Ensuring clinical safety: safety by design
Published: Wed 20 Jan 2021
We continued the conversation with Dr Matthew Fenech and Stuart Harrison about clinical safety. On this week’s episode, we looked at the meaning of ‘Safety by design’, mitigating design challenges, how manufactures can demonstrate safety in innovations and more.
This week, we asked our guests:
- Engineers are familiar with the phrase, ‘Safety by design’. What meaning does that have in terms of healthcare technologies?
- What are the different ways you might use design safety versus impaired safety that might arise due to a manufacturing defect?
- What kind of evidence can manufacturers be producing to demonstrate the effective safety of innovations in this area that can mitigate some of the design challenges?
- How can a digital health intervention, in practice, lead to harm in a clinical sense?
Useful resources
- Machine learning AI in medical devices
- A Method of Justifying Confidence in the Safety of Digital Health Interventions
- World Economic Forum Chatbots RESET project
- ITU/WHO AI for Health Focus Group
- AIDE project: joint Oxford-Osaka University project aimed at designing a platform for meaningful stakeholder engagement in AI development for health
- The Topol Review
- Centre for Health Informatics at Macquarie University
Meet our guests
Dr Matthew Fenech
Matt, MD, Ph.D. is Medical Safety Lead at Ada Health, a global digital health company making personalised health accessible for all. His main interest is in developing frameworks that ensure healthtech tools are safe, effective, and acceptable to patients and healthcare providers alike. Following 10 years of experience at the sharp end of clinical academia, he worked in technology policy, where he was the lead author of a seminal Wellcome Trust report on ‘Ethical, Social, and Political Challenges of AI in Health’, wrote a chapter for the Chief Medical Officer’s Annual Report on 'Health 2040 - better health within reach', and led the design of an NHSX-supported toolkit to accompany the Code of Conduct for data-driven technologies in health. He has also authored a number of peer-reviewed publications on the ethical and safety considerations of the application of AI in healthcare, as well as reports about the risks and opportunities of emerging technologies in low-/middle-income countries.
Stuart Harrison
Stuart Harrison has led the Clinical Safety movement in the NHS alongside some of the most prominent clinical leaders for over 15 years. Stuart has refined NHS Clinical Safety & Risk Management Systems, re-authored NHS safety standards using plain English campaigns, and worked at the highest level to ensure core safety engineering principles are embedded in the NHS code of practice. These will be the foundational principles in which health informatics will be led throughout the next ten years or more. Stuart is now the co-founder & director of a company providing ethical services to the health industry. ETHOS Ltd was formed in 2014 as a result of a feasibility study completed in partnership with a large Pharmaceutical company in the interests of furthering medical science/ MedTech innovation.
