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Publication of the OIG's provider self-disclosure protocol--Office of Inspector General (OIG), HHS. Notice.

This Federal Register notice sets forth the OIG's recently-issued Provider Self-Disclosure Protocol. This Self-Disclosure Protocol offers health care providers specific steps, including a detailed audit methodology, that may be undertaken if they wish to work openly and cooperatively with the OIG to efficiently quantify a particular problem and, ultimately, promote a higher level of ethical and lawful conduct throughout the health care industry.

Documentation↗

Projective identification, self-disclosure, and the patient's view of the object: the need for flexibility.

Certain patients, through projective identification and splitting mechanisms, test the boundaries of the analytic situation. These patients are usually experiencing overwhelming paranoid-schizoid anxieties and view the object as ruthless and persecutory. Using a Kleinian perspective, the author advocates greater analytic flexibility with these difficult patients who seem unable to use the standard analytic environment. The concept of self-disclosure is examined, and the author discusses certain technical situations where self-disclosure may be helpful. (The Journal of Psychotherapy Practice and Research 1999; 8:225-233)

Adult↗

Regulating through information: disclosure laws and American health care.

Efforts to reform the American health care system through direct government action have failed repeatedly. Nonetheless, an alternative strategy has emerged from these experiences: requiring insurance organizations and health care providers to disclose information to the public. In this Article, Professor Sage assesses the justifications for this type of regulation and its prospects. In particular, he identifies and analyzes four distinct rationales for disclosure. He finds that the most commonly articulated goal of mandatory disclosure laws--improving the efficiency of private purchasing decisions by giving purchasers complete information about price and quality--is the most complicated operationally. The other justifications--which he respectively terms the agency, performance, and democratic rationales--hold greater promise, but make different, sometimes conflicting assumptions about the sources and uses of information. These insights have implications not only for health care, but also for other regulated practices and industries.

Decision Making↗

Full amnesty could encourage provider self-disclosure.

The Federal government's current policy toward healthcare providers that voluntarily disclose improprieties has been ineffective because it offers no guarantee of immunity from prosecution. To be successful, a self-disclosure program must offer real incentives to providers to come forward. The government's self-disclosure programs with respect to tax, environmental, and antitrust laws provide models for an effective amnesty program. The success of these three programs, and particularly of the antitrust program, suggests that healthcare providers would be encouraged to come forward and disclose improprieties if, under certain specific conditions, the OIG and DOJ offered a guarantee of full amnesty to the entity and its officers, directors, and employees.

Financial Management, Hospital↗

Bioethics for clinicians: 23. Disclosure of medical error.

Adverse events and medical errors are not uncommon. In this article we review the literature on such events and discuss the ethical, legal and practical aspects of whether and how they should be disclosed to patients. Ethics, professional policy and the law, as well as the relevant empirical literature, suggest that timely and candid disclosure should be standard practice. Candour about error may lessen, rather than increase, the medicolegal liability of the health care professionals and may help to alleviate the patient's concerns. Guidelines for disclosure to patients, and their families if necessary, are proposed.

Attitude to Health↗

Medical disclosure and refugees. Telling bad news to Ethiopian patients.

The strong value in American medical practice placed on the disclosure of terminal illness conflicts with the cultural beliefs of many recent refugees and immigrants to the United States, who often consider frank disclosure inappropriate and insensitive. What a terminally ill person wants to hear and how it is told are embedded in culture. For Ethiopians, "bad news" should be told to a family member or close friend of the patient who will divulge information to the patient at appropriate times and places and in a culturally approved and recognized manner. Being sensitive to patients' worldviews may reduce the frustration and conflict experienced by both refugees and American physicians.

Adolescent↗

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.

Awards and Prizes↗

[The process of disclosure of an HIV/AIDS problem in the family to children--an exploratory study].

AIM: The aim of the study was to describe the process of disclosing HIV/AIDS problem in the family to children and to explore its possible determinants. MATERIAL AND METHODS: The investigations were carried in 37 children, aged 4-16 years, living in families with HIV/AIDS problem (25 children were HIV+ and 12 HIV-) and in their parents/ caregivers. Empirical material consisted of protocols of clinical interviews with parents and children, observation of child's behaviour in different contexts and results of selected projective tests. RESULTS: Only six children (3 were HIV+ and 3 HIV-) had been informed about the problem of HIV/AIDS by the parents and could freely talk with them on that subject. The most important reasons impeding the process of disclosure according to the parents were: risk of depriving the child of a happy childhood and fear that the child may not be able to keep the family secret. As a result of cluster analysis four distinct subgroups of the children under study were discerned. The largest number of emotional and behavioural problems was noted in the case of older, infected children, who were quite aware of their serious medical condition and whose parents were in the phase of secrecy or exploration in the process of disclosure. CONCLUSIONS: The process of disclosing HIV/AIDS problem in the family by parents to children requires taking into account many different factors. Providing professional psychological services may be of great importance in many instances.

Adolescent↗

Personal risking: lesbian self-disclosure of sexual orientation to professional health care providers.

Thirty-three lesbians ranging in age from 18-68 participated as respondents in this qualitative, theory-generating study. Data were obtained through a written demographic questionnaire and in-depth taped interviews. Findings revealed a two-phase basic social process (BSP) identified as personal risking that is used by lesbians to secure their physical and/or psychological safety within the health care system. In the anticipatory phase, the risk of self-disclosure is calculated using both imaginative and cognitive strategies to determine a disclosure stance. In the interactional phase, scanning and monitoring enable the lesbian client to reevaluate the stance assumed. The data confirm that lesbians are uncomfortable in many health care situations and suggest provider responses to improve their comfort and the level of health care they receive.

Adaptation, Psychological↗

Native Hawaiian preferences for informed consent and disclosure of results from research using stored biological specimens.

Increasingly, genetic and biomedical researchers are developing protocols to reexamine human tissue specimens that were obtained and stored during clinical care or previous research studies. Although some communities and associations are developing guidelines for human-tissue research, guideline development rarely considers consumer preferences for informed consent and disclosure of results. This study, examining Native Hawaiian preferences for informed consent and disclosure of results (n = 429, 83.2% Native Hawaiian), was modeled after a national study of consumer preferences, allowing comparison between the national sample and the Hawai'i-based sample. The interview schedule included two scenarios on research requiring the re-use of clinically derived and research-derived biological specimens. For each, participants were asked if informed consent should be required: a) in general; b) if the specimen was personally identified; and c) if the specimen was de-identified, or anonymized. Participants were also asked if they would want to know the results of the research and if they would want their doctor to be told. Regardless of how specimens were obtained, 78% of Native Hawaiians would want to be asked for their consent for the re-use of identified specimens and about 35% would want to be consented for the re-use of anonymized specimens. In both cases, Native Hawaiians in the Hawai'i sample were more likely than Whites in the national sample to want an informed consent process. Similar proportions in both samples would want findings from research on stored specimens reported to them (about 90%) and to their physicians (about 80%). These findings call into question the "Common Rule" and the guidelines of the American Society of Human Genetics, which do not require researchers to obtain informed consent for research use of anonymized specimens.

Adolescent↗

Effects of method on participants and disclosure rates in research on sensitive topics.

This study replicates and extends the research of Rosenbaum, Rabenhorst, Reddy, Fleming, and Howells, which also appears in this special issue. Responses from 398 randomly assigned participants regarding differentially sensitive topics were collected via four methods of data collection: written questionnaires, face-to-face interviews, telephone interviews, and an automated telephonic data collection system (ATDC). Several significant differences in data collection methodology and topic area were found, including greater disclosure of sensitive information via the ATDC system than via face-to-face and paper-and-pencil conditions. Participants who were assigned to the ATDC condition felt significantly more comfortable answering questions compared to those in the face-to-face interview condition. Participants in the telephone interview condition reported answering significantly more carefully than participants answering via written questionnaire. Taken together, the results of this study and the previous one it replicates suggest that the ATDC produces disclosure rates that are at least equivalent to, if not greater than, those generated using traditional methods for collecting sensitive data.

Adolescent↗

Diagnostic testing of genetic disorders: limiting the scope of patent claims through disclosure requirements.

The breadth of claims in patents relating to genetic inventions has been controversial for some time. Possible adverse effects of broad claims include inhibiting research and higher costs, restricting patient access to genetic testing. The Australian Law Reform Commission's Report on Genes and Ingenuity--Gene Patenting and Human Health examined this issue, and concluded that the existing disclosure requirements contained in s 40 of the Patents Act 1990 (Cth) provide adequate mechanisms to control the breadth of claims. However, application of these requirements may be problematical in practice due to lack of relevant case law to provide guidance to patent examiners. It has been suggested that this deficit in direct judicial guidance can be obviated by developing appropriate analogies with other chemical systems in decided cases. This article focuses on gene-based diagnostic patents for human diseases, such as those held by Myriad Genetics for testing predisposition towards breast and ovarian cancer using the gene BRCA1. By examining the application of disclosure requirement by courts in genetic and non-genetic chemical inventions, it is possible to provide insight into how this might be applied by courts considering the validity of patent claims for diagnostic testing methods based on mutations in a gene such as BRCA1.

Australia↗

Problems experienced by nurses in relation to disclosure of patient data immediately after enforcement of the personal information protection law in Japan.

An extension course for nurses providing details about the Act on the Protection of Personal Information was offered using a remote conferencing system. Experiences or problems related to disclosure of patient data were collected from the participants using a questionnaire. Most of the problems were placed in the category of disclosure of personal data to a third party, followed by those related to security safeguards and administration of employees. It is necessary for the JMHLW to gather more cases in order to expand the number of items in the Casebook by JMHLW. Also, systematic on-the-job education will be needed for nurses.

Confidentiality↗

Rape acknowledgment and postassault experiences: how acknowledgment status relates to disclosure, coping, worldview, and reactions received from others.

Many rape victims are unacknowledged. These victims do not label their experience as rape; instead they give the experience a more benign label, such as a miscommunication. The current study examined the relationship between victims' acknowledgment status and post-assault behaviors, moving beyond prior research. Analyses of covariance were conducted comparing the post-assault experiences of unacknowledged and acknowledged college rape victims (n = 256), controlling for differences in victims' assault characteristics, multiple victimization, and post-traumatic stress symptoms. Results supported that unacknowledged and acknowledged victims differed in their coping, disclosure, belief in justice, and receipt of egocentric reactions following disclosure. Implications for future work examining the dynamic interplay among assault characteristics, sexual scripts, acknowledgment status, and post-assault factors are discussed.

Adaptation, Psychological↗

[Physician's disclosure form a legal viewpoint].

Concerning the physician's duty to disclose information, it has to be distinguished between the information of the diagnosis, the therapeutical instructions on the patient's behaviour and the disclosure of the risks incidental to the treatment. Practically the last-mentioned is the most important, because the effectiveness of the patient's consent depends on its performance. In case the physician violates this duty, he is liable for battery, even if the medical procedure is performed skillfully. The modes of disclosure and its omission for therapeutical reasons are discussed.

Austria↗

Disclosure of stigmatizing conditions: the discloser's perspective.

Stigmatizing conditions such as family violence, AIDS, and herpes contribute to feelings of shame and the wish to conceal or hide. However, those who experience such conditions often need to confide in others and seek help from professionals. This grounded theory study describes the process of disclosure from the perspective of the one with a stigmatizing condition and from the theory that nurses can develop intervention strategies to facilitate disclosure.

Acquired Immunodeficiency Syndrome↗

Disclosure of diagnosis to children with human immunodeficiency virus or acquired immunodeficiency syndrome.

This paper reviews research and clinical literature relevant to the question of disclosure of diagnosis to children with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). The model of pediatric oncology, in which much research already exists, is evaluated for its applicability to HIV and AIDS. Although children seem to benefit from early disclosure of diagnosis of life-threatening illnesses, special cultural and social conditions complicate the question with regard to HIV and AIDS. These conditions include the parent-to-child transmission of HIV and the unique social stigma of having HIV because of its association with homosexuality, drug use, and sexual conduct. The paper presents existing treatment approaches and suggests avenues for further research.

Acquired Immunodeficiency Syndrome↗

Rape death and resurrection: male reaction after disclosure of the secret of being a rape victim.

Males are also rape victims. The scant information we have on this phenomenon can be explained by its rarity or by the reluctance of male victims to disclose their past victimization. In this study, 23.8% of 235 prisoners that were interviewed disclosed their past sexual abuse. Eleven suffered an acute reaction (for example, attempted suicide). 77.7% of the prisoners who did not have an acute reaction after this disclosure were sex offenders. Sexual abuse has a special meaning for the male victim. Their gender identity and gender image are tarnished by the use which another male had with their body. It seems that sex offenders come to terms with this fact by acting out or by proving their sexual virility in a strange and cruel way. This article describes male prisoners' reactions after their disclosure of having been a rape victim, and suggests a tentative explanation, based on theory and therapeutic experience.

Adaptation, Psychological↗