LEXIS-NEXIS® Congressional Universe-Document

Search Terms: personal w/5 information w/5 privacy, House or Senate or Joint

Document 224 of 261.

MAY 27, 1999, THURSDAY

SECTION: IN THE NEWS

LENGTH: 2214 words

HEADLINE: PREPARED STATEMENT OF
DR. STEVEN JACOBSEN
DIRECTOR
THE MAYO FOUNDATION
BEFORE THE HOUSE COMMERCE COMMITTEE
HEALTH AND THE ENVIRONMENT SUBCOMMITTEE
SUBJECT - MEDICAL RECORDS CONFIDENTIALITY

BODY:

Chairman Bilirakis, members of the committee, I am Dr. Steve Jacobsen, a physician researcher at Mayo Clinic. Thank you for the opportunity to testify before you regarding the important issue of medical records confidentiality.
Today, I would like to discuss two fundamental questions bearing on this issue. The first is: What is the importance of medical records- based research to the public? And the second is: What is the impact of legislation restricting access to medical records on this category of research?
For the past eight years, I have been privileged to work at the Mayo Clinic. I truly believe that Mayo Clinic's international reputation as a center of excellence in medicine and surgery grew out of its commitment to improve patient care through research, often through the use of the medical record. In fact, our founders, Drs. Will and Charlie Mayo went on record in the early years of this century saying that the best way to improve care was to rigorously evaluate patient outcomes. In order to do this, they and their colleagues designed a unit medical record in which medical data on each patient is stored in one self-contained packet that is kept in perpetuity. This was done so that all information about a patient was immediately available to the physician treating the patient and so that a systematic review of the outcomes of care could be performed easily. They also built indexes that identified records of patients with specific conditions or who had undergone specific procedures. They recognized that there was a wealth of information collected as part of routine clinical care and that no subset of this information could be conceived that would capture sufficient detail for all potential studies. Through these efforts, they set the precedent for the scores of studies of the outcomes of care that have changed medical practice at Mayo Clinic and throughout the world.
Medical records research is vital to maintaining and improving the health of the American public. In fact, virtually every health hazard that we know of today has been identified using information from medical records. Take AIDS, for example. If researchers had not been allowed to study the medical records of patients with unusual immune deficiency problems in the late 1970's, the characterization of the AIDS epidemic would have been delayed at a substantial cost to the public's health. Other examples include studies examining the benefits and risks of estrogen treatment, as well as the health risks of smoking, dietary fats, obesity, and certain occupations. You may have read that an outbreak of invasive streptococcal infection was identified at Mayo in 1995. Without access to the medical records of patients with these unusual infections, characterization of this syndrome and isolation of this deadly bacterial strain would have been delayed. And over one hundred school children - which our research showed were the unwitting carriers of this deadly germ in their throats - would have gone untreated. This discovery led to the designation of invasive strep as a reportable disease. Such a designation permits earlier recognition and control of epidemics. Medical records research is also critical for evaluating the long-term side effects of drugs, the safety of medical devices or procedures, the cost effectiveness of alternative medical practices, and the usefulness of diagnostic tests.
Mayo Clinic, as I mentioned, is committed to improving the practice of medicine and patient care though its long-standing tradition of performing these types of studies, looking at groups of patients. This approach is important because physicians may remember patients who have done well with a particular treatment. Likewise, they can remember the patients who have not. However, they cannot remember these results in sufficient detail to quantify the likelihood of a good or bad result. We use systematic studies of groups of patients so that we can sort out true differences from random outcomes. Furthermore, when we perform these studies, we have to be sure that the findings reflect any true differences and not just the factors related to which medical records were reviewed. I will expand on this in a moment.
Before doing so, however, I need to stress the point that Mayo Clinic also maintains its commitment to the confidentiality of medical information as well. It is one of our most basic tenets that this information is available because of the trust between the patient and the providers of care. All employees are instructed on the importance of confidentiality; there are strict penalties, including loss of employment, for violations of this trust.
As part of this, we strongly maintain that research access IS NOT open access to the medical record. All studies are monitored by our Institutional Review Board. Information is collected from the medical record by trained individuals, usually just one or two for any given study. All of these individuals have been thoroughly briefed about the importance of confidentiality and procedures to help ensure it. The information is summarized and never published in identifiable form. This is not casual access.
As you consider legislation concerning research use of medical records, there are several important factors that I hope you will take into account. These include the importance of medical record research, the potential impact of legislation blocking access to some medical records, and the importance of consistency in the laws across all states.
First, it is important to understand that information from medical record research is vital to patients and their physicians. Most advocates of increased restrictions paint the issue as one of society's need for information versus the patient's right to privacy. However, the patients, themselves, have a great need for this information. Let me give you an example. I recently had a friend who was diagnosed with prostate cancer. Upon hearing of the diagnosis, he immediately had a number of questions. What is going to happen to me? Among each of the treatments, what are the long-term outcomes? Are there things I should tell my sons about their risk of developing this disease? I am sure that if you think back to your own encounters with the medical system, you can think of when you have asked some of those same types of questions. These kinds of questions can only be answered by studying the experience of large groups of patients. It is because of the importance of answering these questions for patients and their physicians that Mayo Clinic maintains it commitment to accurate medical record research.
The second point is that we all need to be concerned about the potential impact of legislation that might block access to some medical records for research purposes. This concern comes from the potential threats to the accuracy of findings of studies due to incomplete ascertainment of outcomes. To illustrate, let me go back to my friend recently diagnosed with prostate cancer. One of the important factors in his decision about whether or not to undergo surgical therapy was the risk of certain side effects. Imagine what would happen if, over the past several years, men who experienced the side effects were upset with their outcome, perhaps blamed their surgeon, and refused access to medical record for research purposes. A study based only on those patients who did not experience those side effects would suggest that the surgery was much safer than in reality. Thus, my friend would be making his decision on the basis of misinformation.

This potential threat is the crux of the concern for limiting access to medical records for research purposes. At Mayo Clinic, we feel it our responsibility to provide patients and their physicians the best possible information so that the best possible decisions can be made.
Is this threat real? I believe the answer is Yes
I was principal investigator of a study recently published in the Mayo Clinic Proceedings, a copy of which is included in the Appendix to my written statement. We conducted this Institutional Review Board approved study to compare the characteristics of persons refusing to provide a general authorization of the use of medical record for research purposes with those who did. This was prompted by passage of a law in the State of Minnesota that limits access to medical records for research except with the prior authorization of the patients in question. Institutionally, we felt it necessary to understand the potential impact of the recent Minnesota bill on the quality of information generated from medical record studies.
In this study among patients recently seen at Mayo Clinic, we found that slightly over 3% of patients explicitly told us, "I do not authorize Mayo to review medical records about me for medical research." Approximately 80% of patients provided us an explicit authorization and 17% did not explicitly give us an indication of their wishes despite three written contacts. This demonstrates the importance of how the response of persons not explicitly expressing their wishes are treated. If considered a No, the effective refusal rate would have been over 20%. This high proportion greatly increases the chance that a bias such as I described in the hypothetical example, could influence the results of any study.
Another important finding was that refusal rates were higher among certain subgroups. In general, women were more likely to refuse authorization than men, persons under 60 years of age were more likely to refuse than older individuals, and patients traveling longer distances for care at Mayo Clinic were less likely to refuse than those from the local community. In addition, we found that persons with certain underlying illnesses, such as mental disorders, breast cancer and reproductive problems were also more likely to refuse authorization. While some of these findings may be somewhat predictable, it is not possible to know how refusal rates might systematically differ between any particular comparison groups.
Furthermore, it is likely that our assessment of potential differences underestimates what would likely be happening at other institutions that don't enjoy the same level of trust and respect from their patients. The bottom line is that the degree of inaccuracy introduced by restricting access to medical records for research purposes is probably not knowable in any particular study and is likely to vary from question to question and from setting to setting. The only way to ensure accurate information is through complete and unbiased inclusion of all medical records.
Finally, this third point that I would like to make relates to the potential harm of allowing the rules regarding research use of medical records to vary from state to state. Mayo Clinic Rochester is about 60 miles west of the Wisconsin border and 40 miles north of the Iowa border. Thus, a substantial proportion of our referral practice comes from these two neighboring states. In fact, Mayo operates in five states. Imagine if you will, the complexity of trying to deal with three separate sets of laws, each with different standards for the use of medical records for research purposes. More important, however, is the concern for different sets of biases imposed as a consequence of these laws. For example, imagine a study comparing the outcomes of prostate cancer surgery in patients from the University of Iowa and Mayo Clinic Rochester. If different laws affected the selection factors for this study, the results would be extremely difficult to interpret. It would be virtually impossible to sort out if any observed differences were due to patient characteristics, processes of care, or simply biases introduced by different laws controlling access to medical records for research purposes. This might preclude the investigator's ability to identify certain patient characteristics or patterns of care that may benefit patients with prostate cancer. It is extremely important that laws concerning the research use of medical records are uniform across all states.
In closing, I would like to emphasize that medical record research is vital to the continued improvement of patient care. Furthermore, information generated from medical record research is essential to patients and physicians as they consider decisions about courses of care. Consequently, it is absolutely essential that this information be as accurate as possible. The only way to ensure this is through complete and unbiased information. At the same time, it is important to recognize the need for confidentiality of information. We mustn't, however, confuse research access with open access to medical information. Mr. Chairman, legislation restricting access to medical records for research purposes does not ensure privacy of personal medical information and does not address the public's concerns regarding the potential misuse of public health information. Instead, it hinders scientific research and puts the public's health and well- being at risk for serious harm. Your attention should be focused on stopping the actual abuses of medical record information that harms patients. Thank you for your attention.
END

LOAD-DATE: June 3, 1999

Document 224 of 261.


Search Terms: personal w/5 information w/5 privacy, House or Senate or Joint
To narrow your search, please enter a word or phrase: