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Document 69 of 103.

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JULY 20, 1999, TUESDAY

SECTION: IN THE NEWS

LENGTH: 2784 words

HEADLINE: PREPARED TESTIMONY OF
G. RICHARD SMITH, JR., M.D.
PROFESSOR OF PSYCHIATRY AND MEDICINE
UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES
BEFORE THE HOUSE COMMITTEE ON WAYS AND MEANS
SUBCOMMITTEE ON HEALTH
SUBJECT - MEDICAL RECORDS' CONFIDENTIALITY LEGISLATION

BODY:

Mr. Chairman and members of the Subcommittee, I am Richard Smith, M.D., Professor of Psychiatry and Medicine at the University of Arkansas for Medical Sciences. I am a practicing psychiatrist and also conduct mental health services research. I lead the Centers for Mental Health Services Research at the University of Arkansas, which is one of the nation's largest mental health and services research groups, as well as our College of Medicine's health services research program. I am a recent past member of the National Mental Health Advisory Council for the National Institute of Mental Health (NIMH). I also chaired the NIMH Initial Review Group for mental health services research, which reviews virtually all of the mental health services research grant applications submitted to NIMH.
I am speaking today on behalf of the Association of American Medical Colleges (AAMC). The AAMC represents the nation's 125 accredited medical schools, nearly 400 major teaching hospitals and health care systems, more than 87,000 faculty in 89 professional and scientific societies, and the nation's 67,000 medical students and 102,000 residents.
The AAMC strongly supports the general intent of current Congressional efforts to strengthen the protection of individuals' personally identified health information from inappropriate and harmful misuse that can lead to discrimination or stigmatization.
Confidentiality legislation must acknowledge the compelling public interest in continuing to ensure access to patient records and other archival materials required to pursue biomedical, behavioral, epidemiological and health services research. Medicine has always been, and largely remains to this day, an empirical discipline, and the history of medical progress has been created over many centuries from the careful, systematic study of normal and diseased individuals. From those studies has emerged our present level of understanding of the definition, patterns of expression and natural history of human diseases, and their responses to ever improving strategies of diagnosis, treatment, and prevention. In particular, health services researchers continue to depend upon the ready accessibility of archival materials to collect the large and appropriately structured and unbiased population samples required to generate meaningful conclusions regarding the incidence and expression of diseases in specified populations, the beneficial and adverse outcomes of particular therapies, and the medical effectiveness and economic efficiency of the health care system. Indeed, in the present climate of major public concern about the costs, quality, and efficiency of our rapidly changing health care delivery system, the need to support and promote such retrospective epidemiological and health services research has become an urgent priority.
The AAMC strongly believes that in attempting to deal with the difficult issues of medical information confidentiality, the most feasible and effective approach is not to erect costly and burdensome new barriers to accessing medical information required to conduct research. Rather, legislative efforts should be directed, as most of the current proposals attempt to do, toward requiting the establishment of strong administrative, technical and physical safeguards to protect the confidentiality, security, accuracy and integrity of information that directly identifies an individual. Included among these safeguards should be strong institutional policies of confidentiality, which might appropriately meet federal standards to be developed. To complete the "security package," legislation should specify stiff criminal, civil, and administrative penalties for intentional or recklessly negligent actions that violate medical information confidentiality. With stringent security requirements of this kind in place, the AAMC believes that legislation should refrain from attempting to construct elaborate barriers to the relatively unimpeded flow of medical information that is required for the promotion of a comprehensive national agenda of medical research.
Given the substantial penalties contained in the confidentiality bills now in draft or under consideration, it is imperative that bills' definitions be crafted with great clarity. Of particular importance is the definition of "individually identifiable health information," the class of medical information most in need of protection from inappropriate disclosure and harmful misuse, and correspondingly of "non-individually identifiable health information," the class that would fall outside the purview of confidentiality legislation. The AAMC believes that the protected class of medical information should be sharply circumscribed and limited to "information that directly reveals the identity or provides a direct means of identifying an individual." Such a definition is least ambiguous and incorporates the sum and substance of the information that the public is most concerned to protect.
Correspondingly, the definition of"nonidentifiable health information" should encompass "information that does not directly reveal the identity of an individual." This definition should explicitly include coded or encrypted information (sometimes called "anonymized"), whether or not the information is linkable to individuals, as long as the encryption keys are secured and kept separate from the encrypted information itself. The justification for including encrypted, linkable information in the definition of nonidentifiable health information is significantly strengthened by adding additional provisions that make it a crime to attempt to use encrypted patient data to discover an individual's identity by any means other than the lawful use of an encryption key.
The AAMC believes that a set of properly constructed definitions of protected health information and nonidentifiable health information will serve both to foster medical research and establish an incentive system for using nonidentifiable health information in such research to the maximum extent practical.
The AAMC is especially concerned about the conduct of secondary research on archival patient materials. These studies utilize patient records as primary research materials and do not involve interaction with individual patients. In mental health services research, for example, secondary research on patient records has established that pediatric patients treated for attention deficit disorder (ADHD) were far less likely to use and become dependent upon illegal drugs during adolescence and young adulthood than patients with ADHD who had not received appropriate treatment. Archival data were essential in recently establishing the safety of the new generation of antidepressant drugs (selective serotonin reuptake inhibitors) on the fetuses of mothers who had been receiving these chugs chronically for the treatment of depression. As these examples suggest, archival patient data are critical to establishing the post-marketing safety and effectiveness of drugs. Since many patients with major mental illness require long-term medication treatment, and the effects of chronic use of new drugs cannot be adequately assessed in conventional pre-marketing clinical trims, the consequences can only be recognized by retrospective study of large populations over prolonged periods of time. In sum, access to archival data is critical to assuring the health of patients with mental illnesses.
Archival data can also be useful in identifying risk factors related to the onset of a mental illness. For example, there continues to be strong interest in the role of genetic factors in the etiology of major mental illnesses such as schizophrenia, bipolar disorder, major depression and obsessive compulsive disorder.

In seeking clues that could help to direct future research in this area, it is critical for researchers to be able to access archival patient care records, for example, of deceased family members of patients involved in genetic studies. It is possible that mental illnesses that are now not linked in any way might be found to cluster in families in a manner that suggests a common genetic etiology. Archival data can also help to clarify the relative contribution of genetic, environmental and developmental factors related to risk of specific mental disorders in families across generations.
In contrast to the typical interventional clinical research study, in which researchers directly interact with patients in well-defined protocols and can provide them with the detailed information required for informed consent, the uncertainties and unpredictability of secondary research make the applicability of traditional informed consent procedures problematic. Accordingly, under the provisions of the federal Common Rule, such retrospective research has been singled out for special attention and, under the criterion that the proposed research is commonly deemed to be of no more than minimal risk to research subjects, has typically been handled by Institutional Review Boards (IRBs) by use of the expedited review mechanism, or even on occasion, by wavier of review.
For secondary research using medical information that is individually identified, i.e. that fall within the definition of protected health information, the AAMC believes that a statutory requirement of specific authorization would be unwise and could seriously bias, and thereby undermine the integrity of these vital research databases. Rather, the Association recommends that all such proposed research must be reviewed by an IRB or equivalent mechanism. The reviewing body should be required to determine that (1) the organizational setting in which the research will be conducted is in conformity with statutory requirements for safeguarding medical information confidentiality; (2) the research requires the use of individually identifiable patient information and could not be performed without it; and (3) it would not be practicable or feasible for the investigators to attempt to obtain individual informed consent from the subject population. Such a review procedure would sufficiently protect the privacy interests of the research subjects, while at the same time continuing to facilitate the conduct of a broad spectrum of beneficial secondary research on archival patient materials. Instead of mandating specific consent for secondary research, the Association recommends that IRBs or other equivalent review bodies should continue to review such research and determine whether specific consent is necessary on a project by project basis.In addition, AAMC firmly believes that patients' confidence in medical research uses of their personal medical information would be greatly enhanced by the inclusion of a "statutory assurance of confidentiality" as provided by S. 881 sponsored by Senator Bennett and H.R. 2470 sponsored by Rep. Greenwood. Such an assurance would prohibit any unauthorized attempts to gain access for non-research purposes to individually identifiable health information contained in research databases, including Federal, State, or local civil, criminal, administrative, legislative, or other proceedings. Consequently, researchers could confidently assure patients that all individually identifiable medical information that might be used in the course of research would be shielded from forced disclosure to anyone, including family members, employers, insurers, health care organizations or legal or judiciary processes.
The "statutory assurance of confidentiality" provision is modeled on the existing Certificate of Confidentiality issued by the National Institutes of Health on a project by project basis. The origin of the Certificate of Confidentiality dates back to the Vietnam War era. Scientists and policy makers were very concerned about the extent of heroin use by our soldiers in Vietnam -- and the danger that they might be permanently addicted when they returned to the United States. Since heroin possession was then -- and is -- a crime, it would have been impossible to enlist the subjects necessary to conduct a followup study of heroin use in the US by these ex-GIs. The grant of confidentiality enabled scientists to track a cohort of former service men, to collect urine to screen for drugs, and to conduct detailed interviews. The study documented an extremely low percentage of heroin use in the US by former users in Vietnam. The Certificate of Confidentiality has been applied to other studies in the addictions field, for example, to the studies that demonstrated the effectiveness of Methadone substitution therapy for heroin addicts, and it continues to be crucial to much clinical research in this area.
The AAMC strongly supports the argument that new federal legislation dealing with medical information privacy be preemptive of state privacy laws, with the exception of those state laws dealing with public health reporting requirements, which are well established, time tested and closely integrated with the nationwide data collection and evaluation activities of the Centers for Disease Control and Prevention. The Association recognizes that this recommendation is controversial, but argues that the support of medical research is a long-established and high priority of the federal government, and that there is therefore a compelling federal interest in ensuring that medical research is facilitated, and not hindered or blocked by a discoordinated patchwork of burdensome state privacy legislation. Much contemporary medical research, especially epidemiological and health services research, requires access to large, unbiased population samples encompassing many states. Accordingly, the Association recommends that any new federal confidentiality legislation should over-ride state laws to ensure consistent nation-wide governance of access to archival patient materials for research. The Association is troubled by legislation that allow states to enact tougher privacy laws or carve-out certain disease-specific state statutes from federal pre-emption. While acknowledging the sensitivity of this issue, we point out that many different diseases are considered especially sensitive by those who suffer from them and their advocates, and to single out a particular type of information, such as mental health records, for special protection opens a loophole in the intended federal preemption that the AAMC believes would prove very difficult to limit.
The impact of managed behavioral health care on mental health services has been profound. The health insurance programs of more than 162 million Americans requires them to access mental health services through these carve-out companies. The major companies offer services across the country. The positive side of managed behavioral health care is that it has made parity of health care coverage for mental illness a realistic option. In addition, the companies have been able to amass a great deal of information on the mental health services being provided to the US population. On the down side, controversies abound regarding the quality of care in some managed behavioral health care programs. Health services researchers have a great opportunity and responsibility to help the American public to assess the quality of mental health services in these programs. This is not an issue that can be stopped at a state line. It is critical that managed behavioral health care companies be encouraged to work with the health services research community to assess quality of treatment outcomes, and that federal law pre-empt state privacy laws that would make this impossible.
The AAMC commends this Subcommittee for convening this hearing to address the need for confidentiality legislation and the efforts of Chairman Thomas and Rep. Cardin in crafting legislation that would enhance the security of medical records. The Association urges Congress to be mindful of the fact that the facilitation of biomedical,epidemiological and health services research is a compelling public priority that has served this nation well and offers bright promise for the future of human health. The AAMC strongly believes that the combination of statutory safeguards of the security of individually identifiable medical information, stiff penalties for violations, and the creation of special protections for medical information that is created in research and maintained in research databases, as we have suggested, make it unnecessary to elaborate new, burdensome and potentially chilling restrictions of access to medical information for purposes of retrospective non-interventional research.
END

LOAD-DATE: July 22, 1999

Document 69 of 103.


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