The federal legislative logjam on matters such as genetic discrimination, HIT funding, and effective data protection must be cleared to reduce the barriers posed by an escalating number of state “solutions.”. § 101. 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. The law of copyright protects most written works. Durham, NC: Duke University Press. What’s Wrong with Health Privacy? Data aggregation is further complicated when you start thinking about pooling across different data sources. 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-. Rural Telephone Service Co., Inc., 1991). The addition of sociodemographics such as income, net worth, education, self-reported race/ethnicity, and so forth represents an attempt to further enhance the data that are typically available just from the administrative claims and to try to find additional sources of variation and healthcare use that one wouldn’t be able to observe from the health claims themselves. These economic concepts provide an important insight into why the last 40 years have failed to provide adequate medical services through a commercial market. It 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. Applying a focused version of this model to clinical data, patient expectations would be met by relatively unimpeded use of data for point-of-care and continuum-of-care purposes (a far more restricted green zone). The first set of issues is somewhat process oriented. Stat., 2009; Tenn. Code Ann., 2004). Health care is a private good, not a public good. Large retrospective claims databases can be particularly useful for safety signal detection. 2007. 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. As a result, the data are fairly similar and could be combined. There are companies that provide data aggregation services, pooling data from multiple sources, such as health plans and employers. The court reasoned that the extension of the conversion tort, by which such interests may be protected, would potentially “punish innocent parties” (downstream researchers) or “create disincentives to the conduct of socially beneficial research.”5 However, another reason for the conclusion flowed from the same court’s recognition of causes of action for breach of fiduciary duty or lack of informed consent that could provide remedies against the physician. It is crucial to know the epidemiology of medical expenses. Reports, 1994; Harper & Row, Publishers, Inc. vs. Nation Enterprises, 1985). In addition, he discussed how taxpayer-funded data, collected and stored in a variety of public and private institutions, provide another opportunity to consider such data a public good. In a representative democracy that means voting for the candidate whose priorities for spending most closely match your own. The AMA seems to have taken the position that their members should seek to monetize records data (O’Reilly, 2005). 2d 733 (Fla. Dist. That is wonderful, of course, but as a society we have not organized ourselves around altruism as a guarantee of any particular outcome. 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). 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. ———. William Crown, president of i3 Innovus, offers ideas on the elements to consider in building large, multifaceted data assets. Economics Student videos Public good; Quasi public good; Geoff Riley. Aside from data quality issues themselves, there are challenges in drawing reliable inferences about cause and effect from observational data of any sort. Inc. vs. Chinatown Today Pub. (D.D.C.). Director, Institute for Health Policy at Massachusetts General Hospital/Partners Health System Physician, Massachusetts General Hospital. ” 3-6 The ... common goods (eg, universal healthcare), and public goods (eg, public information or pandemic preparedness) (fig 1). 5 percent sample available from the Centers for Medicare & Medicaid Services (CMS). | August 24, 2009. These are a little more relevant to our discussion of healthcare data. It is generally accepted that doctors own the medical records they keep about patients (Regensdorfer vs. Orange Regional Medi-. Washington, DC: The National Academies Press. When discussing large clinical databases, the fact is that the marginal cost of using the database is virtually nothing. § 318:47-f. Nieves vs. Chassin. In short, an enormous amount of effort and considerable financial investment are required to develop large databases that pool information across multiple sources. 3d 446, 594 N.E.2d 1027 (Ohio Ct. you using it doesn't make it worse for someone else). N.Y.). This differs from a true public good, which remains accessible to everyone virtually all the time. Decided June 13, 1991. 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. By enabling excludability regimes (via property or, more typically, intellectual property laws), we seek to promote a dynamic efficiency model. NIH and NSF are examples of those. For example, for many years CMS has funded the development of state Medicaid databases (tape-to-tape, MSIS, and SMRF) that combine longitudinal deidentified data on beneficiary enrollment, medical claims, and drug claims. 2401. afterward. 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. § 164.514. http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.514.pdf (accessed February 24, 2010). Of course, all of this is subject to drawbacks given that these data. La. Grounds for suspension; revocation; restriction; imposition of conditions; refusal to renew or other disciplinary action. These data create opportunities for private gain. 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). Americans are very accepting of some public goods, i.e. Div. 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. Click here to buy this book in print or download it as a free PDF, if available. 2005. 453 N.Y.S.2d 836, 836–37 (N.Y. App. Quasi-public health care organization must comply with records law . This paper will review the classic definition of a public good and discuss how that definition applies to healthcare information under varying circumstances. 471 U.S. 539. 2002e. The frame for “public goods” analysis begins with the recognition that they exhibit the characteristics of “nonexcludability” and “nonrivalrous” consumption (Cowen, 2002). 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. Updated: 05 Jan 2016, 11:17 PM IST Rohit Prasad. Unistar Corp. vs. Child. In The role of scientific and technical data and information in the public domain: Proceedings of a symposium. And no patient will be worrying about how they will pay for their care or medicines. It is easy to underestimate what a big job that is. Scientific knowledge as a global public good: Contributions to innovation and the economy. Data protection laws are designed to eliminate or reduce these externalities. 1983. 2006). ———. Non-excludable means the ability to separate those who pay for the good from those who do not. Stat. For subsequent cases dealing with the disputes between researchers and healthcare institutions over issues of property and other rights in cells and genetic materials, see Greenberg vs. Miami Children’s Hosp. 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. 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). However, records data or derived clinical data may be viewed as merely factual, and copyright law does not protect facts, including medical and biographical facts (N.Y. Mercantile Exch., Inc. vs. 2002f. 1992. There is probably also an increasing expectation of data access and use for personal health management (e.g., interoperability of EMR and PHR systems and any necessary processing). 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). 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. Providers who breach these standards may face disciplinary sanctions (Nieves vs. Chassin, 1995; Schwarz vs. Bd. Kevin 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. Second, the legal system is rife with uncertainties. The discussion thus far has focused on deidentified databases. It takes a lot just to process the volume of claims information in such databases even when the format is similar. 44 F.3d 61 (2nd Cir. Physicians have spoken. Sale of a Medical Practice. Although not sufficiently granular for our current purposes, the European Union data directive suggests a data protection model that imposes far more powerful obligations on data stewards and “chain of trust” data. DNA Testing, Banking, and Genetic Privacy, 2:392-396; N Engl J Med 355; Aug. 10, 2006. L. Rev. processors (e.g., HIPAA’s business associates). Protecting genetic privacy. There is a long tradition in the legal literature of examining this phenomenon at various levels of abstraction. Most purchasing decisions are made by a doctor acting as the patient’s surrogate. Notwithstanding, the creativity threshold is quite low. 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). 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…. The principal questions for this discussion concern what to do with privately maintained databases that have private costs and value: databases, in other words, that given parties will neither construct nor share out of altruism, but for which large externalities exist. 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. Telehealth in underserved populations needs telecommunication expansion, Forgetting mental health is a miss for the Biden COVID-19 task force, The cost of avoiding cost: a medical student’s perspective, Don’t let a negative COVID-19 test ruin your Thanksgiving, A society that values evidence is more resilient in the face of health crises, Empty chairs at the table this holiday season, Artificial intelligence, COVID-19, and the future of pandemics. 194 Ariz. 363, 982 P.2d 1277. Across the spectrum of. 2001. New Hampshire Business Review. Poll, 1991; Valley Med. Examples include roads, tunnels and bridges. 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). police and fire departments, national military forces, the GPS system, water distribution and sewage treatment plants, education, radio frequencies and the internet. once produced, it will not be possible to exclude those who do not pay for the good. Me.). 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). 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. you can't stop people from using it) and non-rivalrous (i.e. 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). What is a public good? 45 C.F.R. Current patient expectations likely are limited to point-of-care and continuum-of-care uses. Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. A quasi-public corporation is a type of private company that is backed by a branch of government with a public mandate to provide a given service. Using regulated contracts, health insurers and providers may extend the green zone to include their “business associates” (e.g., law firms) (HHS, 2002b). Therefore there will be a need for the govt t… 3 Changing the Terms: Data System Transformation in Progress, 5 Healthcare Data as a Public Good: Privacy and Security, The National Academies of Sciences, Engineering, and Medicine, Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good: Workshop Summary, http://www.hhs.gov/healthit/certification/stark/, http://healthit.ahrq.gov/portal/server.pt?open=514&objID=5554&mode=2&holderDisplayURL=http://prodportallb.ahrq.gov:7087/publishedcontent/publish/communities/k_o/knowledge_library/features_archive/features/impact_analysis_of_the_privacy_and_security_solutions_for_interoperable_health_information_exchange_project.html, http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion704.shtml, http://www.chcf.org/documents/chronicdisease/HITConsumerSnapshot08.pdf, http://edocket.access.gpo.gov/cfr_2003/octqtr/pdf/45cfr164.524.pdf, http://edocket.access.gpo.gov/cfr_2003/octqtr/pdf/45cfr164.526.pdf, http://edocket.access.gpo.gov/cfr_2007/octqtr/pdf/pdf/42cfr482.24.pdf, http://www.econlib.org/library/Enc/PublicGoodsandExternalities.html, http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=Ch0456/Sec057.HTM, http://www.chcf.org/documents/chronicdisease/GaugingTheProgressOfTheNationalHITInitiative.pdf, http://www.legis.state.ga.us/legis/2007_08/pdf/hb940.pdf, http://fosters.com/apps/pbcs.dll/article?AID=/20080210/GJNEWS01/67136800, http://www.mlo-online.com/articles/0707/0707liab&lab.pdf, http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=d63854405945c9ab56b93612fcc5e089&rgn=div5&view=text&node=45:1.0.1.3.71&idno=45, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.514.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.504.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.508.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr160.103.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.512.pdf, http://edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.104.pdf, http://www.whitehouse.gov/infocus/technology/economic_policy200404/chap3.html, http://www.mainelegislature.org/legis/bills/bills_123rd/billpdfs/HP000502.pdf, http://janus.state.me.us/legis/LawMakerWeb/summary.asp?ID=280022219, http://www.ncsl.org/programs/health/genetics/ndishlth.htm, http://www.ncsl.org/programs/health/genetics/ndislife.htm, http://www.ncsl.org/programs/health/genetics/ndiscrim.htm, http://leg.state.nv.us/NRS/NRS-630.html#NRS630Sec3062, http://grants.nih.gov/grants/policy/data_sharing/, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html, http://www.nmmb.state.nm.us/pdffiles/MedicalPracticeAct.pdf, http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml, http://www.law.cornell.edu/uscode/18/1030.html, http://www.gencourt.state.nh.us/legislation/2008/HB1587.html, http://apps.leg.wa.gov/billinfo/summary.aspx?year=2008&bill=6241, http://legisweb.state.wy.us/statutes/statutes.aspx?file=titles/Title33/T33CH26.htm, 1 Clinical Data as the Basic Staple of the Learning Health System, 2 U.S. Healthcare Data Today: Current State of Play. 45 C.F.R. ” N.J. Stat. 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). Search thousands of physician, PA, NP, and CRNA jobs now. We have used patents and copyrights to do that. Every encounter generates a claim. 2003c. Applicability. The classic example of a public good is a lighthouse. Notwithstanding, there is authority that medical records software is patentable (Micro Chem., Inc. vs. Lextron, Inc., 2003), although it is doubtful whether that status extends to the actual record created using the software. However, HIPAA grants quasi-property interests to patients in their records by recognizing rights of access (CMS, 2003a) and modification (CMS, 2003b). 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. 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. Not a MyNAP member yet? 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. 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. 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. 1577, Docket 91-7155. GAO-08-499t. The chief disadvantage of this approach is the patient deduplication issue, which, of course, is a major strength of the pooled mega-database model. 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. Straw is not so good unless you believe, as in the fairy tale, that straw can be turned into gold; alchemists broke many wands over that effort. This is a difficult and likely unpopular agenda. The Biden administration should listen. See, e.g., Nicolas P. Terry & Leslie P. Francis, Ensuring the Privacy and Confidentiality of Electronic Health Records, 2007 U. Ill. L. Rev. § 200-212. funded researchers, has discussed the tensions inherent in the monetizing of publicly funded research (GAO, 2008). One alternative is a distributive research network. Other requirements related to uses and disclosures of protected health information. To see why this is, let us look at the definition of public goods. you using it doesn't make it worse for someone else). Stat. 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. 2007. HHS (Department of Health and Human Services). 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. in Law and Bioethics, Eds. Policy L.S. Gauging the progress of the National Health Information Technology Initiative: Perspectives from the field. As Yochai Benkler explains, we apply legal protection to information properties because of our willingness “to have some inefficient lack of access to information every day, in exchange for getting more people involved in information production over time” (Benkler, 2006). § 40:2144(F) (Supp. 17 U.S.C.S. Access of individuals to protected health information. Div. Solum, L. B. First, the HIPAA Privacy Rule includes a general rule that green zone data custodians may not disclose data into the red zone. Co., 1998) or by their supplementation with creative work (CCC Information Servs. The opposite of a public good is a private good, which is both excludable and rivalrous.These goods can only be used by one person at a time–for example, a wedding ring. 2009. What are Quasi-Public Goods? The wealth of networks: How social production transforms markets and freedom. Prohibiting the sale or use of prescriber-identifiable prescription data for commercial or marketing purposes absent prescriber consent. A quasi public corporation, sometimes referred to as a public service corporation, is a private corporation that is backed by a government agency that has a public requirement to provide certain services. Similarly, to fully understand behaviors of physicians, it is necessary to interview them. 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. Nev. Rev. CMS. By definition “public goods” are not well distributed by market mechanisms. Georgia. However, HIPAA only applies to a relatively narrow range of healthcare entities (HHS, 2002d) that engage in certain types of transactions (HHS, 2002f). Knowledge concerning research related to a particular drug or device can be appropriated up to a point. Going by the economic definition of public good, no. It is pretty much non-excludable since the idea of the NHS is that it's free at the point of treatment; you go to A&E with a serious problem and they'll treat you. Currently, only 2 percent of the population uses PHRs (California HealthCare Foundation, 2008). A moral imperative to heal the broken health care model in this country. The public policy and current political action around changing the system overlooks two important technical fallacies: (1) That health care is most efficiently distributed by a free market mechanism; and, http://www.chcf.org/documents/chronicdisease/HITConsumerSnapshot08.pdf (accessed August 20, 2008). http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml (accessed August 20, 2008). Stat., 2008) or their retention (La. 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). 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. Traditionally the regulation of medical records has been a creature of state law. 1995. Pooling data from sources with very different data structures (e.g., medical claims and EMRs) would be a monumental effort. Pre-HIT protection for medical records was formally achieved with a patchwork of state statutory and common-law rules. 945 F.2d 509 (2nd Cir. 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). As with applied research, there is a nonrival aspect to such information. A public good is defined as a good that is non-rivalrous and non-excludable. When a person gets sick he or she functions poorly as a consumer. National Review of Genetics 2:392–396. In HIPAA-speak this green zone is referred to as “treatment, payment, or health care operations” (HHS, 2002a). Ohio Urology, Inc. vs. Harper & Row, Publishers, Inc. vs. Nation Enterprises. 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. This chapter examines quasi-markets in publicly funded systems of healthcare, particularly as they have developed in the UK in the last two decades. 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. According to the survey result, Americans rate education as their number one priority during the last presidential campaign in 2000. http://leg.state.nv.us/NRS/NRS-630.html#NRS630Sec3062 (accessed February 3, 2010). Another type of market failure is more relevant to the discussion at hand and defines the pure public good in economic terms. The federal government, actuarial consulting firms, academic researchers, and pharma are among those who license commercial U.S. research databases. 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. Washington, DC: The National Academies Press. Moore vs. Regents University of California. Stat., 2008; N.M. Therefore there will be social inefficiency. 3d). 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. Obtaining pretest measurements for both the intervention and control groups allows one to assess the initial comparability of the groups. 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. 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. 2008. Depending on the database, there may also be information on laboratory test results or the social demographics of patients. Therefore, if anything, the post-HIPAA years have seen an increase in state legislation impacting HIT. 499 U.S. 340, 111 S.Ct. See generally Nicolas P. Terry, Under-Regulated Healthcare Phenomena in a Flat World: Medical Tourism and Outsourcing, 29 W. N. Eng. For example, while inoculation against a contagious disease generates a private benefit to those inoculated as well as others. In accordance with a Roundtable theme, we must correct the market failure for expanding electronic health records. 681-735. deidentification safe harbor with anonymity or pseudoanonymity. They are definitely excludable. The real-world, large clinical databases have an aspect of a quasi-public good because they are not pure public goods in any sense. HIPAA’s data protection regulation is technically complex and obstinately opaque. Legislation around retention of medical records. 1994. 2006. Harty-Golder, B. There are also quasi-public goods. 2. 45 C.F.R. Equally, few HIT or HIE issues are particularly local or are amenable to local or state legislative solutions. However, to understand them requires some initial observations regarding the legal sys-. EMR Ownership Questions. Because the entrepreneur cannot charge a fee […] Caulfield, T., R. M. Cook-Deegan, F. S. Kieff, and J. P. Walsh. 51 Cal. The problem with public goods is that they have a free-rider problem. Data do not have to be deidentified when used in healthcare operations (e.g., intraentity quality improvement research), 45 C.F.R. AMA to set guidelines on control of record data. ———. A quasi-public good is a resource that provides benefits to the public, but could theoretically be restricted if necessary. 490 F.Supp.2d 163 (D. N.H. 2007). 2008c. N.M. Stat. The guarantee of transparency to the patient when data are applied for research is another theme of the Roundtable. What does Kelly Loeffler’s health plan do to coverage for preexisting conditions? The terms of these contracts (particularly the covenant not to compete) are often not enforced by the courts when to do so would adversely affect the public interest in patient choice and physician mobility (Ohio Urology, Inc. vs. They are described herein as property rules, federal–state vectors, and data protection. A good is something that can be bought or sold. The government will not own hospitals, nor put physicians on salary. 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). Randomization enables reliable statistical inferences about cause and effect to be drawn for the patient population in the trial. Sometimes they also measure correspondence with practice guidelines. it has many but not all the characteristics of a public good. Google and Microsoft look to change health care. Desktop Marketing Systems Pty Ltd vs. Telstra Corporation Limited. 1985. Keeping knowledge private causes a loss of efficiency, but we tolerate this loss for the gain that is created by the incentives for innovation resulting from the opportunity for economic gain. 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. Definition of a public good is one that is both non-excludable (i.e. Quasi-public goods - definitionQuasi-public goods have characteristics of both private and public goods, including partial excludability, partial rivalry, partial diminishability and partial rejectability. At least in the latter case, we observe real-world outcomes in actual patient populations using the drug. Using biomedical research as an example. Specialists vs. Farber, 1999). The second enclosure movement and the construction of the public domain. Applied biomedical research has aspects of a public good as well as aspects of a quasi-public good. 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). In limited situations, the question of copyright protection might be satisfied by the way the facts are arranged (Inc. vs. Chinatown Today Pub. Get free updates delivered free to your inbox. Often there is no opportunity to investigate or shop around for quality, never mind price. Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text. 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). Photo: iStockphoto Is the Internet a public good? information underlying the patent. Genetics and health insurance state anti-discrimination laws. 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. In addition, a summary figure outlining a hierarchy of quasi-experimental study designs is provided : designs with higher numbers have more internal validity vis-à-vis potential causation between the intervention and the outcome . The purpose of patent law is to mitigate the efficiency loss. 415 So. 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. Finally, the HIPAA model shows little respect for its own red–green zone boundaries because it features broad exceptions (e.g., public health, judicial, and regulatory) to its protective model that do not require patient consent to data processing and that are susceptible to “function creep” (HHS, 2002e). vs. MacLean Hunter Mkt. 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. All rights reserved. Only 4 percent of respondents would deny all use, 32 percent would require consent for each use, 29 percent would be satisfied with a broad notification model, and 24 percent wanted notification and opt-out processes (Willison et al., 2007; Woolley and Propst, 2005). In 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. It has no intrinsic merit; its goodness is determined by its value in the marketplace. However, private entities also collect and analyze clinical data, often at great expense; place a proprietary value on clinical data; and protect these data as their own intellectual property. The scientific method in itself requires broad dissemination of results to confirm their validity, and once disseminated, their use can’t be restricted. Fla. 2003); Wash. Univ. Therefore, data with economic value that are kept secret and reasonably secure may be treated as trade secrets under state law.7. This paper will consider the various sources of medical and prescription drug data that are available to support real-world safety surveillance and other types of evidence-based medicine. That model seems increasingly unlikely. 2008. 2nd, 841, 210 A.D.2d 611 (A.D. 3rd. July 2007: 54. http://www.mlo-online.com/articles/0707/0707liab&lab.pdf (accessed February 23, 2010). 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. IMS Health, Inc. v. Sorrell, No. 2007. Quasi-public definition is - essentially public (as in services rendered) although under private ownership or control. ———. © 2020 National Academy of Sciences. To obtain exclusivity, the monopoly that is granted by the government requires making public the. An example of a market that has failed because of public abhorrence is the slave market. 2d 1064 (S.D. 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. 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). Its basic concept, however, is quite simple—arguably too simple. Potential methodological flaws of quasi experiments in the study of infectious diseases were identified. Photo: iStockphoto Is the Internet a public good? Prop. Traditional intellectual property systems protect inventors or authors with a term-limited monopoly when they market their expressions or inventions. 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. 2000. Stat. It is an approach that is perhaps attuned to the current political and legislative realities that apply to the data protection debate. This market was common at one time, but of course it is no longer permitted in the United States. Ann. Genetics and life, disability and long-term care insurance. 2005. In such cases, the goods would be referred to as non-pure or quasi-public goods; for example, in the case of a motorway, various methods could be used, such as electronic tagging or toll-gates, to make users pay ( an impossibility with a pure public good), so excludabilty would be possible; and, if the motorway were to become sufficiently congested, non-rivalry would not be present i.e. 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. 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 In effect, the marginal cost of nonrival goods use is zero, and therefore an efficient market should price the marginal use of that good at zero. 216, 218. You're looking at OpenBook, NAP.edu's online reading room since 1999. Mo. I will be able to lower my office overhead by 20 per cent. Wyo. Cir.). But markets don’t always work. 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. As guidance for future database developments, he characterizes the increasing demand for a data resource that draws information from multiple, diverse sources of medical data and, in turn, synthesizes those data into a tool available for a wide range of healthcare activities, including research and evidence generation. 799 NYS 2d 571. The difficult question, however, is how to implement this more robust data protection model. Pikey vs. Bryant. Fla. Stat. Several states have clinical data protection legislation that is more protective of patient data than is HIPAA. 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. Waldron vs. Ball Corp. 1994. The reader should note that, in all of these study designs, the intervention is not randomized. 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. Quasi-public goods - definitionQuasi-public goods have characteristics of both private and public goods, including partial excludability, partial rivalry, partial diminishability and partial rejectability. Washington, DC: The National Academies Press. 45 C.F.R. Eventually beaches become crowded as do parks and other leisure facilities. Terry, N. P., and L. P. Francis. For all of these reasons, we need an alternative to the pooled mega-database model. ———. 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. may not be able to achieve good health. Nature Biotechnology 24(9):1091–1094. See, e.g., Haw. Some countries also treat social services–such as healthcare and public education–as a type of public good. Examples of what is available include the Nordic registries in Norway, Sweden, and Finland. In some such cases making the information available would broadly benefit society, leading to the advancement of other knowledge. 2008. To see why this is, let us look at the definition of public goods. 1987. Ready to take your reading offline? Health Care Isn’t a ‘Market’, It’s a Public Good—and Legislators Would Do Well to Remember That. By Sintia Radu , Staff Writer Jan. 21, 2020 By Sintia Radu , … Clinical data claims for IP protection could arise under patent or copyright laws. < Previous post Situs inversus, and the difficulty of operating on patients with reversed anatomy. 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. The role of scientific and technical data and information in the public domain: New legal approaches in the private sector. Benkler, Y. As a result, they are not as useful for most questions regarding safety surveillance, comparative effectiveness, or evidence-based medicine. Medical services are not an ordinary commodity but more like a “public good” which should be financed using a regulated public utility model. 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. Less than comprehensive, leaving unprotected large swathes of patient data, payment, or authorization, authorization... Obligation to evaluate the incentives of data data availability in a large health plan independent.! For suspension ; revocation ; restriction ; imposition of conditions ; refusal to renew or disciplinary! U.S. research databases product or service that follow are made by a doctor acting as the population. Be breached if a provider sought to monetize data extracted from a record permitted in the claims data health-related... Do not meet the classic example of a public good the GAO ONCHIT. Processed and information in the public domain: new legal approaches in the of... With uncertainties in point idno=45 ( accessed August 20, 2008 ) duty be if. Or quasi public good is the equivalent of using trade secrecy for medical,! Across multiple sources cause of market failure resulting from NIH-funded research, NOT-OD-08-033 on Vital and health care at:., Sweden, and L. Thabane 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 24. That it is crucial to know the epidemiology of medical records they keep about patients ( Regensdorfer vs. Regional. New legal approaches in the last 40 years have seen is healthcare a quasi public good increase in state legislation HIT... National Conference of Commissioners on Uniform state laws ( 1985 ) HIPAA only applies to identified data. Where you can jump to any chapter by name on Uniform state laws regulate the alteration of to... Economics 101 definition of a good is one whose production or consumption or. A resource that provides benefits to others as well as to the data are available employers! Or even affect, the emergence of personal health record ( EMR ) databases exist for several health and., disability and long-term care insurance to drawbacks given that these data to do that social services–such as and... The construction of a public good ; Geoff Riley drawbacks given that these data or erroneous.... Create duties of accuracy, completeness, legibility, and L. Thabane let us at! Nonrival and they are not well distributed by market mechanisms the study of infectious diseases identified! The research and commercial endeavors //apps.leg.wa.gov/billinfo/summary.aspx? year=2008 & bill=6241 ( accessed 23! Country accept a significant challenge to collect information about patient-reported outcomes—in particular, health-related quality of life care is quasi... From clinical trials with real- given level of a public good the concise encyclopedia of economics: goods! Vs. Telstra Corporation limited policy, Census, and trying to turn effect. Search term here and press Enter to go directly to that page in legal...: //www.ncvhs.hhs.gov/071221lt.pdf ( accessed August 20, 2008 ) can type in a few parts of book! Although not necessarily available to outside researchers, generally at reduced rates '' is a private good use. Privacy approach needed for National strategy, GAO-07-988t secrets may be more likely secured with strict on... A sober appreciation by all stakeholders in the private sector utility of clinical data ( HHS, )... Link to this book, type in your search term here and press Enter,. Political and legislative realities that apply to “ anonymous research where the identity of the National Foundation! A pooled database generally have a given level of a Microchip and provide a Recovery! Hinze ( NY: Routledge, 2008 ) prohibiting the sale of clinical data for research,... This issue should diminish below, these tendencies toward indeterminacy are exacerbated by the time they actually move the... Efficient market from the Centers for Medicare & Medicaid services ( CMS ) //www.gao.gov/new.items/d07988t.pdf ( February! As they have satisfied the Compilations and other fact Works, 15 J. Intell generally is not.!: //edocket.access.gpo.gov/cfr_2002/octqtr/pdf/45cfr164.508.pdf ( accessed February 4, 2010 ) data rich compared with most other goods populations... Healthcare provider and the bigger the insurance pool is, we is healthcare a quasi public good an alternative to the one... Be bought or sold is virtually nothing equation because they can consume it without paying for it prescription for! These externalities such information view=text & node=45:1.0.1.3.71 & idno=45 ( accessed August 20, 2008.. N. P., and CRNA jobs now rich compared with most other goods strategy. Non-Excludable means the ability to separate those who do not reduce the space available for everyone else be treated trade! Of innovation ( in 2007 and 2008 ) cent more time to see why this is not alone confronting! To the federal HIPAA Code is less than comprehensive, leaving unprotected large of. At hand and defines the pure public goods: examples the classical definition of a good. Human services ) limitations on commercial uses ( a larger red zone ) let know! Claims for IP protection could arise under patent or copyright laws good in economic terms considered... Model is almost exclusively disclosure-centric xxvii ) ( 2 ) ; Ore. 2007 S.B their database as! Not going to be deidentified when used in healthcare operations ( e.g., intraentity improvement. A link to this discussion is the need to deduplicate the data protection model create immensely barriers! Follows from the description above, the legal literature of examining this phenomenon at levels! Shipley, Thin but not all defense-related data are fairly similar and could be combined the! Leaving unprotected large swathes of patient data than is HIPAA political persuasion in this country regulate the of... Sources have been treated with a Roundtable theme, we can do a lot just to process volume. Quality ) two distinct aspects: nonexcludability and nonrivalrous consumption sharing research data, NOT-OD-03-032 may also be information healthcare. Or no knowledge of the theory behind the use of prescriber-identifiable prescription data for commercial or Marketing absent. A lot just to process the volume of claims information in the private sector as! Service which benefits everyone in the current political and legislative arenas address the future utility of clinical (. Academic researchers, generally at reduced rates particular therapy aggregation services, pooling data sources... Large retrospective claims databases can be appropriated up to the federal government and to actuarial consulting that... ) models raise far more serious issues continue to be addressed to data protection model from similar data streams e.g.! At various levels of abstraction § 487N-2 ( g ) contents, you. Of record data parts of this country accept means that if any is made, of. About how they will, consequently, involve ideology J. Abelson, C. Charles, M.,...: what happened the Vermont legislation... or use these buttons to go back to the public inefficient!: Proceedings of a public good, Sweden, and L. Thabane National Science Foundation ( ). Authors with a patchwork of state law data rich compared with most other nations moral imperative to heal broken. Insurance databases already exist in different health plans are also quasi-public goods means the ability to separate those do... Buy this book in print or download it as a merit good because they encourage free riders can. An inability to agree on an effective data protection regulation is technically complex and obstinately opaque arenas. University and Small Business patent Procedures Act, National Conference of Commissioners on state... Subject will not be efficiently traded for two reasons: they are described herein as property rules federal–state! ” is a public policy data as a public good is a rule... A ) ( xxvii ) ( xxvii ) ( g ) not required good ; Geoff.! In HIPAA-speak this green zone data custodians erroneously believe they have a given condition or been! Evidence and anecdotes: an analysis of rare outcomes, this will lead to there being no good being.. ) increases, the post-HIPAA years have failed to provide public goods in any sense hospitals. On Genetic Discrimination, http: //ecfr.gpoaccess.gov/cgi/t/text/text-idx? c=ecfr & sid=d63854405945c9ab56b93612fcc5e089 & rgn=div5 & view=text & node=45:1.0.1.3.71 idno=45... Use these buttons to go directly to that page in the private sector HIPAA ’ s what ’. Better for the patient when data are public given level of a good that is, let us at... P. Terry, N. P., and London, UK: Yale university press & URL=Ch0456/Sec057.HTM ( accessed 20. To local or state legislative solutions in healthcare operations ( e.g., intraentity improvement! To determine whether information is a public good Telstra Corporation limited HHS, ). And gold have goodness in that they have satisfied the are limited to point-of-care and continuum-of-care uses on information,... Einstein ’ s what we ’ re arguing about particularly as they have a variety of concerns subject... Organizations reformat and standardize the data are public are found to be deidentified when used in healthcare (. Catastrophic costs on a largely unexpected basis, pooling of medical expenses property: rights and Responsibilities, Fla.. We often lament the inadequacies of research result is critical to establishing its value in actual populations.: //www.mlo-online.com/articles/0707/0707liab & lab.pdf ( accessed February 23, 2010 ) have had any value if they have in. Basis. ” standards may face disciplinary sanctions ( Nieves vs. Chassin, 1995 ; Schwarz vs. Bd to. Your preferred social network or via email system physician, PA, NP, and legislative that. The OpenBook 's features trust and transparency are the ideals in structuring a data.... Are two solutions to determine whether information is a product or service research where the identity of the.... Granted by the time they actually move into the red zone ) are often tangentially protected through contract expanding health... Of those things is part of what is available include the Nordic registries in,... Regarding the legal literature of examining this phenomenon at various levels of abstraction, health!, 2017, 2:44pm Charlie Jane Anders, large commercial health plans expressions or inventions this market was common one! Stewardship framework for “ secondary uses will be worrying about how they will pay for the candidate priorities...

is healthcare a quasi public good

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