Local perspective of the impact of the HIPAA privacy rule on research

Abstract

BACKGROUNDThe operational and economic impact of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 was evaluated. The setting was a natural experiment which involved a single‐site, clinical research study that was initiated before the enactment of HIPAA and subsequently modified to be compliant with the new policy.METHODSA formative assessment was conducted of the recruitment process to a clinical trial evaluating the efficacy of an educational strategy to inform Veterans about the National Cancer Institute/Department of Veterans Affairs cosponsored Selenium and Vitamin E Cancer Prevention Trial (SELECT). Personnel time and costs were determined based on weekly accrual for study periods before and after the implementation of HIPAA. Root cause analysis was used to assess the recruitment protocol and to identify areas for improvement.RESULTSThe implementation of HIPAA resulted in a 72.9% decrease in patient accrual (7.0 patients/wk vs. 1.9 patients/wk, P < 0.001), and a threefold increase in mean personnel time spent recruiting (4.1 hrs/patient vs. 14.1 hrs/patient, P < 0.001) and mean recruitment costs ($49/patient vs. $169/patient, P < 0.001). Upon review of the modified HIPAA‐compliant protocol, revisions in the recruitment procedure were adopted. The revised protocol improved weekly accrual by 73% (1.9 patients/wk vs. 7.1 patients/wk, P < 0.001) and resulted in improvements in personnel time (5.4 hrs/patient) and recruitment costs ($65/patient).CONCLUSIONEnactment of HIPAA initially placed a considerable burden on research time and costs. Establishing HIPAA‐compliant recruitment policies can overcome some of these obstacles, although recruitment costs and time are likely to be greater than those observed before HIPAA. Cancer 2006. © 2005 American Cancer Society.

Routine data from hospital information systems can support patient recruitment for clinical studies

“…Therefore, researchers who are not directly involved in the care of a patient can no longer recruit that patient HIS for patient recruitment 187 directly [31]. There are reports that patient recruitment and follow-up declined significantly after implementation of HIPAA [32,33]. HIS-based patient recruitment needs to be designed carefully to comply with HIPAA requirements, but it seems to be feasible [17,18].…”

Evaluating the Total Costs of Chemotherapy-Induced Febrile Neutropenia: Results from a Pilot Study with Community Oncology Cancer Patients

“…Second, only cancer patients who received care in 10 community oncology practices were included in this pilot study. However, after the introduction of the Health Insurance Portability and Accountability Act, it may be more expensive to recruit patients to cost of toxicity studies, because health care personnel, rather than research assistants, may be required to identify eligible patients [23]. Third, the choice of the inpatient versus outpatient setting and approach to treatment of febrile neutropenia was based primarily on physician preference, taking into consideration such factors as patient comorbidities and physical examina- tion and laboratory findings.…”

Complications in using automated methods to increase clinical trial accrual

“…In [28], it was shown that HIPAA resulted in a 73% decrease in patient accrual after implementation. Since we did not work without it, we cannot say how much effect it had, but it clearly had a negative effect as seen in the earlier study.…”