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Biomedical subjects

L O Gostin

Publications and source records attributed to L O Gostin.

At least 19 recordsLinked to original sources
PubMed2001

Informed consent for population-based research involving genetics.

Bridging the gap between gene discovery and our ability to use genetic information to benefit health requires population-based knowledge about the contribution of common gene variants and gene-environment interactions to the risk of disease. The risks and benefits associated with population-based research involving genetics, especially lower-penetrance gene variants, can differ in nature from those associated with family-based research. In response to the urgent need for appropriate guidelines, the Centers for Disease Control and Prevention formed a multidisciplinary group to develop an informed consent approach for integrating genetic variation into population-based research. The group used expert opinion and federal regulations, the National Bioethics Advisory Commission's report on research involving human biological materials, existing consent forms, and literature on informed consent to create suggested language for informed consent documents and a supplemental brochure. This language reflects the premise that the probability and magnitude of harm, as well as possible personal benefits, are directly related to the meaning of the results for the health of the participant and that appropriate disclosures and processes for obtaining consent should be based on an assessment at the outset of the likelihood that the results will generate information that could lead directly to an evidence-based intervention. This informed consent approach is proposed to promote discussion about how best to enable potential participants to make informed decisions about population-based research involving genetics and to suggest issues for consideration by research sponsors, institutional review boards, and investigators.

DNA↗
PubMed2001

National health information privacy: regulations under the Health Insurance Portability and Accountability Act.

Health information privacy is important in US society, but existing federal and state law does not offer adequate protection. The Department of Health and Human Services, under powers granted by the Health Insurance Portability and Accountability Act of 1996, recently issued a final rule providing systematic, nationwide health information privacy protection. The rule is extensive in its scope, applying to health plans, health care clearinghouses, and health care providers (hospitals, clinics, and health departments) who conduct financial transactions electronically ("covered entities"). The rule applies to personally identifiable information in any form, whether communicated electronically, on paper, or orally. The rule does not preempt state law that affords more stringent privacy protection; thus, the health care industry will have to comply with multiple layers of federal and state law. The rule affords patients rights to education about privacy safeguards, access to their medical records, and a process for correction of records. It also requires the patient's permission for disclosures of personal information. While privacy is an important value, it may conflict with public responsibilities to use data for social goods. The rule has special provisions for disclosure of health information for research, public health, law enforcement, and commercial marketing. The privacy debate will continue in Congress and within the president's administration. The primary focus will be on the costs and burdens on health care providers, the ability of health care professionals to use and share full medical information when treating patients, the provision of patient care in a timely and efficient manner, and parents' access to information about the health of their children.

Confidentiality↗
PubMed2001

Health information: reconciling personal privacy with the public good of human health.

The success of the health care system depends on the accuracy, correctness and trustworthiness of the information, and the privacy rights of individuals to control the disclosure of personal information. A national policy on health informational privacy should be guided by ethical principles that respect individual autonomy while recognizing the important collective interests in the use of health information. At present there are no adequate laws or constitutional principles to help guide a rational privacy policy. The laws are scattered and fragmented across the states. Constitutional law is highly general, without important specific safeguards. Finally, a case study is provided showing the important trade-offs that exist between public health and privacy. For a model public health law, see www.critpath.org/msphpa/privacy.

Access to Information↗
PubMed2001

Health promotion and the First Amendment: government control of the informational environment.

Government efforts to protect public health often include controlling health information. The government may proscribe messages conveyed by commercial entities (e.g., false or misleading), recommend messages from commercial entities (e.g., warnings and safety instructions), and convey health messages (e.g., health communication campaigns). Through well-developed, albeit evolving, case law, government control of private speech has been constrained to avoid impinging on such values as free expression, truthfulness, and autonomous decision making. No simple legal framework has been developed for the government's own health messages to mediate between the legitimate goals of health protection and these other values. Nevertheless, government recommendations on matters of health raise difficult social and ethical questions and involve important societal trade-offs. Accordingly, this article proposes legal and ethical principles relating to government control of the health information environment.

Advertising↗
PubMed2001

Public health law reform.

Public health law reform is necessary because existing statutes are outdated, contain multiple layers of regulation, and are inconsistent. A model law would define the mission and functions of public health agen cies, provide a full range of flexible powers, specify clear criteria and procedures for activities, and provide protections for privacy and against discrimination. The law reform process provides an opportunity for public health agencies to draw attention to their resource needs and achievements and to form ties with constituency groups and enduring relations with the legislative branch of government. Ultimately, the law should become a catalyst, rather than an impediment, to reinvigorating the public health system.

Confidentiality↗
PubMed2001

Informational privacy and the public's health: the Model State Public Health Privacy Act.

Protecting public health requires the acquisition, use, and storage of extensive health-related information about individuals. The electronic accumulation and exchange of personal data promises significant public health benefits but also threatens individual privacy; breaches of privacy can lead to individual discrimination in employment, insurance, and government programs. Individuals concerned about privacy invasions may avoid clinical or public health tests, treatments, or research. Although individual privacy protections are critical, comprehensive federal privacy protections do not adequately protect public health data, and existing state privacy laws are inconsistent and fragmented. The Model State Public Health Privacy Act provides strong privacy safeguards for public health data while preserving the ability of state and local public health departments to act for the common good.

Community Health Planning↗
PubMed2000

A proposed national policy on health care workers living with HIV/AIDS and other blood-borne pathogens.

In 1991, scientific uncertainty about the risk of transmission of human immunodeficiency virus or hepatitis B virus (hepatitis B e antigen [HBeAg]-positive) led the Centers for Disease Control and Prevention to recommend that infected health care workers (HCWs) be reviewed by an expert panel and inform patients of their serologic status before engaging in exposure-prone procedures. The data demonstrate that risks of transmission in the health care setting are exceedingly low, suggesting that the national policy should be reformed. Implementation of the current national policy at the local level poses significant human rights burdens on HCWs, but does not improve patient safety. A new national policy should focus on the management of the workplace environment and injury prevention by creating a program to prevent blood-borne pathogen transmission; by encouraging infected HCWs to promote their own health and well-being; by discontinuing expert review panels and special restrictions for exposure-prone procedures, which stigmatize HCWs; by discontinuing mandatory disclosure of a HCW's infection status in low-level risk procedures; and by imposing practice restrictions to avert significant risks to patients. Inclusion of these principles would achieve high levels of patient safety without discrimination and invasion of privacy. JAMA. 2000;284:1965-1970.

Blood-Borne Pathogens↗
PubMed2000

Public health law in a new century: part III: public health regulation: A systematic evaluation.

Public health interventions need justification because they intrude on individual rights and incur economic costs. Coercive interventions can be justified in only 3 cases: to avert a risk of serious harm to other persons, to protect the welfare of incompetent persons, and, most controversially, to prevent a risk to the person himself/herself. This article proposes a systematic evaluation of public health regulation. The article recommends that public health authorities should bear the burden of justification and, therefore, should demonstrate (1) a significant risk based on scientific evidence; (2) the intervention's effectiveness by showing a reasonable fit between means and ends; (3) that economic costs are reasonable; (4) that human rights burdens are reasonable; and (5) that benefits, costs, and burdens are fairly distributed. The 3 articles in this series have sought to provide a fuller understanding of the varied ways in which law can advance the public's health. Public health law should be seen broadly as the government's power and responsibility to ensure the conditions for the population's health. As such, public health law has transcending importance in how we think about government, politics, and policy. JAMA. 2000.

Cost of Illness↗
PubMed2000

Public health law in a new century: part II: public health powers and limits.

The Constitution allocates public health powers among the federal government and the states. Federal public health powers include the authority to tax, spend, and regulate interstate commerce. These powers enable the federal government to raise revenues, allocate resources, economically penalize risk behavior, and broadly regulate in the public's interest. States have an inherent authority to protect, preserve, and promote the health, safety, morals, and general welfare of the people, termed police powers. Police powers enable states to preserve the public health in areas ranging from injury and disease prevention to sanitation, waste disposal, and environmental protection. The Rehnquist Court has emphasized the limits of federal powers and the primacy of states in public health issues affecting local concerns. Finally, the Constitution safeguards individual interests in autonomy, privacy, liberty, and property. The Supreme Court often defers to public health authorities in matters of public health, but engages in strict scrutiny if government interferes with fundamental freedoms or discriminates against a suspect class. Provided that they act justly and reasonably to avert a serious health threat, the Court should cede to agencies the power to act for the communal good. JAMA. 2000.

Contracts↗
PubMed2000

Public health law in a new century: part I: law as a tool to advance the community's health.

Statutes, regulations, and litigation are pivotal tools for creating conditions for people to lead healthier and safer lives. Law can educate, create incentives, and deter; mandate safer product design and use of property; and alter the informational, physical, or economic environment. This article defines public health law as the power and duty of the state to ensure conditions for people to be healthy and limitations on the state's power to constrain autonomy, privacy, liberty, and proprietary interests of individuals and businesses. The 5 essential characteristics of public health law discussed are (1) the government's responsibility to defend against health risks and promote the public's health; (2) the population-based perspective of public health, emphasizing prevention; (3) the relationship between government and the populace; (4) the mission, core functions, and services of the public health system; and (5) the power to coerce individuals, professionals, and businesses for the community's protection. JAMA. 2000;283:2837-2841

Community Health Services↗
PubMed2000

Water quality laws and waterborne diseases: Cryptosporidium and other emerging pathogens.

Waterborne diseases, such as cryptosporidiosis, cause many cases of serious illness in the United States annually. Water quality is regulated by a complex system of federal and state legal provisions and agencies, which has been poorly studied. The authors surveyed state and territorial agencies responsible for water quality about their laws, regulations, policies, and practices related to water quality and surveillance of cryptosporidiosis related to drinking water. In this commentary they review the development and current status of federal drinking water regulations, identify conflicts or gaps in legal authority between federal agencies and state and territorial agencies, and describe court-imposed limitations on federal authority with regard to regulation of water quality. Recommendations are made for government actions that would increase the efficiency of efforts to ensure water quality; protect watersheds; strengthen waterborne disease surveillance; and protect the health of vulnerable populations.

Animals↗
PubMed1999

Legal issues concerning electronic health information: privacy, quality, and liability.

Personally identifiable health information about individuals and general medical information is increasingly available in electronic form in health databases and through online networks. The proliferation of electronic data within the modern health information infrastructure presents significant benefits for medical providers and patients, including enhanced patient autonomy, improved clinical treatment, advances in health research and public health surveillance, and modern security techniques. However, it also presents new legal challenges in 3 interconnected areas: privacy of identifiable health information, reliability and quality of health data, and tortbased liability. Protecting health information privacy (by giving individuals control over health data without severely restricting warranted communal uses) directly improves the quality and reliability of health data (by encouraging individual uses of health services and communal uses of data), which diminishes tort-based liabilities (by reducing instances of medical malpractice or privacy invasions through improvements in the delivery of health care services resulting in part from better quality and reliability of clinical and research data). Following an analysis of the interconnectivity of these 3 areas and discussing existing and proposed health information privacy laws, recommendations for legal reform concerning health information privacy are presented. These include (1) recognizing identifiable health information as highly sensitive, (2) providing privacy safeguards based on fair information practices, (3) empowering patients with information and rights to consent to disclosure (4) limiting disclosures of health data absent consent, (5) incorporating industry-wide security protections, (6) establishing a national data protection authority, and (7) providing a national minimal level of privacy protections.

Computer Communication Networks↗