Radhakrishnan Lakshmi, Schenk Gundolf, Muenzen Kathleen, Oskotsky Boris, Ashouri Choshali Habibeh, Plunkett Thomas, Israni Sharat, Butte Atul J
Academic Research Services, Information Technology, University of California, San Francisco, San Francisco, California, USA.
Bakar Computational Health Sciences Institute, University of California, San Francisco, San Francisco, California, USA.
JAMIA Open. 2023 Jul 4;6(3):ooad045. doi: 10.1093/jamiaopen/ooad045. eCollection 2023 Oct.
Clinical notes are a veritable treasure trove of information on a patient's disease progression, medical history, and treatment plans, yet are locked in secured databases accessible for research only after extensive ethics review. Removing personally identifying and protected health information (PII/PHI) from the records can reduce the need for additional Institutional Review Boards (IRB) reviews. In this project, our goals were to: (1) develop a robust and scalable clinical text de-identification pipeline that is compliant with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule for de-identification standards and (2) share routinely updated de-identified clinical notes with researchers.
Building on our open-source de-identification software called Philter, we added features to: (1) make the algorithm and the de-identified data HIPAA compliant, which also implies type 2 error-free redaction, as certified via external audit; (2) reduce over-redaction errors; and (3) normalize and shift date PHI. We also established a streamlined de-identification pipeline using MongoDB to automatically extract clinical notes and provide truly de-identified notes to researchers with periodic monthly refreshes at our institution.
To the best of our knowledge, the Philter V1.0 pipeline is currently the and certified, de-identified redaction pipeline that makes clinical notes available to researchers for nonhuman subjects' research, without further IRB approval needed. To date, we have made over 130 million certified de-identified clinical notes available to over 600 UCSF researchers. These notes were collected over the past 40 years, and represent data from 2757016 UCSF patients.
临床记录是有关患者疾病进展、病史和治疗计划的信息宝库,但这些记录被锁定在安全数据库中,只有经过广泛的伦理审查后才能用于研究。从记录中删除个人身份识别信息和受保护的健康信息(PII/PHI)可以减少机构审查委员会(IRB)额外审查的需求。在本项目中,我们的目标是:(1)开发一个强大且可扩展的临床文本去识别流程,该流程符合《健康保险流通与责任法案》(HIPAA)隐私规则的去识别标准;(2)与研究人员共享定期更新的去识别临床记录。
在我们名为Philter的开源去识别软件基础上,我们增加了以下功能:(1)使算法和去识别数据符合HIPAA要求,这也意味着通过外部审计认证实现无第二类错误的编辑;(2)减少过度编辑错误;(3)对日期PHI进行规范化和移位处理。我们还使用MongoDB建立了一个简化的去识别流程,以自动提取临床记录,并在我们机构每月定期更新,为研究人员提供真正去识别的记录。
据我们所知,Philter V1.0流程目前是首个且唯一经过认证的去识别编辑流程,可在无需IRB进一步批准的情况下,将临床记录提供给研究人员用于非人体研究。迄今为止,我们已为600多名加州大学旧金山分校的研究人员提供了超过1.3亿条经过认证的去识别临床记录。这些记录是在过去40年中收集的,代表了来自2757016名加州大学旧金山分校患者的数据。