With the increasing computerization of medical records and the consolidation of the health care system, people have become more concerned about the potential threat to the confidentiality of individual health information. The biotechnology industry and the health community believe that it is of paramount importance to provide strong protections for sensitive patient health information. Patients do not want sensitive health information about them to be inappropriately disclosed or used against them. Patients also want access to their medical records and to have procedures in place to inspect and correct information in these records.
While it is critical to ensure confidentiality, most patients are comfortable with and support the use of health information to undertake important medical research. Biotechnology research relies on medical information to perform the studies that identify new treatments and cures. Access to accurate and timely medical information is crucial to the research, development of and proper use of biotechnology products to treat patients. It is imperative that patient identifiable information meet high standards of security to ensure patient confidence in quality health care. With complete, accurate medical information, doctors will be assured that they are using accurate information to make decisions about a patient's health care, including whether to use a biotechnology product for a given patient.
We urge Congress to pass comprehensive confidentiality legislation that protects patients while facilitating the positive uses of medical information for treating patients and continuing the breakthrough scientific achievements that are taking medicine into the 21st century. As Congress seeks to protect medical information, we hope it will ensure that the entrepreneurial biotechnology industry can continue to develop new treatments that can dramatically improve the lives of people with serious conditions.
The public has a strong interest in the medical achievements of biotechnology. Restricting access to important patient data would slow research efforts and might make it impossible to follow promising research leads. Individual privacy can be protected without burdening biotechnology research with onerous authorization requirements and additional layers of review that do not enhance confidentiality. For example, it would be virtually impossible to recruit patients to participate in a clinical trial of a product to treat a small sub-population with a specific genetic disease if a researcher could not use biological samples to identify the subset of people whom the product might benefit.
Defining what sensitive health information should be protected is critical to the debate. Federal confidentiality laws should protect sensitive patient health information as "protected health information." This includes any medical information created by a health care provider or a health plan that identifies the individual and relates to the past, present or future health or health care of the individual.
Medical information is extremely useful in the clinical and epidemiological research that forms the foundation for developing new biotechnology products. Medical information that does not reveal the individual's identity, such as information from which the name, address and social security number have been encrypted or replaced with an alphanumeric code, should not be subject to federal law. People's privacy can be protected by utilizing coding and encryption technologies, by security laws and careful restriction of the codes, and by strong penalties for unauthorized use of any such code or de-encryption device to reveal the individual's identity.
Furthermore, genetic information should be given the same strong protections as all medical information. As our understanding of science progresses, we recognize that virtually all medical facts have a genetic component. All medical information, including information about infectious or genetic diseases, is extremely sensitive and deserves strong protection.
Currently, patients who participate in clinical trials are protected by FDA oversight and the Common Rule, as applicable. This includes the safeguards of oversight by an Institutional Review Board (IRB), and its application of appropriate informed consent requirements and assurance of confidentiality of sensitive health information. Creating additional, or conflicting burdens on the collection and use of information is neither necessary nor appropriate.
Medical archives of tissues and other biological materials are valuable public resources that must be preserved for use by medical researchers. Science is a process of constant discovery. What the scientist is looking for today may not have been imaginable yesterday. For example, sequencing the human genome, which is well within our grasp, was widely believed to be impossible until very recently.
Thus, even when patients provide informed consent for their materials to be used for research purposes, it is impossible to anticipate the specific tests and purposes for which such materials may be used. Because providing tissue samples allows science to proceed, possibly benefitting many generations, we must be careful not to impose overly burdensome consent requirements or mandatory destruction of archived samples, particularly where those materials do not disclose the individual's identity.