BIO Testifies Proposed Rule On Confidentiality Of Patient Records Could Impede Research

WASHINGTON, D.C. (April 26, 2000) Dr. Joanna C. Horobin, testifying on behalf of the Biotechnology Industry Organization (BIO), said today the Clinton administration’s proposed rule for confidentiality of medical records could impede biotech drug development by precluding access to information essential for research even though that information does not compromise patient privacy.

Dr. Joanna C. Horobin, senior vice president of commercial development for EntreMed Inc. of Rockville, Md., testified at a hearing called by the Senate Health, Education, Labor and Pensions Committee. The hearing examined proposed federal regulations for protecting the privacy of individually identifiable health information maintained or transmitted for certain administrative and financial transactions.

Dr. Horobin said BIO supports strict confidentiality guidelines that not only protect patient privacy, but also allow medical researchers to share information vital to development of life-saving therapies and cures. She observed that BIO favors adopting federal legislation to achieve this balance. Dr. Horobin’s testimony is posted on BIO’s website (

Dr. Horobin pointed out that the Clinton administration’sproposal does not recognize that medical researchers must use and share -identity-encoded medical information where there is no potential for compromises in patient confidentiality. During the public debate over patient privacy, no one from patient groups to privacy advocates, providers, payers and government officials has said that research should be made more difficult or costly by the legal framework established to protect medical confidentiality. Unfortunately, the proposed rule has precisely that unintended adverse effect.

Federal legislation and regulation, Dr. Horobin observed, must facilitate the legitimate research uses of medical information to help ensure that the biotechnology industry will continue to develop the most effective breakthrough drugs and vaccines for patients, many of whom currently have no treatment options.

BIO represents more than 900 companies, academic institutions and state biotech centers in 47 states and 26 nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.