The mental health clinical records has evolved through a long journey and its structure has been stable for decades. Until the scientific basis of mental disorders is understood at an aetiological level, the current format of case notes needs to be replicated in EHRs but the use of free text needs to be curtailed. Better design of EHRs and increased use of standard clinical terms can enhance the ability to code information in the EHRs. This in turn can support adoption of technical solutions that better manage workflows and provide clinical decision support to reduce variation in care and ensure higher quality of care. Professional bodies need to develop guidance for their members and the competencies impacting on use of EHRs need to be part of training curricula and evaluations.

Leaders at high levels in the healthcare hierarchy, such as the CEOs and other top administrators in healthcare systems, have a great degree of decision-making authority and control of resources. They are in a position to drive change within the healthcare systems that they lead. Their effectiveness depends to some extent on implementing management best practices that have been identified in healthcare. There are many such best practices that executives in healthcare can implement more or less directly. There are others that require higher levels of authority, but for which they can actively advocate. Unfortunately, many of the identified strategies are still not widely implemented. Still, there is a growing movement to create and staff the role of a chief wellness officer in healthcare systems. Such a move should help in keeping the focus on systems-level solutions to the burnout crisis, solutions that are more or less directly under the control of leaders in the system. Such solutions will continue to be critically important in the post-pandemic era.

Why are medical errors so common? We identify primary sources of medical error as system factors (both local workplace policies and procedures and broader societal and governmental requirements and technological advancements), teamwork factors, and individual factors. These three levels of influence interact and operate concurrently as healthcare providers are working with their patients. Each is a potential primary source of a medical error, but as in other HROs, error rarely has a single “cause.” Poorly designed systems can make it more difficult for teams to operate effectively and for individual healthcare providers to avoid mistakes. As much as all three levels of influence over safe practice are important, it ultimately comes down to the safe individual, the doctor who is “fit for duty.” They can operate effectively, contribute to team performance (help identify and correct the errors of others), and, as needed, lobby for improved policies and procedures. Again, the pandemic has added significant stress to the healthcare provider, calling for solutions at all three levels, addressing all three potential sources of error.

Burnout is a specific work-related syndrome resulting from chronic workplace stress that has not been successfully managed. Sufferers experience physical and mental exhaustion, cynicism and a sense of depersonalization, and reduced feelings of efficacy; these are the defining facets of burnout. The syndrome shows itself in a variety of dysfunctional emotions, thought processes, and behaviors. The primary culprit is stress. While the “natural” response to a stressor (the fight-or-flight reaction) is adaptive in the short term, prolonged activation of that response can eventually result in burnout. Research over the last several decades has highlighted the risk for physicians and other healthcare providers, and recent studies have shown that the risk has been dramatically enhanced during the coronavirus pandemic. This book will explore the syndrome in detail, the specific risks that healthcare providers incur, and the relation between burnout and medical error. As our ultimate goal is to provide support for those healthcare workers and those affected by their work, we explore a range of critical approaches to reducing burnout (our proposed evidence-based “solutions”).

Are Electronic Health Records Medical Devices? While statute (largely) excludes EHRs from the medical device category, commentators have struggled to offer a justification. They have argued that EHRs inform but do not replace clinical decision-making, do not directly interact with patients, and are constantly being upgraded and modified. But all these characteristics are often true of many medical devices. I argue the key aspect of EHRs that render them foreign to the FDA’s jurisdiction is their systemwide interconnectedness. The patient’s EHR affects others. EHRs must work in a certain way, for the integrity of the whole system. EHR data is used for both clinical and quality management research. Alternatively, the safety of EHRs involves greater systematic, upstream regulation – of third-party networks, data formats, and other issues that present collective action problems. This goes far beyond the mandate of the FDA that fails to consider such issues and lacks jurisdiction over many necessary third parties. I argue that the distinction between EHR functions that have a direct and primary effect on the particular patient versus those such as data format and interoperability that present these third-party and systematic considerations should determine the respective jurisdictions of the FDA and health data subagencies.