Future Developments of Medical Informatics from the Viewpoint of Networked Clinical Research

2009 ◽  
Vol 48 (01) ◽  
pp. 45-54 ◽  
Author(s):  
W. Kuchinke ◽  
C. Ohmann

Summary Objectives: To be prepared for future developments, such as enabling support of rapid innovation transfer and personalized medicine concepts, interoperability of basic research, clinical research and medical care is essential. It is the objective of our paper to give an overview of developments, indicate problem areas and to specify future requirements. Methods: In this paper recent and ongoing large-scaled activities related to interoper-ability and integration of networked clinical research are described and evaluated. The following main topics are covered: necessity for general IT-conception, open source/open community approach, acceptance of eSource in clinical research, interoperability of the electronic health record and electronic data capture and harmonization and bridging of standards for technical and semantic inter-operability. Results: National infrastructures and programmes have been set up to provide general IT-conceptions to guide planning and development of software tools (e.g. TMF, ca BIG, NIHR). The concept of open research described by transparency achieved through open access, open data, open communication and open source software is becoming more and more important in clinical research infrastructure development (e.g. ca BIG, ePCRN). Meanwhile visions and rules for using eSource in clinical research are available, with the potential to improve interoperability between the electronic health record and electronic data capture (e.g. CDISC e SDI, eClinical Forum/PhRMA EDC/eSource Taskforce). Several groups have formulated user requirements, use cases and technical frameworks to advance these issues (e.g. NHIN Slipstream-project, EHR/CR-project, IHE). In order to achieve technical and semantic interoperability, existing standards (e.g. CDISC) have to be harmonized and bridged. Major consortia have been formed to provide semantical inter-operability (e.g. HL7 RCRIM under joint leadership of HL7, CDISC and FDA, or BRIDG covering CDISC, HL7, FDA, NCI) and to provide core sets of data collection fields (CDASH). Conclusions: The essential tasks for medical informatics within the next ten years will now be the development and implementation of encompassing IT conceptions, strong support of the open community and open source approach, the acceptance of eSource in clinical research, the uncompromising continuity of standardization and bridging of technical standards and the widespread use of electronic health record systems.

2017 ◽  
Vol 14 (2) ◽  
pp. 130-139 ◽  
Author(s):  
Gayan Perera ◽  
Lars Pedersen ◽  
David Ansel ◽  
Myriam Alexander ◽  
H. Michael Arrighi ◽  
...  

2021 ◽  
Vol 15 (2) ◽  
pp. 181-195
Author(s):  
Hossain Shahriar ◽  
Hisham M. Haddad ◽  
Maryam Farhadi

Electronic health record (EHR) applications are digital versions of paper-based patient health information. EHR applications are increasingly being adopted in many countries. They have resulted in improved quality in healthcare, convenient access to histories of patient medication and clinic visits, easier follow up of patient treatment plans, and precise medical decision-making process. The goal of this paper is to identify HIPAA technical requirements, evaluate two open source EHR applications (OpenEMR and OpenClinic) for security vulnerabilities using two open-source scanner tools (RIPS and PHP VulnHunter), and map the identified vulnerabilities to HIPAA technical requirements.


2017 ◽  
Vol 25 (5) ◽  
pp. 496-506 ◽  
Author(s):  
Adam Wright ◽  
Angela Ai ◽  
Joan Ash ◽  
Jane F Wiesen ◽  
Thu-Trang T Hickman ◽  
...  

Abstract Objective To develop an empirically derived taxonomy of clinical decision support (CDS) alert malfunctions. Materials and Methods We identified CDS alert malfunctions using a mix of qualitative and quantitative methods: (1) site visits with interviews of chief medical informatics officers, CDS developers, clinical leaders, and CDS end users; (2) surveys of chief medical informatics officers; (3) analysis of CDS firing rates; and (4) analysis of CDS overrides. We used a multi-round, manual, iterative card sort to develop a multi-axial, empirically derived taxonomy of CDS malfunctions. Results We analyzed 68 CDS alert malfunction cases from 14 sites across the United States with diverse electronic health record systems. Four primary axes emerged: the cause of the malfunction, its mode of discovery, when it began, and how it affected rule firing. Build errors, conceptualization errors, and the introduction of new concepts or terms were the most frequent causes. User reports were the predominant mode of discovery. Many malfunctions within our database caused rules to fire for patients for whom they should not have (false positives), but the reverse (false negatives) was also common. Discussion Across organizations and electronic health record systems, similar malfunction patterns recurred. Challenges included updates to code sets and values, software issues at the time of system upgrades, difficulties with migration of CDS content between computing environments, and the challenge of correctly conceptualizing and building CDS. Conclusion CDS alert malfunctions are frequent. The empirically derived taxonomy formalizes the common recurring issues that cause these malfunctions, helping CDS developers anticipate and prevent CDS malfunctions before they occur or detect and resolve them expediently.


2019 ◽  
Author(s):  
Daniel M. Bean ◽  
James Teo ◽  
Honghan Wu ◽  
Ricardo Oliveira ◽  
Raj Patel ◽  
...  

AbstractAtrial fibrillation (AF) is the most common arrhythmia and significantly increases stroke risk. This risk is effectively managed by oral anticoagulation. Recent studies using national registry data indicate increased use of anticoagulation resulting from changes in guidelines and the availability of newer drugs.The aim of this study is to develop and validate an open source risk scoring pipeline for free-text electronic health record data using natural language processing.AF patients discharged from 1st January 2011 to 1st October 2017 were identified from discharge summaries (N=10,030, 64.6% male, average age 75.3 ± 12.3 years). A natural language processing pipeline was developed to identify risk factors in clinical text and calculate risk for ischaemic stroke (CHA2DS2-VASc) and bleeding (HAS-BLED). Scores were validated vs two independent experts for 40 patients.Automatic risk scores were in strong agreement with the two independent experts for CHA2DS2-VASc (average kappa 0.78 vs experts, compared to 0.85 between experts). Agreement was lower for HAS-BLED (average kappa 0.54 vs experts, compared to 0.74 between experts).In high-risk patients (CHA2DS2-VASc ≥2) OAC use has increased significantly over the last 7 years, driven by the availability of DOACs and the transitioning of patients from AP medication alone to OAC. Factors independently associated with OAC use included components of the CHA2DS2-VASc and HAS-BLED scores as well as discharging specialty and frailty. OAC use was highest in patients discharged under cardiology (69%).Electronic health record text can be used for automatic calculation of clinical risk scores at scale. Open source tools are available today for this task but require further validation. Analysis of routinely-collected EHR data can replicate findings from large-scale curated registries.


2014 ◽  
Vol 53 (03) ◽  
pp. 202-207 ◽  
Author(s):  
M. Haag ◽  
L. R. Pilz ◽  
D. Schrimpf

SummaryBackground: Clinical trials (CT) are in a wider sense experiments to prove and establish clinical benefit of treatments. Nowadays electronic data capture systems (EDCS) are used more often bringing a better data management and higher data quality into clinical practice. Also electronic systems for the randomization are used to assign the patients to the treatments.Objectives: If the mentioned randomization system (RS) and EDCS are used, possibly identical data are collected in both, especially by stratified randomization. This separated data storage may lead to data inconsistency and in general data samples have to be aligned. The article discusses solutions to combine RS and EDCS. In detail one approach is realized and introduced.Methods: Different possible settings of combination of EDCS and RS are determined and the pros and cons for each solution are worked out. For the combination of two independent applications the necessary interfaces for the communication are defined. Thereby, existing standards are considered. An example realization is implemented with the help of open-source applications and state-of-the-art software development procedures.Results: Three possibilities of separate usage or combination of EDCS and RS are pre -sented and assessed: i) the complete independent usage of both systems; ii) realization of one system with both functions; and iii) two separate systems, which communicate via defined interfaces. In addition a realization of our preferred approach, the combination of both systems, is introduced using the open source tools RANDI2 and Open-Clinica.Conclusion: The advantage of a flexible independent development of EDCS and RS is shown based on the fact that these tool are very different featured. In our opinion the combination of both systems via defined interfaces fulfills the requirements of randomization and electronic data capture and is feasible in practice. In addition, the use of such a setting can reduce the training costs and the error-prone duplicated data entry.


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