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). The reader should note that, in all of these study designs, the intervention is not randomized. One area discussed is the notion of a combined National Committee on Vital and Health Statistics (NCVHS) secondary stewardship model with that of the European data directives, which might guard against data misuse while addressing the growing need for access to patient clinical information by supporting strong obligations for data stewards. N.H. Rev. Specialists vs. Farber. interoperability (e.g., a standardized export format) increases, the importance of this issue should diminish. Rural Telephone Service Co., Inc., 1991). 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. 10 The bank’s description of objects and activities as “goods” reflects its economic approach to human health, in which market demand and supply affect healthcare … 1141. (2) That medical services are an ordinary commodity. in Law and Bioethics, Eds. Of course, property and IP debates are not new to the scientific community, as evidenced by the worldwide literature on gene patenting and attempts to balance research incentives and public goods arguments (Caulfield et al., 2006; ORNL, 2008). For example, New Jersey law requires: “No person shall obtain genetic information from an individual, or from an individual’s DNA sample, without first obtaining informed consent from the individual…. Delivering health care at a retail clinic isn’t something to be proud of, How MOC is contributing to the demise of physicians. Washington, DC: The National Academies Press. Rural Telephone Service Co., Inc. 1991. In short, a variety of reasons for behaviors cannot be observed in the claims data and can only be gathered from the patient. State malpractice principles weigh in on some questions about the sufficiency of records (Thomas vs. United States, 1987), while the emerging tort of spoliation of evidence increasingly deters alteration or destruction of records (Pikey vs. Bryant, 2006; Rosenblit vs. Zimmerman, 2001). When the GAO pushed back, ONCHIT agreed that an “overall approach” was required and instituted further study.20 Yet, in its February 2008 report on nationwide HIT implementation by the HHS, the GAO noted, “Our recommendation for protecting health information has not yet been implemented” (GAO, 2008). Such an approach is potentially a way to address the possible concerns of data contributors. The classic example of a public good is a lighthouse. Data do not have to be deidentified when used in healthcare operations (e.g., intraentity quality improvement research), 45 C.F.R. Medical services are not an ordinary commodity but more like a “public good” which should be financed using a regulated public utility model. http://www.ncsl.org/programs/health/genetics/ndiscrim.htm (accessed August 20, 2008). The Microchip Consent Act of 2008. vs. MacLean Hunter Mkt. 4 Healthcare Data: Public Good or Private Property? 2007. New Hampshire Business Review. More simply, my use of the public good does not diminish, or even affect, the amount available for everyone else. Although not sufficiently granular for our current purposes, the European Union data directive suggests a data protection model that imposes far more powerful obligations on data stewards and “chain of trust” data. A simplistic data protection model would simply outlaw some or all of these uses, but thereby deny patients the benefits of appropriate uses and resulting research. Rather than trying to pool everything in one massive file, these large subsets of data could be kept as separate nodes in a distributed network. For example, when patients are found to be switching medications, it. Poll, 1991; Valley Med. 23, 2009). Thus we can say that those contemporary proposed solutions for health reform which mandate (subsidized) buying into the fragmented commercial health insurance based system are likely to be intolerably expensive, economically inefficient, and, in the end, not solutions to the problem. In terms of the trade-offs between a pooled mega-database and pulling data from different data aggregators, the need is growing for a mega-database that would pull data from different health plans, the Department of Veterans Affairs, Medicare, and so forth. United States House of Representatives. 2003a. ———. 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 (accessed August 20, 2008). Ideology is a powerful force in our highly partisan political environment. Ann. Intercontinental Exchange, Inc., 2007). Going by the economic definition of public good, no. Public goods have two main aspects. 421-72 (2007) and H.B. Health Corp. vs. Rowe, 2007). However, private entities also collect and analyze clinical data, often at great expense; place a proprietary value on clinical data; and protect these data as their own intellectual property. Because the entrepreneur cannot charge a fee […] world cost data from other sources. Finally, the HIPAA model shows little respect for its own red–green zone boundaries because it features broad exceptions (e.g., public health, judicial, and regulatory) to its protective model that do not require patient consent to data processing and that are susceptible to “function creep” (HHS, 2002e). 2004. With regard to data protection, the clinical data as a public good question requires a threshold issue to be addressed. I will start with rather esoteric, highly abstract observations, then make the argument that theory actually provides practical guidance in the development of policy and action. In Moore, the Supreme Court of California held that a leukemia patient did not have a property-based interest in his removed tissue from which the defendant established a potentially profitable cell line. To see why this is, let us look at the definition of public goods. In such cases, the goods would be referred to as non-pure or quasi-public goods; for example, in the case of a motorway, various methods could be used, such as electronic tagging or toll-gates, to make users pay ( an impossibility with a pure public good), so excludabilty would be possible; and, if the motorway were to become sufficiently congested, non-rivalry would not be present i.e. Arguably, the position on ownership of records is slightly more complicated. South Dakota. July 2007: 54. http://www.mlo-online.com/articles/0707/0707liab&lab.pdf (accessed February 23, 2010). 940. http://www.legis.state.ga.us/legis/2007_08/pdf/hb940.pdf (accessed February 24, 2010). 3d Dist.). 1. Legislation around retention of medical records. All rights reserved. Show this book's table of contents, where you can jump to any chapter by name. 3d). Eventually beaches become crowded as do parks and other leisure facilities. As is the case with health privacy, much of this activity in the states is a function of Congress’s apparent inability to pass comprehensive legislation dealing with the issues.11, Recent legislation in New Hampshire (N.H. Rev. Equally clearly healthcare is … Uses and Disclosures for which an authorization is required. Fla. Stat. Some EMR technology providers (the owners of the enabling software platform) may retain proprietary rights in that technology and so to an extent the records built on that platform (Harty-Golder, 2007). ———. Americans are very accepting of some public goods, i.e. A quasi public corporation, sometimes referred to as a public service corporation, is a private corporation that is backed by a government agency that has a public requirement to provide certain services. 45 C.F.R. Thomas vs. United States. 45 C.F.R. Both Einstein’s theory of mass-energy equivalence and the double-helix nature and structure of the DNA molecule are examples of public goods. 1987. Decided June 13, 1991. 194 Ariz. 363, 982 P.2d 1277. The critical feature of patent law is that in order to get a patent, one must reveal the science and practice that led to the patent. Stat., 2008) or their retention (La. marching with medicine but in the rear and limping a little” (Windeyer, 1970). Consider, for example, that there is no such thing as a hospitalization in a claims database—all you have is many events happening in the hospital. This paper identifies the major clusters of legal rules that create barriers to clinical data morphing into a public good: property or inalienability rules, federal–state disconnects, and evolving data protection models. HHS (Department of Health and Human Services). Public and quasi-public goods are purchased through government, by group, or collective, choice. Into this real or perceived vacuum, some states are floating their own “carrots” and “sticks” designed to provide new impetus toward HIE projects. § 1030 et seq. L. 91 (2007). To the befuddlement of “real” scientists, lawyers seems to spend less time providing efficient “yes/no” answers, and far more billable time delivering annoyingly inefficient “maybe” responses (Solum, 1987).1 Consider some of the real or perceived barriers to HIT and how many physicians have been discouraged from improving access to care by using telemedicine because of uncertainties about the impact of state licensure laws, the standard of care, or the application of malpractice insurance (Terry, 2004). § 318:47-f. Nieves vs. Chassin. Sometimes they also measure correspondence with practice guidelines. Beyond the laying of a conceptual foundation, however, there is as yet no measurable increase in HIT or EHR adoption.” Dealing with the specifics of the Administration’s proposed National Health Information Network (NHIN), the Foundation concluded, “[t]hough it represents a worthy goal, the NHIN is impractical and cannot be implemented” (Fried, 2008). Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. This paper will review the classic definition of a public good and discuss how that definition applies to healthcare information under varying circumstances. Some countries also treat social services–such as healthcare and public education–as a type of public good. The state created two new quasi-publics this year — the Paid Family and Medical Leave Insurance Authority and the Connecticut Municipal Redevelopment Authority — and Mounds said the administration did not want another new agency to be put in a similar situation to the port authority. No money should be made in an efficient market from the sale of that product. In practice, however, related protections under the law of trade secrets may be more important. This means that if any is made, all enjoy that amount. Public goods have two distinct aspects: nonexcludability and nonrivalrous consumption. A quasi-public corporation is a type of private company that is backed by a branch of government with a public mandate to provide a given service. you using it doesn't make it worse for someone else). 2007. In addition, there are a variety of government databases, including state Medicaid files (Medicaid Statistical Information System [MSIS] and State Medical Research Files [SMRF]) and the Medicare. Research Inst., Inc., 264 F. Supp. First, in this debate the legal system is neither a spectator nor an independent actor. Tenn. Code Ann. University of Illinois Law Review 681:707–708. 583, Chapter 759; Mich. Comp. NIH and NSF are examples of those. Prohibiting the sale or use of prescriber-identifiable prescription data for commercial or marketing purposes absent prescriber consent. Human genome project information: Genetics and patenting. § 14-6-2. When that happens, socially optimal rates of production or patterns of distribution are not achieved. We have used patents and copyrights to do that. 766 A.2d 749 (N.J.). By enabling excludability regimes (via property or, more typically, intellectual property laws), we seek to promote a dynamic efficiency model. If your care is inadequate you may be dead or disabled or in any case set back and it is heroic to seize the opportunity to identify and ‘consume’ alternative services. police and fire departments, national military forces, the GPS system, water distribution and sewage treatment plants, education, radio frequencies and the internet. 1983. Jacqueline Lipton has argued more broadly that proprietary rights in “information property,” while necessary to provide incentives and protect private property, must be balanced by broad new duties placed on rights holders, such as obligations of accuracy, confidentiality, and “an obligation to facilitate scientific, technical, and educational uses of information.”16 Agreement on how to operationalize such an approach has been elusive. 10 The bank’s description of objects and activities as “goods” reflects its economic approach to human health, in which market demand and supply affect healthcare provision. The federal government, actuarial consulting firms, academic researchers, and pharma are among those who license commercial U.S. research databases. 45 C.F.R. ———. The commercial market model is a failing economic and public policy ideology used to rationalize and justify corporate control of the health care system to profit from the enterprise. 2002d. One of the goals of Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good was to evaluate the nature of goods, both public and private, in the healthcare data marketplace and to propose concepts, opportunities, and guidance for improving access to and sharing of medical data. These data elements are linked together via a unique member ID. Public goods have “externalities,” that is, value that accrues to people who benefit by other’s consumption of them without paying for it themselves. The NCVHS also recommended that “HHS should work with other federal agencies and the Congress … for more inclusive, federal privacy legislation so that all individuals and organizations that use and disclose individually identifiable health information are covered by the data stewardship principles inherent in such legislation, including a range of organizations not currently covered by HIPAA” (NCVHS, 2007). Clearly this has externalities. It is easy to underestimate what a big job that is. In the years that followed, innumerable critical questions have been raised about the HIPAA codes, primarily regarding the costs (to data custodians), reach, and enforcement of the privacy regulations. Where and when do markets fail? It has some of the characteristics of a public good especially when it becomes rival in consumption at times of peak demand. My focus here is on the linkage of drug data with medical claims because those sources provide the most comprehensive view of drug treatment or treatment of a patient, whether it is with a procedure or with a pharmaceutical, and then capture all the other healthcare uses of those patients. Other state legislation operates on the periphery of HIPAA. Records property of hospitals—Access—Not Public—Funding for medical record requests. I am a critical care physician. 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). Reports, 1994; Harper & Row, Publishers, Inc. vs. Nation Enterprises, 1985). I will have 10 per cent more time to see sick people. These ideals reflect patient expectations on how their data are processed and information they require before permitting unexpected uses. 532 F.Supp.2d 153 (D. Ensuring the Privacy and Confidentiality of Electronic Health Records. http://www.gao.gov/new.items/d07988t.pdf (accessed August 20, 2008). The NCVHS has noted that some data custodians erroneously believe they have satisfied the. The theory of special and general relativity and the structure of molecules of DNA are nonrival because, no matter how often the research results are used, their value remains and they are available for general use. Many of those doctors will perceive HIE as inconsistent with their professional standards of confidentiality or as creating liability “traps,” and either refuse to participate or, if given no choice, reduce or distort their charting (Terry and Francis, 2007). Obtaining pretest measurements for both the intervention and control groups allows one to assess the initial comparability of the groups. However, HIPAA grants quasi-property interests to patients in their records by recognizing rights of access (CMS, 2003a) and modification (CMS, 2003b). Evidence and anecdotes: An analysis of human gene patenting controversies. ———. Quasi Public Goods. That is, they are fundamentally nonexcludable. 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. Health plans are also very concerned about protecting patient confidentiality. The potential to support evidence-based medicine through the wide variety of prescription drug and medical databases continues to grow because these data can offer greater insight into the practices of care delivery and safety surveillance. A few seek to go considerably further. Michael Jackson dead from propofol, is Dr. Conrad Murray solely to blame? Terry, N. P. 2004. The observations that follow are made on the assumption that theory still matters. Stat., 2009) and practices endorsed by the American Medical Association (AMA, 1983) confirm this position. § 101. Terry, N. P., and L. P. Francis. As discussed below, these tendencies toward indeterminacy are exacerbated by the relationship between federal and state regulatory and statutory models. Randomization enables reliable statistical inferences about cause and effect to be drawn for the patient population in the trial. ———. 158 F.3d 693 (2nd Cir. 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). Security & Privacy. § 164.504. http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.504.pdf (accessed February 24, 2010). Overall, it is tempting to recall a well-known phrase coined by an Australian judge discussing the interaction of law and medicine: “Law. 1995. In my opinion the only real solution is a government run, universal care, single-payer, public utility type financing of medical services. The real-world, large clinical databases have an aspect of a quasi-public good because they are not pure public goods in any sense. Access to all of those things is part of what enables everyone to become a full member of society. Any time patient-level data (even though they are deidentified) are made available to third parties, the potential exists for reidentification of a patient either intentionally or by accident. Additionally, at certain times, making data available to the public is inefficient. Therefore there will be social inefficiency. What are Quasi-Public Goods? These data create opportunities for private gain. 2007). Part 164. 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 (accessed February 24, 2010). Finally, data aggregators who have invested tremendous amounts of money in creating their databases will be hesitant to turn them over to a pooled database unless they have a commercial incentive that enables them to recoup the value of the investments they have made in constructing these databases. Private producers have no incentive to provide public goods because. The legislation sought to encourage, by creating private incentives, the use of publicly developed information. When markets fail it means they have ceased to be efficient at determining or recognizing the value of a good or service. Health care is a private good, not a public good. Under our insurance system, the patient is rarely the consumer. The principal questions for this discussion concern what to do with privately maintained databases that have private costs and value: databases, in other words, that given parties will neither construct nor share out of altruism, but for which large externalities exist. These economic concepts provide an important insight into why the last 40 years have failed to provide adequate medical services through a commercial market. NCVHS (National Committee on Vital and Health Statistics). Non-excludable means the ability to separate those who pay for the good from those who do not. 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. It could be a positive or a negative effect. 1998. Theory is of practical importance because it strongly affects the political thinking of key actors, whether they are aware of this effect or not. Kevin Thus, policy makers and legislators dealing with HIT and HIE issues must be better informed of the technologies and future technologies they seek to regulate to better reduce indeterminacies, and unintended consequences. Markets can also fail in the cases of pure public goods and quasi-public goods. Uses and disclosures for which consent, or authorization, or opportunity to agree or object is not required. Notwithstanding this unfriendly reception, Maryland introduced H.B. Genetics and health insurance state anti-discrimination laws. Scientific knowledge as a global public good: Contributions to innovation and the economy. Public Goods: Examples The classical definition of a public good is one that is non‐excludable and non‐rivalrous. Between these extreme groupings, patient trust about research must be earned through transparency. Co. 1998. Definition of a public good is one that is both non-excludable (i.e. National Review of Genetics 2:392–396. Harty-Golder, B. The role of scientific and technical data and information in the public domain: New legal approaches in the private sector. Responses by the research and education communities in preserving the public domain and promoting open access. N.M. Stat. Data aggregation is further complicated when you start thinking about pooling across different data sources. § 10:5-45 (a)(5). Furthermore, the Bayh-Dole Act changed the rules of the game for patent rights flowing from government-funded research.19 More recently, the GAO, in examining contracting issues with. The second is to have the government produce the good in question. you can't stop people from using it) and non-rivalrous (i.e. When a person gets sick he or she functions poorly as a consumer. Knowledge concerning research related to a particular drug or device can be appropriated up to a point. 681-735. deidentification safe harbor with anonymity or pseudoanonymity. La. Definitions. HIPAA’s data protection regulation is technically complex and obstinately opaque. In The role of scientific and technical data and information in the public domain: New legal approaches in the private sector. For example, for many years CMS has funded the development of state Medicaid databases (tape-to-tape, MSIS, and SMRF) that combine longitudinal deidentified data on beneficiary enrollment, medical claims, and drug claims. 2008. These are a little more relevant to our discussion of healthcare data. Journal of the American Medical Information Association 14(6):706–712. Differences on degrees of support may vary in terms of the inherent value of their basic research, but few argue that markets could achieve what these agencies do. Both are the products of fundamental research. Health care at risk: A critique of the consumer-driven movement. 2000. What defines a public good is whether it is non-excludable and non-rivalrous. Roche PA, Annas GJ. 415 So. Recent state initiatives (few of which have met with legislative approval) have included the funding of a pilot program for clinical data sharing (West Virginia, 2008a), mandating the use of EMRs (Indiana, 2008), prohibiting providers from buying EMRs. AMA to set guidelines on control of record data. Terms of Use | Disclaimer | Privacy Policy | DMCA Policy | All Content © KevinMD, LLC, ✓ Join 150,000+ subscribers ✓ Get KevinMD's most popular stories, Situs inversus, and the difficulty of operating on patients with reversed anatomy. Nicolas Terry, Chester A. Myers Professor of Law and codirector of the Center for Health Law Studies at Saint Louis University School of Law, provides an overview of legal rules and regulations that preclude effective data sharing and aggregation. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion704.shtml (accessed February 3, 2010). That is, HIPAA does not limit or regulate collection of data. A lighthouse is: Non‐excludable because it’s not possible to exclude some ships from enjoying the benefits of Real-world observational studies allow us to see what transpires in actual clinical practice. HIPAA only applies to identified clinical data (HHS, 2002a). 216, 218. The data runs and bytes of information are there whether used or not. In a representative democracy that means voting for the candidate whose priorities for spending most closely match your own. ———. N.M. Stat. Regensdorfer vs. Orange Regional Medical Center. The Feist court famously held that “‘Original,’ as the term is used in copyright, means only that the work was independently created by the author (as opposed to copied from other works), and that it possesses at least some minimal degree of creativity” (Feist Publications, Inc. vs.