Label2Enable Workshop

In 2014 the EU published the Green Paper on mobile health. The document addressed the potential benefits and risks of health apps and questioned how to verify or ensure the efficacy of these apps. Should there be a certification scheme? And how to better inform users on their quality and safety?
Fast forward a few years later, Technical Specification CEN-ISO 82304-2 – health and wellness apps quality and reliability, an assignment from the European Commission, was published. Its main content is a health app quality assessment framework and a health app quality label. The label, inspired by the EU Energy label, Nutri-Score food label design and the FDA over-the-counter medicine label, and tested with people with low health literacy, intends to help citizens choose a health app. The more detailed version of the label, the health app quality report, is intended to help health professionals decide which app to recommend, and HTA bodies which apps to reimburse. The framework was founded in 26 existing frameworks, and—appropriate in a Greek context—a Delphi consensus study with 83 experts from 8 stakeholder groups, aligned with existing standards and tested for the Dutch Ministry of Health with 11 Covid symptom apps.

In this workshop you’ll learn more about the framework, the label, what the European Health Data Space includes on labelling apps, and the Label2Enable project that supports implementation of CEN-ISO/TS 82304-2 throughout Europe. You’ll hear the latest on the development of the certification scheme for CEN-ISO/TS 82304-2 and testing it with 24 intentionally very diverse health apps, including recently a Greek one. The related manufacturer will join the workshop to share their experiences and thoughts. And we’ll explore with both local and international stakeholders what their thoughts are on benefits and risks of health apps and success of labelling in 5 to 10 years and how to get there.

Speakers

• Lefteris Thireos* – Athens Medical Society
• Apostolia Karabatea – Gnomon (App provider)
• Derek Ritz – IHE (beyond EU)
• Nicolas Pallikarakis – INBIT (assessor)
• Petra Hoogendoorn and Zoi Kolitsi – Label2Enable
• Mina Boubaki* – Hellenic Ministry of Health
• Carme Pratdepadua Bufill – TIC Salut (Catalonia) – online
• Dimitris Kontopidis – Greek Patients Association

*To be confirmed