Experimentation as a Trust-Building Tool in HealthTech

Why Real-Life Testing Matters for Patients, Providers, and Regulators

Trust is one of the most underestimated barriers in healthcare innovation.

HealthTech solutions promise better outcomes, smoother transitions, and more personalized care. Yet patients hesitate, healthcare professionals remain cautious, and regulators demand extensive evidence before approving deployment. The question is not whether innovation is needed, but whether it can be trusted.

At EVOLVE2CARE, we approach experimentation not as a technical checkpoint, but as a human, ethical, and social process. Real-life testing in Living Labs allows innovation to be shaped with people and not simply delivered to them.

Our approach is grounded in the work carried out within the project to better understand what different stakeholders truly need from HealthTech innovation in transitional care. These insights have been consolidated in Deliverable D1.2 – Stakeholder Needs Analysis and KPI Framework, which offers a deeper look into how experimentation can align innovation with real-world expectations across patients, healthcare providers, Living Labs, and regulators.

Why patients hesitate

For patients and caregivers, trust is deeply personal.

New digital health tools often raise concerns around data privacy, usability, and the fear that technology may replace, rather than support, human care. When innovations are introduced without sufficient explanation or involvement, uncertainty quickly turns into resistance.

Real-life experimentation helps address these concerns by actively involving patients and caregivers in the development process. Living Labs create safe, supportive environments where individuals can test solutions, provide feedback, and influence how technologies evolve. When patients see that their experiences, preferences, and limitations are taken seriously, trust begins to grow.

Why healthcare providers resist

Healthcare professionals operate in demanding environments, balancing patient care with administrative responsibilities and fragmented digital systems. New technologies are often perceived as adding complexity rather than relieving pressure.

Through real-life experimentation, healthcare providers can assess whether innovations genuinely integrate into existing workflows, reduce administrative burden, and support clinical decision-making. Testing solutions in realistic settings allows professionals to identify what works, what doesn’t, and what needs refinement before wider adoption.

Why regulators are cautious

Regulators play a critical role in safeguarding patient safety, data protection, and ethical standards. Their caution is not a barrier to innovation, but a necessary responsibility in a highly sensitive sector.

Living Lab experimentation offers regulators early insight into how HealthTech solutions function in real-world conditions. By observing technologies as they are tested with users, regulators can better understand emerging risks, ethical implications, and compliance challenges. Early engagement reduces uncertainty, helps avoid costly redesigns, and supports smoother pathways to approval.

Living Labs as trust enablers

Living Labs sit at the intersection of innovation, care delivery, and regulation.

Beyond providing physical spaces or technical infrastructure, Living Labs act as trusted intermediaries that facilitate transparent collaboration among patients, healthcare professionals, innovators, and policymakers. Living Labs ensure that ethical considerations, data protection, inclusivity, and societal context are embedded throughout the experimentation process and not only addressed as afterthoughts.

Trust is not built through promises or pilot demonstrations alone.
Trust is built through real-life evidence, transparency, and shared responsibility.

For readers interested in exploring the methodological foundations behind this trust-driven approach, Deliverable D1.2 – Stakeholder Needs Analysis and KPI Framework is publicly available and offers further insight into how real-life experimentation can support responsible HealthTech innovation in transitional care.

 

A conversation with Heikki Pitkänen on building a regulation-smart Europe

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Europe’s innovators are full of ambition — but often struggle to navigate the maze of regulations that govern digital and health technologies. As new frameworks like the AI Act, Data Act, and European Health Data Space (EHDS) take shape, the need for clear, accessible, and practical regulatory literacy has never been greater.

We had a talk with Heikki Pitkänen, CEO and Founder of Lean Entries, a company that translates complex regulations into digital guidance tools for innovators, startups, and SMEs. Drawing from his decades of experience in medical device regulation, Heikki shares his insights on how Europe can turn compliance into a competitive advantage — and why simplifying complexity is the next big step for innovation.

Read the full interview below:

Question: Many innovators feel “drowned in regulatory complexity.” From your experience, what are the most common misconceptions or challenges among startups in digital health and MedTech?

I think the main challenge is that there are numerous regulations. It is a maze, and despite all the simplification from the European Commission and the European legislator’s perspective, the maze will remain. In my opinion, the more foundational issue is clarity—regulatory clarity, and as a result, regulatory literacy—which should be established at the earliest possible stage of innovation. What happens very typically is that innovator teams do not have the knowledge or prior experience in compliance with regulations. They often assume it can be addressed later, but in fact, regulations and related standards hold critical inputs that need to be considered from the start to avoid costly re-design. When establishing a company and writing a business plan, the regulatory strategy should be part of that package. This helps innovators understand what they face, make informed decisions, manage risks, and estimate costs.

Question: According to Mario Draghi’s 2024 report on the future of European competitiveness, over half of European SMEs see regulation as their No.1 barrier. How can we close this gap?

The reason, I think, is that many innovators don’t realize early on how critical it is to understand the basics. We’ve seen rare cases where founders have prior experience in highly regulated fields, like medical devices. These companies already have systems in place for the Medical Device Regulations (MDR or IVDR), so adding AI Act requirements—such as an AI life cycle or change management protocol—is straightforward. For them, compliance is practical, even though it consumes a substantial amount of resources and requires adapting to the evolving requirements for AI systems. But most early-stage teams lack this experience and miss the opportunity to make educated decisions on compliance. In my experience, this causes many failures and losses, not only in Europe but globally. This is also an opportunity for Europe to lead by improving compliance with its own and global regulations. Beyond top-down simplification, we need to recognize the foundational importance of bottom-up regulatory clarity. That is the most effective means of closing the gap.

Question: The EU is introducing several landmark regulations — AI Act, Data Act, European Health Data Space (EHDS) — all of which will shape the future of digital health. What do these mean for innovators in practice?

These regulations are designed with good intentions and offer clear benefits. For example, the EHDS aims to enable harmonised secondary use of health data across Europe, supporting faster development of AI-driven health solutions. However, practical challenges remain: How will the data-sharing work? Are hospitals and other data holders ready? What are the timelines for compliance? In practice, innovators face a steep learning curve with the increased maze. For early-stage innovators, the biggest hurdle is the overlap and volume of regulations. Recertification cycles add unnecessary burden while unannounced audits already keep manufacturers sharp with their processes. Greater trust and smarter monitoring could reduce this workload and the spending of resources.

Question: Lean Entries has developed e-tools that translate complex regulations like the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), AI Act, Data Act, and European Health Data Space (EHDS) into step-by-step, no-code guidance. How do these tools work in practice, and how do they help innovators make compliance easier and faster from day one?

Our tools are delivered through partnerships with innovation hubs, universities, and clusters. These organizations provide the access free of charge to startups, SMEs, and public-sector teams, including translational researchers and even students. The platform applies a unique step-engine questionnaire that guides users through the myriad of regulatory requirements in a structured and personalized way. It builds on a fully referenced breakdown of regulations and related guidance documents, combined with examples, terminology, and guidance from those sources embedded directly in the interface, where innovators need it. The platform helps innovators navigate complex frameworks like the MDR or the AI Act, explore classification options, and find justification for whether a product qualifies as a medical device or not. 

This approach addresses the strong demand for regulatory clarity—critical for competitiveness and investor trust. Without regulatory literacy uncertainty remains and innovation slows. Today, Lean Entries offers the most nuanced and scalable tooling globally to establish regulatory clarity, covering multiple regulations and expanding to new ones like the Cyber Resilience Act and General Data Protection Regulation (GDPR). Furthermore, we are in the process of empowering the production of the tools with AI.

Question: How can we ensure that simplification doesn’t mean oversimplification — that innovators still internalize the “why” behind the rules?

Our experience shows that the Entries tools act as a wake-up call for innovators. They don’t solve all problems, but make them realize what they don’t know and where they need help. Unlike generic AI tools, like ChatGPT, which often give incomplete or unreferenced answers, the Entries platform provides structured guidance based on official sources and complete references. When innovators apply for support from a European Digital Innovation Hub (EDIH), university, or cluster, the Entries platform ensures they absorb essential knowledge. Compliance builds on that knowledge—setting up a regulatory strategy, Quality Management System (QMS) and implementing processes—but this first step is critical. Beyond guidance, Entries can be harnessed to collect valuable data points—currently over 800—from the five existing tools that could help universities, EDIHs, and the Commission understand what innovators are working on and where compliance hurdles exist. This way, we could serve innovators better and potentially match them directly through APIs to digital services and other service providers throughout their compliance journey. This enables the compression of value chains in innovation.

Heikki Pitkänen, CEO and Founder of Lean Entries

Question: Is Europe at risk of regulatory fragmentation — or can shared literacy frameworks, like those promoted through Lean Entries, help harmonize understanding across borders?

Regulatory fragmentation is a real challenge in Europe. While EU regulations aim for harmonization, many directives—such as NIS2 or the Machinery Directive—allow national deviations and interpretations. This means innovators often face 27 different variations layered on top of the core rules. Beyond safety, privacy and security regulations, there are additional administrative requirements like taxation, IP, and other compliance obligations, making cross-border expansion complex and costly. In my point of view, the European Commission should push for deeper harmonization, learning from best practices within EU Member States and aligning with global frameworks, including the U.S. and other regions. 

Question: How do you see AI sandboxes and EDIHs contributing to regulatory readiness? What should be done to make them more effective in supporting innovators?

AI regulatory sandboxes are a promising initiative, heavily supported by EU funding, to be launched by national competent authorities in August 2026. The assumed sandbox operators, such as EDIHs, already serve as key resources for innovators in the digital and AI space. They provide a strong foundation, but being still young, they need best practices, knowledge sharing and harmonisation of services across Europe. For EDIHs, we propose integrating regulatory literacy at the gateway of each hub. This means offering innovators clear, structured guidance on essential regulations as part of their onboarding process. Our platform Entries can act as a regulatory due diligence tool. Innovators entering an AI sandbox would first complete a basic compliance check through Entries, ensuring they know the most critical requirements, followed by local coaching, training or workshops to confirm their findings. This approach would also feed valuable data back to EDIHs, improving their support services. National competent authorities, Notified Bodies and service providers would experience more straightforward, value-adding transactions with innovators.We suggest starting with a pilot program, which could operate at minimal cost per EDIH to maintain and scale the system. This approach would not only strengthen regulatory readiness but also create feedback loops and analytics to improve support for innovators over time.

Question: You’ve called for a “shared literacy baseline.” What would that look like in practice? Who should lead it – the EU, national authorities, or innovation networks?

All stakeholders need to be involved—the EU, national authorities, and innovation networks. While much of what I’ve explained applies here, I believe the Entries tooling could be the key element to establish a regulatory literacy baseline. At the same time, I’d like to emphasise that training, coaching, and advice remain essential. These should continue through local regulatory experts in workshops where I recommend the innovators pitch their regulatory strategies and learn from peers. Existing elements, such as those offered by EDIHs, universities and incubators, should stay in place. The digital learning component simply creates the wake-up call, possibility to boost efficiency and provide a stable and harmonised learning curve. Activities carried out nationally or by EDIHs, Testing and Experimentation Facilities (TEFs) or AI factories would then become more effective. The European Commission should be strongly involved, endorsing or branding the initiative to show its support. Open-source APIs from Entries should be expected to make this most effective. Unfortunately, the topic of regulatory clarity, as foundational as it has become for European competitiveness, mostly dissolves under other priorities like funding and regulatory simplification. It’s time to make it a visible, actionable and measurable goal for the sake of our innovation!

Question: Can European projects like EVOLVE2CARE or organisations such as the European Network of Living Labs play a role in testing and scaling such literacy tools?

Absolutely. The health sector is an ideal environment for piloting regulatory literacy tools. Entries was originally developed for health tech, and our existing tools already cover key regulations such as MDR, IVDR, AI Act, Data Act, and EHDS. Future tools—like those for the Cyber Resilience Act and GDPR—will also impact healthcare systems. Projects like EVOLVE2CARE could provide the perfect environment to test and scale these tools in real-world settings.

Question: Looking ahead to 2030, what does a “regulation-smart Europe” look like to you?

By 2030, regulatory literacy should be a true baseline for innovators across Europe, supported by AI and data-driven tools. It will be assumed that innovators know what regulations mean for them. If they cannot show their regulatory data—such as classification, applicable regulations, and their compliance pathway—they cannot expect to receive funding or services from EDIHs and other parties. This will become a basic requirement, easily achievable through tools like Entries. By then, the digital and health tech sectors will have strong regulatory sandboxes. Universities and EDIHs will be able to perform due diligence on regulatory basics, ensuring innovators start from a shared understanding of compliance. From there, everyone remains free to compete and innovate, but with shared clarity on compliance. This common understanding will benefit innovators, investors, universities, and authorities alike. Five years is enough to establish this baseline for health tech and digital sectors, measure the results and continue expanding it to other industries.

Question: What message would you share with young innovators or startups who see regulation as a burden rather than a guide?

I think the baseline is that innovators need to understand that safety and security are the baselines for business when it comes to regulated sectors. If an innovator is developing a medical device, safety is the baseline for business. Many startups try to avoid regulatory work or costly clinical investigations. My advice is to integrate regulatory strategy into their business plans and budgets early—and use clinical investigations not only for compliance but also to collect valuable business data, engage early adopters, and strengthen market entry.

Start with what I call the eight early principles. The first four apply broadly:

  1. Qualification – Determine which regulations apply to the product.
  2. Classification – Understand the risk class and the workload ahead.
  3. List your standards – Recognise the best practices instead of re-inventing the wheel
  4. Regulatory Strategy – Make it part of the business plan.

The next four are health tech-specific but can be adjusted to other sectors:

  1. Literature reviews reveal existing clinical practices, competitors and benchmarks and are a natural first step into clinical evaluation and investigations.
  2. Whenever a team member speaks of risks, start writing them down, and collect a good bunch of more from the regulations and standards. Then let a risk management professional help you expand it into a full-blown risk management system.
  3. Study the feasibility of your product with good knowledge of the eventual safety and documentation requirements (i.e., design controls) in mind.
  4. Assess your most critical suppliers for their regulatory competence and include compliance in quality agreements. You should only work with suppliers that make your path to market easier, not harder.

Ignoring these principles creates a high risk of failure. Starting early saves months in the process and ensures your compliance aligns with business goals and market success.

Question: In such a complex regulatory landscape, do innovators need to develop multitasking skills to balance compliance, product development, and business growth?

Yes, absolutely. And innovators need to include early regulatory advice in their budget. If they cannot hire an experienced regulatory professional right away, consider combining a young expert with a consultant who can mentor them. This way, their team builds internal expertise over time to own their compliance, a key business enabler. This also means the leadership team should understand the basics of regulation, and their regulatory people should speak the language of business. Bridging that gap is essential. We’ve seen this challenge in MedTech for years, and now it’s hitting digital health and AI sectors, which face high-risk classifications and complex systems. The sooner innovators build this capability, the stronger their foundation for growth!

As Europe races to build a digital single market grounded in trust and transparency, voices like Heikki Pitkänen’s remind us that innovation and regulation aren’t opposites — they are partners in progress.

Two training programs, one goal — Your feedback matters

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Over the past months, EVOLVE2CARE has successfully wrapped up two insightful six-part training programs — one for HealthTech Innovators & Researchers, led by Anthology Ventures, and one for Living Labs, guided by ENoLL.

Across twelve sessions, we saw great participation, masterful speakers, and lively discussions that turned every meeting into a space for shared learning and collaboration. Together, we explored how innovation can move more quickly from the Living Labs to the market and how Living Labs can play a stronger role in supporting that journey.

Now, it’s your turn to assess the experience.

We invite all participants to share their feedback through our short questionnaires. Your insights will help us refine and improve future initiatives.

If you attended at least four out of six sessions, keep an eye on your inbox: your Certificate of Participation is coming soon!

The EVOLVE2CARE Open Call is still open! Take the next step and put what you have learned into practice; innovators and Living Labs are supported to collaborate and test a HealthTech solution in real-world conditions. Apply now: https://evolve2care.eu/open-call/

Accelup in focus | Interview with the Project Coordination team of EVOLVE2CARE

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As the EVOLVE2CARE Open Call continues to welcome applications from HealthTech innovators across Europe in order to matchmaking with Health and Wellbeing Living Labs and test their digital HealthTech solutions, one platform stands at the heart of the collaboration process: Accelup. Designed to streamline matchmaking, Accelup ensures that project proposals meet the right expertise, infrastructure, and support. In this interview, Evdokimos Konstantinidis, Project Coordinator, and Despoina Petsani, Project Mission Coordinator, share how Accelup works, what makes it unique, and why it’s a key enabler for co-creation and real-world validation in the EVOLVE2CARE ecosystem.

Read on to discover how Accelup is shaping collaboration in EVOLVE2CARE:

1. What is the Accelup platform, and how does it help innovators and Living Labs collaborate more effectively?

The Accelup platform is a digital matchmaking platform designed to connect innovators with Living Lab infrastructures. The platform offers the possibility for the innovator to upload a specific project specifying the services that would be required for its completion. For the design of the platform, a continuous assessment of stakeholder needs, existing tools and frameworks has been conducted, ensuring improved efficiency for the collaboration of the two parties.

2. How is it used within the EVOLVE2CARE project?

Within the EVOLVE2CARE project, the primary objective is to facilitate matchmaking between Health Tech companies and Living Labs. Rather than requiring innovators to independently identify a suitable Living Lab, Accelup facilitates improved communication and ensures that the matching process is streamlined, thereby relieving innovators of the need to undertake this task on their own. Therefore, it is designed to bring users with diverse research on demand needs together with Living Labs to co-develop, validate, and test innovative HealthTech solutions in real-life conditions.

3. Please give us a simple overview of how Accelup works.
Accelup enables innovators to create projects by submitting key details such as title, description, services required, budget range, and bid. ENoLL Certified Living Labs can then browse these projects, review the information provided, and submit bids with the required amount to perform the project, creating a structured and transparent matchmaking process.

4. Are there other platforms that aim to connect innovators with Living Labs? If so, what makes Accelup stand out in this space?

Yes, there are some other matchmaking tools that can be used in a similar way as Accelup. Such tools involve both digital and methodological approaches that facilitate the matchmaking process. However, Accelup’s mission is to enable transparent and effective matchmaking between innovators and Living Labs. Accelup is the only platform that gives the opportunity to innovators to get in contact with ENoLL Certified Living Labs that can facilitate their work. ENoLL certification provides a quality seal so that the innovators know that they will receive high-quality Living Lab services.

5. And finally, how is Accelup currently supporting the EVOLVE2CARE Open Call?

Accelup is the main form of connection of the two parties, with the innovator being given the opportunity to select a desired Living Lab. EVOLVE2CARE supports the collaboration by providing €5,000 to the selected Living Lab to perform the work that the innovator requested.

Ready to take the next step?

If you’re a HealthTech innovator looking to validate your solution or a Living Lab eager to collaborate on cutting-edge projects, join the EVOLVE2CARE Open Call and experience the power of Accelup matchmaking.

Learn more here

Smarter Matchmaking in HealthTech Innovation – Methodological Approaches

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While digital tools outlined in the previous blog provide speed and scalability, certain methodological approaches/processes, frameworks and best practices can ensure that the matchmaking system yields effective results. These approaches concern what data to collect, how to structure it, and how humans can facilitate the match process. Methodologies can be just as important as technology: a fancy algorithm will underperform if profiles are poorly defined, and conversely, a simple tool can excel if guided by a solid methodology!

As outlined in the latest project deliverable D1.3 – EVOLVE2CARE Action Plan, effective matchmaking relies on structured data, active engagement, and co-creation practices that make partnerships sustainable and impactful.

Structured profile frameworks and taxonomies

A fundamental step is defining what information innovators and Living Labs should provide to enable meaningful matches. Structured profiling means having well-defined fields and classification systems that capture the relevant attributes of each side.

  • Living Lab Information: Clearly describe services and capabilities using standardized frameworks.
  • Innovator Information: Include project details, target users, stage (e.g., prototype), and specific requirements (e.g., access to patients or regulatory advice).
  • Rating and Compatibility Scores: Profiles are scored on key factors such as project stage, domain match, and size to recommend the best matches.
  • Data Quality and Verification: Regular updates ensure accuracy; verification processes prevent mismatches.
  • Use of Structured Fields in Application Process: Shifting from free-text descriptions to dropdowns and tags improves matching, transparency, and fairness, with stakeholder input ensuring fields capture what truly matters.

Co-Creation and Engagement Methods in Matchmaking

Applying the principles of co-creation and user engagement to the matchmaking process can be beneficial. Methodologically, this means treating matchmaking not just as a database query, but as a collaborative journey where innovators and Living Labs actively engage to find a fit.

  • Moderated Matchmaking by Facilitators: Innovation brokers help bridge public and private sectors, review profiles, propose matches, and provide introductions, improving early-stage or critical pairings.
  • Case Studies and Best-Practice Sharing: Sharing examples of successful collaborations guides users in selecting the right partners.
  • KPI Framework for Matchmaking: Metrics such as successful matches, time to project start, user satisfaction, and match diversity allow continuous improvement.

By combining structured data, co-creation, and user engagement, Accelup’s methodological approaches ensure that the matchmaking process is transparent, fair, and of high quality. These approaches, along with the digital tools discussed earlier, make Accelup a comprehensive platform for fostering successful HealthTech collaborations. Together, the digital and methodological elements ensure that Accelup not only accelerates the matchmaking process but also guarantees that these connections create lasting, impactful partnerships.

Smarter Matchmaking in HealthTech Innovation – Digital Approaches

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In healthcare innovation, getting the right collaborators is essential for success, and this is the actual goal for the EVOLVE2CARE project as a whole! In order to bring this into life, the project utilises the Accelup platform, a product of ENoLL that provides an online space for wider, simplified, and more efficient access to the best Living Lab infrastructures and their research on demand services. As outlined in one of the latest public deliverables of the project, the D1.3 – EVOLVE2CARE Action Plan, the Accelup platform adds value by accurately profiling both innovators and Living Labs to create the most suitable partnerships.

To further enhance the Accelup matchmaking capabilities, the EVOLVE2CARE team has compiled an inventory of existing tools, surveying digital platforms and methodological frameworks that support similar processes—focusing on European examples and notable global initiatives. This blog highlights the most prominent digital functions used for effective and transparent matchmaking, knowledge exchange, and collaboration.

Digital approaches to innovator-Living Lab matchmaking

Digital approaches are categorized in D1.3 EVOLVE2CARE Action Plan into three groups: lightweight plug-ins, APIs & integrations, and AI-based recommendation systems.

Lightweight Plug-ins and Modular Tools:

Lightweight plug-ins add matchmaking features to existing platforms without building complex systems. They use structured profile data and simple algorithms, such as tag matching or rule-based filtering.

  1. Tag-Based Matching Modules: Use tags to identify shared interests or needs. The goal is to deliver “personalized connections” by filtering the community’s profiles to find resonant matches for each user.
  2. Profile Search and Filters as Plug-In Features: Platforms enable advanced search and filters, allowing users to find matches autonomously.
  3. Simple Recommender Libraries: Open-source libraries, like Python or JavaScript recommendation engines, provide plug-in solutions for developers.

API-Driven Integrations and Data Sharing

APIs allow Accelup to integrate external platforms to enrich profiles and improve matchmaking. For example, innovators can import LinkedIn or ORCID data, and startups can sync Crunchbase info automatically.

  1. Cross-platform Profile Federation: Users can pull in existing data to seed their Accelup profile, reducing manual input and improving accuracy.

AI-Based Recommendation Systems

AI recommenders analyze complex data to suggest the most relevant match between Living Labs and innovators, going beyond simple tags by using past interactions, project descriptions, and success rates.

  1. Machine Learning Recommenders in Innovation Networks: Platforms like Crowdhelix, which is a global open innovation network, connecting universities, SMEs and innovators and organizations for Horizon Europe collaboration. By harnessing bespoke AI technology, Crowdhelix claims to “establish synergetic connections” among its 18,500+ members.
  2. Collaborative Filtering & User Feedback: In a mature recommender, the system learns from user behavior and feedback from successful collaborations to improve future recommendations.
Digital tools can significantly streamline the process of matching innovators with Living Labs by automating profile collection, search, and recommendations. While these tools are not mutually exclusive, combining elements from all three could offer a flexible and scalable approach for future development. In the next blog, we’ll dive into how methodological approaches complement these digital tools, ensuring that matchmaking remains not only fast but also fair, transparent, and of high quality.

From insight to impact: The procedures behind the project’s framework

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Developing EVOLVE2CARE’s framework means first of all crafting a solid foundation of meaningful Key Performance Indicators (KPIs) that support the efficient and evidence-based integration innovations into healthcare. Such effort might be interestingly similar to a professional athlete’s preparation! Before stepping into a major event, an athlete undergoes a series of procedures—from training sessions with targeted practice to blood tests and stress assessments—to ensure peak performance. These procedures help highlight what’s effective, what needs improvement, and what’s essential for success.

Likewise, as it is analytically written in Deliverable 1.2 ‘Stakeholder Needs Analysis and KPI framework’, EVOLVE2CARE consortium applied multiple procedures to ensure that the framework of key indicators of the project is adequately accurate and relevant to foster successful innovations of HealthTech solutions for patients transitioning between care settings; which is called Transitional Care.

The primary goal, highlighted on previous blog, was to understand the needs of primary stakeholders—such as researchers, Living Labs, end-users, and regulators—and translate these insights into a practical framework of key indicators. Building on the barriers and enablers identified in Deliverable 1.1 “Roadmap on Navigating the Complexities of Enabling Innovative Technologies in Transitional Care”, we outlined the needs across two major dimensions: (1) collaboration between Living Labs and innovators, and (2) the implementation of HealthTech solutions in Transitional Care. As a result, we developed two distinct key indicators repositories:

  • Use Case Evaluation KPI Repository, which focuses on individual collaborations and end-user alignment.
  • Impact Assessment KPI Repository, which evaluates broader impacts such as regulatory readiness, financial sustainability, and social inclusion.

In practical terms, the accuracy and relevance of the framework were validated through a stakeholder-driven process. To make it more concrete, internal feedback was gathered via an online workshop involving the project partners. On top of that, three webinars conducted in March 2025 titled ‘Accelerating Innovation in Transitional Care – Identifying Key Needs & Meaningful Impact’, featuring distinguished professionals, designed to engage healthcare providers, experts, innovators, and stakeholders in co-developing solutions that enhance patient care during transitions from hospital to home. In addition to the valuable insights regarding the repositories of indicators that arose during the workshops’ discussions, further feedback came from a live session at the 14th Medical Conference at the Aristotle University of Thessaloniki, and from the collaboration with the GILL project supported the development of social key indicators, especially around gender-responsive innovation and inclusive healthcare.

Next Steps: Engaging stakeholders and ensuring continuous improvement

To make sure the framework of key indicators keeps evolving and finds its way into real-world use, we are focusing on expanding its reach, getting feedback from the relevant stakeholders and to foster adoption, and making it as practical and user-friendly as possible. To keep the framework relevant and aligned with the dynamic needs of stakeholders, we will set up feedback channels to refine the framework of key indicators over time. In particular, here’s how we are moving forward by channeling our efforts towards three dimensions:

  • Living Labs Engagement: The Living Lab KPI Repository will be shared with the Health & Wellbeing Working Group of the European Network of Living Labs (ENoLL), helping us align the framework with the needs of real-world testing environments and innovators.
  • End-Users Integration: Keeping work on a user-centric approach, we will connect with EIT Health to explore how the End-User KPI Repository can be circulated within their network. We will also collaborate with HADEA (Health and Digital Agency) of the European Commission to assess the framework’s relevance to ongoing and future initiatives.
  • Wider Impact and Solution Deployment: To proliferate real-world adoption, the framework will be presented to organizations such as EHTEL (European Health Telematics Association) and the Era4health partnership since these entities play a critical role in shaping policy and practice around digital health solutions.

At EVOLVE2CARE, we think of the framework of key indicators as a magnifying glass that helps us check whether the project is able to make a difference in the healthcare sector! We aim to make sure that the framework is effective and relevant for all stakeholders involved.

Navigating through multiple barriers to HealthTech for the Transitional Care

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While HealthTech holds immense potential to transform transitional care, the challenges don’t stop at legal, regulatory, and fiscal barriers. Even with clear policies and sustainable funding, technical, operational, social and economic obstacles continue to hinder widespread adoption. Issues like interoperability, provider resistance, and patient trust must also be addressed to ensure these innovations can thrive.

The Evolve2Care Project is committed to tackling these challenges head-on. As outlined in Deliverable D1.1, “Roadmap on Navigating the Complexities of Enabling Innovative Technologies in Transitional Care,” a structured approach is needed to help stakeholders—healthcare providers, innovators, policymakers, and investors—overcome these hurdles. In this second part, we dive into the technical, operational, social and economic factors that stand in the way of seamless HealthTech integration.

3. Technical Challenges

Integrating HealthTech innovations into existing healthcare systems brings various technical hurdles that must be resolved for well-tempered implementation.

Interoperability Issues

HealthTech solutions rely on seamless data exchange between electronic health records (EHRs), diagnostic tools, and monitoring devices. However, varying formats and standards create inefficiencies, errors, and delays, making it difficult to ensure continuity of care.

Scalability and Customization

Innovators face challenges in making HealthTech solutions adaptable to different healthcare environments. What works in a small clinic may not suit large hospitals, and vice versa. Additionally, tailoring solutions to meet the diverse needs of patients, healthcare professionals, and institutions remains a key hurdle.

User-Centred Design and Accessibility

HealthTech solutions must prioritize user-friendly design to ensure accessibility for all users, especially patients with limited technical expertise. If a technology is difficult to use or understand, patients may disengage, reducing its impact on transitional care.

4. Operational Challenges

Healthcare providers often struggle to integrate new HealthTech solutions, especially in transitional care, where continuity is key.

Integration into Existing Care Pathways

Integrating new technologies into healthcare workflows is challenging, often facing resistance due to changes in care pathways. Successful adoption requires effective change management and alignment with existing processes.

Training and Support for Healthcare Professionals

Lack of adequate training hinders the effective use of new tools. Comprehensive training programs and ongoing technical support ensure that healthcare professionals can confidently integrate new technologies into their practice.

Patient Engagement and Adoption

For HealthTech solutions to succeed, patients must understand and engage with them. User-friendly design, patient education, and trust-building are essential to driving adoption and achieving better health outcomes.

5. Economic and Social Challenges

Beyond legal, regulatory, fiscal, technical and operational hurdles, economic and social factors also impact the success of HealthTech innovations in transitional care.


Economic Viability and Long-Term Sustainability


Many stakeholders have raised concerns about the long-term sustainability of HealthTech solutions. Ensuring cost-effectiveness in improving patient outcomes and reducing healthcare costs is crucial. A thorough evaluation of their economic impact is necessary to align with healthcare system budgets and ensure financial viability.

Social Acceptance and Trust

Public trust is essential for the adoption of HealthTech solutions. Concerns about data privacy, care dehumanization, and potential misuse of patient information must be addressed through trust in HealthTech solutions.

What needs to be done to overcome these hurdles?

Overcoming these challenges requires collaboration between innovators, healthcare providers, policymakers, and regulators. By addressing legal, financial, technical, operational, and social barriers, stakeholders can create an ecosystem where HealthTech innovations thrive.

Evolve2Care is committed to driving change—because better technology means better outcomes for patients and a more efficient healthcare system.

HealthTech in transitional care: What’s standing in the way?

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HealthTech innovations hold great promise for improving transitional care, enhancing patient outcomes, and streamlining healthcare processes. However, their implementation faces significant challenges, including regulatory hurdles, financial constraints, technical limitations, and social acceptance issues.

The Evolve2Care Project is dedicated to identifying and addressing these obstacles through collaboration and evidence-based strategies. As part of this effort, Deliverable D1.1, “Roadmap on Navigating the Complexities of Enabling Innovative Technologies in Transitional Care,” provides a structured framework to support stakeholders—including startups, researchers, investors, healthcare professionals, and policymakers—in recognizing and overcoming barriers to HealthTech adoption. Let’s dive into the challenges!

1. Legal and Regulatory Challenges:

Fragmented and Inconsistent Regulations

Regulations differ across regions, slowing down approval and market entry. Some countries have clear policies, while others lag behind. In Europe, complex regulatory frameworks make scaling innovations difficult and add compliance burdens.

Regulatory Uncertainty in New Technologies

Technologies like AI diagnostics and telemedicine often do not fit neatly within existing regulatory structures, creating uncertainty for innovators. Rapid technological advances often outpace the ability of regulators to adapt, making approval processes unpredictable and slow and innovators unsure of the approval process.

Data Privacy and Security Concerns

Strict regulations like GDPR in Europe require strong data protection measures. Innovators must ensure compliance while safeguarding patient data, especially when using cloud storage or cross-border transfers.

Liability and Accountability

Determining responsibility when a HealthTech solution fails is complex. Who is accountable? The lack of clear liability frameworks increases risks for innovators and discourages investment in new technologies.

2. Fiscal Challenges

Financial constraints slow down the adoption and scaling of HealthTech solutions, limiting innovation and access.

Lack of Sustainable Funding and Investment

Innovators face difficulties in securing long-term funding. While some early-stage funding is available, there is a notable gap in financial support for scaling up innovations.

High Upfront Costs of Implementation

HealthTech solutions offer long-term cost savings, but high upfront costs often discourage healthcare providers from adopting new technologies. Hospitals and clinics with limited budgets struggle to allocate funds for new systems, especially when immediate returns on investment are unclear.

Reimbursement Issues

Unclear reimbursement policies prevent many HealthTech innovations, especially in transitional care, from being covered by traditional insurance or public funding. Without financial incentives, healthcare providers hesitate to adopt new technologies, limiting their potential to improve patient transitions and care quality.

Conclusion

Regulatory frameworks, fiscal limitations, and legal uncertainties create significant hurdles for HealthTech adoption in transitional care. But even if these hurdles are overcome, will the technology be technically feasible, operationally sustainable, and socially accepted?

In Part 2, we’ll explore how HealthTech innovations must tackle technical, operational, and social challenges to truly succeed in transforming patient care.

Bridging Perspectives: The challenge of Transitional Care Innovation

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Why is Transitional Care innovation so challenging?

Moving between healthcare settings, whether an elderly patient returning home after hospitalization or a young adult shifting from pediatric to adult care, can be overwhelming. While innovative solutions have the potential to make these transitions smoother and more efficient, real-world implementation is often hindered by regulatory, financial, and practical challenges.

Addressing these challenges requires a strategic approach to integrating innovative solutions into transitional care. The Evolve2Care Project is committed to this goal, leveraging collaboration and evidence-based strategies to drive meaningful change. Deliverable D1.1, “Roadmap on Navigating the Complexities of Enabling Innovative Technologies in Transitional Care,” provides a structured framework to support stakeholders—such as startups, researchers, investors, healthcare professionals, and policymakers—in overcoming barriers to HealthTech adoption.

Through literature review, surveys and stakeholder interviews conducted within the preparation of D1.1, the findings highlight key trends, stakeholder perspectives, and the crucial steps needed to drive effective innovation in transitional care.

What common patterns emerge in transitional care innovation?

Through research, surveys, and expert interviews, three major themes emerged as pivotal in shaping the future of transitional care:

● Regulatory Complexities: Navigating healthcare regulations is challenging due to inconsistencies across regions.
● User-Centered Design & Usability: Healthcare professionals and patients stress the importance of easy-to-use technologies. No matter how advanced a solution is, its success hinges on real-world usability and seamless integration into existing healthcare workflows.
● The Role of Funding as a Key Enabler: Funding is a major driver of transitional care innovation, helping ideas grow from prototypes to real-world impact. However, many innovators struggle with financial barriers, while policymakers stress the need for sustainable funding models. Public-private partnerships are emerging as a key solution, especially for high-risk healthcare technologies that need validation and testing.

Where do stakeholders see things differently?

Despite a shared goal of improving transitional care, different stakeholders often approach the problem from unique angles:

● Innovators vs. End-Users (Healthcare Providers and Patients): Innovators focus on technical challenges like interoperability and data security, while healthcare providers prioritize ease of integration and efficiency in daily practice. Patients, on the other hand, value user-friendly solutions that empower them in self-care.
● Innovators vs. Policymakers: While innovators push for faster regulatory approval pathways, policymakers emphasize regulatory rigor to ensure safety.
● Healthcare Providers vs. Patients: Healthcare providers are concerned with the adoption of new technologies within clinical workflows such as training requirements, costs, and system integration, while patients focus on ease of use and how well a technology fits into their daily lives.
● Living Labs vs. Innovators: Living labs focus on real-world testing and iteration of new healthcare technologies, while innovators prioritize technology development and market readiness, sometimes viewing feedback as an added complexity.

How can we align perspectives and drive change?

To turn challenges into opportunities, stakeholders must work together to ensure the effective advancement of transitional care innovations.
Key areas for alignment include:

● Collaboration between Innovators and End-Users: Engaging healthcare providers and patients early in the design process ensures solutions that are practical and easy to adopt.
● Balancing Flexibility and Regulation: Policymakers and innovators must work together to harmonize regulatory frameworks across countries, making pathways clearer while maintaining patient safety standards.
● Sustainable Funding Models: Policymakers and funding bodies must establish long-term, outcome-driven funding models to support the development and scaling of transitional care innovations.

What’s next for transition care innovation?

To truly transform transitional care, innovation must be practical, well-regulated, and financially sustainable. Here’s how we can make it happen:

● User-Centred, Interdisciplinary Approaches: By involving interdisciplinary teams in the development process, new solutions can be ensured to be clinically effective, user-friendly, and seamlessly integrated into care workflows.
● Clear and Flexible Regulatory Pathways: Streamlining approval processes while ensuring patient safety requires ongoing collaboration between innovators, regulators, and healthcare providers.
● Improved Funding Support: Policymakers must ensure long-term financial backing for impactful solutions. Sustainable funding structures are needed to support pilot projects, commercialization, and scaling of transitional care innovations.

The Evolve2Care Project continues to explore how we can bridge the gaps in transitional care, ensuring that innovation leads to real-world improvements for patients, providers, and the entire healthcare ecosystem.