Label2Enable

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 Coordination and Support Action funded by the European Commission and coordinated 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 market was 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.