Regulatory considerations to keep pace with innovation in digital health products.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 35986056.
- Also identified by DOI 10.1038/s41746-022-00668-9 and PMC identifier 9390099.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation.