Digital Health Software Safety and Risk Management Unit 5: Safety Engineering and Risk Management- Compliance
In this unit we are going to learn about compliance with the various standards and requirements for health software.
The objective of this unit will be to provide you the context and industry in which health software is regulated and the definitions of the various terms used. This will enable you to navigate the information available to those people who wish to operate to higher quality standards and perform due diligence with digital health innovations.
We will provide a different perspective from each of the main domains or areas of compliance, and how these relate to clinical safety in general.
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Stuart Harrison has led the Clinical Safety movement in the NHS alongside some of the most prominent Clinical leaders for over 15 years. He 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 codes of practise.
Stuart's background is engineering, particularly safety critical industries where safety has immediate risk to harm to system users or the wider general population. He was one of the original authors, reviewers and implementers of the clinical safety standards over ten years ago. Stuart led the review into the implementation and effectiveness of clinical risk management and its relationship with design and assurance across the organisation and wider NHS. Having rewritten both standards as part of an independent consultation, and restructuring their methods provides a more agile model and easier uptake for users – therefore safer systems in healthcare.
• We will also look at the basic foundational elements of health software and how we can view the vast landscape of information in a uniformed manner and make sense of the large volumes of information available.
• Understand a more up to date view of digital health from an international industry view and the converging themes and foundational elements of health software.