Strametz Reinhard, Jahn Dirk, Müller Hardy, Huf Wolfgang
Hochschule RheinMain, Wiesbaden Business School, Wiesbaden, Deutschland; Aktionsbündnis Patientensicherheit APS, Berlin, Deutschland.
Katholische Kliniken, Essen, Deutschland; Aktionsbündnis Patientensicherheit APS, Berlin, Deutschland.
Z Evid Fortbild Qual Gesundhwes. 2019 Jun;143:30-34. doi: 10.1016/j.zefq.2019.03.002. Epub 2019 Apr 3.
Digital transformation in healthcare presents enormous challenges as it partially redefines care processes and interaction between patients and doctors. In order to seize opportunities to improve patient care as well as patient safety by using digital innovations, arising patient safety risks due to these changes have to be considered and addressed. The German Coalition for Patient Safety, the Austrian Network for Patient Safety and the Swiss Foundation for Patient Safety decided to develop a recommendation for members of all professional groups in healthcare to sensitize for arising risks, inform about cause-effect relationships and to empower professionals to perform an individual risk-benefit-assessment for existing and upcoming digital innovations. In May 2017 the German Coalition on Patient Safety implemented its working group Digitization and Patient Safety with its subgroup Digitization and Risk Management. Based on open brainstorming of experts followed by a nominal group technique process the most relevant risks for patient safety arising from digitization were identified and assessed by using a modified scenario analysis. After internal consultation of all members of the German Coalition for Patient Safety and all executive boards of participation associations, the recommendation was published at the annual meeting of the German Coalition for Patient Safety in May 2018. We identified six core risks that were assessed by modified scenario technique: insufficient protection of the IT system from external attacks, insufficient protection of the IT system from unauthorized access, non-availability of IT system or patient data, handing over data to external service providers, unsafe embedding of medical devices in IT systems and insufficient digital literacy of healthcare professionals. In addition, we developed a checklist for the self-assessment of risks arising from implementing digital innovation, using risk criteria according to ONR 49002-2:2014, and provided key questions for decision makers. On the basis of the approach described a multiprofessional and intersectoral recommendation for clinical core risks associated with digitization in healthcare was developed within a 12-month period. The dissemination of this recommendation in German language can be regarded as very successful since the German Coalition for Patient Safety received more than 22,000 requests for paper copies, and 1,200 downloads of this open-access publication have been registered. An English version of this recommendation will soon be available.
医疗保健领域的数字化转型带来了巨大挑战，因为它部分地重新定义了护理流程以及患者与医生之间的互动。为了通过利用数字创新抓住改善患者护理和患者安全的机会，必须考虑并应对因这些变化而产生的患者安全风险。德国患者安全联盟、奥地利患者安全网络和瑞士患者安全基金会决定为医疗保健领域所有专业团体的成员制定一项建议，以提高对出现的风险的敏感度，告知因果关系，并使专业人员能够对现有和即将出现的数字创新进行个人风险效益评估。2017年5月，德国患者安全联盟成立了数字化与患者安全工作组及其子组数字化与风险管理组。在专家开放式头脑风暴之后，通过名义小组技术流程，使用改进的情景分析确定并评估了数字化给患者安全带来的最相关风险。在德国患者安全联盟所有成员和参与协会的所有执行委员会进行内部协商之后，该建议于2018年5月在德国患者安全联盟年会上发布。我们确定了六个核心风险，通过改进的情景技术进行了评估：IT系统防范外部攻击的保护不足、IT系统防范未经授权访问的保护不足、IT系统或患者数据不可用、将数据交给外部服务提供商、医疗设备在IT系统中的不安全嵌入以及医疗保健专业人员的数字素养不足。此外，我们根据ONR 49002-2:2014的风险标准制定了一份用于自我评估实施数字创新所产生风险的清单，并为决策者提供了关键问题。基于所描述的方法，在12个月内制定了一项针对医疗保健领域数字化相关临床核心风险的多专业和跨部门建议。该建议的德语版本传播非常成功，因为德国患者安全联盟收到了超过22000份纸质副本请求，并且该开放获取出版物已有1200次下载记录。该建议的英文版即将推出。
