Journal of Medical Systems

, Volume 30, Issue 1, pp 65–69 | Cite as

Barriers of HIPAA Regulation to Implementation of Health Services Research

  • Jay J. Shen
  • Linda F. Samson
  • Elmer L. Washington
  • Phyllis Johnson
  • Constance Edwards
  • Amy Malone
Research Article


Although many perspectives on the impact of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) on health services research have been wide spread, little empirical evidence has been reported about HIPAA-related barriers during the implementation of research projects. Using three cases of health services research projects, this study examined practical barriers created by HIPAA regulation. During the stage of implementation of the three projects, we experienced some HIPAA-related concerns, previously raised in the field of health services research. We found that technically complicated consent forms and privacy protection forms as well as socially-sensitive clinical conditions make patients less willing to participate in research projects; concerns about safety of patient medical information makes health organizations more hesitant to let researchers have access to the patient’s information, especially through electronic transfer; more restrictive IRB processes and challenging patient recruiting processes make health services researchers reluctant to go through the process; and as a result, they may compromise with the scientific soundness of the project. Overall, HIPAA complicates the research process and requires more resources and longer time to conduct research.


HIPAA Health Services Research IRB Consent form 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Ross S, Lin C (2003) The effects of promoting patient access to medical records: A review. J Am Med Inform Assoc 10(2):129–138CrossRefGoogle Scholar
  2. 2.
    Dimond K (2002) The impact of privacy regulations on clinical research. J Biolaw Bus 5(3):50–53Google Scholar
  3. 3.
    Amatayakul M (2002) American health information management association. Another layer of regulations: Research under HIPAA. J Am Med Inform Assoc 74(1):16A–16DGoogle Scholar
  4. 4.
    Kulynych J, Korn D (2003) The new HIPAA (Health Insurance Portability and Accountability Act of 1996) medical privacy rule: Help or hindrance for clinical research? Circulation 108(8):912–914CrossRefGoogle Scholar
  5. 5.
    Olsen D (2003) HIPAA privacy regulations and nursing research. Nurs Res 52(5):344–348CrossRefMathSciNetGoogle Scholar
  6. 6.
    O'Herrin J, Fost N, Kudsk K (2004) Health Insurance Portability Accountability Act (HIPAA) regulations: Effect on medical record research. Ann Surg 239(6):772–776, discussion 776–778CrossRefGoogle Scholar
  7. 7.
    Cook County Health Department, Statistics: 2000 census data. 2004. Available at Accessed on November 3, 2004
  8. 8.
    Swoboda C (2004) Steps for Kids 2003. Food and health communications. Available at Accessed on August 23, 2004
  9. 9.
    Lucas C, Zhang H, Fisher P, Shaffer D, Regier D, Narrow W, Bourdon K, Dulcan M, Canino G, Rubio-Stipec M, Lahey B, et al. (2001) The DISC predictive scales (DPS): Efficiently screening for diagnoses. J Am Acad Child Adolesc Psychiatry 40(4):443–449CrossRefGoogle Scholar
  10. 10.
    Derlet RW, Richards JR (2000) Overcrowding in the nation's emergency departments: Complex causes and disturbing effects. Ann Emerg Med 35(1):63–68CrossRefGoogle Scholar
  11. 11.
    Lambe S, Washington DL, Fink A, Laouri M, Liu H, Scura FJ, Brook RH, Asch SM (2003) Waiting times in California's emergency departments. Ann Emerg Med 41(1):35–44CrossRefGoogle Scholar
  12. 12.
    Miro O, Antonio MT, Jimenez S, De Dios A, Sanchez M, Borras A, Milla J (2000) Decreased health care quality associated with emergency department overcrowding. Eur J Emerg Med 7(1):79–80Google Scholar
  13. 13.
    National Center for Health Statistics, 2004, National Health and Nutrition Examination Survey. Available at Accessed on January 3, 2005
  14. 14.
    Office of Human Subjects Protections. Consent forms from federal regulation, 2004. Available at Accessed on September 3, 2004

Copyright information

© Springer Science + Business Media, Inc. 2006

Authors and Affiliations

  • Jay J. Shen
    • 1
  • Linda F. Samson
    • 2
  • Elmer L. Washington
    • 3
  • Phyllis Johnson
    • 2
  • Constance Edwards
    • 4
  • Amy Malone
    • 5
  1. 1.Department of Health Administration, College of Health ProfessionsGovernors State UniversityUniversity Park
  2. 2.College of Health ProfessionsGovernors State UniversityUniversity Park
  3. 3.Aunt Martha’s Youth Service CenterChicago Heights
  4. 4.Department of NursingGovernors State UniversityUniversity Park
  5. 5.Department of Physical TherapyGovernors State UniversityUniversity Park

Personalised recommendations