Barbara J. Evans

University of Florida Levin College of Law

P.O. Box 117625

Gainesville, FL 32611-7625

United States

  • University of Florida Levin College of Law

SCHOLARLY PAPERS

20

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SSRN CITATIONS
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8

CROSSREF CITATIONS

7

Scholarly Papers (20)

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1.

Much Ado About Data Ownership

Harvard Journal of Law and Technology, Vol. 25, Fall 2011, University of Houston Law Center No. 1857986
Number of pages: 62 Posted: 05 Jun 2011 Last Revised: 21 Feb 2014
Barbara J. Evans
University of Florida Levin College of Law
Downloads 548 (57,568)
Citation 3

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health information technology, privacy, data ownership, HIPAA, Common Rule, HITECH Act

2.

Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science

American Journal of Law and Medicine, Vol. 42, No. 4, 651-685, 2016
Number of pages: 36 Posted: 20 Mar 2016 Last Revised: 11 Apr 2019
Barbara J. Evans
University of Florida Levin College of Law
Downloads 307 (113,833)

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precision medicine, citizen science, data commons, privacy, interoperable health data resources

3.

Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era

Notre Dame Law Review, Vol. 85, 2009, U of Houston Law Center No. 2009-A-11
Number of pages: 106 Posted: 14 Mar 2009 Last Revised: 28 Apr 2015
Barbara J. Evans
University of Florida Levin College of Law
Downloads 268 (131,433)

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drug safety, torts, preemption, Wyeth v. Levine, Food & Drug Administration, FDA, genetic tests, drug regulation, clinical trial, health data network, Food & Drug Administration Amendments Act, FDAAA, pharmacogenomics

4.

The First Amendment Right to Speak about the Human Genome

University of Pennsylvania Journal of Constitutional Law (2014), Vol. 16(3):549-636, U of Houston Law Center No. 2013-A-4
Number of pages: 88 Posted: 17 Feb 2013 Last Revised: 28 Jul 2015
Barbara J. Evans
University of Florida Levin College of Law
Downloads 267 (131,942)
Citation 1

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genetics, return of results, First Amendment, direct-to-consumer genetic testing, CLIA

5.

Waiving Your Privacy Goodbye: Privacy Waivers and the HITECH Act’s Regulated Price for Sale of Health Data to Researchers

Univ. of Houston Public Law and Legal Theory Working Paper No. 2010-A-22
Number of pages: 46 Posted: 24 Aug 2010
Barbara J. Evans
University of Florida Levin College of Law
Downloads 200 (174,534)

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HITECH Act, HIPAA Privacy Rule, consent waiver, privacy waiver, health IT, informational privacy

6.

The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act

38 American Journal of Law and Medicine 577-606 (2012), U of Houston Law Center No. 2012-A-19
Number of pages: 30 Posted: 15 Mar 2012 Last Revised: 02 Jul 2014
Barbara J. Evans
University of Florida Levin College of Law
Downloads 197 (176,981)

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privacy, food and drug law, section 505(o)(3), postmarketing observational studies, HIPAA privacy Rule, Common Rule

7.

The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing

Symposium: Emerging Issues and New Frontiers for FDA Regulation, 70 Food and Drug Law Journal 259-287 (2015), U of Houston Law Center No. 2014-A74
Number of pages: 30 Posted: 22 Aug 2014 Last Revised: 26 Aug 2015
Barbara J. Evans
University of Florida Levin College of Law
Downloads 186 (186,365)
Citation 1

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FDA, gene sequencing, high-throughout sequencing, Part 812, IDE, research

8.

The Challenge of Regulating Clinical Decision Support Software after 21st Century Cures

American Journal of Law and Medicine, 2018
Number of pages: 15 Posted: 21 Mar 2018
Barbara J. Evans and Pilar Ossorio
University of Florida Levin College of Law and University of Wisconsin-Madison, School of Law; Morgridge Institute for Research
Downloads 158 (214,468)

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Clinical Decision Support Software, Software as a Medical Device, FDA, Artificial Intelligence, Machine Learning

9.

Congress' New Infrastructural Model of Medical Privacy

Notre Dame Law Review, Vol. 84, No. 3, 2009, U of Houston Law Center No. 2008-A-22
Number of pages: 70 Posted: 30 Jul 2008 Last Revised: 02 Jun 2013
Barbara J. Evans
University of Florida Levin College of Law
Downloads 152 (221,479)

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Privacy, Sentinel System, health database, Nationwide Health Information Network (NHIN), public health, infrastructure regulation, infrastructure financing, Food and Drug Administration Amendments Act of 2007 (FDAAA), HIPAA Privacy Rule, privacy authorization, informed consent, drug safety, FDA

10.

The Law of Genetic Privacy: Applications, Implications, and Limitations

Journal of Law and the Biosciences, 1–36, 2019, Vanderbilt Law Research Paper No. 20-36
Number of pages: 37 Posted: 17 Jun 2020 Last Revised: 06 Nov 2020
Ellen Wright Clayton, Barbara J. Evans, James Hazel and Mark A. Rothstein
Vanderbilt University - Law School, University of Florida Levin College of Law, Center for Genetic Privacy & Identity in Community Settings, Vanderbilt University Medical Center and University of Louisville - Institute for Bioethics, Health Policy, and Law
Downloads 135 (243,703)
Citation 3

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DNA, genetics, genomics, GINA, HIPAA, privacy

11.

The Genetic Information Nondiscrimination Act at Age 10: GINA's Controversial Assertion that Data Transparency Protects Privacy and Civil Rights

William & Mary Law Review, Forthcoming
Number of pages: 69 Posted: 13 Apr 2018
Barbara J. Evans
University of Florida Levin College of Law
Downloads 117 (271,398)

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Genetic Information Nondiscrimination Act, HIPAA Privacy Rule, genomic data, data privacy, data transparency, civil rights, genetic discrimination

12.

Why the Common Rule is Hard to Amend

U of Houston Law Center No. 2012-W-4
Number of pages: 50 Posted: 02 Dec 2012 Last Revised: 02 Jul 2014
Barbara J. Evans
University of Florida Levin College of Law
Downloads 110 (283,384)
Citation 1

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Common Rule, Human-subject protections, Common Rule ANPRM, administrative law

13.

Institutional Competence to Balance Privacy and Competing Values: The Forgotten Third Prong of HIPAA Preemption Analysis

46 U.C. Davis Law Review 1175-1230 (2013), U of Houston Law Center No. 2012-A-15
Number of pages: 56 Posted: 05 Sep 2012 Last Revised: 02 Jul 2014
Barbara J. Evans
University of Florida Levin College of Law
Downloads 94 (314,821)

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Privacy, HIPAA, Preemption, Public Health, Interoperable Health Data Networks, Health IT

14.

Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

J.L. Med & Ethics, 48(Supp. 1) 2020
Number of pages: 31 Posted: 21 Nov 2019 Last Revised: 30 Apr 2020
Mark A. Rothstein, John Wilbanks, Laura M. Beskow, Kathleen Brelsford, Kyle Brothers, Megan Doerr, Barbara J. Evans, Catherine Hammack, Michelle McGowan and Stacey A. Tovino
University of Louisville - Institute for Bioethics, Health Policy, and Law, Sage Bionetworks, Duke University - Institute for Genome Sciences & Policy, Vanderbilt University - Center for Biomedical Ethics and Society, University of Louisville - School of Medicine, Sage Bionetworks, University of Florida Levin College of Law, Independent, affiliation not provided to SSRN and University of Nevada, Las Vegas, William S. Boyd School of Law
Downloads 93 (316,957)

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Citizen Science, Common Rule, FDA, IRB, IRBs, Mobile Devices, NIH, Research Ethics

15.

Authority of the Food and Drug Administration to Require Data Access and Control Use Rights in the Sentinel Data Network

65 Food and Drug Law Journal 67 (2010), U of Houston Law Center No. 2009-A-34
Number of pages: 47 Posted: 19 Nov 2009 Last Revised: 12 Jun 2013
Barbara J. Evans
University of Florida Levin College of Law
Downloads 75 (360,916)

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FDA, Sentinel network, FDAAA, health information technology, data network, health database, governance, HIPAA, privacy, data access, data use rights, public-private partnership

16.

Introduction and Front Matter, Transparency in Health and Health Care in the United States: Law and Ethics

Transparency in Health and Health Care in the United States: Law and Ethics (Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, Barbara J. Evans, eds., Cambridge University Press 2019), Harvard Public Law Working Paper No. 19-38
Number of pages: 28 Posted: 16 Jun 2019 Last Revised: 05 Nov 2019
Carmel Shachar, I. Glenn Cohen, Holly Fernandez Lynch and Barbara J. Evans
Harvard Law School, Harvard Law School, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania and University of Florida Levin College of Law
Downloads 54 (426,668)

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Transparency, Health Insurance, Contracts, Clinical Trials, ERISA, Antitrust

17.

Can Clinical Genetics Laboratories be Sued for Medical Malpractice?

Alexandra L. Foulkes et al., Can Clinical Genetics Laboratories be Sued for Medical Malpractice? 29 Annals Health L. & Life Sci. 153 (2020). , University of Florida Levin College of Law Research Paper No. 20-47
Number of pages: 18 Posted: 18 Mar 2020 Last Revised: 15 Dec 2020
Alexandra Foulkes, Jessica L. Roberts, Paul Appelbaum, Wendy K. Chung, Ellen Wright Clayton, Barbara J. Evans and Gary E. Marchant
U.S. District Court Western District of Oklahoma, University of Houston Law Center, Columbia University - Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetics, affiliation not provided to SSRN, Vanderbilt University - Law School, University of Florida Levin College of Law and Arizona State University - College of Law
Downloads 43 (469,467)

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Reclassification, Genetics, Bioethics, Biolaw, Fifty-State Survey, Medical Malpractice, Torts

18.

The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?

J. L. Med. & Ethics 48(Supp. 1), 2020 Forthcoming , U of Houston Law Center No. 2019-A-11
Number of pages: 22 Posted: 10 Jan 2020 Last Revised: 18 Mar 2020
Barbara J. Evans
University of Florida Levin College of Law
Downloads 22 (579,464)
Citation 1

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Data privacy, individual access rights, HIPAA Privacy Rule, citizen science, FDA research regulations

19.

Minding the Gaps in Regulation of Do-it-Yourself Biotechnology

21 DePaul J. Health Care L. (2020), University of Florida Levin College of Law Research Paper No. 20-36
Number of pages: 19 Posted: 18 Jun 2020 Last Revised: 29 Oct 2020
Barbara J. Evans
University of Florida Levin College of Law
Downloads 19 (599,362)

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20.

Product Liability Suits for FDA-Regulated AI/ML Software

in The Future of Medical Device Regulation: Innovation and Protection (I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson & Carmel Shachar eds., Cambridge University Press, 2021 forthcoming), Brooklyn Law School, Legal Studies Paper No. 656
Number of pages: 15 Posted: 17 Dec 2020
Barbara J. Evans and Frank A. Pasquale
University of Florida Levin College of Law and Brooklyn Law School
Downloads 42

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Clinical Decision Support (CDS) Software, Food and Drug Administration (FDA), Software as a Medical Device (SaMD), product liability, artificial intelligence

Other Papers (1)

Total Downloads: 88
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1.

A Faustian Bargain That Undermines Research Participants' Privacy Rights and Return of Results

71 Florida Law Review 1281 - 1345 (2019)
Number of pages: 65 Posted: 11 Apr 2019 Last Revised: 06 Dec 2019
Barbara J. Evans and Susan M. Wolf
University of Florida Levin College of Law and University of Minnesota Law School
Downloads 88 (391,728)

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Data Privacy, Return of Results, Genomics, Biomedical Research, Civil RIghts, HIPAA, GINA, CLIA laboratory regulations