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Protection of human subjects and sensitive information in electronic health record (EHR) reviews: Additional elements for the Medical Record Review-Conduction (MRR-C) Model
Tuesday, November 18, 2014
Patricia Kloser, MD, MPH, FACP
,
Department of Medicine, Rutgers-New Jersey Medical School, Newark, NJ
Donna White, Ph.D., MPH
,
Department of Medicine, Section of Gastroenterology & Hepatology, Baylor College of Medicine, Houston, TX
The Medical Record Review-Conduction (MRR-C) Model was proposed as a guide for developing medical records review (MRR) instruments using a standardized process to improve inter-rater reliability. Elements specific to the MRR-C Model are the Investigator in charge of the review, who, with the assistance of the Abstractor(s), examines the Data Source and develops the Data Abstraction Manual and the Abstraction Tool to ensure Data Collection Quality. Electronic health records (EHR) have improved the ease with which data is collected, but threats to data safety have increased, particularly in vulnerable populations, such as women with HIV infection. While the MRR-C Model provides a foundation from which to develop the MRR, little is mentioned about the protection of sensitive information collected from the EHR. A dissertation study utilizing MRR methodology to collect data from the EHR of 110 women with HIV infection was submitted to the Institutional Review Board by the doctoral student, and a waiver of informed consent was granted because the university, like many institutions, considers the EHR to be the property of the facility and/or the physician treating the client. However, when the MRR is conducted for evaluation purposes, such as determining which clients are utilizing a program, a human subjects review is frequently not sought so the waiver is not always obtained. Whether the MRR is conducted for research or evaluation purposes, the Investigator and Abstractor(s) should take responsibly for protecting the data from a client’s EHR during the MRR process, as well as after the MRR is completed, and the plan for protecting EHR data should be documented in the Data Abstraction Manual a priori as part of the MRR process. Protection of human subjects should be added to the MRR-C Model so the safety of data from the EHR is routinely addressed.
Learning Areas:
Conduct evaluation related to programs, research, and other areas of practice
Ethics, professional and legal requirements
Public health or related organizational policy, standards, or other guidelines
Learning Objectives:
Describe two purposes for conducting a medical record review
Discuss the elements of the MRR-C Model
Discuss how the MRR-C Model improves the quality of EHR reviews
Identify threats to the safety of sensitive data in the EHR
Name one element suggested as an addition to the MRR-C Model
Keyword(s): Methodology, Vulnerable Populations
Presenting author's disclosure statement:Qualified on the content I am responsible for because: I designed and conducted the study for my dissertation as partial fulfillment of requirements for my PhD in Public Health/Epidemiology, I was a clinical research coordinator (CPCRA/ACTG) and nurse researcher/co-investigator (UMDNJ-Newark, ID Clinic) for HIV/AIDS-related industry and government sponsored studies and I have had several oral and poster presentations at national and international conferences.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines,
and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed
in my presentation.
