Potential Adverse Impact of HIPAA on Clinical Research

Abstract & Commentary

By David J. Pierson, MD, Editor, Professor, Pulmonary and Critical Care Medicine, Harborview Medical Center, University of Washington, is Editor for Critical Care Alert

Synopsis: Because of the requirement for advanced written consent prior to patient contact for a telephone interview, participation in a follow-up study using an established registry of patients after acute coronary syndromes fell from 96% in the pre-HIPAA period to 34% in the post-HIPAA period.

Source: Armstrong D, et al. Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome. Arch Intern Med. 2005;165:1125-1129.

Implementation of the Health Insurance Portability and Accountability Act (HIPAA), and especially its Privacy Rule, has affected everyone who works in health care. This study from the University of Michigan sought to determine the potential effect of the Privacy Rule on the conduct of clinical research in the form of a telephone interview-based follow-up study. The patients were a consecutive group of patients with acute coronary syndrome prior to implementation of the HIPAA rules, and a similar group of patients after the HIPAA rules were put into effect. Armstrong and colleagues used a quasi-experimental pretest-posttest study design to assess participation rates in a telephone follow-up study in these cohorts. The pre-HIPAA period included telephone interviews, conducted 6 months after hospitalization for an acute coronary syndrome, for which verbal informed consent was sought from the patients. In the post-HIPAA period, telephone contact could not be initiated until written informed consent had been received by Armstrong et al, using a mailed form requesting permission to conduct the interview. Armstrong et al determined incremental costs involved in this study once the HIPAA rules were put into force, as well as the percentage of patients who provided consent.

There were 1221 patients in the pre-HIPAA group and 967 patients in the post-HIPAA group. Overall success in obtaining 6-month follow-up occurred in 1177 patients (96.4%) in the pre-HIPAA period and in 329 (34.0%) patients in the post-HIPAA period (P < 0.01). In the post-HIPAA period, 343 patients returned a completed consent form, 95.9% of whom granted consent; 112 forms were not sent out, in part because of "administrative oversights associated with instituting several simultaneous requirements" of HIPAA, and 490 patients failed to respond to the mailed request. Only 14 of the patients (4.1%) who returned the form refused consent. The authors calculated that the additional costs of HIPAA compliance, over and above the other costs of conducting this study, were $8704.50, including $4146.00 in start-up costs and $4558.50 per year in ongoing costs.

Commentary

No one working in US health care has been unaffected by the implementation of HIPAA. The act has reduced inappropriate divulgence of protected health information, but the methods by which this important goal has been achieved have also created headaches for both clinicians and researchers. This article reports the impact of the HIPAA requirement for written informed consent prior to telephone contact for the purposes of research. Armstrong et al, established investigators at a major academic medical center with an established registry of patients who had experienced an acute coronary syndrome, found that their ability to contact the patients and do the research was markedly impaired, at least under the conditions of this investigation.

As Armstrong et al note, this experience at a single center may not be representative of those of clinical researchers elsewhere. The initial period of HIPAA implementation has been a time of learning and adjustment for everyone. It is possible that investigators at other centers will be more successful in carrying out their work in the face of the HIPAA Privacy Rule. Armstrong et al admit that they employed a conservative interpretation of the rule in designing this study, although they point out that the harsh penalties mandated by the HIPAA Privacy Rule create a strong incentive for research centers to interpret it strictly. They caution that "although everyone agrees that maintaining patient privacy is a laudable goal, the HIPAA Privacy Rule may create a substantial burden and prohibit the development of valuable research."

The impact of the new, more stringent privacy regulations, both on clinicians’ access to needed information for patient management and on investigators’ abilities to carry out valid clinical research, remains to be fully demonstrated. Clinicians and researchers-as well as patients and their families-should follow future study findings and policy rulings relating to this issue closely.