‘Health apps: regulation and quality control’ report published

On 19 November 2014, the Academy of the Medical Sciences, jointly with the Royal Academy of Engineering, hosted a meeting on ‘Health apps: regulation and quality control’.

Recent years have seen an explosion in the number of health applications (also known as ‘apps’) for smartphones and tablets, which aim to support both consumer health and healthcare providers’ professional activities. Used appropriately, apps have the potential to increase the quality and efficiency of healthcare, empower consumers to manage their health better, and deliver economic benefits to the UK (in terms of employment opportunities, trade, increased productivity and reduced healthcare costs).

However, health apps present a new challenge to regulatory authorities, and questions have been raised about the appropriate levels of regulation and oversight, and whether current regulatory frameworks are fit for purpose.

This joint meeting brought together stakeholders from across the health app landscape, including regulators, clinicians, app developers and engineers, to discuss the evolving regulatory landscape and how it might be shaped in the future. It featured introductory presentations to the current regulatory regimes and oversight mechanisms, case studies of apps that have successfully navigated regulatory pathways in the UK and the US, and examined whether lessons could be learnt from regulatory regimes and approaches to software development in engineering, such as the automotive and nuclear industries.

During the workshop, participants highlighted areas for future consideration, including: the complexity of current regulation and the suitability of the current legal framework; vigilance and monitoring; obstacles to, and promotion of, app use; generation and evaluation of evidence for clinical utility; the potential role of aggregation services; and software development practices.

The report of the meeting, as well as the speakers’ presentations, is available to download on the right-hand side of this page. 


This meeting was part of the Academy of Medical Sciences’ programme of FORUM events. Our FORUM was established in 2003 to recognise the role of industry in medical research, and to catalyse connections across industry and academia. Since then, a range of FORUM activities and events have brought together researchers, research funders and research users from across academia, industry, government, and the charity, healthcare and regulatory sectors. For more information about FORUM and future events, please visit the FORUM homepage or contact FORUM coordinator Dr Claire Cope (claire.cope@acmedsci.ac.uk).

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