A seriously ill person has no price sensitivity – care is needed now and many patients will face even bankruptcy to get needed care in spite of looming bills. Testimony before the Subcommittee on Information Policy, Census, and National Archives Committee on Oversight and Government Reform, U.S. House of Representatives. § 10:5-45. Examples include roads, tunnels and bridges. Of course “[c]opyright protection … is not available for any work of the United States Government,”18 but that does not apply to most federally funded research. What does Kelly Loeffler’s health plan do to coverage for preexisting conditions? For example, some countries, including Canada, Mexico, the United Kingdom, … Part 164. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=d63854405945c9ab56b93612fcc5e089&rgn=div5&view=text&node=45:184.108.40.206.71&idno=45 (accessed February 24, 2010). 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. Testimony before the Senate Committee on the Budget: Health information technology—HHS is pursuing efforts to advance nationwide implementation, but has not yet completed a national strategy. 2007. Similarly, Watson and Crick broadly shared their findings. United States Court of Appeals, Second Circuit. You had best get the right care the first time. vs. Catalona, 490 F.3d 667 (8th Cir. Pre-HIT protection for medical records was formally achieved with a patchwork of state statutory and common-law rules. This chapter examines quasi-markets in publicly funded systems of healthcare, particularly as they have developed in the UK in the last two decades. However, the real reasons for the switching behavior may not be observable in the claims data. Prohibiting the sale or use of prescriber-identifiable prescription data for commercial or marketing purposes absent prescriber consent. 2003b. VICTOR LALLI ENTERPRISES, INC., vs. BIG RED APPLE, INC. No. 532 F.Supp.2d 153 (D. With regard to data protection, the clinical data as a public good question requires a threshold issue to be addressed. Quasi-public goods. That model seems increasingly unlikely. 2008. ———. Using regulated contracts, health insurers and providers may extend the green zone to include their “business associates” (e.g., law firms) (HHS, 2002b). Co. 1998. Washington, DC: The National Academies Press. EMR Ownership Questions. 471 U.S. 539. Institutions contributing information to a pooled database generally have a variety of concerns. To see why this is, let us look at the definition of public goods. ———. 2001. 2006). 22 M.R.S.A. 1987. Not a MyNAP member yet? Quasi-public goods - definitionQuasi-public goods have characteristics of both private and public goods, including partial excludability, partial rivalry, partial diminishability and partial rejectability. Additionally, for example, there is no prohibition. The observations that follow are made on the assumption that theory still matters. Quasi Public Goods • A quasi-public good is a near-public good. 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. From the standpoint of forecasting what is going to happen in the real world, there are at least as many dangers in the use of clinical trials data to predict real-world outcomes as there is danger in inferring cause and effect from observational data. Similar issues arise in the pooling of medical records data across multiple sources when these sources use different medical record systems. I am a critical care physician. In terms of content, the standard medical claims database includes enrollment information and pharmacy, physician, and facility claims (Figure 4-1). This is a difficult and likely unpopular agenda. Legislation around retention of medical records. Div. The AMA seems to have taken the position that their members should seek to monetize records data (O’Reilly, 2005). Kaiser could exclude others from the use of their database, as could my own institution, the Partners Health System. 1990. § 164.508. http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.508.pdf (accessed February 24, 2010). A radio broadcast . And the bigger the insurance pool is, the better it functions economically. This market was common at one time, but of course it is no longer permitted in the United States. Furthermore, most doctors provide care with little or no knowledge of the patient’s actual purchasing power, with or without insurance. The concise encyclopedia of economics: Public goods and externalities. The issue has even been raised in some tense exchanges between the GAO and ONCHIT. As in the case of customer lists, patient records are often tangentially protected through contract. There are also cases where goods may be nonrival, but not nonexcludable, or perhaps nonexcludable, but not nonrival. Stat., 2009) and practices endorsed by the American Medical Association (AMA, 1983) confirm this position. In the words of the NCVHS, “Erosion of trust in the healthcare system may occur when there is divergence between what individuals reasonably expect health data to be used for and when uses are made for other purposes without their knowledge and permission” (NCVHS, 2007). Now, the emergence of personal health record (PHR) models raise far more serious issues. No money should be made in an efficient market from the sale of that product. Examples include roads, tunnels and bridges. Probably the best known research database outside of the United States is the United Kingdom’s General Practitioner Research Database, an outpatient encounter database. Fried, B. M. 2008. 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. 1985. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Real-world observational studies allow us to see what transpires in actual clinical practice. Its basic concept, however, is quite simple—arguably too simple. In some such cases making the information available would broadly benefit society, leading to the advancement of other knowledge. And no patient will be worrying about how they will pay for their care or medicines. Again, this requires access to the PHI. The legislation sought to encourage, by creating private incentives, the use of publicly developed information. Surely Healthcare is a quasi – public good and better for the economy as a whole if given to everyone. 45 C.F.R. The NCVHS has noted that some data custodians erroneously believe they have satisfied the. Additionally, at certain times, making data available to the public is inefficient. A lighthouse is: Non‐excludable because it’s not possible to exclude some ships from enjoying the benefits of A quasi-public good is one whose production or consumption generates or might generate effects on third parties. example of quasi public good. However, a growing number also seem to apply to cases of medical identity theft, only granting providers a safe harbor when they are subject to and in compliance with HIPAA.13. State-required public filings by an incorporated health care organization do not exempt it from the state’s open records law, the New Hampshire Supreme Court ruled Tuesday. 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. Clearly healthcare is a good. 164.506. 2005. Ann. Terry, N. P. 2004. See generally National Human Genome Research Institute, Legislation on Genetic Discrimination, http://www.genome.gov/10002077#2. 2001. … However, in certain situations, such as in large health plans or physician practices, there is also the possibility to access protected health information (PHI), under Institutional Review Board (IRB) approval, to abstract medical charts and conduct surveys of the patients related to reasons for medication behaviors and health-related quality of life. Digital Millennium Copyright Act. 45 C.F.R. A public good, as defined by economists, is a service or resource that is available to all who wish to use it (Dawes, 1980). Both Einstein’s theory of mass-energy equivalence and the double-helix nature and structure of the DNA molecule are examples of public goods. In short, an enormous amount of effort and considerable financial investment are required to develop large databases that pool information across multiple sources. Applicability. There is a long tradition in the legal literature of examining this phenomenon at various levels of abstraction. were never intended for research purposes, so there are inherent pitfalls, such as falsely inferring causality or erroneous coding. 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. | 583, Chapter 759; Mich. Comp. A good is something that can be bought or sold. ...or use these buttons to go back to the previous chapter or skip to the next one. Caulfield, T., R. M. Cook-Deegan, F. S. Kieff, and J. P. Walsh. Photo: iStockphoto Is the Internet a public good? That is, they are fundamentally nonexcludable. Published on: 10/3/2009. 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. Quasi public goods are: Semi-non-rival: up to a point, extra consumers using a park, beach or road do not reduce the space available for others. You're looking at OpenBook, NAP.edu's online reading room since 1999. Also, you can type in a page number and press Enter to go directly to that page in the book. cal Center, 2005; Waldron vs. Ball Corp., 1994). Although it did not address the issue of property rights in records or other clinical data, the well-known case of Moore vs. Regents, University of California,4 is a useful starting position from which to predict the likely judicial attitude to property-based arguments by patients (Moore vs. Regents, University of California, 1990). A quasi-public good is a near-public good i.e. Stat. Ann. 2005. By . Another example is prostitution, which is not only allowed, but flourishes in a few parts of this country. In contrast to the more familiar charts, paper records, and electronic medical records maintained by healthcare providers, PHRs are medical records created and maintained by patients. A more robust yet sophisticated protective model must be able to distinguish between these uses and adjust the responsibilities of data stewards and processors accordingly. Durham, NC: Duke University Press. It is generally accepted that doctors own the medical records they keep about patients (Regensdorfer vs. Orange Regional Medi-. See http://www.hhs.gov/healthit/certification/stark/. The Santa Barbara county care data exchange: What happened? 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. 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. Healthcare is classified as a merit good because consuming it provides benefits to others as well as to the individual consumer. The Microchip Consent Act of 2008. Pikey vs. Bryant. Current data sources have been constructed to serve as potential resources for research and commercial endeavors. Rev. Perhaps the greatest flaw of the HIPAA data protection model is how quickly it has been rendered wanting by new technologies. These characteristics may cause market failures in information properties because they encourage free riders and can create positive externalities (Cowen, 2002). Databases already exist in different health plans that use a common EMR provider. it has many but not all the characteristics of a public good. http://www.gao.gov/new.items/d07988t.pdf (accessed August 20, 2008). In practice, however, the fragmentation of paper records across innumerable data silos provided the greatest protection. example of common resource. H.B. Increasingly, national accreditation standards such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) rules3 and federal Medicare standards (CMS, 2005) are entering the records space by mandating record retention rules. Doctors are fleeing the medical field. http://legisweb.state.wy.us/statutes/statutes.aspx?file=titles/Title33/T33CH26.htm (accessed February 3, 2010). Unistar Corp. vs. Child. As they observe the failure of high-profile regional health information organization (RHIO) projects (Miller and Miller, 2007), state actors may now perceive that the Office of the National Coordinator for Health Information Technology (ONCHIT) lacks a coherent, sustainable strategy or, at least, that its flat budgets confirm there will be no centralized funding that goes beyond demonstration projects. Most of these statutes apply only to financial identity theft. 44 F.3d 61 (2nd Cir. United States House of Representatives. This situation suggests implicitly that these data should be shared widely and used for the common good of improving the nation’s health and healthcare system. Argued May 29, 1991. Going by the economic definition of public good, no. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion704.shtml (accessed February 3, 2010). There are companies that provide data aggregation services, pooling data from multiple sources, such as health plans and employers. Stat. It may be seen as counterintuitive and as propagating still more legal barriers to public goods access to clinical data, but a stronger data protection model for medical privacy is a necessary predicate for greater sharing of patient data. 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. A quasi-public good is one whose production or consumption generates or might generate effects on third parties. Chester A. Myers Professor of Law, Codirector, Center for Health Law Studies. Health information technology: Efforts continue but comprehensive privacy approach needed for national strategy, GAO-07-988t. California HealthCare Foundation. For example, how do you effectively combine information from different health plans, where one plan has fee-for-service dollar amounts attached to each service provided and another plan is fully capitated and only the service encounters are recorded? A variety of sources of linked medical and drug claims data are available. The Economics 101 definition of a good is that it is a product or service. 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…. § 164.104(a). Delivering health care at a retail clinic isn’t something to be proud of, How MOC is contributing to the demise of physicians. The HIPAA privacy and health records debates have been marked by a serious disconnect between data custodians and government policy makers on one side and privacy advocates on the other. 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. Most states have adopted the Uniform Trade Secret Act, National Conference of Commissioners on Uniform State Laws (1985). The classic example of a public good is a lighthouse. Kevin 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). Equally clearly healthcare is rivalrous and excludable–that’s what we’re arguing about. police and fire departments, national military forces, the GPS system, water distribution and sewage treatment plants, education, radio frequencies and the internet. Quasi-public health care organization must comply with records law . Solum, L. B. In its Stewardship Framework report (NCVHS, 2007), the NCVHS did an admirable job in suggesting tweaks to the HIPAA model by calling for stronger guidance, strengthening of business agreements and their parties’ expectations, and calling on the Federal Trade Commission to increase its footprint in areas not regulated by HIPAA (such as PHRs). In HIPAA-speak this green zone is referred to as “treatment, payment, or health care operations” (HHS, 2002a). Licensure laws create duties of accuracy, completeness, legibility, and timeliness (Nev. Rev. What is a public good? Ensuring the Privacy and Confidentiality of Electronic Health Records. Integrated medical claims, prescription drug data, and enrollment information are also assembled by the Department of Defense. 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. One alternative is a distributive research network. 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. 3d Dist.). Stat., 1978; Wyo. 2006. A public good is defined as a good that is non-rivalrous and non-excludable. See generally Nicolas P. Terry, Under-Regulated Healthcare Phenomena in a Flat World: Medical Tourism and Outsourcing, 29 W. N. Eng. Prop. Where are we headed? Enhanced protections for uses of health data: A stewardship framework for “secondary uses” of electronically collected and transmitted health data. Overall, the Agency for Healthcare Research and Quality’s (AHRQ’s) 2007 Health Information Security and Privacy Collaboration Privacy and Security Project report (AHRQ, 2007) noted more than 300 current state initiatives relating to HIT and HIE. Nonetheless, with current statistical methods, we can do a lot with observational data to control for confounders. Uses and Disclosures for which an authorization is required. Also relevant to this discussion is the existence of another type of less controversial informational public good. 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. In most situations, and as is generally the case with information properties, the legal system will treat the content of records and derived clinical data as more abstract properties that potentially are protected by the law of intellectual property (IP). In general, there are two solutions to determine whether information is a quasi-public good or a public good. 3d 120. 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. Micro Chem., Inc. vs. Lextron, Inc. 2003. Furthermore, although facts themselves can never be the subject of copyright, their organization may be protected as a “compilation” (United States Code, 1992). By enabling excludability regimes (via property or, more typically, intellectual property laws), we seek to promote a dynamic efficiency model. Ready to take your reading offline? 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. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website. Today, the legal system considers itself as being under a mandate to create or support structures that treat clinical data as a private good (NRC, 2003c). 4 min read. This differs from a true public good, which remains accessible to everyone virtually all the time. When a person gets sick he or she functions poorly as a consumer. 2007. Next post > Michael Jackson dead from propofol, is Dr. Conrad Murray solely to blame? 2008. Quasi Public Corporation. That is, we “trade off some static inefficiency to achieve dynamic efficiency” (Benkler, 2006). Jacqueline Lipton, Information Property: Rights And Responsibilities, 56 Fla. L. Rev. Grounds for suspension; revocation; restriction; imposition of conditions; refusal to renew or other disciplinary action. 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). These barriers will not be reduced with better legislative or regulatory drafting. The paper will conclude with some thoughts about how it might be possible to construct a data asset that would represent the broad experience of patients from several national databases. Terry, Nicolas, 2008. Regensdorfer vs. Orange Regional Medical Center. § 164.512. http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.512.pdf (accessed February 24, 2010). 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. Large commercial health plans and employers often have such data, but for their own systems. A demerit good is a good whose consumption leaves a negative impact on its consumer and on others in the society. Harty-Golder, B. Do you enjoy reading reports from the Academies online for free? 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. Conceptually, the simplest way to accomplish deduplication is to pool the data. In the course of this workshop’s discussions of large private clinical databases, some of the examples used are of groups that have made public the data they collect available to third parties essentially free of charge, usually out of altruism. It has some of the characteristics of a public good • A public good may take on some of the features of a private good • Quasi public goods are: 1. Do you want to take a quick tour of the OpenBook's features? Mo. Notwithstanding, the creativity threshold is quite low. IMS Health Corp. vs. Rowe. The control groups chosen are comparison groups. There are certainly signs that the clinical data enclosure movement already has momentum. Both types of information have a role. 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. This is not socialized medicine (like the VA system). Diamonds and gold have goodness in that they have market value. Thus, a majority of states have legislation prohibiting employment discrimination based on genetic information.10 A minority of states go farther and prohibit the genetic testing of employees (NCSL, 2008c). 45 C.F.R. http://www.ncsl.org/programs/health/genetics/ndiscrim.htm (accessed August 20, 2008). Clearly this has externalities. AMA (American Medical Association). ———. N.Y.). 23, 2009). Stat. Director, Institute for Health Policy at Massachusetts General Hospital/Partners Health System Physician, Massachusetts General Hospital. Applied biomedical research has aspects of a public good as well as aspects of a quasi-public good. 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. MyNAP members SAVE 10% off online. Nature Biotechnology 24(9):1091–1094. One theme that has emerged in the legal literature is to inquire whether IP rights holders should owe concomitant “public” duties. As is well known, in 2000 the federal government sought to address the costs to data subjects imposed by the HIPAA transactional standards with apparently comprehensive privacy and security regulations (HHS, 2000). Arguably, the position on ownership of records is slightly more complicated. § 40:2144(F) (Supp. 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. They also license the data to academic researchers, generally at reduced rates. There are judgment calls and trade-offs, with different people … affected differently by alternative decisions…. South Dakota. The second is to have the government produce the good in question. These data create opportunities for private gain. ———. Public goods have two main aspects. Providers who breach these standards may face disciplinary sanctions (Nieves vs. Chassin, 1995; Schwarz vs. Bd. 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). Which of the following is an example of a public good? 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. However, as. That is, HIPAA does not limit or regulate collection of data. Second, the legal system is rife with uncertainties. The social benefit of a given level of a public good is the vertical sum of all private benefits for that level. For all of these reasons, we need an alternative to the pooled mega-database model. Roche PA, Annas GJ. We have national probabilistic surveys (e.g., National Medical Expenditure Survey [NMES]/Medical Expenditure Panel Survey [MEPS]; Medicare Current Beneficiary Survey [MCBS]; Surveillance, Epidemiology, and End Results [SEER]; National Long Term Care Survey [NLTCS]; and National Health and Nutrition Examination Survey [NHANES]); hospital discharge data from payers (e.g., Healthcare Cost and Utilization Project [HCUP]/National Immunization Survey [NIS]); pharmaceutical claims (e.g., drug-switch data from IMS and Wolters-Kluwer); linked enrollment; medical and drug claims databases from commercial health plans and large self-insured employers; and combinations of such databases assembled and made available in the form of commercial databases by data aggregators such as Ingenix, Medstat, and Pharmetrics. Every encounter generates a claim. 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. GAO (Government Accountability Office). Washington, DC: The National Academies Press. 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. ———. you can't stop people from using it) and non-rivalrous (i.e. Click here to buy this book in print or download it as a free PDF, if available. 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. It has no intrinsic merit; its goodness is determined by its value in the marketplace. For example, when patients are found to be switching medications, it. Ct. App. a good that is exclusadable but not rival. The law of copyright protects most written works. 2008a. 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. The paper will also examine rationales for making data publicly available even when they do not meet the classic definition of a public good. 1992. 2008c. http://www.chcf.org/documents/chronicdisease/HITConsumerSnapshot08.pdf (accessed August 20, 2008). FIGURE 4-1 Data availability in a large health plan. Decisions about the management of health information will involve politics at many levels and they will, consequently, involve ideology. It follows that any move away from clinical data excludability to public good status must deal not only with the technical legal barriers also with their economic underpinnings. It is an approach that is perhaps attuned to the current political and legislative realities that apply to the data protection debate. Uses and disclosures for which consent, or authorization, or opportunity to agree or object is not required. 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. 799 NYS 2d 571. (D.D.C.). quasi public good. This chapter reviews perspectives on clinical data; effects of the medical care data marketplace on research priorities, gaps, and possibilities; characteristics of a public good or utility—and on which dimensions healthcare data compare; distinctions that can be made within data types or sources; barriers to broader sharing of and access to medical data; and the conceptual advances, guidance, or policy needed. There are some real challenges (Box 4-2). Most states apply a similar model to applications for health insurance (NCSL, 2008a), and some states have extended that to disability and life insurance (NCSL, 2008b). Stat., 2009; Tenn. Code Ann., 2004). Definitions. Pooling data from sources with very different data structures (e.g., medical claims and EMRs) would be a monumental effort. 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. Rosenblit vs. Zimmerman. As with applied research, there is a nonrival aspect to such information. Woolley, M., and S. M. Propst. Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. True. From a private-sector perspective, Crown outlines some of the potential standardization, privacy, and statistical challenges associated with data aggregation and provides insight into the variety of sources of clinical data. Enterprises, Inc., 1991; Matthew Bender & Co. vs. West Publ. Semi-non-rival: up to a point, more consumers using a park, beach or road do not reduce the space available for others. 3d). Comments are moderated before they are published. Yet, unlike its security code, HIPAA’s Privacy Rule does not preempt more stringent state protections (a phenomenon leading to what is known as the HIPAA floor). Vt. Stat. 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]). Stat., 2008) or their retention (La. § 164.504. http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.504.pdf (accessed February 24, 2010). Is health care public or private good? Overall, it is tempting to recall a well-known phrase coined by an Australian judge discussing the interaction of law and medicine: “Law. In practice, decisions are made on a case-by-case basis.”. June 18, 2007. http://janus.state.me.us/legis/LawMakerWeb/summary.asp?ID=280022219. Across the spectrum of. Health Corp. vs. Rowe, 2007). See generally David E. Shipley, Thin but Not Anorexic: Copyright Protection for Compilations and Other Fact Works, 15 J. Intell. The data create competitive advantage by enabling organizations to learn from their experience, perhaps to achieve better outcomes than their rivals; for example, they may learn how to treat a certain disease better. This means that it is very difficult to prevent everyone from enjoying the public good, if it’s available to everyone. Dept.).Dept.). Knowledge concerning research related to a particular drug or device can be appropriated up to a point. Indeed, the Stewardship Framework report identified a variety of such health-related (in contrast to law enforcement or regulatory) uses, including (1) payment; (2) healthcare operations (including internal quality assessment); (3) quality measurement, reporting, and improvement; (4) clinical research; (5) public health research; and (6) sale or barter of the data for commercial uses, including marketing (NCVHS, 2007). N.Y.). These are a little more relevant to our discussion of healthcare data. Non-excludable production. House, T. W. 2004. 1982. Stat. 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. Fla. 2003); Wash. Univ. 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). National Review of Genetics 2:392–396. Terry elaborates on concepts of property and inalienability rules, the disconnect between federal and state regulations, and the continued development of legal models protecting privacy of health data.
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