Data Sharing: An Ethical and Scientific Imperative Bauchner, Howard; Golub, Robert M; Fontanarosa, Phil B
JAMA : the journal of the American Medical Association,
03/2016, Letnik:
315, Številka:
12
Journal Article
Recenzirano
Sharing data produced from clinical trials has 2 principal purposes: verification of the original analysis and hypothesis generation. It has the potential to advance scientific discovery, improve ...clinical care, and increase knowledge gained from data collected in these trials. As such, data sharing has become an ethical and scientific imperative. The data sharing process has generated controversy,1- 5 for example, about which data should be shared, with whom, and how quickly. However, there is limited information to help guide the discussion. Here, Bauchner et al comment on the study by Navar et al that details the experience of data sharing that has occurred in 3 clinical trial databases to which 14 pharmaceutical companies have contributed individual patient data from 3255 trials.
Healthcare data held by state-run organisations is a valuable intangible asset for society. Its use should be a priority for its administrators and the state. A completely paternalistic approach by ...administrators and the state is undesirable, however much it aims to protect the privacy rights of persons registered in databases. In line with European policies and the global trend, these measures should not outweigh the social benefit that arises from the analysis of these data if the technical possibilities exist to sufficiently protect the privacy rights of individuals. Czech society is having an intense discussion on the topic, but according to the authors, it is insufficiently based on facts and lacks clearly articulated opinions of the expert public. The aim of this article is to fill these gaps. Data anonymization techniques provide a solution to protect individuals' privacy rights while preserving the scientific value of the data. The risk of identifying individuals in anonymised data sets is scalable and can be minimised depending on the type and content of the data and its use by the specific applicant. Finding the optimal form and scope of deidentified data requires competence and knowledge on the part of both the applicant and the administrator. It is in the interest of the applicant, the administrator, as well as the protected persons in the databases that both parties show willingness and have the ability and expertise to communicate during the application and its processing.
While rich medical, behavioral, and socio-demographic data are key to modern data-driven research, their collection and use raise legitimate privacy concerns. Anonymizing datasets through ...de-identification and sampling before sharing them has been the main tool used to address those concerns. We here propose a generative copula-based method that can accurately estimate the likelihood of a specific person to be correctly re-identified, even in a heavily incomplete dataset. On 210 populations, our method obtains AUC scores for predicting individual uniqueness ranging from 0.84 to 0.97, with low false-discovery rate. Using our model, we find that 99.98% of Americans would be correctly re-identified in any dataset using 15 demographic attributes. Our results suggest that even heavily sampled anonymized datasets are unlikely to satisfy the modern standards for anonymization set forth by GDPR and seriously challenge the technical and legal adequacy of the de-identification release-and-forget model.
To conduct a systematic review of deep learning models for electronic health record (EHR) data, and illustrate various deep learning architectures for analyzing different data sources and their ...target applications. We also highlight ongoing research and identify open challenges in building deep learning models of EHRs.
We searched PubMed and Google Scholar for papers on deep learning studies using EHR data published between January 1, 2010, and January 31, 2018. We summarize them according to these axes: types of analytics tasks, types of deep learning model architectures, special challenges arising from health data and tasks and their potential solutions, as well as evaluation strategies.
We surveyed and analyzed multiple aspects of the 98 articles we found and identified the following analytics tasks: disease detection/classification, sequential prediction of clinical events, concept embedding, data augmentation, and EHR data privacy. We then studied how deep architectures were applied to these tasks. We also discussed some special challenges arising from modeling EHR data and reviewed a few popular approaches. Finally, we summarized how performance evaluations were conducted for each task.
Despite the early success in using deep learning for health analytics applications, there still exist a number of issues to be addressed. We discuss them in detail including data and label availability, the interpretability and transparency of the model, and ease of deployment.
Objective Clinical documents made available for secondary use play an increasingly important role in discovery of clinical knowledge, development of research methods, and education. An important step ...in facilitating secondary use of clinical document collections is easy access to descriptions and samples that represent the content of the collections. This paper presents an approach to developing a collection of radiology examinations, including both the images and radiologist narrative reports, and making them publicly available in a searchable database.
Materials and Methods The authors collected 3996 radiology reports from the Indiana Network for Patient Care and 8121 associated images from the hospitals’ picture archiving systems. The images and reports were de-identified automatically and then the automatic de-identification was manually verified. The authors coded the key findings of the reports and empirically assessed the benefits of manual coding on retrieval.
Results The automatic de-identification of the narrative was aggressive and achieved 100% precision at the cost of rendering a few findings uninterpretable. Automatic de-identification of images was not quite as perfect. Images for two of 3996 patients (0.05%) showed protected health information. Manual encoding of findings improved retrieval precision.
Conclusion Stringent de-identification methods can remove all identifiers from text radiology reports. DICOM de-identification of images does not remove all identifying information and needs special attention to images scanned from film. Adding manual coding to the radiologist narrative reports significantly improved relevancy of the retrieved clinical documents. The de-identified Indiana chest X-ray collection is available for searching and downloading from the National Library of Medicine (http://openi.nlm.nih.gov/).
Objective: Patient notes in electronic health records (EHRs) may contain critical information for medical investigations. However, the vast majority of medical investigators can only access ...de-identified notes, in order to protect the confidentiality of patients. In the United States, the Health Insurance Portability and Accountability Act (HIPAA) defines 18 types of protected health information that needs to be removed to de-identify patient notes. Manual de-identification is impractical given the size of electronic health record databases, the limited number of researchers with access to non-de-identified notes, and the frequent mistakes of human annotators. A reliable automated de-identification system would consequently be of high value.
Materials and Methods: We introduce the first de-identification system based on artificial neural networks (ANNs), which requires no handcrafted features or rules, unlike existing systems. We compare the performance of the system with state-of-the-art systems on two datasets: the i2b2 2014 de-identification challenge dataset, which is the largest publicly available de-identification dataset, and the MIMIC de-identification dataset, which we assembled and is twice as large as the i2b2 2014 dataset.
Results: Our ANN model outperforms the state-of-the-art systems. It yields an F1-score of 97.85 on the i2b2 2014 dataset, with a recall of 97.38 and a precision of 98.32, and an F1-score of 99.23 on the MIMIC de-identification dataset, with a recall of 99.25 and a precision of 99.21.
Conclusion: Our findings support the use of ANNs for de-identification of patient notes, as they show better performance than previously published systems while requiring no manual feature engineering.
Genomics data introduce a substantial computational burden as well as data privacy and ownership issues. Data sets generated by high-throughput sequencing platforms require immense amounts of ...computational resources to align to reference genomes and to call and annotate genomic variants. This problem is even more pronounced if reanalysis is needed for new versions of reference genomes, which may impose high loads to existing computational infrastructures. Additionally, after the compute-intensive analyses are completed, the results are either kept in centralized repositories with access control, or distributed among stakeholders using standard file transfer protocols. This imposes two main problems: (1) Centralized servers become gatekeepers of the data, essentially acting as an unnecessary mediator between the actual data owners and data users; and (2) servers may create single points of failure both in terms of service availability and data privacy. Therefore, there is a need for secure and decentralized platforms for data distribution with user-level data governance. A new technology, blockchain, may help ameliorate some of these problems. In broad terms, the blockchain technology enables decentralized, immutable, incorruptible public ledgers. In this Perspective, we aim to introduce current developments toward using blockchain to address several problems in omics, and to provide an outlook of possible future implications of the blockchain technology to life sciences.
The medical and machine learning communities are relying on the promise of artificial intelligence (AI) to transform medicine through enabling more accurate decisions and personalized treatment. ...However, progress is slow. Legal and ethical issues around unconsented patient data and privacy is one of the limiting factors in data sharing, resulting in a significant barrier in accessing routinely collected electronic health records (EHR) by the machine learning community. We propose a novel framework for generating synthetic data that closely approximates the joint distribution of variables in an original EHR dataset, providing a readily accessible, legally and ethically appropriate solution to support more open data sharing, enabling the development of AI solutions. In order to address issues around lack of clarity in defining sufficient anonymization, we created a quantifiable, mathematical definition for "identifiability". We used a conditional generative adversarial networks (GAN) framework to generate synthetic data while minimize patient identifiability that is defined based on the probability of re-identification given the combination of all data on any individual patient. We compared models fitted to our synthetically generated data to those fitted to the real data across four independent datasets to evaluate similarity in model performance, while assessing the extent to which original observations can be identified from the synthetic data. Our model, ADS-GAN, consistently outperformed state-of-the-art methods, and demonstrated reliability in the joint distributions. We propose that this method could be used to develop datasets that can be made publicly available while considerably lowering the risk of breaching patient confidentiality.
The article presents an approach to data anonymization with the use of generally available tools. The focus is put on the practical aspects of using open-source tools in conjunction with programming ...libraries provided by suppliers of industrial control systems. This universal approach shows the possibilities of using various operating systems as a platform for process data anonymization. An additional advantage of the described approach is the ease of integration with various types of advanced data analysis tools based both on the out-of-the-box approach (e.g., business intelligence tools) as well as customized solutions. The discussed case describes the anonymization of data for the needs of sensitive analysis by a wider group of recipients during the construction of a predictive model used to support decisions.
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