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Regulatory risk differentiation is the process used by a regulatory authority (the regulator - most often a tax administration) to systemically treat entities differently based on the regulator's assessment of the risks of the entity's non-compliance.
The European Medical Device Regulation (MDR 2017/745) [10] and the medical EMC collateral standard (IEC 60601-1-2) [13] are built on a legal foundation that specifies a risk-based approach, as outlined by the risk management standard ISO14971. [14] The ISO14971 risk-based EMC approach has also been incorporated into the ETERNITY project. [12]
In this context, risk-based regulation refers to the approach of identifying and assessing potential risks of money laundering and terrorist financing and implementing regulatory measures proportional to those risks. However, the shared enforcement powers between EU and national authorities in the implementation and enforcement of AML/CFT ...
Legal compliance is the process or procedure to ensure that an organization follows relevant laws, regulations and business rules. [5] The definition of legal compliance, especially in the context of corporate legal departments, has recently been expanded to include understanding and adhering to ethical codes within entire professions, as well.
ERM can also be described as a risk-based approach to managing an enterprise, integrating concepts of internal control, the Sarbanes–Oxley Act, data protection and strategic planning. ERM is evolving to address the needs of various stakeholders, who want to understand the broad spectrum of risks facing complex organizations to ensure they are ...
Economic approaches to the issue of regulation also emphasize the high risk that regulatory costs may exceed benefits. From this perspective, the central purpose of RIA is to ensure that regulation will be welfare-enhancing from the societal viewpoint - that is, that benefits will exceed costs.
GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems; GAMP Good Practice Guide: Calibration Management; GAMP Good Practice Guide: Electronic Data Archiving; GAMP Good Practice Guide: Global Information Systems Control and Compliance; GAMP Good Practice Guide: IT Infrastructure Control and Compliance [3]
By December 2023, the Ministry of Innovation and the Ministry of Justice published a joint AI regulation and ethics policy paper, outlining several AI ethical principles and a set of recommendations including opting for sector-based regulation, a risk-based approach, preference for "soft" regulatory tools and maintaining consistency with ...