About

On April 4th, 2024 we announced the formal launch of the LabelDigitalHealth, as a sustainable initiative hosted by the Institute of Innovation through Health Data (i~HD), to operationalise European TS82304-2 App standardised quality assessments in Europe. This would be through the establishment of the LabelDigitalHealth European Assessment Network. The delivery structure includes a scheme owner of an ISO 17026 / 2015 Certification scheme, certification bodies, and conformity assessment bodies (CABs), and a governance structure to safeguard trust”.

LabelDigitalHealth is the sustainable transitioning result of the Label2Enable project, a Co-ordination and Support Action funded by the European Commission and co-ordinated by Petra Hoogendoorn (Leiden University Medical Centre, The Netherlands).

i~HD was the lead beneficiary responsible for the development of the health and wellness app quality certification scheme. Conformity assessments and certification are based on the CEN-ISO/TS 82304-2 standard, which provides a common health app quality assessment framework, targeting simultaneously efficient transformation of health and care systems and a digital single market of Apps. The size of this marketwas estimated in 2022 to be about €50 billion and foreseen to escalate to over €800 billion in 2030. 

As part of the LabelDigitalHealth 2024 workplan, a Task Force (TF) has been set up with the remit to transfer the legacy of Label2Enable into sustainable operations. The TF is powered by a core group, supported by a multi-stakeholder constellation, to guide the transposition of project deliverables into operational components of the network and will deliver on its assignment by the end of 2024, rendering LabelDigitalHealth market-ready by January 2025.

Mission and Vision

Building on fertile ground of i-HD’s mission, to strive for a world in which multiple stakeholders collaborate in yhe trustworthy use high-quality data and a to continuously improve care and accelerate research, the LabelDigitalHealth Network will ensure the delivery of trusted, highly valued App quality Labels, through operationalising the implementation of the Pan Europena quality app label roadmap and overseeing the uniform trustworthy assessments across the EU and beyond.

The Network will achieve this through:

  • developing and delivering education about the certification programme, and signposting other educators
  • maintaining an inventory of tools and good practices, in a neutral way
  • liaising with other relevant organisations and establishing formal connections with them as needed to fulfil the objectives of the LabelDigitalHealth organisation
  • running events, promoting the label and the importance of trustworthy digital health solutions

Activities

Setting -up of the LabelDigitalHealth Network

Governance of the Network

Assuring uniformity of app assessments and certifications across the EU and beyond

Maintenance and publication of the LabelDigitalHealth certification scheme

Maintaining scientific oversight of LabelDigitalHealth certification and capacity across Europe, developing periodic recommendations for the next version of the ISO TS 82304-2

Issuing certificates after positive conformity assessments performed by licensed CAB’s

Fostering a community (forum) of CAB’s and CB’s and other stakeholders, to share experiences, support each other and advance label adoption

Running a secretariat to support the operation of its governance

LabelDigitalHealth Network Governance Structure

The Network is governed by:

  • has been set up with the remit to transfer the legacy of Label2Enable into sustainable operations.
  • During this period the TF Chair and the LabelDigitalHealth Ambassador will continue to liaise with European Member State HTA bodies and other relevant agencies to ensure the acceptability to them of LabelDigitalHealth certificates and to receive their feedback on the value of the LabelDigitalHealth organisation, the uptake and benefits of its scheme and any problems or new requirements that should be taken on board
  • is powered by a core group, supported by a multi-stakeholder constellation.
  • is responsible for an efficient, clear and inclusive process for running organising and implementing a demonstration phase of operation of the assessment and certification network, which will culminate into the certification of at least 50 Apps.
  • will provide the needed feedback for optimising operations as well as the evidence to the community of the trustworthiness of LabelDigitalHealth.
  • the TF will deliver its assignment by the end of 2024, rendering LabelDigitalHealth fully operational.

The Governance Board will:

  • assure a transparent, clear and inclusive process for promoting, offering, providing and reporting on the certifications of the Certification Bodies (CBs) and Conformity Assessment Bodies (CABS) across Europe.
  • assure the conformity assessments and the certification activities are compliant with the Certification Scheme.
  • review and adopt the proposed amendments to the Certification Scheme and the Assessors Handbook.
  • liaise with European Member State HTA bodies and other relevant agencies to ensure the acceptability to them of LabelDigitalHealth certificates and to receive their feedback on the value of the LabelDigitalHealth organisation, the uptake and benefits of its scheme and any problems or new requirements that should be taken on board.
  • liaise with other CBs accrediting CABs or issuing LabelDigitalHealth certificates, across Europe and globally, in order to track uptake, the outcomes of assessments including issues needing clarification of, or changes to, the criteria or scheme.
  • monitor the adoption, outcomes and issues regarding CAB assessment, digital health product assessment, recommend improvements to the assessment process, changes to the assessment criteria or scheme, and to compile recommendations for future updates to ISO TS 82304-2.
  • advise on the overall activities of the LabelDigitalHealth organisation, its operations, financial planning, advisory board and multi-stakeholder forum.

The Advisory Board will:

  • discuss topics that are considered relevant to the objectives of the LabelDigitalHealth organisation or to the field of digital health.
  • monitor the digital health landscape including requirements, new standards, digital and technology innovations and threats, adoption success and challenges, published evaluations and evolution in adjacent fields.
  • advice to the LabelDigitalHealth organisation non-exclusively on:
  • maintaining a common vision and alignment of stakeholder roadmaps concerning the accelerated adoption and uptake of the Label
  • LabelDigitalHealth certification and labelling interest and delivery capacity across Europe
  • possible changes to the next version of the ISO TS 82304-2
  • initiatives with which the LabelDigitalHealth organisation could form useful liaisons and collaborations
  • content and delivery forms that may be cocreated as needed and useful that provide education about the label, and rising awareness within the Board of other educators and educational resources
  • the nature and availability of tools and good practices that may serve the development, assessment and adoption of digital health products and services, in a neutral way
  • recommendations for future events that LabelDigitalHealth might run, contribute to or attend
  • strategies and resources to promote the label and the importance of trustworthy digital health solutions


As the ecosystem of health and wellness apps is a continuously changing ecosystem due to technological evolution, adaptation and new legislation and regulations, scientific research, conformity assessment methodologies etc, implicates that, to be able to maintain the Certification Scheme, there is a need for expert’s advice from the different fields.

Therefore, an expert panel will be put in place. The Governance Board will organise an experts consultation round at least once a year. If needed more consultation rounds will be organised on demand.

The following field experts can be consulted (list not limited to):

  • Experts in the quality requirements described in ISO TS 82304-2.
  • Experts in the standards related to quality assessments of medical applications.
  • Experts in the EU legislations and regulations related to the quality assessment of medical applications.
  • Experts in the conformity assessment procedures of medical applications.
  • Experts in the certification procedures of medical applications.
  • Experts of the health technology authorities of the Member States.
  • Experts of the mhealth and wellness apps industry.
  • Experts from Academia.


The governance model used within the LabelDigitalHealth Network subdivision shall be compliant with the Articles of i~HD. 

i~HD