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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]
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.
Upfront articulation of Arguments (rationale and claims) to be used and (2) independent review to verify and validate. Since Safety Cases are structured, evidence based approaches to satisfy the safety argument established at the start of programs, they may find a good fit in augmenting existing and proven hazard analyses methods and techniques.
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 ...
Taxonomy-based risk identification – The taxonomy in taxonomy-based risk identification is a breakdown of possible risk sources. Based on the taxonomy and knowledge of best practices, a questionnaire is compiled. The answers to the questions reveal risks. [21] Common-risk checking [22] – In several industries, lists with known risks are ...
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 ...
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.