Engagement with Health Technology Assessment (HTA) and regulatory bodies is an essential component of the SYNTHIA project, ensuring that innovations in synthetic data are not only scientifically and technically sound but also can meet real-world requirements of healthcare decision-makers. 

Opportunities and key concerns for synthetic data in healthcare decision-making 

From a regulatory and HTA perspective, the most important opportunities for using synthetic data in healthcare lie in starting with low risk uses. Low-medium fidelity synthetic data has already helped to achieve improvements in assessing feasibility of analysis without requiring lengthy access processes, since privacy is preserved. It is also already being used to improve the training of prediction models used in the health service, or to develop health technologies that perform prediction or diagnostic tasks. Such technologies are likely to be evaluated by regulators and HTA agencies increasingly, and they could also improve patient outcomes. However, its use for generating data to validate these models is more controversial. In the near term, synthetic data could be used to gain access to data that would otherwise be difficult to access quickly. For example, synthetic trial data could aid sharing between competitors and decision-making agencies, support greater use of surrogate outcomes, or enable individual patient data network meta-analyses. Synthetic data could also provide faster access to data needed to support input parameters in economic models. Emerging uses include boosting sample size or correcting bias in existing sources, which could support decisions in areas where sufficient high-quality data is currently lacking, such as rare diseases or early assessments of certain medicines. 

At the same time, several challenges and barriers remain. The higher-risk uses of synthetic data are not yet sufficiently supported by benchmarking studies, which are critical for building trust in fidelity and utility. Without this, decision committees are unlikely to view synthetic data as pivotal rather than peripheral evidence. For example, if synthetic data were used as an external control arm for a single-arm trial, even a small difference in survival compared to the real data it was derived from could significantly affect lifetime health and cost estimates. Another challenge is that, while it is posited that synthetic data may support transparency through data sharing, in practice it requires specialized expertise to assess whether it was generated robustly, and which metrics best evaluate its reliability. 

Where SD can deliver the most value

Synthetic data offers the greatest value in situations where it can extend beyond what real-world data infrastructures already provide.

Its key advantages include:

  • Faster access to usable data
  • Greater flexibility for analysis
  • The ability to generate data where gaps exist

One area with significant potential is improving the sharing of clinical trial data, which could help HTA agencies and regulators access information needed for evidence generation and decision-making.

To support broader acceptance in decision-making, frameworks are needed to assess the reliability of synthetic data generation, including what can go wrong and what good looks like. More benchmarking studies will be essential to establish trust, and until then, use will likely remain restricted to low-risk applications. 

Impact for HTA and Regulators 

SYNTHIA aims to demonstrate how synthetic health data can inform evidence-based policy, regulatory decision-making, and health technology assessment (HTA) while ensuring privacy, security, and ethical integrity. Our policy approach is grounded in the Assessment List for Trustworthy AI (ALTAI) and fully aligned with EU data protection standards such as GDPR and ENISA guidance. 

We apply privacy-preserving mechanisms, including Differential Privacy and Secure Multi-Party Computation, to ensure synthetic data is not personal data. Ethical, legal and social issues (ELSI) are continuously reviewed by our dedicated working group, while public trust is fostered through a structured patient involvement process and a roadmap on public trust. 

SYNTHIA integrates regulatory and HTA perspectives across all phases of the project. 

  • Understanding current regulatory and payer perceptions of SD through literature review and expert interviews with EMA, FDA, HTA bodies, and payers, 
  • Assessing the use of SD in regulatory submissions, such as control arms in trials, stress testing of AI tools, and evaluation under EU MDR, IVDR, and the AI Act, 
  • Issuing consensus-based recommendations in the form of a policy white paper to support uptake by regulators, payers, and industry.
 

SYNTHIA develops multilevel policy models to integrate synthetic data into European public health and digital agendas.

  • A Health in All Policies (HiAP) approach to align governance across sectors (health, research, digital). 
  • A policy roadmap for prevention strategies, showing how synthetic data can support evaluation of screening and public health interventions. 
  • Support for the European Health Data Space (EHDS) via interoperable infrastructure and contributions to EU standardization (e.g., OMOP-CDM extensions). 

Activities

 

SYNTHIA hosts first HTA and Regulatory advisory group meeting

An important activity has been assembling the first SYNTHIA HTA and Regulatory Advisory Group in April 2025, comprising experts from organisations across Canada, England, Germany, Greece, Ireland, Netherlands, Norway, Poland, Scotland, Spain, Sweden, Ukraine and Wales.

The aim of this group is to embed the views of HTA and Regulatory stakeholders across the project, ensuring consideration is given to how this kind of data might eventually be used and accepted in real-life settings. Read more > 

The second HTA and Regulatory advisory group meeting was organized in November 2025, stay tuned for more information.

The third HTA and Regulatory advisory group meeting is organized in June 2026, stay tuned for more information.

 

SYNTHIA hosts second HTA and Regulatory advisory group meeting

On 24 November 2025, the HTA and Regulatory Advisory Group reconvened for its second meeting. Fifteen representatives from HTA and regulatory organisations participated alongside SYNTHIA partners representing the project's work packages and disease-specific use cases.

Building on discussions from the first meeting held in April 2025, the second forum focused on specific healthcare applications of synthetic data, approaches for assessing synthetic data quality, progress across the SYNTHIA use cases, synthetic control arm development, and regulatory considerations for medical devices developed using synthetic data. Read more >

 

SYNTHIA hosts third HTA and Regulatory advisory group meeting

On 18 June 2026, the HTA and Regulatory Advisory Group reconvened for its third meeting. Building on the first two meetings held in April and November 2025, this third forum moved from exploring the potential of synthetic data towards examining how it might be assessed when presented as part of an HTA or regulatory evidence submission.

Previous discussions highlighted that the acceptability of synthetic data depends strongly on the context in which it is used. To make the third meeting more tangible, SYNTHIA therefore adopted a vignette-based approach, using hypothetical evidence submissions inspired by real-world scenarios. Read more >

Let's connect

We look forward to hearing from you, your ideas, experiences, and questions can make a real difference in shaping how synthetic data works for HTA and Regulators. Reach out to our SYNTHIA to share your thoughts send an email to: contact@ihi-synthia.eu