Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 136
Book Description
Improving Regulatory Transparency for New Medical Therapies Act
Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 136
Book Description
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 136
Book Description
Improving Regulatory Transparency for New Medical Therapies Act, July 29, 2014, 113-2 H. Rept. 113-565, Pt. 1
Improving Regulatory Transparency, ... Sept. 19, 2014, 113-2 House Rept. 113-565, Pt. 2
Improving Regulatory Transparency for New Medical Therapies Act
Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 12
Book Description
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 12
Book Description
Improving Predictability and Transparency in DEA and FDA Regulation
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Drug accessibility
Languages : en
Pages : 224
Book Description
Publisher:
ISBN:
Category : Drug accessibility
Languages : en
Pages : 224
Book Description
Examining Public Health Legislation to Help Patients and Local Communities
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Public health laws
Languages : en
Pages : 172
Book Description
Publisher:
ISBN:
Category : Public health laws
Languages : en
Pages : 172
Book Description
Beyond the HIPAA Privacy Rule
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334
Book Description
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334
Book Description
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Calendars of the United States House of Representatives and History of Legislation
Author: United States. Congress. House
Publisher:
ISBN:
Category : Legislative calendars
Languages : en
Pages : 300
Book Description
Publisher:
ISBN:
Category : Legislative calendars
Languages : en
Pages : 300
Book Description
Journal of the House of Representatives of the United States
Author: United States. Congress. House
Publisher:
ISBN:
Category : CD-ROMs
Languages : en
Pages : 2112
Book Description
Some vols. include supplemental journals of "such proceedings of the sessions, as, during the time they were depending, were ordered to be kept secret, and respecting which the injunction of secrecy was afterwards taken off by the order of the House".
Publisher:
ISBN:
Category : CD-ROMs
Languages : en
Pages : 2112
Book Description
Some vols. include supplemental journals of "such proceedings of the sessions, as, during the time they were depending, were ordered to be kept secret, and respecting which the injunction of secrecy was afterwards taken off by the order of the House".