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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]
Talk: Risk-based approach to EMC regulation and standardization. Add languages. Page contents not supported in other languages. ... Download as PDF; Printable version;
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.
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 ...
The Risk Management Framework (RMF) is a United States federal government guideline, standard, and process for managing risk to help secure information systems (computers and networks). The RMF was developed by the National Institute of Standards and Technology (NIST), and provides a structured process that integrates information security ...
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.
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 ...