Selected Papers, in Full Detail

Medical Devices - Health Policy & Regulatory

PMD14

THE EVOLUTION OF REGULATORY FRAMEWORKS OF

DIGITAL THERAPEUTICS (DTX) AND IMPLICATIONS FOR

MARKET ACCESS

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 literature 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 potential 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 conforms 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.

Biomarker Stratification in Rare Disease Drug Registration

An analysis of regulatory submission outcomes across rare-disease programmes where biomarker-defined patient populations were used as primary endpoints, examining approval rates and post-market surveillance requirements.

Plain language: Rare diseases affect small patient numbers, making standard clinical trials impractical. This paper assessed whether selecting patients by biological markers — not just diagnosis — improves the evidence regulators accept.

Methodology: Retrospective regulatory dataset analysis, EMA and FDA submission records, 2015–2023. Peer-reviewed; full citation and DOI in the publications archive.

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