In the rapidly evolving realm of digital health, ensuring that innovative technologies are both safe and effective is paramount. For digital health manufacturers, understanding and navigating the assessment frameworks that govern market access and reimbursement is critical. This blog provides an in-depth exploration of two prominent European assessment frameworks: Finland’s Digital Health Technology Assessment (Digi-HTA) and France’s Early Coverage of Digital Medical Devices (PECAN). Whether you are developing innovative software applications or sophisticated hardware devices, understanding these frameworks will empower you to streamline your product’s journey from conception to market.
Health Technology Assessment (HTA) frameworks evaluate the clinical, economic and social implications of health technologies. These assessments ensure that new digital health solutions meet regulatory standards and deliver tangible benefits to healthcare systems and patients. For manufacturers, aligning with HTA criteria is essential for successful market entry, securing reimbursement and fostering trust among stakeholders.
Finnish Digi-HTA and French PECAN are robust assessment frameworks tailored to evaluate digital health technologies (DHTs). While both aim to ensure the safety, efficacy and economic viability of digital health solutions, they differ in scope, focus areas and operational mechanics.
Digi-HTA (Finland): Universally applicable to a wide range of DHTs, including software applications, digital therapeutics (DTx), remote patient monitoring (RPM), AgeTech, artificial intelligence (AI) and robotic solutions. It accommodates both medical and non-medical devices across all EU risk classes.
PECAN (France): Specifically targets DTx and RPM applications, including those incorporating AI algorithms. It requires products to be CE-marked medical devices, covering all EU risk classes and integrates a national reimbursement model.
Understanding these frameworks’ nuances is crucial for digital health manufacturers aiming to penetrate the Finnish and French markets effectively.
Comprehensive Breakdown of Digi-HTA
Digi-HTA is designed with versatility in mind, catering to a diverse array of DHTs. This broad applicability extends to non-medical devices that influence health outcomes, offering manufacturers flexibility in their product offerings. It has a wide range of technologies including digital health applications, DTx, RPM, AgeTech, AI and robotics. Applicable to medical devices across EU risk classes I-IV and non-medical devices.
The unified framework allows you to streamline your assessment process for multiple products within a single framework. And provides the flexibility and opportunity to assess a broader portfolio of products, including non-medical technologies that impact health.
Digi-HTA incorporates a dedicated domain for AI products or those utilising AI, ensuring a thorough evaluation of AI-related functionalities and implications. This dedicated focus addresses the complexities and ethical considerations inherent in AI-driven health technologies. It also has a dedicated AI domain that offers comprehensive evaluation of AI functionalities, ethical implications, and algorithmic transparency. AI assessments are seamlessly integrated with clinical and economic evaluations.
The comprehensive AI Evaluation addresses all aspects of AI integration, from technical performance to ethical considerations and will demonstrate the reliability and transparency of your AI algorithms, fostering stakeholder trust.
Digi-HTA includes specialised domains such as robotics, reflecting the framework’s comprehensive coverage of advanced technologies. The consistent terminology aligned with EU regulations facilitates clear communication and understanding among international stakeholders. It addresses unique challenges related to robotic health technologies. And is aligned with EU standards for clarity and ease of navigation.
Both Digi-HTA and PECAN typically require 2-3 months for the assessment process, balancing thoroughness with the need for timely evaluations.
Digi-HTA offers a cost-free assessment and consultation process, lowering financial barriers for manufacturers, including startups and SMEs. It is cost efficent due to the allocation of financial resources for product development and marketing rather than assessment fees. Beneficial from an accessible framework regardless of company size or financial standing.
Digi-HTA is anchored in both national and EU-level regulations, including the Act on the Provision of Digital Services and the General Data Protection Regulation (GDPR), alongside international standards. It complies with national Finnish laws and broader EU directives and adheres to global standards, facilitating cross-border compliance.
Currently, Digi-HTA provides informative data that can be used for regional procurement decisions, supporting decentralised reimbursement strategies. The data supports regional decision-making rather than a centralised reimbursement model and can be used to inform multi-national evaluations and broader market access.
Comprehensive Breakdown of PECAN
PECAN is tailored specifically for digital therapeutics (DTx) and remote patient monitoring (RPM) applications, including those that incorporate AI algorithms. This focused approach allows for specialised assessment criteria that address the unique clinical and operational aspects of these technologies. It targets DTx and RPM applications exclusively and requires products to be CE-marked, ensuring compliance with EU Medical Device Regulation (MDR). Manufacturers benefit from criteria specifically designed for DTx and RPM, enhancing the relevance of evaluations. CE-marking serves as a baseline for safety and performance, simplifying the assessment process.
PECAN incorporates a separate analysis grid for AI components within digital medical devices, ensuring that AI functionalities are systematically assessed. The AI Analysis Grid provides a structured approach to evaluate AI algorithms, focusing on validation, bias mitigation and performance metrics and ensures AI-driven decisions are transparent and fair. A structured AI Evaluation follows a clear framework for AI assessments, addressing critical aspects such as bias and algorithmic transparency which demonstrates the reliability and ethical grounding of AI components to secure stakeholder confidence.
PECAN uses differentiated terminology for assessment domains, reflecting national regulatory priorities and cultural approaches to technology assessment within the French healthcare system. Categories like “Data Management” instead of “Information Security” illustrate tailored regulatory focuses. Terminology and domains are aligned with French healthcare priorities.
PECAN maintains a similar assessment timeline of 2-3 months, ensuring timely evaluations for manufacturers as well as Phased Reviews: Iterative assessments with continuous feedback loops.
While PECAN offers free, voluntary, non-binding and confidential preliminary consultations and free application, a predetermined fee is required for permanent listing in reimbursement lists (LPPR or LATM). Charges apply for inclusion in reimbursement lists, supporting the sustainability of the reimbursement system.
Manufacturers budget for the fees associated with a permanent listing to ensure successful reimbursement and market access as well as allocate resources to cover the costs of a listing in LPPR or LATM, which can provide significant long-term returns through reimbursement.
PECAN is rooted in French national legislation and aligns with EU-level regulations, ensuring comprehensive compliance within the broader European regulatory landscape. It adheres to French laws and EU directives, ensuring comprehensive regulatory alignment and incorporates specific French legal nuances, reflecting national healthcare priorities and regulatory practices.
PECAN integrates a national reimbursement model based on legislation, providing a clear and standardised pathway for financial coverage of approved digital medical devices.
Comparative Scientific Insights
Assessment Methodologies
- Digi-HTA:
- Comprehensive and Multi-Domain: Broad evaluation across multiple domains ensures a thorough assessment.
- Evidence Synthesis: Systematic reviews and meta-analyses enhance robustness.
- Lifecycle Perspective: Considers the entire technology lifecycle, ensuring sustained relevance.
- PECAN:
- Focused and Specialised: In-depth assessments tailored to DTx and RPM.
- Iterative and Dynamic: Adapts to technological advancements and emerging evidence.
- Value-Based Emphasis: Prioritises economic value and cost-effectiveness.
Evidence Appraisal and Integration
- Digi-HTA:
- Diverse Evidence Sources: Integrates clinical trials, real-world evidence, economic analyses and user studies.
- Robust Analytical Techniques: Advanced statistical methods and modelling.
- Stakeholder Engagement: Involves a wide range of stakeholders for comprehensive evaluations.
- PECAN:
- High-Quality Clinical Evidence: Emphasises RCTs and pragmatic trials.
- Economic Rigor: Stringent economic evaluations to ensure cost-effectiveness.
- AI-Specific Assessments: Dedicated grids for thorough AI evaluations.
Cybersecurity and Data Privacy
- Digi-HTA:
- Integrated Security Evaluation: Cybersecurity embedded across multiple domains.
- Advanced Security Standards: Adheres to ISO/IEC 27001 and ISO/SAE 21434.
- Pro-active Risk Management: Continuous vulnerability assessments and incident response plans.
- PECAN:
- Dedicated Security Criteria: Explicit focus on cybersecurity and data privacy.
- Regulatory Alignment: Compliance with national and EU cybersecurity laws.
- Continuous Monitoring: Ongoing security assessments and real-time threat detection.
Reimbursement and Market Integration
- Digi-HTA:
- Informative Data for Regional Decisions: Supports decentralised reimbursement strategies.
- Potential for Broader EU Integration: Facilitates multi-national evaluations.
- PECAN:
- Direct Link to National Reimbursement: Inclusion in LPPR or LATM ensures financial coverage.
- Predictable Reimbursement Pathways: Aids in financial planning and investment decisions.
Case Studies and Practical Applications
Finnish Digi-HTA: Telehealth Platform Assessment
Scenario: A Finnish startup develops a telehealth platform integrating AI-driven diagnostics, patient monitoring, and EHR integration.
Assessment Process:
- Clinical Evaluation:
- RCTs: Demonstrated improved diagnostic accuracy and disease management.
- Real-World Evidence: Increased patient engagement and reduced hospital re-admissions.
- Economic Analysis:
- Cost-Effectiveness: €15,000 per QALY, below the national threshold.
- Budget Impact: Initial €2 million investment with €5 million savings over five years.
- Usability Testing:
- User Experience Studies: High satisfaction rates (>80%).
- Usability Metrics: Task completion rates above 95%.
- Cybersecurity Review:
- Compliance Verification: Achieved ISO/IEC 27001 certification.
- Security Measures: Implemented AES-256 encryption and TLS 1.3, with regular vulnerability assessments.
Outcome: Positive Digi-HTA assessment enabled regional healthcare authorities to adopt the platform, enhancing telehealth services and patient outcomes.
French PECAN: AI-Powered Remote Monitoring Device
Scenario: A French company develops an AI-powered remote monitoring device for chronic disease management, integrating predictive analytics.
Assessment Process:
- Clinical Trials:
- Pragmatic Trials: 20% reduction in hospitalisations and 15% improvement in disease metrics.
- Safety Profiles: Minimal adverse events (<1%) with reliable AI predictions.
- Economic Evaluation:
- ICER: €10,000 per QALY, below the national threshold.
- Budget Impact: €3 million annually with €7 million savings.
- AI Component Assessment:
- Algorithm Validation: 95% accuracy in predictive analytics.
- Bias Mitigation: Ensured equitable AI predictions across diverse populations.
- Cybersecurity Assurance:
- GDPR Compliance: Robust data anonymisation and consent management.
- Continuous Monitoring Systems: Real-time threat detection and incident response mechanisms.
Outcome: Successfully listed in the LPPR, facilitating nationwide reimbursement and widespread adoption, improving disease management and reducing healthcare costs.
Strengths and Limitations
Finnish Digi-HTA
Strengths:
- Comprehensive Scope: Evaluates a wide range of DHTs, promoting versatility.
- Free Assessment Process: Lowers financial barriers, encouraging diverse participation.
- Robust Evidence Integration: Utilises diverse data sources and advanced analytical techniques.
- Lifecycle Perspective: Ensures sustained evaluation and adaptability.
Limitations:
- Decentralised Reimbursement: Regional variability can complicate uniform market access.
- Resource Intensive: Comprehensive assessments require significant resources and expertise.
French PECAN
Strengths:
- Focused Expertise: Specialises in DTx and RPM, allowing for in-depth assessments.
- Direct Reimbursement Link: Facilitates straightforward market access through reimbursement lists.
- Value-Based Emphasis: Aligns technology adoption with economic sustainability.
Limitations:
- Narrow Applicability: Limited to specific categories, potentially excluding other innovative DHTs.
- Fee-Based Model: Application fees for permanent listing may deter smaller vendors.
- Potential for Bottlenecks: High demand in specialised categories could lead to processing delays.
Future Directions and Innovations
Greater alignment with emerging EU-wide HTA standards to facilitate cross-border evaluations and streamlined assessments for multi-national market access through mutual recognition between frameworks.
Adaptive Assessment Models that update criteria to incorporate technologies like blockchain-based health records and virtual reality therapies. Implementation of continuous evaluation frameworks addressing algorithm drift and ethical AI practices.
Increased involvement of patient advisory boards to ensure DHTs meet patient needs as well as fostering the collaboration between clinicians, technologists, economists, ethicists and data scientists for enriched assessments.
Operational and Strategic Implications for Manufacturers
Market Entry Strategy
- Digi-HTA:
- Broader Product Range: Assess multiple DHTs within a single framework.
- Cost-Effective Access: Free assessments reduce financial barriers.
- PECAN:
- Specialised Focus: Align assessments with DTx and RPM criteria.
- Reimbursement Integration: Clear financial pathways aid in revenue projection.
Compliance and Quality Assurance
- Digi-HTA:
- Comprehensive Compliance: Meets a wide range of regulatory and quality standards.
- Regional Decision Support: Tailor products to specific regional healthcare needs.
- PECAN:
- Streamlined Reimbursement: Direct link to reimbursement lists simplifies financial support.
- Quality Emphasis: Mandatory CE-marking ensures high safety and performance standards.
Strategic Considerations
- Digi-HTA:
- Scalability: Informative assessments support broader European market strategies.
- Innovation Promotion: Free assessments encourage continuous innovation.
- PECAN:
- Market Penetration: Direct reimbursement linkage facilitates widespread adoption.
- Financial Planning: Predictable reimbursement models aid in long-term investments.
Recommendations for Stakeholders
For Manufacturers:
- Assess Product Alignment: Determine whether your product aligns more closely with Digi-HTA’s broad scope or PECAN’s specialised focus.
- Budget for Fees: If targeting France via PECAN, account for fees associated with the permanent listing.
- Strengthen Cybersecurity Posture: Implement robust cybersecurity measures to meet both frameworks’ stringent requirements.
- Leverage Informative Data: Use Digi-HTA’s informative data to inform product development and regional strategies.
For Policymakers and Regulators:
- Harmonise Standards: Explore opportunities to align assessment criteria and cybersecurity standards across Digi-HTA and PECAN.
- Support Innovation: Maintain frameworks that encourage innovation while ensuring compliance with safety and performance standards.
- Enhance Collaboration: Promote collaboration between national and EU-level regulatory bodies to share best practices.
For Healthcare Providers:
- Understand Assessment Outcomes: Familiarise yourself with Digi-HTA and PECAN criteria to make informed adoption decisions.
- Engage with Vendors: Collaborate with vendors to provide feedback, contributing to continuous improvement and alignment with clinical needs.
The Finnish Digi-HTA and French PECAN frameworks embody sophisticated, scientifically grounded approaches to assessing and integrating digital health technologies within their respective healthcare systems. Digi-HTA’s comprehensive and multi-domain evaluation ensures a holistic understanding of DHTs, fostering innovation and regional adaptability. In contrast, PECAN’s focused and value-based assessments provide clear pathways for reimbursement and market access, aligning technology adoption with national healthcare priorities.
Both frameworks emphasise clinical efficacy, economic value, and cybersecurity, yet cater to different strategic objectives and market dynamics. Digi-HTA’s broad applicability and free assessment process encourage diverse participation and innovation, while PECAN’s specialised focus and direct reimbursement linkage facilitate targeted adoption and financial sustainability.
For stakeholders navigating the European digital health landscape, understanding these nuanced differences is crucial for optimising technology development, regulatory compliance, and market entry strategies. As digital health continues to evolve, ongoing collaboration, harmonisation and methodological innovation will be essential to maximise the benefits of DHTs for healthcare systems and patient outcomes across Europe.
For further detailed insights, please refer to the full reports available here.
References
- Finnish Coordinating Centre for Health Technology Assessment (FinCCHTA). (2024, October 28). Comparison report of Finnish Digi-HTA and French PECAN assessment criteria. Retrieved from https://oys.fi/fincchta/katsauksia-ja-suosituksia/
- European Medicines Agency (EMA). (2023). Guidelines on Health Technology Assessment (HTA).
- International Organisation for Standardisation (ISO). (2023). ISO/IEC 27001: Information Security Management.
- French National Authority for Health (HAS). (2024). PECAN Framework Documentation.
- General Data Protection Regulation (GDPR). (2018). Regulation (EU) 2016/679.
- EU Medical Device Regulation (MDR). (2017). Regulation (EU) 2017/745.
- Porter, M. E. (2010). What is Value in Health Care? New England Journal of Medicine, 363(26), 2477-2481.
- Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & PRISMA Group. (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med, 6(7), e1000097.
- Littell, J. H., Seltman, H., & Strand, N. M. (2008). SAS for Mixed Models. Cary, NC: SAS Institute.