BIO's Recommendations for National Privacy Legislation

Establishing ownership rights in medical information and samples would require record-keeping obligations that would not only be prohibitively expensive for hospitals and physicians but also would be in direct conflict with the goal of protecting confidentiality. Patients can best be protected and served if their identities are protected from inappropriate disclosure by implementing strong remedies, by keeping samples and records confidential, and by continuing to govern the use of information in medical research and development efforts through current regulations.

Furthermore, as property laws not intended for this kind of application are brought to bear on medical information and samples, there is likely to be an explosion of unnecessary litigation.

Q. Why is it necessary to store tissue samples and medical information for research?

A. Collections of tissue samples are essential to research both in academia and in industry, as well as state and federal public health agencies. Samples from tissue banks may be used, for example, to study the mechanisms and stages of disease, to test new therapeutic compounds, and to understand patterns of disease in populations. Agencies such as the Centers for Disease Control and Prevention use archived samples to look for new forms of disease and to deal with potential immune resistance to drugs.

Tissue samples stored over generations by clinical labs can help families make health care decisions, help to create tumor registries and aid in the design of new diagnostic and treatment protocols. While some samples remain identifiable in order to be useful to the patient in the future, other portions of the samples may be saved in non-identifiable form for quality assurance purposes, such as developing and validating new testing techniques.

Q. Should privacy legislation require the destruction of medical information and samples?

A. No. Legislation should not require the destruction of medical information and samples. Destroying information may conflict with FDA requirements for information collected for clinical trials. Furthermore, requiring destruction of DNA samples could jeopardize the integrity of research projects. These projects are carefully constructed to include certain types and numbers of participants in order to ensure the scientific validity of the research findings. Allowing withdrawal of samples or information would delay research studies, or possibly even force the termination of some studies. Instead, individuals should be permitted to withdraw from research projects as provided under current FDA and NIH regulations.

Q. What type of remedies should be applied to violations?

A. Privacy legislation should provide strong, effective remedies for violations where a pattern and practice of material violations of the legislation are demonstrated. Any consideration of damages should be limited to actual harm proven.

Q. Should states enact different laws to protect privacy?

A. No. Privacy legislation should be national in scope to avoid impeding medical research with a patchwork of inconsistent state laws. Efforts to protect personal health information and research are best served by a uniform standard. Federal law should preempt all state health information law with certain exceptions, such as doctor-patient privilege and licensing.

Research endeavors often cross state lines. Disease crosses borders as well. States that impose greater restrictions on research than a strong national standard could drive research out of a state, denying patients in those states access to clinical research.

In Summary

Privacy of medical information is not a new issue. But as our society acquires more information--and more ways to access it--privacy and confidentiality have become urgent issues. BIO believes that medical information, of which genetic information is an integral part, should be protected by uniform, national legislation. Privacy legislation needs to be constructed carefully and prudently to protect the confidentiality of individuals' medical information, while facilitating medical research that can benefit us all.