From Raw Data to FAIR Data: The FAIRification Workflow for Health Research

BackgroundFAIR (findability, accessibility, interoperability, and reusability) guidingprinciples seek the reuse of data and other digital research input, output, and objects(algorithms, tools, and workflows that led to that data) making themfindable, accessible,interoperable, and reusable. GO FAIR - a bottom-up, stakeholder driven and self-governedinitiative-defined a seven-step FAIRificationprocessfocusingondata,butalsoindicatingtherequired work for metadata. This FAIRification process aims at addressing the translation ofraw datasets into FAIR datasets in a general way, without considering specific requirementsand challenges that may arise when dealing with some particular types of data.This work was performed in the scope of FAIR4Healthproject. FAIR4Health has received funding from the European Union’s Horizon 2020 research and innovationprogramme under grant agreement number 824666

Challenges and opportunities beyond structured data in analysis of electronic health records

Electronic health records (EHR) contain a lot of valuable information about individual patients and the whole population. Besides structured data, unstructured data in EHRs can provide extra, valuable information but the analytics processes are complex, time-consuming, and often require excessive manual effort. Among unstructured data, clinical text and images are the two most popular and important sources of information. Advanced statistical algorithms in natural language processing, machine learning, deep learning, and radiomics have increasingly been used for analyzing clinical text and images. Although there exist many challenges that have not been fully addressed, which can hinder the use of unstructured data, there are clear opportunities for well-designed diagnosis and decision support tools that efficiently incorporate both structured and unstructured data for extracting useful information and provide better outcomes. However, access to clinical data is still very restricted due to data sensitivity and ethical issues. Data quality is also an important challenge in which methods for improving data completeness, conformity and plausibility are needed. Further, generalizing and explaining the result of machine learning models are important problems for healthcare, and these are open challenges. A possible solution to improve data quality and accessibility of unstructured data is developing machine learning methods that can generate clinically relevant synthetic data, and accelerating further research on privacy preserving techniques such as deidentification and pseudonymization of clinical text

Automated Transformation of Semi-Structured Text Elements

Interconnected systems, such as electronic health records (EHR), considerably improved the handling and processing of health information while keeping the costs at a controlled level. Since the EHR virtually stores all data in digitized form, personal medical documents are easily and swiftly available when needed. However, multiple formats and differences in the health documents managed by various health care providers severely reduce the efficiency of the data sharing process. This paper presents a rule-based transformation system that converts semi-structured (annotated) text into standardized formats, such as HL7 CDA. It identifies relevant information in the input document by analyzing its structure as well as its content and inserts the required elements into corresponding reusable CDA templates, where the templates are selected according to the CDA document type-specific requirements

Free DICOM de-identification tools in clinical research:functioning and safety of patient privacy

To compare non-commercial DICOM toolkits for their de-identification ability in removing a patient's personal health information (PHI) from a DICOM header. Ten DICOM toolkits were selected for de-identification tests. Tests were performed by using the system's default de-identification profile and, subsequently, the tools' best adjusted settings. We aimed to eliminate fifty elements considered to contain identifying patient information. The tools were also examined for their respective methods of customization. Only one tool was able to de-identify all required elements with the default setting. Not all of the toolkits provide a customizable de-identification profile. Six tools allowed changes by selecting the provided profiles, giving input through a graphical user interface (GUI) or configuration text file, or providing the appropriate command-line arguments. Using adjusted settings, four of those six toolkits were able to perform full de-identification. Only five tools could properly de-identify the defined DICOM elements, and in four cases, only after careful customization. Therefore, free DICOM toolkits should be used with extreme care to prevent the risk of disclosing PHI, especially when using the default configuration. In case optimal security is required, one of the five toolkits is proposed. aEuro cent Free DICOM toolkits should be carefully used to prevent patient identity disclosure. aEuro cent Each DICOM tool produces its own specific outcomes from the de-identification process. aEuro cent In case optimal security is required, using one DICOM toolkit is proposed

Anonymization of DICOM electronic medical records for radiation therapy

Electronic medical records (EMR) and treatment plans are used in research on patient outcomes and radiation effects. In many situations researchers must remove protected health information (PHI) from EMRs. The literature contains several studies describing the anonymization of generic Digital Imaging and Communication in Medicine (DICOM) files and DICOM image sets but no publications were found that discuss the anonymization of DICOM radiation therapy plans, a key component of an EMR in a cancer clinic. In addition to this we were unable to find a commercial software tool that met the minimum requirements for anonymization and preservation of data integrity for radiation therapy research. The purpose of this study was to develop a prototype software code to meet the requirements for the anonymization of radiation therapy treatment plans and to develop a way to validate that code and demonstrate that it properly anonymized treatment plans and preserved data integrity. We extended an open-source code to process all relevant PHI and to allow for the automatic anonymization of multiple EMRs. The prototype code successfully anonymized multiple treatment plans in less than 1. min/patient. We also tested commercial optical character recognition (OCR) algorithms for the detection of burned-in text on the images, but they were unable to reliably recognize text. In addition, we developed and tested an image filtering algorithm that allowed us to isolate and redact alpha-numeric text from a test radiograph. Validation tests verified that PHI was anonymized and data integrity, such as the relationship between DICOM unique identifiers (UID) was preserved. © 2014 Elsevier Ltd

Data preparation for artificial intelligence in medical imaging: A comprehensive guide to open-access platforms and tools

The vast amount of data produced by today's medical imaging systems has led medical professionals to turn to novel technologies in order to efficiently handle their data and exploit the rich information present in them. In this context, artificial intelligence (AI) is emerging as one of the most prominent solutions, promising to revolutionise every day clinical practice and medical research. The pillar supporting the development of reliable and robust AI algorithms is the appropriate preparation of the medical images to be used by the AI-driven solutions. Here, we provide a comprehensive guide for the necessary steps to prepare medical images prior to developing or applying AI algorithms. The main steps involved in a typical medical image preparation pipeline include: (i) image acquisition at clinical sites, (ii) image de-identification to remove personal information and protect patient privacy, (iii) data curation to control for image and associated information quality, (iv) image storage, and (v) image annotation. There exists a plethora of open access tools to perform each of the aforementioned tasks and are hereby reviewed. Furthermore, we detail medical image repositories covering different organs and diseases. Such repositories are constantly increasing and enriched with the advent of big data. Lastly, we offer directions for future work in this rapidly evolving field

Artificial intelligence tools in clinical neuroradiology: essential medico-legal aspects

Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues warrant an interdisciplinary approach and may affect the way we work in daily practice. In this article, we seek to address three major topics: medical malpractice liability, regulation of AI-based medical devices, and privacy protection in shared medical imaging data, thereby focusing on the legal frameworks of the European Union and the USA. As many of the presented concepts are very complex and, in part, remain yet unsolved, this article is not meant to be comprehensive but rather thought-provoking. The goal is to engage clinical neuroradiologists in the debate and equip them to actively shape these topics in the future

The Open Brain Consent: Informing research participants and obtaining consent to share brain imaging data

Having the means to share research data openly is essential to modern science. For human research, a key aspect in this endeavor is obtaining consent from participants, not just to take part in a study, which is a basic ethical principle, but also to share their data with the scientific community. To ensure that the participants' privacy is respected, national and/or supranational regulations and laws are in place. It is, however, not always clear to researchers what the implications of those are, nor how to comply with them. The Open Brain Consent (https://open-brain-consent.readthedocs.io) is an international initiative that aims to provide researchers in the brain imaging community with information about data sharing options and tools. We present here a short history of this project and its latest developments, and share pointers to consent forms, including a template consent form that is compliant with the EU general data protection regulation. We also share pointers to an associated data user agreement that is not only useful in the EU context, but also for any researchers dealing with personal (clinical) data elsewhere