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From Gatekeeper to Process Architect: The New Role of In-house Counsel in AI Governance

Abstract

In an era of accelerated advancement in AI technology, dynamic and variable global legislative approaches to AI risk management, and unrelenting commercial pressure for agile AI adoption, the role of in-house counsel is undergoing a pivotal transformation from traditional gatekeeper to proactive process architect. Drawing examples from Align Legal’s early adoption of and approach to AI governance, this paper explores how legal departments can build scalable, risk-based governance frameworks that guide and enable innovation within calibrated legal guardrails. It recommends that in-house counsel design systems that embed legal and ethical criteria directly into AI development and business workflows, bolstering compliance safeguards without bottlenecking progress. The paper discusses the design of effective AI policies and principled guidelines that steer development while avoiding unintended liabilities, aligning with corporate values and emerging global regulations. It assesses the limitations of human-in-the-loop oversight, acknowledging that manual review may not feasibly catch every issue at scale, and advocates for focused human intervention through predefined triggers and “kill-switch” protocols for high-risk scenarios. Ultimately, by recasting Legal as a strategic advisor and governance platform, organizations reinforce stakeholder trust and regulatory confidence, positioning in-house counsel as critical enablers of AI-supported innovation.

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Authors

Portrait image of Cam-Van (Vannie) Nguyen
Cam-Van (Vannie) Nguyen
Senior Managing Counsel, Office of the Chief Legal & Regulatory Officer, Align Technology, Inc., USA

Cam-Van (Vannie) Nguyen is a Senior Managing Counsel, Office of the Chief Legal & Regulatory Officer, at Align Technology, where she provides strategic legal support across commercial and corporate matters. Her experience spans corporate governance, commercial contracting, compliance, and risk management in fast-growing, global organizations, including advising on the use of artificial intelligence in products, business operations, and internal workflows. She holds a Juris Doctor from University of the Pacific, McGeorge School of Law.

Portrait image of Karen Jaenike
Karen Jaenike
Legal Director, Strategic Commercial Affairs, Align Technology, Inc., USA

Karen Jaenike, in her role as Legal Director in the Strategic Commercial Affairs global legal group at Align Technology, Inc., leads legal strategy for global product commercialization, clinical research, and artificial intelligence governance initiatives. She counsels on Align’s development and deployment of AI technologies, including regulatory risk for AI in medical devices, implementation of global governance frameworks, and cross-functional risk mitigation. Karen brings deep experience in medical device regulation, healthcare compliance, and technology law. Karen began her legal career at Pillsbury Madison & Sutro LLP, now Pillsbury Winthrop Shaw Pittman LLP, and holds a Juris Doctor with distinction from Stanford Law School.

Companies

Align Technology, Inc.

Align Technology, Inc. designs and manufactures the Invisalign® System, the most advanced clear aligner system in the world, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 291 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 28 years, Align has helped doctors treat over 21.4 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align™ Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners.

Align Technology, Inc. logo

Align Technology, Inc.

Align Technology, Inc. designs and manufactures the Invisalign® System, the most advanced clear aligner system in the world, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 291 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 28 years, Align has helped doctors treat over 21.4 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align™ Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners.

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