Development and harmonisation of methodologies for assessing digital health technologies in Europe
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2023-IND-06-07
- Programme
- A competitive health-related industry (Single stage - 2023)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- January 12, 2023
- Deadline
- April 13, 2023
- Deadline Model
- single-stage
- Budget
- €8,000,000
- Min Grant Amount
- €3,000,000
- Max Grant Amount
- €5,000,000
- Expected Number of Grants
- 2
- Keywords
- HORIZON-HLTH-2023-IND-06-07HORIZON-HLTH-2023-IND-06Health policy and servicesHealth technology assessmentHealthcare system
Description
This 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[1]’, 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[2].
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.
The proposals should address all of the following activities:
- Develop and/or expand a general methodological framework and standardised approaches to assess digital health technologies with a particular focus on criteria such as privacy, cybersecurity, data quality, data storage and handling, interoperability etc.;
- Comply with the relevant requirements proposed in the European Health Data Space (EHDS) legal provisions;
- Test the robustness of the developed methodologies on minimum 3 different digital health technology use cases;
- Pilot the development of common specifications to the harmonisation of assessment frameworks (pre-market and post-market phases) throughout the EU and Associated Countries;
- Include end-users of digital health technologies (be it professionals, care users or citizens), developers of digital health technologies, producers of health services, regulators and governments;
- Collect best practice for common approaches in methodology for digital health technology assessment and develop an open access European repository for evaluation methods, studies, results and evidence of digital health technologies and services;
- Contribute to a framework to evaluate and monitor whether the uptake and use of digital health services contribute to the overall goals of the health and care system;
Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
[1] ASSESSING THE IMPACT OF DIGITAL TRANSFORMATION OF HEALTH SERVICES, Report of the Expert Panel on effective ways of investing in Health (EXPH) - https://ec.europa.eu/health/system/files/2019-11/022_digitaltransformation_en_0.pdf
Destination & Scope
Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘A competitive and secure data-economy’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘EU health industry is innovative, sustainable and globally competitive thanks to improved up-take of breakthrough technologies and innovations, which makes the EU with its Member States more resilient and less dependent from imports with regard to the access to and supply of critical health technologies’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘Industrial leadership in key and emerging technologies that work for people’, ‘High quality digital services for all’, and ‘Good health and high-quality accessible health care’.
The health industry is a key driver for growth and has the capacity to provide health technologies to the benefit of patients and providers of health care services. The relevant value chains involve a broad variety of key players from supply, demand and regulatory sides. In addition, the path of innovation in health is long and complex. The development of novel health technologies is generally associated with uncertainties and market barriers due to expensive and risky development (e.g. high attrition rate in pharmaceutical development), high quality and security requirements (e.g. clinical performance, safety, data privacy and cybersecurity) and market specificities (e.g. strong regulation, pricing and reimbursement issues). In addition, the growing concern about environmental issues is putting more pressure on this industry. Therefore, there is a need for research and innovation integrating various stakeholders to facilitate market access of innovative health technologies (medical technologies, pharmaceuticals, biotechnologies, digital health technologies).
In order to address these challenges, in particular green and digital transitions and proper supply of health technologies and products, destination 6 will focus on research and innovation activities that aim at:
- Facilitating the production of pharmaceuticals in compliance with the objectives of the European Green Deal.
- Developing methodologies, guidelines and standards, assessment studies, and structuring activities adapted to digital solutions and interventions for GDPR compliant translation into health care practice, including inter-operability, cyber-security and data confidentiality.
- Supporting public authorities with better methodologies and interdisciplinary approaches to assess and value new health technologies and interventions.
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on industrial research and innovation infrastructures (pilot plants, testing and simulation facilities, open innovation hubs); additive manufacturing and other production technologies (incl. bio manufacturing); safe, smart and sustainable materials.
Expected Impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to maintaining an innovative, sustainable and globally competitive health industry, and more specifically to one or several of the following expected impacts:
- Health industry in the EU is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and digital technologies, contributing to job creation and economic growth, in particular with small- and medium-sized enterprises (SMEs).
- Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, health care providers, health authorities and regulators ensuring suitability and acceptance of solutions.
- European standards, including for operations involving health data, ensure patient safety and quality of healthcare services as well as effectiveness and interoperability of health innovation and productivity of innovators.
- Citizens, health care providers and health systems benefit from a swift uptake of innovative health technologies and services offering significant improvements in health outcomes, while health industry in the EU benefits from decreased time-to-market.
- Health security in the EU benefits from reliable access to key manufacturing capacity, including timely provision of essential medical supplies of particularly complex or critical supply and distribution chains, such as regards vaccines or medical radioisotopes.
Eligibility & Conditions
General conditions
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE RIA, IA) - call-specific application form is available in the Submission System
Standard evaluation form (HE RIA, IA)
HE General MGA v1.0
Information on clinical studies (HE)
Additional documents:
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Programme Guide
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
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The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
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Latest Updates
Call HORIZON-HLTH-2023-IND-06
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 17
Number of inadmissible proposals: 0
Number of ineligible proposals: 1
Number of above-threshold proposals: 8
Total budget requested for above-threshold proposals: EUR 50,650,760.
Call HORIZON-HLTH-2023-IND-06
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 17
Number of inadmissible proposals: 0
Number of ineligible proposals: 1
Number of above-threshold proposals: 8
Total budget requested for above-threshold proposals: EUR 50,650,760.
Call HORIZON-HLTH-2023-IND-06 closed on 13 April 2023. 17 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2023-IND-06-01: 1 proposals
- HORIZON-HLTH-2023-IND-06-02: 3 proposals
- HORIZON-HLTH-2023-IND-06-04: 3 proposals
- HORIZON-HLTH-2023-IND-06-05: 2 proposals
- HORIZON-HLTH-2023-IND-06-07: 8 proposals
Evaluation results are expected to be communicated on Friday 04 August 2023 at the earliest.