaches that could emerge with a more flexible approach.
Increased Development Costs: Addressing all compliance requirements upfront might lead to over-engineering and increased development costs, especially if the chosen solutions are complex or require significant modifications to existing systems.
Slower Time to Market: Extensive compliance checks and validations during RE could prolong the development cycle, potentially delaying the release of innovative SIPS to the market.
However, these potential drawbacks can be mitigated by adopting strategies that integrate compliance and innovation:

Compliance as a Driver for Innovation: Instead of viewing compliance as a constraint, organizations can leverage it as a driver for innovation. For instance, designing privacy-preserving features into SIPS can become a competitive advantage in a privacy-conscious market.
Flexible and Iterative Approach: Adopting agile methodologies and iterative development processes allows for incorporating compliance requirements incrementally. This flexibility enables adapting to evolving regulations and exploring innovative solutions throughout the SDLC.
Collaboration and Communication: Fostering close collaboration between software engineers, legal experts, and regulators ensures that compliance requirements are understood and addressed in a way that doesn't unnecessarily restrict innovation.
Ultimately, the key lies in finding a balance between proactively addressing regulatory compliance during RE and fostering an environment that encourages innovation. By viewing compliance as an opportunity for creative problem-solving and adopting flexible development approaches, organizations can build compliant and innovative SIPS.

What are the ethical implications of increasingly relying on automated systems to ensure regulatory compliance in SIPS, particularly in sensitive domains like healthcare or autonomous vehicles?

While automated systems offer significant potential for ensuring regulatory compliance in SIPS, their increasing reliance, especially in sensitive domains like healthcare and autonomous vehicles, raises several ethical implications:

Accountability and Liability: Determining accountability in case of compliance failures becomes complex when relying heavily on automated systems. If an AI-powered medical device violates HIPAA regulations, is it the developer, the healthcare provider, or the AI system itself that is ultimately responsible?
Bias and Discrimination: Automated systems are susceptible to inheriting and amplifying biases present in the data they are trained on. This can lead to discriminatory outcomes, for example, in healthcare SIPS that make biased treatment recommendations based on a patient's demographics.
Transparency and Explainability: Many AI-based compliance systems operate as "black boxes," making it challenging to understand their decision-making processes. This lack of transparency raises concerns about fairness and accountability, particularly in sensitive domains where decisions can have significant consequences.
Job Displacement and Human Oversight: Increased automation in compliance monitoring might lead to job displacement for human auditors and compliance officers. It's crucial to consider the ethical implications for the workforce and ensure adequate retraining and reskilling opportunities.
Over-reliance and Deskilling: Over-reliance on automated systems can lead to "deskilling" among human operators, potentially reducing their ability to identify and address compliance issues independently. Maintaining a balance between human oversight and automation is crucial.
To mitigate these ethical implications, it's essential to adopt a responsible approach to developing and deploying automated compliance systems:

Human-in-the-Loop Design: Incorporate human oversight and intervention mechanisms into automated compliance systems, especially in critical decision-making processes.
Bias Detection and Mitigation: Implement robust mechanisms for detecting and mitigating bias in data used to train and operate automated compliance systems.
Explainable AI (XAI): Develop and utilize XAI techniques to enhance the transparency and interpretability of automated compliance decisions.
Ethical Frameworks and Guidelines: Establish clear ethical guidelines and frameworks for developing and deploying automated compliance systems in sensitive domains.
Ongoing Monitoring and Evaluation: Continuously monitor and evaluate the performance and impact of automated compliance systems to identify and address potential ethical concerns.
By proactively addressing these ethical implications, we can harness the power of automation to enhance regulatory compliance in SIPS while ensuring fairness, transparency, and accountability.