Author: Orlando López
Publisher: CRC Press
ISBN: 1000223035
Category : Business & Economics
Languages : en
Pages : 216
Book Description
Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
Ensuring the Integrity of Electronic Health Records
Author: Orlando López
Publisher: CRC Press
ISBN: 1000223035
Category : Business & Economics
Languages : en
Pages : 216
Book Description
Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
Publisher: CRC Press
ISBN: 1000223035
Category : Business & Economics
Languages : en
Pages : 216
Book Description
Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Ensuring the Integrity of Electronic Health Records
Author: Orlando López
Publisher: CRC Press
ISBN: 1000222993
Category : Business & Economics
Languages : en
Pages : 341
Book Description
Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
Publisher: CRC Press
ISBN: 1000222993
Category : Business & Economics
Languages : en
Pages : 341
Book Description
Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
The Computer-Based Patient Record
Author: Committee on Improving the Patient Record
Publisher: National Academies Press
ISBN: 030957885X
Category : Medical
Languages : en
Pages : 257
Book Description
Most industries have plunged into data automation, but health care organizations have lagged in moving patients' medical records from paper to computers. In its first edition, this book presented a blueprint for introducing the computer-based patient record (CPR). The revised edition adds new information to the original book. One section describes recent developments, including the creation of a computer-based patient record institute. An international chapter highlights what is new in this still-emerging technology. An expert committee explores the potential of machine-readable CPRs to improve diagnostic and care decisions, provide a database for policymaking, and much more, addressing these key questions: Who uses patient records? What technology is available and what further research is necessary to meet users' needs? What should government, medical organizations, and others do to make the transition to CPRs? The volume also explores such issues as privacy and confidentiality, costs, the need for training, legal barriers to CPRs, and other key topics.
Publisher: National Academies Press
ISBN: 030957885X
Category : Medical
Languages : en
Pages : 257
Book Description
Most industries have plunged into data automation, but health care organizations have lagged in moving patients' medical records from paper to computers. In its first edition, this book presented a blueprint for introducing the computer-based patient record (CPR). The revised edition adds new information to the original book. One section describes recent developments, including the creation of a computer-based patient record institute. An international chapter highlights what is new in this still-emerging technology. An expert committee explores the potential of machine-readable CPRs to improve diagnostic and care decisions, provide a database for policymaking, and much more, addressing these key questions: Who uses patient records? What technology is available and what further research is necessary to meet users' needs? What should government, medical organizations, and others do to make the transition to CPRs? The volume also explores such issues as privacy and confidentiality, costs, the need for training, legal barriers to CPRs, and other key topics.
Secondary Analysis of Electronic Health Records
Author: MIT Critical Data
Publisher: Springer
ISBN: 3319437429
Category : Medical
Languages : en
Pages : 435
Book Description
This book trains the next generation of scientists representing different disciplines to leverage the data generated during routine patient care. It formulates a more complete lexicon of evidence-based recommendations and support shared, ethical decision making by doctors with their patients. Diagnostic and therapeutic technologies continue to evolve rapidly, and both individual practitioners and clinical teams face increasingly complex ethical decisions. Unfortunately, the current state of medical knowledge does not provide the guidance to make the majority of clinical decisions on the basis of evidence. The present research infrastructure is inefficient and frequently produces unreliable results that cannot be replicated. Even randomized controlled trials (RCTs), the traditional gold standards of the research reliability hierarchy, are not without limitations. They can be costly, labor intensive, and slow, and can return results that are seldom generalizable to every patient population. Furthermore, many pertinent but unresolved clinical and medical systems issues do not seem to have attracted the interest of the research enterprise, which has come to focus instead on cellular and molecular investigations and single-agent (e.g., a drug or device) effects. For clinicians, the end result is a bit of a “data desert” when it comes to making decisions. The new research infrastructure proposed in this book will help the medical profession to make ethically sound and well informed decisions for their patients.
Publisher: Springer
ISBN: 3319437429
Category : Medical
Languages : en
Pages : 435
Book Description
This book trains the next generation of scientists representing different disciplines to leverage the data generated during routine patient care. It formulates a more complete lexicon of evidence-based recommendations and support shared, ethical decision making by doctors with their patients. Diagnostic and therapeutic technologies continue to evolve rapidly, and both individual practitioners and clinical teams face increasingly complex ethical decisions. Unfortunately, the current state of medical knowledge does not provide the guidance to make the majority of clinical decisions on the basis of evidence. The present research infrastructure is inefficient and frequently produces unreliable results that cannot be replicated. Even randomized controlled trials (RCTs), the traditional gold standards of the research reliability hierarchy, are not without limitations. They can be costly, labor intensive, and slow, and can return results that are seldom generalizable to every patient population. Furthermore, many pertinent but unresolved clinical and medical systems issues do not seem to have attracted the interest of the research enterprise, which has come to focus instead on cellular and molecular investigations and single-agent (e.g., a drug or device) effects. For clinicians, the end result is a bit of a “data desert” when it comes to making decisions. The new research infrastructure proposed in this book will help the medical profession to make ethically sound and well informed decisions for their patients.
Information Technology - New Generations
Author: Shahram Latifi
Publisher: Springer
ISBN: 3319770284
Category : Computers
Languages : en
Pages : 775
Book Description
This volume presents a collection of peer-reviewed, scientific articles from the 15th International Conference on Information Technology – New Generations, held at Las Vegas. The collection addresses critical areas of Machine Learning, Networking and Wireless Communications, Cybersecurity, Data Mining, Software Engineering, High Performance Computing Architectures, Computer Vision, Health, Bioinformatics, and Education.
Publisher: Springer
ISBN: 3319770284
Category : Computers
Languages : en
Pages : 775
Book Description
This volume presents a collection of peer-reviewed, scientific articles from the 15th International Conference on Information Technology – New Generations, held at Las Vegas. The collection addresses critical areas of Machine Learning, Networking and Wireless Communications, Cybersecurity, Data Mining, Software Engineering, High Performance Computing Architectures, Computer Vision, Health, Bioinformatics, and Education.
Electronic Health Records
Author: Rebecca S. Busch
Publisher: John Wiley & Sons
ISBN: 0470399465
Category : Business & Economics
Languages : en
Pages : 256
Book Description
Electronic Health Records: An Audit and Internal Control Guide describes the infrastructure of electronic health records and the impact that the government's new criteria will have on the private and public marketplace. Understand what to look for in a health care record management system and find tips and helpful guidance for implementation. If you are trying to facilitate an audit of a health record management system, you can apply the example described in the model, which will serve as a timely model and invaluable resource.
Publisher: John Wiley & Sons
ISBN: 0470399465
Category : Business & Economics
Languages : en
Pages : 256
Book Description
Electronic Health Records: An Audit and Internal Control Guide describes the infrastructure of electronic health records and the impact that the government's new criteria will have on the private and public marketplace. Understand what to look for in a health care record management system and find tips and helpful guidance for implementation. If you are trying to facilitate an audit of a health record management system, you can apply the example described in the model, which will serve as a timely model and invaluable resource.
Capturing Social and Behavioral Domains and Measures in Electronic Health Records
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309312450
Category : Medical
Languages : en
Pages : 287
Book Description
Determinants of health - like physical activity levels and living conditions - have traditionally been the concern of public health and have not been linked closely to clinical practice. However, if standardized social and behavioral data can be incorporated into patient electronic health records (EHRs), those data can provide crucial information about factors that influence health and the effectiveness of treatment. Such information is useful for diagnosis, treatment choices, policy, health care system design, and innovations to improve health outcomes and reduce health care costs. Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 identifies domains and measures that capture the social determinants of health to inform the development of recommendations for the meaningful use of EHRs. This report is the second part of a two-part study. The Phase 1 report identified 17 domains for inclusion in EHRs. This report pinpoints 12 measures related to 11 of the initial domains and considers the implications of incorporating them into all EHRs. This book includes three chapters from the Phase 1 report in addition to the new Phase 2 material. Standardized use of EHRs that include social and behavioral domains could provide better patient care, improve population health, and enable more informative research. The recommendations of Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 will provide valuable information on which to base problem identification, clinical diagnoses, patient treatment, outcomes assessment, and population health measurement.
Publisher: National Academies Press
ISBN: 0309312450
Category : Medical
Languages : en
Pages : 287
Book Description
Determinants of health - like physical activity levels and living conditions - have traditionally been the concern of public health and have not been linked closely to clinical practice. However, if standardized social and behavioral data can be incorporated into patient electronic health records (EHRs), those data can provide crucial information about factors that influence health and the effectiveness of treatment. Such information is useful for diagnosis, treatment choices, policy, health care system design, and innovations to improve health outcomes and reduce health care costs. Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 identifies domains and measures that capture the social determinants of health to inform the development of recommendations for the meaningful use of EHRs. This report is the second part of a two-part study. The Phase 1 report identified 17 domains for inclusion in EHRs. This report pinpoints 12 measures related to 11 of the initial domains and considers the implications of incorporating them into all EHRs. This book includes three chapters from the Phase 1 report in addition to the new Phase 2 material. Standardized use of EHRs that include social and behavioral domains could provide better patient care, improve population health, and enable more informative research. The recommendations of Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 will provide valuable information on which to base problem identification, clinical diagnoses, patient treatment, outcomes assessment, and population health measurement.
Cybersecurity for Industry 4.0
Author: Lane Thames
Publisher: Springer
ISBN: 3319506609
Category : Computers
Languages : en
Pages : 273
Book Description
This book introduces readers to cybersecurity and its impact on the realization of the Industry 4.0 vision. It covers the technological foundations of cybersecurity within the scope of the Industry 4.0 landscape and details the existing cybersecurity threats faced by Industry 4.0, as well as state-of-the-art solutions with regard to both academic research and practical implementations. Industry 4.0 and its associated technologies, such as the Industrial Internet of Things and cloud-based design and manufacturing systems are examined, along with their disruptive innovations. Further, the book analyzes how these phenomena capitalize on the economies of scale provided by the Internet. The book offers a valuable resource for practicing engineers and decision makers in industry, as well as researchers in the design and manufacturing communities and all those interested in Industry 4.0 and cybersecurity.
Publisher: Springer
ISBN: 3319506609
Category : Computers
Languages : en
Pages : 273
Book Description
This book introduces readers to cybersecurity and its impact on the realization of the Industry 4.0 vision. It covers the technological foundations of cybersecurity within the scope of the Industry 4.0 landscape and details the existing cybersecurity threats faced by Industry 4.0, as well as state-of-the-art solutions with regard to both academic research and practical implementations. Industry 4.0 and its associated technologies, such as the Industrial Internet of Things and cloud-based design and manufacturing systems are examined, along with their disruptive innovations. Further, the book analyzes how these phenomena capitalize on the economies of scale provided by the Internet. The book offers a valuable resource for practicing engineers and decision makers in industry, as well as researchers in the design and manufacturing communities and all those interested in Industry 4.0 and cybersecurity.
Preservation of the Integrity of Electronic Records
Author: L. Duranti
Publisher: Springer Science & Business Media
ISBN: 9401598924
Category : Social Science
Languages : en
Pages : 188
Book Description
By Terry Eastwood This book reports the findings of a research project on the means of protecting the integrity of active and semi-active electronic records. The project, which is commonly referred to as "the UBC Project," was conceived by two of the authors of this book, Luciana Duranti and Terry Eastwood, and conducted between 1994 and 1997. The third author, Heather MacNeil, who worked formally as the principal research assistant on the project, acted as an equal in the research and in the writing of this book. The project investigated a number of fundamental questions that have arisen over the past decade as a consequence of the rapid development and use of computer technology for the creation, maintenance, and preservation of recorded information. One of the first comprehensive studies of the issues associated with the management of electronic records was conducted by the United Nations. The study, commonly known as the ACCIS report, aimed to "develop guidelines for implementation of electronic archives and records management programmes for use by United Nations organizations, taking into account traditional archives and records management practices. " The report of the study of electronic records in eighteen United Nations organizations identified a number of enduring issues. It recognized that the United Nations had to "distinguish between record and non-record material. "l It recognized the problem of ensuring the authenticity of records, which, rather narrowly, it construed as "assuring legality.
Publisher: Springer Science & Business Media
ISBN: 9401598924
Category : Social Science
Languages : en
Pages : 188
Book Description
By Terry Eastwood This book reports the findings of a research project on the means of protecting the integrity of active and semi-active electronic records. The project, which is commonly referred to as "the UBC Project," was conceived by two of the authors of this book, Luciana Duranti and Terry Eastwood, and conducted between 1994 and 1997. The third author, Heather MacNeil, who worked formally as the principal research assistant on the project, acted as an equal in the research and in the writing of this book. The project investigated a number of fundamental questions that have arisen over the past decade as a consequence of the rapid development and use of computer technology for the creation, maintenance, and preservation of recorded information. One of the first comprehensive studies of the issues associated with the management of electronic records was conducted by the United Nations. The study, commonly known as the ACCIS report, aimed to "develop guidelines for implementation of electronic archives and records management programmes for use by United Nations organizations, taking into account traditional archives and records management practices. " The report of the study of electronic records in eighteen United Nations organizations identified a number of enduring issues. It recognized that the United Nations had to "distinguish between record and non-record material. "l It recognized the problem of ensuring the authenticity of records, which, rather narrowly, it construed as "assuring legality.