Regulatory considerations to keep pace with innovation in digital health products
John Torous, Ariel Dora Stern, Florence T. Bourgeois
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.
Topics & Concepts
PaceBusinessRisk analysis (engineering)Medical deviceEmerging technologiesHealth technologyComputer scienceEngineeringHealth careEconomicsEconomic growthGeodesyArtificial intelligenceGeographyBiomedical engineeringBiomedical Ethics and RegulationHealth Systems, Economic Evaluations, Quality of LifePharmaceutical Economics and Policy