JMIR Publications

ABSTRACT

Regulatory misalignment represents a critical barrier to digital health innovation. However, the Innovative Health Initiative Joint Undertaking (IHI-JU) INTERCEPT (GA n. 101194766), an initiative involving European public and private sectors aimed at intercepting Crohn’s disease prior to the manifestation of symptoms-advocates that the development of AI-powered digital platforms with compliance inherently integrated 'by design' is not only achievable but also imperative as the lack of systematic approaches for integrating regulatory requirements creates inefficiencies and delays in market access. In this perspective, we outline INTERCEPT’s strategic plan for an evolutionary digital infrastructure, coupled with AI-driven analytics, which is meticulously aligned with EU 2016/769 General Data Protection Regulation – GDPR, data privacy regulation, medical device regulation (EU 2017/745 Medical Device Regulation) and recommendations from the Medical Device Coordination Group – MDCG of the European Commission), Health Technology Assessment (HTA) criteria, and the recently enacted EU AI legislation (Regulation EU 2024/1689), which entered into force in 2024 with staggered implementation deadlines extending through 2027. Although presently in the start-up phase with clinical activities about to commence, INTERCEPT functions as a practical blueprint.

Methods:

Our analysis followed a multi-phase methodology comprising three sequential components. First, we conducted systematic regulatory landscape mapping to identify and categorize the most relevant EU frameworks (GDPR, Data Governance Act, EHDS, Clinical Trials Regulation, AI Act, and MDR) applicable to digital health innovation. Second, we implemented a structured stakeholder engagement through comprehensive surveys administered to all Work Package leaders (n=10), assessing both regulatory relevance and anticipated regulatory risk using high/medium/low categories, coupled with implementation timeline mapping (2025-2029). Third, we established iterative feedback cycles through structured dialogue sessions with project coordinators to identify current and anticipated regulatory challenges, implementation barriers, and mitigation strategies. Through retrospective analysis of survey responses, regulatory deliverables, and stakeholder feedback, we extracted and synthesized core principles into a generalizable regulatory-aligned innovation framework.

Conclusions:

The INTERCEPT regulatory-aligned framework aims to enhance digital health innovation by leveraging systematic regulatory integration to support project development and enable faster, more reliable market access for Software as Medical Device solutions, and contributes to regulatory science theory by establishing systematic principles for proactive compliance integration and offers practical guidance for digital health innovators navigating the complex EU regulatory landscape. Future research should validate the framework across diverse therapeutic areas and assess long-term impact on market success rates.