Patient data: Property, privacy & the public interest

American Journal of Law and Medicine

Volumn 36, Issue 4, 2010, Pages 586-618

  Rodwin, Marc A ^a  

^a SUFFOLK UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONFIDENTIALITY; ELECTRONIC MEDICAL RECORD; HEALTH CARE ORGANIZATION; HUMAN; LEGAL ASPECT; MANAGEMENT; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; UNITED STATES;

CONFIDENTIALITY; GUIDELINES AS TOPIC; HUMANS; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; OWNERSHIP; POLICY MAKING; PRIVATE SECTOR; PUBLIC SECTOR; SOCIETIES; UNITED STATES;

EID: 79953130868     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885881003600403     Document Type: Article

References (311)

1. See generally David M. Eddy, Evidence-Based Medicine: A Unified Approach, 24 HEALTH AFF. 9 (2005).
2. See Jonathan B. Perlin & Joel Kupersmith, Information Technology and the Inferential Gap, 26 HEALTH AFF. w192, w194 (2007).
3. For numerous examples of how patient data is already used for beneficial secondary uses, and a thoughtful discussion of its potential, see generally CAN. INST, OF HEALTH RESEARCH, SECONDARY USE OF PERSONAL INFORMATION IN HEALTH RESEARCH: CASE STUDIES (2002).
4. The FDA is developing a database to monitor adverse drug events. However, there are limitations in the database it is developing for this purpose. See Barbara J. Evans, Authority of the Food and Drug Administration to Require Data Access and Control Use Rights in the Sentinel Data Network, 65 FOOD & DRUG L. J. 67 (2010);
5. Richard Platt et al., The New Sentinel Network-Improving the Evidence of Medical-Product Safety, 361 NEW ENG. J. MED. 645, 646 (2009);
6. see also FDA'S SENTINEL INITIATIVE, http://www.fda.gov/Safety/ FDAsSentinelInitiative/default.htm (last updated Sept. 30, 2010);
7. U. S. FOOD & DRUG ADMIN., U. S. DEP'T OF HEALTH & HUMAN SERVS., THE SENTINEL INITIATIVE: NATIONAL STRATEGY FOR MONITORING MEDICAL PRODUCT SAFETY (2008), available at http://www.fda.gov/oc/initiatives/advance/reports/ report0508.pdf.
8. One research team purchased such data from IMS to identify such practices. See generally David W. Bates et al., Using Computerized Data to Identify Adverse Drug Events in Outpatients, 8 J. AM. MED. INFORMATICS ASS'N 254 (2001);
9. David C. Radley et al., Off-Label Prescribing Among Office-Based Physicians, 166 ARCHIVES OF INTERNAL MEDICINE 1021 (2006).
10. Some of the limitations of observational data from patient records can be addressed when the data is used in simulation models. See, e.g., Carol C. Diamond et al., Collecting and Sharing Data For Population Health: A New Paradigm, 28 HEALTH AFF. 454, 456 (2009);
11. David M. Eddy, Linking Electronic Medical Records to Large-Scale Simulation Models: Can We Put Rapid Learning on Turbo?, 26 HEALTH AFF. wl25, W125-36 (2007);
12. Lynn M. Etheredge, A Rapid-Learning Health System, 26 HEALTH AFF. wl07, w110-13 (2007);
13. Ralph I. Horowitz et al., Developing Improved Observational Methods for Evaluating Therapeutic Effectiveness, 89 AM. J. MED. 630 (1990);
14. Rita Kukafka et al., Redesigning Electronic Health Record Systems to Support Public Health, 40 J. BIOMEDICAL INFORMATICS 398, 403-05 (2007);
15. John R. Lumpkin, Archimedes: A Bold Step into the Future, 26 HEALTH AFF. wl37 (2007);
16. Walter F. Stewart et al., Bridging the Inferential Gap: The Electronic Health Record and Clinical Evidence, 26 HEALTH AFF. W181, W184-90 (2007).
17. See RTI INT'L, RECOMMENDED REQUIREMENTS FOR ENHANCING DATA QUALITY IN ELECTRONIC HEALTH RECORD SYSTEMS § 4.2.1, at 4-6 to -7 (2007), available at http://www.rti.org/pubs/enhancing-data-quality-in-ehrs.pdf;
18. see generally AM. HEALTH INFO. MGMT. ASS'N, DEVELOPMENT OF A NATIONAL HEALTH DATA STEWARDSHIP ENTITY (2007), available at http://www.ahima.org/dc/ documents/MicrosoftWord-AHIMANHDSERFIresponse-final-2007-08-03-.pdf.
19. G. J. ANNAS, THE RIGHTS OF PATIENTS: THE AUTHORITATIVE ACLU GUIDE TO THE RIGHTS OF PATIENTS 224-45 (2004).
20. Marc A. Rodwin, The Case for Public Ownership of Patient Data, 302 JAMA 86, 86 (2009);
21. see Marc A. Rodwin, Patient Data: Professionalism, Property & Policy, in MEDICAL PROFESSIONALISM IN THE INFORMATION AGE (David Rothman & David Blumenthal eds.) (forthcoming 2010) (on file with author);
22. see generally Mark A. Hall & Kevin A. Schulman, Ownership of Medical Information, 301 JAMA 1282 (2009);
23. Adele A. Waller & Oscar L. Alcantara, Ownership of Health Information in the Information Age, 69 J. AH IMA 28 (1998).
24. In most states, patients' medical records are available to patients, providers, as well as hospitals and other institutions that provide medical services. Patients have a right to obtain copies of their medical records. They may have their medical records transferred to another physician if they change doctors. Hospitals and other institutions can keep copies of patient medical records after patients are discharged. See generally Paul V. Stearns, Access to and Cost of Reproduction of Patient Medical Records: A Comparison of State laws, 21 J. LEGAL MED. 79 (2000);
25. Hall & Schulman, supra note 9.
26. See generally Robert Steinbrook, For Sale: Physicians' Prescribing Data, 354 NEW ENG. J. MED. 2745 (2006).
27. U. S. COPYRIGHT OFF., REPORT ON LEGAL PROTECTION FOR DATABASES (1997).
28. For an overview of the European and American law, see MARK J. DAVISON, THE LEGAL PROTECTION OF DATABASES (William R. Cornish ed., 2003).
29. See also P. Bernt Hugenholtz, Stephen M. Maurer & Harlan J. Onsrud, Europe's Database Experiment, 294 SCIENCE 789, 789-90 (2001).
30. J. H. Reichman & Pamela Samuelson, Intellectual Property Rights in Data?, 50 VAND. L. REV. 49, 72-110 (1997). Moreover, once data are made public, trade secrecy law no longer protects the originator, except through two party contracts.
31. See Int'l News Serv. v. Associated Press, 248 U. S. 215, 218-19 (1918);
32. Wendy Gordon, On Owning Information: Intellectual Property and the Restitutionary Impulse, 78 VA. L. REV. 149 (1992);
33. Dennis S. Karjala, Misappropriation as a Third Intellectual Property Paradigm, 94 COLUM. L. REV. 2594 (1994);
34. Jerome H. Reichman, Electronic Information Tools: The Outer Edge of World Intellectual Property Law, 17 U. DAYTON L. REV. 797 (1992).
35. See Database Investment and Intellectual Property Antipiracy Act of 1996, H. R. 3531, 104th Cong. (2nd Sess. 1996);
36. U. S. COPYRIGHT OFFICE, supra note 12, at 57-61;
37. Council Directive 96/9, 1996 O. J. (L 077) 1-17 (EC);
38. COMM. ON ISSUES IN THE TRANSBORDER FLOW OF SCIENTIFIC DATA, NAT'L RESEARCH COUNCIL, BITS OF POWER: ISSUES IN GLOBAL ACCESS TO SCIENTIFIC DATA (1997);
39. Reichman & Samuelson, supra note 14, at 72-102.
40. However, the EC did adopt a directive that protects the content of databases when, due to selection or arrangement of their contents, they are original. The directive extends this protection to nationals of other countries where the other country offers comparable protection to EU databases. Council Directive 96/9, 1996 O. J. (L 077) 1-17 (EC). In 1996, legislation was introduced in the U. S. Congress to grant special protection for databases. The U. S. Copyright Office has studied the pros and cons of granting new legal protection for databases and analyzed the principles and interests at stake. It says that copyright should not harm science, research, education, or reporting but it also says that "substantial copying for commercial, competitive purposes should not be permitted."
41. See H. R. 3531, Database and Collections of Information Misappropriation Act, H. R. 3261, 108th Cong. (2004).
42. Those bills were not enacted, nor were similar bills introduced in 2003. "U. S. Copyright Office Report on Legal Protections for Databases" U. S. COPYRIGHT OFFICE, http://www.copyright.gov/reports/dbase.html.
43. The Subcommittee on Courts, the Internet, and Intellectual Property, Committee on the Judiciary and the Subcommittee on Commerce, Trade and Consumer Protection Committee on Energy and Commerce. Statement of David O. Carson, General Counsel, United States Copyright Office, Sept. 23, 2003, http://www.copyright.gov/docs/regstat092303.html.
44. Copyright Office for Senator Orrin Hatch, Executive Summary, U. S. Copyright Office Report on Legal Protections for Databases, ix, edited by U. S. Copyright Office, http://www.copyright.gov/reports/exsum.pdf.
45. Feist Publ'n v. Rural Tel. Serv. Co., 499 U. S. 340, 340-41 (1991).
46. Knowing this, some lawyers advise clients to arrange patient data in new formats to obtain copyright protection for their creative arrangement. See Waller & Alcantara, supra note 9, at 33.
47. BEN GAFFIN & ASSOC, REPORT ON A STUDY OF ADVERTISING AND THE AMERICAN PHYSICIAN, pt. 1 (1958) as reprinted in Drug Industry Antitrust Act: Hearings Before the Subcomm. on Antitrust and Monopoly of the S. Comm. on the Judiciary, 87th Cong. 490-520 (1961).
48. Jeremy A. Green, Pharmaceutical Marketing Research and the Prescribing Physician, 146 ANNALS INTERNAL MED. 742, 743-46 (2007).
49. Steinbrook, supra note 11, at 2746-47.
50. Data obtained from the AMA identified physicians by their practice specialty, affiliations with hospitals and insurers, practice location and other variables. Information from pharmacies and other firms revealed information on drugs prescribed and sold. Combining such information reveals individual physician and aggregate prescribing patterns. Similar information allows firms to track the use of medical devices and other medical products. EMRs expand the kind and volume of patient data available. They reveal the profile of patients treated by individual physicians and hospitals and the particular diagnosis of patients for which drugs and medical devices are prescribed.
51. Joe Priest, Hospital-Centric Prescription Data Opens New Patient Level Insights and Marketing Opportunities, PHARMACEUTICAL COM., Aug. 20, 2007, http://www.pharmaceuticalcommerce.com/frontEnd/main. php?idSeccion=677;
52. Jean-Patrick Tsang, Patient-Data Come of Age, 23 PHARMACEUTICAL EXECUTIVE 84 (2003).
53. Taryi Forni, Using Patient-Level Data to Take Your Market Assessment to the Next Level, J. LONGITUDINAL DATA, Jan. Feb. 2005, at 12, 12-17;
54. Taryi Forni, Using Anonymous Patient-Level Information to Inform the Brand-Planning Process: Part 2, PRODUCT MGMT. TODAY, May 2006, at 14, 14-15;
55. Julie Klossner & Jack Newson, Studying Drug Utilization by Production Indication, PRODUCT MGMT. TODAY, Oct. 2005, at 16, 16-17;
56. Taryi Forni & Zohar Porat, Assessing Treatment Patterns in Complex Disease Markets: An Example from the Mental Health Market, PRODUCT MGMT. TODAY, Apr. 2005, at 12, 12-13;
57. John Martin & Stephen J. Boccuzzi, Analyzing Drug Utilization Patterns in the Oncology Market, PRODUCT MGMT. TODAY, Mar. 2006, at 14, 14-15.
58. IMS HEALTH INC., ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (D) OF THE SECURITIES EXCHANGE ACT OF 1934 (2007), http://sec.gov/Archives/edgar/data/ l058083/00010474690800l69l/a2182946zl0-k.htm.
59. IMS, HEALTH ECONOMICS AND OUTCOMES RESEARCH, GENERATING CREATIVE AND INFORMATIVE CONTENT FOR THE PHARMACEUTICAL, SCIENCE AND MEDICAL FIELDS, http://www.imshealth.com/web/channel/0, 3147, 64576068-63872702-73l63984, 00.html.
60. IMS, HEALTH ECONOMICS AND OUTCOMES RESEARCH, MEDICAL WRITING AND COMMUNICATION, http://www.imshealth.com/web/channel/0, 3147, 77141581-63872702-77140611,00.html.
61. Id.
62. See AM. HEALTH MGMT. ASS'N, Development of a National Health Data Stewardship Entity, Response to Request for Information 10 (Aug. 3, 2007), http://google.ahima.org/search?q= Development+of+a+National+Health+Data+Stewardship+ Entity&btnG= Search&client=AHIMA-ORG-NEWER&output=xml-no-dtd&proxystylesheet= AHIMA-ORG-NEWER&sort=date%3AD%3AL%3Adl&entqr=3&oe=UTF-8&ie= UTF-8&ud=l&site=all-collection (follow "August 3, 2007 Jonathan White, MD Health IT Director Agency for-" hyperlink).
63. IMS, supra note 24, at 3;
64. Press Release, IMS HEALTH INC., Wolters, Kluwer Health and Verispan, Comment on Federal Judge's Decision to Grant Preliminary Injunction Blocking Enforcement of Main Prescription Restraint Law, (Dec. 26, 2007) http://www.imshealth.com/portal/site/imshealth/menuitem. a46c6d4df3db4b3d88f6ll019418c22a/?vgnextoid= e7ebld3be7a29110VgnVCM10000071812ca2RCRD.
65. IMS, supra note 24, at 8.
66. Steve Bailey, Your Data for Sale?, BOSTON GLOBE, Mar. 24, 2006, at C1.
67. Edmund F. Haislmaier, Health Care Information Technology: Getting the Policy Right THE HERITAGE FOUNDATION, 3 (June 16, 2006), http://www.heritage. org/Research/Reports/2006/06/Health-Care-Information-Technology-Getting-the- Policy-Right.
68. David J. Brailer et al., Financial, Legal and Organizational Approaches to Achieving Electronic Connectivity in Healthcare 18 (Markle Foundation, Report by the Working Group on Financial, Organizational and Legal Sustainability of Health Information Exchange, Oct. 2004), available at http://www. connectingforhealth.org/resources/professionals.html.
69. Charles Safran et al., Toward a National Framework for the Secondary Use of Health Data: An American Medical Informatics Association White Paper, 14 J. AM. MED. INFORMATICS ASS'N 1, 1 (2007).
70. Id. at 3.
71. Safran et al., supra note 34, at 6. AMIA reasserts that view recently. See AM. HEALTH INFO. MGMT. ASS'N, supra note 28, at 4.
72. Jill Burrington-Brown, Beth Hjort & Lydia Washington, Health Data Access, Use, & Control, 78 J. AHIMA 63 (2007), http://library.ahima.org/ xpedio/groups/public/documents/ahima/bokl-034053.hcsp?dDocN ame=bokl-034053.
73. The Department of Health and Human Services requested comments on a National Health Stewardship Entity in the summer of 2007. See Agency for Healthcare Research and Quality, National Health Data Stewardship, Request for Information, 72 Fed. Reg. 30, 803 (June 4, 2007). The idea was harshly criticized by industry in its comments to HHS.
74. See AM. HEALTH INFO. MGMT. ASS'N, supra note 28.
75. Id. at 17.
76. Letter from Connecting for Health, Markle Found., to P. John White, Health Info, and Tech. Dir., Agency for Healthcare Research and Quality, 4 (July 30, 2007), http://www.connectingforhealth.org/resources/cfh-ahrq-aqa-rfi- 073007.pdf (responding to a request for information regarding a national data stewardship entity).
77. Nat'l Comm'n on Quality Assurance, Nat'l Quality Forum & The Joint Comm'n, Response to National Health Data Stewardship Request for Information (FR Doc. 07-2733) (July 27, 2007), http://healthit.ahrq.gov/portal/server.pt/ gateway/PTARGS-0-3882-80O781-0-0-18/NCQA-NQF-TJC%20Joint%20NHDSE%20AHRQ- AQA%20RFI%20Response%20072707.pdf.
78. Id. at 15.
79. Enrico Coiera, Building a National Health IT System from the Middle Out, 16 J. AM. MED. INFORMATIC ASS'N 271, 271 (2009).
80. See Jonah Frohlich et al., Retrospective: Lessons Learned from the Santa Barbara Project and Their Implications for Health Information Exchange, 26 HEALTH AFF. 5 w589 (2007);
81. Julia Adler-Milstein et al., The State of Regional Health Information Organizations: Current Activities and Financing, 27 HEALTH AFF. 1 w60 (2008);
82. Joy M. Grossman et al., Creating Sustainable Local Health Information Exchanges: Can Barriers to Stakeholders Participation Be Overcome?, (Feb. 2008), http://www.hschange.org/CONTENT/970/970.pdf;
83. Robert H. Miller & Bradley S. Miller, The Santa Barbara County Care Data Exchange: What Happened?, 26 HEALTH AFF. 5W568 (2007).
84. See Health Information Technology for Economic and Clinical Health (HITECH) Act, Pub. L. No. 111-5, 123 Stat. 226 (2009)
85. (enacted as part of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5, 123 Stat. 115);
86. STEVEN C. REDHEAD, CONG. RESEARCH SERV., R40892
87. PUBLIC HEALTH, WORKFORCE, QUALITY, AND RELATED PROVISIONS IN H. R. 3962 (2009).
88. See Medicare and Medicaid Programs; Electronic Health Record Incentive Program, Fed. Reg. 75 44314 (July 28, 2010)
89. (to be codified at 42 C. F. R. pt. 412);
90. David Blumenthal, Launching HITECH, 362 NEW ENG. J. MED. 382 (2010);
91. David Brailer, Guiding the Health Information Technology Agenda, 29 HEALTH AFF. 586 (2010).
92. See Etheredge, supra note 6.
93. See Joel Kupersmith et al., Advancing Evidence-Based Care for Diabetes: Lessons from the Veteran's Health Administration, 26 HEALTH AFF. 2wl56, 165 (2007).
94. See Stewart et al., supra note 6, at wl85, wl87.
95. Judith Waltz & Lena Robins, CMS Makes Medicare Part D Data Available for the FDA Sentinel Initiative, External Research, and Other Outside Uses, 21 HEALTH LAW 31 (2009).
96. Sean R. Tunis, Tanisha V. Carino, Reginald D. Williams II & Peter B. Bach, Federal Initiative to Support Rapid Learning About New Technologies, 26 HEALTH AFF. w140, wl40-49 (2007).
97. John S. Brownstein et al., Rapid Identification of Myocardial Infarction Risk Associated with Diabetic Medications Using Electronic Medical Records, 33 DIABETES CARE 526, 526-31 (2010).
98. CTRS. FOR DISEASE CONTROL & PREVENTION & AGENCY FOR TOXIC SUBSTANCES & DISEASE REGISTRY, POLICY ON RELEASING AND SHARING DATA MANUAL GUIDE: GENERAL ADMINISTRATION, CDC-102 (2003), available at http://www.cdc.gov/ od/foia/policies/sharing.htm.
99. The reporting began with the passage of the California Hospital Disclosure Act by the California Legislature, Senate Bill 283 in 1971. Since then the reporting requirements have been revised through legislation and regulation several times. For a history, see OFFICE OF STATEWIDE HEALTH PLANNING & DEVELOPMENT, CALIFORNIA INPATIENT DATA REPORTING MANUAL: MEDICAL INFORMATION REPORTING FOR CALIFORNIA vi, vi-ix (7th ed. 2010), available at http://www.oshpd.ca.gov/HID/MIRCal/Text-pdfs/ManualsGuides/IPManual/Intro.pdf. For information on the availability of the data
100. see OFFICE OF STATEWIDE HEALTH PLANNING & DEVELOPMENT, CALIFORNIA INPATIENT DATA REPORTING MANUAL: MEDICAL INFORMATION REPORTING FOR CALIFORNIA § 97215 (d) (7th ed. 2010), available at http://www.oshpd.ca.gov/HID/ MIRCal/Text-pdfs/ManualsGuides/IPManual/RptngReq.pdf.
101. For a manual that describes the data see OFFICE OF STATEWIDE HEALTH PLANNING & DEVELOPMENT, CALIFORNIA INPATIENT DATA REPORTING MANUAL: MEDICAL INFORMATION REPORTING FOR CALIFORNIA 1, 1-22 (7th ed. 2010), available at http://www.oshpd.ca.gov/HID/MIRCal/Text-pdfs/ManualsGuides/IPManual/RptngReq. pdf.
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117. See ROBERT K. MERTON, THE SOCIOLOGY OF SCIENCE: THEORETICAL AND EMPIRICAL INVESTIGATIONS (Norman W. Storer ed., 1973). Merton holds that the norms of science involve: communalism, universalism, disinterestedness, originality and skepticism.
118. Id. at 270. He says that the accumulation of knowledge relies on cooperative enquiry and reporting of results.
119. Id. at 316.
120. Jerome H. Reichman, Discussion Framework: A Contractually Reconstructed Research Commons for Science and Innovation, in THE ROLE OF SCIENTIFIC AND TECHNICAL DATA AND INFORMATION IN THE PUBLIC DOMAIN: PROCEEDINGS OF SYMPOSIUM 141, 142 (Julie M. Esanu & Paul F. Uhlir eds., 2003);
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126. S. J. Liebowitz & Stephen E. Margolis, Network Effects and Externalities, in THE NEW PALGRAVE DICTIONARY OF ECONOMICS AND THE LAW 671, 671-74 (Peter Newman ed., 1998);
127. Mark A. Lemley & David McGowan, Legal Implications of Network Economic Effects, 86 CALIF. L. REV. 479, 479-611 (1998);
128. JAMES BESSEN & MICHAEL J. MEURER, PATIENT FAILURE: HOW JUDGES, BUREAUCRATS, AND LAWYERS PUT INNOVATORS AT RISK (2008);
129. Mark A. Hall, Property, Privacy, and the Pursuit of Interconnected Electronic Medical Records, 95 IOWA L. REV. 631, 631-63 (2010);
130. RUSSELL HARDIN, COLLECTIVE ACTION (1982);
131. CONGRESSIONAL BUDGET OFFICE, EVIDENCE ON THE COSTS AND BENEFITS OF HEALTH INFORMATION TECHNOLOGY (2008), available at https://www.cbo.gov/ftpdocs/91xx/ doc9l68/05-20-HealthIT.pdf;
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134. See Guilhem Fabre, Propriété intellectuelle, sante Publique et innovation pharmaceutique, in PROPRIÉTÉ INTELLECTUELLE, CONTREFAÇON ET INNOVATION: LES MULTINATIONALES FACE À L'ÉCONOMIE DE LA CONNAISSANCE 71, 71-104 (2009);
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136. OXFAM, CUT THE COST: FATAL SIDE EFFECTS: MEDICINE PATENTS UNDER THE MICROSCOPE (2001);
137. OXFAM, PATENT INJUSTICE: HOW WORLD TRADE RULES THREATEN THE HEALTH OF POOR PEOPLE (2000).
138. Arti Rai & James Boyle, Synthetic Biology: Caught Between Property Rights, the Public Domain, and the Commons, 5 PUB. LIBR. SCI. BIOLOGY 389, 389-93 (2007).
139. Carol Rose, The Comedy of the Commons: Custom, Commerce, and Inherently Public Property, 53 U. CHI. L. REV. 711, 774 (1986).
140. David Lange, Recognizing the Public Domain, 44 LAW & CONTEMP. PROBS. 147, 147-78 (1981).
141. JAMES BOYLE, SHAMANS, SOFTWARE, AND SPLEENS: LAW AND THE CONSTRUCTION OF THE INFORMATION SOCIETY (1996);
142. James Boyle, A Politics of Intellectual Property: Environmentalism for the Net?, 47 Duke L. J. 87, 87-116 (1997); (Pubitemid 127431345)
143. Robert Mazzoleni & Richard R. Nelson, Economic Theories About the Benefits and Costs of Patents, 32 J. ECON. ISSUES 1031, 1031-52 (1998);
144. LAWRENCE LESSIG, THE FUTURE OF IDEAS: THE FATE OF THE COMMONS IN A CONNECTED WORLD (2001);
145. SIVA VAIDHYANATHAN, COPYRIGHTS AND COPYWRONGS: THE RISE OF INTELLECTUAL PROPERTY AND HOW IT THREATENS CREATIVITY (2001);
146. PETER DRAHAOS & JOHN BRAITHWAITE, INFORMATION FEUDALISM: WHO OWNS THE KNOWLEDGE ECONOMY? (2002);
147. PHILIPPE AIGRAIN, CAUSE COMMUNE: L'INFORMATION ENTRE BIEN COMMUN ET PROPRIETE (2005);
148. JAMES BOYLE, THE PUBLIC DOMAIN: ENCLOSING THE COMMONS OF THE MIND (2008);
149. GUILHEM FABRE, PROPRIÉTÉ INTELLECTUELLE, CONTREFAÇON ET INNOVATION: LES MULTINATIONALES FACE À L'ÉCONOMIE DE LA CONNAISSANCE (2009).
150. See Jack Hirshleifer, The Private and Social Value of Information and the Reward to Inventive Activity, 61 AM. ECON. REV. 561 (1971);
151. RICHARD R. NELSON & SIDNEY G. WINTER, AN EVOLUTIONARY THEORY OF ECONOMIC CHANGE (1982).
152. See LAWRENCE LESSIG, CODE: AND OTHER LAWS OF CYBERSPACE (2001);
153. LAWRENCE LESSIG, THE FUTURE OF IDEAS: THE FATE OF THE COMMONS IN A CONNECTED WORLD (2001);
154. PHILIPPE AIGRAIN, INTERNET & CRÉATION: COMMENT RECONNAÎTRE LES ÉCHANGES SUR INTERNET EN FINANÇANT LA CRÉATION (2008);
155. PHILIPPE AIGRAIN, CULTURE AND THE ECONOMY IN THE INTERNET AGE (forthcoming).
156. See WILLIAM M. LANDES & RICHARD A. POSNER, THE ECONOMIC STRUCTURE OF INTELLECTUAL PROPERTY LAW (2003).
157. I assume that databases will only use data already recorded so that there is no additional work to collect data. The situation is different if databases that will be used require collecting data that is not yet recorded. There is probably also some value to organizations generating additional data that might also have yield spillover benefits. There is thus a case for treating such new data as a merit good and the government subsidizing its production.
158. The conventional wisdom is that private ownership is more efficient than public ownership. This is not necessarily so. For example, roads and waterways often more efficiently help as public rather than private property. See Rose, supra note 63, at 714 n. 17, 774-78.
159. For a critique of the idea that private property is generally efficient see Duncan Kennedy & Frank Michelman, Are Property and Contract Efficient?, 8 HOFSTRA L. REV. 711 (1979-1980);
160. Harold Demsetz, When Does the Rule of Liability Matter?, 1 J. LEGAL STUD. 13, 25-28 (1972);
161. Uwe E. Reinhardt, Can Efficiency in Health Care Be Left to the Market?, 26 J. HEALTH POL. POL'Y & L. 967 (2001).
162. See, e.g., J. D. WASSENAAR & S. L. THRAN (AM. MED. ASS'N) PHYSICIAN SOCIOECONOMIC STATISTICS 2000-2002 (2003);
163. M. L. GONZALEZ AND P. ZHANG (AM. MED. ASS'N), PHYSICIAN SOCIOECONOMIC STATISTICS 1997/1998 (1998);
164. S. G. VAHOVICH (AM. MED. ASS'N) PROFILE OF MEDICAL PRACTICE (1973).
165. For a discussion of antitrust and intellectual property law, see LANDES & POSNER, Antitrust and Intellectual Property, in THE ECONOMIC STRUCTURE OF INTELLECTUAL PROPERTY LAW, supra note 67, at 372-402.
166. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U. N. T. 299; [hereinafter TRIPS Agreement]. Article, 39.3 of TRIPS Agreement applies to clinical trial test data.
167. See generally Carlos M. Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products under Free Trade Agreements, in NEGOTIATING HEALTH INTELLECTUAL PROPERTY AND ACCESS TO MEDICINE 81 (Pedro Roffe, Geoff Tansey & David Vivas Eugui eds., 2006);
168. Meir Perez Pugtach, Intellectual Property, Data Exclusivity, Innovation and Market Access, in NEGOTIATING HEALTH INTELLECTUAL PROPERTY AND ACCESS TO MEDICINE, at 110-12;
169. Robert Weisman, Data Protection: Options for Implementation, in NEGOTIATING HEALTH INTELLECTUAL PROPERTY AND ACCESS TO MEDICINE, at 151.
170. Jerome H. Reichman, The International Legal Status of Undisclosed Clinical Trial Data: From Private to Public Goods?, in NEGOTIATING HEALTH INTELLECTUAL PROPERTY AND ACCESS TO MEDICINE, supra note 72, at 133-34, 133.
171. Gregory D. Curfman, Stephen Morrissey & Jeffrey M. Drazen, Expression of Concern: Bombardier et al., "Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis, " New Engl. J. Med. 2000;343:1520-8
172. NEW ENG. J. MED. 2813, 2813 (2005);
173. see also John Abramson, False and Misleading: The Misrepresentation of Celebrex and Vioxx, in OVERDOÉ AMERICA: THE BROKEN PROMISE OF AMERICAN MEDICINE 23, 23-28 (2004).
174. Catherine De Angelis et al., Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors, 351 NEW ENG. J. MED. 1250, 1250 (2004);
175. Christine R. Laine et al., Clinical Trial Registration-Looking Back and Moving Ahead, 356 NEW ENG. J. MED. 2734, 2734 (2007).
176. Jeffrey M. Drazen, Stephen Morrissey & Gregory D. Curfman, Open Clinical Trials, 357 NEW ENG. J. MED. 1756, 1756 (2007).
177. Steve Bailey, supra note 31, at C1.
178. The term "tragedy of the commons" was coined by Garret Hardin in his classic essay, Garrett Hardin, The Tragedy of the Commons, 162 SCIENCE 1243 (1968). The issue has generated a large scholarly literature.
179. See, e.g., James E. Krier, The Tragedy of the Commons, Part Two, 15 HARV. J. L. & PUB. POL'Y 325 (1992).
180. Frank I. Michelman defines a commons as the opposite of private property, NOMOS XXIV. Frank I. Michelman, Ethics, Economics and the Law of Property, in ETHICS, ECONOMICS AND THE LAW 3, 9 (J. Roland Pennock & John W. Chapman eds., 1982).
181. GARY D. LIBECAP, CONTRACTING FOR PROPERTY RIGHTS 29, 29-114 (James Alt & Douglass C. North eds., 1989).
182. Harold Demsetz, Toward a Theory of Property Rights, 57 AM. ECON. REV. 347 (1967).
183. ELINOR OSTROM, GOVERNING THE COMMONS: THE EVOLUTION OF INSTITUTIONS FOR COLLECTIVE ACTION (James Alt & Douglass C North eds., 1990);
184. ELINOR OSTROM, ROY GARDNER & JAMES WALKER, RULES, GAMES, AND COMMON-POOL RESOURCES (1994);
185. see also Rose, supra note 63, at 711.
186. Many writers emphasize the value of private ownership to avoid the tragedy of the commons but management of the publicly owned resource can be equally effective. The later possibility is often forgotten, but Garret Hardin discusses this subject in his thoughtful review of the issue 30 years later. See Garrett Hardin, Extensions of "The Tragedy of the Commons", 280 SCIENCE 682 (1998).
187. See generally Michael A. Heller, The Tragedy of the Anti-commons: Property in the Transition from Marx to Markets, 111 HARV. L. REV. 621 (1998);
188. James M. Buchanan & Yong J. Yoon, Symmetric Tragedies: Commons and Anti-commons, 43 J. L. & ECON. 1 (2000);
189. Margaret Jane Radin, Property Evolving in Cyberspace, 15 J. L. & COM. 509 (1996);
190. Hanoch Dagan & Michael A. Heller, The Liberal Commons, 110 YALE L. J. 549 (2001);
191. Fiona E. Murray & Scott Stern, Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-Commons Hypothesis (NBER, Working Paper No. 11465, 2005);
192. Heller & Eisenberg, supra note 57.
193. Andrzej Rapaczynski, The Roles of the State and the Market in Establishing Property Rights, 10 J. ECON. PERSP. 87 (1996).
194. R. H. Coase, The Problem of Social Cost, 3 J. L. & ECON. 1, 2-6 (1960).
195. R. H. COASE, THE FIRM, THE MARKET AND THE LAW 174-76 (1988).
196. DOUGLAS G. BAIRD, ROBERT H. GERTNER, & RANDAL C. PICKER, GAME THEORY AND THE LAW 143 (1994);
197. ROBERT C. ELLICKSON, ORDER WITHOUT LAW: HOW NEIGHBORS SETTLE DISPUTES 180-83 (1991).
198. Rebecca S. Eisenberg, Public Research and Private Development: Patents and Technology Transfer In Government-Sponsored Research, 82 VA. L. REV. 1663, 1725 (1996). (Pubitemid 126408602)
199. W. Brian Arthur, INCREASING RETURNS AND PATH DEPENDENCE IN THE ECONOMY (1994);
200. Mark J. Roe, Chaos and Evolution in Law and Economics, 109 HARV. L. REV. 641, 646-47 (1996).
201. Richard A. Epstein & Bruce N. Kuhlik, Is There a Biomedical Anticommons?, 27 REGULATION 54 (2004);
202. Richard A. Epstein & Bruce N. Kuhlik, Navigating the Anticommons for Pharmaceutical Patents: Steady the Course on Hatch Waxman (John M. Olin L. & Econ., Working Paper No. 209, 2004);
203. Heller & Eisenberg, supra note 57.
204. Eisenberg, supra note 86, at 1663-64.
205. Heller & Eisenberg, supra note 57, at 698.
206. Id. at 699.
207. Carl Shapiro, Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard-Setting, in 1 INNOVATION POLICY AND THE ECONOMY 119, 124 (Adam B. Jaffe, Josh Lerner, & Scott Stern eds., 2001), available at http://www.nber.org/chapters/cl0778.pdf.
208. Robert P. Merges & Richard R. Nelson, On the Complex Economics of Patent Scope, 90 COLUM. L. REV. 839, 875-77 (1990).
209. These examples and discussions are based on Lori B. Andrews, Genes and Patent Policy: Rethinking Intellectual Property Rights, 3 NATURE REVIEWS GENETICS 803 (2002).
210. The analysis of these problems is developed further in Lori B. Andrews & Jordan Paradise, Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 YALE J. HEALTH POL'Y L. & ETHICS 403 (2005);
211. Jordan Paradise, Lori B. Andrews & Timothy Holbrook, Intellectual Property: Patents on Human Genes: An Analysis of Scope and Claims, 307 SCIENCE 1566 (2005).
212. U. S. Patent No. 5, 508, 167 (filed Apr. 13, 1994).
213. E. U. Patent No. EP699754 (filed Aug. 11, 1995).
214. Onsrud, supra note 60, at 146.
215. Vera Bergelson, It's Personal but Its Mine? Toward Property Rights in Personal Information, 37 U. C. DAVIS L. REV. 379, 418 (2003);
216. Daniel D. Branhizer, Symposium: Cyberpersons, Propertization, and Contract in the Information Culture: Propitiation Metaphors for Bargaining Power and Control of the Self in the Information Age, 54 CLEV. ST. L. REV. 69, 104 (2006);
217. Pamela Samuelson, Privacy as Intellectual Property, 52 STAN. L. REV. 1125, 1137 (2000);
218. Sonia M. Suter, Disentangling Privacy from Property: Toward a Deeper Understanding of Genetic Privacy, 72 GEO. WASH. L. REV. 737, 804-05 (2004). For a sample of those opposed to making personal information property
219. see Anita L. Allen, Coercing Privacy, 40 WM. & MARY L. REV. 723 (1999);
220. Julie E. Cohen, Examined Lives: Informational Privacy and the Subject as Object, 52 STAN. L. REV. 1373 (2000);
221. Mark A. Lemley, Private Property, 52 STAN. L. REV. 1545 (2000);
222. Marc Rotenberg, Fair Information Practices and the Architecture of Privacy, 2001 STAN. TECH. L. REV. 1 (2001).
223. F. Scott Kieff, Coordination, Property and Intellectual Property: An Unconventional Approach to Anticompetitive Effects and Downstream Access, 56 EMORY L. J. 327, 391, 395-68 (2006);
224. Heller & Eisenberg, supra note 57, at 700;
225. Mark A. Lemley & Carl Shapiro, Patient Holdup and Royalty Stacking, 85 TEX. L. REV. 1991, 2008-11 (2007).
226. Lemley & Shapiro, supra note 99, at 2008.
227. Id. at 1992.
228. Lloyd Cohen, Holdouts and Free Riders, 20 J. LEGAL STUD. 351 (1991).
229. Thomas J. Miceli & C. F. Sirmans, The Holdout Problem, Urban Sprawl, and Eminent Domain, 16 J. HOUSING ECON. 309, 311-12 (2007).
230. Richard A. Epstein, The Permit Power Meets the Constitution, 81 IOWA L. REV. 407, 414-15 (1995).
231. l05 See Lemley & Shapiro, supra note 99, at 2010.
232. F. Scott Kieff & Troy A. Paredes, Engineering a Deal: Toward a Private Ordering Solution to the Anti-commons Problem, 48 B. C. L. REV. 111 (2007).
233. See Hall, supra note 61, at 631.
234. Id. at 660.
235. Id. at 657.
236. Id. at 661.
237. Email from Mark Hall, Fred D. & Elizabeth L. Turnage Professor of Law, Wake Forest University School of Law, to Marc A. Rodwin, Professor of Law, Suffolk University Law School (Oct. 31, 2010 10:50 EST) (on file with author).
238. Hall, supra note 61, at 654.
239. PAUL SCHWARTZ & JOEL R. REIDENBERG, DATA PRIVACY LAW: A STUDY OF UNITED STATES DATA PROTECTION 31-90 (1996).
240. For civil rights as developed in European law, see Council Directive 95/46, art. 1, 1995 O. J. (L 281) (EC) (protecting individuals regarding use of personal data). For discussion of default licensing rules, see Samuelson, supra note 98, at 1151-67.
241. Kenneth C. Laudon, Markets and Privacy, 39 COMM. ASS'N OF COMPUTING MACHINERY 92, 92-93 (1996) ("[T]o ensure the protection of individual privacy beyond 2000 we should consider market-based mechanisms based on individual ownership of personal information and a National Information Market (NIM) in which individuals can receive fair compensation for the use of information about themselves");
242. see also LAWRENCE LESING, CODE AND OTHER LAWS OF CYBERSPACE (1999) (discussing property rights to protect priva|cy on the internet);
243. Bergelson, supra note 98, at 442 ("In a nutshell, the suggested legal regime would give individuals property rights in their personal information. They would own this information during their lifetime, subject to a (i) non-exclusive automatic inalienable license to the original collector and (ii) limited non-exclusive automatic license to the general public");
244. A. Machael Froomkin, The Constitution and Encryption Regulation: Do We Need a "New Privacy"?, 3 N. Y. U. J. LEGIS. & PUB. POL'Y 34 (1999) ("We would personalize ownership of facts about us in transitions, perhaps even sometimes in public, and we would try to use the property regime and intellectual property regime to take back some control over personal data");
245. Jerry Kang, Information Privacy in Cyberspace Transactions, 50 STAN. L. REV. 1193, 1246-94 (1998);
246. Kenneth C. Laudon, Extensions to the Theory of Market and Privacy: Mechanics of Pricing Information, in PRIVACY AND SELF-REGULATION IN THE INFORMATION AGE 78 (U. S. Dep't of Commerce ed., 1997), http://www.ntia.doc.gov/ reports/privacy/selfregl.htm;
247. Lawrence Lessig, The Architecture of Privacy, 1 VAND. J. ENT. L. & PRAC. 56, 63 (1999) ("A better solution, [to protect privacy] I suggest, is one that links the protection of architecture with the incentives of the market. Information is an asset. It is a resource which has become extremely valuable. And as it has become extremely valuable, commerce has tried to exploit it. This use has a cost-an externality borne by those who would prefer that this data not be used. So the trick is to construct a regime where those who would use the data internalize this cost, by paying those whose data are used. The laws of property are one such regime. If the law gave individuals the rights to control their data, or more precisely, if those who wanted to use that data had first to secure the right to use it, then a negotiation would occur over whether, and how much, data should be used. The market could negotiate these rights, if a market in these rights could be constructed.");
248. Patricia Mell, Seeking Shade in a Land of Perpetual Sunlight: Privacy as Property in the Electronic Wilderness, 1 BERKELEY TECH. L. J. 1, 10 (1996) ("I describe the scope of the individual's right or privacy as being a type of property right in his electronic persona... [E]ach of four interest groups-the individual, the commercial, the public and government-could have a property interest in the individual's persona.... The rights of any other entity... that might obtain, access, or make use of or disclose the persona would be subordinate to those of the individual. As with other forms of property, the individual's right to restrict the use of his person by others would vary depending on the reasons for their use");
249. Richard S. Murphy, Property Rights in Personal Information: An Economic Defense of Privacy, 84 GEO. L. J. 2381, 2383-84 (1996) ("Such [personal] information, like all information, is property. The question that law must answer is: Who owns the property rights to such information...?"); (Pubitemid 126406877)
250. Paul M. Schwartz, Property, Privacy and Personal Data, 117 HARV. L. REV. 2056 (2003);
251. Paul Schwartz, Beyond Lessig's Code for Internet Privacy: Cyberspace Filters, Privacy Control and Fair Information Practices, 2000 WIS. L. REV. 743, 744 (2000);
252. see also Alan F. Westin Developments in the Law-the Law of Cyberspace, 112 HARV. L. REV. 1574, 1644-45 (1999). Some special considerations arise in privacy/property issues concerning genetic information.
253. See Suter, supra note 98;
254. George J. Annas, Leonard H. Glantz & Patricia A. Roche, Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations, 23 J. L. MED. & ETHICS 360 (1995).
255. Schwartz, Property, Privacy and Personal Data, supra note 115, at 2094-2128.
256. See, e.g., Murphy, supra note 115, at 2407-16;
257. Steven A. Bibas, A Contractual Approach to Data Privacy, 17 HARV. J. L. & PUB. POL'Y 591, 606-07 (1994); (Pubitemid 24795082)
258. Craig Martin, Mailing Lists, Mailboxes, and the Invasion of Privacy: Finding a Contractual Solution to a Transnational Problem, 35 HOUS. L. REV. 801, 830-31 (1998);
259. Schott Schorr, Personal Information Contacts: How to Protect Privacy Without Violating the First Amendment, 80 CORNELL L. REV. 1756, 1759 (1995).
260. Schwartz, Property, Privacy and Personal Data, supra note 115, at 2126.
261. Jessica Litman, Information Privacy/Information Property, 52 STAN. L. REV. 1283, 1293 (2000).
262. Samuelson, supra note 98, at 1135.
263. Laudon, Markets and Privacy, supra note 115, at 101-03.
264. Allen, supra note 98, at 733-34;
265. Cohen, supra note 98, at 1423-28;
266. Rochelle Cooper Dreyfuss, Warren and Brandeis Redux: Finding (More) Privacy Protection in Intellectual Property Lore, 8 STAN. TECH. L. REV. 8, ¶ 8-13 (1999), available at WESTLAW;
267. Lemley, supra note 60, at 1545-55;
268. Litman, supra note 111;
269. Rotenberg, supra note 98 ("A property-based regime [for personal information]... lacks any commitment to an institutional structure (or more broadly democratic institutions) that could be established to protect an underlying public interest.");
270. Samuelson, supra note 98.
271. Samuelson, supra note 98, at 1145.
272. See Litman, supra note 119;
273. Hal R. Varian, Economic Aspects of personal Privacy, in U. S. DEPT. OF COM., PRIVACY AND SELF REGULATION IN THE INFORMATION AGE 35-37 (1997), http://www.ntia.doc.gOv/reports/privacy/selfregl.htmlC.
274. Even when patient privacy interest is not compromised, patients still have other interests in how information from their medical records is used. They have interests in such information being used to improve medical care for themselves and others. They may also have interests in sharing the commercial gain from such information or in restricting the use of such information in ways that harm patients or compromise good medical practice. The interest in data resembles, in part, that of research subjects in how their tissue or cells are used. For analysis of the interest of research subjects see Lori Andrews & Julie Burger, A Pound of Flesh: Patient Legal Acton for Human Research Protection in the Biotech Age, in IMPATIENT VOICES: PATIENTS AS POLICY ACTORS (Beatrice Hoffmaan et al., eds.) (forthcoming 2011).
275. Tarasoff v. Regents of the Univ. of Cal., 551 P.2d 334 (Cal. 1976).
276. Medical institutions, insurers, and governmental agencies also use patient information to oversee the quality of medical care.
277. See Privacy of Individually Identifiable Health Data, 47 C. F. R. § 164, 500-34 (2009).
278. See Other Requirements Relating to Uses and Disclosures of Protected Health Information, 45 C. F. R. § 164. 514 (2009).
279. ROBERT GELLMAN, THE WORLD PRIVACY FORUM, PERSONAL HEALTH RECORDS: WHY MANY PHRS THREATEN PRIVACY 3-4 (Feb. 20, 2008), http://www.worldprivacyforum. org/pdf/WPF-PHR-02-20-2008fs.pdf;
280. Nicolas P. Terry, Personal Health Records: Directing More Costs and Risks to Consumers?, 1 DREXEL L. REV. 216, 239-40 (2009).
281. Arvind & Vitaly Shamatikov, Myths and Fallacies of "Personally Identifiable Information", 53 COMMC'N OF THE ACM 24, 24-26 (2010);
282. Paul Ohm, Broken Promises of Privacy: Responding to the Surprising Failure of Anonymization, 57 UCLA L. REV. 1701, 1716-31 (2010).
283. See Lucas v. S. Carolina Coastal Council, 505 U. S. 1003 (1992);
284. Joseph L. Sax, Takings, Private Property and Private Rights, 81 YALE L. J. 149 (1971).
285. ALASDAIRE ROBERTS, BLACKED OUT: GOVERNMENT SECRECY IN THE INFORMATION AGE 11-14, 201 (2006).
286. See, e.g., THE STATISTICAL ABSTRACT OF THE UNITED STATES, http://www.census.gov/compendia/statab/.
287. Securities and Exchange Act of 1934, 15 U. S. C. § 78b (2006).
288. 42 U. S. C. § 11004 (2006).
289. See Research, Statistics and Data Systems, CENTER FOR MEDICARE AND MEDICAID SERVICES, http://www.cms.hhs.gov/home/rsds.asp (last visited Oct. 1, 2010) (providing links to the results of various CMS studies).
290. See, e.g., An Act Providing Access to Affordable, Quality, Accountable Health Care, 2006 Mass. Acts 77, 80-87 (creating the Massachusetts Health Care Quality and Cost Council to promote quality and cost control). The Council created an all-payer claims database which is publicly available, some of it online as of 2008. My Health CareOptions, http://hcqcc.hcf.state.ma.us (last visited Oct. 1, 2010).
291. The reporting began with the passage of the California Hospital Disclosure Act by the California Legislature in 1971. Since then the reporting requirements have been revised through legislation and regulation several times. For a history, see CAL. OFFICE OF STATEWIDE HEALTH PLANNING AND DEV., INPATIENT DATA REPORTING MANUAL vi-xi (7th ed. 2010), available at http://www.oshpd.ca. gov/HID/MIRCal/IPManual.html.
292. For information on the availability of the data and a manual that describes the data, see generally CAL. OFFICE OF STATEWIDE HEALTH PLANNING AND DEV., INPATIENT DATA REPORTING MANUAL (7th ed. 2010), available at http://www.oshpd.ca.gov/HID/MIRCal/IPManual.html.
293. I am indebted to Eugene Declercq for helping me understand the limitations of data.
294. See Frontline: Sick Around the World (PBS television broadcast Apr. 15, 2005), available at http://www.pbs.org/wgbh/pages/frontline/sickaroundtheworld/ view.
295. JEAN-JACQUES ROUSSEAU, THE SOCIAL CONTRACT AND DISCOURSES 10-11 (G. D. H. Cole, trans., 2003).
296. See ELISABETH ZOLLER, INTRODUCTION TO PUBLIC LAW: A COMPARATIVE STUDY 1-23 (2008).
297. See id.
298. E.g., Steven Kelman, The Wellspring of Public Behavior: Alternative Views, in MAKING PUBLIC POLICY: A HOPEFUL VIEW OF AMERICAN GOVERNMENT 239-47 (James Q. Wilson ed., 1987);
299. DEBORAH STONE, THE SAMARITAN'S DILEMMA: SHOULD GOVERNMENT HELP YOUR NEIGHBOR? (2008).
300. Deborah Stone, The Struggle for the Soul of Health Insurance, 18 J. HEALTH POL., POL'Y & L. 287, 290-92 (1993).
301. See, e.g., DAN E. BEAUCHAMP, THE HEALTH OF THE REPUBLIC: EPIDEMICS, MEDICINE, AND MORALS AS CHALLENGES TO DEMOCRACY (1990);
302. ROBERT N. BELLAH ET AL., HABITS OF THE HEART (1985);
303. MICHAEL WALTZER, SPHERES OF JUSTICE: A DEFENSE OF PLURALISM AND EQUALITY (1983);
304. Dan E. Beauchamp, Community: The Neglected Tradition in Public Health, 26 HASTINGS CENTER REP. 28 (1985);
305. Jean Forster, A Communitarian Ethical Model for Public Health Interventions: An Alternative to Individual Behavioral Change Strategies, 3 J. PUB. HEALTH POL'Y 150 (1982).
306. See Anthony Downs, The Public Interest: Its Meaning in a Democracy, 29 SOC. RES. 1, 18-25 (1962).
307. See, e.g., JAMES BUCHANAN & GORDON TULLOCK, THE CALCULUS OF CONSENT 11-15 (1962);
308. ANTHONY DOWNS, AN ECONOMIC THEORY OF DEMOCRACY 4-11 (1957);
309. MANCUR OLSON, THE LOGIC OF COLLECTIVE ACTION 1-3 (1965);
310. George J. Stigler, The Theory of Economic Regulation, 2 BELL J. ECON. & MGMT. SCI. 3 (1971) (applying the self-interest model to industry regulation). For a critique of this view
311. see Amartya K. Sen, Rational Fools: A Critique of the Behavioral Foundations of Economic Theory, 6 PHIL. & PUB. AFF. 317 (1977).