Sharona Hoffman

Case Western Reserve University School of Law

Professor of Law, Professor of Bioethics and Co-Director of Law-Medicine Center

11075 East Boulevard

Cleveland, OH 44106-7148

United States

View CV
SCHOLARLY PAPERS

38

DOWNLOADS
Rank 3,148

SSRN RANKINGS

Top 3,148

in Total Papers Downloads

9,686

CITATIONS
Rank 16,896

SSRN RANKINGS

Top 16,896

in Total Papers Citations

20

Scholarly Papers (38)

1.

E-Health Hazards: Provider Liability and Electronic Health Record Systems

Berkeley Technology Law Journal, Vol. 24, No. 4, p. 1524, 2009, Case Legal Studies Research Paper No. 09-25
Number of pages: 61 Posted: 29 Aug 2009 Last Revised: 05 Feb 2014
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 1,074 (13,830)

Abstract:

Electronic Health Record (EHR), E-Health, provider liability, health law, health care providers, health information technology, administrative law, clinical practice guidelines, medical malpractice, electronic medical records, American Recovery and Reinvestment Act of 2009

2.

Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems

Case Legal Studies Research Paper No. 08-13, Harvard Journal of Law and Technology, Vol. 22, No. 1, 2008
Number of pages: 65 Posted: 21 Apr 2008 Last Revised: 02 Jun 2013
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 625 (25,017)
Citation 1

Abstract:

Electronic health record, National Health Information Network, medical files, health information technology, computerized physician order entry systems, health care, medical record, patient privacy, HIPAA, evidence-based medicine, medical software, FDA, clinical practice guidelines

3.

Securing the HIPAA Security Rule

Journal of Internet Law, Spring 2007, Case Legal Studies Research Paper No. 06-26
Number of pages: 18 Posted: 26 Dec 2006
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 484 (36,685)

Abstract:

HIPAA, HIPAA Security Rule, Health Data, Data Security, Internet, Health Privacy

4.

Responders' Responsibility: Liability and Immunity in Public Health Emergencies

Georgetown Law Journal, Vol. 96, p. 1913, 2008, Case Legal Studies Research Paper No. 07-29
Number of pages: 58 Posted: 27 Sep 2007 Last Revised: 15 Aug 2008
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 439 (48,973)
Citation 1

Abstract:

liability, immunity, public health emergencies

5.

Preparing for Disaster: Protecting the Most Vulnerable in Emergencies

UC Davis Law Review, Vol. 42, p. 1491, 2009, Case Legal Studies Research Paper No. 08-27
Number of pages: 58 Posted: 19 Sep 2008 Last Revised: 06 Jul 2009
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 404 (44,839)
Citation 1

Abstract:

Disaster Readiness, Vulnerable Populations, Distributive Justice, Civil Rights, Director of At-Risk Individuals, The Post-Katrina Emergency Management Reform Act, Voluntary Registries, Electronic health record system

6.

In Sickness, Health, and Cyberspace: Protecting the Security of Electronic Private Health Information

Boston College Law Review, Vol. 48, No. 2, March 2007, Case Legal Studies Research Paper No. 06-15
Number of pages: 58 Posted: 20 Sep 2006 Last Revised: 05 Feb 2014
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 383 (46,964)
Citation 1

Abstract:

Cyberspace, Health Information, Privacy, HIPAA Security Rule, Administrative Law, Computer Security, Internet, Software

7.

Employing E-Health: The Impact of Electronic Health Records on the Workplace

Case Legal Studies Research Paper No. 2010-1
Number of pages: 25 Posted: 04 Jan 2010 Last Revised: 26 Apr 2014
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 361 (60,222)

Abstract:

Electronic Health Record (EHR), Employment Discrimination, Privacy, Americans with Disabilities Act (ADA), Health Insurance Portability and Accountability Act (HIPPA), Genetic Information Non-Discrimination Act (GENIA), Electronic Medical Records, Regulatory Oversight, Health Information Technology

8.

The Use of Placebos in Clinical Trials: Responsible Research or Unethical Practice?

Connecticut Law Review, Forthcoming
Number of pages: 78 Posted: 18 Oct 2000
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 359 (59,506)
Citation 1

Abstract:

Clinical research, Institutional Review Board, placebos, FDA, HHS,research regulation, research ethics, autonomy, beneficence

9.

Balancing Privacy, Autonomy, and Scientific Needs in Electronic Health Records Research

65 Southern Methodist University Law Review 85 (2012), Case Legal Studies Research Paper No. 2011-22
Number of pages: 61 Posted: 07 Sep 2011 Last Revised: 25 Apr 2014
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 337 (53,341)

Abstract:

Privacy, Clinical research, Human subject autonomy, Electronic health records, Informed consent, HIPAA Privacy Rule, HIPAA Security Rule, Records-based research, De-identification, Re-identification, Common good, Research oversight, Human subject protections, Informational risks

10.

Big Bad Data: Law, Public Health, and Biomedical Databases

Journal of Law, Medicine and Ethics, Forthcoming, Case Legal Studies Research Paper No. 2012-34
Number of pages: 6 Posted: 30 Oct 2012
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 300 (63,102)

Abstract:

electronic health records, public health, biomedical databases, health care informatics, clinical care, public health emergencies, causal inference, data infrastructure, data integrity, interoperability, data collection, data storage, data analysis

11.

Is There a Place for 'Race' as a Legal Concept?

36 Arizona State Law Journal 1093 (2004), Case Legal Studies Research Paper No. 04-4
Number of pages: 68 Posted: 25 Apr 2004 Last Revised: 26 Apr 2014
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 257 (92,530)

Abstract:

Civil rights, employment, race, discrimination, jurisprudence

12.

The Suitability of IRB Liability

Case Legal Studies Research Paper No. 05-4
Number of pages: 54 Posted: 22 Feb 2005
Sharona Hoffman and Jessica Wilen Berg
Case Western Reserve University School of Law and Case Western Reserve University School of Law
Downloads 246 (97,531)
Citation 2

Abstract:

Biomedical Research, Safety of Biomedical Research Participants, Oversight, Institutional Review Boards (IRBs), Oversight System, Qualified Immunity, Litigation as Oversight System

13.

The Drugs Stop Here: A Public Health Framework to Address the Drug Shortage Crisis

67 Food and Drug L.J. 1 (2012), Case Legal Studies Research Paper No. 2012-4
Number of pages: 25 Posted: 10 Feb 2012 Last Revised: 18 May 2012
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 241 (99,979)

Abstract:

drug shortage, FDA, public health, pharmaceutical manufacturing, supply and demand, treatment outcomes, health care costs, comparative effectiveness research, market failure, regulatory constraints, DEA quotas, tax and market incentives, failure-to-supply provisions, Medicare reimbursement

14.

Citizen Science: The Law and Ethics of Public Access to Medical Big Data

Berkeley Technology Law Journal, Forthcoming, Case Legal Studies Research Paper No. 2014-21
Number of pages: 100 Posted: 04 Sep 2014
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 239 (55,183)

Abstract:

Citizen science, big data, data sharing, medical privacy, HIPAA Privacy Rule, medical research, data de-identification, disability discrimination, data stewardship, data use agreements, data mining

15.

Regulating Clinical Research: Informed Consent, Privacy, and Irbs

Capital University Law Review, Vol. 31, 2003
Number of pages: 25 Posted: 21 Apr 2003
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 235 (102,543)

Abstract:

16.

The Use and Misuse of Biomedical Data: Is Bigger Really Better?

39 American Journal of Law & Medicine 497 (213) , Case Legal Studies Research Paper No. 2013-10
Number of pages: 43 Posted: 19 Mar 2013 Last Revised: 05 Feb 2014
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 210 (98,301)

Abstract:

electronic health records, biomedical research databases, health informatics, data errors, selection bias, measurement bias, confounding bias, causal inference techniques, data quality assessment, limitations of technology, data mining

17.

Meaningful Use and Certification of Health Information Technology: What About Safety?

Journal of Law, Medicine and Ethics Supplement, Vol. 77, Spring 2011, Case Legal Studies Research Paper No. 2010-34
Number of pages: 5 Posted: 26 Oct 2010 Last Revised: 05 Feb 2014
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 202 (113,854)

Abstract:

Health information technology (HIT), Electronic health records, National Health Information Network, regulation, “Meaningful Use,” certification criteria, electronic medical records, certification bodies

18.

The Importance of Immutability in Employment Discrimination Law

52 William & Mary Law Review 1483 (2011), Case Legal Studies Research Paper No. 2010-32
Number of pages: 65 Posted: 22 Sep 2010 Last Revised: 02 Apr 2015
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 189 (104,297)
Citation 1

Abstract:

Employment Law, Constitutional Law, Discrimination, Genetic Information Nondiscrimination Act (GINA), Americans with Disabilities Act Amendments Act (ADAAA), “immutable characteristic”, Unalterable Characteristics , Sexual Orientation, Appearance, Parental Status, Marital Status, Political Affiliati

19.

Settling the Matter: Does Title I of the ADA Work?

Alabama Law Review, Vol. 59, No. 2, p. 305, 2008, Case Legal Studies Research Paper No. 07-14
Number of pages: 41 Posted: 03 Apr 2007 Last Revised: 08 Aug 2011
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 188 (119,763)
Citation 3

Abstract:

ADA, Americans with Disabilities Act, EEOC, workplace accommodations, employment discrimination, disability employment policies and procedures, settlement statistics, extra-judicial resolutions, expressive power of the law

20.

Birth after Death: Perpetuities & the New Reproductive Technologies

Georgia Law Review, Forthcoming
Number of pages: 55 Posted: 21 Apr 2003
Sharona Hoffman and Andrew P. Morriss
Case Western Reserve University School of Law and Texas A&M School of Law
Downloads 172 (130,328)
Citation 1

Abstract:

21.

Medical Big Data and Big Data Quality Problems

21 Connecticut Insurance Law Journal 289 (2014), Case Legal Studies Research Paper No. 2015-18
Number of pages: 29 Posted: 11 Jul 2014 Last Revised: 05 Mar 2015
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 152 (96,322)

Abstract:

Big data, Medical data quality, Electronic health records, Electronic health record problems, Meaningful use regulations, HIPAA Privacy Rule, HIPAA Security Rule

22.

'Racially-Tailored' Medicine Unraveled

American University Law Review, Vol. 55, No. 2, pp. 395-452, December 2005, Case Legal Studies Research Paper No. 05-32
Number of pages: 59 Posted: 08 Sep 2005 Last Revised: 02 Jun 2013
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 126 (176,060)
Citation 1

Abstract:

BiDil, Federal Drug Administration, Race, Medicine, Discrimination, Race-based Medicine, Racially-tailored Medicine, Attribute-based Medicine, Racial Profiling, Institutional Review Boards, Scientific Review Boards

23.

Aids Caps, Contraceptive Coverage, and the Law: An Analysis of the Federal Anti-Discrimination Statutes' Applicability to Health Insurance

Cardozo Law Review, February 2002, Forthcoming
Number of pages: 52 Posted: 30 Nov 2001
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 111 (200,625)

Abstract:

24.

Preplacement Examinations and Job-Relatedness: How to Enhance Privacy and Diminish Discrimination in the Workplace

Kansas Law Review, April 2001
Number of pages: 92 Posted: 01 Nov 2000
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 101 (205,929)

Abstract:

Americans with Disabilities Act, disability discrimination, employment discrimination, pre-employment medical testing, genetic discrimination,privacy

25.

Beneficial and Unusual Punishment: An Argument in Support of Prisoner Participation in Clinical Trials

Indiana Law Review, Vol. 33, 1999
Number of pages: 44 Posted: 30 Mar 2000 Last Revised: 24 May 2014
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 92 (185,994)

Abstract:

26.

Corrective Justice and Title I of the ADA

American University Law Review, 2003
Number of pages: 80 Posted: 19 Mar 2003
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 87 (241,382)

Abstract:

27.

Continued Concern: Human Subject Protection, the Irb, and Continuing Review

Tennessee Law Review, Forthcoming
Number of pages: 59 Posted: 15 May 2001
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 85 (229,663)
Citation 2

Abstract:

Clinical research, Institutional Review Board, continuing review of clinical studies, FDA, HHS, research regulation

28.

Unmanaged Care: Towards Moral Fairness in Health Care Coverage

Indiana Law Journal, Forthcoming
Number of pages: 84 Posted: 04 May 2002
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 81 (239,661)
Citation 3

Abstract:

Health Care Coverage, Health Insurance, Uninsured, Moral fairness in health, distributional justice, health care reform, universal health care

29.

Drug-Drug Interaction Alerts: Emphasizing the Evidence

5 Saint Louis University Journal of Health Law & Policy, Vol. 5 (2012) , Case Legal Studies Research Paper No. 2012-22
Number of pages: 15 Posted: 11 Jun 2012
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 76 (248,660)

Abstract:

DDI, drug-drug interaction, clinical decision support system, malpractice liability, malpractice litigation, alert fatigue, contraindication, Dutch drug-drug interaction oversight, expert panel, FDA

30.

Improving Health Care Outcomes Through Personalized Comparisons of Treatment Effectiveness Based on Electronic Health Records

Journal of Law, Medicine and Ethics, Vol. 39, No. 3, p. 425, Case Legal Studies Research Paper No. 2011-24
Number of pages: 13 Posted: 13 Sep 2011
Sharona Hoffman and Andy Podgurski
Case Western Reserve University School of Law and Case Western Reserve University
Downloads 74 (234,613)

Abstract:

Electronic health records, Comparative effectiveness research, Health care outcomes, Health care innovations, Health care costs, Personalized comparison of treatment effectiveness, Personalized medicine, Medical informatics, Medical data integrity

31.

Genetic Testing, Genetic Medicine, and Managed Care

Wake Forest Law Review, Vol. 34, No. 3, 1999
Number of pages: 40 Posted: 05 Feb 2010
Sharona Hoffman and Mark A. Rothstein
Case Western Reserve University School of Law and University of Louisville - Institute for Bioethics, Health Policy, and Law
Downloads 34 (336,784)

Abstract:

genetics, managed care, genetic counseling, human genome project, genetic medicine, quality of care

32.

A Proposal for Federal Legislation to Address Health Insurance Coverage for Experimental and Investigational Treatments

Oregon Law Review, Vol. 78, p. 203, 1999
Number of pages: 48 Posted: 30 Mar 2000 Last Revised: 24 May 2014
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 31 (373,600)
Citation 2

Abstract:

33.

Aging with a Plan: How a Little Thought Today Can Vastly Improve Your Tomorrow

Aging with a Plan: How a Little Thought Today Can Vastly Improve Your Tomorrow, Praeger (May 2015), Case Legal Studies Research Paper No. 2015-13
Number of pages: 10 Posted: 28 May 2015 Last Revised: 08 Jun 2015
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 27 (290,682)

Abstract:

Aging, Legal planning, advance directives, retirement savings, retirement communities, medical care coordination, end of life decisions, long-term care, long-term care insurance, hospice, elderly driving

34.

Improving Regulatory Enforcement in the Face of Inadequate Resources

43 (S2) The Journal of Law, Medicine & Ethics 33 (2015), Case Legal Studies Research Paper No. 2015-19
Number of pages: 13 Posted: 06 Sep 2015
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 9 (431,239)

Abstract:

Teaching Exercise, In-home Care Agencies (IHCA), Oregon, Health Law, Regulatory Compliance, Limited Resources

35.

The Perplexities of Age and Power

Elder Law Journal, Forthcoming, Case Legal Studies Research Paper No. 2017-5
Number of pages: 46 Posted: 21 Mar 2017
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 0 (441,594)

Abstract:

public choice theory, Older Americans Act, media, long-term care insurance, long-term care, lobbying, geriatric care, elder law, driving regulation, caregiving, aging.

36.

Electronic Health Records and Medical Big Data: Law and Policy (Introduction)

Electronic Health Records and Medical Big Data: Law and Policy (Cambridge University Press, December 2016) , Case Legal Studies Research Paper No. 2016-39
Number of pages: 8 Posted: 15 Dec 2016
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 0 (254,296)

Abstract:

Electronic Health Records, Big Data, Health Information Technology, Medical Records, Health Data Security, Privacy, Meaningful Use Regulations, Medical Malpractice Liability, Informed Consent, Medical Data Quality, Open Data, HIPAA, Secondary Use of Health Data, Medical Research

37.

Big Data's New Discrimination Threats: Amending the Americans with Disabilities Act to Cover Discrimination Based on Data-Driven Predictions of Future Disease

Forthcoming in Glenn Cohen, Allison Hoffman and William Sage (eds.), Big Data, Health Law, and Bioethics (Cambridge University Press 2017) , Case Legal Studies Research Paper No. 2016-38
Number of pages: 13 Posted: 14 Dec 2016
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 0 (308,157)

Abstract:

Social Media, Data Brokers, Wellness Programs, Open Data, Disability Discrimination, Privacy, Data Mining, Employment Discrimination, Lending Discrimination, Americans with Disabilities Act, Big Data

38.

Big Data and the Americans with Disabilities Act

68 Hastings Law Journal 777 (2017), Case Legal Studies Research Paper No. 2016-33
Number of pages: 19 Posted: 23 Sep 2016 Last Revised: 28 Jun 2017
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 0 (241,382)

Abstract:

Social Media, Data Brokers, Wellness Programs, Disability Discrimination, Employment Discrimination, Americans with Disabilities Act, Big Data