Regulationsbased

Regulationsbased is a term used to describe approaches, systems, and decision processes that are explicitly grounded in applicable laws, regulations, and regulatory guidance. In a regulationsbased framework, requirements are derived from statutes, rules, and enforcement expectations, and are used to shape data models, workflows, controls, and evaluation criteria. The term is commonly applied in regulated industries and in governance-oriented software development.

Key features of regulationsbased design include explicit regulatory mapping, traceability from regulatory text to technical or organizational controls, versioning aligned with regulatory updates, and auditable decision trails. It emphasizes transparency, accountability, and alignment with compliance programs, often leveraging rule-based engines, policy-based access control, and evidence repositories to demonstrate conformity during audits.

Applications span financial services compliance programs, healthcare data governance, energy and environmental reporting, product safety, and regulatory technology (RegTech). In software development, a regulationsbased approach supports compliance-by-design and regulatory change management, enabling organizations to respond to new requirements with minimal risk.

Challenges include dealing with ambiguous or multi-jurisdictional rules, maintaining up-to-date mappings as regulations evolve, and balancing regulatory requirements with efficiency and innovation. Implementations can incur significant initial and ongoing costs for regulation extraction, interpretation, and verification, and require strong governance to prevent rule fatigue and misalignment.

Regulationsbased relates to broader concepts such as compliance by design, policy-based governance, rule-based systems, and RegTech. It shares objectives with standards-based and risk-based approaches but centers on legal enforceability as the primary source of requirements.