Towards an evaluation framework for medical device-integrated electronic medical record

Medical device (MD)-integrated (I) electronic medical record (EMR) (MDI-EMR) poses cyber threats that undermine patient safety, and thus, they require effective control mechanisms. We reviewed the related literature, including existing EMR and MD risk assessment approaches, to identify MDI-EMR comprehensive evaluation dimensions and measures.

We searched multiple databases, including PubMed, Web of Knowledge, Scopus, ACM, Embase, IEEE and Ingenta. We explored various evaluation aspects of MD and EMR to gain a better understanding of their complex integration. We reviewed numerous risk management and assessment frameworks related to MD and EMR security aspects and mitigation controls and then identified their common evaluation aspects. Our review indicated that previous evaluation frameworks assessed MD and EMR independently. To address this gap, we proposed an evaluation framework based on the sociotechnical dimensions of health information systems and risk assessment approaches for MDs to evaluate MDI-EMR integratively.

The emergence of MDI-EMR cyber threats requires appropriate evaluation tools to ensure the safe development and application of MDI-EMR. Consequently, our proposed framework will continue to evolve through subsequent validations and refinements. This process aims to establish its applicability in informing stakeholders of the safety level and assessing its effectiveness in mitigating risks for future improvements.