Jean Campbell, Ph.D.
Research Assistant Professor
Missouri Institute of Mental
Health
St. Louis, MO 63139
MENTAL HEALTH CONSUMER CONCERNS REGARDING THE USE OF THEIR CLINICAL AND ADMINISTRATIVE HEALTH DATA: Privacy, Confidentiality, Access, and Informed Consent
Dear Committee Members:
The following remarks represent the concerns and policy positions of behavioral health consumers regarding protections in data access, and privacy/confidentiality protocols for data subjects within behavioral health management systems. I am both a mental health consumer and a professional services researcher, and, therefore, feel qualified to represent mental health consumer constituencies to this Committee as we move forward in generating federal policies regarding the collection, use, and distribution of health data.
The handwritten progress notes of clinicians that have historically been stored in manila folders in locked file cabinets are giving way to vast electronic warehouses. Confidentiality protections for an individual's health record implies that access to client data and clinical records is limited by informed consent, the law, medical ethical protocols, and/or policy to protect the client, the client's family, and the individual provider and agencies that collect and manage the client data/records. However, with the current emphasis on the collection of outcome measures, the expansion of electronic records, and the transmission of clinical records through fax machines and other means of duplicating and transporting confidential health information, the potential for misuse has increased enormously. Further, protocols defining data subject's protections for confidentiality and privacy of behavioral health data in health management information systems are now in a regulatory gray zone. The role of the client, data manager, and the provider agency in determining access and denial of access needs clear definition.
The growing data infrastructure and technological advances in electronic data management has provided health care systems with the capacity to horizontally and vertically integrate, synthesize, and use health information with few restraints. Virtual data networks can now link people's health and social service records to all other data collection and storage systems such as the Internal Revenue Service, law enforcement agencies, and the Department of Motor Vehicles. Therefore, people can be tracked and monitored in the most personal aspects of their lives. Most of this has occurred without the knowledge or permission of the recipients of health care services.
When the Kennedy-Kassebaum Health Care Reform Bill created portability and more coverage for pre-existing conditions, it added at the last moment a provision to facilitate the computerization of medical records in national databases run by the government and private corporations. It also will impose an unique health identifier for everyone so private medical records can be easily accessed. In some cases, physicians will no longer be able to guarantee to patients the privacy of their medical records, and the responsibility for developing standards to protect confidential medical records will have been turned over entirely to the Secretary of Health and Human Services. Neither patients nor their physicians will know when sensitive information is released or to whom. Don Haines, the Legislative Counsel of the ACLU in Washington, D.C. has warned that, "This bill will be remembered by Americans not as health care reform but as the thief who stole from us the privacy we deserve for our most confidential medical information."
On the other hand, the development and implementation of managed health care plans depend on information about individuals in order to determine who should be enrolled, to set rates, to determine quality and effectiveness of services, and to engage in prior and concurrent review. Therefore, personal health data has become a refined commodity that had considerable worth in the health care market place. The capacity to transmit patient specific information within the network of providers benefits patients since care is now integrated through access to computerized information, rather than each episode remaining a discrete, unrelated event. Still, arguments for public acceptance of such electronic data systems based on promises of better services are not compelling, and issues over access to and confidentiality of health records between providers and recipients have grown over the past few years. In 1996 a CNN Poll found that 87% of Americans believed that patients should be asked permission every time any information about them is used.
Degradation, anger, and sadness are often voiced by people with mental illness when they speak about the privacy and confidentiality of their behavioral health records. These experiences stand as a robust critique of management information systems and services research. Rather than a shared reality, data collection represents two quite separate worlds, the meanings of one being significantly different from the other. Separated by role and function from the person and his/her suffering, clinical and administrative health data monitors functionality, recidivism, and symptom control. However, people judge benefit and harm of data collection systems by the impact on the quality of their lives. This inherent tension around who should have access to health data, and issues of confidentiality of health records has vast implications for the production and distribution of health information. Data collection policies and protocols also impact the development of the cultural reference points that underlie every aspect of the personal and social relationships in the data collection, storage, and utilization process. Ultimately, the social relations of health data management have the potential to alter the symbolic processes where a mental health consumer's reality is produced, maintained, repaired and transformed.
The growing tide of health consumerism is one of the most compelling forces in the future role of mental health consumers in the production, storage, and use of their health data. It is based on the assumption that persons who seek health services are consumers just as are persons who seek other types of services. The doctor is perceived to be the purveyor of a service, and the patient is viewed as the buyer. The consumer listens to the thoughts of the provider, but ultimately makes his or her own decisions. Consumerism implies that values derived from principles of good medical care must be interpreted and operationalized through reference to the patient's personal health care values and desires.
Although consumerism has periodically emerged as a force in American society, its current application in health care draws its roots from two marketplace trends: consumer rights protections with its concerns regarding manufacturing and product safety, and Total Quality Management (TQM) with its focus on customer satisfaction. The former is grounded in a profound distrust by individuals of the actions and motives of providers of products and services, the latter promotes collaboration between provider and consumer and seeks to answer such questions as what do customers prefer. Both trends emphasize the need for information that accommodates consumer rights and interests.
However, while there is general acceptance of medical consumerism, psychiatric consumers must overcome tremendous personal and political barriers to gain control over and responsibility for their own lives in the medical marketplace. Persons with psychiatric disabilities are embraced by the mass media as secular versions of the devil. With madness the scapegoat for violence and uncontrollable mayhem in modern society, mental health consumers are seen as the quintessential "Other"--people who represent the subterranean depths of humanity and whose differentness makes them not really human at all. This is compounded by the assumption that the individual is morally at fault. The diagnosis of mental illness permeates all aspects of the lives of mental health consumers by establishing authority over their ideological, material, and emotional resources. It strips away a person's objective power and will to power as he/she encounters the social world and participates in the reproduction of daily life.
Because of pervasive cultural stereotypes of "the mentally ill" as violent and incompetent, as well as the profound poverty of most, it is not surprising that mental health systems have been slow to change traditional paternalistic medical relationships to ones that empower the customers of psychiatric services and products. The problem of enabling psychiatric consumers to participate in setting data collection and services research protocols, and to serve on review boards that evaluate and monitor compliance of those protocols, is that the perspectives of the mental health consumer movement are discredited by large sectors of its potential audience. In general, the role of the mental health research professional is to direct and prescribe; the role of the subject is to cooperate. While many ex-patients are angry at treatment they have received or witnessed regarding behavioral health records in the mental health system, it is presumed that they do not know what is in their own best interests.
It is not surprising that managers and scientists have been unable to cope with growing demands for changes in the data management process, particularly those coming from people with mental illness and their families. As with science in general, psychiatric research is bound by the past and inscribed with power, bias, and stereotypy. Reform in research methods, protocols, and human subjects' protections has historically been based on the assumption that "the expert knows best" about the operating principles of research. Further, scientists believe they know values and preferences of their subjects; they are disinterested and objective without biases of their own; and, they choose for their subjects what the subject would choose for themselves if they had the same knowledge. This seduction by authority inevitably influences future behavior to mimic current practices, and has led to the creation of data protocols and protections without knowledge of how consumers would address these issues. The marginalization of consumer concerns pervade behavioral health management information systems as well.
Therefore, one of the most important forces for reform of data protections is dialogue and collaborative work with health consumers regarding ethical issues in health data systems. By listening respectfully and treating data subjects with dignity, dialogue has the power to bridge the differences between data manager, clinician, and client and to generate new knowledge and understanding. Instead of resisting criticism, policy-makers and administrators should welcome mental health consumers and their families to the process, saying, "Gee, how can we improve?" The first step is for each one of us to interrogate the a priori assumptions of the data collection enterprise. What are the values, sensibilities, biases, and stereotypes that inform that work?
It is clear that an improperly thought out and implemented data system can result in invasion of privacy, personal surveillance, abridgment of constitutional rights, inappropriate monitoring and control of individuals, and access to personal data for private profit or criminal use. No segment of the population is potentially more vulnerable to these type of violations than those who receive behavioral health services. For people labeled as mental health consumers, the practical consequences of stigma associated with a diagnosis of mental illness can be profound. Inadvertent breaches of confidentiality have precipitated the loss and denial of employment, the inability to obtain housing, and a cascading host of other problems. For this reason, the issues of personal privacy and confidentiality loom very large in the minds of mental health consumers. Further, activities such as the federally mandated data searches authorized under the Brady Bill to restrict people with mental illness from buying weapons, and data merging activities to assure treatment compliance have created a chilling effect on people who seek help for psychiatric and substance abuse conditions. In one state, a disability law center is initiating a law suit to block the implementation of a public mental health information system asserting that the protocols are a violation of state rights to privacy.
At the same time, access to one's own health record to review or make corrections has became increasingly more difficult. The American Psychiatric Association has repeatedly lobbied Congress when health data access and confidentiality bills are being considered in order to prevent access of a person to his/her personal psychiatric records if the clinician feels such access is a danger to the person's psychological health. Further, efforts by consumer groups to monitor quality of services and to advocate for patient rights through use of data have been hindered. Fearing public scrutiny and the loss of enrollees and contracts, managed health care companies are claiming proprietary rights of data ownership to control access to information. Often when public agencies and private companies pay for data collection, they demand the right to prohibit the review or publication of health service system information without their permission. Contractual language with such limitations between state mental health authorities and researchers have begun to emerge. Also, access to populations for services research is being denied where results may be unfavorable.
It is important that the Committee of Vital and Health Statistics to look at the context in which Internal Review Boards (IRBs) and human subjects' protections in research operate, not just examine the regulations themselves. The gritty work of churning over knowledge is much like any other labor process. In the management of data, dehumanization naturally occurs: one forgets that the objects of inquiry are human beings. As relationships are routinized, you lose touch with the relatedness of one person to another whether you are serving burgers at McDonalds or interviewing people with schizophrenia. Therefore, data managers continually need the conscience of others. One way is to adopt a person-centered language in psychiatric research rather than continuing to use terms such as "schizophrenic." Such terms implicitly dehumanize people with mental illness. A people first construction challenges the social relations of domination in the review and conduct of psychiatric research and could help keep our consciousness alive to people's humanity and worth.
This Committee must strive for excellence and not just focus on minimal compliance to regulations. We need to rigorously apply the data protections that already exist; and we need to look at the applications of protections to determine if they are effective. We also need to create an environment in which whistle-blowing is really supported. One approach to fostering excellence, is to develop a gold standard for human subjects' protections, and to find and support those people that have gone beyond the regulations to develop superior types of protocols. I believe that people who have a mental illness and are researchers or data managers should be sought out and supported as the jewels of a data use reform process. In some cases, efforts to enhance and strengthen protections would restrict the conduct of services research, and data management. However, this effort also has the potential to force psychiatric research to develop better protocols and methodologies.
In research much attention is focused on ethical dilemmas in neurobiological research (especially experimental psychotropic drug research). Yet, the services researchers and professionals who conduct survey research or design and direct quality assurance and management information systems also face important challenges in their investigations and data collection efforts involving mental health consumers. There is the assumption that these forms of data collection pose minimal risk to participants. However, subjects report that there has been considerable abuse and greater risks are involved than most researchers realize. Ethical issues are rarely considered in this field and the research and data community has yet to achieve consensus about standards and policy recommendations. Such trends as the growth of survey and services research in the community and in institutions; increasingly rigorous evaluation of services demonstrations; the ascendance of randomized controlled trials in services research; the development of management information systems used for patient tracking, managed care and quality assurance programs; and the expanding influence of consumers, family members and consumer advocates in the research and data collection arena have clouded traditional human subjects' protections and compromised boundaries of appropriate ethical authority and protocol. There are exceedingly complicated questions in the following areas: appropriate use and language of informed consent forms and protocols; confidentiality and privacy of subject identified data; professional conflicts of interest; limited or bias evaluations of risks and benefits to subjects; consumer participation in research and data system designs, implementation, and monitoring; provisions for adequate human subjects review and oversight in community settings not covered by IRBs; the ethics of randomization and sample recruitment; use of coercion in subject recruitment and retention; and, gender and ethnic parity in research samples. These are the gray zones of IRB responsibility. IRBs do not appreciate ethical issues in survey research or management information systems, although they compromise client confidentiality and privacy as well as the ability of participants to consent to data collection.
Since feedback is essential for a reiterative, continuous quality improvement process, the promotion of alliances in human subjects' protections is essential. It is especially important to engage mental health system stakeholders in dialogue related to ethical concepts and current protocols, provide training, and begin to develop recommendations from the field because of evolving complexities and ambiguities in research and data collection. Since most current policies and protocols were developed without the insight and perspective of the consumers themselves, researchers, clinicians, and data managers have to be open and welcome input as critical to the excellence of their own work. Ironically, the existence of IRBs is often used as a shield against reform to counter the concerns of research subjects and their families.
In order to prevent an escalation in the struggle over access to and security of electronic patient health records and electronic management information systems, a fundamental change in corporate philosophy is needed. The focus on continuous quality improvement of the individual clinician and the service system must be encouraged through the collaborative use of information by all stakeholders in the health delivery system. For consumers, fear can be driven out of electronic data collection by developing participatory action research initiatives, establishing data protections review boards with multistakeholder membership, and building trust and incentives for data sharing. As consumers become equal health information partners and data trustees with providers, they will recognize that even the best systems are not absolutely safe from security failures. Health information partnerships will enable the healthcare industry to move beyond issues of confidentiality and control of health records to embrace the principles of health informatics. It is only by making sure that people's privacy and confidentiality are protected, and that people have access to needed health information--both clinical and administrative--can the mental health system effectively engage service recipients in building electronic health information networks. At the core of this approach is the belief that the goals of health care data reform can not be achieved without attending to the way individual health decisions are made. Therefore, healthcare recipients have a right and responsibility to know as much as they can about their conditions, and to partner absolutely in decision-making. In direct response to increasing public demand and pressure from government for health organizations to be more open and accountable, a new vision for health care in the 21st century that is humane, effective, and affordable can be achieved as informed and empowered consumers used the health care system more intelligently, with better outcomes, and at significant cost reductions.
With the initiative and support of progressive scientists, data managers, clinicians and policy-makers the behavioral health data community is slowly moving towards more accepting attitudes and reciprocal relationships. Still, no set of regulations--no matter how carefully drawn or enforced--can really protect human data subjects without a profound change in how people who collect and manage data relate to the people they monitor or study. We need only to remember that there were protections in place in Germany prior to World War II. Still scientists brutalized people without compunction, seeing them as less than human and expendable for scientific progress. It is clear that neither psychiatric research nor the methodological and communication technologies that facilitate its activities are simply mechanical, electronic, or intellectual tools and protocols that serve the needs of individuals and groups within society. Since reform in protecting research subjects is limited by the attitudes and social relationships of those that research, manage, and deliver services, it therefore follows that the source of new knowledge to guide the generation of human subjects' protections may lie in the incongruities between the perceptual and experiential framework of the "experts" and those that receive services.
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