The regulatory gap in digital health and alternative pathways to bridge it
Jeffrey David Iqbal, Nikola Biller‐Andorno
Abstract
Physicians and patients are overwhelmed with the number and variety of digital health technologies coming to market. Marketing authorizations by the U.S. FDA and its European counterparts normally bear signal effects: a product has been tested in a way that it is safe and efficacious for its intended purpose. This is currently not the case for digital health technologies (DHTs) given their characteristics, changes in actors and use contexts and lack of specific regulation in regard to those challenges. The consequent regulatory gap, i.e. the lack of effective regulation of such technologies, poses a threat to patient-consumers. Alternatives to regulatory agency-based assessments are evaluated and proposed to offer some value in bridging the current regulatory gap until it is closed but cannot replace the role of regulatory agencies.