JMIR Medical Informatics
Clinical informatics, decision support for health professionals, electronic health records, and ehealth infrastructures
JMIR Medical Informatics (JMI, ISSN 2291-9694; Impact Factor: 2.96) (Editor-in-chief: Christian Lovis MD MPH FACMI) is a PubMed/SCIE-indexed journal that focuses on clinical informatics, big data in health and health care, decision support for health professionals, electronic health records, ehealth infrastructures and implementation. In June 2021, the journal received an impact factor of 2.96.
Published by JMIR Publications, JMIR Medical Informatics has a focus on applied, translational research, with a broad readership including clinicians, CIOs, engineers, industry and health informatics professionals.
JMIR Medical Informatics adheres to rigorous quality standards, involving a rapid and thorough peer-review process, professional copyediting, professional production of PDF, XHTML, and XML proofs (ready for deposit in PubMed Central/PubMed).
Real-world data (RWD) and real-world evidence (RWE) are playing increasingly important roles in clinical research and health care decision-making. To leverage RWD and generate reliable RWE, data should be well defined and structured in a way that is semantically interoperable and consistent across stakeholders. The adoption of data standards is one of the cornerstones supporting high-quality evidence for the development of clinical medicine and therapeutics. Clinical Data Interchange Standards Consortium (CDISC) data standards are mature, globally recognized, and heavily used by the pharmaceutical industry for regulatory submissions. The CDISC RWD Connect Initiative aims to better understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance needed to more easily implement them.
Artificial intelligence (AI) is a broad discipline that aims to understand and design systems that display properties of intelligence. Machine learning (ML) is a subset of AI that describes how algorithms and models can assist computer systems in progressively improving their performance. In health care, an increasingly common application of AI/ML is software as a medical device (SaMD), which has the intention to diagnose, treat, cure, mitigate, or prevent disease. AI/ML includes either “locked” or “continuous learning” algorithms. Locked algorithms consistently provide the same output for a particular input. Conversely, continuous learning algorithms, in their infancy in terms of SaMD, modify in real-time based on incoming real-world data, without controlled software version releases. This continuous learning has the potential to better handle local population characteristics, but with the risk of reinforcing existing structural biases. Continuous learning algorithms pose the greatest regulatory complexity, requiring seemingly continuous oversight in the form of special controls to ensure ongoing safety and effectiveness. We describe the challenges of continuous learning algorithms, then highlight the new evidence standards and frameworks under development, and discuss the need for stakeholder engagement. The paper concludes with 2 key steps that regulators need to address in order to optimize and realize the benefits of SaMD: first, international standards and guiding principles addressing the uniqueness of SaMD with a continuous learning algorithm are required and second, throughout the product life cycle and appropriate to the SaMD risk classification, there needs to be continuous communication between regulators, developers, and SaMD end users to ensure vigilance and an accurate understanding of the technology.
The criteria for the diagnosis of kidney disease outlined in the Kidney Disease: Improving Global Outcomes guidelines are based on a patient’s current, historical, and baseline data. The diagnosis of acute kidney injury, chronic kidney disease, and acute-on-chronic kidney disease requires previous measurements of creatinine, back-calculation, and the interpretation of several laboratory values over a certain period. Diagnoses may be hindered by unclear definitions of the individual creatinine baseline and rough ranges of normal values that are set without adjusting for age, ethnicity, comorbidities, and treatment. The classification of correct diagnoses and sufficient staging improves coding, data quality, reimbursement, the choice of therapeutic approach, and a patient’s outcome.
Knowledge about adverse drug reactions (ADRs) in the population is limited because of underreporting, which hampers surveillance and assessment of drug safety. Therefore, gathering accurate information that can be retrieved from clinical notes about the incidence of ADRs is of great relevance. However, manual labeling of these notes is time-consuming, and automatization can improve the use of free-text clinical notes for the identification of ADRs. Furthermore, tools for language processing in languages other than English are not widely available.
Rigorous development of mobile technologies requires the use of validated instruments to evaluate the usability of these tools, which has become more relevant with the expansion of these technologies. Although various usability evaluation tools have been developed, there are relatively few simple evaluation instruments that have been validated across diseases and languages in mobile health (mHealth) information technology for use in multiple diseases.
Disease prevention is a central aspect of primary care practice and is comprised of primary (eg, vaccinations), secondary (eg, screenings), tertiary (eg, chronic condition monitoring), and quaternary (eg, prevention of overmedicalization) levels. Despite rapid digital transformation of primary care practices, digital health interventions (DHIs) in preventive care have yet to be systematically evaluated.
Although digital and data-based technologies are widespread in various industries in the context of Industry 4.0, the use of smart connected devices in health care is still in its infancy. Innovative solutions for the medical environment are affected by difficult access to medical device data and high barriers to market entry because of proprietary systems.
Blockchain technology is a part of Industry 4.0’s new Internet of Things applications: decentralized systems, distributed ledgers, and immutable and cryptographically secure technology. This technology entails a series of transaction lists with identical copies shared and retained by different groups or parties. One field where blockchain technology has tremendous potential is health care, due to the more patient-centric approach to the health care system as well as blockchain’s ability to connect disparate systems and increase the accuracy of electronic health records.
Patient representation learning aims to learn features, also called representations, from input sources automatically, often in an unsupervised manner, for use in predictive models. This obviates the need for cumbersome, time- and resource-intensive manual feature engineering, especially from unstructured data such as text, images, or graphs. Most previous techniques have used neural network–based autoencoders to learn patient representations, primarily from clinical notes in electronic medical records (EMRs). Knowledge graphs (KGs), with clinical entities as nodes and their relations as edges, can be extracted automatically from biomedical literature and provide complementary information to EMR data that have been found to provide valuable predictive signals.
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