Serialization Of Prescription Drugs In The Usa

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Countering the Problem of Falsified and Substandard Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309269393
Total Pages : 377 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine

Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Strategy is Digital

Author : Carlos Cordon
Publisher : Springer
ISBN 13 : 3319311328
Total Pages : 151 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Strategy is Digital by : Carlos Cordon

Download or read book Strategy is Digital written by Carlos Cordon and published by Springer. This book was released on 2016-06-01 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents strategies and practices to allow everyday companies to cope with the fundamentally changing landscape of business models and to take advantage of the huge business opportunities arising from the advent of big data. It develops several case studies from companies in traditional industries like LEGO, Yamato and Mediq, but also examines small start-ups like Space Tango, which is partnering with major multinationals to develop new business models using big data. The book argues that businesses need to adapt and embark on their big data journey, helps them take the first step, and guides them along their way. It presents successful examples and deducts essential takeaway lessons from them, equipping executives to capitalize on big data and enabling them to make intelligent decisions in the big data transformation, giving their companies an essential competitive edge.

Pharmaceutical Anti-Counterfeiting

Author : Mark Davison
Publisher : John Wiley & Sons
ISBN 13 : 1118023668
Total Pages : 432 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Pharmaceutical Anti-Counterfeiting by : Mark Davison

Download or read book Pharmaceutical Anti-Counterfeiting written by Mark Davison and published by John Wiley & Sons. This book was released on 2011-08-04 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.

Making Medicines Affordable

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309468086
Total Pages : 235 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine

Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Healthcare Reference Book

Author : Mergent
Publisher :
ISBN 13 : 9781592748952
Total Pages : 0 pages
Book Rating : 4.7/5 (489 download)

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Book Synopsis Healthcare Reference Book by : Mergent

Download or read book Healthcare Reference Book written by Mergent and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Medical-Legal Aspects of Acute Care Medicine

Author : James E. Szalados
Publisher : Springer Nature
ISBN 13 : 3030685705
Total Pages : 694 pages
Book Rating : 4.0/5 (36 download)

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Book Synopsis The Medical-Legal Aspects of Acute Care Medicine by : James E. Szalados

Download or read book The Medical-Legal Aspects of Acute Care Medicine written by James E. Szalados and published by Springer Nature. This book was released on 2021-04-02 with total page 694 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a comprehensive resource intended to provide a state-of-the-art overview of complex ethical, regulatory, and legal issues of importance to clinical healthcare professionals in the area of acute care medicine; including, for example, physicians, advanced practice providers, nurses, pharmacists, social workers, and care managers. In addition, this book also covers key legal and regulatory issues relevant to non-clinicians, such as hospital and practice administrators; department heads, educators, and risk managers. This text reviews traditional and emerging areas of ethical and legal controversies in healthcare such as resuscitation; mass-casualty event response and triage; patient autonomy and shared decision-making; medical research and teaching; ethical and legal issues in the care of the mental health patient; and, medical record documentation and confidentiality. Furthermore, this volume includes chapters dedicated to critically important topics, such as team leadership, the team model of clinical care, drug and device regulation, professional negligence, clinical education, the law of corporations, tele-medicine and e-health, medical errors and the culture of safety, regulatory compliance, the regulation of clinical laboratories, the law of insurance, and a practical overview of claims management and billing. Authored by experts in the field, The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a valuable resource for all clinical and non-clinical healthcare professionals.

Advances in Production Management Systems. Production Management for the Factory of the Future

Author : Farhad Ameri
Publisher : Springer Nature
ISBN 13 : 3030300005
Total Pages : 747 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Advances in Production Management Systems. Production Management for the Factory of the Future by : Farhad Ameri

Download or read book Advances in Production Management Systems. Production Management for the Factory of the Future written by Farhad Ameri and published by Springer Nature. This book was released on 2019-08-23 with total page 747 pages. Available in PDF, EPUB and Kindle. Book excerpt: The two-volume set IFIP AICT 566 and 567 constitutes the refereed proceedings of the International IFIP WG 5.7 Conference on Advances in Production Management Systems, APMS 2019, held in Austin, TX, USA. The 161 revised full papers presented were carefully reviewed and selected from 184 submissions. They discuss globally pressing issues in smart manufacturing, operations management, supply chain management, and Industry 4.0. The papers are organized in the following topical sections: lean production; production management in food supply chains; sustainability and reconfigurability of manufacturing systems; product and asset life cycle management in smart factories of industry 4.0; variety and complexity management in the era of industry 4.0; participatory methods for supporting the career choices in industrial engineering and management education; blockchain in supply chain management; designing and delivering smart services in the digital age; operations management in engineer-to-order manufacturing; the operator 4.0 and the Internet of Things, services and people; intelligent diagnostics and maintenance solutions for smart manufacturing; smart supply networks; production management theory and methodology; data-driven production management; industry 4.0 implementations; smart factory and IIOT; cyber-physical systems; knowledge management in design and manufacturing; collaborative product development; ICT for collaborative manufacturing; collaborative technoloy; applications of machine learning in production management; and collaborative technology.

Medication Errors

Author : Michael Richard Cohen
Publisher : American Pharmacist Associa
ISBN 13 : 1582120927
Total Pages : 707 pages
Book Rating : 4.5/5 (821 download)

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Book Synopsis Medication Errors by : Michael Richard Cohen

Download or read book Medication Errors written by Michael Richard Cohen and published by American Pharmacist Associa. This book was released on 2007 with total page 707 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this expanded 600+ page edition, Dr. Cohen brings together some 30 experts from pharmacy, medicine, nursing, and risk management to provide the most current thinking about the causes of medication errors and strategies to prevent them.

Basic Concepts of Track And Trace System For Pharmaceutical Industry

Author : Rameshwar Verma
Publisher : OrangeBooks Publication
ISBN 13 :
Total Pages : 196 pages
Book Rating : 4./5 ( download)

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Book Synopsis Basic Concepts of Track And Trace System For Pharmaceutical Industry by : Rameshwar Verma

Download or read book Basic Concepts of Track And Trace System For Pharmaceutical Industry written by Rameshwar Verma and published by OrangeBooks Publication. This book was released on 2021-05-25 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Book “Basic concepts of Track and Trace System for Pharmaceutical Industry” is collection of my experience and guide of my Team, the book gives the clear understanding of serialization processes, Global standards, Regulatory requirements and supply chain visibility using various technologies like RFID, Al, IoT and Blockchain etc. Complete understanding of regulatory requirements like DSCSA, EU FMD along with emerging markets. Concise explanations of terminologies. The book basic for beginner and expert the peoples. Who’s want to know all about the track and trace system.

Applications of Blockchain Technology in Business

Author : Mohsen Attaran
Publisher : Springer Nature
ISBN 13 : 3030277984
Total Pages : 116 pages
Book Rating : 4.0/5 (32 download)

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Book Synopsis Applications of Blockchain Technology in Business by : Mohsen Attaran

Download or read book Applications of Blockchain Technology in Business written by Mohsen Attaran and published by Springer Nature. This book was released on 2019-09-25 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book discusses the various ways that blockchain technology is changing the future of money, transactions, government, and business. The first two chapters walk through the foundation of blockchain. Chapters 3–12 look at applications of blockchain in different industries and highlight its exciting new business applications. It show why so many companies are implementing blockchain, and present examples of companies who have successfully employed the technology to improve efficiencies and reduce costs. Chapter 13 highlights blockchain’s powerful potential to foster emerging markets and economies including smart cities, value-based healthcare, decentralized sharing economy, machine to machine transactions, data-sharing marketplace, etc. Chapter 14 offers a conceptual model, provides information and insights, and covers a step-by-step approach to plan and develop blockchain-based technology.

Drug Safety in Developing Countries

Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
ISBN 13 : 0128204125
Total Pages : 656 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Drug Safety in Developing Countries by : Yaser Mohammed Al-Worafi

Download or read book Drug Safety in Developing Countries written by Yaser Mohammed Al-Worafi and published by Academic Press. This book was released on 2020-06-03 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. - Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues - Describes current achievements of drug safety practice in developing countries - Addresses the challenges of drug safety in developing countries - Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

Social Monitoring for Public Health

Author : Michael J. Paul
Publisher : Morgan & Claypool Publishers
ISBN 13 : 1681736101
Total Pages : 188 pages
Book Rating : 4.6/5 (817 download)

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Book Synopsis Social Monitoring for Public Health by : Michael J. Paul

Download or read book Social Monitoring for Public Health written by Michael J. Paul and published by Morgan & Claypool Publishers. This book was released on 2017-08-31 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public health thrives on high-quality evidence, yet acquiring meaningful data on a population remains a central challenge of public health research and practice. Social monitoring, the analysis of social media and other user-generated web data, has brought advances in the way we leverage population data to understand health. Social media offers advantages over traditional data sources, including real-time data availability, ease of access, and reduced cost. Social media allows us to ask, and answer, questions we never thought possible. This book presents an overview of the progress on uses of social monitoring to study public health over the past decade. We explain available data sources, common methods, and survey research on social monitoring in a wide range of public health areas. Our examples come from topics such as disease surveillance, behavioral medicine, and mental health, among others. We explore the limitations and concerns of these methods. Our survey of this exciting new field of data-driven research lays out future research directions.

Food Fraud Prevention

Author : John W. Spink
Publisher : Springer Nature
ISBN 13 : 1493996215
Total Pages : 665 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Food Fraud Prevention by : John W. Spink

Download or read book Food Fraud Prevention written by John W. Spink and published by Springer Nature. This book was released on 2019-10-18 with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook provides both the theoretical and concrete foundations needed to fully develop, implement, and manage a Food Fraud Prevention Strategy. The scope of focus includes all types of fraud (from adulterant-substances to stolen goods to counterfeits) and all types of products (from ingredients through to finished goods at retail). There are now broad, harmonized, and thorough regulatory and standard certification requirements for the food manufacturers, suppliers, and retailers. These requirements create a need for a more focused and systematic approach to understanding the root cause, conducting vulnerability assessments, and organizing and implementing a Food Fraud Prevention Strategy. A major step in the harmonizing and sharing of best practices was the 2018 industry-wide standards and certification requirements in the Global Food Safety Initiative (GFSI) endorsed Food Safety Management Systems (e.g., BRC, FSSC, IFS, & SQF). Addressing food fraud is now NOT optional – requirements include implementing a Food Fraud Vulnerability Assessment and a Food Fraud Prevention Strategy for all types of fraud and for all products. The overall prevention strategy presented in this book begins with the basic requirements and expands through the criminology root cause analysis to the final resource-allocation decision-making based on the COSO principle of Enterprise Risk Management/ ERM. The focus on the root cause expands from detection and catching bad guys to the application of foundational criminology concepts that reduce the overall vulnerability. The concepts are integrated into a fully integrated and inter-connected management system that utilizes the Food Fraud Prevention Cycle (FFPC) that starts with a pre-filter or Food Fraud Initial Screening (FFIS). This is a comprehensive and all-encompassing textbook that takes an interdisciplinary approach to the most basic and most challenging questions of how to start, what to do, how much is enough, and how to measure success.

The Drug Supply Chain Security Act Explained

Author : Dirk Rodgers
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781522904908
Total Pages : 352 pages
Book Rating : 4.9/5 (49 download)

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Book Synopsis The Drug Supply Chain Security Act Explained by : Dirk Rodgers

Download or read book The Drug Supply Chain Security Act Explained written by Dirk Rodgers and published by Createspace Independent Publishing Platform. This book was released on 2016-01-26 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Drug Supply Chain Security Act (DSCSA) was passed by Congress in the fall of 2013 and signed into law by President Barack Obama on November 27, 2013. The DSCSA was Title II of the Drug Quality and Security Act (DQSA). The law establishes new requirements that must be administered by the Food and Drug Administration (FDA). These requirements escalate over time from 2015 through 2023 in a series of stages. They include lot-based tracing of prescription pharmaceuticals from the manufacturer to the dispenser from 2015 through 2023 and serialization-based tracing after 2023. Drug manufacturers must apply unique identifiers on all prescription drug packages by November 2017 and repackagers, wholesale distributors and dispensers must begin to buy and sell products marked with those identifiers by November of 2018, 2019 and 2020 respectively. This book explains the DSCSA, section by section, so that drug manufacturers, repackagers, wholesale distributors, dispensers, contract partners (CMOs, CPOs, 3PLs), solution providers, consultants, law firms, regulators and students can understand the text, the meaning and the significance of the law. The book also includes more than two dozen of the most informative RxTrace essays about various aspects of the DSCSA. These essays, by Dirk Rodgers, help to expose the implications of the law and provide the context necessary to understand its full impact on companies in the supply chain. In these essays, the latest FDA guidance related to the DSCSA, as of book publication, are explained. Praise for The Drug Supply Chain Security Act Explained, Second Edition: "Dirk Rodgers has an unparalleled knowledge of federal track and trace legislation. This book is essential reading for anyone who wants to understand and benefit from coming changes to the pharmaceutical supply chain." -- Adam J. Fein, Ph.D., president, Pembroke Consulting, Inc., and CEO, Drug Channels Institute "Through RxTrace, Dirk Rodgers has provided stakeholders valuable insights on DSCSA. As DSCSA has evolved, his questions and opinions have helped all the stakeholders understand compliance. Dirk's new book brings years of wisdom from RxTrace and more together in one volume." -- Napoleon Monroe, Managing Director, New Directions Technology Consulting, LLC "As dispensers entrusted with the last encounter for patient safety, it is important to have a venue for discussion on DSCSA implementation challenges amongst trading partners. In this book, Dirk provides his experience as a resource for companies to use to create solutions." -- Chris Chandler, PharmD, VP of USDM Healthcare

Performance Artists Talking in the Eighties

Author : Linda M. Montano
Publisher : Univ of California Press
ISBN 13 : 0520919661
Total Pages : 588 pages
Book Rating : 4.5/5 (29 download)

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Book Synopsis Performance Artists Talking in the Eighties by : Linda M. Montano

Download or read book Performance Artists Talking in the Eighties written by Linda M. Montano and published by Univ of California Press. This book was released on 2023-09-01 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: Performance artist Linda Montano, curious about the influence childhood experience has on adult work, invited other performance artists to consider how early events associated with sex, food, money/fame, or death/ritual resurfaced in their later work. The result is an original and compelling talking performance that documents the production of art in an important and often misunderstood community. Among the more than 100 artists Montano interviewed from 1979 to 1989 were John Cage, Suzanne Lacy, Faith Ringgold, Dick Higgins, Annie Sprinkle, Allan Kaprow, Meredith Monk, Eric Bogosian, Adrian Piper, Karen Finley, and Kim Jones. Her discussions with them focused on the relationship between art and life, history and memory, the individual and society, and the potential for individual and social change. The interviews highlight complex issues in performance art, including the role of identity in performer-audience relationships and art as an exploration of everyday conventions rather than a demonstration of virtuosity.

Advertising and Public Relations Law

Author : Carmen Maye
Publisher : Routledge
ISBN 13 : 1351051725
Total Pages : 431 pages
Book Rating : 4.3/5 (51 download)

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Book Synopsis Advertising and Public Relations Law by : Carmen Maye

Download or read book Advertising and Public Relations Law written by Carmen Maye and published by Routledge. This book was released on 2019-06-25 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Addressing a critical need, Advertising and Public Relations Law explores the issues and ideas that affect the regulation of advertising and public relations speech, some of the most dynamic and prevalent areas of professional communications today. This updated third edition explores the categorization of different kinds of speech and their varying levels of First Amendment protection as well as common areas of litigation for communicators such as defamation, invasion of privacy, and copyright and trademark infringement. Features of this edition include: A new chapter on Internet-related laws affecting advertising and public relations speech. History and background of major legal theories affecting professional communicators. Extended excerpts from major court decisions. Overviews of relevant federal and state regulatory schemes, including those promulgated and enforced by the FTC, FCC, FDA and others. Appendices providing a legal glossary, a chart of the judicial system, sample model releases and copyright agreement forms. The volume is developed for upper-level undergraduate and graduate students in media, advertising and public relations law or regulation courses. It also serves as an essential reference for advertising and public relations practitioners.

New Health Technologies

Author : Collectif
Publisher : OECD
ISBN 13 : 9264266445
Total Pages : 239 pages
Book Rating : 4.2/5 (642 download)

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Book Synopsis New Health Technologies by : Collectif

Download or read book New Health Technologies written by Collectif and published by OECD. This book was released on 2017-02-03 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report discusses the need for an integrated and cyclical approach to managing health technology in order to mitigate clinical and financial risks, and ensure acceptable value for money. The analysis considers how health systems and policy makers should adapt in terms of development, assessment and uptake of health technologies. The first chapter provides an examination of adoption and impact of medical technology in the past and how health systems are preparing for continuation of such trends in the future. Subsequent chapters examine the need to balance innovation, value, and access for pharmaceuticals and medical devices, respectively, followed by a consideration of their combined promise in the area of precision medicine. The final chapter examines how health systems can make better use of health data and digital technologies. The report focuses on opportunities linked to new and emerging technologies as well as current challenges faced by policy makers, and suggests a new governance framework to address these challenges.