This will be a seminar and mini practical. In the seminar, I’ll introduce our work on a proposed framework to guide clinical risk assessment of health apps (see abstract below).This will be followed by a mini practical in which you will get the opportunity to test the framework on a health app of your choice and provide feedback. You are welcome to work together with others. It would be helpful if you could identify and/or download a health app onto your smartphone or tablet before the mini practical.
Aim: Globally, health systems are struggling with reliably appraising the safety and efficacy of rapidly changing digital health interventions whilst allowing useful innovations to be rapidly adopted. Assessment and regulation of the large number of health apps should be proportional to their clinical risk, but there is large uncertainty about suitable criteria to assess risk. We aimed to identify criteria for assessing clinical risks associated with different types of health apps.
Methods: Our work builds on previous studies that identified some of the risks that health apps can pose and contextual factors that can mediate these risks. This work is grounded in a review of existing literature; consultation with stakeholders; and participation in multiagency policy discussion. We combined different risk domains for apps (technical safety, usability, intervention quality, and engagement) with their functions (learning, behaviour and cognition change, communication, record keeping, and clinical decision support).
Results: We developed a comprehensive generic risk framework that app users, developers, commissioners, regulators and other stakeholders worldwide can use to guide assessment of the likely risks posed by a specified health app in a specific context. We also propose questions that should help determine whether these risks have been addressed.
Conclusions: Apps are very promising in healthcare but are very numerous, complex, rapidly evolving and with overlapping functions. A rigorous risk framework should help stakeholders to deal with the large quantity of health apps, classify and manage clinical risks, and improve patient safety by applying generic risk assessment criteria. Further work is needed to test and develop the criteria we propose, especially as apps that integrate different functions are emerging, which will make risk assessment more complex.
Bio Michelle van Velthoven * Postdoctoral researcher in digital health, Nuffield Department of Primary Care Health Sciences, University of Oxford * Associate editor, DIGITAL HEALTH (SAGE journal) * Honorary research fellow, Global eHealth Unit, Imperial College London
I am a health services researcher in the digital health group and work with Professor John Powell. My research interests are mobile health, Health Technology Assessment (HTA), primary care, and global health. Currently, I am researching whether and how health apps can be assessed and appraised. Also, I am working on projects that explore online patient ratings and experiences to improve health services and an online intervention to reduce anxiety.
My background is an undergraduate degree in Biomedical Sciences and MSc in HTA and International Health, both from Radboud University Nijmegen in the Netherlands. I received my PhD from Imperial College London in 2014, which explored mHealth-based collection of information relevant to childhood diarrhoea and pneumonia in rural China.