HIPAA's Effect on Patient Enrollment in Clinical Trials

Abstract

Ommani, Sophia J., HIPAA’s Effect on Patient Enrollment in Clinical Trials. Master of Medical Science, August, 2002, pp. 88, 10 tables, 11 figures, references, 34 titles. The new regulation disseminated under the Health Insurance Portability and Accountability Act may impose serious restrictions as to how medical information can be used and disclosed. The law’s basic provisions began to take effect in 1997 with three principles: 1) to make it possible for people to get coverage even when they have past or present medical conditions/health factors, 2) to help people maintain the coverage needed when changing insurance or jobs, and 3) to make insurance more accessible for those who work in small businesses. A separate provision in the law imposes strict regulations on the privacy and security or patient health information. This provision has created the need to conduct research on the impact that this will have on a variety of health care issues. While some clinical practice research may be conducted without information linked to medical records, other research relies on personal identifiers to track treatment of an individual over time or link multiple sources of patient information. A randomized study was conducted to test the hypothesis that HIPAA would effect patient enrollment in clinical trials, and results supported the hypothesis. A lack of 1) willingness to authorize release of medical information and 2) a lack of understanding of the informed consent with the HIPAA language were the two predominant reasons given for refusing to sign.