On 19 November 2014, the Academy of the Medical Sciences and the Royal Academy of Engineering hosted a FORUM meeting on ‘Health apps: regulation and quality control’.Status: Ongoing
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Health apps: regulation and quality control
The recent and ongoing expansion of the software landscape, particularly health applications (also known as ‘apps’), presents 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.
On 19 November 2014, the Academy of the Medical Sciences and the Royal Academy of Engineering hosted a FORUM meeting on ‘Health apps: regulation and quality control’, which brought together stakeholders from across the health app landscape – including regulators, clinicians, app developers and engineers – to:
- Explore the current and proposed regulatory frameworks for health apps.
- Hear case studies of the development of health apps and of the regulation and oversight of software development in other medical, nuclear and automotive sectors.
- Discuss the current and future challenges faced in the oversight of health apps and devise solutions to these issues.
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.
- 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.