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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 also referred to as the Compliance Model in some regulatory agencies. [1] See for example the Australian Prudential Regulatory Authority risk differentiation approach known as: PAIRS [2] / SOARS. [3] PAIRS is the Probability And Impact Rating System, while SOARS is the Supervisory Oversight And Response System.
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 term Foundation IRB or F-IRB is an abbreviation of foundation internal ratings-based approach, and it refers to a set of credit risk measurement techniques proposed under Basel II capital adequacy rules for banking institutions.
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 ...
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 ...
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 ...
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.