Harrison Stuart, Despotou George, Arvanitis Theodoros N
Institute of Digital Healthcare, WMG, University of Warwick, UK.
Stud Health Technol Inform. 2020 Jun 26;272:179-182. doi: 10.3233/SHTI200523.
Digital health interventions (DHIs) enable improvements in health strategy and address health system challenges. The World Health Organization provides a formal classification for DHIs. However, safety claims, about such interventions, vary in quality and are often vague as to how they are communicated between technical, clinical experts and stakeholders. By combining the classifications with a method of safety analysis and justification, we postulate confidence in the safety of digital technology. Confidence is resulting from the application of the framework to the DHI, using defined health system challenges. The framework and derived safety justifications can be applied to any DHI. It can serve as guideline for health strategy, regulatory and standards based compliance.
数字健康干预措施（DHIs）有助于改善健康战略并应对卫生系统挑战。世界卫生组织对数字健康干预措施进行了正式分类。然而，关于此类干预措施的安全声明质量参差不齐，而且在技术专家、临床专家和利益相关者之间的沟通方式往往含糊不清。通过将分类与安全分析和论证方法相结合，我们假定对数字技术的安全性有信心。信心源于将该框架应用于数字健康干预措施，并利用已确定的卫生系统挑战。该框架和由此得出的安全论证可应用于任何数字健康干预措施。它可以作为健康战略、监管和基于标准的合规性的指导方针。
