Mason-Blakley Fieran, Weber Jens
University of Victoria.
Stud Health Technol Inform. 2013;183:214-9.
Jurisdictions in Canada, the US, the EU and Australia are struggling with regulation of ever evolving software in medicine. Recently this discussion has had a focus on electronic medical records (EMRs). There is a mountain of evidence that EMRs have actualized potential to lead to the injury of patients through the information they offer to facilitate care. We are undertaking a systematic review of relevant literature in the field to uncover some of the latent hazards. We hypothesize that this exploration, using a variation on Leveson's system theoretic accidents models and processes (STAMP) model as a classification tool, will provide two benefits. First, the model will be sufficient to capture the complexity of the domain and its hazards, thus providing a holistic perspective on the problem. Second, the classification process will provide insight as to what steps might be taken to mitigate the risk that medical errors associated with these software tools will arise in health care systems which employ them. In this continuation of our study we still have not been able to produce evidence which contradicts either hypothesis.
加拿大、美国、欧盟和澳大利亚的司法管辖区都在努力应对对医学领域不断发展的软件的监管问题。最近，这场讨论聚焦于电子病历（EMR）。有大量证据表明，电子病历通过提供有助于医疗护理的信息，已具备导致患者受伤的可能性。我们正在对该领域的相关文献进行系统综述，以发现一些潜在危害。我们假设，采用对莱维森系统理论事故模型与过程（STAMP）模型进行变体作为分类工具的这种探索，将带来两个好处。首先，该模型将足以捕捉该领域的复杂性及其危害，从而提供对该问题的整体视角。其次，分类过程将为如何采取措施降低在使用这些软件工具的医疗保健系统中出现与这些软件工具相关的医疗差错风险提供见解。在我们研究的这个后续阶段，我们仍然未能找到与任何一个假设相矛盾的证据。
