2006. 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. The scientific method in itself requires broad dissemination of results to confirm their validity, and once disseminated, their use can’t be restricted. 583, Chapter 759; Mich. Comp. DNA Testing, Banking, and Genetic Privacy, 2:392-396; N Engl J Med 355; Aug. 10, 2006. The New York Times. In effect, the marginal cost of nonrival goods use is zero, and therefore an efficient market should price the marginal use of that good at zero. Windeyer, J., Mount Isa Mines vs. Pusey, 1970. This is the equivalent of using trade secrecy for medical practice, and it is possible today. For example, an individual’s use of an aircraft carrier for protection does not exclude general use of it, nor does it diminish the value to others. 2005. 6 Creating a Next-Generation Data Utility: Building Blocks and the Action Agenda, 8 Clinical Data as the Basic Staple of Health Learning: Ideas for Action, Appendix B: Biographical Sketches of Workshop Participants, Appendix D: The IOM Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule, Other Publications in the Learning Healthcare System Series. H.B. Semi-non-rival: up to a point, more consumers using a park, beach or road do not reduce the space available for others. § 164.104(a). Legislation around retention of medical records. 2d 1064 (S.D. 2004. Currently, only 2 percent of the population uses PHRs (California HealthCare Foundation, 2008). Some countries also treat social services–such as healthcare and public education–as a type of public good. 945 F.2d 509 (2nd Cir. In a local market, it is true that people compete with others on a new treatment for diabetes or coronary artery disease; however, someone in Singapore probably could not compete with me, and there might be enormous gains to sharing the knowledge with people in Singapore. Medical Laboratory Observer. Although voluminous for their service types, the large inpatient databases such as HCUP and the NIS, as well as the prescription drug databases from organizations such as IMS and Wolters-Kluwer, typically are not linked to other data types such as outpatient medical claims. See generally Nicolas P. Terry, Under-Regulated Healthcare Phenomena in a Flat World: Medical Tourism and Outsourcing, 29 W. N. Eng. The social benefit of a given level of a public good is the vertical sum of all private benefits for that level. The data runs and bytes of information are there whether used or not. common goods (eg, universal healthcare), and public goods (eg, public information or pandemic preparedness) (fig 1). Thus, it has been stated, “a compilation of preexisting facts … can still meet the constitutional minimum for copyright protection if it features original selection, coordination or arrangement of those facts” (Victor Lalli Enterprises, Inc. vs. Big Red Apple, Inc., 1991).6. For example, although health plans generally have an interest from a public health standpoint in contributing their data to a pooled database, they may have concerns about the potential to inadvertently provide their competitors with information on charges and payments for different types of services, benefit design, and more. Electronic aggregation of records, powerful data-mining technologies, and a growing market for secondary uses have exponentially increased the negative externalities faced by data subjects (Terry, 2008). If trust and transparency are the ideals in structuring a data protection model for medical data, what should follow? Health plans are also very concerned about protecting patient confidentiality. However, … 2008c. Americans are very accepting of some public goods, i.e. ———. Terry, N. P. 2004. of Regents, 1982). § 10:5-45 (a)(5). Because the entrepreneur cannot charge a fee […] 45 C.F.R. The stewards of clinical data (again, in part motivated by data protection laws) likely will protect their data with security and related rights management systems. ———. quasi public good. Pre-HIT protection for medical records was formally achieved with a patchwork of state statutory and common-law rules. Prescriptions sans Frontières (or How I Stopped Worrying about Viagra on the Web but Grew Concerned about the Future of Healthcare Delivery), 4 Yale JHPLE 183. That makes scientific progress based on protected information possible, while individuals enjoy economic fruits of innovation. 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. Therefore, in effect, a way must be found to realize these benefits without losing the incentive to put the database together. N.M. Stat. Sandra H. Johnson, Ana S. Iltis, and Barbara A. Hinze (NY: Routledge, 2008), 68-94. This is particularly the case given that so many of the new products emerging from clinical development programs now are biologics, with very high price points, 10, 20, 30, or even 100 times the price of existing conventional pharmaceuticals. 2005. Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text. To see why this is, let us look at the definition of public goods. ———. Furthermore, HIPAA does not place any restrictions on secondary uses of data, other than simple patient consent that is mainly oblivious to the informational and bargaining asymmetries between the parties (HHS, 2002c). The guarantee of transparency to the patient when data are applied for research is another theme of the Roundtable. 2002d. It will consider why these databases are initially constructed, the implications this has for their use as research tools, and their commercial applications. Health care at risk: A critique of the consumer-driven movement. Scientific knowledge as a global public good: Contributions to innovation and the economy. 2006. 4 Healthcare Data: Public Good or Private Property? 2003b. Stat. 23, 2009). Micro Chem., Inc. vs. Lextron, Inc. 2003. Conceptually, the simplest way to accomplish deduplication is to pool the data. 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. The discussion thus far has focused on deidentified databases. Here’s why. 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. The observations that follow are made on the assumption that theory still matters. Instead, they require a sober appreciation by all stakeholders in the clinical data space that they must support fundamental reforms. 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.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion704.shtml (accessed February 3, 2010). Regensdorfer vs. Orange Regional Medical Center. By . Wyo. To obtain exclusivity, the monopoly that is granted by the government requires making public the. 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. After putting all this effort into creating these databases, it is not surprising that claims aggregators commonly create deidentified research databases that they then license to third parties. In conclusion, in the context of data protection and ownership, and patient expectations, it follows that there are two broad sets of legal barriers to a public goods future for clinical data. Information properties in data and an inability to agree on an effective data protection model create immensely difficult barriers. 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. Genetics and life, disability and long-term care insurance. In practice, decisions are made on a case-by-case basis.”. combine all consumer demand curves horizontally . In my opinion the only real solution is a government run, universal care, single-payer, public utility type financing of medical services. Health information technology: Efforts continue but comprehensive privacy approach needed for national strategy, GAO-07-988t. All rights reserved. Share: Share on Facebook Share on Twitter Share on Linkedin Share on Google Share by email. This mixed legal basis carries over to the question of property rights in clinical data. 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. These ideals reflect patient expectations on how their data are processed and information they require before permitting unexpected uses. it has many but not all the characteristics of a public good. Updated: 05 Jan 2016, 11:17 PM IST Rohit Prasad. http://www.ncsl.org/programs/health/genetics/ndislife.htm (accessed August 20, 2008). Health record privacy rules may get tighter, Foster’s Daily Democrat. Into this real or perceived vacuum, some states are floating their own “carrots” and “sticks” designed to provide new impetus toward HIE projects. That is a big challenge. § 160.103. http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr160.103.pdf (accessed February 24, 2010). Share a link to this book page on your preferred social network or via email. Equally clearly healthcare is … As these initiatives continue and state data-related laws run faster and deeper than federal protections do, unraveling them and finding agreement on a federal model for data protection and sharing will become immeasurably more difficult. These are a little more relevant to our discussion of healthcare data. 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. Between these extreme groupings, patient trust about research must be earned through transparency. As a consequence, the ability to follow large cohorts of people longitudinally would provide researchers with the statistical power to detect extremely rare events that could not be detected, or certainly not in a statistically significant way, within smaller subsets of the data. 2001. Ct. App). There is probably also an increasing expectation of data access and use for personal health management (e.g., interoperability of EMR and PHR systems and any necessary processing). Claims aggregators spend literally hundreds of millions of dollars entering these data, pooling them, standardizing them, and trying to turn. FIGURE 4-1 Data availability in a large health plan. Potential methodological flaws of quasi experiments in the study of infectious diseases were identified. What is a public good? ORNL (Oak Ridge National Laboratory). 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). 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). Enhanced protections for uses of health data: A stewardship framework for “secondary uses” of electronically collected and transmitted health data. Suit has also been filed regarding the Vermont legislation. However, it is difficult to see any alternative if there is to be a long-term accommodation of patient and researcher interests. CCC Info. Revised policy on enhancing public access to archived publications resulting from NIH-funded research, NOT-OD-08-033. It takes a lot just to process the volume of claims information in such databases even when the format is similar. 2007. ” N.J. Stat. 1577, Docket 91-7155. Quasi-public goods. 203 S.W.3d 817 (Mo. § 164.524. http://edocket.access.gpo.gov/cfr_2003/octqtr/pdf/45cfr164.524.pdf (accessed February 4, 2010). 2008b. 194 Ariz. 363, 982 P.2d 1277. In fact, the government produces many examples of classic public goods without controversy. It is as likely, however, that most “owners” of records or derived clinical data will seek to protect them by keeping them private or “secret.” Indeed, the application of data protection rules, discussed below, essentially mandates “secrecy.” Looked at this way, patient records and derived clinical data are more analogous to customer lists and other business records (Unistar Corp. vs. Child, 1982). 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. With regard to data protection, the clinical data as a public good question requires a threshold issue to be addressed. As Yochai Benkler explains, we apply legal protection to information properties because of our willingness “to have some inefficient lack of access to information every day, in exchange for getting more people involved in information production over time” (Benkler, 2006). § 445.72. that lack interoperability (New Jersey, 2006), and granting providers a state tax credit to offset investments in EMRs (West Virginia, 2008b). A public good is defined as a good that is non-rivalrous and non-excludable. Arrayed against the IOM public goods goal, the current aggregation of IP and related laws and technologies maintains excludability and so denies public use; what, in a broader context, James Boyle has referred to as “the second enclosure movement” (Boyle, 2003). A “public good” is a product or service which benefits everyone in the community. Stat. Similarly, to fully understand behaviors of physicians, it is necessary to interview them. Therefore there will be a need for the govt t… Also relevant to this discussion is the existence of another type of less controversial informational public good. Trust will be further earned by permitting patient opt-out or data sequestering. Stat., 1978; Wyo. Examples include roads, tunnels and bridges. Nonetheless, with current statistical methods, we can do a lot with observational data to control for confounders. 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 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. Overall, it is tempting to recall a well-known phrase coined by an Australian judge discussing the interaction of law and medicine: “Law. Pikey vs. Bryant. An Act relative to patient health care information House Bill 1587. http://www.gencourt.state.nh.us/legislation/2008/HB1587.html (accessed August 31, 2010). … There are also quasi-public goods. 2007. 1994. Many other markets are banned in the United States on moral grounds: contract killing, sale of human organs, selling votes, illicit substances such as heroin, and sale of cigarettes to minors. The short answer is that legal indeterminacies surrounding deidentification, variations in institutional data policies and practices, and uncertainties about the contemplated “public” secondary uses place data protection front and center as a potential barrier to outcomes research. For example, Patricia Roche and George Annas have called for a comprehensive genetic privacy law that goes beyond the current model seen in state antidiscrimination laws (Roche and Annas, 2001, 2006). Reports, 1994; Harper & Row, Publishers, Inc. vs. Nation Enterprises, 1985). However, it is hard to see how a patchwork of additional protections, particularly when based on a model as flawed as HIPAA, can deliver the robust model that is a predicate to patient-supported outcomes research. One is national defense. Chester A. Myers Professor of Law, Codirector, Center for Health Law Studies. Quasi public goods. As guidance for future database developments, he characterizes the increasing demand for a data resource that draws information from multiple, diverse sources of medical data and, in turn, synthesizes those data into a tool available for a wide range of healthcare activities, including research and evidence generation. 3d Dist.). United States Code. In The role of scientific and technical data and information in the public domain: Proceedings of a symposium. Many of us think we know what a public good is, and the term is often used, but it is a term in which intuition is not a good guide. 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. In a representative democracy that means voting for the candidate whose priorities for spending most closely match your own. Feist Publications, Inc. vs. Given the growing complexity of data gathering, access, and pooling, many legal issues must be considered. Amendment of protected health information. This is going to drive a need for real-world data collection—going beyond retrospective data to collect clinical data that we typically do not have in these administrative databases to get the clinical endpoints about effectiveness. The Bayh-Dole Act of 1980 was meant to remedy underuse of results of publicly funded research when there was no way to privatize the resulting intel-. 45 C.F.R. One issue currently being considered by the Food and Drug Administration (FDA) Sentinel Network is exactly this issue—how to develop methods either with restricted databases or with IRB approval for the deduplication function to pool data across multiple sources. 2007. < Previous post Situs inversus, and the difficulty of operating on patients with reversed anatomy. 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). In general, there are two solutions to determine whether information is a quasi-public good or a public good. Kevin Pho, MD shares the stories of the many who intersect with our health care system but are rarely heard from. However, to understand them requires some initial observations regarding the legal sys-. Journal of the American Medical Association 294(11):1380–1384. On the indeterminacy crisis: Critiquing critical dogma, U. Chi. 3d). 3d 446, 594 N.E.2d 1027 (Ohio Ct. Dept.).Dept.). Medical Code of Ethics, E-704. Although patients may not own the actual paper records, they may have some ownership rights in the information contained in the records (although this position has been rejected by the High Court of Australia [Breen vs. Williams, 1996]). vs. Catalona, 490 F.3d 667 (8th Cir. In the aftermath, pharmacy data aggregators have successfully challenged such legislation in the federal courts for violation of protected commercial speech principles (IMS Health vs. Sorrell, 2007; IMS Health, Inc. vs. Ayotte, 2007; IMS. Harty-Golder, B. 216, 218. Miller, R. H., and B. S. Miller. As in the case of customer lists, patient records are often tangentially protected through contract. In short, an enormous amount of effort and considerable financial investment are required to develop large databases that pool information across multiple sources. 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. Responses by the research and education communities in preserving the public domain and promoting open access. 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. § 33-26-402(a) (xxvii) (G). Intercontinental Exchange, Inc., 2007). 45 C.F.R. 2008. The classic example of a public good is a lighthouse. 1982. Some say that in theory, there is no difference between theory and practice, but in practice there is. Quasi-public health care organization must comply with records law . public good. Genetics and health insurance state anti-discrimination laws. One of the biggest challenges is the need to deduplicate the data. The federal government, actuarial consulting firms, academic researchers, and pharma are among those who license commercial U.S. research databases. I will be able to lower my office overhead by 20 per cent. Next post > Michael Jackson dead from propofol, is Dr. Conrad Murray solely to blame? See generally National Human Genome Research Institute, Legislation on Genetic Discrimination, http://www.genome.gov/10002077#2. The basic question no longer is whether the U.S. should have universal health care insurance but what specific health care policy the country should adopt in order to strengthen the market system and to maximize social welfare as effectively as possible. Blumenthal explores how research data can have characteristics of a public good while simultaneously holding significant value and inherent costs as a private database asset. In the context of the federal NHIN project, the Bush Administration has narrowly framed the privacy–confidentiality issue, merely identifying divergent state laws as impeding implementation. 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). ———. 1978. An example of a market that has failed because of public abhorrence is the slave market. Consumption of alcohol can cause health problems for the drinker.