Abstract
Objective
This paper describes a process for ensuring and documenting Health Insurance Portability
and Accountability Act (HIPAA) compliance in clinical practice-based research.
Methods
The Center of Excellence for Research in Complementary and Alternative Medicine was
funded by National Center for Complementary and Integrative Health to develop the
methods for researching the appropriateness of care in complementary and integrative
health, which previously was known as complementary and alternative medicine. We recruited
125 participating chiropractic clinics for enrolling patients and gathering their
data via the online surveys. Chiropractic clinics completed the following: (1) obtained
the files of patients who provided prior consent (the prospective sample), (2) obtained
the files of the patients selected randomly using specified randomization procedures
(the retrospective sample), and (3) transferred all patient data to the RAND Corporation
via an encrypted file.
Results
Most of the doctors of chiropractic from clinical practices had no concerns about
obtaining and transferring the files of patients who provided informed consent. However,
some doctors were uneasy about allowing the researchers to access the randomly selected
files of patients who had not provided prior authorization. This led us to develop
a set of forms to provide clinics about HIPAA compliance.
Conclusion
For this study, we provided clinics with information about the rules under HIPAA,
demonstrated how the study complied with those rules, explained the logic behind the
necessity for collecting files from both the prospective and retrospective samples,
and, if requested, provided clinics with a confidentiality agreement signed by the
study principal investigator and an organizational contracts representative. The process
we developed may assist other complementary and integrative health researchers and
practitioners in future studies.
Key Indexing Terms
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Article info
Publication history
Published online: February 10, 2019
Accepted:
November 2,
2018
Received in revised form:
October 9,
2018
Received:
October 3,
2018
Identification
Copyright
© 2018 by National University of Health Sciences.
