The European Commission has proposed an ambitious package of measures to improve the health of EU citizens while ensuring the long-term resilience and competitiveness of the healthcare sector. This comprehensive initiative includes a Biotech Act, revised rules for medical devices, and a Safe Hearts Plan which is commonly referred to as the “Omnibus” regulation. Since that is quite a lot to take in, we are going to unpack exactly how these changes will simplify the road ahead.

This sweeping legislative initiative acts as a bridge between multiple regulatory silos to create a more modern and efficient ecosystem. The broader package includes the landmark Biotech Act to build a world leading biotechnology industry along with the “Safe Hearts Plan“ which is a comprehensive strategy to tackle cardiovascular disease as the leading cause of death in Europe. Furthermore, it overhauls medical device regulations to transform the EU into a more agile environment for health technology while ensuring that the path from laboratory to patient is both faster and more efficient.

Medical devices

Despite the EU market leadership in the field of medical devices, worth 170 billion euros and a workforce of nearly one million people, current regulatory bottlenecks are causing significant delays and rising costs. This reform addresses these challenges by digitizing procedures, establishing clear assessment timelines, and expanding the mandate of the EMA to offer technical expertise and manage device shortages. By creating a coherent framework for AI enabled devices, the EU expects to achieve 3.3 billion euros in annual savings while ensuring the highest standards of safety and global competitiveness.

Within this massive legislative effort, the focus specifically sharpens on the Omnibus MDR and IVDR proposal which fundamentally redefines how AI driven medical technologies are governed. For developers, the “Omnibus” nature of this reform means that the AI Act, Medical Devices Regulation (MDR), and In Vitro Diagnostics Regulation (IVDR) will finally operate under a single and coherent framework. By introducing uniform rules for devices incorporating AI and strengthening the role of the European Medicines Agency (EMA), the proposal eliminates the legal uncertainty and administrative bottlenecks that have delayed innovation. This targeted reform ensures that patient safety remains the highest priority. The path from the laboratory to the market is streamlined to offer a predictable and digital first environment for the next generation of healthcare technology.

Strategic Pillars of the Medical Device Reform

In the context of the new Omnibus proposal, medical devices ranging from instruments and implants to software and reagents are defined as essential tools for the diagnosis, prevention, and treatment of disease or injury. The following pillars outline how this sweeping reform simplifies the journey for these technologies from the laboratory to the patient.

Regulatory and Administrative Efficiency

The reform significantly reduces the administrative burden on manufacturers. The costly 5-year maximum validity period for notified body certificates is abolished and replaced with continuous, risk-proportionate periodic reviews.

For low- and medium-risk devices (such as class IIa, non-implantable class IIb, and class C IVDs), notified bodies will only need to assess the technical documentation of one representative device per generic group or category. The rules also introduce a framework for “well-established technology devices,” exempting them from certain stringent clinical and conformity requirements.

Furthermore, AI-powered devices will no longer face redundant assessments, as the application of the AI Act will be limited to prevent a double layer of regulatory requirements. Finally, reporting duties are lightened by reducing the frequency of Periodic Safety Update Reports (PSURs) and removing the need for notified bodies to separately validate the draft Summary of Safety and Clinical Performance (SSCP).

Innovation and Competitiveness

To boost the EU’s global competitiveness, the proposal establishes adaptive pathways for “breakthrough devices” and “orphan devices“. Once designated by an expert panel, these devices benefit from prioritized assessments, rolling reviews, and conditional market access based on limited pre-market clinical data, provided the manufacturer commits to post-market follow-up.

The legislation also introduces national and Union-level “regulatory sandboxes” allowing developers to test innovative technologies in controlled environments under regulatory supervision. To reduce reliance on animal testing and lengthy trials, the definition of clinical evidence is expanded to promote New Approach Methodologies (NAMs), such as in silico testing and computer modeling.

Patient Safety and Product Availability

To prevent shortages of critical devices, the proposal mandates a centralized IT tool within Eudamed for manufacturers to report supply interruptions. The EMA will develop a methodology to identify and publish a list of critical devices.

The rules also include a “grandfathering” clause for legacy orphan devices, allowing them to remain on the market beyond transitional periods without a new conformity assessment if they meet specific safety criteria.

In the event of public health emergencies or crises, the Commission and Member States gain new powers to authorize the distribution of critical devices even if standard conformity assessments are incomplete.

Coordination and Cooperation

The governance structure is overhauled to ensure harmonized practices across the EU. The coordination mechanism (the “Helsinki procedure”) is codified to resolve disputes between Member States over product classification, utilizing expert panels for guidance.

The EMA’s role is expanded to provide scientific, technical, and administrative support to national authorities for vigilance, market surveillance, multi-country clinical studies, and borderline classifications.

The oversight of notified bodies is streamlined through Joint Assessment Teams, and the requirement for a full reassessment every five years is eliminated. Additionally, the proposal promotes global convergence by officially supporting international reliance mechanisms like the International Medical Device Regulators Forum.

Digitalisation

The proposal transitions compliance into a digital-first environment. Manufacturers can provide the EU declaration of conformity electronically, and subject to future implementing rules, product labels and instructions for use may also be provided in digital formats.

Technical documentation submitted to notified bodies can now be shared in structured, machine-readable formats to easily enable retrospective conformity checks.

To close cybersecurity gaps, manufacturers of connected devices must report actively exploited vulnerabilities and severe cybersecurity incidents directly to national Computer Security Incident Response Teams (CSIRTs) and ENISA via Eudamed.

Support for Small and Medium-Sized Enterprises (SMEs)

Since SMEs make up roughly 90% of the medical technology industry, the proposal specifically alleviates their regulatory burdens. Micro and small enterprises relying on an external Person Responsible for Regulatory Compliance are no longer required to have them “permanently and continuously” available.

Notified bodies are legally required to offer a 50% fee reduction for micro-enterprises and a 25% reduction for small enterprises, alongside the option to defer fee payments until the assessment is finalized.

Finally, the EMA is mandated to establish a dedicated support scheme to offer regulatory guidance specifically tailored to SMEs.

If you are looking for a deeper dive into these regulatory changes, you can explore the detailed Questions and Answers: Medical Devices document for specific technical clarifications. For a high-level visual summary of the reform’s goals and its expected impact on the industry, the Factsheet: Medical Devices is an excellent additional resource. Both documents are part of the Commission’s official package to help manufacturers and developers navigate this new era of innovation.

Sources

1. European Commission (16 December 2025). Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices (COM(2025) 1023 final, 2025/0404 COD). Strasbourg
2. European Commission (16 December 2025). Annexes 1 to 2 to the Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 (COM(2025) 1023 final). Strasbourg
3. European Commission (16 December 2025). Questions and answers on simpler and more effective rules for medical devices. Brussels

Objava The EU Omnibus: A Single Framework for AI in Healthcare pojavila se prvi puta na Shaiped.

Digital transformation in healthcare is no longer a question of if, but how. Across Europe, clinicians are encountering a rapid influx of digital tools—AI diagnostics, connected devices, remote monitoring, and data-driven decision support. Yet many innovations struggle to scale due to fragmented regulation, limited interoperability, insufficient trust, and weak stakeholder engagement.

This is precisely where European collaboration becomes essential. No single institution, country, or discipline can solve these challenges alone. The HIMSS25 European Projects Insight Report provides a snapshot of how EU-funded initiatives are collectively addressing these issues by co-creating solutions with clinicians, patients, regulators, and innovators. Rather than focusing solely on technology, the report highlights the conditions needed for digital health to deliver real-world clinical value.

What the European Projects Insight Report is — and why it matters

The European Projects Insight Report brings together insights from 12 EU-funded digital health projects showcased at HIMSS25 Europe. Its purpose is not to evaluate individual technologies in isolation, but to examine how these projects contribute to a broader transformation of healthcare systems. The report focuses on cross-cutting challenges such as cybersecurity, trust, health data access, interoperability, health technology assessment, and patient empowerment.

What makes this report particularly relevant for clinicians and health system leaders is its emphasis on translation into practice. Many EU-funded projects produce high-quality technical outputs, yet struggle with sustainability, scale-up, or regulatory alignment. The Insight Report explicitly addresses this gap by examining how innovation can be embedded into real-world healthcare settings. In doing so, it positions EU collaboration as a catalyst—not just for innovation, but for implementation.

SHAIPED featured at HIMSS 25

At HIMSS25, SHAIPED showcased its approach to safely deploying AI-based medical devices under EU regulations. Watch the coordinator explain the project’s vision and early impact in the video below.

Beyond SHAIPED, HIMSS25 showcased a range of European projects tackling key challenges in digital health, from cybersecurity and trust to data interoperability, AI, and patient empowerment:

• CYLCOMED (Cyber securitY tooLbox for COnnected MEdical Devices) is a 36-month Horizon Europe Research and Innovation Action that ended in November 2025. It addressed the growing cybersecurity risks of connected medical devices, which can directly affect patient safety and clinical outcomes. The project developed lifecycle-based cybersecurity tools, methods, and training, integrating security into both design and clinical use to maintain trust in digital healthcare
• EDiHTA (European Digital Health Technology Assessment) responds to the challenge of evaluating digital health technologies that evolve more rapidly than traditional assessment frameworks allow. EDiHTA will be the first flexible, inclusive, validated and ready-for-use European HTA framework allowing the assessment of different digital health technologies at different maturity levels, different decision-making levels (national, regional and local) and perspectives.
• ENTRUST (End-to-End Trust Management for Connected Medical Devices) is a 36-month Horizon Europe Research and Innovation Action that ends in Decembar2025. ENTRUST strengthened trust and privacy across the medical ecosystem by developing cybersecurity solutions, verified trust models, risk assessments, secure lifecycle procedures, security policies, technical recommendations, and the first real-time Conformity Certificates, embedding trust throughout the device lifecycle to enable safe and effective clinical use
• FLUTE (Federated Learning and Multi-party Computation Techniques for Prostate Cancer) explores how AI can be trained across institutions without transferring sensitive patient data. High-quality AI models require diverse datasets, yet privacy regulations often limit data sharing. By applying federated learning to prostate cancer imaging, FLUTE enables collaborative research while maintaining GDPR compliance. The project demonstrates how advanced analytics and data protection can coexist in clinical research.
• TRUMPET (Trustworthy Privacy-Preserving Federated Learning Platform) addresses how health data can be used at scale without compromising patient privacy through federated learning. TRUMPET enables advanced analytics while keeping data under local control. This approach supports multi-centre research and AI development without central data pooling.
• ONCOVALUE (Implementing value-based oncology care at European cancer hospitals) is a Horizon Europe Research and Innovation Action. It aims to improve cancer care by unlocking high‑quality real‑world data from European cancer hospitals and applying AI‑based tools to generate real‑world evidence for regulators, HTA bodies, and clinicians. The project builds infrastructure and methods for structured data collection, harmonisation, and analysis to support value‑based assessment of novel cancer therapies and better decision‑making in clinical, regulatory, and policy context
• Gravitate-Health (Empowering Patients with Digital Health Information) runs until 30 June 2026 under the Innovative Medicines Initiative. The project aims to equip and empower citizens with digital information tools including the Gravitate Lens (G‑Lens) that improve access to and understanding of reliable health and medicines information, support safer use of medication, and enhance patient engagement and health outcomes.
• MedSecurance (Cybersecurity Assurance for the Internet of Medical Things) EU co-funded project that focuses on new technologies that address cybersecurity and safety assurance challenges for connected medical devices in the context of emerging healthcare architectures. The project developed novel methodologies, infrastructures, and tools to address cybersecurity and safety assurance challenges for connected medical devices in emerging healthcare architectures.
• NEMECYS (Security-by-Design for Connected Medical Devices) advances the principle that cybersecurity must be embedded early in device development. Retrofitting security after deployment is often costly and ineffective, particularly in clinical environments. The project develops tools and guidelines that support secure design, deployment, and operation of connected devices. NEMECYS contributes to a safer foundation for next-generation medical technologies.
• IDERHA (Interoperable Data Exchange for Real-World Health Analysis) contributes to building interoperable health data infrastructures aligned with the European Health Data Space. Fragmented data limits both clinical insight and research potential. By harmonizing data models and governance approaches, the project improves data usability across borders and institutions. IDERHA helps transform health data into actionable clinical knowledge.
• XiA (Xpanding Innovative Alliance) is an Erasmus+ co‑funded project running from January 2025 to December 2028. Building on the XpanDH foundation, it aims to bridge the skills gap in digital health interoperability by developing educational programmes, micro‑credentials, and training materials to prepare healthcare and IT professionals for European Health Data Space standards, fostering cross‑border collaboration and a more integrated, secure digital health ecosystem.

Strategic lessons from HIMSS25 European Projects Insight Report for translating innovation into practice

Several strategic lessons emerge across these projects. First, trust and cybersecurity are no longer optional add-ons; they are foundational to patient safety and clinical adoption. Second, interoperability and data governance must be addressed early, or innovation risks remaining siloed and unsustainable. Third, evaluation frameworks must evolve, particularly for AI and digital tools that do not fit traditional assessment models.

Perhaps most importantly, the projects show that stakeholder engagement is a determinant of success, not a checkbox exercise. Clinicians and patients involved from the start help ensure solutions align with real-world workflows, ethical expectations, and care priorities. Sustainability and scale are more likely when value is co-created rather than imposed.

What this means for the future of digital health in Europe

The HIMSS25 European Projects Insight Report illustrates a clear shift in how digital health innovation is approached in Europe. The focus is moving away from isolated technological breakthroughs toward system-level transformation grounded in trust, collaboration, and real-world impact. For clinicians, this means digital tools that are safer, more usable, and better aligned with patient needs. For health systems, it signals a pathway toward innovation that is both scalable and sustainable.

As Europe continues to build the European Health Data Space and align regulatory frameworks for AI and medical devices, projects like these provide practical guidance on how transformation can succeed. The future of digital health will not be built by technology alone—but by the communities that co-create, evaluate, and implement it together.

Further Reading

HIMSS25 European Projects Insight Report – Download the PDF.

Objava How Europe is co-creating the future of digital health: Insights from the HIMSS25 European Projects Report pojavila se prvi puta na Shaiped.

The EAB is much more than a formality. It will actively review deliverables, advise on strategy, and ensure SHAIPED’s solutions remain fully aligned with Europe’s evolving regulatory and technical landscape for AI in healthcare.

A Strategic Compass for SHAIPED

SHAIPED operates at the intersection of several key European regulations — the European Health Data Space (EHDS), the AI Act, the Medical Devices Regulation (MDR) and the Health Technology Assessment Regulation (HTAR).

To navigate this complex terrain, the EAB brings together experts from public authorities, academic institutions, research centers, and industry innovators, ensuring SHAIPED’s outputs are both technically robust and regulatory-ready.

Four Expert Colleges – One Shared Mission

To channel expertise efficiently, the EAB is structured into four thematic groups, each addressing a crucial dimension of SHAIPED’s mission.

Legal Group

Comprising legal specialists in health data governance and ethics, this group includes experts in the EHDS Regulation, AI Act, MDR and cross-border legal harmonisation. Their backgrounds span European universities and bioethics councils, ensuring SHAIPED’s proposals are grounded in legal reality and ethical integrity.

Regulatory Group

This group brings together representatives from competent authorities and health ministries, such as the Italian Ministry of Health and Agenas, alongside HTA advisors, insurance experts and contributors to EU initiatives like IDERHA. Their collective insight will help SHAIPED address market access, certification and post-market surveillance challenges for AI-based medical devices.

Technical / Data Group

A dynamic mix of AI innovators, SMEs, and computing infrastructure leaders, including representatives from the Barcelona Supercomputing Center (EuroHPC), EGI, NHS England AI team, Synthia Project and Enversion, this group focuses on AI development, interoperability, data discovery, and computing capacity. They ensure SHAIPED’s technical outputs meet both performance and compliance standards.

EHDS & HDABs Group

Representatives from national Health Data Access Bodies (HDABs) and data services — including the German DACO, GÖG (Austria), the Swedish eHealth Agency, the Luxembourg National Data Service and the Italian Ministry of Health — bring firsthand experience from the front lines of health data governance. Their perspectives ensure SHAIPED’s tools and frameworks complement real EHDS infrastructures and support cross-border data sharing.

Key Themes from the Kick-off Discussion

At the inaugural EAB meeting, members discussed how to turn complex European regulatory frameworks into actionable, technically implementable solutions.
Core themes included:

• Harmonising interpretations of EU regulations and translating them into practical technical requirements.
• Ensuring trustworthy and transparent AI, including robust validation and post-market monitoring
• Managing the data lifecycle to safeguard reproducibility, reliability, and cross-border interoperability
• Exploring synthetic and proxy data to enable innovation while protecting privacy
• Embedding machine-actionable compliance – automating data quality and certification checks within SHAIPED’s tools

Looking Ahead

The EAB will remain an integral part of SHAIPED until the project’s conclusion in 2028, providing continuous feedback and strategic direction across work packages — particularly WP3 (Pathways for AIaMD development & testing) and WP4 (Pathways for AIaMD deployment).

Members will review deliverables, join workshops, and advise on regulatory readiness, ensuring that SHAIPED’s technical outputs translate into usable, policy-aligned, and patient-centered innovations.

Strengthening Europe’s AI and Health Data Future

With its External Advisory Board now in place, SHAIPED reinforces its commitment to trustworthy, regulation-compliant, and sustainable AI in health.

By connecting expertise from ministries, research, regulation, and technology, SHAIPED is building a bridge between policy and practice — helping make Europe a global leader in responsible, data-driven healthcare innovation.

Objava Expert Voices Join Forces: SHAIPED’s External Advisory Board Kicks Off pojavila se prvi puta na Shaiped.

With the EHDS phased implementation requiring key acts by 2027 and full application by 2029, embedding ethical oversight from the start is essential. This ensures privacy, transparency, fairness and accountability supporting compliance with GDPR, EHDS and upcoming AI legislation while fostering public trust. Dr. Ségolène Aymé will advise the consortium to align its work with evolving ethical and regulatory standards, keeping SHAIPED innovative and responsible.

Why an Ethics Advisor is Crucial for SHAIPED

Integrating AI into healthcare offers transformative opportunities but also presents complex ethical challenges. AI systems can enhance diagnostics, optimise workflows and provide scalable access to high-quality care, yet their deployment raises critical concerns around patient autonomy, algorithmic fairness, transparency, data privacy and accountability. SHAIPED project, which focuses on cross-border medical data sharing and AI-driven validation of medical devices, addresses these challenges by appointing an independent Ethics Advisor. This role, designed for projects facing substantial ethical considerations, ensures that SHAIPED adheres to ethical, legal, and regulatory requirements, including GDPR, the EU Medical Device Regulation, and the emerging EHDS.

Figure 1, adapted from Jha et al., 2025, illustrates key ethical dimensions of medical AI including data governance, bias mitigation, explainability, clinical validation and accountability. Within this framework, SHAIPED’s Ethics Advisor provides continuous guidance throughout the project lifecycle, ensuring that AI models are trained on ethically sourced, representative datasets, that privacy and consent protocols are strictly adhered to, and that clinical validation incorporates human oversight. By operationalising high-level ethical principles such as autonomy, fairness, transparency, and sustainability across data collection, model development, and deployment, SHAIPED promotes trustworthy AI practices while safeguarding patient rights and fostering equitable healthcare access.

Ethical Oversight: Building Trust in Health AI

Independent ethical oversight is vital for maintaining public trust as healthcare AI advances. Experts consistently emphasise that transparent and robust ethical governance is essential to ensure AI tools are safe, fair, and reliable for both patients and clinicians. For example, under the EU Artificial Intelligence Act, high-risk AI systems in healthcare must be designed, developed, and deployed to ensure safety, transparency, human oversight, and respect for fundamental rights, thereby promoting ethical, equitable and responsible use..

In SHAIPED, Dr. Aymé serves as the Ethics Advisor, guiding the project on ethical issues and ensuring compliance with all relevant ethical requirements. Her responsibilities include producing reports reviewing the project’s policies and deliverables, including general ethics briefs and data use frameworks. She advises on potential ethical risks, assesses alignment with EU values and human rights, and recommends measures to uphold fairness, transparency, and accountability. These activities directly support the objectives of the EU AI Act, helping SHAIPED promote trustworthy and responsible AI in healthcare.

About Dr. Ségolène Aymé

Dr. Ségolène Aymé is a distinguished medical geneticist and expert in rare diseases and health data ethics. She is Emeritus Director of Research at INSERM, the French Institute of Health and Medical Research and in December 2022 was appointed President of the Scientific Advisory Board of France’s Health Data Hub.

Dr. Aymé founded Orphanet in 1997, the leading information portal for rare diseases and orphan drugs, and led it as Executive Manager until 2011. She has also held prominent leadership positions in European and global rare disease policy bodies, including Chair of the European Committee of Experts on Rare Diseases and membership in the WHO Topic Advisory Group on Rare Diseases.

Her ethical leadership is extensive. She is President of the Comité d’éthique et de déontologie, the Ethics and Professional Conduct Committee, at the Paris Brain Institute, and has participated in ethics oversight in genetics policy and research through various EU and WHO expert committees. This combination of deep expertise in genetics and rare diseases, alongside leadership in ethics and data policy, uniquely equips her for the SHAIPED role, particularly in complex areas such as data governance, safeguarding vulnerable patient groups and ensuring ethical compliance in cross-border health AI.

SHAIPED’s Commitment to Responsible Innovation

Dr. Aymé’s appointment underscores SHAIPED’s commitment to ethical, regulation-aligned innovation alongside technical achievement. Her advisory role spans the entire project, informing all work packages, from drafting guidelines for secure data access to interpreting AI Act requirements for clinical tools. This ensures that SHAIPED’s deliverables consistently reflect ethical best practices. By integrating an Ethics Advisor from the outset, SHAIPED demonstrates a proactive approach, developing AI medical devices not only to meet market needs but also to satisfy societal expectations for transparency, fairness, and patient-centric care.

Through this approach, SHAIPED reinforces the EU’s vision of a secure, citizen-empowered health data space. As part of Europe’s digital health strategy, the project contributes to the practical implementation of the new EHDS rules and forthcoming AI legislation. In short, the consortium aims to serve as a model for responsible development of AI medical devices, protecting individuals while fostering innovation.

Objava Dr. Ségolène Aymé Joins SHAIPED as Ethics Advisor pojavila se prvi puta na Shaiped.

The event brought together key stakeholders, project partners, and leading experts from across Europe to align on SHAIPED’s strategic goals and establish a strong foundation for future activities. SHAIPED is a non-profit public-private consortium of experts in field of healthcare and artificial intelligence (AI) focused on enhancing the development, testing, and deployment of AI-based medical devices (AIaMD) within the framework of the European Health Data Space (EHDS). The consortium brings together 30 partners coordinated by the Health Data Hub (HDH) and is funded under the Digital Europe Program with almost 4 million euros for a period of three years.

Over the next three years, SHAIPED will bring the EHDS ecosystem closer to the AI medical device innovation and regulatory ecosystems. SHAIPED consortium aims to address key challenges in AI-based healthcare by defining structured pathways for AI model development and market access. Furthermore it will support the synergistic implementation of the EHDS regulation and the Artificial Intelligence Act (AI Act), strengthen the EHDS ecosystem and support capacity building at the health data access bodies (HDAB) level. The project will leverage synergies with existing European initiatives such as EUCAIM and TEF-Health, while ensuring compliance with the evolving regulatory landscape, including the AI Act, Medical Devices Regulation (MDR) and Health Technology Assessment (HTA) Regulation.

Day 1 AM – Monday 10 March 2025 – Working sessions

The SHAIPED Project kick-off meeting began with a productive morning working session that brought together key stakeholders from Work Packages (WPs), Tasks and  Use Cases (UCs). The primary objectives were to gather these crucial team members, revisit the project’s main activities and expected outputs, and collaboratively explore the dependencies and synergies within SHAIPED’s internal structure and with external actors. To facilitate focused discussions, participants were divided into two groups. The first group concentrated on WP3 and UC1, while the second group addressed WP4 and UC2 and UC3. This strategic division allowed for in-depth exploration of specific project components and their interconnections.

The working sessions yielded valuable insights into the dependencies and needs of each WP and UC. Participants identified critical areas for collaboration, potential challenges, and opportunities for synergy both within the project and with external stakeholders. These discussions laid a strong foundation for the project’s future activities, highlighting the importance of cross-functional cooperation and strategic partnerships to achieve SHAIPED’s ambitious goals in advancing AI-based medical device ecosystem within the European healthcare landscape.

Day 1 PM – Monday 10 March 2025 – Official launch

The official launch was led by Emmanuel Bacry, Chief Scientific Officer at HDH. In his opening remarks, Bacry emphasized the strategic importance of SHAIPED as the second major EU-funded project coordinated by HDH after HealthData@EUPilot. He outlined four key objectives for SHAIPED: establishing a clear overview of the project’s deliverables, strengthening collaboration between partners, ensuring alignment on key activities and timelines, and building a dynamic working environment for innovation and problem-solving.

Following the official launch Luis Martí-Bonmatí, Director of the Clinical Area of Medical Imaging Department at University Hospital La Fe and Scientific Coordinator of EUCAIM project, and Ignacio Blanquer, Professor at Universitat Politècnica de València, presented an overview of the EUCAIM project, which serves as a federated infrastructure for cancer imaging data across Europe. This initiative aims to make research cancer imaging data from various EU-level and national sources accessible and usable, supporting the development of AI-driven solutions for precision medicine.

EUCAIM’s alignment with EHDS  and its involvement in the SHAIPED project were highlighted during the presentation. The speakers detailed the EHDS data user journey for accessing the EUCAIM Atlas of Cancer Images. Furthermore, EUCAIM’s potential contributions to SHAIPED, particularly in the oncology use case, were outlined. These include offering hosted data, processing capabilities, a catalogue of tools, and implementation methodologies, all of which could significantly enhance SHAIPED’s objectives in developing AI solutions for medical devices. This collaboration underscores EUCAIM’s pivotal role in advancing European healthcare through innovative data sharing and AI technologies.

Line Farah, pharmacist and Project Director at la DNS (French eHealth delegation at the Ministry of Health and Prevention) presented France’s National Strategy for AI in healthcare. Farah outlined the challenges facing AI-based medical devices in terms of evaluation, market access, and regulatory compliance. Improved scientific standards and regulatory frameworks are needed to build trust in AI models. Farah concluded by emphasizing the ongoing challenges in establishing trustworthy AI in healthcare and suggested that SHAIPED could play a crucial role in supporting this process.

EU Strategy for AI in Healthcare: Insights from European Commission and HaDEA Leaders

Aleksandra Wesolowska, Programme Officer from European Commission, outlined the EU’s strategic ambition for AI leadership, emphasizing continuous investments in key technologies and initiatives to foster an innovative European AI ecosystem. Wesolowska also presented relevant DIGITAL Europe programmes, including AI factories for healthcare, the TEF-Health programme, and the European Digital Innovation Hubs (EDIHs) network, which will play crucial roles in SHAIPED’s activities and the sustainable development of AI-based medical devices within the European Health Data Space (EHDS).

Irini Kessissoglou, PhD, Policy Officer from European Commission, focused on the EHDS and its cross-border secondary use infrastructure, HealthData@EU. She explained the user journey for AI model innovators within the EHDS and emphasized the role of authorized participants like European Digital Infrastructure Consortiums (EDICs) in SHAIPED. Kessissoglou highlighted DG SANTE’s high expectations for the project, particularly regarding the capacity of Health Data Access Bodies (HDABs) to extract AI models from Secure Processing Environments while maintaining GDPR compliance, the use of the EHDS framework, and lessons learned on federated analysis and EU data.

Both speakers underscored the importance of SHAIPED in advancing AI in healthcare within the European regulatory landscape and its potential to contribute significantly to the EU’s AI leadership goals.

European Health and Digital Executive Agency (HaDEA), created in 2021, implements European programmes and initiatives within the health, food safety, digital, industry and space sectors. Maria Saarela, Project Officer from HaDEA, outlined SHAIPED-specific objectives, Grant Agreement details, roles and responsibilities, and key processes including reporting and financial management.

WP5 Use Cases were presented at the Kickoff

Pauline Cohen, European Project Manager at Health Data Hub, provided an overview of SHAIPED, including its EU context, consortium composition, project approach, main deliverables, structure, and high-level timelines. Youness Khalil, AI Project Manager at Health Data Hub, opened the deep-dive session on WP5, presenting three key use cases that leverage AI to address distinct healthcare challenges. Experts from various institutions led the discussions, outlining objectives, timelines, risks, and mitigation strategies. Each presentation was followed by a Q&A session, addressing regulatory and technical considerations

The Chronic Kidney Disease (CKD) use case was presented by Philip Munch and Christian Fynbo Christiansen from Aarhus University, focusing on AI-based prediction models for CKD. A key topic of discussion was the EU common data access form, introduced under TEHDAS II. DG SANTE emphasized the importance of adopting the EU common data permit application form, but some countries’ representatives clarified that, since the EHDS regulation is not yet in effect, they must use their national data access forms, with the EU form serving only for comparative testing.

DG SANTE highlighted SHAIPED as an opportunity to test synthetic data as a workaround for potential data access delays, but use case leaders cautioned that regulatory challenges remain, as EHDS is focused on real health data, not synthetic substitutes. The challenge of extracting the model from the SPE was also discussed, with an agreement to focus on learnings rather than complexity. Additionally, there was a discussion about the feasibility of a horizontal data model across use cases, but it was concluded that the differences in scope make this unlikely.

The second use case, focused on oncology, was originally set to be presented by Alizée Diatchenko but was instead led by Anaïs Arliaud from Centre Léon Bérard. This use case aims to support healthcare organizations in evaluating AI models, with a particular focus on AIaMD. Arliaud emphasized potential synergies with EUCAIM, which could provide data hosting and software benchmarking, although funding limitations remain a challenge. The evaluation process will primarily assess already approved AI models using a standardized methodology and validation cohorts. The EUCAIM Scientific Director highlighted that the models will initially be tested across four national datasets, with the possibility of expanding to additional EUCAIM data holders in the future. Additionally, discussions addressed how EUCAIM services, such as data hosting and pipeline implementation, could be leveraged to enhance the use case, though a preliminary state-of-the-art assessment will be conducted to map potential collaborations.

Presented by Camille Dorra, Corporate Development Manager from Implicity, cardiology use case aims to explore AI models’ role in market access and reimbursement pathways. She explained that the use case was originally designed to test support for innovators navigating reimbursement processes, but it will now also provide insights for WP4 tasks, particularly around post-market surveillance Currently, the linkage between German data and Implicity still presents a challenge as HDLs are not yet operational, with no timeline for when data linkage services will be available. DG SANTE emphasized the importance of developing these services within the EHDS framework, noting that the SHAIPED project presents an opportunity for HDABs, including German bodies, to enhance their data preparation services. Additionally, DG SANTE discussed the potential use of synthetic data as a workaround if real-world data is unavailable, although the Nico Ridel pointed out that synthetic data still requires real data for generation, meaning delays may persist.

The session emphasized the challenges of regulatory compliance, data access, and AI integration while showcasing the progress made in leveraging AI for healthcare under SHAIPED. It highlighted the potential for improving healthcare outcomes through collaboration and innovation. The day ended with a networking session, allowing participants to strengthen professional relationships and encourage cross-functional collaboration.

Day 2 – Tuesday 11 March 2025

The second day of the kick-off meeting featured insightful presentations, providing a deep dive into ongoing EU projects and the pathways for AI development and deployment in healthcare.

The day opened with a speech by Mario Jendrossek, European Project Lead from Health Data Hub, who set the stage for the day’s discussions and emphasized the importance of a shared vision moving forward.

Petra Ritter, Neuroscientist at Charité University Medicine Berlin, provided an overview of the EU AI Act and its implications for medical devices with AI systems. She discussed how the AI Act classifies these devices as “high risk” and outlined the upcoming compliance deadlines. Petra also introduced the TEF-Health initiative, which will support AI implementation in line with the AI Act. The session included a Q&A session where Petra clarified that TEF-Health is not only cataloging existing services but also developing new services to adapt to the evolving regulations.

Following this, Enrique Bernal-Delgado, Senior Scientist at Aragon Institute for Health Sciences, presented the QUANTUM project, which focuses on creating data quality and utility labels for HealthData@EU. The project aims to ensure that all data collected with public funds meets specific quality and utility standards. Enrique highlighted the project’s ongoing phases and the development of a self-assessment tool for data quality labeling.

Next, the EUCAIM Software Marketplace, which offers tools for data preprocessing and AI model evaluation, was presented by Leonor Cerdá Alberich, Head of the Computing and AI Department at IIS La Fe. Leonor explained the software registration and validation process and stressed the importance of benchmarking tools for AI models based on fairness, quality, and clinical outcomes. She also proposed offering EUCAIM’s infrastructure and services to support AI model testing in SHAIPED’s UC2.

Identification of pathways for supporting AI development and testing

The afternoon session focused on Pathways for AI Development & Testing, where Pascal Derycke, WP3 Lead, and other task leads presented the objectives and timelines of the work package. Key topics included the role of HDABs in supporting synthetic data creation and the integration of synthetic data within use cases. The discussion also covered aligning WP3 with other work packages and assessing how synthetic data could expedite the process of data accessibility.

Elaboration of pathways for AI medical device deployment

The day concluded with a deep dive into WP4, which addresses the pathways for AI deployment. Persephone Doupi from the Finnish Institute for Health and Welfare led the discussion together with Silvia Moler-Zapata from the Aragon Institute for Health Sciences. They presented objectives, timelines, expected deliverables, and the dependencies between other work packages, use cases, and external actors.

During the Q&A, it was highlighted that the new EU HTA Regulation  would harmonize HTA procedures across the EU. The external market benchmarking discussion emphasized the need to examine practices in countries like Korea, where processes for AI models are already in place. One of the key challenges was identified as the rapidly evolving nature of AI models, which requires agile and flexible certification and evaluation processes to keep pace with these advancements.

The day ended with closing remarks from Mario Jendrossek, who reflected on the significance of the kick-off meeting in aligning the project’s goals and fostering collaboration.

Key Takeaways and Future Steps

The SHAIPED kick-off meeting successfully established a clear strategic direction for the project and outlined concrete action points for the next phases. One of the key takeaways was the importance of collaboration between work package leads and use case partners to ensure alignment and avoid duplication of efforts. Early engagement with regulatory bodies will be essential to navigate the complex certification requirements for AI-based medical devices.

SHAIPED’s next general assembly meeting is scheduled for June 2025, where progress on work packages and use cases will be reviewed. All partners were encouraged to maintain open communication and actively contribute to SHAIPED’s shared goals.

SHAIPED represents a significant step forward in the development and deployment of AI-based medical devices in Europe. With strong support from the European Commission and alignment with EU regulations, SHAIPED is poised to drive innovation and improve healthcare outcomes across Europe.

Objava Successfully launched SHAIPED pojavila se prvi puta na Shaiped.

With the adoption of the regulation for a European Health Data Space – EHDS – due at the end of 2024, the SHAIPED consortium is a concrete expression of the European Commission’s ambition to foster a network of dynamic players to exploit data on a European scale while complying with the highest standards of data protection.

With 30 partners from 11 Member States, the SHAIPED consortium is the largest to date to include the future Health Data access Bodies of the EHDS. This project is a continuation of the pilot project for the EHDS, which was entrusted to the HDH by the European Commission and which aims to build a European infrastructure for the secondary use of health data.

Meeting the challenges of AI in healthcare in Europe

In the age of artificial intelligence, a major challenge for medical devices (MDs) is access to real world data to train, test and validate these tools. Integrating these devices into healthcare information systems (HIS) and proving their clinical effectiveness are also major challenges. The SHAIPED consortium is addressing these issues through several working groups, seeking to :

• Facilitating access to health data for AI-based medical devices,
• Validate the clinical effectiveness of these devices on a large scale,
• Integrating medical devices into European healthcare systems.

Three use cases will provide a framework for testing and validating the solutions developed by the consortium. These examples show the potential of AI to improve patient care and boost the efficiency of European healthcare systems.

• The first use case will focus on chronic kidney disease. Led by Aarhus University Hospital (Denmark), this project will explore the ability of existing AI models to adapt to cohorts of data from several European countries.
• The second will focus on the detection of metastases. In collaboration with the Centre Léon Bérard and the Health Data Hub (France), this use case will analyse cohorts of patients to assess the performance of AI in detecting lung metastases and mammograms.
• Finally, the third will focus on the prevention of heart failure. Led by Implicity (France), this last use case will evaluate AI software for preventing Heart failure hospitalizations in patients with Cardiac Implantable electronic devices (CIED).

Meeting Europe’s strategic challenges

By facilitating the integration of medical devices into healthcare information systems, the SHAIPED project not only contributes to improving the quality of care, but also to the competitiveness of European companies. In a context of increasing international competition, AI innovations are essential to maintain Europe’s leading position in the healthcare sector.

SHAIPED will begin in 2025, with the first results expected in autumn of the same year.

Objava 30 European players join forces to form a “European space for AI in healthcare” pojavila se prvi puta na Shaiped.

In this study, the model will be deployed within secure data environments at Health Data Access Bodies (HDABs) in Denmark, Finland, and France, using patient data from laboratory and nephrology records. To enable comparisons, a common data model will standardize variables, allowing the super learner algorithm to evaluate model performance across these datasets. This case study is crucial in demonstrating AI model “transportability,” providing HDABs with validated, predictive AI models that support chronic disease management across diverse populations in Europe.

Objava Chronic Kidney Disease (CKD) Prediction Model pojavila se prvi puta na Shaiped.

To accomplish this, SHAIPED will collaborate with a consortium of healthcare and AI experts across France, the Netherlands, Italy and Spain. Participating cancer centers will manually annotate patient images to create a high-quality dataset for model validation. Approximately 1,000 images per site, covering both lung scans and mammograms, will be collected across Europe. HDABs will run validation tests in secure environments, using 20% of the data for developer testing and 80% for independent evaluation. This standardized approach allows SHAIPED to rigorously test the effectiveness of AI tools for cancer imaging, ensuring they meet clinical, regulatory, and operational standards.

Objava Oncology – AI for Detecting Metastasis and Nodules pojavila se prvi puta na Shaiped.

In Germany, an epidemiological study will establish baseline data on hospitalization and mortality rates among HF patients, using data from the German Health Data Lab. Following this, a comparative study will assess HF patients using the Implicity solution against this baseline data, using a doubly robust method to adjust for population differences. Meanwhile, in France, a real-world longitudinal study will assess how HF patients using Smart SignalHF compare to those using conventional monitoring in terms of hospitalization rates, healthcare costs, and workload optimization for clinicians. Supported by HDABs in both countries, this use case provides vital evidence for the solution’s effectiveness, paving the way for regulatory approval and reimbursement throughout Europe.

Objava Cardiology – Heart Failure Management with Remote Monitoring pojavila se prvi puta na Shaiped.