Learning from practices within safety–critical industries: the use of safety cases in healthcare is a recent phenomenon (Ray and Cleaveland, 2013;
Despotou et al., 2012). Far from being an accepted best practice, the safety case approach is being trialled for small subsets of the healthcare system,
which tend to be close to the traditional engineering tradition. In these areas, learning from best practices in other industries and review of their
respective standards and approaches to safety management, have driven the current developments
Low maturity of safety management practices: it could be argued that safety management practices in healthcare at present are less mature than those in
other safety–critical industries. The introduction of goal-based approaches to regulation including the development of safety cases may have the
potential to contribute to a more structured and rigorous approach to safety management in this industry
Education and training: a significant threat to the successful uptake of the safety case approach is the lack of experience with the concept and the lack of
expertise both within the regulatory bodies as well as among the stakeholders within the domain. Education and training for regulators,
manufacturers, and service providers, as well as research evidence about the efficacy of the approach will be essential prerequisites for spreading the
approach to the wider healthcare sector