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Results for “Government Regulation”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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PubMed1992

Medicare and Medicaid programs; advance directives--HCFA. Interim final rule with comment period.

This interim final rule amends the Medicare and Medicaid regulations governing provider agreements and contracts to establish requirements for States, hospitals, nursing facilities, skilled nursing facilities, providers of home health care or personal care services, hospice programs and prepaid health plans concerning advance directives. An advance directive is a written instruction, such as a living will or durable power of attorney for health care, recognized under State law, relating to the provision of health care when an individual's condition makes him or her unable to express his or her wishes. The intent of these provisions is to enhance an individual's control over medical treatment decisions. This rule implements sections 4206 and 4751 of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), Public Law 101-508.

Advance Directives↗
PubMed1982

Requirements applicable to projects for family planning services: Public Health Service. Proposed rule.

The Secretary of Health and Human services proposes to amend the regulations governing the program for family planning services funded under Title X of the Public Health Service Act in order to implement a recent amendment of that Act. The statutory amendment requires family planning projects to encourage family participation in the provision of services by the projects, to the extent practical. The Secretary proposes to implement this amendment by requiring projects to notify the parents of unemancipated minors seeking family planning services when prescription drugs or devices are provided. In addition, where state law requires family planning providers to provide Title X services to unemancipated minors only with notification to or the consent of their parents, projects would be required to comply with that law.

Adolescent↗
PubMed1988

Statutory prohibition on use of appropriated funds in programs where abortion is a method of family planning; standard of compliance for family planning services projects--PHS. Final rules.

The Public Health Service (PHS) amends the regulations governing the use of funds for family planning services under Title X of the Public Health Service Act in order to set specific standards for compliance with the statutory requirement that none of the funds appropriated under Title X may be used in programs where abortion is a method of family planning. It is expected that the amendments will improve compliance by grantees with the statute and facilitate monitoring of compliance by PHS.

Abortion, Induced↗
PubMed1999

How will we regulate genetic enhancement?

Genetic enhancement technologies present difficult and novel regulatory issues, including the problem of measuring and comparing risks and benefits and dealing with the impact of these technologies on social values. This Article describes and evaluates the potential approaches that may be taken to regulate these technologies. The author concludes that a variety of approaches will be necessary, involving self-regulation, government restrictions on access and use, licensing, and a national lottery.

American Medical Association↗
PubMedDate not supplied

Uninformed decisionmaking. The case of surrogate research consent.

A New York court recently struck down state Office of Mental Health regulations governing research involving subjects with impaired decisionmaking capacity. The court held that neither incapacitated adults nor minors could participate in any research protocol that contained a nontherapeutic element, irrespective of possible benefits to the subject or the importance of the knowledge to be gained. Although the decision rested on a technical point of law and dealt only with psychiatric research, the court's holding has significantly broader implications.

Adolescent↗
PubMed1977

How BRH, FCC, CPSC, FDA & OSHA regulations affect you.

United States Government regulations cover industrial, medical and consumer ultrasound products for the protection of those using the equipment. There are currently five government agencies which regulate permissible power, intensity and radiation field patterns; permissible frequency and power bands; safety standards for the protection of consumers using ultrasound devices; safety and design standards for diagnosis and therapy by physicians; and standards for the protection of workers in factories using ultrasonic equipment.

Accident Prevention↗
PubMedDate not supplied

Regulation of tattooing in Minneapolis and St. Paul, Minnesota: tattooists' attitudes and relationship between regulation and practice.

OBJECTIVE: This study investigated tattooists' attitudes regarding government regulation and the relationship between existing tattooing regulation and tattooists' knowledge and practice of infection control. METHODS: Self-reported and observational data were collected in a cross-sectional study of professional tattooists. A written survey was used to investigate knowledge and practice of infection control and attitudes toward government regulation. Infection control practice was also examined through direct observation of tattooing. Rating scales were used to compare tattoo artists subject to local tattooing ordinances with those in areas without ordinances. RESULTS: Sixty-one tattooists (45 regulated, 16 unregulated) completed surveys and 25 (17 regulated, 8 unregulated) were observed. Attitudes toward regulation were generally positive. Most participants supported health department inspections and training requirements. The presence of local tattooing ordinances was not associated with tattooists' knowledge (p=0.53), but was associated with self-reported practices (p=0.05). A more positive attitude toward regulation was associated with the use of more self-reported infection control procedures (p<0.01). CONCLUSION: Tattoo artists in areas with local tattooing ordinances may implement more bloodborne pathogen precautions than those in areas without ordinances, despite working from a similar knowledge base. Tattooists most in need of improvement may be difficult to reach due to opposition to government intrusion. Federal guidelines, clarification of OSHA rules applying to tattooists, and statewide regulation are needed. Tattooists should be involved in the development of regulations.

Attitude to Health↗
PubMed1999

Nef-induced CD4 and major histocompatibility complex class I (MHC-I) down-regulation are governed by distinct determinants: N-terminal alpha helix and proline repeat of Nef selectively regulate MHC-I trafficking.

The Nef protein of primate lentiviruses triggers the accelerated endocytosis of CD4 and of class I major histocompatibility complex (MHC-I), thereby down-modulating the cell surface expression of these receptors. Nef acts as a connector between the CD4 cytoplasmic tail and intracellular sorting pathways both in the Golgi and at the plasma membrane, triggering the de novo formation of CD4-specific clathrin-coated pits (CCP). The downstream partners of Nef in this event are the adapter protein complex (AP) of CCP and possibly a subunit of the vacuolar ATPase. Whether Nef-induced MHC-I down-regulation stems from a similar mechanism is unknown. By comparing human immunodeficiency virus type 1 (HIV-1) Nef mutants for their ability to affect either CD4 or MHC-I expression, both in transient-transfection assays and in the context of HIV-1 infection, it was determined that Nef-induced CD4 and MHC-I down-regulation constitute genetically and functionally separate properties. Mutations affecting only CD4 regulation mapped to residues previously shown to mediate the binding of Nef to this receptor, such as W57 and L58, as well as to an AP-recruiting dileucine motif and to an acidic dipeptide in the C-terminal region of the protein. In contrast, mutation of residues in an alpha-helical region in the proximal portion of Nef and amino acid substitutions in a proline-based SH3 domain-binding motif selectively affected MHC-I down-modulation. Although both the N-terminal alpha-helix and the proline-rich region of Nef have been implicated in recruiting Src family protein kinases, the inhibitor herbimycin A did not block MHC-I down-regulation, suggesting that the latter process is not mediated through an activation of this family of tyrosine kinases.

CD4 Antigens↗
PubMedDate not supplied

Government as regulator.

Explore the source record for details and available documents.

Costs and Cost Analysis↗
PubMed2002

Ethical regulations for innovative surgery: the last frontier?

BACKGROUND: There are no clear federal regulations governing innovative surgery, even though general guidelines regulating research with human subjects do exist. We hypothesized that US surgeons are unaware of Department of Health and Human Services regulations, rarely seek IRB review, generally oppose outside regulation of innovative surgery, and are uncertain what constitutes innovation and research. These circumstances, if true, would pose a significant ethical problem and present potential harm to patients as unwitting subjects of research. STUDY DESIGN: In a pilot study we reviewed 527 issues of US surgical and medical journals, selecting 59 articles published between 1992 and 2000, that described innovative surgery. Corresponding authors from university hospitals (71%) and other facilities (29%) were sent an anonymous questionnaire. RESULTS: The survey was conducted between November 2000 and May 2001. Twenty-one questionnaires were returned, completed with responses, constituting a 35% overall response rate. Fourteen authors confirmed their work was research, yet only six had sought prior IRB review. The majority of authors (15 of 21) did not submit their protocol to IRB. Only seven authors had mentioned the innovative nature of the procedure in the informed consent form. Seven authors claimed familiarity with Office for Human Research Protections definitions of research and human subject. Two-thirds of the respondents stated that government regulations for the protection of human subjects of innovative surgery would not be appropriate. CONCLUSIONS: The current system of definitions, ethical theories, and voluntary professional guidelines may be inadequate to meet the challenge of surgical innovation. Further research is proposed to examine the adequacy of the existing guidelines.

Ethical Review↗
PubMed1991

Government should strengthen regulation in the weight loss industry.

Rationales for government regulation in the weight loss industry are developed on the basis of the concepts of market failure and potential harm to consumers. Evidence shows that consumers face problems in judging the quality of the industry's products and services, and they lack adequate protection against possible harm. The pros and cons of a variety of public and private strategies are examined for correcting these deficiencies. Recommendations are suggested for strengthening existing government regulations and expanding research.

Consumer Product Safety↗
PubMed2004

Pharmaceuticals in Australia: developments in regulation and governance.

The pharmaceutical domain represents a type of internationalised policy network theorised in recent writings on neo-liberalism, neo-corporatism and governance. This article presents an analysis of developments in prescription drug regulation in Australia. A relatively stable, state-managed pattern of interaction has been superseded by less closed exchange, and the government itself has fragmented into agencies pursuing different objectives. Developments in the three core regulatory areas are described: safety and efficacy controls, social policy (access and equity), and state support for industry (economic) development. Consensus-building occurs within the context of the National Medicines Policy. The pharmaceutical industry, represented by Medicines Australia, has a stake in all aspects of pharmaceutical policy and regulation, and draws upon unique resources (expertise and lobbying capacity). The context for the developments described is Australia's abandonment of a protectionist version of the Keynesian welfare national state in favour of the model of the competition state, which is oriented towards support for the growth of high technology industries such as pharmaceuticals, premised on partnerships with business.

Australia↗
PubMed2002

Programs and policies to discourage the use of tobacco products.

The past 50 years has witnessed a dramatic change in attitudes toward and use of tobacco by Americans that has resulted in recent declines in the incidence of lung cancer. Most public health scholars believe that this change has been accelerated by public policy interventions to reduce tobacco use. The research literature suggests that the most potent demand reducing influences on tobacco use have been efforts to increase the financial cost of using tobacco products primarily through taxation, smoke-free policies, comprehensive advertising bans, and paid counter-advertising campaigns. New therapies for treating nicotine dependence and measures to liberalize access to medicinal forms of nicotine have the potential to revolutionize the way societies address the problem of tobacco use in the future. Unfortunately, the economic reality of the tobacco business has hindered public health efforts to curb the use of tobacco products. While government regulation of tobacco products is a worthy goal, capitalism, and not government regulation, most likely holds the greatest potential to rapidly alter the worldwide epidemic of tobacco caused disease. It is up to the public health community to harness the powers of capitalism to speed the development of less dangerous alternatives to the conventional cigarette.

Health Education↗
PubMed1995

The introduction of new drugs into anaesthetic practice: a perspective in pharmaceutical development and regulation.

This article reviews the process by which new drugs are introduced into anaesthetic practice with particular emphasis on pharmaceutical development and government regulation. After a brief overview of the drug development process, new trends in drug development are discussed including implementation of pharmacokinetic, pharmacodynamic and toxicokinetic studies in both preclinical and human phases of drug evaluation. A synopsis of the drug regulatory process is provided and, in particular, the problem of unapproved drug use in anaesthesia is discussed. Ethical issues regarding physician-industry interactions are highlighted by examples of conflict of interest in anaesthesia. The processes of drug development and regulation require much effort and cooperation between clinicians, pharmaceutical manufacturers and government regulators to achieve a common goal; the development and utilization of safe and effective drugs. A fundamental understanding of these processes may further facilitate optimal drug utilization and the active involvement of anaesthetists in the drug development process.

Anesthetics↗
PubMed2004

Risk perceptions of mobile phone use while driving.

Numerous governments have introduced regulations governing the use of mobile (cellular) telephones while driving. Despite significant research into the "objective" risks, there is relatively little research into risk perceptions either in relation to other in-car distractions or with respect to the factors underlying such perceptions. The current article reports on two studies addressing these issues. Study 1 (N= 199) found that whereas the use of hand-held sets is seen as one of the riskiest activities to perform while driving, the risks of using a hands-free kit are perceived to be relatively small. Study 2 (N= 1,320) found that nearly half of all drivers in the sample with a mobile phone reported having used it while driving and that, overall, the probability of having an accident was perceived to be less for oneself than for one's peers, indicating an optimistic bias. Two factors underpinned risk perceptions, "impact" including perceived severity and equitability, and "controllability" including immediacy, detectability, and probability. While higher "impact" scores were associated with increased preferences for restrictions on the use of hand-held mobiles while driving, the "controllability" scores moderated this relationship such that when perceived "controllability" was low, restriction preferences were high irrespective of perceived "impact." However, when "controllability" was high, restriction preferences remained high when "impact" was high but were low when "impact" was low. Given the growing number of in-car technological innovations, it is suggested that regulators act strategically, rather than finding themselves developing a series of "hazard-specific" regulations, which may ultimately lack coherence.

Automobile Driving↗