Congress must act before August. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires Congress to pass federal standards for the confidentiality of patient health information by August 1999. If Congress does not do this, responsibility automatically goes to the Department of Health and Human Services (HHS) to prepare regulations solely regarding the use and disclosure of patient information in certain electronic transactions. If Congress does not set forth comprehensive federal standards, the country will remain mired in a patchwork quilt of potentially contradictory existing and forthcoming state laws.
Uniform protections imposed at the national level are needed to preserve patient confidentiality and to foster medical research. Clinical trials are necessarily multi- state ventures. National uniformity allows researchers to create informed consent procedures and forms that meet the needs of patients and comply with the law in all states.
Further, national uniformity will enhance the public's confidence that their medical information is subject to strong protections. It also will enhance a patient's willingness to share information with biomedical researchers. Giving people greater confidence in the uniform security of their medical information will promote higher quality health care and facilitate better research to treat disease.
We urge the Congress to enact strong federal laws that safeguard the public's interest in medical privacy and biomedical research, while preempting state laws that inhibit essential access to information for research.
The Biotechnology Industry Organization is an industry organization representing over 850 biotechnology companies, academic institutions and state biotech centers and related organizations in 46 states and more than 26 countries. BIO members are involved in research and development of health care, agricultural, industrial and environmental biotechnology products. For more information contact Nancy Myers, Director of Federal Government Relations at (202) 776-0602.