Confidentiality, Consent and Autonomy in the Physician-Patient Relationship

In the practice of medicine there has long been a conflict between patient management and respect for patient autonomy. In recent years this conflict has taken on a new form as patient management has increasingly been shifted from physicians to insurers, employers, and health care bureaucracies. The consequence has been a diminshment of both physician and patient autonomy and a parallel diminishment of medical record confidentiality. Although the new managers pay lip service to the rights of patients to confidentiality of their records, in fact they advocate very liberal medical records access policies. They argue that a wide range of parties has a need to know the contents of individually identifiable medical records in order to control costs, promote quality of care, and undertake research in the public interest. Broad interpretations of the need to know, however, are at odds with strict interpretations of the right to confidentiality. Strict confidentiality policies require that, with few exceptions, patient consent be obtained whenever a patient's record is used outside the treatment context. The traditional criterion for overriding the consent requirement has been that without the override some harm would directly result. This rule is now challenged by the claim that patients have a duty to make their records available for a wide range of research and public health purposes. The longstanding tension between physician responsibility for patient welfare and respect for patient autonomy is being replaced by a debatable requirement that both physician and patient autonomy be subordinated to the goals of data collection and analysis. This revised version was published online in July 2006 with corrections to the Cover Date.     

患者个人信息保护模式的概况、问题及启示

当前常见的保护患者个人信息的模式是通过立法赋予医疗机构病历所有权,并要求其保护患者的知情权与隐私权。但是,在现实中存在知情权未能实现、隐私权受到侵害的情形。将病历所有权归于医方的立法忽视了病历的客观信息部分,超越了医疗合同的内容,增加了医方的风险等。应该淡化病历所有权归于医方的观念,强化医学研究与教育中对患者权利的保护。     

Parental notice and consent for abortion: out of step with family law principles and policies

In 1990, the US Supreme Court in Hodgson v. Minnesota allowed a state to require, with limited exceptions, notification of both parents before a woman under 18 has an abortion, as long as the law provides a judicial bypass procedure. If the judge finds that she is mature enough to give informed consent or that notification is not in her best interest, judicial bypass permits nondisclosure to the parents. The notification requirement is contrary to many of the general principles to family law. The Minnesota statute requires physicians to notify both parents; notice to merely one parent is permissible only if the other parent is dead or cannot be located after a "reasonably diligent effort." Without the judicial bypass procedure Justice O'Connor would have invalidated the statute as unconstitutional, for conflicting with the best interests of the minor, infringing on family autonomy, and failing to foster the state's alleged goal of improving parent-child communication. We are left with a ruling that fails to protect the privacy of family decision making from government interference, fails to uphold court-ordered custody and parental decision making arrangements, fails to recognize state laws allowing minors access to medical services relating to sexual activity, and conflicts with the general rule of requiring only 1 parents' consent before a minor receives medical treatment. The parental notification law can cause serious harm, precipitating a dangerous family crisis where physical, psychological, or sexual abuse is present, and can cause delay in pursuing and abortion until it is too late to get one, causing life-long repercussions. The best interests of minors strongly argue against mandatory parental consent and notification laws.     

Legal review: AIDS patient records--legal issues of access and disclosure

All 50 states require AIDS cases to be reported to the department of health. Many jurisdictions require HIV and ARC reporting, as well. Many states have also enacted confidentiality provisions that prohibit health care providers from releasing HIV-related information without the patient's consent, although exceptions to the statutes authorize disclosure without consent to other health providers, spouses, and other persons under certain conditions set forth in the legislation. In addition, the patient may obtain access to his or her own records and may authorize release to third parties. Providers who violate the provisions are subject to liability. The patient usually has a private cause of action for damages and costs; in addition, the state may impose fines and jail terms for more egregious violations. Finally, courts may authorize disclosure of confidential HIV information in certain situations. In the absence of a statutory provision governing court-ordered disclosures, courts will balance the patient's privacy interest against the plaintiff's need to know and the public interest involved. Several states have enacted statutes that modify this traditional balancing approach, although it is unclear whether these statutes provide additional protection for health care providers and patients seeking to prevent disclosure of information. Health record practitioners should keep abreast of legislative and regulatory developments in their states that affect use and disclosure of AIDS patient records. Careful discussion with the health institutions' legal counsel of any situation not covered clearly by applicable statue or regulation is strongly recommended.     

The Right to Withdraw Consent to Research on Biobank Samples

Ethical guidelines commonly state that research subjects should have a right to withdraw consent to participate. According to the guidelines we have studied, this right applies also to research on biological samples. However, research conducted on human subjects themselves differs in important respects from research on biological samples. It is therefore not obvious that the same rights should be granted research participants in the two cases. This paper investigates arguments for and against granting a right to withdraw consent to research on biobank samples. We conclude that (1) there are no explicit arguments for such a right in the guidelines we have studied, (2) the arguments against such a right are inconclusive, (3) considerations of autonomy, privacy, personal integrity, and trust in medical research provide sufficient reasons for granting a right to withdraw consent to research on biobank samples, (4) in certain cases, research participants should be allowed to waive this right.     

The therapeutic partnership: legal and ethical aspects of consumer health information

Patients' rights to information in the UK are based on a mixture of statute (including legislation on access to medical records) and case law (principally revolving around the issue of informed consent). These rights are set out in the Patient's Charter, which is itself a mixture of rights based on legislation and those enforced by management practice. Failure to provide adequate information to a patient could expose a medical practitioner to action for negligence or battery. Negligent information-giving could also expose consumer health information services to damages, for which the best defence is a high standard of professional competence and adequate professional indemnity insurance. Sharing information about the risks and benefits of treatment to enable truly informed decision making and consent by the patient is a key element of an ethical relationship between care giver and consumer--the therapeutic partnership.     

When is research on patient records without consent ethical?

Current regulations do not allow most low-risk research using patient records without patient consent. One of the main reasons adduced for this is that such research constitutes an unacceptable breach of confidentiality. By contrast, it is argued in this paper that it may, on occasion, be acceptable for confidentiality to be breached according to all three of the major ethical justifications for respecting patient confidentiality. In practice, the arguments against allowing research using patient records are usually grounded in claims about the link between confidentiality and respect for patient autonomy rather than legitimate patient expectations. Patients may have good reason to expect, or come to expect, that their records will be used without their consent for low-risk research, under certain conditions. Where this is the case, such expectations provide reasonable grounds for considering such research to be ethical.     

Hospital cannot be held liable for breach of patient's privacy

The Minnesota Court of Appeals ruled that a law guaranteeing the confidentiality of a patient's medical records did not create a private cause of actions for damages when the patient's HIV was revealed. The plaintiff, known as J.T.P., requested that his stepbrother not be told his HIV status. A relative gained access to his medical file while working at a medical center and disclosed J.T.P's HIV status to his stepbrother. J.T.P. sued the relative and the hospital. The district court ruled that he did not have a cause of action against the hospital and the Court of Appeals agreed. The State does not recognize claims for an invasion of privacy under the Minnesota Patients Bill of Rights.     

Bennett's medical privacy bill would pre-empt State HIV laws

In April 1999, Senator Robert Bennett (R-Utah) introduced a bill that could protect medical privacy, but preempt confidentiality statutes adopted by the States. The proposed Medical Information Protection Act (S. 881) would result in a single Federal standard for processing patient records. The legislation was submitted in an effort to meet an Aug. 19 deadline established by the Health-Care Insurance Portability and Accountability Act in 1996. If Congress does not meet the deadline, the responsibility for developing medical privacy safeguards falls onto the Department of Health and Human Services.     

Privacy protection and population-based health research

In this article we discuss obstacles of privacy protection measures to population-based health research and we give suggestions for policies facilitating this research as well as protecting the privacy of the patient. Privacy is the capacity of the individual to determine which information is communicated to whom. Population-based health research is research among human populations and refers to health services research, medical sociology, epidemiology, occupational health, social dentistry, family medicine a.o. Although population-based health research focuses on groups and not on individuals, the access to health and other vital records and the possibility to identify the individuals for subsequent interview and study are of crucial importance. In various countries the legislation regarding privacy protection requires that medical records should not be disclosed unless with the consent of the individual. Therefore it forms a major obstacle to population-based health research as this research is very difficult to carry out if prior consent is required in order for the investigator to have access to medical records. Population-based health research has given us important knowledge about the etiology of many diseases and the effect of interventions. In the case of population-based health research disclosure of patient information without the explicit patient consent should be seriously considered. This disclosure should only be permitted if an institutional board has studied the project plans of the investigators and has carefully watched the privacy aspects of their studies.     

明晰患者知情同意权 完善医院管理制度

随着我国法律制度的不断完善,医疗行为正逐步全面纳入法制轨道。知情同意权,作为患者的一项基本权利,越来越为人们所接受和认同。尊重患者的知情同意权将有助于防范和减少医疗纠纷的发生,改善医患关系。本文试图从知情同意权的内容、构成等角度明晰患者的知情同意权,通过设计相应的医院管理制度来切实保障患者的知情同意权,最终从根本上防范医疗纠纷。     

Electronic medical records and patient privacy

Networks of health care providers and payers increasingly rely upon electronic databases to coordinate and analyze medical information. Benefits of linking databases include saving lives and reducing costs. However, access to and use of medical records raise serious privacy concerns. Potential misuse of records may harm patients and undermine the quality of health care. In the clinical setting, stringent security procedures must be instituted, including limited access to electronic records, audit trails, and security audits. Patient consent should be obtained before personal information is disclosed. Current law does not provide the strong, consistent guidelines needed. Adequate privacy protection requires a comprehensive federal law.     

医疗服务的知情同意规范及其要求

知情同意是现代医患法律关系的重要内容，医疗机构及其医务人员在医疗活动中需要重视知情同意的法律规范及其相关注意义务。     

契约与侵权——从外国法理上论医师的说明义务

作为医学领域的一个基本伦理原则,医师的说明义务起源于英美法系的"Informed Consent"理论。在我国,对医师的说明义务的研究多集中在伦理学方面,而对说明义务的法理基础,尚无统一的学说。以美国、德国为代表,简要介绍国外有关说明义务的法理基础的学说,希望能够为我国的相关研究提供参考。     

细化尊重患者知情同意权的临床实践

尊重患者知情同意权是法律法规的要求、临床工作的需要、新医学模式必需的临床工作。文章对尊重患者知情同意权的必要性和内容以及细化尊重患者知情同意权的实施行为做了初步的探讨和总结。作者认为应将患者该承担的伦理责任作为患者知情同意的内客。同时还对实施尊重患者知情同意权的临床实践所存在的问题进行了分析，作者认为细化尊重患者知情同意权的临床实践不仅需要医务人员的责任心、同情心，更需要医惠双方具有风险意识、法律意识。     

Realtors granted exemption for nondisclosure of AIDS

Idaho enacted legislation protecting real estate agents in situations where they are asked to violate an HIV patient's privacy. Would-be buyers often ask for a psychological impact statement, including whether the home has been a crime site or whether the owners have HIV, about a property in which they are interested. Senate Bill 1313 has guidelines for realtors, who in the past were torn between disclosure and privacy. If buyers request the information in writing, the agent must ask for the owner's consent to release the information. The buyers must be told if the owner declines. The law shields realtors from legal liability once the requirements are met.     

Attitudes to privacy,health records and interconnection: implications for healthcare organizations

About nine in 10 Canadians support legislation that would protect patient confidentiality. However, the Canadian public is not consistent in its views regarding privacy. Data suggest that the public's attitudes to privacy, and particularly access to medical records, are heavily influenced by the context in which the situation is presented and potential benefits to the individual or to the public.     

尊重患者知情同意权 构建和谐医患关系

因侵害患者知情同意权引发的医疗纠纷越来越多,已影响到和谐医患关系的构建。医疗机构及其医务人员应当充分认识患者知情同意权的本质,尊重患者知情同意权;增强责任心,防止过失侵害患者知情同意权;提高医疗水平,避免对患者知情同意权的侵害;严格规范告知义务履行的程序和方式,防止医患之间因侵害知情同意权而发生纠纷,保护医患双方的合法权益,构建和谐的医患关系。     

Children in medical research: Australian ethical standards

Summary This paper examines standards for the use of children as research participants in medical research which are relevant to Australia and relates the standards to pivotal ethical issues. The standards include the National Health and Medical Research Council's NHMRC Statement and Supplementary Notes, professional codes of ethics, international human rights conventions, United Kingdom and United States codes of ethics, and statute and case law. The key ethical issues of potential risk and benefit to the child, and consent to research participation are discussed. Suggestions for the improvement of the NHMRC Statement are made.     

Whose interest? British newspaper reporting of use of medical records for research

OBJECTIVE: There is increasing debate about the ethics of using medical records for research. We aimed to characterize newspaper reporting in this area. METHOD: We searched Lexis-Nexis to find newspaper reports about the use of medical records for research from 1 June 2005 to 30 November 2006. Following screening for relevance, we generated a coding scheme and classified articles using this, assisted by QSR N6 software. RESULTS: Our analysis shows that much newspaper coverage portrays the use of medical records as uncontentious, but also presents ethical arguments for and against such research. Arguments in favour of access to medical records emphasize the public interest and patients' legitimate expectations that research will be carried out. Arguments against such use emphasize the importance of confidentiality and the violation of rights of privacy. Our findings highlight that there is no single dominant position on the rights and wrongs of access to medical records by researchers. Within newspaper reporting in this area, patient voices are currently noticeable by their absence. CONCLUSIONS: Use of medical records for research raises important ethical questions, in particular regarding the balance between the rights and interests of the individual and the public interest benefits of the research. Understanding how these positions are represented within the mass media is important because the media can inform and influence the public's views and public policy. Empirical research into patient views is needed.