Towards a Regulatory Framework for Electronic Medical Record Interoperability in Canada

All complex systems are potentially predisposed to failure. Healthcare systems are complex systems that are prone to many errors that can result in dire consequences for patients and healthcare providers. The healthcare system in Canada is under unprecedented strain due to shortages of healthcare providers, provider burnout, inefficient workflows, and a lack of appropriate digital infrastructure. We used failure mode and effects analysis (FMEA) to identify the failure modes for care provided in primary care settings. We identified failure modes in appointment scheduling, patient-provider communications, referrals, laboratory and diagnostic procedures, and medication prescriptions as the main failure modes. To mitigate the detected risks, we recommend solutions to 'close the loop' on failure modes to prevent patients from falling through the cracks, as vulnerable patients who cannot advocate for themselves are most likely to do so. We provide preliminary requirements for a regulatory regime for electronic health records that can reduce provider burnout, improve regulatory compliance, and improve system efficiency, all while improving patient safety, experience, and outcomes.