Published online by Cambridge University Press: 06 January 2021
Changes in technology sometimes raise important public policy choices and require that we clarify key values and reexamine legal concepts. Such is the case with the development of electronic medical records (EMRs), which facilitate obtaining patient data from provider and insurer records. EMRs expand our ability to tap patient data and thereby create great potential benefits as well as risks. This new technology requires that we clarify the ambiguous property interests in patient data. How the law defines ownership of patient data will shape whether its benefits can be developed and also affects patient confidentiality.
EMRs make it feasible to collect aggregate patient data that can be used to vastly improve medical knowledge, patient safety and public health. Researchers have long used patient data from clinical trials to evaluate the benefits and risks of drugs and medical therapy, compare their relative effectiveness, and analyze health care cost and quality.
My work was supported by a Robert Wood Johnson Investigator Award and Suffolk University Law School, and Université de Rennes, l'Institut de l'Ouest: Droit et Europe, UMR CNRS 6262. Anthony Ruggiero. J.D., and LLM Candidate Suffolk University Law School, assisted with research. Thomas Rice, Lori Andrews, Mark Hall, Gene Declercq, Joel Weissman, Kristin Madison, Andrew Beckerman-Rodau, Guilhem Fabre and Philippe Aigrain made helpful comments on drafts. I also benefited from the comments of the DEMOTIS group (Deáfinir, Evaluer et Modeáliser les Technologies de l'Information de Santeá), a project of the French Agence National de la Recherche, grant ANR-08-SEGI-007. Dedicated to Thomas F. Bergin, who stimulated my interest in the law and economics of property.
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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.
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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.
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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).
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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
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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.
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#.
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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.
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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.
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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.
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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.
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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
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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.
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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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101 Id. at 1992.
103 Miceli, Thomas J. & Sirmans, C.F., The Holdout Problem, Urban Sprawl, and Eminent Domain, 16 J. Housing Econ. 309, 311-12 (2007).CrossRefGoogle Scholar
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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
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121 Laudon, Markets and Privacy, supra note 115, at 101-03.
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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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