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One of the important objectives of EDiHTA is to tailor the HTA framework to the different stages of digital product development along its life cycle. Innovations go through a maturation process, from their conception and idea to market access, known as Innovation Maturity Level (IML, development stages = 1-10) or Technology Readiness Level (TRL, development stages = 1-10). At each stage, the feasibility and appropriateness of requiring the accomplishment of different assessment domains and their criteria vary. The first step to properly approach which domains and criteria should be collected or assessed by developers and other stakeholders is to establish a proper TRL/IML scale specific for Digital Health Technologies (DHTs) development. DHTs exhibit very different features and dynamics compared to traditional health technologies (e.g., medical devices – MDs), which calls into question the use of MD-specific TRL/IML scales to DHTs.  

To address this issue, partners from HCB/FCRB-IDIPABS and RUMC collaboratively conducted a study to identify available scales for measuring the life cycle development of innovative health technologies and analyze their appropriateness in capturing the unique characteristics of DHTs’ life cycle development.  

Different search strategies, including targeted (Pubmed & Scopus) and grey literature searches, were conducted. Snowballing from two key identified papers was also carried out. Five scales addressing the development or assessment of DHTs at different life cycle stages were identified. Key findings from this research include:  

1. The existence of specific TRL scales demonstrates the recognition of the specifications linked to DHTs’ life cycle development. Therefore, using an MD TRL/IML scale to assess DHTs’ life cycle development is inaccurate.   
2. There is heterogeneity in the approach taken by the different DHT TRL/IML scales. The differences related to the intended use of the scales are closely associated with the potential end user (i.e., developers, DHTs evaluators). 
3. TRL scales for developers (product focus) aim to define the DHT stage of development and the type of information/evidence they need to demonstrate its safety and efficacy. Scales that are used by evaluators address other aspects of value, not just related to the product, such as the impact of the DHT on the health system. 

In concluding remarks, it is important to note that developers of DHTs aiming to access the healthcare market need to know, at early stages of technology development, the pathway and information requirements needed by different stakeholders along the technology life cycle development. Currently, TRL/IML scales are fragmented: some deal with clinical, business/market, regulatory and technology, which are mainly development requirements; while others address some aspects of value more linked to HTA requirements. Having a TRL/IML scale that integrates requirements for both players (developers and evaluators) will make a more informative and smoother DHTs’ life cycle development flow (from idea to health system uptake). 

This work was presented as a poster at ISPOR Europe 2024. 

Join our esteemed partners from the Clinic Barcelona University Hospital and Research Foundation Clínic Barcelona-August Pi i Sunyer Biomedical Research Institute at the ISPOR Europe 2024 conference in Barcelona, Spain, on November 17-20, as they showcase the EDiHTA project and their research results. Their groundbreaking research identifies scales for measuring the development of innovative health technologies and analyses their appropriateness in capturing the unique characteristics of DHTs’ lifecycle development. The research presented is a collaborative effort between the partners from HCB/FCRB-IDIPABS, including Joan Fibla-Reixachs, Marcelo Soto Alarcón, and Laura Sampietro-Colom, and RUMC, Wija Oortwijn and Annapoorna Prakash. 

Sonia Muñoz López, will be presenting their poster during session 3, November 19, from 10:30 am to 1:30 pm. Don’t miss this opportunity to join in on stimulating discussions, as their work provides a comprehensive comparison of TRL scales and addresses the issue of their current fragmentation.

Be sure to stay tuned for more updates about the ISPOR Europe 2024 event and our EDiHTA partner there!

We are excited to announce that our partners from the National Institute for Health and Care Excellence (NICE) will be presenting at the ISPOR Europe 2024 conference in Barcelona, Spain, on November 17-20. We in the EDiHTA project are thrilled to have the opportunity to showcase the project, particularly the research results from the NICE team on mapping existing methodology and practices of assessing DHT.

Our partners, Jeremy Dietz and Zoe Garrett, will be presenting their poster during poster session 5, on Wednesday, November 20, from 9:00 to 11:30 am. Prior to this, there will also be an insightful discussion from 9:00 to 10:00 am. Their work includes a review of the existing literature, HTA frameworks, and HTA reports to identify which domains are being utilised in assessing DHT and which will finally be incorporated into the EDiHTA framework.

This year’s theme of the ISPOR conference, “Generating Evidence Toward Health and Well-Being,” focuses on the importance of scientific evidence in understanding and improving global health. The conference program will feature sessions that highlight the role of health economics and outcomes research (HEOR) in evaluating the physical, mental, and social health aspects of innovation in healthcare. The ISPOR Europe 2024 conference offers a valuable platform for networking and learning about other projects and initiatives. We look forward to engaging with other professionals and experts in the field and sharing our knowledge and expertise we have gained within EDiHTA.

Be sure to follow the link for more information and stay tuned for further updates about the event!

We are excited to announce that our esteemed project partner and health technology expert, Iga Lipska, Chairwoman of the Board at the Health Policy Institute, was recently featured in an exclusive interview with ICT&health magazine. In the interview, she provides valuable insights into the progress and goals of our EDiHTA project, which is working towards establishing the first Health Technology Assessment (HTA) framework for digital health technologies in Europe.

During the interview, Dr. Lipska highlights the significance of applying the HTA approach to digital solutions, taking into consideration factors unique to these technologies such as environmental impact and organisation of healthcare delivery. By reading the interview, you will gain a better understanding of the EDiHTA project’s plans to develop guidelines for evaluating a diverse range of digital innovations, with a focus on telemedicine, mobile health apps, and AI-driven technologies.

Dr. Lipska also discusses the potential impact of these guidelines, drawing on the success of the EU HTA regulation for cancer drugs and advanced therapies (ATMPs) as an example of how a legal framework for joint clinical assessments can be established at a European level. She emphasises the importance of ensuring that digital health solutions comply with current regulations and ethical standards, while also acknowledging the challenges posed by the rapid pace of technological development.

The EDiHTA consortium is currently focused on conducting a review of existing solutions for assessing digital technologies and collaborating with various agencies to gather information. The goal is to complete the literature review by the fall of 2024. The next step will be to design frameworks and consult with key stakeholders, including patients, HTA agencies, decision-makers, and digital technology developers.

To learn more, we invite you to read the full interview with Dr. Iga Lipska by clicking the button below.

The world of healthcare is constantly evolving, with new digital health solutions emerging every day. However, the process of assessing these technologies and determining their effectiveness can often be slow and fragmented, leading to delayed access for patients in need. This is where the European project EDiHTA comes in, seeking to harmonise health technology assessment across Europe.

In a recent interview at HIMSS in Rome, Emmanouil Tsiasiotis, EDiHTA’s Project Manager shared insights into the EDiHTA project and its mission to revolutionise the way digital health solutions are evaluated and offered to patients.

“We want to involve the stakeholders of the European health ecosystem in our project: building something from the ecosystem, for the ecosystem,” Tsiasiotis said. This approach highlights the project’s focus on collaboration and inclusivity, as it aims to benefit all parties involved in the healthcare industry.

So, what exactly is EDiHTA and what is its strategy for harmonising health technology assessment across Europe? Watch the full interview with Emmanouil Tsiasiotis below and find out!

We are pleased to invite you to participate in a two-round Delphi survey aimed at developing a common definition and taxonomy for Digital Health Technologies (DHTs). This survey is part of the broader effort by the European Digital Health Technology Assessment (EDiHTA) consortium to establish a framework for the assessment of DHTs. Health Technology Assessment International (HTAi) is supporting this initiative.

Over the past weeks, the EDiHTA project has been presented and discussed at prominent conferences across Europe. Members of the EDiHTA project showcased the project’s ambitions and engaged with interested stakeholders at the Healthcare Information and Management Systems Society (HIMSS) conference, the European Health Management Association (EHMA) conference, and the Health Technology Assessment International (HTAi) conference in Rome, IT, Bucharest, RO and Seville, ES, respectively.