Implementation of the Data Protection Directive in Relation to Medical Research in Europe

Implementation of the Data Protection Directive in Relation to Medical Research in Europe

The Data Protection and Medical Research in Europe: PRIVIREAL series focuses on the ‘Privacy in Research Ethics and Law’ EC-funded project examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development […]

Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements under Patient Protection and Affordable Care Act (US Department of Health and Human Services Regulation) (HHS) (2018 Edition)

Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements under Patient Protection and Affordable Care Act (US Department of Health and Human Services Regulation) (HHS) (2018 Edition)

The Law Library presents the complete text of the Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements under Patient Protection and Affordable Care Act (US Department of Health and Human Services Regulation) (HHS) (2018 Edition).Updated as of May 29, 2018 This document contains the interim final regulation implementing medical loss ratio (MLR) requirements for […]

Human Subject Protection - Acceptance of Data From Clinical Investigations for Medical Devices (US Food and Drug Administration Regulation) (FDA) (2018 Edition)

Human Subject Protection – Acceptance of Data From Clinical Investigations for Medical Devices (US Food and Drug Administration Regulation) (FDA) (2018 Edition)

The Law Library presents the complete text of the Human Subject Protection – Acceptance of Data From Clinical Investigations for Medical Devices (US Food and Drug Administration Regulation) (FDA) (2018 Edition).Updated as of May 29, 2018 The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations […]

Preemption, Tort Reform, And Pharmaceutical Claims: Part Two: Has the Food and Drug Administration Shown It is Solely Responsible for the Protection of Patients? can It Do So? will It Do So?(Medicolegal Issues)

Preemption, Tort Reform, And Pharmaceutical Claims: Part Two: Has the Food and Drug Administration Shown It is Solely Responsible for the Protection of Patients? can It Do So? will It Do So?(Medicolegal Issues)

There should be no question that adverse drug events are a significant issue. A recent report indicated that in 2005 there were 89,842 serious adverse drug-related events (1), and 15,107 of these adverse events were deaths (1). In 2002, adverse drug events were associated with more than 3 million hospital admissions and increased the US […]

Protection of Human Participants in Health Research--a Comparison of Some US Federal Regulations and South African Research Ethics Guidelines (Issues IN RESEARCH)

Protection of Human Participants in Health Research–a Comparison of Some US Federal Regulations and South African Research Ethics Guidelines (Issues IN RESEARCH)

In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a […]

Alteration of Brain Monoamines & EEG Wave Pattern in Rat Model of Alzheimer's Disease & Protection by Moringa Oleifera (Electroencephalography) (Report)

Alteration of Brain Monoamines & EEG Wave Pattern in Rat Model of Alzheimer’s Disease & Protection by Moringa Oleifera (Electroencephalography) (Report)

Background & objectives: The monoaminergic systems which exert a modulatory role in memory processing, are disturbed in Alzheimer’s disease (AD) and Moringa oleifera (MO) has been shown to exert its effect in CNS by altering the brain monoamines. The present study aims to see whether chronic oral treatment of ethanolic extract of MO leaves can […]

Will the New Consumer Protection Act Prevent Harm to Nutritional Supplement Users?(Original Articles)

Will the New Consumer Protection Act Prevent Harm to Nutritional Supplement Users?(Original Articles)

There is no clear distinction between food, supplements and medicines in South Africa. As these are regulated differently, grey areas exist in implementing the legislation, particularly in the supplement industry. The increase in supplement sales in South Africa can be attributed partly to aggressive marketing by manufacturers. Claims made by the companies selling supplements are […]