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At least 469 records · Page 26Linked to original sources
PubMed1998

Premerger notification: reporting and waiting period requirements--FTC. Notice of adoption of formal interpretation and request for comments.

The Premerger Notification Office ("PNO") of the Federal Trade Commission ("FTC"), with the concurrence of the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice ("DOJ"), is adopting a Formal Interpretation of the Hart-Scott-Rodino Act, which requires certain persons planning certain mergers, consolidations, or other acquisitions to report information about the proposed transactions to the FTC and DOJ. The Interpretation concerns the reportability of certain transactions involving a Limited Liability Company ("LLC"), a relatively new form of entity authorized by state statutes. Under the Interpretation, the formation of an LLC will be reportable if it will unite two or more pre-existing businesses under common control. Similarly, acquisitions of existing LLC membership interests will be reportable if they would have the effect of uniting two or more pre-existing businesses under common control.

Antitrust Laws↗
PubMed1989

Medical devices; patient examination glove; revocation of exemptions from the premarket notification procedures and the current good manufacturing practice regulations--FDA. Final rule.

The Food and Drug Administration (FDA) is revising the patient examination glove classification regulation, set forth in 21 CFR 880.6250, by revoking exemptions from the premarket notification procedures and certain current god manufacturing practice (CGMP) requirements identified in the regulation. The revocations are necessary because of the importance of this device in helping to prevent the transmission between patients and health-care workers of the HIV (human immunodeficiency virus) virus that causes AIDS (acquired immunodeficiency syndrome).

Accident Prevention↗
PubMed1989

Followup in HIV testing. Partner notification: the Colorado Department of Health approach.

The Colorado Department of Health finds that partner notification, a procedure that has been beneficial in stemming epidemics of communicable diseases (most notably of syphilis), has proved useful and cost beneficial when applied to the current human immunodeficiency virus (HIV) epidemic. Of key importance is the extremely high level of confidentiality maintained by the department. Highly trained disease intervention specialists search for contacts, advise them to seek HIV testing, and counsel them on safer sex and I.V. practices.

Acquired Immunodeficiency Syndrome↗
PubMed2000

Design of a clinical alert system to facilitate development, testing, maintenance, and user-specific notification.

Creation and maintenance of electronic clinical alerts within a hospital's electronic medical record (EMR) or database poses a number of challenges. Development can require significant programming effort. Final testing should ideally be performed in a real clinical environment without clinician notification, which may create technical challenges. After an alert is in production, modifications may become necessary in response clinician feedback, changes in clinical factors, or technical issues. Changes may be required in the knowledge base utilized by the alert or in the presentation of the alert condition to the clinicians. Occasionally, different users within the clinical environment may wish to have the same alert data presented differently. We have developed a strategy which allows development of multi-functional alerts and facilitates modification of alert function and/or presentation with minimal to no programming effort. Some elements of this scheme may be appropriate for incorporation into clinical alerting standards.

Artificial Intelligence↗
PubMed2001

A radiation safety infraction notification form.

The use of a well constructed form can serve as an official notification of the violation of good radiation safety practice while providing a paper trail for documentation of corrective action.

Health Physics↗
PubMed2001

[Notification of unexpected patients' death to the police].

Controversies continue to exist in what situation the surgeons are obliged to report the perioperative patients' death to the police. With regard to this issue, Japan Surgical Society and twelve other Japanese Surgical Societies have declared that 1) patients' death due to evident malpractice must be reported to the police, 2) patients' death resulting from anticipated surgical complications need not be reported to the police, 3) an independent organization be founded for collection and investigation of medical accident/incident reports. Japan Surgical Society will take a responsibility of making a practical guideline as to the notification of accidents to the police and take a leadership in establishing the independent medical accident/incident center.

Aged↗
PubMed2001

Medical devices; exemption from premarket notification requirements; class I devices; technical amendment. Final rule; technical amendment.

The Food and Drug Administration (FDA) is amending the language in its medical device classification regulations for class I devices for consistency, to include in sections where it was not present, a specific reference to the limitations on exemptions from premarket notification requirements for each generic device classified. The specific reference language was included when some class I generic devices were first exempted under provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). These amendments will provide the same reference for devices that were exempted before that time. The language is intended to conveniently provide the reference, and make the sections clear and easy to read. The status of the devices is not being changed.

Device Approval↗
PubMed2001

Medical devices; exemptions from premarket notification; class II devices. Final rule.

The Food and Drug Administration (FDA) is publishing a final rule exempting from the premarket notification requirements the fluoroscopic compression device, a manual compression device that allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam. The device is classified as an accessory to the image-intensified fluoroscopic x-ray system. FDA received a petition requesting an exemption for the F-Spoon device, a type of fluoroscopic manual compression device. FDA is expanding the exemption for this type of generic device to include other fluoroscopic compression devices. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗
PubMed2002

AIDS, partner notification and gender issues.

The interplay between public health, human rights, legal obligations and physicians' ethical concerns was revealed dramatically in Israel in recent cases involving reporting of the HIV positive status of patients. This paper reviews and critically analyses the decision-making process of Israeli Ethics Committees regarding HIV partner notification. One aim of this analysis is to suggest principles that may guide the decision in such cases. It is argued that the resolution concerning disclosure to partners be based on the Principle of Proportionality, taking into account the type of relationship between partner and patient, their cultural background and gender issues. The paper demonstrates the advantages of addressing such issues by professional multidisciplinary Ethics Committees, whose decisions can bring to bear the scope of relevant considerations.

Confidentiality↗
PubMed2002

Partner notification among asymptomatic Chlamydia trachomatis cases, by means of mailed specimens.

The objective of the study was to evaluate the prevalence of Chlamydia trachomatis infection and the participation, among partners of asymptomatic cases in general practice. Index cases were requested to invite partners for testing by mailed urine samples. One or more partners of 62% of the index cases participated, and the prevalence of infection among partners was 48%. A steady relationship was a determinant of both participation and prevalence. In conclusion, the mailing strategy is an effective strategy for partner notification. A high prevalence wasfound among partners.

Chlamydia Infections↗
PubMed1988

Notification, 15 June 1988.

The effect of this Notification is to prohibit the manufacture and sale of the following in India: fixed-dose combinations of estrogen and progestin (other than oral contraceptives) having, per tablet, an estrogen content of more than 50 mcg (equivalent to ethinyl estradiol) and a progestin content of more than 3 mg (equivalent to norethisterone acetate).

Asia↗
PubMed1997

Iowa trial court blocks parental notification law.

The US District Court for the Southern District of Iowa issued a preliminary injunction on January 22 that prohibits enforcement of that state's parental notification requirement for young women seeking abortions. Under the law, which was passed by the Iowa legislature in March 1996, one parent of a woman under the age of 18 must be notified at least 48 hours before the procedure (see RFN V/6). Alternatively, the young woman may seek a court waiver of the mandate. Judge Ronald Longstaff found that the women's health care providers challenging the law were likely to prevail in their claim that the statute presents an unconstitutional obstacle to young women's right to choose abortion. Affirming findings made in a temporary restraining order that prevented the law from taking effect earlier in the month, Judge Longstaff held that the law would put doctors who provide emergency abortions to young women at risk of liability, a possibility that could discourage physicians from providing abortion services (see RFN VI/1). The court also found that the judicial bypass laid out in the statute failed to sufficiently protect a young woman's confidentiality or guarantee an expeditious procedure. The plaintiffs in Planned Parenthood of Greater Iowa vs. Miller are represented by Dara Klassel and Roger Evans of the Planned Parenthood Federation of America, CRLP's Priscilla Smith and Michael Erdos, Mark Lambert of Planned Parenthood of Greater Iowa, and Randall Wilson of the Iowa Civil Liberties Union.

Abortion, Induced↗
PubMed2000

Development of notification policy in Namibia.

On 21 April, 1999, the Namibian press reported that the government was going to declare AIDS a notifiable disease. This announcement sparked much debate about the role of confidentiality in a sound public health approach to the prevention and control of HIV/AIDS. It also became apparent that in Namibia people's understanding of the principle of confidentiality varies widely. Many seem to confuse the concepts of secrecy and confidentiality. They see preserving confidentiality about HIV/AIDS information as strengthening the "veil of secrecy" that surrounds HIV, reinforcing stigma and undermining efforts to control the spread of HIV. A consultative process, initiated by Joint UN Program on HIV/AIDS, led to the formulation of a much needed policy framework for reporting and notification of HIV/AIDS. A task force was established to identify, discuss and report on national issues, policies and experiences that could inform the discussion on HIV reporting and confidentiality.

Acquired Immunodeficiency Syndrome↗
PubMed2002

[ACN (Automatic Collision Notification)--reducing fatalities in traffic accidents by automated accident reporting].

To improve patient's outcome of seriously injured occupants after vehicle accident rescue should be performed as soon as possible. While the rescue-time-period after EMS alarming is well-defined the rescue-time-period before EMS-alarm is very variable from minutes to several hours. To reduce the rescue-time-period between accident occurrence and EMS-alarm the Automatic Collision Notification (ACN) was developed. The ACN is a new invehicle-equipment which detects a severe vehicle crash and alarms via cellular phone the EMS automatically. Simultaneously the exact accident location is transmitted (GPS). Official data of the European Community predict a 15% reduction of road traffic fatalities with ACN. Thereby the economical benefit of about 561 million [symbol: see text] could be calculated for Germany 2000.

Accidents, Traffic↗
PubMed1992

The EPI in Borno State, Nigeria: impact on routine disease notifications and hospital admissions.

An earlier report on the Nigerian expanded programme on immunization (EPI), covering 1974-1988, failed to demonstrate a clear-cut impact of the programme. This report attempts to determine the effectiveness of EPI in Borno State, Nigeria. We analysed trends in routine notifications for diphtheria, pertussis, tetanus, tuberculosis, measles, and pneumonia, from 1985 to 1991; data on poliomyelitis were excluded because of poor documentation, while we included data on pneumonia for comparison. We also performed a before (1983-1987) after (1988-1991) comparison in terms of the intensifications of EPI by age-specific strata amongst paediatric hospitalization for all EPI diseases at the University of Maiduguri Teaching Hospital, the sole referral hospital for childhood infectious diseases. Our results show an apparent reduction in morbidity from diphtheria, pertussis, tetanus, measles and pneumonia, and this was particularly prominent following intense vaccinations between 1988 and 1991. The reduction in these EPI diseases and pneumonia occurred despite the prevailing adverse socioeconomic conditions, and the absence of a specific control strategy for pneumonia in Nigeria. On the other hand, in spite of national BCG coverage of about 90% there has been a recent (1989-1991) increase in the registered cases of tuberculosis in infants and older children in Borno State. There is a need to intensify other intervention measures alongside EPI activities.

Adult↗
PubMed2003

Is low immunisation coverage in inner urban areas of Australia due to low uptake or poor notification?

INTRODUCTION: The Australian Childhood Immunisation Register (ACIR) consistently reveals pockets of lower immunisation coverage in inner urban areas. We investigated whether low uptake or poor notification of immunisation is the main reason for this difference. METHODS: We estimated under reporting by telephone surveying the parents of 640 children recorded as incompletely immunised on the ACIR at 12 months of age. Immunisation status was based on parental report of written records and/or date of receipt. RESULTS: Of the 97 children living in inner urban areas (defined by postcode and population density), 55 (57%) were shown to be 'definitely immunised'. One hundred and thirty-four (53%) of the 253 children in other urban areas were shown to be 'definitely immunised'. Both these groups were significantly more likely to be 'definitely immunised' than the 104 (36%) of 290 children in areas outside capital cities (p < 0.0001). DISCUSSION: Apparent lower immunisation uptake in inner urban areas of Australia may be attributable to reporting error.

Australia↗
PubMed1992

The introduction of a computerized system for notification and improved analysis of infectious diseases in Sheffield.

In 1989 the manual system of recording and analysing notifications of infectious disease in Sheffield was replaced by a computerized system based on the Epi Info software package. An analysis of the costs and benefits of this change shows that there has been a one-off cost of 780-930 h spent in developing the system. Offset against this is a continuing saving of time of around 400 h per annum. Other benefits which are harder to measure are enumerated and discussed. Costs of computer hardware and software are not substantial in comparison with the savings in staff time.

Communicable Diseases↗