RF Quarterly, December 2022: Artificial intelligence

RF Quarterly | 09 December 2022 | Citation  |  PDF Link PDF

Welcome to the December issue of RF Quarterly in which global regulatory experts write about the role of artificial intelligence (AI) in regulatory practice, with a focus on global change management of AI-based medical devices, AI in regulatory intelligence knowledge management, synthetic data and the innovation, assessment, and regulation of AI medical devices, and digital transformation.
We thank the authors for their generosity in sharing their knowledge and expertise with the RAPS regulatory community and hope these articles will serve as useful guidance and resources.
AI in medical devices and regulatory intelligence

The healthcare industry generates a significant amount of data through the delivery of routine care. Leveraging such data through AI as medical devices (AIaMDs) could improve patient experiences, produce better health outcomes, and reduce healthcare cost pressures, write Tahir Rizvi and Savannah Hari in Change control in the artificial intelligence era. However, AIaMDs are capable of “learning" from real-world performance and over time and may provide a different output than that initially cleared for a given set of inputs. At the same time, regulatory frameworks have remained relatively unchanged. Regulators have therefore shifted toward a total product lifecycle (TPLC) approach, resulting in recent regulatory updates to core global medical device standards that place a greater emphasis on feedback loops from postmarket surveillance back into design and development. The authors explain the US Food and Drug Administration’s (FDA’s) current thinking on enabling a TPLC approach for AIaMDs, with a specific focus on predetermined change control plans in the US as well as the UK and EU.

In AI in regulatory intelligence knowledge management: A primer, Valerie Limasi, Jingming Yuan, Sheila Galan, Krish Perumal, and Amin Osmani discuss how recent advances in AI can be applied to support and expand upon regulatory intelligence functions, including knowledge management and precedent research. They introduce the concepts of natural language processing and computer vision, the two main fields of AI that can be applied to various RI functions. Adoption of AI in the regulatory intelligence functions will expand and automate workflows by helping differentiate relevant from irrelevant content, speeding up the research processes, and supporting data collection. These large-scale analyses of regulatory processes and pathways can be achieved more efficiently and facilitate collaboration around improving regulatory policies and practices.

Synthetic data, big data, and data ecosystems
Synthetic data are artificial data that mimic the properties of and relationships in real data. They show promise for facilitating data access, validation, and benchmarking, addressing missing data and under-sampling, sample boosting, and the creation of control arms in clinical trials, write Puja Myles and colleagues, Johan Ordish and Richard Branson, of the UK Medicines and Healthcare products Regulatory Agency. In Synthetic data and the innovation, assessment, and regulation of AI medical devices the authors describe the agency’s current research into the development of high-fidelity synthetic data to develop its regulatory position on AI medical devices trained on synthetic data, and on synthetic data as a tool for the validation and benchmarking of AI medical devices.
Wael William Diab chairs SC 42, the technical subcommittee for AI of the ISO/IEC’s joint technical committee 1. In Transforming industry and society through beneficial AI, he outlines the work of SC 42, which aims to develop and maintain standards for AI and promote their adoption. Diab describes the subcommittee’s ecosystem approach, which entails looking at emerging requirements from a range of perspectives, such as regulatory, business, societal, and ethical. The subcommittee assimilates these requirements, translating them to technical requirements and developing horizontal deliverables applicable across industry sectors.
Renée Matthews, Senior Editor, is responsible for RF Quarterly and Regulatory Focus Features. She can be reached at rmatthews@raps.org
Acknowledgment I thank the following colleagues for their assistance in preparing and publishing this issue: art director Simon Fong and graphic designer Ericka Nguyen; designer Connie Hameedi; Denise Fulton and Laura Loria for editorial support and guidance; Nicole Duran and Ryan Connors for marketing support; and Ravi Gaddipati for web production support.
Citation Matthews R. Introduction: Regulatory history. RF Quarterly. 2022;2(4):1-2. Published online 9 December 2022. https://www.raps.org/news-and-articles/news-articles/2022/9/introduction-regulatory-strategy
Upcoming in RF Quarterly during 2023
  • Patient-focused regulatory practice (March)
  • Global health and regulatory authorities (June)
  • Leadership (September; print issue to 2023 Convergence)
  • 2023 RAPS Convergence (December)
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