Key Highlights:



  • 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.


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