A Master’s thesis topic is available at the Centre for Digital Health Interventions:

Validating and Scaling Digital Health Solutions: Insights from International Initiatives and Adaptation Strategies for the Swiss Market

Background: Digital health technologies—ranging from mobile health apps and wearable devices to AI-enabled diagnostic tools—hold great potential to improve healthcare outcomes. However, many of these technologies fail to achieve sustainable integration into healthcare systems. Key barriers include regulatory complexity, limited market access, fragmented healthcare infrastructures, and unclear reimbursement pathways.

Globally, public and private initiatives have emerged to support the validation and adoption of digital health technologies. In Switzerland, despite the presence of several innovation hubs (e.g., Future of Health Grant, DayOne Accelerator, KSB Innovation Hub), a standardized national validation process is missing. This lack of alignment hinders national scalability and the transition of solutions from pilot projects into reimbursed clinical use.

This thesis aims to analyze and compare leading international validation initiatives and derive lessons for the Swiss healthcare and regulatory environment.

Objective: To systematically examine how selected international digital health validation initiatives define, implement, and enforce validation requirements, with an emphasis on:

• Regulatory approval pathways
• Classification schemes
• Evidence requirements
• Conditions for reimbursement and adoption

Scope of Literature Review – Country Cases:

1. Germany (DiGA Fast-Track) – BfArM’s fast-track for CE-marked digital health apps with provisional listing and reimbursement based on “positive healthcare effect.”
2. France (PECAN) – Early-access reimbursement model with one-year coverage for mature tools, overseen by ANS and HAS.
3. United States (FDA Digital Health Center of Excellence) – Lifecycle-based regulatory approach supporting innovation through initiatives like Software Pre-Certification.
4. Spain (Barcelona Health Hub Validation Center) – Private-sector hub providing clinical validation and tech transfer services in partnership with Spanish hospitals.
5. UK/Scotland (Glasgow Digital Health Validation Lab) – Publicly supported lab offering trial access and regulatory support to accelerate evaluation and clinical adoption.

Key Topics to Explore:

• Mission & Scope: Strategic goals; technology types covered
• Governance & Ownership: Public vs. private models; legal authority
• Definition of Digital Health Technology: Focus on DTx, diagnostics, SaMD
• Eligibility Criteria: CE/FDA classification, maturity, intended use
• Validation Evidence & Measurements: Clinical, technical, economic, organizational endpoints
• Process Design: Timelines, phases, provisional mechanisms
• Reimbursement Pathway & Pricing: Coverage criteria, pricing rules, incentive alignment
• Data & Interoperability: Security standards, privacy, interoperability
• Stakeholder Engagement: Involvement of patients, clinicians, industry, regulators
• Funding & Sustainability: Public-private models, service fees, grants

Methodology:

• Systematic Literature Review:
  • Regulatory documents (e.g., BfArM, FDA, EU MDR, HAS)
  • Peer-reviewed literature (e.g., NPJ Digital Medicine, JMIR, Health Policy)
  • Official websites and white papers
  • Evaluation case studies (e.g., approved DiGAs, FDA-cleared AI tools)
• Expert Interviews:
  • To complement literature with practical insights and validate interpretations
  • Stakeholders include regulators, developers, evaluators, and international experts

Deliverables:

• Comparative matrix summarizing validation frameworks, strengths, weaknesses, and outcomes
• (Optional) Narrative synthesis of regulatory similarities and differences
• Lessons and adaptation strategies for the Swiss context

For more information, please contact Dr. Mia Jovanova, Odile-Florence Giger and Wasu Mekniran (wasu.mekniran@unisg.ch).