PMD14
THE EVOLUTION OF REGULATORY FRAMEWORKS OF
DIGITAL THERAPEUTICS (DTX) AND IMPLICATIONS FOR
MARKET ACCESS
https://www.valueinhealthjournal.com/action/showPdf?pii=S1098-3015%2820%2933303-9
Objectives: As technological development and uptake of consumer devices increase,
the relevance of Digital Therapeutics (DTx) becomes increasingly relevant and viable.
The objective is to identify how regulatory frameworks have developed to assess
benefit and value of DTx and how this impacts of innovation, market access and
ultimately patient care in the US and UK. Methods: The research methodology
included a literature review, based on peer-reviewed materials but also grey litera-
ture to make up for the academic material paucity. Thematic analysis identified
common perspectives on regulatory framework development and status. Policy
analysis review identified working regulatory requirements, definitions, and po-
tential future developments. Case studies were used to map regulatory pathways and
market access strategies and to elucidate how these frameworks are realised in the
real-world. Qualitative interviews were conducted to contextualise the findings and
further inform the research with a focus on hurdles to the further development of
value frameworks for DTx and foreseeable trends Results: US and UK frameworks
define DTx as medical devices. There is a lack of clarity over when Digital Health apps
require regulatory oversight. US policy has been borne out of a risk-based approach
encouraging innovation, market expansion and access. Recent FDA Pre-Certification
pathway has shifted the assessment of DTx to Quality Assurance of the developer. UK
policy requires a ‘declaration of conformity’ outlining how the product design con-
forms to EU’s Medical Device Directive which prioritises safety and performance
data, through the CE marking requirement, with a lower burden of clinical efficacy
evidence. Conclusions: DTx require demonstrations of clinical effectiveness. The US
shows greater regulatory maturity, flexibility and nimbleness in DTx appraisal than
the UK. The postponement of EU Medical Device Regulation and subsequent impact
of Brexit provides an opportunity for the UK to their approach to DTx to better
capture value and efficacy outcomes.