J Manipulative Physiol Ther. 2018 (Nov); 41 (9): 807–813 ~ FULL TEXT
Praise O. Iyiewuare, BA, MPH, Ian D. Coulter, PhD, Margaret D. Whitley, BA, MPH, Patricia M. Herman, ND, PhD
University of California Los Angeles,
Southern California Health Sciences,
Santa Monica, California.
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.
KEYWORDS: Chiropractic; Complementary Therapies; Integrative Medicine
From the FULL TEXT Article:
As the landscape of health care delivery and data security in the United States becomes more complex, health care practitioners and their staff must be increasingly knowledgeable about which activities are allowable under the Health Insurance Portability and Accountability Act (HIPAA). Created by U.S. legislators in 1996, HIPAA outlines data privacy and security provisions for safeguarding medical information.  The Act balances the following 2 objectives: (1) the safety and protection of patient health records and (2) the accessibility of such records as necessary to those providing care.
All health care providers and their clinic staff must be HIPAA compliant. Most state associations, including those of doctors of chiropractic and physical therapists, offer courses and presentations to educate their professions about their legal HIPAA responsibilities. Numerous outside organizations offer a variety of online and offline education modules that are also accessible.  Because compliance is a legal obligation, many practitioners and their office managers and staff are rightly concerned about the protection of patient data. However, this can have a chilling effect on practice-based research. It is our experience that while the profession is literate about the HIPAA regulations, they are less educated about the rules regarding research under HIPAA. This lack of knowledge can severely hinder research studies because it increases the difficulty of obtaining data needed to complete such endeavors.
The focus on practice-based primary data collection is beneficial to health care, including complementary and integrative health (CIH); previously known as complementary and alternative medicine), chiropractic, and other professions, for several reasons. First, it re-centers the role of the clinical practice in evidence-based research and increases the likelihood that research focuses more on actual holistic care instead of just modalities such as manipulation or manual therapy. Further, this relationship is more likely to promote comparative effectiveness research, which has advantages for the professions compared with traditional randomized controlled trials.  Given these factors, practice-based primary data collection, which often occurs through the extraction of data from patient charts, will constitute an important source of research data for the chiropractic and physical therapy communities.
The purpose of this paper is to describe the processes we have developed during our research efforts to address these issues. In this paper, we draw on our research project on chiropractic manipulation and mobilization for chronic low back pain and chronic neck pain to explore this issue and to share the solutions we have used. We provide suggestions for other researchers in the United States who want to collect data from chiropractic clinics and similar settings in the United States. Hopefully, the information will also be helpful to practitioners and their staffs as they negotiate the landscape of HIPAA.
Research Under HIPAA in the United States
Chiropractic and other manipulative and manual care is still largely conducted in independent clinical practices and may not be covered in many insurance schemes. Also, the clinical practices are still a mixture of paper and electronic records. In this study, [4, 5] 23% of the clinics had only electronic records, 32% only paper, and 45% a combination. This limits the ability to use large pre-existing electronic and insurance datasets for research. Therefore, for the foreseeable future, much of manual and manipulative research will involve primary data collection from clinical practices with a mixture of record types.
The process of using patient files for research is not an issue when the patient provides informed consent for such access. This consent is distinct from their consent to treat, which they must give. The difficulty arises when the researchers wish to access patient files without first obtaining informed consent.
One may ask why the researchers do not just obtain the patients’ consent to use their files. In many cases this is simply not possible, not practical, or not cost-effective. In these instances, insisting on patient consent might in fact mean the study cannot be done. The task of obtaining the random sample and then approaching all the patients who are included is quite costly because it may require multiple visits to a clinic and considerable time to obtain the consent. When it is not possible, not practical, or not cost-effective to obtain patient consent, conducting research on randomly selected patient files without their prior authorization is difficult. Another example of the logistical problems is if a researcher wanted to access a random sample of all the treatments that doctors of chiropractic have submitted under Medicare.  It would be logistically impossible to obtain patient consent because of the magnitude of the task. Furthermore, given that the files in the sample are randomly selected, the research cannot predetermine which files are to be included and thus cannot obtain patient consent before drawing the sample. However, because such research is imperative to understanding various aspects of patient care, a set of rules has been devised to allow it.
There are rules that allow researchers to obtain patient files without informed consent and without violating HIPAA. The following section will describe the study currently in progress at the RAND Corporation that collected patient files from chiropractic clinics in a manner adherent to these regulations.
In 2014, RAND was funded by the National Center for Complementary and Integrative Health to create a Center of Excellence for Research in Complementary and Alternative Medicine. It was not a clinical trial but was registered as an observational study on ClinicalTrials.gov ID: NCT03162952. The study has been described previously in the literature. [4, 5] Specifically, we were to investigate the appropriateness of manipulation and mobilization for chronic low back and neck pain. At over $8 million, this is one of the largest studies ever funded by the National Institutes of Health to study chiropractic care.
Given the huge concern about the opioid epidemic in the United States, [6, 7] the execution of this project is quite timely. There is currently a huge interest in the United States in nonpharmacological alternatives for pain treatment, and chronic back and neck pain are 2 of the most prevalent forms of pain. As such, the chiropractic profession may be strategically placed to provide such care. However, to do so may require the profession to produce data to answer following questions:
1.How much chronic low back and neck pain do chiropractors treat?
2.What are the treatments delivered?
3.How much of said treatment is appropriate?
4.What outcomes do patients derive from this care?
5.What are the costs of the treatment to the patients or insurance companies?
To date, there exists very little information and even less data to answer these questions.
The RAND chiropractic study was designed to provide the answers.
Although a full description of the study is beyond this article,  addressing these questions required that we recruit chiropractic clinics across the United States using a systematic stratified cluster sample (New York, Minnesota, Oregon, Texas, Florida, California), and in those clinics, we did 2 things. We enrolled a prospective sample of patients with chronic back and neck pain and followed them over 3 months to record their outcomes, preferences, and costs associated with chiropractic care. All patients in this prospective sample were recruited in chiropractic clinics using web-enabled tablets, then consented, enrolled, and followed in the study via online surveys. Using this method, we recruited 2,024 patients, 83% of whom completed the final 3–month survey. Of those recruited, 92% signed a consent to also release their patient files to the research team so that we could abstract information from those files. For the second part of the study, we drew a random sample of files from each clinic’s chronic back and neck pain patient population to examine the care received by these individuals. Combined, obtaining the files of the patients who completed the online surveys (prospective sample) and the files of the randomly selected patients (retrospective sample) was termed the “chart pull” portion of the study. In total, around 80% of the clinics participated in the chart pulls. From those, we had 1,477 charts from patients who participated in the study and 2,116 carts obtained randomly.
Most of the 125 participating chiropractic clinics had no problem with our methods for enrolling patients and gathering their data via the online surveys. For the chart pull portion of the study, which occurred after the web survey data collection period ended, participating chiropractic clinics had to do the following: (1) obtain the files of patients who provided prior consent (the prospective sample), (2) obtain the files of the patients randomly selected using specified randomization procedures (the retrospective sample), and (3) transfer all patient data to RAND via an encrypted file. To assist with this process, we offered to either send a RAND study team to the clinic and work with staff to obtain and transfer all requested patient files or train clinic staff (via either in-person visit or phone call) and provide all necessary equipment for them to obtain and transfer the requested patient files.
Most of the participating clinical practices had no concerns about obtaining and transferring the files of patients who provided informed consent, but many were uneasy about allowing the study to access the randomly selected files of patients who had not provided any prior authorization. For some of the clinics, it caused some concern about the legality of obtaining the files. This was often raised by the officer manager or, in some instances, the legal advisor to the clinic. This then made us revisit the question of what do we need to provide to clinics to deal with this concern. But it also raised in our minds that this should perhaps be a standard process for all clinics we approach in future studies. The following section outlines the method used to allay concerns.
Our approach to addressing concerns about sharing patient files focused on providing a review of the HIPAA rules, noting why sharing the data in these files was important and how the study complied with the rules. We also provided, if requested, a confidentiality agreement between the clinic and the study team that was signed by both the study’s principal investigator and RAND’s contracts office.
By using this comprehensive approach to address the HIPAA concerns associated with collecting patient files, we have been largely successful. Using these protocols, 90 of the 125 study clinics provided patient files for the study. Of the 90 clinics, only 3 refused to provide patient files for the random sample. This highlights that most of those who gave patient chart data at all also gave us patient chart data for the random sample.
It is imperative to the profession that practitioners who employ manipulation and mobilization, and the individuals leading the professions’ educational programs and advising clinics on HIPAA regulations, are well versed on the rules for conducting research that involve patient data collection. All practitioners must understand that adhering to HIPAA regulations is not a barrier to research participation; if fact, these laws allow for the collection of such patient data provided certain safeguards are in place. With this paper, we have explained the stipulations under which the HIPAA Privacy Rule allows for use of identified patient information without prior patient authorization and demonstrated the steps taken in our current study to comply with these regulations. It is our hope that in providing this information, practitioners will continue to participate in studies that require the release of protected patient information because they may ultimately benefit both the patients and the professions. We must add that HIPAA does not replace or in any way diminish the obligations of going through a full IRB review. All the protocols shared here and described here also were reviewed by the human protection committee at RAND. The Health Insurance Portability and Accountability Act adds another layer of protection to participants that must be followed by those conducting research, albeit while allowing the research to occur. Charts cannot be obtained for research without having an IRB review. It meets the 2 requirements for all IRB reviews: it is research and it is on humans. There is an expanding literature base on HIPAA that deals with the rules and regulations, what is covered, and what is not. [11–13]
For further detail about HIPAA and a waiver of patient authorization for identifiable patient health information, [8–10] please visit: https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html?language=es.
Information about HIPAA applies in the United States, although other countries do have similar rules regarding protection of the patient’s privacy. The approach adopted here was developed specifically for RAND and for this particular research project, so it may be limited in other applications. Other projects should adapt this method or use other methods to confront different problems, but the general principles should be the same.
For this study, we provided clinics with information about what the rules are 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. We hope that the process we developed will assist other CIH researchers and practitioners in future studies.
The paper contains information for CIH researchers who might wish to conduct practice-based research.
This information also is helpful to chiropractic practitioners who might want, or be asked, to participate in research and must know what the HIPAA rules are for research.
Funding Sources and Conflicts of Interest
This study was funded by the NIH’s National Center for Complementary and Integrative Health Grant No: 1U19AT007912-01. No conflicts of interest were reported for this study.
Concept development (provided idea for the research): P.O.I., I.D.C., M.D.W., P.M.H.
Design (planned the methods to generate the results): P.O.I., I.D.C., P.M.H.
Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): I.D.C., P.M.H.
Data collection/processing (responsible for experiments, patient management, organization, or reporting data): P.O.I., I.D.C., M.D.W.
Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): P.O.I, I.D.C., M.D.W.
Literature search (performed the literature search): P.O.I.
Writing (responsible for writing a substantive part of the manuscript): P.O.I., I.D.C., M.D.W.
Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): P.O.I., I.D.C., M.D.W., P.M.H.
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