We have pulled together a library of useful resources on Mobile Health Apps, including information and guidance on App development and regulation.
Is your App a medical device? It’s healthy to know: regulator issues updated guidance
An updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe.
Code of Conduct on privacy for mHealth apps
A draft Code of Conduct has been released and is expected to raise awareness of the data protection rules in relation to mHealth apps, facilitate and increase compliance at the EU level for app developers.
European Commission Enterprise and Industry Directorate General: Guidelines on Medical Devices
Guidelines of application of EU-Directives on Medical Devices and their clinical evaluation.
NHS Choices Health Apps Library
Digital Health and Care Alliance Medical Medical App-Processes
DHACA and North West Coast AHSN’s guidance to help with the commissioning, developing & acquisition by patients of medical apps.
Health and wellness apps – Quality Criteria across the life cycle – Code of practice
Developed by British Standard Institution and sponsored by Innovate UK, this document contains a set of principles for health and wellness app developers that should be followed throughout an app project life cycle. This PAS is developed for use in the United Kingdom.
Using apps in clinical practice. Important things that you need to know about apps and CE
A set of guidelines developed by the Royal College of Physicians of London, advising how doctors should use medical apps
Accelerated Access –Innovative Medicines and Medical Technologies Review
This report presents the work undertaken in Workstream 1 of the Accelerated Access – Innovative Medicines and Medical Technologies Review during March 2015.
Technology Enabled Care Services (TECS) for Commissioners
This toolkit is the first component of a suite of resources being developed on implementation, procurement, measurement and improvement.
What makes a good clinical app? Introducing the RCP Health Informatics Unit checklist
The Royal College of Physicians’ Health Informatics Unit has developed and piloted an 18-item checklist to help clinicians assess the structure, functions and impact of medical apps.
MHRA Guidance on medical device stand-alone software (including apps)
This guidance explains how software applications (apps) for both healthcare and social care needs are regulated and includes examples of what can be considered a medical device
The Regulation of Medical Mobile Apps
This joint report, commissioned by University of Bristol and West of England AHSN, clarifies the regulatory processes and procedures that are relevant to the mobile apps with medical applications in the European Union and the United States of America.
Digital Health and Care Alliance (DHACA)
An independent membership-led body of statutory and private service providers, manufacturers, software developers, consumer representative bodies, regulatory bodies, trade bodies and others in the UK who want to create an opportunity to develop large-scale, collaborative business models.
Green Paper on mobile health (mHealth)
The objective of this Green Paper announced in the eHealth Action Plan 2012-20203, is to launch a broad stakeholder consultation on existing barriers and issues related to mHealth deployment and help identify the right way forward to unlock mHealth potential.
Oxford Academic Health Science Network report “App Development Roadmap”
This report intends to provide some basic guidance on app development and commercialisation using current approaches