1 See generally Eddy, David M., Evidence-Based Medicine: A Unified Approach, 24 Health Aff. 9 (2005).CrossRefGoogle ScholarPubMed

2 See Perlin, Jonathan B. & Kupersmith, Joel, Information Technology and the Inferential Gap, 26 Health Aff. w192, w194 (2007).CrossRefGoogle ScholarPubMed

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 Evans, Barbara J., 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)Google ScholarPubMed; Platt, Richard et al., The New Sentinel Network-Improving the Evidence of Medical-Product Safety, 361 New Eng. J. Med. 645, 646 (2009)CrossRefGoogle ScholarPubMed; see also FDA's Sentinel Initiative, http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm (last updated Sept. 30, 2010); 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.

5 One research team purchased such data from IMS to identify such practices. See generally Bates, David W. et al., Using Computerized Data to Identify Adverse Drug Events in Outpatients, 8 J. Am. Med. Informatics Ass’n 254 (2001)Google Scholar; Radley, David C. et al., Off-Label Prescribing Among Office-Based Physicians, 166 Archives of Internal Medicine 1021 (2006).CrossRefGoogle ScholarPubMed

6 Some of the limitations of observational data from patient records can be addressed when the data is used in simulation models. See, e.g., Diamond, Carol C. et al., Collecting and Sharing Data For Population Health: A New Paradigm, 28 Health Aff. 454, 456 (2009)CrossRefGoogle ScholarPubMed; Eddy, David M., Linking Electronic Medical Records to Large-Scale Simulation Models: Can We Put Rapid Learning on Turbo?, 26 Health Aff. w125, w125-36 (2007)CrossRefGoogle ScholarPubMed; Etheredge, Lynn M., A Rapid-Learning Health System, 26 Health Aff. w107, w110-13 (2007)CrossRefGoogle ScholarPubMed; Horowitz, Ralph I. et al., Developing Improved Observational Methods for Evaluating Therapeutic Effectiveness, 89 Am. J. Med. 630 (1990)CrossRefGoogle Scholar; Kukafka, Rita et al., Redesigning Electronic Health Record Systems to Support Public Health, 40 J. Biomedical Informatics 398, 403-05 (2007)CrossRefGoogle ScholarPubMed; Lumpkin, John R., Archimedes: A Bold Step into the Future, 26 Health Aff. w137 (2007)CrossRefGoogle ScholarPubMed; Stewart, Walter F. et al., Bridging the Inferential Gap: The Electronic Health Record and Clinical Evidence, 26 Health Aff. w181, w184-90 (2007).CrossRefGoogle ScholarPubMed

7 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; 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.

8 G.J. Annas, The Rights of Patients: The Authoritative ACLU Guide to the Rights of Patients 224-45 (2004).

9 Rodwin, Marc A., The Case for Public Ownership of Patient Data, 302 JAMA 86, 86 (2009)CrossRefGoogle ScholarPubMed; 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); see generally Hall, Mark A. & Schulman, Kevin A., Ownership of Medical Information, 301 JAMA 1282 (2009)CrossRefGoogle ScholarPubMed; Waller, Adele A. & Alcantara, Oscar L., Ownership of Health Information in the Information Age, 69 J. AHIMA 28 (1998).Google ScholarPubMed

10 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 Stearns, Paul V., Access to and Cost of Reproduction of Patient Medical Records: A Comparison of State laws, 21 J. Legal Med. 79 (2000)CrossRefGoogle ScholarPubMed; Hall & Schulman, supra note 9.

11 See generally Steinbrook, Robert, For Sale: Physicians’ Prescribing Data, 354 New Eng. J. Med. 2745 (2006).CrossRefGoogle ScholarPubMed

12 U.S. Copyright Off., Report on Legal Protection for Databases (1997).

13 For an overview of the European and American law, see Mark J. Davison, The Legal Protection of Databases (William R. Cornish ed., 2003). See also Hugenholtz, P. Bernt, Maurer, Stephen M. & Onsrud, Harlan J., Europe's Database Experiment, 294 Science 789, 789-90 (2001).Google Scholar

14 Reichman, J.H. & Samuelson, Pamela, Intellectual Property Rights in Data?, 50 Vand. L. Rev. 49, 72-110 (1997).Google Scholar Moreover, once data are made public, trade secrecy law no longer protects the originator, except through two party contracts. See Int’l News Serv. v. Associated Press, 248 U.S. 215, 218-19 (1918); Gordon, Wendy, On Owning Information: Intellectual Property and the Restitutionary Impulse, 78 Va. L. Rev. 149 (1992)CrossRefGoogle Scholar; Karjala, Dennis S., Misappropriation as a Third Intellectual Property Paradigm, 94 Colum. L. Rev. 2594 (1994)CrossRefGoogle Scholar; Reichman, Jerome H., Electronic Information Tools: The Outer Edge of World Intellectual Property Law, 17 U. Dayton L. Rev. 797 (1992).Google Scholar

15 See Database Investment and Intellectual Property Antipiracy Act of 1996, H.R. 3531, 104th Cong. (2nd Sess. 1996); U.S. Copyright Office, supra note 12, at 57-61; Council Directive 96/9, 1996 O.J. (L 077) 1-17 (EC); 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); Reichman & Samuelson, supra note 14, at 72-102. 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.” See H.R. 3531, Database and Collections of Information Misappropriation Act, H.R. 3261, 108th Cong. (2004). 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. 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. 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.

16 Feist Publ’n v. Rural Tel. Serv. Co., 499 U.S. 340, 340-41 (1991).

17 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.

18 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).

19 Green, Jeremy A., Pharmaceutical Marketing Research and the Prescribing Physician, 146 Annals Internal Med. 742, 743-46 (2007).CrossRefGoogle Scholar

20 Steinbrook, supra note 11, at 2746-47.

21 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.

22 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; Tsang, Jean-Patrick, Patient-Data Come of Age, 23 Pharmaceutical Executive 84 (2003).Google Scholar

23 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; Taryi Forni, Using Anonymous Patient-Level Information to Inform the Brand-Planning Process: Part 2, Product Mgmt. Today, May 2006, at 14, 14-15; Julie Klossner & Jack Newson, Studying Drug Utilization by Production Indication, Product Mgmt. Today, Oct. 2005, at 16, 16-17; 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; John Martin & Stephen J. Boccuzzi, Analyzing Drug Utilization Patterns in the Oncology Market, Product Mgmt. Today, Mar. 2006, at 14, 14-15.

24 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/1058083/000104746908001691/a2182946z10-k.htm.

25 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_73163984,00.html.

26 IMS, Health Economics and Outcomes Research, Medical Writing and Communication, http://www.imshealth.com/web/channel/0,3147,77141581_63872702_77140611,00.html.

27 Id.

28 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%3Ad1&entqr=3&oe=UTF-8&ie=UTF-8&ud=1&site=all_collection (follow “August 3, 2007 Jonathan White, MD Health IT Director Agency for …” hyperlink).

29 IMS, supra note 24, at 3; 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.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=e7eb1d3be7a29110VgnVCM10000071812ca2RCRD#.

30 IMS, supra note 24, at 8.

31 Steve Bailey, Your Data for Sale?, Boston Globe, Mar. 24, 2006, at C1.

32 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.

33 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.

34 Safran, Charles 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).CrossRefGoogle Scholar

35 Id. at 3.

36 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.

37 Burrington-Brown, Jill, Hjort, Beth & Washington, Lydia, Health Data Access, Use, & Control, 78 J. AHIMA 63 (2007), http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_034053.hcsp?dDocName=bok1_034053.Google ScholarPubMed

38 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.

39 See Am. Health Info. Mgmt. Ass’n, supra note 28.

40 Id. at 17.

41 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).

42 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_800781_0_0_18/NCQA-NQF-TJC%20Joint%20NHDSE%20AHRQ-AQA%20RFI%20Response%20072707.pdf.

43 Id. at 15.

44 Coiera, Enrico, Building a National Health IT System from the Middle Out, 16 J. Am. Med. Informatic Ass’n 271, 271 (2009).CrossRefGoogle ScholarPubMed

45 See Frohlich, Jonah et al., Retrospective: Lessons Learned from the Santa Barbara Project and Their Implications for Health Information Exchange, 26 Health Aff. 5 w589 (2007)CrossRefGoogle Scholar; Adler-Milstein, Julia et al., The State of Regional Health Information Organizations: Current Activities and Financing, 27 Health Aff. 1 w60 (2008)Google ScholarPubMed; 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; Miller, Robert H. & Miller, Bradley S., The Santa Barbara County Care Data Exchange: What Happened?, 26 Health Aff. 5 w568 (2007).CrossRefGoogle Scholar

46 See Health Information Technology for Economic and Clinical Health (HITECH) Act, Pub. L. No. 111-5, 123 Stat. 226 (2009) (enacted as part of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5, 123 Stat. 115); Steven C. Redhead, Cong. Research Serv., R40892, Public Health, Workforce, Quality, and Related Provisions in H.R. 3962 (2009).

47 See Medicare and Medicaid Programs; Electronic Health Record Incentive Program, Fed. Reg. 75 44314 (July 28, 2010) (to be codified at 42 C.F.R. pt. 412); Blumenthal, David, Launching HITECH, 362 New Eng. J. Med. 382 (2010)CrossRefGoogle ScholarPubMed; Brailer, David, Guiding the Health Information Technology Agenda, 29 Health Aff. 586 (2010)CrossRefGoogle Scholar.

48 See Etheredge, supra note 6.

49 See Kupersmith, Joel et. al., Advancing Evidence-Based Care for Diabetes: Lessons from the Veteran's Health Administration, 26 Health Aff. 2 w156, 165 (2007).CrossRefGoogle Scholar

50 See Stewart et al., supra note 6, at w185, w187.

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54 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.

55 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 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. 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.

56 Letter from W. David Helms, President & CEO, Academy Health, to P. John White, Health IT Director, Agency for Healthcare Research and Quality (July 26, 2007) (in response to request for comments), available at http://www.chsr.org/AHRQRFI.pdf.

57 See generally Yochai Benkler, The Wealth of Networks: How Social Production Transforms Markets and Freedom (2006); Paul A. David, The Economic Logic of “Open Science” and the Balance Between Private Property Rights and the Public Domain in Scientific Data and Information: A Primer, in The Role of Scientific and Technical Data and Information in the Public Domain: Proceedings of a Symposium 19, 19-34 (Julie M. Esanu & Paul F. Uhlir eds., 2003); David, Paul A., Common Agency Contracting and the Emergence of ‘Open Science’ Institutions, 88 Am. Econ. Rev. 15, 15-21 (1998)Google Scholar; David, Paul A., Reputation and Agency in the Historical Emergence of the Institutions of ‘Open Science’ (Stanford U. Ctr. for Econ. Policy Research, Publication No. 261, 1994, revised 1998)Google Scholar; Dana Dalrymple, Scientific Knowledge as a Global Public Good: Contributions to Innovation and the Economy, in The Role of Scientific and Technical Data and Information in the Public Domain: Proceedings of a Symposium 35, 35-51 (Julie M. Esanu & Paul F. Uhlir eds., 2003); Boyle, James, The Second Enclosure Movement and the Construction of the Public Domain, 66 L. & Contemp. Probs. 33, 33-74 (2003)Google Scholar; Nicolas P. Terry, Legal Barriers to Realizing the Public Good in Clinical Data, in Institute of Medicine, Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good (forthcoming 2010); Paul A. David, Intellectual Property Institutions and the Panda's Thumb: Patents, Copyrights, and Trade Secrets in Economic Theory and History, in Global Dimensions of Intellectual Property Rights in Science and Technology 19, 19-61 (Mary E. Wallerstein et al. eds., 1993); David, Paul A., & Foray, Dominique, Accessing and Expanding the Science and Technology Knowledge Base, 16 Sci. Tech. Industry Rev. 13, 13-68 (1995)Google Scholar; David, Paul A., The Digital Technology Boomerang: New Intellectual Property Rights Threaten Global ‘Open Science’, (Stanford U. Dep't of Econ., Working Paper No. 00-16, 2000)Google Scholar; Paul A. David, The Political Economy of Public Science: A Contribution to the Regulation of Science and Technology, in The Regulation of Science and Technology 33, 33-57 (Helen L. Smith ed., 2002); David, Paul A. et al., Analysing the Payoffs From Basic Research, 2 Econ. Innovation & New Tech. 73, 73-90 (1992)CrossRefGoogle Scholar; Heller, Michael A. & Eisenberg, Rebecca S., Can Patents Deter Innovation?: The Anti-commons in Biomedical Research, 280 Science 698, 698-701 (1998)CrossRefGoogle Scholar. See also Litman, Jessica, The Public Domain, 39 Emory L.J. 965, 965-1023 (1990).Google Scholar

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59 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); National Research Council, supra note 15; Reichman, J.H. & Uhlir, Paul F., A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment, 66 L. & Contemp. Probs. 315, 315-462 (2003).Google Scholar

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62 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); Philippe Aigrain, Innovation partagée et biens communs en biologie (2008), available at http://paigrain.debatpublic.net/docs/pha-Autrement-complet.pdf; http://creativecommons.org/licenses/by-nc-nd/2.0/fr/; Oxfam, Cut the Cost: Fatal Side Effects: Medicine Patents Under the Microscope (2001); Oxfam, Patent Injustice: How World Trade Rules Threaten the Health of Poor People (2000). Rai, Arti & Boyle, James, Synthetic Biology: Caught Between Property Rights, the Public Domain, and the Commons, 5 Pub. Libr. Sci. Biology 389, 389-93 (2007).Google ScholarPubMed

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66 See Lawrence Lessig, Code: and Other Laws of Cyberspace (2001); Lawrence Lessig, The Future of Ideas: The Fate of the Commons in a Connected World (2001); Philippe Aigrain, Internet & Création: Comment Reconnaître Les Échanges Sur Internet En Finançant La Création (2008); Philippe Aigrain, Culture and the economy in the Internet age (forthcoming).

67 See William M. Landes & Richard A. Posner, The Economic Structure of Intellectual Property Law (2003).

68 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.

69 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.

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71 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.

72 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. 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); Meir Perez Pugtach, Intellectual Property, Data Exclusivity, Innovation and Market Access, in Negotiating Health Intellectual Property and Access to Medicine, at 110-12; Robert Weisman, Data Protection: Options for Implementation, in Negotiating Health Intellectual Property and Access to Medicine, at 151.

73 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.

74 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, 353 New Eng. J. Med. 2813, 2813 (2005); see also John Abramson, False and Misleading: The Misrepresentation of Celebrex and Vioxx, in Overdo$Ed America: The Broken Promise of American Medicine 23, 23-28 (2004).

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77 Steve Bailey, supra note 31, at C1.

78 The term “tragedy of the commons” was coined by Garret Hardin in his classic essay, Hardin, Garrett, The Tragedy of the Commons, 162 Science 1243 (1968)Google ScholarPubMed. The issue has generated a large scholarly literature. See, e.g., Krier, James E., The Tragedy of the Commons, Part Two, 15 Harv. J.L. & Pub. Pol’y 325 (1992).Google Scholar 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).

79 Gary D. Libecap, Contracting for Property Rights 29, 29-114 (James Alt & Douglass C. North eds., 1989). Demsetz, Harold, Toward a Theory of Property Rights, 57 Am. Econ. Rev. 347 (1967)Google Scholar.

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81 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 Hardin, Garrett, Extensions of “The Tragedy of the Commons”, 280 Science 682 (1998).CrossRefGoogle Scholar

82 See generally Heller, Michael A., The Tragedy of the Anti-commons: Property in the Transition from Marx to Markets, 111 Harv. L. Rev. 621 (1998)CrossRefGoogle Scholar; Buchanan, James M. & Yoon, Yong J., Symmetric Tragedies: Commons and Anti-commons, 43 J.L. & Econ. 1 (2000)CrossRefGoogle Scholar; Radin, Margaret Jane, Property Evolving in Cyberspace, 15 J.L. & Com. 509 (1996)Google Scholar; Dagan, Hanoch & Heller, Michael A., The Liberal Commons, 110 Yale L.J. 549 (2001)CrossRefGoogle Scholar; 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); Heller & Eisenberg, supra note 57.

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89 Eisenberg, supra note 86, at 1663-64.

90 Heller & Eisenberg, supra note 57, at 698.

91 Id. at 699.

92 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/c10778.pdf.

93 Merges, Robert P. & Nelson, Richard R., On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 839, 875-77 (1990).CrossRefGoogle Scholar

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95 U.S. Patent No. 5,508,167 (filed Apr. 13, 1994).

96 E.U. Patent No. EP699754 (filed Aug. 11, 1995).

97 Onsrud, supra note 60, at 146.

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100 Lemley & Shapiro, supra note 99, at 2008.

101 Id. at 1992.

102 Cohen, Lloyd, Holdouts and Free Riders, 20 J. Legal Stud. 351 (1991).CrossRefGoogle Scholar

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105 See Lemley & Shapiro, supra note 99, at 2010.

106 Kieff, F. Scott & Paredes, Troy A., Engineering a Deal: Toward a Private Ordering Solution to the Anti-commons Problem, 48 B.C. L. Rev. 111 (2007).Google Scholar

107 See Hall, supra note 61, at 631.

108 Id. at 660.

109 Id. at 657.

110 Id. at 661.

111 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).

112 Hall, supra note 61, at 654.

113 Paul Schwartz & Joel R. Reidenberg, Data Privacy Law: A Study of United States Data Protection 31-90 (1996).

114 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.

115 Laudon, Kenneth C., Markets and Privacy, 39 Comm. Ass’n of Computing Machinery 92, 92-93 (1996)Google Scholar (“[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”); see also Lawrence Lessig, Code and Other Laws of Cyberspace (1999) (discussing property rights to protect privacy on the internet); 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”); Froomkin, A. Machael, The Constitution and Encryption Regulation: Do We Need a “New Privacy”?, 3 N.Y.U. J. Legis. & Pub. Pol’y 34 (1999)Google Scholar (“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”); Kang, Jerry, Information Privacy in Cyberspace Transactions, 50 Stan. L. Rev. 1193, 1246-94 (1998)CrossRefGoogle Scholar; Laudon, Kenneth C., 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/selfreg1.htm;Google Scholar Lessig, Lawrence, The Architecture of Privacy, 1 Vand. J. Ent. L. & Prac. 56, 63 (1999)Google Scholar (“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.”); Mell, Patricia, Seeking Shade in a Land of Perpetual Sunlight: Privacy as Property in the Electronic Wilderness, 1 Berkeley Tech. L.J. 1, 10 (1996)Google Scholar (“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”); Murphy, Richard S., Property Rights in Personal Information: An Economic Defense of Privacy, 84 Geo. L.J. 2381, 2383-84 (1996)Google Scholar (“Such [personal] information, like all information, is property. The question that law must answer is: Who owns the property rights to such information … ?”); Schwartz, Paul M., Property, Privacy and Personal Data, 117 Harv. L. Rev. 2056 (2003)CrossRefGoogle Scholar; Schwartz, Paul, Beyond Lessig's Code for Internet Privacy: Cyberspace Filters, Privacy Control and Fair Information Practices, 2000 Wis. L. Rev. 743, 744 (2000)Google Scholar; see also Westin, Alan F. Developments in the Law—the Law of Cyberspace, 112 Harv. L. Rev. 1574, 1644-45 (1999).Google Scholar

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116 Schwartz, Property, Privacy and Personal Data, supra note 115, at 2094-2128.

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118 Schwartz, Property, Privacy and Personal Data, supra note 115, at 2126.

119 Litman, Jessica, Information Privacy/Information Property, 52 Stan. L. Rev. 1283, 1293 (2000).CrossRefGoogle Scholar

120 Samuelson, supra note 98, at 1135.

121 Laudon, Markets and Privacy, supra note 115, at 101-03.

122 Allen, supra note 98, at 733-34; Cohen, supra note 98, at 1423-28; 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; Lemley, supra note 60, at 1545-55; Litman, supra note 111; 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.” ); Samuelson, supra note 98.

123 Samuelson, supra note 98, at 1145.

124 See Litman, supra note 119; 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/selfreg1.htm#1C.

125 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).

126 Tarasoff v. Regents of the Univ. of Cal., 551 P.2d 334 (Cal. 1976).

127 Medical institutions, insurers, and governmental agencies also use patient information to oversee the quality of medical care.

128 See Privacy of Individually Identifiable Health Data, 47 C.F.R. § 164, 500-34 (2009).

129 See Other Requirements Relating to Uses and Disclosures of Protected Health Information, 45 C.F.R. § 164.514 (2009).

130 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; Terry, Nicolas P., Personal Health Records: Directing More Costs and Risks to Consumers?, 1 Drexel L. Rev. 216, 239-40 (2009)Google Scholar.

131 Arvind, & Shamatikov, Vitaly, Myths and Fallacies of “Personally Identifiable Information”, 53 Commc’n of the ACM 24, 24-26 (2010)Google Scholar; Ohm, Paul, Broken Promises of Privacy: Responding to the Surprising Failure of Anonymization, 57 UCLA L. Rev. 1701, 1716-31 (2010).Google Scholar

132 See Lucas v. S. Carolina Coastal Council, 505 U.S. 1003 (1992); Sax, Joseph L., Takings, Private Property and Private Rights, 81 Yale L.J. 149 (1971).CrossRefGoogle Scholar

133 Alasdaire Roberts, Blacked Out: government secrecy in the information age 11-14, 201 (2006). See, e.g., The Statistical Abstract of the United States, http://www.census.gov/compendia/statab/.

134 Securities and Exchange Act of 1934, 15 U.S.C. § 78b (2006).

135 42 U.S.C. § 11004 (2006).

136 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).

137 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. MyHealthCareOptions, http://hcqcc.hcf.state.ma.us (last visited Oct. 1, 2010).

138 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. 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.

139 I am indebted to Eugene Declercq for helping me understand the limitations of data.

140 See Frontline: Sick Around the World (PBS television broadcast Apr. 15, 2005), available at http://www.pbs.org/wgbh/pages/frontline/sickaroundtheworld/view.

141 Jean-Jacques Rousseau, The Social Contract and Discourses 10-11 (G. D. H. Cole. trans., 2003).

142 See Elisabeth Zoller, Introduction to Public Law: A Comparative Study 1-23 (2008).

143 See id.

144 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); Deborah Stone, The Samaritan's Dilemma: Should Government Help Your Neighbor? (2008).

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