Honest Brokers for Secure Deidentification of Patient Records
Project – CSE 5810 – Introduction to
Biomedical Informatics
Krishna Kalaparti
Date: 04/20/2016
Agenda
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Honest Brokers – Background
What is a Honest Broker?
What can a Honest Broker do?
21 items in PHI which should be de-identified by the Honest Broker
Use of Honest Broker Creation of a Data Set
Optimal Roles of the Honest Broker
Review of the Honest broker system of the Ohio State University
Medical Center
• Summary of Honest Brokers in 10 biomedical research organizations
• Future Work
Honest Brokers – Background
• The collection and use of human specimens have become essential to
biomedical research.
• Coupled with associated clinical data and the power of bioinformatics,
these specimens represent an invaluable resource for current and
future research on human health and disease.
• At the same time, there are significant ethical, legal and social policy
implications relating to the collection, storage and use of bio
specimens.
• Institutions, investigators, institutional review boards(IRBs), funding
agencies and the public are struggling with issues like informed
consent, ownership, stewardship, genetic testing and future uses that
are often unspecified at the time specimens are first obtained.
• The research community would benefit from federal-level guidance.
Background Continued…
• The HHS Secretary's Advisory Committee on Human
Research Protections(SACHRP) formed a Subcommittee,
which deliberated on these issues and presented its
recommendations to SACHRP for further discussion and
approval.
• The goal of the recommendations was to provide a framework
for IRBs, institutions and investigators to consider individual
research scenarios without prescribing the final outcome,
recognizing that those decisions will always be case-specific.
What is a Honest Broker?
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According to the recommendations, the following concepts have been
defined:
– Honest Broker:
A neutral intermediary (person or system) between the individual
whose tissue and data are being studied and the researcher. The
honest broker collects and collates pertinent information regarding
the tissue source,
replaces identifiers with a code, and releases
only coded information to the researcher.
– Code:
• is a means to identify information (such as name or social
security number) that would enable the investigator to readily
ascertain the identity of the individual to whom the private
information or specimens pertain has been replaced with a
number, letter, symbol or a combination thereof
• a key to decipher the code exists, enabling linkage of the
identifying information to the private information or specimens.
Adapted from: http://www.hhs.gov/ohrp/sachrp/commsec/attachmentdfaq'stermsandrecommendations.pdf.pd
More on Honest Broker
• A Honest Broker is a neutral intermediary(person or system), who is a
workforce member and is certified to collect specified health
information from the tissue or data bank, remove all patient
identifiers, and provide the de-identified health information or tissue
to research investigators, clinicians, or other healthcare workforce
members, in such a manner that it would not be reasonably possible
for any individual to identify the patients directly or indirectly based on
the data.
• The purpose of the honest broker policy is to establish standard
operating procedures for de-identification of Protected Health
Information(PHI) for the purpose of safely and securely linking
together or sharing clinical data to support research in compliance
with HIPAA and IRB requirements.
Adapted from: https://wiki.unmc.edu/index.php/Honest_Broker
What can an honest broker do?
• An Honest broker can provide a firewall between the investigator
and the subjects' identifiable information.
• For example, an honest broker could generate or receive a
dataset and then strip out subject identifiers so that the data was
no longer readily identifiable. They could either create a deidentified data set or a limited data set.
• Additional protections for confidential information:
– The honest broker can add a layer of protection to enhance
the confidentiality of subjects' data and specimens.
– This typically involves prospectively collected data and
specimens.
– For example, CAG uses the honest broker to encrypt the data
and specimens collected so that the researchers are no
longer able to identify the individuals from whom they were
obtained.
What can an honest broker do?
• Converting identifiable data into data/specimens that are not readily
identifiable:
– When the research involves existing specimens - from clinical
care or prior research - using an honest broker can alter the
regulatory category of the research by providing the investigator
with data and bio specimens that are not readily identifiable.
– This makes the secondary use of the data/specimens not human
subjects research and therefore, without requirements for prior
IRB review and approval. If an investigator strips out the
identifiers themselves, the research would require a
determination of exemption.
• If the data provided by the honest broker contains dates or zip codes
then the data set is considered a limited data set/bio specimens.
The data provider and the data recipient must enter into a data use
agreement before the data/specimens are shared. This does not
require IRB review or approval.
21 items in PHI which should be deidentified by the Honest Broker
Adapted from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4690386/pdf/peerj-03-1506.pdf
Use of Honest Broker Creation of a
Data Set
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An honest broker is an individual who has access to the desired data by
virtue of his or her Hospital responsibilities and who is not involved as a
listed researcher on the respective research study.
– The honest broker accesses the desired medical record information and
provides the researcher with de-identified data or a limited data set.
– If the honest broker is providing the researcher with a limited data set,
the broker must present an internal data use agreement to the
researcher prior to receiving the data set.
– The honest broker can assign a code to the data, provided that the
researcher does not have access to the information linking the code to
the identities of the research subjects. Using the code, the researcher
can request, through the honest broker, additional medical information
corresponding to a given research subject.
– If the honest broker provides coded data to the research but not the
method to de-code the data, then the information provided will be
considered de-identified or a limited data set depending upon the data
elements included in the data set.
Adapted from: https://irb.research.chop.edu/honest-broker
Optimal Roles of the Honest Broker
The Optimal roles that can be considered ideal for the Honest
brokers can do the following functions:
– sufficient de-identification of clinical data;
– sufficient independence from any form of study team;
– thorough examination of secondary use of clinical data for
purposes restricted to those approved by the IRB; and
– efficient provision of de-identified data to researchers.
Review of the Honest broker system of
the Ohio State University Medical Center
The Information Warehouse at the Ohio State University Medical
Center is a comprehensive repository of business, clinical, and
research data from various source systems. Data collected here is a
valuable resource that facilitates both translational research and
personalized healthcare. The use of such data in research is governed
by federal privacy regulations with oversight by the Institutional Review
Board. In 2006, the Information Warehouse was recognized by the
OSU IRB as an Honest Broker of clinical data, providing investigators
with de-identified or limited datasets under stipulations contained in a
signed data use agreement. In order to streamline this process even
further, the Information Warehouse is developing a de-identified data
warehouse that is suitable for direct user access through a controlled
query tool that is aimed to support both research and education
activities.
The Information Warehouse Honest
broker at the OSUMC
Adapted from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2815386/pdf/amia-f2009-370.pdf
How does the Information Warehouse
work at the OSUMC
• Under the Honest Broker protocol implemented for the Information
Warehouse at the OSUMC, a researcher typically signs a data use
agreement with the IW when they request a de-identified or a limited
dataset.
• IW data analysts prepare the resulting data by removing PHI and deliver
the dataset as a bundle of coherently linked files to the researcher.
• To safeguard against accidental identification, resulting datasets with
less than 25 records are not delivered, only aggregate numbers are
reported to the requestor.
• Re-queries based on previous results are not allowed.
• De-identified codes are changed between datasets to inhibit longitudinal
study of particular subjects.
• Furthermore, should an inadvertent identification occur, the Data Use
Agreement stipulates that the investigator will immediately seek IRB
oversight.
Summary of Honest Brokers in 10
biomedical research organizations
Adapted from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4690386/pdf/peerj-03-1506.pdf
Future Work
• Review of the implementations of the Honest
Broker systems at other medical research
centers.
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