[Developing a recommendation for handling risks through digital transformation in patient care].

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.