Good Informatics Practices (GIP) Module: Risk Management PDF Download

Author: Ford Winslow, Roger Fraumann, CISSP, Robert Sturm, MBA, DeEtte Trubey, PMP
Publisher: HIMSS
ISBN:
Category :
Languages : en
Pages : 128

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Author: Michael Cox, CIPP, Tom Czwornog, Roger Fraumann, CISSP, Oscar Ghopeh, PMP, CSM, David Spellmeyer, DeEtte Trubey, PMP, Ford Winslow
Publisher: HIMSS
ISBN:
Category :
Languages : en
Pages : 111

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Author: Jeffrey Guo
Publisher: HIMSS
ISBN:
Category :
Languages : en
Pages : 90

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Author: Robert Barr
Publisher: HIMSS
ISBN:
Category :
Languages : en
Pages : 92

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Author: Frank Cicero, PMP
Publisher: HIMSS
ISBN:
Category : Medical care
Languages : en
Pages : 248

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Author: Heidi Bargerhuff
Publisher: HIMSS
ISBN:
Category :
Languages : en
Pages : 120

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Author: Fouad Sabry
Publisher: One Billion Knowledgeable
ISBN:
Category : Computers
Languages : en
Pages : 138

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Book Description
What Is Clinical Decision Support System A clinical decision support system, often known as a CDSS, is a type of health information technology that offers physicians, staff members, patients, and other individuals access to knowledge and information that is personal to them in order to improve health and health care. The Clinical Decision Support System (CDSS) is comprised of several different applications that improve clinical workflow decision-making. These tools include computerized alerts and reminders to care providers and patients, clinical guidelines, condition-specific order sets, focused patient data reports and summaries, documentation templates, diagnostic support, and contextually appropriate reference information, as well as a variety of other tools. A working definition of "health evidence" has been offered by Robert Hayward of the Centre. It reads as follows: "Clinical decision support systems link health observations with health knowledge to influence health choices by clinicians for improved health care." CDSSs comprise a prominent topic in artificial intelligence in medicine. How You Will Benefit (I) Insights, and validations about the following topics: Chapter 1: Clinical decision support system Chapter 2: Gello Expression Language Chapter 3: International Health Terminology Standards Development Organisation Chapter 4: Medical algorithm Chapter 5: Health informatics Chapter 6: Personal Health Information Protection Act Chapter 7: Treatment decision support Chapter 8: Artificial intelligence in healthcare Chapter 9: Health information technology Chapter 10: Applications of artificial intelligence (II) Answering the public top questions about clinical decision support system. (III) Real world examples for the usage of clinical decision support system in many fields. (IV) 17 appendices to explain, briefly, 266 emerging technologies in each industry to have 360-degree full understanding of clinical decision support system' technologies. Who This Book Is For Professionals, undergraduate and graduate students, enthusiasts, hobbyists, and those who want to go beyond basic knowledge or information for any kind of clinical decision support system.

Author: Sally Shorthose
Publisher: Kluwer Law International B.V.
ISBN: 9041170022
Category : Law
Languages : en
Pages : 590

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Book Description
In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

Author: Sally Shorthose
Publisher: Kluwer Law International B.V.
ISBN: 9403530235
Category : Law
Languages : en
Pages : 840

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Book Description
In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

Author: Food and Agriculture Organization of the United Nations
Publisher: Food & Agriculture Org.
ISBN: 925109070X
Category : Political Science
Languages : en
Pages : 169

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Book Description
This FAO manual on Risk based imported food control aims to support competent authorities in improving the effectiveness of the control measures they are overseeing, based on an analysis of their specific country situation. It discusses the different types of approach to managing risks related to imported food, and provides concrete illustrations of how Codex guidelines can be implemented in different ways. While respecting the principles, guidance and objectives agreed by the Codex Alimentarius Commission, different options for control measures can be selected and combined to implement a coherent set of import controls to best fit the needs of each country. Different examples, as implemented by a number of countries, are provided to show that there are often several options to reach a common goal. It also provides insights on the legal and institutional frameworks, as well as on the necessary support services to effectively implement risk based food controls.