Call: Promoting a trusted mHealth label in Europe: uptake of technical specifications for quality and reliability of health and wellness apps

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Programme

Horizon Europe - Cluster 1 - Destination 6: Maintaining an innovative, sustainable and globally competitive health industry

Acronym

HORIZON-HLTH-IND

Type of Fund

Direct Management

Description of programme
"Horizon Europe - Cluster 1 - Destination 6: Maintaining an innovative, sustainable and globally competitive health industry"

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. 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:

Production of pharmaceuticals in compliance with the objectives of the European Green Deal.
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.
Public authorities supported with better methodologies and interdisciplinary approaches to assess and value new health technologies and interventions.
Development of pharmaceutical products meeting unmet medical needs in the context of market failures.

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 (3D/4D printing) 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 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.

Link

Link to Programme

Call

Promoting a trusted mHealth label in Europe: uptake of technical specifications for quality and reliability of health and wellness apps

Description of call
"Promoting a trusted mHealth label in Europe: uptake of technical specifications for quality and reliability of health and wellness apps"

Expected Outcome

This topic aims at 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”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

European suppliers of health technology and services benefit from enhanced single market conditions for mHealth that facilitate economies of scale.
Health care systems and authorities are able to integrate mHealth solutions more rapidly thanks to a European ‘mHealth label’.
Citizens, patients and health care professionals make more use of trusted mHealth solutions for promoting their health and self-managing their health care needs.
European mHealth stakeholders build upon a digital ecosystem around a trusted mHealth label, an EU-wide promotion and uptake of technical specifications for health and wellness apps.
Health systems and citizens benefit from the supply and use of health innovations facilitated by the promotion of common pan-European principles for validation and certification.

Scope:

Europe is experiencing a fast growing market for health and wellness apps. At the same time, concerns about the quality and reliability of apps have risen (for example, many health and wellness apps are being published on app stores without clinical evidence supporting the claimed benefits that they will deliver). CEN, together with CEN/TC 251, ISO and IEC, developed a new technical specification for ‘Quality and Reliability of Health and Wellness Apps’ together with a CEN/ISO 82304-2 health app quality label (capturing medical safety, usability, safety of personal data and technical quality of health apps).

The objective of the technical specification is to define quality and reliability criteria, which support app developers to design and users of apps to select better apps.

The specification is intended for use by manufacturers of health apps as well as by app checkers in order to communicate the quality and reliability of a health app.

Applicants should propose activities that bring together app developers, health care system representatives, a diverse range of users (citizens/patients, health care providers), and certification bodies in order to promote and stimulate the use and up-take of the health app quality label, building a digital ecosystem around a trusted mHealth label to support the integration and use of health and wellness apps in the health care system. Proposals should encourage a people-centred approach that empowers citizens and patients, promotes a culture of dialogue and openness between health professionals, citizens, patients and their families, and unleashes the potential of social innovation.

The proposals are expected to address all of the following:

Set up a structured dialogue on the uptake of the technical specifications between app developers, health care system representatives, app stores, medical societies, patient organisations, users (including health care professionals) and certification bodies, building a digital ecosystem around a trustable mHealth label.
Co-create, develop and implement an action plan on the promotion of the mHealth label in the health care system.
Implement concrete actions on the integration and use of secure and qualitative health and wellness apps, using the new label, in specific health care settings, covering the entire EU.
Ensure that the promoted health and wellness apps are bias-free and adequately address the needs of different social groups, considering gender, age, ability and ethnicity, where relevant.
Support and set-up an inclusive dissemination strategy to promote the use of the mHealth app quality label (cfr. EU energy labels and EU Nutri-Score nutrition label) taking into account the different levels of digital health literacy among the actors involved.
Interests of different age groups, sex and gender, as well as other categories like persons with disability, ethnicity and the LGBTI+ community should be considered, where relevant.

Cross-cutting Priorities:

Link

Link to Call

Thematic Focus

Clustering, Development Cooperation, Economic Cooperation, Research & Innovation, Technology Transfer & Exchange, Health, Social Affairs, Sports, Capacity Building, Cooperation Networks, Institutional Cooperation, Digitisation, ICT, Telecommunication, Equal Rights, Human Rights, People with Disabilities, Social Inclusion, Community Integration, European Citizenship, Shared Services

Funding area

EU Member States
Overseas Countries and Territories (OCTs)
United States of America

Origin of Applicant

EU Member States
Overseas Countries and Territories (OCTs)
United States of America

Eligible applicants

Education and Training Centres, Federal State / Region / City / Municipality / Local Authority, Research Institution, Lobby Group / Professional Association / Trade Union, International Organization, Small and Medium Sized Enterprises, SMEs (between 10 and 249 employees), Microenterprises (fewer than 10 employees), NGO / NPO, Public Services, National Government, Other, Start Up Company, University, Enterprise (more than 250 employees or not defined), Association

Applicant details

eligible non-EU countries:

countries associated to Horizon Europe

At the date of the publication of the work programme, there are no countries associated to Horizon Europe. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement.

low-and middle-income countries

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.

Specific cases:

Affiliated entities - Affiliated entities are eligible for funding if they are established in one of the countries listed above.
EU bodies - Legal entities created under EU law may also be eligible to receive funding, unless their basic act states otherwise.
International organisations - International European research organisations are eligible to receive funding. Unless their participation is considered essential for implementing the action by the granting authority, other international organisations are not eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’actions and when provided for in the specific call conditions.

Project Partner

Yes

Project Partner Details

Unless otherwise provided for in the specific call conditions , legal entities forming a consortium are eligible to participate in actions provided that the consortium includes:

at least one independent legal entity established in a Member State;and
at least two other independent legal entities, each established in different Member States or Associated Countries.

Further info

Proposal page limits and layout:

The application form will have two parts:

Part A to be filled in directly online (administrative information, summarised budget, call-specific questions, etc.)
Part B to be downloaded from the Portal submission system, completed and re-uploaded as a PDF in the system

Page limit - Part B: 30 pages

Type of Funding

Grants

Financial details

Expected EU contribution per project	The Commission estimates that an EU contribution of around EUR 2.00 million would allow these outcomes to be addressed appropriately. Nonetheless, this does not preclude submission and selection of a proposal requesting different amounts.
Indicative budget	The total indicative budget for the topic is EUR 2.00 million.
Typ of Action	Coordination and Support Actions (CSA)
Funding rate	100%

Submission

Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOTpossible.