T61. Regulatory risks, constraints, and design parameter analysis

Regulation may impose critical constraints and requirements on AI system design.

Once a tentative understanding of the future intended use case and users of the AI system is reached, the AI System Owner should ensure that the legal function conducts an in-depth analysis of the system and its regulatory environment to identify key regulatory risks, constraints, and design parameters.

The analysis should
1) assess regulatory risks associated with known design options,
2) identify key design constraints,
3) identify design areas with significant regulatory implications (key regulatory issues), and
4) outline possible design options and their implications.

These regulatory focal points should be clearly communicated to all parties active in developing or implementing an AI system within the organization.