Shean Ryan C, Greninger Alexander L
Department of Laboratory Medicine, University of Washington, 1616 Eastlake Avenue East, Suite 320, Seattle, WA 98102, USA.
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Eastlake Avenue East, Seattle, WA 98102, USA.
Virus Evol. 2018 Feb 27;4(1):vey005. doi: 10.1093/ve/vey005. eCollection 2018 Jan.
Infectious pathogens are known for their rapid evolutionary rates with new mutations arising over days to weeks. The ability to rapidly recover whole genome sequences and analyze the spread and evolution of pathogens using genetic information and pathogen collection dates has lead to interest in real-time tracking of infectious transmission and outbreaks. However, the level of temporal resolution afforded by these analyses may conflict with definitions of what constitutes protected health information (PHI) and privacy requirements for de-identification for publication and public sharing of research data and metadata. In the United States, dates and locations associated with patient care that provide greater resolution than year or the first three digits of the zip code are generally considered patient identifiers. Admission and discharge dates are specifically named as identifiers in Department of Health and Human Services guidance. To understand the degree to which one can impute admission dates from specimen collection dates, we examined sample collection dates and patient admission dates associated with more than 270,000 unique microbiological results from the University of Washington Laboratory Medicine Department between 2010 and 2017. Across all positive microbiological tests, the sample collection date exactly matched the patient admission date in 68.8% of tests. Collection dates and admission dates were identical from emergency department and outpatient testing 86.7% and 96.5% of the time, respectively, with >99% of tests collected within 1 day from the patient admission date. Samples from female patients were significantly more likely to be collected closer to admission date that those from male patients. We show that PHI-associated dates such as admission date can confidently be imputed from deposited collection date. We suggest that publicly depositing microbiological collection dates at greater resolution than the year may not meet routine Safe Harbor-based requirements for patient de-identification. We recommend the use of Expert Determination to determine PHI for a given study and/or direct patient consent if clinical laboratories or phylodynamic practitioners desire to make these data available.
传染性病原体以其快速的进化速度而闻名,新的突变在数天到数周内就会出现。利用遗传信息和病原体采集日期快速恢复全基因组序列并分析病原体的传播和进化的能力,引发了人们对实时追踪传染病传播和疫情爆发的兴趣。然而,这些分析所提供的时间分辨率水平可能与受保护健康信息(PHI)的定义以及研究数据和元数据发布与公开共享的去识别隐私要求相冲突。在美国,与患者护理相关的日期和地点,如果其分辨率高于年份或邮政编码的前三位数字,通常被视为患者标识符。卫生与公众服务部的指南中特别将入院和出院日期列为标识符。为了了解从标本采集日期推算入院日期的程度,我们研究了2010年至2017年期间华盛顿大学实验室医学部超过270,000个独特微生物检测结果所关联的样本采集日期和患者入院日期。在所有阳性微生物检测中,样本采集日期与患者入院日期在68.8%的检测中完全匹配。急诊科和门诊检测的采集日期与入院日期分别在86.7%和96.5%的时间内相同,超过99%的检测在患者入院日期的1天内采集。女性患者的样本比男性患者的样本更有可能在接近入院日期时采集。我们表明,可以从存档的采集日期可靠地推算出与PHI相关的日期,如入院日期。我们建议,以高于年份的分辨率公开存档微生物采集日期可能不符合基于常规安全港的患者去识别要求。我们建议,如果临床实验室或系统发育动力学从业者希望提供这些数据,使用专家判定来确定特定研究的PHI和/或直接获得患者同意。