Automating Compliance in Biomedical DevOps: A Policy-as-Code Approach

Abstract

 Governance in regulated biomedical contexts has become more and more reliant on automated mechanisms of governance in order to maintain compliance, security and auditability of swiftly changing software delivery ecosystems. This study shows a Policy-as-Code (PaC) model which includes regulatory criteria into biomedical DevOps pipelines via machine executable, readable policy definitions. The architecture proposed allows compliance controls to be versioned, tested, and enforced with the application code and infrastructure settings to keep them aligned with the regulatory requirements at all times. The framework (which is practiced in the federal biomedical research systems) illustrates the way in which PaC supports real-time compliance verification and automated control enforcement, and the creation of immutable audit artifacts throughout the software lifecycle. It enables to promote conformity in regulatory frameworks, such as NIST SP 800-53, FISMA, and HIPAA, lessening the use of manual reviews and periodic audits. Empirical testing indicates that configuration drift has reduced significantly, the authorization cycles have decreased and compliance overhead is quantifiably reduced without affecting the security or performance of the system. Achieving this by formalizing regulatory requirements by making digital policies a continuously assessed digital policy, the study redefines compliance as an inherent system property and not a post hoc system checking process. The results demonstrate the importance of PaC in promoting secure CI/CD processes, allowing a continuous authorization mechanism, and enhancing governance automation of well-regulated biomedical settings. This publication provides a scaling model of regulatory engineering and provides realistic considerations in the implementation of compliance-aware DevSecOps architectures in public-sector and biomedical cloud systems.