Authority of the food and drug administration to require data access and control use rights in the sentinel data network

Food and Drug Law Journal

Volumn 65, Issue 1, 2010, Pages

  Evans, Barbara J ^a  

^a UNIVERSITY OF HOUSTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AUTHORITY; DATA BASE; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE POLICY; HEALTH SERVICE; HUMAN; MEDICAL INFORMATION; ORGANIZATION; ORGANIZATION AND MANAGEMENT; REVIEW;

ACCESS TO INFORMATION; HUMANS; LEGISLATION, DRUG; PRIVATE SECTOR; SENTINEL SURVEILLANCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77949609511     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (398)

1. Pub. L. No. 110-85, 121 Stat. 823 (Sept. 27, 2007) (codified as amended in scattered sections of 21 U.S.C.).
2. FDAAA § 905(a), 21 U.S.C. § 355(k)(3).
3. FDAAA § 905(a), 21 U.S.C. § 355(k)(3)(B)(ii) (setting targets of 25 million persons by July, 2010 and 100 million by July, 2012).
4. FDAAA § 905(a), 21 U.S.C. § 355(k)(3)(C).
5. U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., FDA's Sentinel Initiative, http://www.fda.gov/Safety/FDAsSentinelInitiative/ default.htm;
6. see also U.S. FOOD & DRUG ADMIN., U.S. DEP'T OF HEALTH & HUMAN SERVS., THE SENTINEL INITIATIVE 1 (2008), http://www.fda.gov/oc/initiatives/advance/reports/report0508.pdf (discussing the goals and structure of the Sentinel data network).
7. JANET M. MARCHIBRODA, EHEALTH INITIATIVE FOUND., DEVELOPING A GOVERNANCE AND OPERATIONS STRUCTURE FOR THE SENTINEL INITIATIVE (2009), available at http://www.regulations.gov/ search/Regs/home.html#documentDetail?R=09000064809a82f0 [hereinafter, REPORT].
8. Id. at 23.
9. Id. at 21.
10. See, e.g., U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., Solicitation No. HHS-FDA-RFI-09-002, FDA Sentinel Initiative: Request for Information (Feb. 20,2009), [hereinafter, FDA, Request for Information], available at https://www.fbo.gov/index?id= 5182af215e556265fde72a8e969fa46e (stating "only data of organizations who agree to participate in this system will be included.").
11. See infra note 41 and accompanying text.
12. See, e.g., DONALD F. KETTL, THE TRANSFORMATION OF GOVERNANCE: PUBLIC ADMINISTRATION FOR TWENTY-FIRST CENTLRY AMERICA 118 (2002) (discussing the late-20th-century transformation in which "American governments at all levels became increasingly interconnected with private corporations and nongovernmental organizations (NGOs) that share the task of delivering public services.");
13. Lester M. Salamon, The New Governance and the Tools of Public Action, in THE TOOLS OF GOVERNMENT: A GUIDE TO THE NEW GOVERNANCE 1-6 (Lester M. Salamon, ed., 2002) (discussing the extent to which a hierarchical, bureaucratic conception of agency action is no longer accurate);
14. Jody Freeman, The Private Role in Public Governance, 75 N.YU. L. REV. 543, 551-56 (2000) [hereinafter, Freeman, Private Role] (discussing the pervasive involvement of private actors in delivering governmentally financed public services and in performing functions traditionally regarded as public functions).
15. See infra Section III (discussing legal mechanisms for authorizing outside uses of Sentinel network data).
16. See Barbara J. Evans, Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era, 85 NOTRE DAME L. REV. 419, 479-85 (2010) (discussing the important role observational study methodologies will play in 21st-century biomedical discovery and describing the Sentinel network as essential infrastructure to support observational studies and research).
17. See A. Michael Froomkin, Wrong Turn in Cyberspace: Using ICANN to Route Around the APA and the Constitution, 50 DUKE L.J. 17, 34 (2000) (describing a similar "private party story" that was put forward in the context of debate over the U.S. Department of Commerce's privatization of the Internet domain name system late in the 1990s).
18. For a useful summary of the large literature on public-private collaborations, see CATHERINE M. DONNELLY, DELEGATION OF GOVERNMENTAL POWER TO PRIVATE PARTIES: A COMPARATIVE PERSPECTIVE (2007) (reviewing literature about U.S. federal and state approaches to public-private collaborations in the course of comparing U.S. law to United Kingdom and European approaches).
19. See also KETTL, supra note 11;
20. Salamon, supra note 11;
21. Kenneth Bamberger, Regulation as Delegation: Private Firms, Decisionmaking, and Accountability in the Administrative State, 56 DUKE LJ. 377 (2006);
22. Jody Freeman, Collaborative Governance in the Administrative State, 45 UCLA L. REV. 1 (1997);
23. Jody Freeman, Private Parties. Public Functions and the New Administrative Law, 52 ADMIN. L. REV. 813 (2000);
24. Jody Freeman. The Contracting State, 28 FLA. ST. U. L. REV. 155 (2000);
25. Jody Freeman, Extending Public Law Norms Through Privatization, 116 HARV. L. REV. 1285 (2003) [hereinafter, Freeman, Extending Public Law Norms];
26. Gillian E. Metzger, Privatization as Delegation, 103 COLUM. L. REV. 1367 (2003);
27. Martha Minow. Public and Private Partnerships: Accounting for the New Religion, 116 HARV. L. REV. 1229 (2003);
28. Edward Rubin, The Myth of Accountability and the Anti-Administrative Impulse, 103 MICH. L. REV. 2073 (2005);
29. Paul R. Verkuil, Public Law Limitations on Privatization of Government Functions, 84 N.C. L. Rev. 397 (2006).
30. DONALD F. KETTL, SHARING POWER: PUBLIC GOVERNANCE AND PRIVATE MARKETS 4 (1993).
31. For discussions of this history, see Jim Chen, The Nature of the Public Utility: Infrastructure, the Market, and the Law, 98 Nw. U. L. REV. 1617,1617-18 (2004);
32. JOSE A. GÓMEZ-IBÁÑEZ, REGULATING INFRASTRUCTURE (2003); Joseph D. Kearney & Thomas W. Merrill. The Great Transformation of Regulated Industries Law, 98 COLUM. L. REV. 1323, 1333-34 (1998);
33. Richard A. Posner, Natural Monopoly and its Regulation, 21 STAN. L. REV. 548, 548 (1969).
34. See supra note 15.
35. Freeman, Private Role, supra note 11, at 544, 549;
36. Minow, supra note 15, at 1266-67;
37. Freeman, Extending Public Law Norms, supra note 15, at 1288.
38. Salamon, supra note 11, at 39, tbl. 1-11.
39. Donnelly, supra note 15, at 18.
40. Id. See also Minow, supra note 15, at 548 (noting that negotiated relationships within a public-private collaboration, because of their impact on public interests, take on a status beyond that of ordinary private contract).
41. REPORT, supra note 6, at 21.
42. Id. at 23.
43. 5 U.S.C. §§ 551-559, 701-706.
44. See REPORT, supra note 6, at 34 (listing sources of law that are relevant to the task of establishing privacy and data security standards). The list includes: FDAAA, privacy laws, the Health Insurance Portability and Accountability Act (HIPAA), federal alcohol and drug abuse treatment regulations, Medicare Part D claims data regulations, the Privacy Act, the Freedom of Information Act, state health information confidentiality laws, the Office for Human Research Protections Act [sic; the intent appears to have been to refer to provisions of the Public Health Service Act that require ethical conduct of research and to the Common Rule and other regulations promulgated in response to these requirements]; and tort liability under the common law for failure to warn. Id.
45. REPORT, supra note 6, at 11.
46. Id. at 11-12 (discussing the option of a private-sector-run entity with governmental oversight and control).
47. University of Massachusetts Medical School Center for Health Policy and Research. National Opinion Research Center & National Governors Association Center for Best Practices, REPORT TO THE STATE ALLIANCE FOR E-HEALTH: PUBLIC GOVERNANCE MODELS FOR A SUSTAINABLE HEALTH INFORMATION EXCHANGE INDUSTRY 27, 32-34, 36-37 (undated), http://www.nga.org/Files/pdf/0902EHEALTHHIEREPORT.PDF [hereinafter. STATE ALLIANCE REPORT).
48. REPORT, supra note 6, at 10.
49. Whalen v. Roe, 429 U.S. 589, 599-600 (1977) (noting that "privacy" has at least two distinct aspects: informational privacy and decisional privacy).
50. See also Helen L. Gilbert, Minors' Constitutional Right to Informational Privacy, 74 U. CHI. L. REV. 1375, 1378 (2007) (discussing the meaning of informational privacy).
51. Whalen v. Roe, 429 U.S. 589 (1977);
52. Nixon v. Administrator of General Services, 433 U.S. 425 (1977).
53. See Gilbert, supra note 30, at 1380;
54. Lawrence O. Gostin, James G. Hodge, Jr. & Mira S. Burghardt, Balancing Communal Goods and Personal Privacy Under a National Health Informational Privacy Rule, 46 ST. Louis U. L.J. 5. 11-12 (2002) (commenting that the scope of the constitutionally protected information privacy right remains unclear).
55. Gilbert, supra note 30, at 1377-88 (summarizing the framework for analyzing informational privacy claims involving adults and discussing approaches taken in various circuits).
56. See, e.g., Whalen, 429 U.S. at 605 (noting the "threat to privacy implicit in the accumulation of vast amounts of personal information in computerized databanks") and at 601 (acknowledging individuals' "clearly articulated fears' about the pernicious effects of disclosure").
57. Id. at 603-04. The Court first positioned the notion of a constitutionally protected "zone of privacy" in the Fourteenth Amendment.
58. See id. at 598, n. 23, citing Roe v. Wade, 410 U.S. at 152-53.
59. See also D. H. Kaye, The Constitutionality of DNA Sampling Upon Arrest, 10 CORNELL J.L. & PUB. POL'Y 455, 467-68 (2001) (discussing this case).
60. 429 U.S. at 593-94 (finding that the public health activities at issue in Whalen were constitutional because they were subject to a stringent framework of statutory privacy and data security requirements) and at 605-06 (leaving the door open for future informational privacy claims involving systems that lack "comparable security provisions").
61. Id. at 597 (noting with favor that the privacy and security standards at issue in Whalen were "manifestly the product of an orderly and rational legislative decision" which had considered recommendations by a "specially appointed commission that had held extensive hearings on the proposed legislation, and drew on experience with similar programs in other states.")
62. Id.
63. The estimate was calculated as follows: Congress established a goal of 100 million persons' data in FDA's Sentinel network by July, 2012. See 21 U.S.C. § 355(k)(3)(B)(ii). It has been suggested that 25 million records will be drawn from other public entities such as the Center for Medicare and Medicaid Services and the Department of Veterans health systems, with which FDA already has entered agreements to facilitate access to data.
64. See U.S. Dep't of Health & Human Servs., New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care (May 22.2009), http://www.hhs.gov/news/press/2008pres/05/20080522a.html and U.S. FOOD SC DRUG ADMIN., THE SENTINEL INITIATIVE, supra note 5, at 18.
65. The remaining 75 million are assumed to be drawn from private health insurers, such as employer-sponsored group health plans and sellers of individual policies that people purchase for themselves. See U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., Proceedings, Sentinel Network Public Meeting 73 (Mar. 7,2007) [hereinafter FDA, March 7 Proceedings], http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/ ucml16513.pdf (Statement of Dr. Richard Piatt) (noting that data from about ten large, private health insurers would suffice to supply the remaining 75 million records). An estimated 168 million Americans are privately insured; this figure excludes people who simply have private supplemental coverage to augment their primary coverage under Medicare or other governmental programs. Using 2007 Census Bureau data, the 168 million figure is calculated as the U.S. population (296.824,000) minus the uninsured population (45,657,000) minus the population covered by governmental programs (83,000,000) such as Medicare, Medicaid, and veterans' health programs.
66. See Carmen DeNavas-Walt, Bernadette D. Proctor & Jessica C. Smith, Income, Poverty, and Health Insurance Coverage in the United States: 2007 (U.S. Census Bureau, Report P60-235, Aug.. 2008), at 21-22. The resulting figure (168 million) is the pool of privately insured persons from which the remaining 75 million Sentinel network data records will be drawn. Thus, 75/168 = 44.6 percent, which are the estimated odds that a privately insured person will end up in the Sentinel data network.
67. Id. This estimate assumes 25 million records are drawn from the estimated 83 million persons covered by federal health programs; 25/83 = 30 percent. Note that the actual percentage risk may be somewhat higher. The assumed denominator of 83 million persons includes Medicaid beneficiaries as well as Medicare/Veterans' health system patients. FDAAA does not envision that Medicaid beneficiaries will be included in the Sentinel network.
68. See 21 U.S.C. 355(k)(3)(C)(i)(III). After removing Medicaid beneficiaries from the denominator, the percentage risk that a Medicare or Veterans' health system patient would be included in Sentinel would be somewhat higher than the 25/83 fraction suggests.
69. See Barbara J. Evans, Congress' New Infrastructural Model of Medical Privacy, 84 NOTRE DAME L. REV. 585 (2009), at 602-03 and at 610-26 (analyzing why the activities contemplated by section 905 of FDAAA do not require privacy authorizations under relevant federal regulations) and at 626-31 (analyzing why informed consent is not required under federal regulations for protection of human subjects of biomedical research).
70. See also KRISTEN ROSATI, AN ANALYSIS OF LEGAL ISSUES RELATED TO STRUCTURING FDA SENTINEL INITIATIVE ACTIVITIES 86-87 (2009), available at http://www.regulations. gov/search/Regs/contentStreamer?objectId=090000648098bad2&disposition= attachment&contentType=pdf (concluding also that individualized informed consent and privacy authorizations are not required).
71. See generally, COMM. ON THE ASSESSMENT OF THE U.S. DRUG SAFETY SYS., INST. OF MED., THE FUTURE OF DRUG SAFETY (Alina Baciu et al. eds.. 2007), available at http://books.nap.edu/ openbook.php?record-id=11750
72. and U.S. Gov't Accountability Office, Doc. No. GAO-06-402, DRUG SAFETY: IMPROVEMENT NEEDED IN FDA'S POSTMARKET DECISION-MAKING AND OVERSIGHT PROCESSES 10 (2006), available at http://www.gao.gov/new.items/ d06402.pdf (discussing limitations of premarket clinical trial data and the need for ongoing postmarket surveillance)
73. and Evans, supra note 13, at 439-50 (discussing evidentiary limitations of premarket clinical drug trials).
74. See Evans, supra note 13, at 450-58 (discussing logistical, ethical, and economic barriers to large-scale, long-term RCTs and ongoing trials that continue after a drug's efficacy has been established).
75. Id. at 478. See also 21 U.S.C. § 355(o)(3)(D) (requiring alternatives such as observational studies and studies with Sentinel System data to be rejected before FDA can order a postmarket clinical trial).
76. Evans, supra note 41, at 601 -02 (discussing the purposes for which Congress authorized development of the Sentinel network).
77. FDAAA §905(a), 21 U.S.C. §355(k)(3)(C)(i)(I)-(V).
78. FDAAA §905(a), 21 U.S.C. §355(k)(3)(C)(i)(IV)-(VI).
79. FDAAA §905(a), 21 U.S.C. §355(k)(4)(A)(ii).
80. FDAAA §905(a), 21 U.S.C. §355(k)(4)(A)(i) and (iii).
81. FDAAA §901(b), 21 U.S.C. §355-l(b)(1),(4);
82. id. §905, 21 U.S.C. §355(k)(3)(C)(i)(II).
83. See also Evans, supra note 41, at 588, 601-04
84. and Evans, supra note 13, at 468-76 (discussing issues with heterogeneity of drug treatment response).
85. U.S. Food & Drug Admin., FDA's Sentinel Initiative, supra note 5.
86. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, http://encepp.eu.
87. See also European Risk Management Strategy, Two-Year Work Programme (2008-09), http://www.emea.europa.eu/pdfs/human/phv/28008907en.pdf
88. Id.
89. See Welcome to the EU-ADR Website, http://www.alert-project.org/.
90. See EMEA-coordinated PROTECT project has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking, Pharmanews (Apr. 30, 2009), http://www.pharmanews.eu/emea/197-emea-coordinated-protect-project-has- been-accepted-for-funding-by-the-innovative-medicines-initiative-joint- undertaking.
91. Canada Institutes of Health Research (CIHR), In Brief: The Drug Safety and Effectiveness Network (DSEN), http://www.cihr-irsc.gc.ca/e/39389.html.
92. See also Health Canada, Medicines that Work for Canadians: Business Plan for a Drug Effectiveness and Safety Network (2007), http://www.hc-sc.gc.ca/hcs-sss/pubs/pharma/2007-med-work-eff/index-eng.php.
93. Government of Canada, Food and Consumer Safety Action Plan, http://www.healthycanadiansca/pr-rp/action-plan-e.html.
94. See CIHR, supra note 56.
95. Kaoru Misawa, Director, Office of Safety, Pharmaceuticals and Medical Devices Agency (PMDA), Sentinel Initiative in Japan: Utilization of Electronic Health Information in Pharmacovigilance, 9th Kitasato University-Harvard School of Public Health Symposium (Sept. 11-12, 2009).
96. HHS, Nationwide Health Information Information Network (NHIN): Background, http://www.hhs.gov/healthit/healthnetwork/background/
97. Clement MacDonald, Protecting Patients in Health Information Exchange: A Defense of the HIPAA Privacy Rule, 28 HEALTH AFFAIRS 447 (2009).
98. U.S. Food & Drug Admin., U.S. Dep't of Health and Human Servs., Proceedings, Sentinel Network Public Meeting 42 (Mar. 8, 2007) [hereinafter FDA, March 8 Proceedings], http://www.fda.gov/ohrms/dockets/dockets/07n0016/07n- 0016-tr00002.pdf (statement of Dr. Robert M. Califf);
99. id. at 23-24 (statement of Dr. Miles Braun).
100. Id. at 24.
101. Promoting Disease Management in Medicare, Hearing Before the House Ways and Means Subcommittee (Apr. 16, 2002) (statement of Dr. Gerard Anderson at 5).
102. C. DesRoches,, E. Campbell,, S. Rao, et al., Electronic Health Records in Ambulatory Care - A National Survey of Physicians, 359 NEW. ENG. J. MED. 1 (2008);
103. A. Jha, C. DesRoches,, E. Campbell, et al.. Use of Electronic Health Records in U.S. Hospitals, 360 NEW ENG. J. MED. 16 (2009).
104. M. Susan Marquis, & Kanika Kapur, Employment Transitions and Continuity of Health Insurance: Implications for Premium Assistance Programs, 22 HEALTH AFFAIRS 198, 198 (2005).
105. See also FDA, March 8 Proceedings, supra note 62, at 53 (statement of Dr. Clement McDonald) (discussing 20 percent membership turnover rate in some Health Maintenance Organizations).
106. Carol C. Diamond, Farzad Mostashari, & Clay Shirky, Collecting and Sharing Data For Population Health: A New Paradigm, 28 HEALTH AFFAIRS 454, 456 (2009).
107. See Mark A. Rothstein, Health Privacy in the Electronic Age, 28 J. LEGAL MED. 487,489 (2007);
108. Nicholas P. Terry & Leslie P. Francis, Ensuring the Privacy and Confidentiality of Electronic Health Records, 2007 U. ILL. L. REV. 681, 700 (2000) (discussing privacy concerns attendant to large health databases).
109. Richard Platt et al. The New Sentinel Network-Improving the Evidence of Medical-Product Safety, 361 NEW ENGL. J. MED. 645-47 (2009). See also Diamond et al, supra note 67, at 460.
110. Evans, supra note 41. at 606.
111. Id. at 594-95.
112. FDAAA §905(a), 21 U.S.C. §355(k)(3)(B)(ii).
113. FDAAA §905(a), 21 U.S.C. §355(k)(3)(C)(v).
114. FDAAA §905(a), 21 USC §355(k)(4)(D)(i)(I)-(V).
115. U.S. FOOD & DRUG ADMIN., THE SENTINEL INITIATIVE, supra note 5.
116. FDAAA §905(a), 21 U.S.C. §§355(k)(3)(C)(i)(III)(aa)-(cc).
117. Medicare Program; Medicare Part D Claims Data, 73 Fed. Reg. 30,664, 30,664 (May 28,2008) (to be codified at 42 C.F.R. §423).
118. HHS, FDA, THE SENTINEL INITIATIVE, supra note 5, at 18.
119. See supra note 39.
120. Id.
121. See Evans, supra note 13, at 483-84 (summarizing limitations of administrative data).
122. FDA, March 7 Proceedings, supra note 39, at 57 (statement of Dr. Marc Overhage).
123. Id. at 57-58.
124. See also, id. at 66-68, 71 (statement of Dr. Richard Platt).
125. See FDAAA §905(a), 21 U.S.C. §§355(k)(3)(C)(i)(III) (aa)-(cc) (listing types of data FDA can include in the system and granting discretion to include "other data as the Secretary [of HHS] deems necessary").
126. DesRoches et al., supra note 65.
127. Pub. L. No. 111-5, 123 Stat. 115 (Feb. 17, 2009).
128. Id., Div. A, Title XIII and Div. B., Title IV of Div. B (providing Medicare and Medicaid incentives to promote installation of electronic records systems and providing for penalties if healthcare providers fail to achieve meaningful use of such systems by 2015).
129. Letter from Robert A. Sunshine, Acting Director, Congressional Budget Office to Rep. Charles B. RangeKJan. 21, 1999) at 3.
130. See e.g., FDA Request for Information, supra note 9; FDA, The Sentinel Initiative: Questions and Answers, http://www.fda.gov/oc/ initiatives/advance/sentinel/qanda.html, at question 7.
131. See also REPORT, supra note 6, at 4, 8, 10, 33 (discussing the first phase of the Sentinel network in which organizations that now possess data would keep the data behind their respective privacy firewalls and provide aggregated, de-identified information in response to queries from FDA).
132. REPORT, supra note 6, at 22.
133. Office of Acquisitions and Grants Servs., U.S. Food & Drug Admin., U.S. Dep't of Health & Human Servs., Solicitation No. FDA1046408: Developing a Governance and Operations Structure for the Sentinel Initiative (Jul. 24, 2008), https://www.fbo.gov/index?s=opportunity&mode=form&id=f5a 0170b012504b7b6f7cf1c17640def&tab=core&-cview=0.
134. eHealth Initiative, http://www.ehealthinitiative.org/about.html (last visited Jan. 24, 2010).
135. eHealth Initiative, eHealth Initiative Members, http://www. ehealthinitiative.org/ehealth-initiative-members.html (last visited Jan. 24, 2010). The organization's membership includes, for example, advocacy organizations and professional societies (e.g., the American Association of Retired Persons, the American Cancer Society, the American Medical Association); academic medical centers and healthcare providers (e.g., Vanderbilt University Medical Center, M.D. Anderson Cancer Center, Christus Health, Cedars Sinai Medical Center, Mayo Clinic); commercial IT and telecommunications companies (e.g., IBM Corporation, Microsoft, Dell, AT&T), pharmaceutical companies, insurers, and pharmacy benefits managers, and pharmacies (e.g., Eli Lilly & Company, Johnson & Johnson, Merck, Pfizer. Inc., Cigna Health Plans, CVS Caremark, Walgreens) and industry trade organizations (e.g., Pharmaceutical Research & Manufacturers of America, Federation of American Hospitals).
136. See, e.g., REPORT, supra note 6, at 4.
137. See, e.g., FDA, Request for Information, supra note 9 ("Data will continue to be managed by its owners...").
138. Mark A. Hall & Kevin A. Schulman, Ownership of Medical Information, 301 JAMA 1282-84 (Mar. 24. 2009).
139. See Susan E. Gindin, Lost and Found in Cyberspace: Informational Privacy in the Age of the Internet, 34 SAN DIEGO L. REV. 1153, 1195 n. 231 (1997) (listing several cases where courts have recognized patients' ownership of medical records).
140. Seth Axelrad, State Statutes Declaring Genetic Information to be Personal Property, http://www.aslme.org/dna-04/reports/axelrad4.pdf (listing statutes of Alaska, Colorado, Florida and Georgia that recognize individual property rights in genetic information).
141. David L. Silverman, Data Security Breaches: The State of Notification Laws, 19 No. 7 INTELL. PROP. & TECH. L.J. 5, 8 (2007);
142. Barbara J. Evans, Ethical and Privacy Issues in Pharmacogenomic Research, in PHARMACOGENOMICS: APPLICATIONS TO PATIENT CARE, 2ND ED. 313, 315 (Howard L. McLeod et al. eds, 2009).
143. See Paul M. Schwartz, Property, Privacy, and Personal Data, 117 HARV. L. REV. 2055, 2076-94 (2004) (discussing conceptual difficulties in applying a regime of property rights to information in databases).
144. See also Silverman, supra note 99, at 8 (noting, "Although it is common for businesses contracting with one another to state that one or another of them 'owns' a particular data set, ownership of the contents of a database is a precarious concept in the United States. The contents of a database may be owned in the sense that the database is protectable as a trade secret, but only if the database independently meets the requirements under applicable state law for protection of trade secrets. As with any trade secret, the right may vanish if secrecy is not maintained. Copyright law typically does not provide protection for the contents of a database, because the contents are facts, not expression; if there is protection under copyright law, it is typically limited to the selection and arrangement of the database and does not extend to the content itself").
145. M. Bloomrosen & D. Detmer, Advancing the framework: use of health data-a report of a working conference of the American Medical Informatics Association, 15 J. AM. MED. INFORM. ASSOC. 715-22 (2008).
146. REPORT, supra note 6, at 34.
147. Id. at 21.
148. FDA, Guidance for Institutional Review Boards and Clinical Investigators [question 52], http://www.fda.gov/oc/ohrt/irbs/faqs.html.
149. See also HHS, Office for Human Research Protection (OHRP)/Office for Protection from Research Risks (OPRR), Cooperative Oncology Group Chairpersons Meeting, "Exculpatory Language" in Informed Consent (Nov. 15, 1996), http://www.hhs.gov/ohrp/humansubjects/guidance/ exculp.htm (taking an analogous position that informed consent documents for research projects regulated under the Common Rule 45 C.F.R. pt. 46, subpt. A should not require research subjects to waive legal rights).
150. Rosati, supra note 41.
151. See discussion infra Section II.G.
152. See discussion supra Section II.C.
153. Diamond et al., supra note 67, at 458.
154. Evans, supra note 41, at 601-04.
155. LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW: POWER, DUTY, AND RESTRAINT 26-27 (2002).
156. Wendy E. Parmet, After September 11: Rethinking Public Health Federalism, 30 XL. MED. & ETHICS 201 (2002).
157. Id. at 202 (tracing origins of the view that public health is a matter of state law to A. Hamilton, Federalist No. 17).
158. Id. at 203 (citing M. S. Morgenstern, The Role of the Federal Government in Protecting Citizens from Communicable Diseases; U. CIN. L. REV. 537-71 (1978)).
159. Joan H. Krause, Healthcare Fraud and Quality of Care: A Patient-Centered Approach, 37 J. HEALTH L. 161, 183 (2004), at note 147.
160. Richard A. Epstein, Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda. 1 J. TORT L. art. 5, at 3 (2006), http://www.bepress.com/jtl/voll/iss1/ art5.
161. GOSTIN, supra note 110, at 42-45.
162. David P. Fidler, Lawrence O. Gostin & Howard Markel, Through the Quarantine Looking Glass: Drug-resistant Tuberculosis and Public Health Governance, Law, and Ethics, 35 J.L. MED. & ETHICS 616, 618(2007).
163. Pub. L. No. 100-578, 102 Stat. 2903 (codified as amended at 42 U.S.C. §263a (2006));
164. see also 42 C.F.R. pt. 493 (outlining regulatory requirements for clinical laboratories).
165. FDAAA §905(a), 21 U.S.C. §355(k)(3)(B).
166. FDAAA §905(a), 21 U.S.C. §355(k)(3)(C)(i)(III).
167. See also 21 U.S.C.§ 355(k)(3)(A) (defining "data" as information with respect to an approved drug or biologic "including claims data, patient survey data, standardized analytic files that allow for the polling and analysis of data from disparate data environments, and any other data deemed appropriate by the Secretary").
168. FDAAA §905(a), 21 U.S.C. §355(k)(3)(B).
169. NORMAN J. SINGER, 2A SUTHERLAND STATUTORY CONSTRUCTION §46.1 (6th ed. 2004).
170. Merriam-Webster's Online Dictionary, http://www.merriam-webster.com/ dictionary/collaborator (defining, collaborate as "1: to work jointly with others or together especially in an intellectual endeavor; 2: to cooperate with or willingly assist an enemy of one's country and especially an occupying force; 3: to cooperate with an agency or instrumentality with which one is not immediately connected.").
171. Id.
172. FDAAA §905(a), 21 U.S.C. §355(k)(3)(C)(i)(III).
173. See infra Section II.F.4.
174. Pub. L. No. 75-717, 52 Stat. 1040 (codified as amended at 21 U.S.C. §§301-399).
175. Drug Amendments of 1962 (Harris-Kefauver Act), Pub. L. No. 87-781, 76 Stat. 780 (codified as amended in scattered sections of 21 U.S.C).
176. David G. Adams, The Food and Drug Administration's Regulation of Health Care Professionals, in 2 FUNDAMENTALS OF LAW AND REGULATION: AN IN-DEPTH LOOK AT THERAPEUTIC PRODUCTS 423 (David G. Adams et al. eds. 1999).
177. See Evans, supra note 13, at 500-03 (discussing the history of this policy).
178. 37 Fed. Reg. at 16,504 (July 30, 1972) (stating that labeling is not intended to impede the physician's exercise of judgment concerning what is best for the patient or to impose liability for prescribing decisions that are at odds with drug labeling).
179. Id.
180. Parmet, supra note 111, at 203.
181. Pub. L. No. 59-384, 34 Stat. 768 (codified as amended at scattered sections of 21 U.S.C.) The Pure Food and Drugs Act of 1906 was the precursor of the Food, Drug, and Cosmetic Act of 1938.
182. Parmet, supra note 111, at 204.
183. 514 U.S. 549(1995).
184. Parmet identifies a handful of Lopez-based challenges involving federal drug laws, the Freedom of Access to Clinic Entrances Act, and Medicare managed care issues, but notes that major federal public health statutes such as the Clinical Laboratory Improvement Amendments of 1988 have not been challenged. Parmet, supra note 111, at 205.
185. 505 U.S. 144(1992).
186. 521 U.S. 898(1997).
187. Parmet, supra note 111, at 205.
188. Id. at 207.
189. Id.
190. Bruce M. Psaty & David Korn, Congress Responds to the IOM Drug Safety Report - In Full, 298 JAMA 2185-87 (2007);
191. see also Bruce M. Psaty & Sheila P. Burke, Protecting the Health of the Public - Institute of Medicine Recommendations on Drug Safety, 355 NEW ENGL. J. MED. 1753-55 (2006).
192. See discussion infra Section II. G. 1.
193. See discussion infra this subsection.
194. See 21 U.S.C. §355(k)(4)(D)(i), providing that "the Secretary shall establish and implement procedures under which the Secretary may routinely contract with one or more outside qualified entities to [perform the five functions listed in 355(k)(4)(D)(i)(I)-(V)]" (emphasis added).
195. 21 U.S.C. §§355(k)(4)(D)(i)(I)-(V).
196. 21 U.S.C. §§355(k)(4)(F),(H).
197. FDAAA §905(a), 21 U.S.C §355(k)(4)(D)(i)(I).
198. FDAAA §905(a), 21 U.S.C §355(k)(4)(D)(i)(II).
199. FDAAA §905(a), 21 U.S.C §355(k)(4)(D)(i)(III).
200. REPORT, supra note 6. at 11. 12.
201. Id. at 14.
202. Id. at U, 12.
203. Id. at 8.
204. Pub. L. No. 104-191, 110 Stat. 1936 (codified as amended at scattered sections of 18, 26, 29, 42 U.S.C).
205. 45 C.F.R. pts. 160, 164.
206. Rosati, supra note 41.
207. Id. at 15-16.
208. Id. at 16.
209. See 45 C.F.R. §164.512(b)(l)(i) (providing an exception to the HIPAA Privacy Rule's usual authorization requirements for disclosures of data to public health authorities for use in public health activities).
210. See also Evans, supra note 41, at 597 n. 73 (describing this and several other exceptions to HIPAA's authorization requirements that have potential applicability in the context of FDA's Sentinel Initiative).
211. See 45 C.F.R. §164.514(h)(2)(ii)(C) (allowing a data holder, when making disclosure to a person acting on behalf of a public official, to rely on "a written statement on appropriate governmental letterhead that the person is acting under the government's authority or other evidence or documentation of the agency, such as a contract for services... that establishes that the person is acting on behalf of the public official" (emphasis added)).
212. Id.; see also Ctrs. for Disease Control & Prevention, HHS, HIPAA Privacy Rule and Public Health, MORBIDITY & MORTALITY, WKLY. REP., (Apr. 11, 2003), available at http://www.cdc.gov/mmwr/pdf/other/m2e4111.pdf, at 1, 1;
213. Evans, supra note 41. at 598.
214. 45 C.F.R. §164.506. See also Rosati, supra note 41, at 50, 53.
215. Rosati, supra note 41, at 16.
216. Deven McGraw, James X. Dempsey, Leslie Harris & Janlori Goldman, Privacy as an Enabler, Not an Impediment: Building Trust Into Health Information Exchange, 28 HEALTH AFFAIRS 419-20 (2009).
217. See 21 U.S.C. §355(k)(4)(F) (requiring FDA to contract with "qualified entities").
218. See also id. at §355(k)(4)(I) (allowing FDA an opportunity to review a contract if the qualified entity with which FDA initially contracted conveys the contract to a successor through merger and acquisition activity).
219. 21 U.S.C. §355(k)(4)(H).
220. See REPORT, supra note 6, at page 11 (suggesting that "FDA could provide funding support either through a contract, cooperative agreement, or grant to the independent entity that would establish and operate
221. See 21 U.S.C. §355(k)(4)(H).
222. 21 U.S.C. §355(k)(4)(G).
223. Privacy Act of 1974, 5 U.S.C. §552a. FDAAA requires compliance with 5 U.S.C. §§552 and 552a.
224. See 21 U.S.C. §355(k)(4)(G)(i)(II).
225. 21 U.S.C. §355(k)(4)(D)(i).
226. Salamon, supra note 11, at 39, tbl. 1-11.
227. Donnelly, supra note 15, at 18.
228. Freeman, Private Role, supra note 11, at 549.
229. See also Freeman, Extending Public Law Norms, supra note 15, at 1288.
230. Freeman, Private Role, supra note 11, at 544.
231. Freeman, Extending Public Law Norms, supra note 15, at 1288.
232. Freeman, Private Role, supra note 11, at 548.
233. Minow, supra note 15, at 1266-67.
234. Id. at 1267.
235. 5 U.S.C. §553(a)(2) (excluding grants and contracts from notice-and-comment rulemaking procedures). See also Freeman, Extending Public Law Norms, supra note 15, at 1305.
236. 21 U.S.C. §355(k)(4)(D)(i).
237. See Evans, supra note 41, at 605-06 (discussing the tension between FDAAA's public health objectives and the objective of ensuring ethical and privacy protections for persons whose data are used).
238. Evans, supra note 13, at 494-97.
239. See, e.g., I. Scott Bass, Enforcement Powers of the Food and Drug Administration: Drugs and Devices, in 2 FUNDAMENTALS OF LAW AND REGULATION,
240. supra note 129, at 55, 70-74
241. and Evans, supra note 41, at 631-33 (discussing FDA's traditional reliance on voluntary regulatory compliance in various contexts).
242. See Freeman, Private Role, supra note 11, at 651-52 (discussing examples in which the background threat of direct regulatory oversight has improved the performance of self-regulatory arrangements).
243. See Evans supra note 41, at 591-94;
244. FDA, March 7 Proceedings, supra note 39, at 30 (statement of Dr. Jeff Shuren, Ass't. Comm'r. for Pol'y, FDA) (inquiring about economies of scale when health data can be used for multiple purposes);
245. State Alliance Report, supra note 28, at 27, 32-34, 36-37.
246. CHARLES F. PHILLIPS, JR., REGULATING PUBLIC UTILITIES 51-54 (3rd. ed. 1993).
247. Evans, supra note 13, at 494-97.
248. Evans, supra note 41, at 607-08.
249. See supra notes 99, 100 and accompanying text.
250. Silverman, supra note 99, at 8.
251. Evans, supra note 13, at 494.
252. See discussion infra section III.B.
253. See Evans, supra note 13, at 438-39.
254. Id. at 450-58 (discussing ethical and practical problems in conducting very long or very large clinical trials);
255. Robert M. Califf, Clinical trials bureaucracy: unintended consequences of well-intentioned policy, 2 CLIN. TRIALS 496, 498 (2006).
256. Evans, supra note 13, at 458-76 (discussing the special problems of validating genetic tests, emerging products in genomic medicine, and products intended for long-term predictive and preventive uses).
257. 45 C.F.R. pt. 46, subpt. A., §§46.101-124.
258. Barbara J. Evans & Eric M. Meslin, Encouraging Translational Research Through Harmonization of FDA and Common Rule Informed Consent Requirements for Research with Banked Specimens, 27 J. LEGAL MED. 119, 120 n. 5 (2006).
259. 21 C.F.R. pts. 50, 56.
260. See Rosati, supra note 41, at 70-76 (appearing to envision that FDA may adopt the Common Rule for the Sentinel network)
261. and Evans, supra note 41, at 627-29 (discussing possible advantages if FDA were to adopt the Common Rule to govern the Sentinel network).
262. See Evans & Meslin, supra note 199, at 135-36 (discussing applicability of the Common Rule).
263. Evans, supra note 41, at 622-24;
264. and Evans, supra note 99, at 330-32.
265. FDAAA §905(a), 21 U.S.C. §§355(k)(4)(A), 355(k)(4)(D)(i)(I) (V).
266. FDAAA §905(a), 21 U.S.C. §355(k)(3)(C)(i)(I). See id. at 21 U.S.C. §355(k)(4)(C)(i)(I)-(VI) (listing other broadly stated uses).
267. 2m FDAAA §905(a), 21 U.S.C. §355(k)(4)(C).
268. Id.
269. Id.
270. FACA, Pub. L. 92-463, 86 Stat. 770; Federal Advisory Committee Act Amendments of 1997, Pub. L. 105-153, 111 Stat. 2689 (codified at 5 U.S.C. App. 2).
271. FDAAA §905(a), 21 U.S.C. §355(k)(3)(C)(v).
272. FDAAA §905(a), 21 U.S.C. §355(k)(4)(D)(i).
273. See FDAAA §905(a), 21 U.S.C. §§355(k)(3)(C)(i)(VI) (authorizing "export" of data for further aggregation, statistical analysis, or reporting).
274. See also HIPAA Privacy Rule, 45 C.F.R. § 164.514(h)(2 )(ii)(C) (authorizing disclosure of data to entities authorized by contract to act on behalf of a public health agency) and discussion supra at Section II.G.2.
275. REPORT, supra note 6, at 22.
276. Id. at 6-7, 13.
277. Id. at 7. (the other two "nondelegable" functions are making final decisions about which methods will be used and deciding on further actions, including risk communication, based on interpretation of results).
278. See discussion infra this subsection.
279. REPORT, supra note 6, at 22 ("Given the voluntary nature of reporting,...")
280. Id. at 22-23.
281. Id. at 23.
282. Id. at 22.
283. Id. at 23.
284. Id. at 11.
285. Id. at 20.
286. Id. at 20.
287. The Report takes no position on how outside uses would be approved. Its companion legal study lists HIPAA waivers among the various legal mechanisms for disclosing data to third parties for research use. See Rosati, supra note 41, at 54.
288. REPORT, supra note 6, at 7.
289. See discussion infra at notes 250-57 and the accompanying text of Section III.D.
290. 298 U.S. 238 (1936).
291. REPORT, supra note 6, at 20.
292. 2311 See supra notes 218-221 and accompanying text;
293. see also Evans supra note 41, at 608.
294. Evans, supra note 41, at 618, 623, 631.
295. REPORT, supra note 6, at 22.
296. Evans, supra note 41, at 631.
297. This estimate is calculated by dividing the number of persons enrolled in employer-sponsored insurance (177.4 million) by the overall number of people with private insurance (202 million). See DeNavas-Walt et al., supra note 39, at 19-20. Note, however, that both figures may include persons who have private policies as a supplement to other forms of insurance such as Medicare. Id.
298. See REPORT, supra note 6, at 35 (suggesting that FDA establish "a central IRB, which would be able to function as the IRB for the data environments that choose to participate in the collaborative effort" to support the Sentinel Initiative).
299. 45 C.F.R. §§46.103(b)(3), 46.108(b) [Common Rule]; 45 C.F.R. §164.512(i)(2)(iv) [HIPAA Privacy Rule].
300. See OFFICE OF INSPECTOR GENERAL, U.S. DEP'T OF HEALTH & HUMAN SERVS., INSTITUTIONAL REVIEW BOARDS: THEIR ROLE IN REVIEWING APPROVED RESEARCH B-I (1998), available at http://www.oig.hhs.gov/oei/reports/oei-01-97-00190.pdf (estimating that 2,000-5,000 IRBs are in operation at academic medical centers and research institutions in the United States);
301. OFFICE OF INSPECTOR GENERAL, U.S. DEP'T OF HEALTH & HUMAN SERVS., PROTECTING HUMAN RESEARCH SUBJECTS 8, 9, 16 (2000), available at http://www.oig.hhs.gov/oei/reports/oei-01-97-00197. pdf (finding spontaneous or on-site reviews of IRBs operating under the Common Rule to be quite rare, with only eighteen site visits between 1990 and April, 1996; one such visit between April, 1997 and May, 1998; and ten visits between June, 1998 and March, 2000);
302. OFFICE OF INSPECTOR GENERAL, U.S. DEP'T OF HEALTH & HUMAN SERVS., INSTITUTIONAL REVIEW BOARDS: A TIME FOR REFORM 9, C-3, C-4 (1998), available at http://www.oig.hhs.gov/ oei/reports/oei-01-97-00193.pdf (indicating that FDA aims to inspect IRBs operating under FDA's regulations once every five years).
303. See Evans, supra note 41, at 624-25 (discussing the weakness of Common Rule and HIPAA procedures governing waiver decisions).
304. Freeman, The Contracting State, supra note 15, at 173.
305. Id. at 165, 180-81.
306. See also KETTL, supra note 11, at 166;
307. Verkuil, supra 15, at 418; Freeman, Extending Public Law Norms, supra note 15, at 1302, 1304;
308. David M. Lawrence, Private Exercise of Governmental Power, 61 IND. L.J. 647, 684 (1986).
309. Harold l. Abramson, A Fifth Branch of Government: The Private Regulators and Their Constitutionality, 16 HASTINGS CONST. L.Q. 165, 184(1989).
310. Freeman, Extending Public Law Norms, supra note 15, at 1303.
311. See also Lawrence, supra note 240, at 659 ("The concern is that governmental power-power coercive in nature - will be used to further the private interests of the private actor, as opposed to some different public interest.").
312. Evans, supra note 41, at 636.
313. Id.
314. Lawrence, supra note 240, at 647-48.
315. Abramson, supra note 241, at 184-86.
316. Freeman, Private Role, supra note 11, at 558.
317. KETTL, supra note 11. at 161.
318. REPORT, supra note 6, at 7.
319. See DONNELLY, supra note 15, at 57-60, 117-26 (summarizing modern federal nondelegation doctrine and discussing the extent to which private delegations of governmental power are allowed in modern practice);
320. Freeman, Private Role, supra note 11, at 580-81 (noting that the desuetude of the federal nondelegation doctrine is well settled);
321. Lawrence, supra note 240, at 648-49, 672 (noting that U.S. federal courts have tended to allow delegations of federal power in the years since the 1936 case, Carter v. Carter Coal Co., 298 U.S. 238 (1936));
322. Salamon, supra note 11, at 3;
323. Verkuil, supra note 15, at 418, 432.
324. DONNELLY, supra note 15, at 127-35.
325. Verkuil, supra note 15, at 432.
326. Freeman, Extending Public Law Norms, supra note 15, at 1305 (noting that, "[a]s part of their inherent power, agencies may further delegate powers entrusted to them to other actors with virtually no limitation, provided that Congress does not prohibit them from doing so.")
327. Salomon, supra note 11, at 2, 3;
328. Donnelly, supra note 15, at 57-60;
329. Freeman, Extending Public Law Norms, supra note 15, at 1309 (noting that service providers exercise considerable discretion even when their activities are characterized as "implementation").
330. Lawrence, supra note 240, at 647-48;
331. DONNELLY, supra note 15, at 57-60, 118-19, 123-24.
332. See also Freeman, Extending Public Law Norms, supra note 15, at 1287 n. 7 (citing PAUL C. LIGHT, THE TRUE SIZE OF GOVERNMENT 13-14 (1999) (discussing the use of contractors by the EPA));
333. see also Freeman, Private Role, supra note 11, at 547-48, 551-52 (describing ways that modern delegations involve roles traditionally regarded as governmental in nature).
334. DONNELLY, supra note 15, at 1 (internal citations omitted).
335. Freeman, Private Role, supra note 11, at 584.
336. 2'8 Evans, supra note 41, at 623.
337. REPORT, supra note 6, at 20.
338. Freeman, Extending Public Law Norms, supra note 15, at 1285.
339. FDA's "financing" could include, for example, direct payments (e.g., grants) to help design, construct, and test the Sentinel infrastructure, payments by FDA for data and services supplied to FDA under contracts, or other indirect infrastructure financing (such as loan guarantees or risk insurance, if used).
340. REPORT, supra note 6, at 22.
341. Id. at 23
342. Rothstein, supra note 68;
343. Terry, supra note 68.
344. Michael D. Greenberg, Susan M. Ridgely & Richard Hillestad, Crossed Wires: How Yesterday's Privacy Rules Might Undercut Tomorrow's Nationwide Health Information Network, 28 HEALTH AFFAIRS, 450, 450-51 (2009).
345. See also MacDonald, supra note 61, at 447 (arguing that the HIPAA Privacy Rule is appropriate for regulation of local or regional networks but is inadequate in the context of national networks).
346. Verkuil, supra note 15, at 403.
347. Id. at 405, 411, 418 (noting that it is hard to measure the impact on the public when a public-private collaboration delegates public functions into private hands, and calling for such delegations to be subject to public law controls to ensure oversight, accountability, fairness, and transparency).
348. See, e.g., supra note 15.
349. See Christopher K. Leman, Direct Government, in THE TOOLS OF GOVERNMENT: A GUIDE TO THE NEW GOVERNANCE 61-62 (Lester M. Salamon, ed., 2002) (discussing factors helpful in identifying inherently governmental functions that should not be delegated to private actors).
350. See also U.S. General Accounting Office, Government Contractors: Are Service Contractors Performing Inherently Governmental Functions? Report No GGD-92-11 (1991) and Executive Office of the President, Office of Management and Budget, Circular No. A-76 (May 29, 2003 as revised), http://www.whitehouse.gov/ omb/circulars/a076/a76-rev2003.pdf, at A-2 (enunciating criteria similar to those in Leman's discussion).
351. See also Freeman, Extending Public Law Norms, supra note 15, at 1291, 1342-51 (identifying factors for assessing whether a given private delegation is problematic in ways that create a need to place the private decisionmaker under special controls to protect the public interest);
352. Texas Boll Weevil Eradication Found. Inc. v. Lewellen, 952 S.W.2d 454 (Tex. 1997) (enunciating eight factors for assessing whether a private delegation is problematic, in the context of a case decided under State nondelegation doctrine).
353. See discussion infra this subsection.
354. REPORT, supra note 11, at 6, 7, 13.
355. Freeman, Private Role, supra note 11, at 574-75 (noting that the four most popular mechanisms for protecting public interests in the context of private delegations are: 1) to treat private delegates as state actors subject to public law norms; 2) to apply nondelegation doctrine or the due process clause to invalidate a private delegation and return the delegated functions to governmental authorities: 3) to impose procedural controls over private actors (for example, by contract or by regulation); and 4) to insinuate public law norms (such as fairness requirements) into private law (e.g., contract law, corporate law) to which the private delegates are subject).
356. Freeman, Extending Public Law Norms, supra note 15, at 1288.
357. Lawrence, supra note 240, at 647-48;
358. Freeman, Private Role, supra note 11, at 550-51,558 (noting that "the concept of the 'public interest' evades rigorous definition");
359. KETTL, supra note 11, at 161 ("Of course, defining 'the public interest' has always been the most daunting of practical and theoretical problems.").
360. Freeman, Extending Public Law Norms, supra note 15, at 1289 (noting that a blending of public and private power is now the norm).
361. KETTL, supra note 11. at 161;
362. Lawrence, supra note 240, at 648.
363. See. e.g., Lawrence, supra note 240, at 670-71 (noting that, in some circumstances, delegation may serve accountability as well or better than leaving a matter with a public agency);
364. Freeman, Private Role, supra note 11, at 566 (noting that some critical legal studies scholars have "given up on the state as a potential source of positive change");
365. Verkuil, supra note 15, at 418 (discussing how contraction of the civil service adversely affects the public interest by limiting agencies' internal capacity to govern and oversee private entities to whom the work of government has been contracted).
366. See discussion supra at Section III.D.
367. Freeman, Extending Public Law Norms, supra note 15, at 1325-26.
368. Lawrence, supra note 240. at 670-71.
369. Id. at 686-87 (discussing delegation to a private, but neutral party).
370. Id.
371. Id.
372. REPORT, supra note 6, at 34.
373. Id. at 11.
374. For summary discussions of this doctrine, see Freeman, Private Role, supra note 11, at 576-79;
375. Metzger, supra note 15. at 1411-20:
376. Abramson, supra note 241. at 183.
377. LeBron v. National Rail Passenger Corp., 513 U.S. 374 (1995).
378. Abramson, supra note 241, at 203-05.
379. Freeman, Private Role, supra note 11, at 576.
380. 45 C.F.R. §160.203(b); see also U.S. Dep't of Health & Human Servs., Does the HIPAA Privacy Rule preempt state laws?, http://www.hhs.gov/hipaafaq/state/399.html (explaining that the HIPAA Privacy Rule does not preempt stricter requirements of state privacy law).
381. See, e.g., Danielle Keats Citron, Technological Due Process, 85 WASH. U. L. REV. 1249, 1295 n. 309 (2008);
382. Donnelly, supra note 15, at 117, 130-31; Asmara Tekle Johnson, Privatizing Eminent Domain: The Delegation of a Very Public Power to Private, Nonprofit, and Charitable Corporations, 56 AM. U. L. REV. 455, 475-76 (2007);
383. Alex Forman, A Call to Restore Limitations on Unbridled Congressional Delegations: American Trucking Ass'ns v. EPA, 34 IND. L. REV. 1477, 1480 n. 19 (2001);
384. Freeman, Private Role, supra note 11, at 585 n. 168;
385. Froomkin, supra note 14, at 153-59; Gillian Metzger, Abortion, Equality, and Administrative Regulation, 56 EMORY L.J. 865, 904 n. 175 (2007).
386. See Edward Brunet, Defending Commerce's Contract Delegation of Power to ICANN, 6 J. SMALL & EMERGING BUS. L. 1, 26 (2002) (noting that Oregon courts, as well as Texas courts, have invalidated delegations of powers to private parties).
387. 952 S.W.2d. at 472.
388. 952 S.W.2d. at 472.
389. See Johnson, supra note 291, at 477-83 (noting that not all of the factors need to be present, discussing subsequent application of the test, and commenting that courts give particular weight to two factors: the absence of meaningful government oversight of the delegate's performance and the existence of conflicts of interest).
390. FDA, March 7 Proceedings, supra note 39, at 253 (presentation of Ms. Denise Love, Exec. Dir., Nat'l. Ass'n. of Health Data Orgs.).
391. Id.
392. Id.
393. Freeman, Extending Public Law Norms, supra note 15, at 1330.
394. Id.
395. 29 U.S.C. Sec. 1001 et seq.
396. See ERISA §514(a), 29 U.S.C. §1144(a) (providing for broad general ERISA preemption of state law).
397. See also ERISA §514(b), 29 U.S.C. §§1144(b)(2)(A), (B) (providing a "savings" clause that exempts certain categories of state laws, including laws regulating insurance, from ERISA preemption, but providing a "deemer" clause that has the effect of causing ERISA preemption to apply in cases involving self-insured ERISA health plans).
398. See supra note 290 and accompanying text.