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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 ...
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 ...
Categorize the information system and the data it processes, stores, and transmits, based on an impact analysis. [6] [7] [8] Select a baseline set of security controls for the information system based on its security categorization. Tailor and supplement the baseline controls as needed, based on an organizational risk assessment and specific ...
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 ...
Risk-weight functions - Functions provided as part of the Basel II regulatory framework, which maps the risk parameters above to risk-weighted assets; Minimum requirements - Core minimum standards that a bank must satisfy to use the internal ratings-based approach; The accord provides two broad approaches that a bank can follow: [5] Foundation ...
The need for RIA arises from the fact that regulation commonly has numerous impacts and that these are often difficult to foresee without detailed study and consultation with affected parties. Economic approaches to the issue of regulation also emphasize the high risk that regulatory costs may exceed benefits.