The EuroScan Toolkit V 2025

EuroScan is a leading global collaborative network dedicated to collecting and sharing information on innovative healthcare technologies. Its mission is to support decision-making, adoption, and use of effective, useful, and safe health-related technologies. It also serves as a principal forum for developing methods for early identification and assessment of new technologies and predicting their impact.

The network has established specific branding initiatives:

• international Healthtech Scan (i-HTS.org): For all member-driven activities.
• Health Innovations and Technologies (GMS HInT): An open-access journal for methodologies and experiences.
• i-HTScience: A Belgian branch supporting scientific projects and network collaborations.

Core Goals of EuroScan:

• Share skills and experience in EAA and disinvestment activities.
• Strengthen methodological approaches for identification, description, and assessment.
• Improve information exchange about new, emerging, or obsolete health technologies.
• Increase the impact of EuroScan's output.
• Identify relevant not-for-profit public partners for collaboration.
• Advise public administrations on establishing EAA/disinvestment activities.

The History of Horizon Scanning and Early Awareness Systems

Horizon Scanning (HS) and Early Awareness (EA) systems have evolved significantly since the mid-1990s. Initially focused on technology forecasting in business, they expanded into healthcare in the early 2000s to anticipate medical advancements and public health threats. Modern systems integrate advanced analytics like AI and consider broader societal implications.

• 1996-2000: Formative years, focus on technology forecasting.
• 2001-2010: Expansion into health sectors.
• 2011-present: Integration of AI and societal impact assessments.

From “Horizon Scanning” to “Early Awareness” Concepts

Early HS approaches focused on lists of upcoming technologies to prepare health systems. Today, with information overload, the focus has shifted to comprehensive evaluation and critical appraisal, enabling anticipation of future developments. Stakeholders now span beyond HTA bodies to include decision-makers across the healthcare sector, valuing detailed information for priority setting.

Early Value Proposition of Emerging Technologies and Indications (EVP)

EVP is crucial during early R&D, defining the anticipated value a new health technology will provide to patients, providers, and payers. It guides development by aligning technology capabilities with healthcare needs. Methodological tools include:

• Outcome Predictions (statistical models)
• Stakeholder Analysis (gathering insights)
• Market Analysis (competitive landscape, market size)
• Early-Stage Clinical Trials (preliminary efficacy/safety data)
• Health Economic Modeling (predicting economic impact)

Health Care Context of Technologies and Related Stakeholders

Integrating multiple stakeholders (patients, providers, payers, policymakers) in health technology R&D ensures effectiveness and relevance. This integration leads to informed decision-making, enhanced transparency, improved technology adoption, alignment with public needs, and addresses ethical considerations. Methods for collecting values include surveys, interviews, focus groups, and Delphi panels.

Early Awareness in connection with HIAP and HFAP

Early Awareness and Horizon Scanning (EAA/HS) are vital for advancing 'Health in All Policies' (HIAP) and 'Health for All Policies' (HFAP). EAA identifies emerging technologies and public health threats early, supporting regulatory and engineering processes, aligning innovations with public health goals, and influencing funding decisions.

EAA and Horizon Scanning in Regulatory and Reimbursement Decisions

EAA systems are crucial for anticipating and managing the impact of emerging health technologies on regulatory and reimbursement decisions. They provide early insights to help bodies prepare for changes, ensuring smooth integration. For regulators, EAA aids in evaluating safety, efficacy, and quality. For reimbursement, it offers critical data on cost-effectiveness and budget impact.

Using MCDA in EAA Systems for Early Awareness and Horizon Scanning

Multi-Criteria Decision Analysis (MCDA) enhances EAA systems by systematically evaluating multiple criteria for healthcare decision-making. It assesses the potential impacts of new technologies from various perspectives, integrating societal, public health, and clinical values. MCDA offers a broader perspective than Health Technology Assessment (HTA) alone, incorporating patient satisfaction and ethical considerations, leading to more comprehensive assessments.

Technology Readiness Evaluation and Intended Purpose Development (TRL)

Technology Readiness Level (TRL) is a scale (1 to 9) assessing technology maturity from concept to market readiness. In healthcare, TRL is crucial for regulatory approval and engineering development, guiding the process and ensuring safety and efficacy standards are met. Tools like checklists and guidelines estimate TRL, which is vital during R&D and for regulatory/reimbursement decisions.

Maturity Level of Health Innovations

The maturity level of health innovations refers to their development and readiness for clinical use or commercialization. It impacts investment, development, and market introduction, influencing business and engineering strategies. Tools like TRL, Integration Readiness Level (IRL), and Market Readiness Level (MRL) assess maturity, aiding in market adaptation, policy development, and regulatory approval.

Lifecycle and Milestones within R&D to Market Implementation

Health technology development involves critical milestones, each with relevant Key Performance Indicators (KPIs), influencing regulatory approval, reimbursement, and market implementation:

• Concept and Feasibility: Initial research, proof of concept.
• Preclinical Development: Lab research, animal testing for safety.
• Clinical Development: Human trials (phases) for safety, efficacy, dosing.
• Regulatory Review: Submission for marketing approval.
• Market Launch: Commercial release after approval.
• Post-Market Surveillance: Ongoing monitoring of performance and safety in real-world settings.

From Technology List to Early Awareness Systems: A Comprehensive Integrative Approach

Integrating emerging technologies into healthcare requires a coordinated approach: assessing health needs, providing entrepreneurial support (early dialogue, advice), obtaining second opinions for funding, and employing decision support for prioritization and pre-commercial procurement. This integration demands a robust framework with centralized digital platforms for collaboration and data sharing among stakeholders.

The EuroScan EAA workflow provides a structured approach to identify, prioritize, assess, and monitor emerging health technologies. This ensures healthcare systems can prepare for innovation adoption while managing risks and costs.

Workflow Steps

Step 0. The Question and Related Background Information

Defining the topic within its health context is crucial for effective decision support. Interests vary widely, and social, legal, and ethical backgrounds differ even within countries. Collecting information on health context, clinical/business aspects, stakeholders, and organizational societal aspects ensures clarity and efficiency in subsequent steps.

Step 1. Identification and Information Retrieval

This step systematically identifies new or emerging health technologies not yet widely adopted. It captures early signals of innovations with significant clinical, economic, or societal impact. Key sources include:

• Scientific Literature (PubMed, ScienceDirect)
• Regulatory Information and Study Databases (WHO, FDA, EMA, ClinicalTrials.gov)
• Patent Databases (WIPO PatentScope)
• Public Health Needs and Guideline Sources (EuroScan, GIN)
• Industry Reports and Market Research (McKinsey, Deloitte)
• Conferences and Trade Fairs (HIMSS, CES, MEDICA)
• Horizon Scanning Platforms (EuroScan International Network)
• Expert Consultations

Step 2. The Prioritization Workflow

Not all identified technologies can be assessed in depth; therefore, prioritization focuses resources on the most relevant or impactful ones. Criteria include potential clinical benefit, population size, cost/budget impact, adoption feasibility, and ethical/legal/social considerations. Stakeholder values are integrated to ensure balanced decisions.

Tools for Prioritization:

• Multi-Criteria Decision Analysis (MCDA): Evaluates technologies based on multiple weighted criteria (clinical effectiveness, cost-effectiveness, patient preference).
• Budget Impact Analysis (BIA): Assesses financial implications and helps understand short- and long-term costs.
• Delphi Method for Expert Consensus: Gathers expert opinions through iterative surveys until consensus is reached.
• Health Impact Assessment (HIA): Systematically evaluates potential public health effects, including health outcomes, affected populations, social determinants, economic factors, and ethical/legal implications.

Stakeholder Value-Based Priorities:

Stakeholder	Value-Based Priorities
Policymakers	Cost-effectiveness, population health outcomes, sustainability
Patients	Quality of life, access to innovative treatments, affordability
Healthcare Providers	Clinical effectiveness, ease of implementation, safety
Industry (Pharma/MedTech)	Market access, regulatory approval, innovation potential
Payers (Insurance)	Cost control, budget impact, long-term benefits
Regulatory Agencies	Safety, efficacy, compliance with standards

Step 3. Data Collection

Detailed information is collected on prioritized technologies to gather a well-rounded picture of their potential effects and readiness.

Classical Approach (during R&D):

• Types of Data: Preclinical, Clinical Trial, Regulatory, Economic/Cost, Real-World Data (RWD).
• Methods: Clinical Trials, Observational Studies, Surveys, Secondary Data Sources, Expert Consultations.
• Modeling: Statistical models, Health Economic models (CEA, BIA), Decision-Tree models, Markov models, Monte Carlo Simulation, Machine Learning models.

Modern Approach (Proactive Co-operation):

Emphasizes structured processes like early dialogue, early advice, and scientific advice to enhance knowledge generation and data exchange during R&D. This improves alignment with regulatory, clinical, and market expectations.

Step 4. Assessment

Technologies undergo early assessment by multidisciplinary teams, evaluating clinical evidence strength, impact on practices, economic analysis (cost-effectiveness, budget impact), and integration feasibility. The purpose is to provide an evidence-based forecast of the technology’s value, benefits, and challenges.

Step 5. Dissemination

Assessment results are compiled into reports or alerts and shared with policymakers, healthcare providers, regulatory agencies, and payers. This is done through early awareness reports, policy briefings, and web platforms to provide timely, actionable information for planning adoption, regulation, or reimbursement.

Step 6. Monitoring and Re-evaluation

Flagged technologies are continuously monitored, tracking their progress through clinical development and regulatory approval. Reports are updated with new evidence (trial results, regulatory changes, adoption trends, post-market data) to ensure accurate long-term impact predictions.

Step 7. Stakeholder Engagement

Continuous engagement with developers, clinicians, patients, and administrators provides practical insights, refines assessments, and ensures relevance. Managing potential conflicts of interest is crucial, achieved through transparency, independent expert panels, ethical guidelines, and balanced representation.

Evaluating EAA Methods, Systems, and Efforts

Evaluation is a continuous process to optimize EAA activities and resource allocation. It covers:

• Structure: Funding, governance, mandate, independence, staffing, facilities, ethos.
• Process: System accuracy (identification, reporting, predictions), timely identification, application of criteria and methods, timely information updating.
• Outputs: Direct (assessments - number, relevance, quality, readability, timeliness, independence, accessibility) and indirect (workshops, publications).
• Impact: Acceptance, awareness, satisfaction, utility (change in knowledge, influence on decisions).

Evaluation methods include internal audits, questionnaires, interviews, focus groups, measuring access to outputs, analysis against external information sources, and content analysis.

Early dialogue, early advice, and scientific advice are instrumental in improving data exchange for early awareness systems, ensuring timely adoption and integration of health technologies.

Benefits for Early Awareness Systems with Early Identification

• Timely Identification: Real-time insights enable earlier identification of innovations.
• Enhanced Data Quality: Feedback ensures robust data aligned with regulatory standards.
• Comprehensive Monitoring: Inclusion of clinical, regulatory, and commercial perspectives for broader impact monitoring.

Early Dialogue

Structured, collaborative interactions between developers, regulators, healthcare professionals, and other stakeholders at early product development stages. This provides critical feedback on regulatory pathways, clinical relevance, and market barriers, enhancing knowledge sharing and data exchange.

Use Case Example: New Cancer Therapy

A pharmaceutical company discusses a novel immunotherapy with regulators, HTA bodies, clinicians, patient groups, and payers to refine target population, trial design, and address adoption barriers, leading to a more refined development process.

Early Advice

Formalized guidance from regulatory agencies during early health technology development, focusing on clinical trial design, methodologies, and regulatory requirements. This improves developers' understanding of criteria for safety, efficacy, and quality, optimizing trial designs and chances of successful submission.

Use Case Example: AI-based Diagnostic Tool

A company seeks early advice from regulatory bodies and HTA agencies on validating its AI-powered diagnostic imaging tool, shaping its evidence-generation strategy and streamlining the approval path.

Scientific Advice

Detailed consultations with regulatory agencies and scientific experts on technical and clinical aspects of health technology development, including trial methodologies and endpoints. This refines research methodologies, improves trial robustness, and aligns scientific evidence with regulatory expectations.

Use Case Example: Biosimilar Product

A pharmaceutical company seeks scientific advice from EMA to understand evidence required for biosimilar similarity, including comparability studies, clinical trials, and manufacturing standards, streamlining the development process.