Affixing the app Quality Label – Ready to take the challenge?
Join this training by registering below!
🗓️ Date: 18 September 2024
đź•’ Time: 15:00 – 16:30 CET
What is this session about?
In the face of today’s healthcare challenges, the pressing need for high quality innovative solutions to bolster health and care delivery has never been clearer. Despite the proliferation of health and wellness Apps, discerning which apps are safe and trustworthy for supporting healthcare remains a major hurdle to adopting and benefiting from these technologies. The session will focus on preparing manufacturers of health and wellness Apps to take the challenge of EU quality labelling of their innovations.
What will you learn?
For the first time, an international Quality App assessment network is gearing up to undertake at scale assessments and labeling, based on the European TS 82304-2 App quality standard and its trust framework as of late 2024. This new initiative addresses the crucial need for standardising criteria and assessments in evaluating digital health and wellness Apps in the EU, fostering adoption by national authorities and fast tracking of labelled Apps, contributing to a harmonised market for healthcare innovation in Europe.Â
The session will focus on creating awareness of the European App Quality Label – the ISO standard, the trust framework and the opportunity to obtain a quality label. It will then discuss the benefits and requirements for manufacturers.
Who’s this session for?
Digital health industry and innovators, especially Health and Wellness app developers.
What will you receive?
- Presentation slides and additional materials. See also relevant DHU publications:
- Leveraging Reimbursement models for the Uptake of Digital Health Solutions
- The certification of Health Apps
Agenda:
- Introduction to the event, Zoi Kolitsi
- What’s in it for manufacturers?
- About ISO/CEN 82304-2
- Why a health app quality specification?
- How does the TS compare to national assessment schemes?
- A pan European Assessment framework
- LabelDigitalHealth EU Assessment Network,
- Building Trust in the process
- Embarking an assessment process for manufacturers,
- Discussion
Meet your Trainer(s):
Zoi Kolitsi, Digital Digital Health and Policy Lead at the EuropeanInstitute of Innovation through Health Data (I~HD)
Zoi Kolitsi, PhD Med. Phys., leads digital health policy and strategy work at the the European Institute for Innovation through Health Data (i~HD). Digital Health governance, health data interoperability and secondary use, business modeling in the FAIR data economy and multistakeholder consultation, including on the EHDS, are the main focus of her work. She is currently coordinating activities to launch the App Quality Labeling assessment network based on the CEN-ISO TS 82304-2 and the Trust framework,. Delivered by the Label2Enable Action.
Â
Petra Hoogendoorn
Lead expert of CEN-ISO/TS 82304-2 (health and wellness apps – quality and reliability), coordinator of the Horizon Europe Label2Enable project, change manager and initiator of two health apps in oncology
Â
Christophe Maes, Business developer I~HD
Certified international auditor and Certification Scheme manager. Christophe has been working in hospital management boards as a project – quality & safety – and innovations manager for over 20 years. He can rely on 11 years of experience (2005-2016) as an external auditor for NIAZ, a hospital accreditation institute. Moreover, as a self-employed consultant he advised tens of hospitals in receiving their NIAZ Accreditation quality label.
Â
Tim Andrews, Co-Founding President and CCO at ORCHAÂ
Originally a Lawyer specializing in Digital Health Technologies, Tim has overall responsibility for the ORCHA Review methodologies and processes and has led the continuous iteration of the review since its initial inception. He has also supported the development of a wide range of digital health assurance approaches and assessment frameworks globally, advising national and pan national bodies regulators and health systems on this key area.