Current data sources have been constructed to serve as potential resources for research and commercial endeavors. 194 Ariz. 363, 982 P.2d 1277. Solum, L. B. However, robust growth is likely if the national EHR initiative slows and as major technology companies such as Microsoft, Google, and Inuit enter the PHR space (Lohr, 2007). HHS (Department of Health and Human Services). http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.104.pdf (accessed February 24, 2010). These ideals reflect patient expectations on how their data are processed and information they require before permitting unexpected uses. 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). 23, 2009). And no patient will be worrying about how they will pay for their care or medicines. 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. N.H. Rev. “Nonexcludability” means that the cost of keeping nonpayers from enjoying the benefits of the good or service is prohibitive. Where are we headed? PHRs are provided by the patient’s health insurer, healthcare provider, or employer, or even on an independent, commercial site potentially supported by advertising (collectively, PHR providers). Ann., 2001; N.M. Stat. Applicability. http://www.econlib.org/library/Enc/PublicGoodsandExternalities.html (accessed August 21, 2008). 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. There are judgment calls and trade-offs, with different people … affected differently by alternative decisions…. MyNAP members SAVE 10% off online. Large physician practices also frequently have such data and, as a by-product of providing EMR software, several vendor organizations have built aggregated EMR databases. 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. 54: 462. There are companies that provide data aggregation services, pooling data from multiple sources, such as health plans and employers. Quasi-public definition is - essentially public (as in services rendered) although under private ownership or control. For all of these reasons, we need an alternative to the pooled mega-database model. L. Rev. 2003b. 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. Stat., 2008) or their retention (La. Genetics and health insurance state anti-discrimination laws. The difficult question, however, is how to implement this more robust data protection model. 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. Additionally, at certain times, making data available to the public is inefficient. 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. It has no intrinsic merit; its goodness is determined by its value in the marketplace. Health Corp. vs. Rowe, 2007). Of course, all of this is subject to drawbacks given that these data. Delivering health care at a retail clinic isn’t something to be proud of, How MOC is contributing to the demise of physicians. To obtain exclusivity, the monopoly that is granted by the government requires making public the. Its basic concept, however, is quite simple—arguably too simple. See, e.g., Nicolas P. Terry & Leslie P. Francis, Ensuring the Privacy and Confidentiality of Electronic Health Records, 2007 U. Ill. L. Rev. 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. Furthermore, interlocking problems of indeterminacy, outdatedness, and overlapping or contradictory legal regimes applied to HIT and health information exchange (HIE) reinforce the sense of unintended consequences. § 10:5-45. 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. 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. Quasi Public Goods • A quasi-public good is a near-public good. A radio broadcast . The public-good nature of basic research is something that people of every political persuasion in this country accept. them into something useful. One might think that data from commercial health plans would be formatted in similar ways, but they actually have different formats and different record layouts. June 18, 2007. http://janus.state.me.us/legis/LawMakerWeb/summary.asp?ID=280022219. However, estimates of comparative cost-effectiveness have generally combined efficacy and safety data from clinical trials with real-. Equally clearly healthcare is rivalrous and excludable–that’s what we’re arguing about. An Act to Prohibit the Implanting of a Microchip and Provide a Civil Recovery. Although the FDA is interested primarily in drug safety, it seems clear that the Sentinel Network might also meet the objectives of a public good database for the purposes of evidence-based medicine and comparative effectiveness research. 2000. What’s Wrong with Health Privacy? Finally, we all know that there is virtually no opportunity for service or product substitution. In The role of scientific and technical data and information in the public domain: Proceedings of a symposium. Statutes in some states (Fla. We end up using the other types of data for research, but that was not their original purpose. 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 will consider why these databases are initially constructed, the implications this has for their use as research tools, and their commercial applications. David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital and Partners Health System, and now the U.S. national coordinator for Health Information Technology, describes the theoretical concept of a public good as a way to guide practical policy development around clinical data. When you come down to it, medical care really isn’t like donuts—it’s a public good, like education, quality air, or clean water, and one that should be universally available. Washington, DC: The National Academies Press. The Department of Health and Human Services (HHS) responded that it already had a “comprehensive and integrated approach for ensuring the privacy and security of health information…” (GAO, 2007). 1987. Conn.). § 40:2144(F) (Supp. Surely Healthcare is a quasi – public good and better for the economy as a whole if given to everyone. A quasi-public good is one whose production or consumption generates or might generate effects on third parties. See generally National Human Genome Research Institute, Legislation on Genetic Discrimination, http://www.genome.gov/10002077#2. CCC Info. Integrated medical claims, prescription drug data, and enrollment information are also assembled by the Department of Defense. 2003b. Is health care public or private good? Click here to buy this book in print or download it as a free PDF, if available. If you believe that health care is just like any other free-market enterprise, then it's fine for millions of poor people to lose coverage. Americans are very accepting of some public goods, i.e. In addition, the Saskatchewan data in Canada are similar to U.S. claims data. Ideology is a powerful force in our highly partisan political environment. you using it doesn't make it worse for someone else). Americans are very accepting of some public goods, i.e. The frame for “public goods” analysis begins with the recognition that they exhibit the characteristics of “nonexcludability” and “nonrivalrous” consumption (Cowen, 2002). Trust will be further earned by permitting patient opt-out or data sequestering. 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. Data aggregation is further complicated when you start thinking about pooling across different data sources. N.M. Stat. Quasi Public Corporation. ———. The complexity of pooling claims data with medical records data is even more complicated. Poll, 1991; Valley Med. 125 CLR 383, 395 (Supreme Court of Queensland). Register for a free account to start saving and receiving special member only perks. Inc. vs. Chinatown Today Pub. Argued May 29, 1991. This market was common at one time, but of course it is no longer permitted in the United States. The federal government, actuarial consulting firms, academic researchers, and pharma are among those who license commercial U.S. research databases. 1982. IMS Health Corp. vs. Rowe. See generally David E. Shipley, Thin but Not Anorexic: Copyright Protection for Compilations and Other Fact Works, 15 J. Intell. Micro Chem., Inc. vs. Lextron, Inc. 2003. HIPAA only applies to identified clinical data (HHS, 2002a). 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. 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.”. Finally, numerous patient registries follow patients longitudinally if they have a given condition or have been treated with a particular therapy. Co., 1998) or by their supplementation with creative work (CCC Information Servs. it has many but not all the characteristics of a public good. A good is nonexcludable if, even if wholly owned and paid for, its use and benefit by others cannot be prevented. United States House of Representatives. A system that tolerates a lack of trust and the exposure of patients to discrimination, embarrassment, or stigma (NCVHS, 2007) will face reactions that compromise individual care and distort the data required for outcomes research. University and Small Business Patent Procedures Act, 35 U.S.C.S. 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). Ann., 2005), while other state laws regulate the alteration of records (Nev. Rev. Therefore there will be social inefficiency. Definition of a public good is one that is both non-excludable (i.e. Designed to reduce the negative externalities imposed on data subjects in HIPAA transactions, it became obvious that the model was flawed in its applicability to emerging interoperable health record systems (Terry and Francis, 2007). The first set of issues is somewhat process oriented. Notwithstanding this unfriendly reception, Maryland introduced H.B. AMNews, American Medical Association. If trust and transparency are the ideals in structuring a data protection model for medical data, what should follow? What defines a public good is whether it is non-excludable and non-rivalrous. If a public good use of clinical data to improve outcomes and effectiveness research only contemplates the use of deidentified data, is there any substantial implication of data protection? http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion704.shtml (accessed February 3, 2010). Roche PA, Annas GJ. Although not necessarily available to outside researchers, electronic medical record (EMR) databases exist for several health plans. A quasi-public good is a resource that provides benefits to the public, but could theoretically be restricted if necessary. July 2007: 54. http://www.mlo-online.com/articles/0707/0707liab&lab.pdf (accessed February 23, 2010). 2003c. Stat. Unistar Corp. vs. Child. The reality is that historically we have not had good data from clinical trials regarding effectiveness in real-world patient populations in order to figure out relative cost-effectiveness. 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. The first solution is to increase the appropriateness or excludability of information. § 482.24(b)(1). These economic concepts provide an important insight into why the last 40 years have failed to provide adequate medical services through a commercial market. 1987. As with applied research, there is a nonrival aspect to such information. Also relevant to this discussion is the existence of another type of less controversial informational public good. It has some of the characteristics of a public good especially when it becomes rival in consumption at times of peak demand. § 200-212. funded researchers, has discussed the tensions inherent in the monetizing of publicly funded research (GAO, 2008). These questions have multiplied14 since President George W. Bush announced the federal EHR initiative (House, 2004). 2005. What does Kelly Loeffler’s health plan do to coverage for preexisting conditions? Public Goods: Examples The classical definition of a public good is one that is non‐excludable and non‐rivalrous. 22 M.R.S.A. United States Code. 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). Health Care Isn’t a ‘Market’, It’s a Public Good—and Legislators Would Do Well to Remember That. Part 164. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=d63854405945c9ab56b93612fcc5e089&rgn=div5&view=text&node=45:18.104.22.168.71&idno=45 (accessed February 24, 2010). 2005. "Public goods" is a cause of market failure. A lighthouse is: Non‐excludable because it’s not possible to exclude some ships from enjoying the benefits of Arguably, the position on ownership of records is slightly more complicated. There are some real advantages to that. 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). The guarantee of transparency to the patient when data are applied for research is another theme of the Roundtable. Digital Millennium Copyright Act. Rev. Ct. App). As a result, the data are fairly similar and could be combined. Guay, V. 2008. 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). Sign up for email notifications and we'll let you know about new publications in your areas of interest when they're released. This differs from a true public good, which remains accessible to everyone virtually all the time. Woolley, M., and S. M. Propst. From the standpoint of payers, one issue from a health economics standpoint is establishing the value of pharmaceutical treatments and other interventions. By rolling all of this information together for each plan member, one can create episodes of care and can follow patients longitudinally in the data, collecting all the information about adverse events, total healthcare use, and more. 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). It could be a positive or a negative effect. You have to figure out what constitutes a hospital stay, when the person was admitted, and when he or she was discharged, then roll up all the events that take place between the dates of admission and discharge and, in essence, create a hospital stay. Published on: 10/3/2009. Patients who lack trust in how data stewards or researchers treat their records will hide information from their doctors. 799 NYS 2d 571. 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. There are also many examples of goods that are quasi-public because of their externalities—their effects on third parties not directly involved in the market transactions involving the goods. Defining a good as nonrival means that using the good does not preclude others’ use of the good. 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). They also license the data to academic researchers, generally at reduced rates. Privacy and security solutions for interoperable health information exchange: Impact analysis. The Biden administration should listen. Quasi public goods. 1983. 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). you can't stop people from using it) and non-rivalrous (i.e. When that happens, socially optimal rates of production or patterns of distribution are not achieved. Uses and disclosures for which consent, or authorization, or opportunity to agree or object is not required. 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. As part of its Learning Health System Series, the Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss expanding the access to and use of clinical data as a foundation for care improvement. cable television, toll roads. 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. 135, 172 (2004). By definition “public goods” are not well distributed by market mechanisms. Another type of market failure is more relevant to the discussion at hand and defines the pure public good in economic terms. Often there is no opportunity to investigate or shop around for quality, never mind price. Georgia. State statutes have extended this model to hospitals and their ownership of records (Fla. Thus, when doctors become employees, shareholders, or members of a medical practice, they often enter a contractual agreement stating that records are owned by the practice and containing a restrictive covenant not to compete if they leave the practice. Roche PA, Annas GJ. 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. CMS. An Arizona bill may go even farther in that it extends the prohibition to commercial uses of “records relating to prescription information that contain patient-identifiable and prescriber-identifiable data.”12, Finally, breach notification statutes demonstrate one of the most rapid explosions of regulation in the privacy-confidentiality-security constellation. 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. Dept.).Dept.). 2009. 415 So. | August 24, 2009. 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. 2002b. a good that is exclusadable but not rival. Category 3: Quasi-experimental designs that use control groups and pretests. There are some real challenges (Box 4-2). N.Y.). More simply, my use of the public good does not diminish, or even affect, the amount available for everyone else. 1995. (D.D.C.). Suit has also been filed regarding the Vermont legislation. It takes a lot just to process the volume of claims information in such databases even when the format is similar. § 445.72. that lack interoperability (New Jersey, 2006), and granting providers a state tax credit to offset investments in EMRs (West Virginia, 2008b). 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. Healthcare is classified as a merit good because consuming it provides benefits to others as well as to the individual consumer. That makes scientific progress based on protected information possible, while individuals enjoy economic fruits of innovation. Because the entrepreneur cannot charge a fee […] Instead, they require a sober appreciation by all stakeholders in the clinical data space that they must support fundamental reforms. There is a common supposition that a public good is something that is so good that somebody—usually the government—should make sure that anyone who wants and needs it can get it. Moore vs. Regents University of California. By 2008, with 9 often-conflicting bills languishing in various congressional committees, 39 additional states had passed similar legislation requiring a data steward to inform data subjects when their data have been compromised. GAO-08-499t. Where and when do markets fail? Those who circumvent these protections may face actions brought under the Computer Fraud and Abuse Act (United States Code, 2009) or the Digital Millennium Copyright Act (United States Code, 1998). 2008a. S.B. The real-world, large clinical databases have an aspect of a quasi-public good because they are not pure public goods in any sense. 2008. These characteristics may cause market failures in information properties because they encourage free riders and can create positive externalities (Cowen, 2002). You had best get the right care the first time. 2007. In 2007 the Supreme Court took some initial steps away from limitless patentability by tightening the requirement of “obviousness” as applied to patent claims (KSR vs. Teleflex, 2007). Consumption of alcohol can cause health problems for the drinker. 2008. Terry, N. P. 2004. § 1201 et seq. 51 Cal. See generally Nicolas P. Terry, Under-Regulated Healthcare Phenomena in a Flat World: Medical Tourism and Outsourcing, 29 W. N. Eng. This means that if any is made, all enjoy that amount. Servs. 2003. Therefore there will be a need for the govt t… § 101. 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. 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. Data protection laws are designed to eliminate or reduce these externalities. The data runs and bytes of information are there whether used or not. That is a big challenge. Probably the best known research database outside of the United States is the United Kingdom’s General Practitioner Research Database, an outpatient encounter database. 2002a. 1. This has been translated into a mandate to replace the HIPAA “floor,” whereby more stringent state privacy protections are not preempted, with existing or reduced HIPAA protections as the new “ceiling” (Terry and Francis, 2007). Kaiser could exclude others from the use of their database, as could my own institution, the Partners Health System. Grounds for suspension; revocation; restriction; imposition of conditions; refusal to renew or other disciplinary action. 2007. Ann. § 61-6-15 D. http://www.nmmb.state.nm.us/pdffiles/MedicalPracticeAct.pdf (accessed February 3, 2010). It is easy to underestimate what a big job that is. Alternatives to project-specific consent for access to personal information for health research: What is the opinion of the Canadian public? A lighthouse is: Non‐excludable because it’s not possible to exclude some ships from enjoying the benefits of 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. I will be able to lower my office overhead by 20 per cent. The New York Times. State of Maine Legislature. Second, the HIPAA Security Rule imposes technical and process obligations on data stewards to build a security wall that impedes those in the red zone (e.g., hackers) from accessing data stored in the green zone. 17 U.S.C.S. 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. Another is chemical production with the pollution of air and water. VICTOR LALLI ENTERPRISES, INC., vs. BIG RED APPLE, INC. No. ———. common resource. In practice, decisions are made on a case-by-case basis.”. These barriers will not be reduced with better legislative or regulatory drafting. Therefore there is no incentive for people to pay for the good because they can consume it without paying for it. 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). 45 C.F.R. AHRQ (Agency for Healthcare Research and Quality). you using it doesn't make it worse for someone else). information underlying the patent. Clearly one can keep this kind of information secret and benefit from it in a marketplace, and many medical device companies make their living without patenting by keeping secret how their devices are produced. 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. 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. Similarly, some form of compulsory licensing model may be possible (NRC, 2003a), although this approach has gained no traction in the gene-patenting arena and policy makers have tended to take the opposite approach in related areas, such as stimulating public benefits by increasing proprietary rights under the Orphan Drug Act.17, As actors seek to find a place for “public goods” considerations at the clinical data table, they must learn from broader (and not wholly successful) experiences recalibrating private and public interests in intellectual property. Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. The control groups chosen are comparison groups. 940. http://www.legis.state.ga.us/legis/2007_08/pdf/hb940.pdf (accessed February 24, 2010). 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. This is not an exhaustive list, of course, but it provides a sense of the breadth of data available in the United States (Box 4-1). 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. http://leg.state.nv.us/NRS/NRS-630.html#NRS630Sec3062 (accessed February 3, 2010). On the indeterminacy crisis: Critiquing critical dogma, U. Chi. United States Court of Appeals, Second Circuit. Not a MyNAP member yet? L. Rev. 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). However, government intervention may not achieve the socially ideal outcome either if the public policy intervention is not Public goods are characterized by: (1) value that has benefit to the community as a whole beyond any purchase price paid, (2) often requiring large initial investment costs that are generally too expensive for any individual or private corporation to afford and earn a reasonable return, (3) requiring a higher level of administration than any individual or company can arrange and (4) having value that accrues over time and is difficult to price properly. Private producers have no incentive to provide public goods because. Markets for these goods are considered to be incomplete markets and their lack of provision by free markets would be considered to be inefficient and 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. Markets can also fail in the cases of pure public goods and quasi-public goods. 583, Chapter 759; Mich. Comp. Depending on the database, there may also be information on laboratory test results or the social demographics of patients. interoperability (e.g., a standardized export format) increases, the importance of this issue should diminish. 2401. Updated: 05 Jan 2016, 11:17 PM IST Rohit Prasad. Terry, Nicolas, 2008. The classic example of a public good is a lighthouse. Public goods have two main aspects. N.M. Stat. 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). In the current health care debate, many have asked if it would be wise for us to … § 1030 et seq. 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. Genetics and life, disability and long-term care insurance. In Feist Publications, Inc., v. Rural Telephone Service Co., a case dealing with lists of subscribers in a telephone directory, the Supreme Court limited copyright protection for nonoriginal, noncreative works (Feist Publications, Inc. vs. 1990. A public good is defined as a good that is non-rivalrous and non-excludable. That is, we “trade off some static inefficiency to achieve dynamic efficiency” (Benkler, 2006). 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). Mo. To see why this is, let us look at the definition of public goods. In terms of content, the standard medical claims database includes enrollment information and pharmacy, physician, and facility claims (Figure 4-1). In closing, we need to acknowledge that this is not going to be simple. ———. ideological opinions about markets, from those who cherish them to those who revile them, there is no question that basic research is nonrival and nonexcludable, and that its support is an appropriate and necessary role of government. According to the survey result, Americans rate education as their number one priority during the last presidential campaign in 2000. L. 91 (2007). combine all consumer demand curves horizontally . Therefore, data with economic value that are kept secret and reasonably secure may be treated as trade secrets under state law.7. Pikey vs. Bryant. Also, follow-up periods are often short. 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. No money should be made in an efficient market from the sale of that product. Share: Share on Facebook Share on Twitter Share on Linkedin Share on Google Share by email. Stat., 2008; N.M. Me.). Between these extreme groupings, patient trust about research must be earned through transparency. 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. However, … Some innovations were motivated in part by a desire to overcome aspects of public sector culture, practice and policy that were perceived in negative terms (e.g. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html (accessed August 20, 2008). Rural Telephone Service Co., Inc., 1991). The Microchip Consent Act of 2008. http://www.ncsl.org/programs/health/genetics/ndishlth.htm (accessed August 20, 2008). ” 3-6 The ... common goods (eg, universal healthcare), and public goods (eg, public information or pandemic preparedness) (fig 1). Enterprises, Inc., 1991; Matthew Bender & Co. vs. West Publ. Uses and Disclosures for which an authorization is required. Nonetheless, with current statistical methods, we can do a lot with observational data to control for confounders. As discussed below, these tendencies toward indeterminacy are exacerbated by the relationship between federal and state regulatory and statutory models. Quasi-public goods. Health plans are also very concerned about protecting patient confidentiality. California passed the first such statute in 2003. To take just the issue of privacy, the federal HIPAA code is less than comprehensive, leaving unprotected large swathes of patient data. A few seek to go considerably further. La. 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). Schwarz vs. Bd. However, it is difficult to see any alternative if there is to be a long-term accommodation of patient and researcher interests. To see why this is, let us look at the definition of public goods. The most likely area for additional protection is to apply data protection to a more expansive list of custodians than HIPAA’s narrow “current entities” model. The legal system enters the “public good” debate because it reflects and thus perpetuates the current “excludability” state of clinical data with property and intellectual property models. Stat. 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. Stat. In fact, the government produces many examples of classic public goods without controversy. Health generally is not considered a public good, because non-paying individuals (for health insurance, healthy food, etc.) vs. MacLean Hunter Mkt. 45 C.F.R. 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. AMA (American Medical Association). 2008. 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. See, e.g., Haw. Instead, a public good is one that has two characteristics that separate it from most other goods. 625 N.Y.S.2d 344 (N.Y. App. § 487N-2(g)(2); Ore. 2007 S.B. Caulfield, T., R. M. Cook-Deegan, F. S. Kieff, and J. P. Walsh. 17 U.S.C.S. 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. 2008. Boyle, J. 2nd, 841, 210 A.D.2d 611 (A.D. 3rd. Law & Contemporary Problems 33. Access to all of those things is part of what enables everyone to become a full member of society. § 318:47-f. Nieves vs. Chassin. A public good, as defined by economists, is a service or resource that is available to all who wish to use it (Dawes, 1980). 1982. Non-excludable means the ability to separate those who pay for the good from those who do not. As discussed earlier, however, a significant challenge to constructing a pooled mega-database for the purposes of evidence-based medicine is the cost of building and maintaining such a database. 1985. As the NCVHS has suggested, “secondary use” is “an ill-defined term” that should be abandoned “in favor of precise description for each use of health data” (NCVHS, 2007). There are certainly signs that the clinical data enclosure movement already has momentum. 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…. 2009. They license the data to the federal government and to actuarial consulting firms that use the data to develop benefit designs. Confidentiality of prescription drug information. Sale of a Medical Practice. Both Einstein’s theory of mass-energy equivalence and the double-helix nature and structure of the DNA molecule are examples of public goods. Ohio Urology, Inc. vs. An act to amend the prescription privacy law. Sandra H. Johnson, Ana S. Iltis, and Barbara A. Hinze (NY: Routledge, 2008), 68-94. Updated: 05 Jan 2016, 11:17 PM IST Rohit Prasad. ———. A public good is defined as a good that is non-rivalrous and non-excludable. Cir.). 2008c. 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. In HIPAA-speak this green zone is referred to as “treatment, payment, or health care operations” (HHS, 2002a). Across the spectrum of. Do you want to take a quick tour of the OpenBook's features? 2008. 50 and Washington is considering similar legislation. For example, an Arizona bill would prohibit non-U.S. outsourcing of medical data processing absent patient consent,8 while several states (Georgia, 2008; South Dakota, 2008) are set to join the ranks of those controlling data acquisition through subcutaneous Radio Frequency Identification (RFID) tags.9, Increasingly, states regulate the use of either individual or aggregated (even de-identified) clinical data. 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. Responses by the research and education communities in preserving the public domain and promoting open access. Ann. 2008. 164.506. http://fosters.com/apps/pbcs.dll/article?AID=/20080210/GJNEWS01/67136800 (accessed February 23, 2010). By definition “public goods” are not well distributed by market mechanisms. 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. A “public good” is a product or service which benefits everyone in the community. Records property of hospitals—Access—Not Public—Funding for medical record requests. Definitions. 2006. The issue has even been raised in some tense exchanges between the GAO and ONCHIT. 1577, Docket 91-7155. outstanding market failures in health care are heavily data driven; those who control the data are likely to have disproportionate control over the metrics. Traditional intellectual property systems protect inventors or authors with a term-limited monopoly when they market their expressions or inventions. Public goods have two main aspects. With a few notable exceptions, the kinds of rich, longitudinal data that we have in the United States either do not exist or are not accessible to researchers in other parts of the world. Get free updates delivered free to your inbox. 499 U.S. 340, 111 S.Ct. Into this real or perceived vacuum, some states are floating their own “carrots” and “sticks” designed to provide new impetus toward HIE projects. vs. Catalona, 490 F.3d 667 (8th Cir. 3d 446, 594 N.E.2d 1027 (Ohio Ct. L.S. Lohr, S. 2007. afterward. H.B. The observations that follow are made on the assumption that theory still matters. Miller, R. H., and B. S. Miller. 945 F.2d 509 (2nd Cir. 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). ORNL (Oak Ridge National Laboratory). Revised policy on enhancing public access to archived publications resulting from NIH-funded research, NOT-OD-08-033. Ready to take your reading offline? Print page. A good is something that can be bought or sold. This intuitive definition of a public good, however, is a reflection of moral, not economic, reasoning. police and fire departments, national military forces, the GPS system, water distribution and sewage treatment plants, education, radio frequencies and the internet. Ann. The Perscription Restraint Law. is always possible to try to analyze this move with deidentified data, looking at factors such as changes in benefit design on subsequent drug switches. This echoed the previous month’s conclusion by the California Healthcare Foundation that “The President’s HIT adoption agenda has raised consciousness about HIT and EHRs. 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). Other state legislation operates on the periphery of HIPAA. The fact that restrictions on gambling and alcohol have declined shows that moral restrictions can change over time. Most states have adopted the Uniform Trade Secret Act, National Conference of Commissioners on Uniform State Laws (1985). 45 C.F.R. This is the equivalent of using trade secrecy for medical practice, and it is possible today. Clinical data claims for IP protection could arise under patent or copyright laws. Durham, NC: Duke University Press. 2002e. Institutions contributing information to a pooled database generally have a variety of concerns. First, in this debate the legal system is neither a spectator nor an independent actor. When discussing large clinical databases, the fact is that the marginal cost of using the database is virtually nothing. Applied biomedical research has aspects of a public good as well as aspects of a quasi-public good. Desktop Marketing Systems Pty Ltd vs. Telstra Corporation Limited. 2003a. © 2020 National Academy of Sciences. 2001. 2007. 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-. 2003. Many forthcoming health-quality initiatives, such as pay-for-performance (P4P) or consumer-directed health care (Jost, 2007), that seek to resolve. § 33-26-402(a) (xxvii) (G). Most of these statutes apply only to financial identity theft. Current patient expectations likely are limited to point-of-care and continuum-of-care uses. New York Mercantile Exchange, Inc. v. IntercontinentalExchange, Inc. 05-5585-CV, 2007 WL 2189129, C.A.2 (N.Y.), 8/1/2007. Nature Biotechnology 24(9):1091–1094. Most purchasing decisions are made by a doctor acting as the patient’s surrogate. 766 A.2d 749 (N.J.). 660 F. Supp. The legislation sought to encourage, by creating private incentives, the use of publicly developed information. 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). If an entrepreneur stages a fireworks show, for example, people can watch the show from their windows or backyards. Using biomedical research as an example. Even the construction of a pooled database built from similar data streams (e.g., commercial health plans) is a huge task. 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. State law continues to dominate the records space. This means that it is not possible to prevent anyone from enjoying a good, once it has been provided. Legal models enter the equation because they reflect and so perpetuate the intended or perceived current state of public policy. Equally, few HIT or HIE issues are particularly local or are amenable to local or state legislative solutions. 1999. These data create opportunities for private gain. Health information technology: Efforts continue but comprehensive privacy approach needed for national strategy, GAO-07-988t. may not be able to achieve good health. One time where they fail is when there is a moral revolt against the operation of markets. Windeyer, J., Mount Isa Mines vs. Pusey, 1970. FIGURE 4-1 Data availability in a large health plan. http://legisweb.state.wy.us/statutes/statutes.aspx?file=titles/Title33/T33CH26.htm (accessed February 3, 2010). Uses and Disclosures: Organizational Requirements.45 C.F.R. 1995. 2007. 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. forest land, tuna in the ocean. 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). Similar issues arise in the pooling of medical records data across multiple sources when these sources use different medical record systems. There are two regulatory “walls” between the green zone and the “red” zone in which patient data generally should not circulate. In fact, 1% of the total population consumes 25% of medical care (by cost), 5% of the population consumes 49% and 50% of the population consumes only 3% of medical care by cost. Kevin Pho, MD shares the stories of the many who intersect with our health care system but are rarely heard from. Reports, 1994; Harper & Row, Publishers, Inc. vs. Nation Enterprises, 1985). ———. NCVHS (National Committee on Vital and Health Statistics). Journal of the American Medical Information Association 14(6):706–712. Using regulated contracts, health insurers and providers may extend the green zone to include their “business associates” (e.g., law firms) (HHS, 2002b). Patients’ expectations are unlikely to include the array of possible secondary uses for their clinical data, including the generation of outcomes and effectiveness research. Data found at the NIH, for example, or developed through the National Health Interview Survey or National Census represent situations where the taxpayer has paid for the information to be collected. 2005. police and fire departments, national military forces, the GPS system, water distribution and sewage treatment plants, education, radio frequencies and the internet. The purpose is to provide a framework for evaluating the case for public release of varying types of data; one Roundtable theme is to ensure that publicly funded data are used for the public benefit. Feist Publications, Inc. vs. example of common resource. Share a link to this book page on your preferred social network or via email. The second is to have the government produce the good in question. 45 C.F.R. Facilitates deduplication of patient data, Concerns of data contributors make it unlikely that they will contribute their data to a pooled database, Concerns about protecting patient confidentiality, Effectively deals with concerns of data contributors, Prior examples of successful collaborations of multiple health plans (e.g., HMO Research Network). The Santa Barbara county care data exchange: What happened? Research Inst., Inc., 264 F. Supp. Restrictions are placed on such data—for example, for national security purposes, not all defense-related data are public. 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]). 4 min read. 1994. Tenn. Code Ann. Access of individuals to protected health information. Harper & Row, Publishers, Inc. vs. Nation Enterprises. In The role of scientific and technical data and information in the public domain: New legal approaches in the private sector. Evidence and anecdotes: An analysis of human gene patenting controversies. ———. 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. Legislation around retention of medical records. To search the entire text of this book, type in your search term here and press Enter. example of quasi public good. 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). Physicians have spoken. 2002c. Going by the economic definition of public good, no. 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). 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. Markets for these goods are considered to be incomplete markets and their lack of provision by free markets would be considered to be inefficient and That is, they are fundamentally nonexcludable. Chester A. Myers Professor of Law, Codirector, Center for Health Law Studies. William Crown, president of i3 Innovus, offers ideas on the elements to consider in building large, multifaceted data assets. An example of a market that has failed because of public abhorrence is the slave market. A quasi-public good is a near-public good. http://www.ncsl.org/programs/health/genetics/ndislife.htm (accessed August 20, 2008). We will get there a lot faster if we recognize the practical challenges raised by alternative data models, as well as the issues and concerns of all the stakeholders. Medical services are not an ordinary commodity but more like a “public good” which should be financed using a regulated public utility model. 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Harty-Golder, B. 1141. § 164.524. http://edocket.access.gpo.gov/cfr_2003/octqtr/pdf/45cfr164.524.pdf (accessed February 4, 2010). 2007. This mixed legal basis carries over to the question of property rights in clinical data. | It is excludable within limits and it is rival within limits. of Regents, 1982). 681-735. deidentification safe harbor with anonymity or pseudoanonymity. 3d). Valley Med. 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. By virtue of the origins of clinical data with individual patients, and because these data are often compiled with public funds, they have many characteristics of a public good or public utility. The Economics 101 definition of a good is that it is a product or service. Researchers have to cull bad information (e.g., men who show up as having had hysterectomies). Health care at risk: A critique of the consumer-driven movement. 2002d. Since relatively few people incur rare, huge, often catastrophic costs on a largely unexpected basis, pooling of risk is necessary. 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. All rights reserved. I will have 10 per cent more time to see sick people. Amendment of protected health information. 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. 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. 2d 733 (Fla. Dist.
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