Patient Safety Informatics: Meeting the Challenges of Emerging Digital Health.

The fourth industrial revolution is based on cyber-physical systems and the connectivity of devices. It is currently unclear what the consequences are for patient safety as existing digital health technologies become ubiquitous with increasing pace and interact in unforeseen ways. In this paper, we describe the output from a workshop focused on identifying the patient safety challenges associated with emerging digital health technologies. We discuss six challenges identified in the workshop and present recommendations to address the patient safety concerns posed by them. A key implication of considering the challenges and opportunities for Patient Safety Informatics is the interdisciplinary contribution required to study digital health technologies within their embedded context. The principles underlying our recommendations are those of proactive and systems approaches that relate the social, technical and regulatory facets underpinning patient safety informatics theory and practice.

Process mining for healthcare: Characteristics and challenges.

Process mining techniques can be used to analyse business processes using the data logged during their execution. These techniques are leveraged in a wide range of domains, including healthcare, where it focuses mainly on the analysis of diagnostic, treatment, and organisational processes. Despite the huge amount of data generated in hospitals by staff and machinery involved in healthcare processes, there is no evidence of a systematic uptake of process mining beyond targeted case studies in a research context. When developing and using process mining in healthcare, distinguishing characteristics of healthcare processes such as their variability and patient-centred focus require targeted attention. Against this background, the Process-Oriented Data Science in Healthcare Alliance has been established to propagate the research and application of techniques targeting the data-driven improvement of healthcare processes. This paper, an initiative of the alliance, presents the distinguishing characteristics of the healthcare domain that need to be considered to successfully use process mining, as well as open challenges that need to be addressed by the community in the future.

Process Mining of Disease Trajectories: A Literature Review.

Disease trajectories model patterns of disease over time and can be mined by extracting diagnosis codes from electronic health records (EHR). Process mining provides a mature set of methods and tools that has been used to mine care pathways using event data from EHRs and could be applied to disease trajectories. This paper presents a literature review on process mining related to mining disease trajectories using EHRs. Our review identified 156 papers of potential interest but only four papers which directly applied process mining to disease trajectory modelling. These four papers are presented in detail covering data source, size, selection criteria, selections of the process mining algorithms, trajectory definition strategies, model visualisations, and the methods of evaluation. The literature review lays the foundations for further research leveraging the established benefits of process mining for the emerging data mining of disease trajectories.

Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool.

PURPOSE: Informatics solutions to early diagnosis of cancer in primary care are increasingly prevalent, but it is not clear whether existing and planned standards and regulations sufficiently address patients' safety nor whether these standards are fit for purpose. We use a patient safety perspective to reflect on the development of a computerized cancer risk assessment tool embedded within a UK primary care electronic health record system. METHODS: We developed a computerized version of the CAncer Prevention in ExetER studies risk assessment tool, in compliance with the European Union's Medical Device Regulations. The process of building this tool afforded an opportunity to reflect on clinical concerns and whether current regulations for medical devices are fit for purpose. We identified concerns for patient safety and developed nine practical recommendations to mitigate these concerns. RESULTS: We noted that medical device regulations (1) were initially created for hardware devices rather than software, (2) offer one-shot approval rather than supporting iterative innovation and learning, (3) are biased toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful, and (4) are biased toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system. Our nine recommendations focus on embedding less-reductionist and stronger system perspectives into regulations and standards. CONCLUSION: Our intention is to share our experience to support research-led collaborative development of health informatics solutions in cancer. We argue that regulations in the European Union do not sufficiently address the complexity of healthcare information systems with consequences for patient safety. Future standards and regulations should continue to follow a system-based approach to risk, safety, and accident avoidance.

The assessment of data quality issues for process mining in healthcare using Medical Information Mart for Intensive Care III, a freely available e-health record database.

There is a growing body of literature on process mining in healthcare. Process mining of electronic health record systems could give benefit into better understanding of the actual processes happened in the patient treatment, from the event log of the hospital information system. Researchers report issues of data access approval, anonymisation constraints, and data quality. One solution to progress methodology development is to use a high-quality, freely available research dataset such as Medical Information Mart for Intensive Care III, a critical care database which contains the records of 46,520 intensive care unit patients over 12 years. Our article aims to (1) explore data quality issues for healthcare process mining using Medical Information Mart for Intensive Care III, (2) provide a structured assessment of Medical Information Mart for Intensive Care III data quality and challenge for process mining, and (3) provide a worked example of cancer treatment as a case study of process mining using Medical Information Mart for Intensive Care III to illustrate an approach and solution to data quality challenges. The electronic health record software was upgraded partway through the period over which data was collected and we use this event to explore the link between electronic health record system design and resulting process models.

Process Mining in Primary Care: A Literature Review.

Process mining is the discipline of discovering processes from event logs, checking the conformance of real world events to idealized processes, and ultimately finding ways to improve those processes. It was originally applied to business processes and has recently been applied to healthcare. It can reveal insights into clinical care pathways and inform the redesign of healthcare services. We reviewed the literature on process mining, to investigate the extent to which process mining has been applied to primary care, and to identify specific challenges that may arise in this setting. We identified 143 relevant papers, of which only a small minority (n=7) focused on primary care settings. Reported challenges included data quality (consistency and completeness of routinely collected data); selection of appropriate algorithms and tools; presentation of results; and utilization of results in real-world applications.

Towards Unsupervised Detection of Process Models in Healthcare.

Process mining techniques can play a significant role in understanding healthcare processes by supporting analysis of patient records in electronic health record systems. Healthcare processes are complex and patterns of care may vary considerably within similar cohorts of patients. Process mining often creates "spaghetti" models and require significant domain expert input to refine. Machine learning approaches such as Hidden Markov Models (HMM) may assist this refinement process. HMMs have been advocated for patient pathways clustering purposes; however these models can also be utilized for detecting hidden processes to help event abstraction. We explore use of an unsupervised method for detecting hidden healthcare sub-processes using HMMs, in particular the Viterbi algorithm. We describe an approach to enrich the event log with HMM-derived states and remodeling the healthcare processes as state transitions using a process mining tool. Our method is applied to event data for 'Altered Mental Status' patients that was extracted from a US hospital database (MIMIC-III). The results are promising and show a successful reduction of model complexity and detection of several hidden processes unsupervised by a domain expert.

NETIMIS: Dynamic Simulation of Health Economics Outcomes Using Big Data.

Many healthcare organizations are now making good use of electronic health record (EHR) systems to record clinical information about their patients and the details of their healthcare. Electronic data in EHRs is generated by people engaged in complex processes within complex environments, and their human input, albeit shaped by computer systems, is compromised by many human factors. These data are potentially valuable to health economists and outcomes researchers but are sufficiently large and complex enough to be considered part of the new frontier of 'big data'. This paper describes emerging methods that draw together data mining, process modelling, activity-based costing and dynamic simulation models. Our research infrastructure includes safe links to Leeds hospital's EHRs with 3 million secondary and tertiary care patients. We created a multidisciplinary team of health economists, clinical specialists, and data and computer scientists, and developed a dynamic simulation tool called NETIMIS (Network Tools for Intervention Modelling with Intelligent Simulation; http://www.netimis.com ) suitable for visualization of both human-designed and data-mined processes which can then be used for 'what-if' analysis by stakeholders interested in costing, designing and evaluating healthcare interventions. We present two examples of model development to illustrate how dynamic simulation can be informed by big data from an EHR. We found the tool provided a focal point for multidisciplinary team work to help them iteratively and collaboratively 'deep dive' into big data.

Informatics and the clinical laboratory.

The nature of pathology services is changing under the combined pressures of increasing workloads, cost constraints and technological advancement. In the face of this, laboratory systems need to meet new demands for data exchange with clinical electronic record systems for test requesting and results reporting. As these needs develop, new challenges are emerging especially with respect to the format and content of the datasets which are being exchanged. If the potential for the inclusion of intelligent systems in both these areas is to be realised, the continued dialogue between clinicians and laboratory information specialists is of paramount importance. Requirements of information technology (IT) in pathology, now extend well beyond the provision of purely analytical data. With the aim of achieving seamless integration of laboratory data into the total clinical pathway, 'Informatics' - the art and science of turning data into useful information - is becoming increasingly important in laboratory medicine. Informatics is a powerful tool in pathology - whether in implementing processes for pathology modernisation, introducing new diagnostic modalities (e.g. proteomics, genomics), providing timely and evidence-based disease management, or enabling best use of limited and often costly resources. Providing appropriate information to empowered and interested patients - which requires critical assessment of the ever-increasing volume of information available - can also benefit greatly from appropriate use of informatics in enhancing self-management of long term conditions. The increasing demands placed on pathology information systems in the context of wider developmental change in healthcare delivery are explored in this review. General trends in medical informatics are reflected in current priorities for laboratory medicine, including the need for unified electronic records, computerised order entry, data security and recovery, and audit. We conclude that there is a need to rethink the architecture of pathology systems and in particular to address the changed environment in which electronic patient record systems are maturing rapidly. The opportunity for laboratory-based informaticians to work collaboratively with clinical systems developers to embed clinically intelligent decision support systems should not be missed.