Clinical Data: Sources and Types, Regulatory Constraints, Applications

Access to clinical data is critical for the advancement of translational research. However, the numerous regulations and policies that surround the use of clinical data, although critical to ensure patient privacy and protect against misuse, often present challenges to data access and sharing. In this article, we provide an overview of clinical data types and associated regulatory constraints and inferential limitations. We highlight several novel approaches that our team has developed for openly exposing clinical data.

[1]  Gustavo Glusman,et al.  Ultrafast Comparison of Personal Genomes via Precomputed Genome Fingerprints , 2017, bioRxiv.

[2]  Karamarie Fecho,et al.  A novel approach for exposing and sharing clinical data: the Translator Integrated Clinical and Environmental Exposures Service , 2019, J. Am. Medical Informatics Assoc..

[3]  Toward A Universal Biomedical Data Translator , 2018, Clinical and translational science.

[4]  Ambarish Vaidyanathan,et al.  Outdoor PM2.5, Ambient Air Temperature, and Asthma Symptoms in the Past 14 Days among Adults with Active Asthma , 2016, Environmental health perspectives.

[5]  Fangyuan Zhao,et al.  Feasibility of Reidentifying Individuals in Large National Physical Activity Data Sets From Which Protected Health Information Has Been Removed With Use of Machine Learning , 2018, JAMA network open.

[6]  L. B. Harman,et al.  Electronic health records: privacy, confidentiality, and security. , 2012, The virtual mentor : VM.

[7]  George Hripcsak,et al.  Columbia Open Health Data, clinical concept prevalence and co-occurrence from electronic health records , 2018, Scientific Data.

[8]  Mark Kramer,et al.  Synthea: An approach, method, and software mechanism for generating synthetic patients and the synthetic electronic health care record , 2017, J. Am. Medical Informatics Assoc..

[9]  Paul A Clemons,et al.  The Biomedical Data Translator Program: Conception, Culture, and Community , 2018, Clinical and translational science.

[10]  Jennifer Lapum,et al.  Privacy, Confidentiality, and Security , 2020 .