VALIDATE: saving lives
by harnessing AI for decision-making

A four-year research project funded by the European Commission and with IBM iX as a partner.

More than a million EU citizens suffer a stroke each year. It is vitally important that they get the right treatment for their individual needs as quickly as possible. IBM iX is working with partners to conduct research on an AI-based solution designed to help doctors achieve this.

The aim of the four-year project funded under the European Commission’s Horizon Europe programme is to develop trustworthy AI-based software for use in everyday clinical settings. The tool is intended to help doctors to select the treatment method with the best possible recovery outcome for stroke victims. The software is being evaluated in a prospective study and the findings will be used to derive guidelines and processes for how such decision support systems could be developed and integrated into the healthcare system.

The VALIDATE project: strong partners with expertise in many disciplines

Ten partners from Europe and Israel are collaborating on the VALIDATE project. These include enterprises with expertise in the development of medical machine learning models, research institutions with a focus on trustworthy AI development, patient organisations, university hospitals with outpatient stroke clinics and IBM iX as an expert in the design and development of user-centric software. Each of the partners is focusing on one of the project objectives, based on their specific specialist background.

In addition to IBM iX, the VALIDATE consortium also consists of Charité Universitätsmedizin Berlin, empirica, TU Dublin, simulamet, Heidelberg Universitätsklinik, Hadassah University Medical Center, Vall d’Hebron, SAFE and Nora.

Project objectives

Creation of a trustworthy clinical AI framework

Transfer of an existing AI forecasting model from TRL 3 to validation at TRL 6

Developing a demonstrator app with the best possible UX for use in everyday clinical practice

Clinical validation of the demonstrator app in a multicentre prospective study

Development of an approval roadmap for the validated prognostic tool, considering the applicable regulations

Provision of a patient communication and integration framework

Derivation of standard operating procedures (SOPs) for integrating AI into healthcare

Evaluation of the cost-effectiveness of the solution developed

The VALIDATE app: AI-assisted treatment forecasting for better and faster decision-making

Milestone 1: demonstrator app for the clinical study

The demonstrator app created by IBM iX was ready in late 2023, a year and a half after the project was launched. It had been specifically optimised for use in the study and to support the treatment of acute stroke. During the design and development of the app, the IBM iX team combined the IBM Garage methodology with the requirements concerning medical software engineering and the ethics framework defined for the project. Doctors will be able to utilise the iOS app in the treatment process itself and access it 24/7 on their smartphones. Apart from having all of the different treatment data available to them in one place, they will be able to use this for AI-assisted analysis of the success of various treatment options. To help with decision-making, the app will provide a prognosis of the patient’s expected state of health after three months.

Special experience design challenges

The design process was particularly challenging: Within the context of time-critical treatment decisions, the developers had to integrate a machine learning model, offer speed and ease of use, and display results in a way that would ensure they could be quickly understood while still conveying enough information. Ultimately, the doctors will choose which approach to take – but they need fast, valid and trustworthy insights to make such decisions.

The prognosis provided by the app will be reviewed during the clinical prospective study, along with the degree to which the usability and trustworthiness requirements have been satisfied.

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“Our interdisciplinary team navigated diverse and sometimes challenging requirements with professionalism, resulting in a sophisticated app with a user-friendly UI design. This collaborative effort not only meets high medical standards but also fosters lasting partnerships in advancing healthcare through AI innovation.”
Dr. Susanne Bonekamp
Study Coordinator | Neuroradiology at Heidelberg University Hospital

Collaborative development

The app was provided to the hospitals taking part in the prospective study at the consortium’s meeting in Oslo on 18 and 19 January 2024, marking the starting point of the next phase in the project. IBM iX will closely support the clinical study and use the findings and requirements from everyday clinical settings to prepare the next iteration of development.

Among other activities, panel discussions with patient representatives will be organised and conducted with the consortium. In addition, the ethical requirements defined throughout the project to date will be structured and converted into development guidelines and software needs.

Ten partners from Europe and Israel are collaborating on the VALIDATE project.

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