Regulated digital medical products
- Submission status
- Closed
- Submission deadline
This Collection will highlight the unique considerations, approaches, challenges, and opportunities associated with regulated digital medical products. Such products can take many forms: they may be therapeutic medical devices, diagnostics, or clinical decision support tools (to name just a few major categories) and they may be stand-alone software or may involve hardware-software combination products. The Collection will highlight international perspectives, regulatory strategy considerations, new approaches (such as digital twins and other modeling and simulation techniques), special considerations related to the regulation of Artificial Intelligence (AI) products, and post-market considerations, including the myriad applications of real world data and real world evidence for regulatory surveillance.
This Collection will curate original research Articles, Reviews, Comments, and Perspectives from thought leaders in the field. In particular, there is an opportunity for those with expertise in regulatory approval/clearance/certification to reflect on what they see as the most important and germane policy, business, and legal issues in this space and share their insights with readers of the journal.
We welcome the submission of product-specific case studies from those conducting translational research to the extent that regulatory strategy and regulation could be a focal discussion point. We will not consider product-specific articles that do not engage with the regulatory approval process and its lessons for the broader digital medicine R&D community.
This Collection supports and amplifies research related to SDG 9.
Editors
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Ariel D. Stern, PhD
Harvard Business School and Harvard-MIT Center for Regulatory Science, USA.
