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Bioinformatics, Medical Informatics and the Law

9781839105944 Edward Elgar Publishing

Elgar Intellectual Property Law and Practice series

Edited by Jorge L. Contreras, Presidential Scholar and Professor of Law, S.J. Quinney College of Law, University of Utah, the late A. James Cuticchia, formerly Adjunct Faculty, Department of Pharmaceutical Sciences, Biomanufacturing Research Institute and Technology Enterprise (BRITE), Founder and Member, AJC Legal Services and Gregory J. Kirsch, Partner - Head of IP Department, Smith, Gambrell & Russell, LLP, Adjunct Professor of Patent/IP Law, Emory University School of Law and Washington University School of Law, US

Publication Date: 2022 ISBN: 978 1 83910 594 4 Extent: 328 pp

In recent years the field of bioinformatics has emerged from the university research laboratory and entered the mainstream healthcare establishment. During this time there has been a rapid increase of legal developments affecting this dynamic field, from Supreme Court decisions radically altering the patentability of informatics inventions to major developments in privacy law both in Europe and the U.S. This edited book strives to offer the reader insight into some of the major legal trends and considerations applicable to these fields today.

This title contains one or more Open Access chapters.

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This book covers a broad range of legal topics relating to the fields of bioinformatics and medical informatics, which relate to the intersection of biomedical information and computer programming within the contexts of scientific research, product development and healthcare delivery. A number of usually distinct bodies of legal doctrine come together in this area, sometimes overlapping, sometimes colliding in unexpected ways.

Key issues discussed in the book include:

• An overview of the current landscape of bioinformatics and medical informatics
• A focus on the legal issues arising from the development and acquisition of informatics tools for use in a laboratory or healthcare setting
• Developments in patent and innovation law that are important for informatics applications
• A discussion of institutions and collaborative arrangements in which informatics applications are developed and used today
• Data protection and privacy issues applicable to informatics applications in the U.S. and Europe.

While no single work can cover the entire set of legal issues arising from large, dynamic and complex fields such as bioinformatics and medical informatics, this book strives to offer the reader insight into some of the major legal trends and considerations applicable to these fields today.

Contributors

Contributors: Jordan J. Bowler, Charley F. Brown, Jeff Carter-Johnson, Jennifer Carter-Johnson, Jorge L. Contreras, Robert Cook-Deegan, A. James Cuticchia, Jane Eckels, John G. Francis, Leslie P. Francis, Jon M. Garon, Janis Geary, Christi Guerrini, Michele K. Herman, Christopher Jones, Gregory J. Kirsch, Brett Lockwood, Mary A. Majumder, Heather J. Meeker, Joanne Montague, Nicole Orlov, Arthur E. Peabody, Jr., Arti K. Rai, Jill Oliver Robinson, Lucy L. Thompson, Adrian Thorogood, Saurabh Vishnubhakat

Contents

Contents:

Preface xvi

Introduction to Bioinformatics, Medical Informatics and the Law xxii
1 Overview of bioinformatics and medical informatics technology for non-specialists 1
A. James Cuticchia
2 Medical Information Commons: conceptual, legal and ethical considerations for stakeholders 12
Janis Geary, Mary A. Majumder, Jill Oliver Robinson, Christi Guerrini and Robert Cook-Deegan
3 Software agreements for bioinformatics and medical informatics applications 31
Brett Lockwood
4 Open source and bioinformatics 44
Michele K. Herman, Jane Eckels, Joanne Montague, Jordan J. Bowler and Nicole Orlov
5 Software development 70
Heather J. Meeker
6 Software patents 80
Gregory J. Kirsch and Charley F. Brown
7 Bioinformatics at the Patent Office 120
Saurabh Vishnubhakat and Arti K. Rai
8 University research and licensing 133
Jeff Carter-Johnson, Jennifer Carter-Johnson and Jorge L. Contreras
9 Technical standards for bioinformatics and medical informatics 153
Jorge L. Contreras and Adrian Thorogood
10 Database protection 180
Jon M. Garon
11 US federal genomic data release and access policies 193
Jorge L. Contreras
12 Privacy and security challenges in bioinformatics 205
Lucy L. Thomson and Arthur E. Peabody, Jr.
13 Bioinformatics, medical informatics and the European General Data Protection Regulation 248
Christopher Jones
14 Informatics and public health surveillance 269
Leslie P. Francis and John G. Francis

Index 297