The first set of issues is somewhat process oriented. Inc. vs. Chinatown Today Pub. This ideology concerns first and foremost the role of markets in our polity, and assumptions about what markets do well and do not do well. The basic problem is that some goods have special characteristics which make it difficult for firms to make money by trying to produce and sell the goods. These rationales apply to situations in which government has supported—through financial or other means—the development of the data in question or in which making the data publicly available has major benefits (i.e., positive externalities) that are not captured in normal market transactions. Therefore there is no incentive for people to pay for the good because they can consume it without paying for it. Arguably, the position on ownership of records is slightly more complicated. reason is that if a good is nonrival and nonexcludable, then leaving its provision to private individuals may result in less than the socially ideal outcome. The paper concludes with some observations on approaches to resolving the current excludability rules and, somewhat counterintuitively, argues that a more rigorous data protection model will be required as a prerequisite for greater access to patient data. In its June 2007 report on HIT and privacy, the GAO recommended that “The Secretary … define and implement an overall approach for protecting health information” (GAO, 2007). 2007. Register for a free account to start saving and receiving special member only perks. H.B. Organizations might be willing to sell clinical information, but are probably not sharing information for free. 3d Dist.). Legislation around retention of medical records. Equally clearly healthcare is … Moore vs. Regents University of California. ORNL (Oak Ridge National Laboratory). What’s Wrong with Health Privacy? 2008a. In practice, however, the fragmentation of paper records across innumerable data silos provided the greatest protection. Terry, Nicolas, 2008. Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories. Private producers have no incentive to provide public goods because. combine all consumer demand curves horizontally . Reports, 1994; Harper & Row, Publishers, Inc. vs. Nation Enterprises, 1985). once produced, it will not be possible to exclude those who do not pay for the good. marching with medicine but in the rear and limping a little” (Windeyer, 1970). Similarly, there is no requirement that patients must opt in or may opt out regarding the collection of certain types of data (e.g., psychiatric or gynecological records). GAO (Government Accountability Office). Access to all of those things is part of what enables everyone to become a full member of society. There are also cases where goods may be nonrival, but not nonexcludable, or perhaps nonexcludable, but not nonrival. ———. how to find marginal social benefit curve for a private good. 1991. Patient acceptance of some secondary uses will be more likely secured with strict limitations on commercial uses (a larger red zone). 2008. Such an approach is potentially a way to address the possible concerns of data contributors. Similar issues arise in the pooling of medical records data across multiple sources when these sources use different medical record systems. 453 N.Y.S.2d 836, 836–37 (N.Y. App. "Public goods" is a cause of market failure. However, HIPAA grants quasi-property interests to patients in their records by recognizing rights of access (CMS, 2003a) and modification (CMS, 2003b). 2003b. The largest market for these commercially licensed databases undoubtedly is pharma, which uses the data for a variety of purposes, including outcomes research, safety monitoring, tracking market trends, and many others. The national probabilistic surveys and, to a lesser extent, the disease registries are probably the only types of data in our list that are collected specifically for research purposes. This is extraordinarily rich information in one sense; in a health plan context, it captures every interaction with the healthcare sector reimbursed by the patient’s insurance—every procedure and date of service, diagnosis, prescription drug filled, use of the emergency room or hospital, and so forth. Perhaps predictive of a future public goods regime for clinical data, the NIH has addressed the nature of the results of funded research with a policy addressing data sharing (NIH, 2003) and has required the public availability of manuscripts prepared by funded investigators (NIH, 2008). Where and when do markets fail? For example, a recently defeated New Hampshire bill (House kills medical privacy bill, 2008) would have increased data protection considerably beyond HIPAA protection standards by restricting data use to the point of care, thereby potentially outlawing many marketing and research uses (Guay, 2008; U.S. House of Representatives, 2008). The state of health information technology in California: Consumer perspective. http://www.law.cornell.edu/uscode/18/1030.html (accessed February 4, 2010). them into something useful. L. Rev. 2007. 2009. Miller, R. H., and B. S. Miller. Only 4 percent of respondents would deny all use, 32 percent would require consent for each use, 29 percent would be satisfied with a broad notification model, and 24 percent wanted notification and opt-out processes (Willison et al., 2007; Woolley and Propst, 2005). Caulfield, T., R. M. Cook-Deegan, F. S. Kieff, and J. P. Walsh. From the standpoint of payers, one issue from a health economics standpoint is establishing the value of pharmaceutical treatments and other interventions. This is also true with respect to medical records in certain settings (staff model health maintenance organizations), and not necessarily true in other settings (e.g., specialized oncology or cardiovascular clinics). Current patient expectations likely are limited to point-of-care and continuum-of-care uses. Clearly healthcare is a good. cal Center, 2005; Waldron vs. Ball Corp., 1994). example of quasi public good. Dept.).Dept.). Roche PA, Annas GJ. Perhaps the greatest flaw of the HIPAA data protection model is how quickly it has been rendered wanting by new technologies. The court reasoned that the extension of the conversion tort, by which such interests may be protected, would potentially “punish innocent parties” (downstream researchers) or “create disincentives to the conduct of socially beneficial research.”5 However, another reason for the conclusion flowed from the same court’s recognition of causes of action for breach of fiduciary duty or lack of informed consent that could provide remedies against the physician. Looked at from an economic and a public policy perspective, health services are the epitome of a “public good.” This is what is meant by the phrase “Health Care is A Human Right!” Hospitals, ambulance systems, mosquito control, TB control, restaurant inspections, sanitation, and vaccines are all good examples. Here’s why. Feist Publications, Inc. vs. 2003. 72 Ohio App. N.Y.). 4 min read. That is why the National Institutes of Health (NIH) and the National Science Foundation (NSF) are not controversial public programs. 42 C.F.R. Equally clearly healthcare is rivalrous and excludable–that’s what we’re arguing about. See Joint Commission on Accreditation of Healthcare Organizations, IM.6.10: “The medical record contains sufficient information to identify the patient; support the diagnosis/condition; justify the care, treatment, and services; document the course and results of care, treatment, and services; and promote continuity of care among providers.”. Ann. These economic concepts provide an important insight into why the last 40 years have failed to provide adequate medical services through a commercial market. It will consider why these databases are initially constructed, the implications this has for their use as research tools, and their commercial applications. June 18, 2007. http://janus.state.me.us/legis/LawMakerWeb/summary.asp?ID=280022219. See generally David E. Shipley, Thin but Not Anorexic: Copyright Protection for Compilations and Other Fact Works, 15 J. Intell. police and fire departments, national military forces, the GPS system, water distribution and sewage treatment plants, education, radio frequencies and the internet. Americans are very accepting of some public goods, i.e. Photo: iStockphoto Is the Internet a public good? However, records data or derived clinical data may be viewed as merely factual, and copyright law does not protect facts, including medical and biographical facts (N.Y. Mercantile Exch., Inc. vs. Kaiser could exclude others from the use of their database, as could my own institution, the Partners Health System. 2008. Chester A. Myers Professor of Law, Codirector, Center for Health Law Studies. This is the equivalent of using trade secrecy for medical practice, and it is possible today. Alternatively, the patient may not like the idea of being dependent on a drug, may be concerned about side effects, or may they think the drug is not really working. It is highly unlikely that most PHR providers will be directly subject to HIPAA data protection rules, although some state privacy statutes may apply and the Federal Trade Commission could exert some general control over PHR providers that promulgate their own privacy policies. Because the entrepreneur cannot charge a fee […] http://www.ncvhs.hhs.gov/071221lt.pdf (accessed August 20, 2008). Windeyer, J., Mount Isa Mines vs. Pusey, 1970. Examples of what is available include the Nordic registries in Norway, Sweden, and Finland. The wealth of networks: How social production transforms markets and freedom. Presumably, the IOM or NIH could explore with data rights holders the possibility of publishing clinical data under a creative commons license that permits noncommercial research (NRC, 2003a). Click here to buy this book in print or download it as a free PDF, if available. Given the national initiatives for HIPAA transactions, privacy and security, and HIE, it should follow that the legal environment would be a cohesive federal one. Boyle, J. N.Y.). 2003a. 2007. Health generally is not considered a public good, because non-paying individuals (for health insurance, healthy food, etc.) It has some of the characteristics of a public good especially when it becomes rival in consumption at times of peak demand. First, in this debate the legal system is neither a spectator nor an independent actor. La. ———. N.H. Rev. A quasi-public good is a near-public good i.e. § 101. 2000. What does Kelly Loeffler’s health plan do to coverage for preexisting conditions? Additionally, for example, there is no prohibition. 45 C.F.R. Randomization enables reliable statistical inferences about cause and effect to be drawn for the patient population in the trial. Both are the products of fundamental research. Ann., 2005), while other state laws regulate the alteration of records (Nev. Rev. 940. http://www.legis.state.ga.us/legis/2007_08/pdf/hb940.pdf (accessed February 24, 2010). Published on: 10/3/2009. Journal of the American Medical Association 294(11):1380–1384. 2008. By . According to the survey result, Americans rate education as their number one priority during the last presidential campaign in 2000. However, because of a variety of issues about the reliability of diagnostic coding in such databases, it is desirable to have access to medical records for the patients represented in the data. It is fair to say that broad interest is coalescing around the virtues of creating a public database to support evidence-based medicine and safety research. Therefore there will be a need for the govt t… Ann. interoperability (e.g., a standardized export format) increases, the importance of this issue should diminish. Non-excludable production. Both types of information have a role. Washington State Legislation. With regard to data protection, the clinical data as a public good question requires a threshold issue to be addressed. William Crown, president of i3 Innovus, offers ideas on the elements to consider in building large, multifaceted data assets. 2007. 2005. Roche PA, Annas GJ. 2007. 2d 1064 (S.D. ...or use these buttons to go back to the previous chapter or skip to the next one. Thus, there are no controls over what or how much data can be collected, for example, by reference to a proportionality rule. There are two regulatory “walls” between the green zone and the “red” zone in which patient data generally should not circulate. Besides this personal cost, it also leads to external costs as the taxpayer may have to pay for the drunkard consumer’s healthcare as a result. Health plans are also very concerned about protecting patient confidentiality. The classic example of a public good is a lighthouse. Similarly, CMS has historically built linked inpatient and outpatient claims datasets for the entire Medicare population and made a 5 percent sample of these files available to researchers. Human genome project information: Genetics and patenting. Quasi public goods. The scientific method in itself requires broad dissemination of results to confirm their validity, and once disseminated, their use can’t be restricted. MyNAP members SAVE 10% off online. http://www.chcf.org/documents/chronicdisease/HITConsumerSnapshot08.pdf (accessed August 20, 2008). Furthermore, it would have been virtually impossible for these findings to have had any value if they were not widely shared. This sense of uncertainty or indeterminacy is increased by the legion of “legacy laws,” such as records laws predating electronic clinical data collection and the potential for data mining of records to improve outcomes and effectiveness. By definition “public goods” are not well distributed by market mechanisms. By Sintia Radu , Staff Writer Jan. 21, 2020 By Sintia Radu , … And the bigger the insurance pool is, the better it functions economically. 6241. http://apps.leg.wa.gov/billinfo/summary.aspx?year=2008&bill=6241 (accessed February 24, 2009). Ready to take your reading offline? DNA Testing, Banking, and Genetic Privacy, 2:392-396; N Engl J Med 355; Aug. 10, 2006. Einstein did not just dream up his theory in isolation—he validated it by sharing it broadly within the community of physics to allow it to be critiqued. NIH and NSF are examples of those. In the current health care debate, many have asked if it would be wise for us to … The federal government, actuarial consulting firms, academic researchers, and pharma are among those who license commercial U.S. research databases. 2401. http://www.whitehouse.gov/infocus/technology/economic_policy200404/chap3.html (accessed August 20, 2004). | August 24, 2009. United States Court of Appeals, Second Circuit. § 1711-E. http://www.mainelegislature.org/legis/bills/bills_123rd/billpdfs/HP000502.pdf (accessed February 24, 2010). A patient may discontinue an antihypertensive drug because he or she feels no direct physical evidence showing the drug is effective in lowering blood pressure. 3d). Traditional intellectual property systems protect inventors or authors with a term-limited monopoly when they market their expressions or inventions. Markets can also fail in the cases of pure public goods and quasi-public goods. Obtaining pretest measurements for both the intervention and control groups allows one to assess the initial comparability of the groups. 2002e. At least in the latter case, we observe real-world outcomes in actual patient populations using the drug. It might be a case in which my contract with you has an effect on somebody else in this room who is not a party to that contract. These data create opportunities for private gain. If information is to be treated in any respect as a public good, it will be necessary to keep in mind that nonmarket mechanisms have a role in its management and distribution. 3 Changing the Terms: Data System Transformation in Progress, 5 Healthcare Data as a Public Good: Privacy and Security, The National Academies of Sciences, Engineering, and Medicine, Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good: Workshop Summary, http://www.hhs.gov/healthit/certification/stark/, http://healthit.ahrq.gov/portal/server.pt?open=514&objID=5554&mode=2&holderDisplayURL=http://prodportallb.ahrq.gov:7087/publishedcontent/publish/communities/k_o/knowledge_library/features_archive/features/impact_analysis_of_the_privacy_and_security_solutions_for_interoperable_health_information_exchange_project.html, http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion704.shtml, http://www.chcf.org/documents/chronicdisease/HITConsumerSnapshot08.pdf, http://edocket.access.gpo.gov/cfr_2003/octqtr/pdf/45cfr164.524.pdf, http://edocket.access.gpo.gov/cfr_2003/octqtr/pdf/45cfr164.526.pdf, http://edocket.access.gpo.gov/cfr_2007/octqtr/pdf/pdf/42cfr482.24.pdf, http://www.econlib.org/library/Enc/PublicGoodsandExternalities.html, http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=Ch0456/Sec057.HTM, http://www.chcf.org/documents/chronicdisease/GaugingTheProgressOfTheNationalHITInitiative.pdf, http://www.legis.state.ga.us/legis/2007_08/pdf/hb940.pdf, http://fosters.com/apps/pbcs.dll/article?AID=/20080210/GJNEWS01/67136800, http://www.mlo-online.com/articles/0707/0707liab&lab.pdf, http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=d63854405945c9ab56b93612fcc5e089&rgn=div5&view=text&node=45:1.0.1.3.71&idno=45, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.514.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.504.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.508.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr160.103.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.512.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.104.pdf, http://www.whitehouse.gov/infocus/technology/economic_policy200404/chap3.html, http://www.mainelegislature.org/legis/bills/bills_123rd/billpdfs/HP000502.pdf, http://janus.state.me.us/legis/LawMakerWeb/summary.asp?ID=280022219, http://www.ncsl.org/programs/health/genetics/ndishlth.htm, http://www.ncsl.org/programs/health/genetics/ndislife.htm, http://www.ncsl.org/programs/health/genetics/ndiscrim.htm, http://leg.state.nv.us/NRS/NRS-630.html#NRS630Sec3062, http://grants.nih.gov/grants/policy/data_sharing/, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html, http://www.nmmb.state.nm.us/pdffiles/MedicalPracticeAct.pdf, http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml, http://www.law.cornell.edu/uscode/18/1030.html, http://www.gencourt.state.nh.us/legislation/2008/HB1587.html, http://apps.leg.wa.gov/billinfo/summary.aspx?year=2008&bill=6241, http://legisweb.state.wy.us/statutes/statutes.aspx?file=titles/Title33/T33CH26.htm, 1 Clinical Data as the Basic Staple of the Learning Health System, 2 U.S. Healthcare Data Today: Current State of Play.