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Bioinformatics Law: Legal Issues for Computational Biology in the Post-Genome Era [Mīkstie vāki]

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  • Formāts: Paperback / softback, 248 pages, height x width x depth: 255x177x14 mm, weight: 444 g
  • Izdošanas datums: 07-Feb-2014
  • Izdevniecība: American Bar Association
  • ISBN-10: 1627220100
  • ISBN-13: 9781627220101
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Bioinformatics Law: Legal Issues for Computational Biology in the Post-Genome EraPalielināt
  • Formāts: Paperback / softback, 248 pages, height x width x depth: 255x177x14 mm, weight: 444 g
  • Izdošanas datums: 07-Feb-2014
  • Izdevniecība: American Bar Association
  • ISBN-10: 1627220100
  • ISBN-13: 9781627220101
Citas grāmatas par šo tēmu:
Permanent link: https://www.kriso.lv/db/9781627220101.html
Keywords:
This is a collection of cutting-edge research and commentary from leading scholars, bioethicists and legal practitioners, covering the broad and ever-changing intersection of law and bioinformatics. The book begins with an overview of the evolving bioinformatics field then explores legal issues surrounding the software tools that enable large-scale computational biology, including procurement and licensing of commercial software systems, in-house and contracted software development and issues surrounding open source software. Legal issues associated with software tools for large-scale computational biology are examined, including procurement and licensing of commercial software systems, in-house and contracted software development, and open source software.
Foreword xiii
Acknowledgments xv
Chapter 1 Bioinformatics Overview 1(14)
A. James Cuticchia
Introduction
1(1)
Biology
2(2)
Some Examples of the Central Dogma at Work
3(1)
Drug Discovery
4(1)
Human Genome Project
5(2)
Goal 1: Map All Human Genes
6(1)
Goal 2: Determine the Human Genome DNA Sequence
6(1)
Goal 3: Determine the Function of All Human Genes
7(1)
The Sequence
7(1)
Databases
8(2)
Software
10(2)
Annotation Software
12(1)
Conclusion
12(1)
Notes
13(2)
Chapter 2 Commercial Software Licensing 15(8)
Jeremy T. Marr
Introduction
15(1)
Selecting Commercial Bioinformatics Software
15(1)
Features
16(1)
Compatibility
16(1)
Vendor Capabilities
16(1)
License Options and Costs
16(1)
Licensing Models and Scope
16(3)
Scope of Use
17(1)
Perpetual Licenses
18(1)
Term/Subscription
18(1)
Editions
18(1)
Points of Negotiation
19(3)
Pricing
19(1)
Warranties/Indemnification
20(1)
Transferability of Licenses
21(1)
Access to Source Code
21(1)
Improvements
21(1)
Term and Termination
22(1)
Summary
22(1)
Note
22(1)
Chapter 3 Open Source Software and Bioinformatics 23(14)
Michele K. Herman
Jane Eckels
Joanne Montague
Jordan J. Bowler
Introduction
23(1)
OSS Licenses
24(1)
Defining OSS
24(1)
Types of OSS Licenses; the Spectrum of Permissiveness
24(1)
Increasing Importance of Bioinformatics Open Source Software
25(1)
Legal Risks Associated with OSS
26(4)
OSS License Compliance
26(1)
OSS Pedigree
27(1)
Patents and OSS
28(1)
OSS Litigation
29(1)
Risk Mitigation Strategies
30(2)
Individual Developers
31(1)
Organizations
31(1)
Conclusion
32(1)
Notes
33(4)
Chapter 4 Software Development 37(8)
Heather J. Meeker
What's New Today?
37(2)
IP Ownership
38(1)
IP Indemnities
38(1)
Testing and Acceptance (and Refunds)
38(1)
Open Source and Third-Party Software
38(1)
Other Issues
39(1)
The Curious Case of the Bioinformatics Deal
39(5)
Data by the Terabyte-High-Performance and Nonstandard Platforms
39(1)
A Picture Is Worth a Thousand Amino Acids-Graphics Formats
40(1)
The Anarchic World of Software-Regulation
41(1)
I Play for the Users-Testing and Acceptance
42(1)
Do You Know Your Salesman's Birthday?-Development and Sales Cycles
43(1)
Greeting the New Day
44(1)
Note
44(1)
Chapter 5 Software Patents 45(16)
Gregory J. Kirsch
Charley F. Brown
The Basics of Patent Law and Protection
45(1)
The Purpose of Patent Law
45(1)
Requirements for Patentability
45(1)
The Patent Application Process
46(3)
Prior Art
46(1)
Timing of Patent Application
46(1)
The Patent Application
47(1)
Issuance of the Patent
48(1)
Patents for Software
49(4)
Legal Environment
49(4)
Bioinformatics Patents
53(3)
What Are Bioinformatics Inventions?
53(1)
Problems in Obtaining Bioinformatics Patents
53(2)
Useful Claim Types for Bioinformatics Inventions
55(1)
Conclusion
56(1)
Examples of Bioinformatics Patents
57(2)
Notes
59(2)
Chapter 6 A Gene Patent Primer 61(16)
Jennifer Carter-Johnson
Introduction
61(2)
Patent Overview
61(1)
Gene-Related Patents in Bioinformatics
62(1)
Patentable Subject Matter
63(2)
Classes of Patentable Subject Matter
63(1)
Types of Gene-Related Patents
64(1)
Requirements for a Patent
65(7)
Written Description and Enablement
65(2)
The Utility Requirement
67(2)
The Novelty Requirement
69(2)
The Nonobviousness Requirement
71(1)
Conclusion
72(1)
Notes
72(5)
Chapter 7 Privacy, Property Rights, and Gene Ownership 77(12)
Richard A. Spinello
Introduction
77(2)
Privacy Rights and Genetic Information
79(3)
Commodifying the Human Body
82(1)
Patenting the Genome
83(4)
Conclusion
87(1)
Notes
87(2)
Chapter 8 Bioinformatics Collaborations: Key Considerations in Negotiating a Deal 89(8)
Kimberly J. Wade
Introduction
89(1)
Where Do We Start?
90(1)
Key Provisions in Collaboration Agreements
91(5)
Exclusivity
91(1)
Field
92(1)
Payment Terms
92(1)
Record Keeping and Audit Rights
93(1)
Intellectual Property
94(1)
Diligence
95(1)
Governance
95(1)
Term and Termination
96(1)
Conclusion
96(1)
Note
96(1)
Chapter 9 University Research and Licensing 97(16)
Jennifer Carter-Johnson
Jeffrey S. Carter-Johnson
Jorge L. Contreras
Introduction
97(1)
Modes of University Research and Technology Transfer
98(2)
Grant Funding
98(1)
Industry Sponsorship
98(1)
Licensing and Technology Transfer
99(1)
Spin-Outs
99(1)
Patent Pools and Commons
100(1)
University Research and the Bayh-Dole Act
100(5)
A Brief History
100(1)
Requirements of the Bayh-Dole Act
101(3)
Accolades and Criticisms
104(1)
Other University Policy Considerations
105(3)
The Research Exemption
105(2)
Publication and Data Release
107(1)
Socially Responsible Licensing
107(1)
Conclusion
108(1)
Notes
108(5)
Chapter 10 Technical Standards and Bioinformatics 113(24)
Jorge L. Contreras
Introduction
113(1)
Standards and Standard Setting: A Brief Overview
114(1)
Types of Standards
114(1)
Mandatory and Voluntary Standards
114(1)
Standards Development Organizations
115(1)
The Bioinformatics Standards Landscape
115(2)
Terminological Artifacts
115(1)
Reporting Requirements
116(1)
Exchange Formats
116(1)
Competition and Antitrust Issues for Standards Developers
117(2)
Improper Exclusion
117(1)
Improper Exchange of Information
118(1)
Compliance Certification
118(1)
Abuse of Process
119(1)
Policies and Precautions
119(1)
Intellectual Property and Standards
119(5)
Copyright in Standards
120(1)
Patenting and Standards
121(2)
SDO Patent Policies
123(1)
Bioinformatics Standards Policies Today: Assessment and Recommendations
124(4)
Summary of Bioinformatics SDO Policies
124(3)
Policy Recommendations
127(1)
Making Policies Binding
128(1)
Conclusion
128(1)
Notes
129(6)
Appendix 1: Sample Bioinformatics "Open" Standards Development Policy
135(2)
Chapter 11 Database Protection 137(10)
Jon M. Garon
Contract Rights in Databases
138(1)
U.S. Copyright Protection for Database
139(1)
Order Selection and Arrangement
139(1)
U.S. Trade Secret Protection for Valuable, Nonpublic Information
140(1)
U.S. Patent Protection for Original Data
141(2)
Processing Methods and Other Inventions
141(2)
E.U. Database Protection
143(1)
Final Considerations Regarding Database Ownership and Authorship
143(1)
Summary
144(1)
Notes
144(3)
Chapter 12 Data Release and Access 147(10)
Jorge L. Contreras
Introduction
147(1)
The Expanding Data Landscape
147(1)
Bermuda and the Origins of Rapid Genomic Data Release
148(1)
Data Release Post-HGP
149(1)
Data-Release Requirements Today
150(2)
The Cancer Genome Atlas
150(1)
The NIH Genome-Wide Association Studies Policy
150(1)
ENCODE and modENCODE
151(1)
The Human Microbiome Project
151(1)
Private Sector Initiatives
152(1)
Policies Outside the United States
152(1)
Genome Canada
152(1)
Welcome Trust Case Control Consortium (WTCCC)
153(1)
UK Medical Research Council
153(1)
Beyond Genomics
153(2)
Notes
155(2)
Chapter 13 Information Security and Privacy Challenges in Bioinformatics 157(24)
Lucy L. Thomson
Arthur E. Peabody Jr
A Torrent of Data
157(1)
In This
Chapter
158(1)
Biological Databases
158(2)
The Future of Bioinformatics (Medical Informatics) and Clinical Practice
160(1)
Legal Requirements and Implications
161(9)
The HIPAA Privacy Rule
161(1)
Use and Disclosure of PHI for Research
162(1)
Is De-Identification Reliable as a Means to Protect Privacy?
163(1)
Genetic Information Nondiscrimination Act (GINA)
164(1)
The GINA/HIPAA Interface
165(1)
HIPAA Coverage of "Business Associates"
166(1)
The HIPAA Security Rule
166(2)
HITECH-The Federal Data Breach Notification Law
168(1)
State Data Breach Notification Laws
169(1)
Health Care Data Breaches and Information Security: Addressing Threats and Risks to Patient Data
170(6)
The Ned for Risk Assessment
170(1)
Health Care Data Breaches on the Rise-Threats and Vulnerabilities Illustrated
170(2)
Causes of Data Breaches
172(2)
Achieving Optimal Network Security through Continuous Monitoring
174(1)
Action Plan to Address Health Care Data Breaches
175(1)
Is Protecting the Privacy and Security of Personal Health Records an Attainable Goal?
175(1)
Notes
176(5)
Chapter 14 DNA Databanks and Informed Consent 181(10)
Herman T. Tavani
Maria Bottis
Introduction
181(1)
The Informed-Consent Process in the Context of Medical Research
181(2)
The Principle of Informed Consent
182(1)
The Challenge Posed by Genetic Exceptionalism
183(1)
The Opacity of Consent, Data-Mining Tools, and DNA Databanks
183(4)
Data Mining and Secondary Uses of Personal Medical Information
184(1)
DNA Databanks and Community Consent Involving Populations
185(2)
The Charitable Trust Model and Informed Consent
187(1)
Conclusion
188(1)
Notes
189(2)
Chapter 15 Informatics and Public-Health Surveillance 191(24)
Leslie P. Francis
John G. Francis
Background: An Overview of Data Use for Health Surveillance
191(2)
Privacy, Confidentiality, and Consent
193(2)
Governmental Openness and Information Protection: Legal Standards
195(6)
U.S. Privacy Act
195(1)
Freedom of Information Act
196(3)
Statutes Protecting Government Statistics
199(1)
Certificates of Confidentiality for Research Data
199(1)
State Law
200(1)
Surveillance: NEDSS, BioSense, and-the National Healthcare Safety Network
201(3)
The National Electronic Disease Surveillance System
202(1)
Syndromic Surveillance: BioSense
202(2)
The National Healthcare Safety Network
204(1)
Adverse Event Surveillance: Mini-Sentinel
204(1)
State Surveillance Practices: A Patchwork of Protections
205(1)
Increasing Confidentiality Protections
206(2)
Increased Use of Distributed Query Architectures
206(1)
Application of the HIPAA Minimum Necessary Standard When Identifying Information Is Collected for Public-Health Purposes
207(1)
Recommendations Regarding DUAs
207(1)
Clarification of FOIA Exceptions
207(1)
Minimum State Law Standards
208(1)
Augmented Publicity for Data Collection
208(1)
Beyond the De-identification Divide
208(1)
Conclusion
208(1)
Notes
209(6)
Afterword 215(2)
About the Authors 217(4)
Index 221
Jorge L. Contreras, an associate professor at American University's Washington College of Law, focuses research on the effects of intellectual property structures on the dissemination and production of technological innovation, with a focus on basic scientific research and technical standards. Dr. A. Jamie Cuticchia, was ranked in 2001 as a Genome Technology All-Star, one of the Top 3 Bioinformaticians worldwide responsible for the success of the Human Genome Project.