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

SCHOLARLY PAPERS

44

DOWNLOADS
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SSRN RANKINGS

Top 3,331

in Total Papers Downloads

10,936

CITATIONS
Rank 16,799

SSRN RANKINGS

Top 16,799

in Total Papers Citations

20

Scholarly Papers (44)

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 1,192 (16,145)

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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 844 (26,937)
Citation 1

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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 677 (36,422)

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

4.

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 633 (39,794)
Citation 1

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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

5.

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 499 (54,112)

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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

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 496 (54,524)
Citation 1

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

7.

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 491 (55,234)

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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

8.

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 470 (58,417)
Citation 1

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liability, immunity, public health emergencies

9.

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 440 (63,306)

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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

10.

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 416 (67,676)

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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

11.

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 412 (68,507)
Citation 1

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

12.

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 305 (96,685)

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

13.

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 294 (100,609)

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Civil rights, employment, race, discrimination, jurisprudence

14.

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 278 (106,815)

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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

15.

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 262 (113,723)
Citation 2

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

16.

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 258 (115,571)

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17.

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 257 (116,026)

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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

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 248 (120,359)
Citation 1

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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.

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 227 (131,517)

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

20.

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 218 (136,764)
Citation 3

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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

21.

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 Innovation
Downloads 201 (147,638)
Citation 1

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22.

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 177 (165,770)

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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

23.

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 152 (191,091)

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

24.

'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 137 (205,621)
Citation 1

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

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 137 (205,621)

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26.

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 119 (229,252)

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27.

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 115 (235,124)

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

28.

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 110 (242,697)

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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

29.

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 99 (261,051)

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

30.

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 99 (261,051)

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

31.

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 97 (264,536)
Citation 2

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

32.

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 94 (269,963)
Citation 3

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

33.

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 90 (277,480)

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34.

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 73 (314,671)

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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

35.

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 48 (386,179)

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

36.

Step Therapy: Legal and Ethical Implications of a Cost-Cutting Measure

73 Food and Drug Law Journal 38 (2018), Case Legal Studies Research Paper No. 2017-19
Number of pages: 29 Posted: 03 Oct 2017 Last Revised: 27 Feb 2018
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 46 (392,992)

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step therapy, health insurance, medical costs, appeals, the Affordable Care Act, ERISA, Medicare, disability discrimination, transparency, precision medicine

37.

The Perplexities of Age and Power

Elder Law Journal, Vol. 25, Forthcoming, Case Legal Studies Research Paper No. 2017-5
Number of pages: 51 Posted: 21 Mar 2017 Last Revised: 27 Feb 2018
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 44 (400,043)

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

38.

Healing the Healers: Legal Remedies for Physician Burnout

Yale Journal of Health Policy, Law, and Ethics (2019, Forthcoming), Case Legal Studies Research Paper No. 2018-10
Number of pages: 56 Posted: 06 Sep 2018
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 42 (407,318)

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Physician burnout, physician wellness, electronic health record systems, health information technology, health care regulations, MACRA, Meaningful Use, EHR certification, usability testing, scribes, direct primary care, clinical autonomy

39.

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 41 (411,003)
Citation 2

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40.

Personal Health Records as a Tool for Transparency in Health Care

in Transparency in Health and Health Care in the United States: Law and Ethics (Cambridge University Press 2018 Forthcoming), Case Legal Studies Research Paper No. 2017-23
Number of pages: 13 Posted: 14 Dec 2017
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 31 (451,942)

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personal health records, physician-patient relationship, transparency, data accuracy, medical liability, secure messaging, and medical data release

41.

Big Data Analytics: What Can Go Wrong

15 Indiana Health Law Review 227 (2018), Case Legal Studies Research Paper No. 2018-7
Number of pages: 21 Posted: 04 Jun 2018
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 26 (476,435)

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Big data, medical research, data analytics, data quality, selection bias, confounding bias, confirmation bias, causal interactions.

42.

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 24 (487,279)

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

43.

What Genetic Testing Teaches About Predictive Health Analytics Regulation

North Carolina Law Review, Forthcoming, Case Legal Studies Research Paper No. 2019-8
Number of pages: 41 Posted: 01 May 2019 Last Revised: 03 May 2019
Sharona Hoffman
Case Western Reserve University School of Law
Downloads 17 (526,657)

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predictive health analytics, artificial intelligence, machine learning, genetic testing, HIPAA Privacy Rule, Americans with Disabilities Act, discrimination, health privacy

44.

Your Money or Your Patient's Life?: Ransomware and Electronic Health Records

Annals of Internal Medicine, 2017
Posted: 23 Sep 2018
I. Glenn Cohen, Sharona Hoffman and Eli Y Adashi
Harvard Law School, Case Western Reserve University School of Law and Brown University Medical School

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Ransomware, HIPAA, Hospital, Privacy