d4 have published a new guidance document today on the regulation of health apps (press release). The document is available for download for free from our website.
Download the guide for free:
Regulation of health apps: a practical guide
The primary purpose of this guide is to highlight the challenges that surround the provision and use of health apps from a regulatory standpoint, whether as a patient, health care professional, application developer, healthcare organisation, pharmaceutical or medical devices company.
As an independent, non-profit organisation, d4 are neither resourced nor qualified to give opinions on legal matters, but we hope that this guide will serve as a useful reference to direct further research and advice. We also hope that this document will provoke further debate on this topic from interested parties in the UK and across the world.
There are three key questions we wanted to address in this guide:
- How are health apps regulated, and how do I know if they are safe to use?
- What other issues should I consider if I’m developing a health app?
- How can I support the use of health apps across my organisation?
We believe this document will be useful for a variety of different audiences
- Health professionals and executives
- Organisations representing the interests of health professionals and patients
- Policy makers and regulators
- Healthcare employers, managers and governors
- Manufacturer and distributors of pharmaceutical products
- Medical device companies
- Mobile device manufacturers
- Mobile network operators
- Software developers
- Patients and the general public as a whole