Open Call HORIZON-HLTH-2023-IND-06-07: Development and Harmonisation of Methodologies for Assessing Digital Health Technologies in Europe

European CommissionThis topic aims at addressing digital transition challenges through supporting activities that are enabling or contributing to one or several expected impacts of destination 6 "Maintaining an innovative, sustainable and globally competitive health industry". More specifically, this topic aims at supporting activities that are contributing to the following impact area: "High quality digital services for all". To that end, proposals under this topic should aim to deliver results that are directed towards and contributing to all of the following expected outcomes:
  • Policymakers in the EU have at their disposal a methodological framework and standardised approaches for assessing digital health technologies, that helps them make evidence-based decisions regarding the introduction of digital health technologies in their health and care systems with added value for patients and society.
  • Regulators have access to robust, scientifically underpinned evaluation methodologies.
  • EU citizens gain faster access to safe and well-performing person-centred digital technologies and are empowered through these tools.
  • Health technology developers are better informed and dispose of more guidance on the evidence needed to demonstrate the added value of digital health technologies and have better insights on market predictability.
  • (Digital) Health Industry/digital health technology developers and HTA bodies can contribute to the development of EU harmonised Health Technology Assessment (HTA) rules based on common principles.
  • Improved cross-border use and interoperability of digital health tools and services throughout the EU and Associated Countries.
  • Increased trust in digital health technologies and better integration of digital health tools and services in health and care systems.

Digital health technologies have been driving a revolution in health and care ranging from general use of computers to algorithms designed to assist radiologists and radiotherapists in detecting and treating diseases, from robotic surgery to artificial intelligence, machine learning, computer aided decision models, and from mobile apps helping patients to self-manage their disease to electronic health records.

Digital health technologies are expected to further contribute to better people-centred health and care systems and have the vast potential to improve our ability to accurately prevent, diagnose and treat diseases.

However, assessing the added value and health benefits for patients and society pose a number of challenges in particular of methodological and technical nature. Best practice for common approaches in methodology for digital health are lacking, especially in the digital health tools that include artificial intelligence algorithms. A framework for the assessment of the digital transformation of health services and its impact is vital to generate the evidence required for decision-making on stimulating, using and/or funding digital health strategies at various levels in the health and care systems.

The Expert Panel on effective ways of investing in Health (EXPH) recommended in its report 'Assessing the impact of digital transformation of health services', further investment in the development of assessment methodologies and in a European repository for evaluation methods and evidence of digital health services.

To date, such assessment frameworks are relatively scarce, especially those addressing the transformative aspects of healthcare delivery on the organisational and operational level.

The proposals are expected to develop and harmonise methodologies for assessing digital health technologies (including mhealth apps and telehealth, as well as Artificial Intelligence powered health technologies) in order to facilitate assessment of their added value at individual, health system and society levels and facilitate the cross-border deployment of digital health services within the EU. Existing Health Technology Assessment (HTA) methodology is well developed for health technologies such as medicinal products, but also for some categories of medical devices; however digitalisation raises new methodological challenges to the standardisation of assessment criteria such as privacy, cybersecurity, data storage and handling, interoperability, usability etc. Also including aspects like learning curves, iterative development of innovations, variability between settings, determining optimal timing of evaluations in the development process (maturity) are not yet solved.

Proposals are expected to build on existing frameworks such as (but not restricted to) 'Model for Assessment of Telemedicine' (MAST framework - Kidholm et al., 2012) and the results of previous EU-funded projects in particular (but not restricted to) COMED, project that already identified HTA challenges of telehealth and mhealth, and mHealth hub.

Proposals should consider involving the JRC to take advantage of its expertise on assessment frameworks of innovative health technologies and its activities at the interface between research and regulatory aspects and/or in translating assessment results into best practice recommendations anchored in EU policies. In that respect, the JRC is open to collaborate with any successful proposal after its approval.

Opening date: 12 January 2023

Deadline: 13 April 2023 17:00:00 Brussels time

Deadline Model: single-stage

Type of action: HORIZON-RIA HORIZON Research and Innovation Actions

For topic conditions, documents and submission service, please visit:
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2023-ind-06-07

Most Popular Now

AI Catches One-Third of Interval Breast …

An AI algorithm for breast cancer screening has potential to enhance the performance of digital breast tomosynthesis (DBT), reducing interval cancers by up to one-third, according to a study published...

Researchers Create 'Virtual Scienti…

There may be a new artificial intelligence-driven tool to turbocharge scientific discovery: virtual labs. Modeled after a well-established Stanford School of Medicine research group, the virtual lab is complete with an...

AI also Assesses Dutch Mammograms Better…

AI is detecting tumors more often and earlier in the Dutch breast cancer screening program. Those tumors can then be treated at an earlier stage. This has been demonstrated by...

RSNA AI Challenge Models can Independent…

Algorithms submitted for an AI Challenge hosted by the Radiological Society of North America (RSNA) have shown excellent performance for detecting breast cancers on mammography images, increasing screening sensitivity while...

AI could Help Emergency Rooms Predict Ad…

Artificial intelligence (AI) can help emergency department (ED) teams better anticipate which patients will need hospital admission, hours earlier than is currently possible, according to a multi-hospital study by the...

Head-to-Head Against AI, Pharmacy Studen…

Students pursuing a Doctor of Pharmacy degree routinely take - and pass - rigorous exams to prove competency in several areas. Can ChatGPT accurately answer the same questions? A new...

NHS Active 10 Walking Tracker Users are …

Users of the NHS Active 10 app, designed to encourage people to become more active, immediately increased their amount of brisk and non-brisk walking upon using the app, according to...

New AI Tool Illuminates "Dark Side…

Proteins sustain life as we know it, serving many important structural and functional roles throughout the body. But these large molecules have cast a long shadow over a smaller subclass...

The Human Touch of Doctors will Still be…

AI-based medicine will revolutionise care including for Alzheimer’s and diabetes, predicts a technology expert, but it must be accessible to all patients. Healing with Artificial Intelligence, written by technology expert Daniele...

Deep Learning-Based Model Enables Fast a…

Stroke is the second leading cause of death globally. Ischemic stroke, strongly linked to atherosclerotic plaques, requires accurate plaque and vessel wall segmentation and quantification for definitive diagnosis. However, conventional...

Brain Imaging may Identify Patients Like…

By understanding differences in how people’s brains are wired, clinicians may be able to predict who would benefit from a self-guided anxiety care app, according to a new analysis from...

Stepping for Digital Rewards

Walking is well known to have significant health benefits, but few people achieve the daily recommended steps. Fortunately, mobile health (mHealth) applications have emerged as promising tools to promote physical...