HealthLawProf Blog

Worth Reading This Week

Ezekiel Emanuel & Jerry Menikoff, Reforming the Regulations Governing Research with Human Subjects, NEJM

Tim Greaney, The Affordable Care Act and Competition: Antidote or Placebo? SSRN/Oregon Law Review

Kate Greenwood, The Ban on 'Off-Label' Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis Against False or Misleading Commercial Speech? SSRN/AJLM

John M. Golden, WARF's Stem Cell Patents and Tensions between Public and Private Sector Approaches to Research, SSRN/JLME

[NPT] 

 

IoM and the Device Industry

Interesting piece in the New York Times by Barry Meier, here, on the device industry's preemptive attack on an Institute of Medicine report prepared for the FDA. [NPT]

Millennium Goals and a Norwegian’s Cognitive Dissonance

This month, the United Nations Department of Economic and Social Affairs released its Millennium Development Goals Report. It detailed how the international community was progressing towards its collective targets to address poverty, diseases, infant mortality, inequality, environmental harm and other problems set out in the Millennium Development Goals. While it acknowledges some progress in many areas, there is a long way to go:  

• The poorest children have made the slowest progress in terms of improved nutrition
• Opportunities for full and productive employment remain particularly slim for women
• Being poor, female or living in a conflict zone increases the probability that a child will be out of school
• Advances in sanitation often bypass the poor and those living in rural areas
• Improving the lives of a growing number of urban poor remains a monumental challenge
• Progress has been uneven in improving access to safe drinking water

The same day I read the report, I also viewed the appalling video “Knights Templar 2083” posted (but now deleted and I am unable to relocate it) by Anders Behring Breivik. The video complemented his manifesto, reported on here. As you may know, Breivik is the Norwegian right-winger who murdered 76 people in Oslo in order stop the Norwegian Labor Party from “driving its ideology” and “deconstructing Norwegian culture and mass-importing Muslims,” according to his reported statement in court. The video reveals the foundations of Breivik’s worldview: the supposed post-WWII institutionalization of Marxist views that is leading to the “deconstruction” of European culture though national governments and bodies like – you guessed it – the United Nations.  

All I can say is that I wish Breivik had been born in a developing country to a single mother suffering from AIDS, malnutrition, and a lack of access to clean water. Or had grown up in an indigenous community where the effects of colonization had wiped out most of his ancestors and deprived them of their lands. Then perhaps he would have really understood what cultural annihilation is all about, and even the role that white, Christian European men may have played in it. The response to his actions should not be fear; it needs to be renewed support for inclusive and compassionate programs that celebrate life and human dignity, programs that the Millennium Goals are designed to generate.

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Proposed Rulemaking for Regulations Governing Medical Research

Thanks to Ellen Fox at the VA for reporting that HHS has proposed major changes to the "Common Rule" that governs medical research on people. You can find the notice of the proposed changes at the HHS website. Ezekiel Emanuel and Jerry Menikoff have an article on the proposal in the New England Journal of Medicine.

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Worth Reading This Week

Nan Hunter, Health Insurance Reform and Intimations of Citizenship, SSRN/U.Pa. L.Rev.

Tim Greaney, Regulating to Promote Competition in Designing Health Insurance Exchanges, SSRN/Kansas Journal of Law & Public Policy

Orly Lobel & On Amir, Healthy Choices: Regulatory Design and Processing Modes of Health Decisions, SSRN

Eric Helland et al, Tort Liability and the Market for Prescription Drugs, SSRN

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Private Equity & British Care Homes

In earlier posts I have discussed the “care/profit tradeoff in nursing homes,” focusing on the role of private equity firms in reducing costs by limiting the liability of their enterprises. Cutting nursing staff and increasing the risk of elder neglect isn’t so costly for private equity barons when “complex corporate structures . . . obscure who controls their nursing homes.” One firm constructed a particularly notable series of corporate moats between itself and the nursing home which it first controlled, and then rented land to.

Daniel JH Greenwood has called a good deal of private equity activity a form of looting, and I have explored its shortcomings in a review of a book on the topic. Sadly, it appears that the private equity influence in Britain is undermining a key part of its health care system. Having stacked various care homes with debt in order to buy them, many private equity firms have abandoned (or are about to abandon) the homes:

[A new] report, delving into the running and funding of the care industry, reveals that the collapse of Southern Cross may not be a one-off, as a number of other social care companies are also on the brink. Private equity takeovers of public services that use similar high risk business models, could leave taxpayers picking up the bill for more company failures. The in-depth study of privatisation shows that the second largest care provider, Four Season, is also in severe financial difficulties and others may follow. If both Southern Cross and Four Seasons were to collapse, around 1,150 nursing and residential care homes would be at risk of closure, affecting nearly 50,000 vulnerable people and their families and hitting over 60,000 staff.

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Position Opening: Garwin Distinguished Visiting Professor of Law and Medicine

The Southern Illinois University School of Law is seeking nominations and applications for the Garwin Distinguished Visiting Professor of Law and Medicine for the 2012-13 academic year.  Established in 1996, the Garwin Professorship is funded in part by a grant from the Garwin Family Foundation which was established in 1993 for the purposes of fostering education and academic research.  Support for the position includes a competitive salary, benefits, travel allowance, housing for one year, and a research assistant.

With 35 faculty members and approximately 350 students, the Southern Illinois University School of Law enjoys one of the best student-faculty ratios of any law school in the country.  The School, and it's Center for Health Law and Policy (established in 2004), offer an outstanding health law program with a variety of courses as well as co-curricular and extra-curricular activities.  This includes a unique M.D./J.D. dual degree program offered in conjunction with the SIU School of Medicine. The School of Law also offers an LL.M. in Health Law and Policy, as well as a Masters of Legal Studies in Health Law and Policy. In conjunction with the American College of Legal Medicine, the School of Law participates in the publication of the Journal of Legal Medicine (since 1981) and Legal-Medical Perspectives (since 2000). The School also hosts each year (since 1992) the National Health Law Moot Court Competition, the only national competition focusing on health law issues. Since 1999, the School has also sponsored the annual SIH/SIU Health Policy Institute. Additionally, beginning in 2006, the School of Law has hosted each spring the John and Marsha Ryan Bioethicist in Residence.

Minimum Qualifications:  Applicants must possess the Juris Doctor degree or its equivalent from a nationally-accredited law school, be currently on the faculty of an accredited school of law or other graduate professional school, and have an outstanding national reputation as a health law/policy scholar and teacher.  Factors to be considered in assessing candidates for the Garwin Visiting Professorship include the following: scholarly and teaching record, honors received (e.g. awards, fellowships, etc.), participation and leadership in national and international organizations, letters of recommendation and other factors relevant to assessing qualifications for this position.

Areas of Concentration: Health law and policy including without limit any of the following – medical malpractice, food and drug law, public health law, and bioethics and the law, and possibly in the area of torts. Duties & Responsibilities:  (a) classroom instruction; (b) research and publication involving legal analysis of a high quality; (c) a public lecture. Deadline for application: October 15, 2011 or until position is filled.

To apply or nominate a candidate:  Applications may be submitted electronically at http://law.siu.edu/employment or by U.S. mail.  A completed application will require a letter of application, a resumé, and the contact information for three references.  The letter should be addressed to:

Professor W. Eugene Basanta, Chair, Garwin Visiting Professor Search Committee, Southern Illinois University School of Law, Mail code 6804, 1150 Douglas Drive,Carbondale, Illinois  62901

Applications and nominations may be submitted on line at http://www.law.siu.edu/employment/.

SIUC is an affirmative action/equal opportunity employer that strives to enhance its ability to develop a diverse faculty and staff and to increase its potential to serve a diverse student population.  All applications are welcomed and encouraged and will receive consideration. 

Guest Blogger Eleanor D. Kinney: Greetings from Puerto Vallarta!!

  El 18 de Julio

 

 

There is a country south of the border – the United Mexican States – with a per capita GNP less than one- third that of the United States (See Figure 1).  Yet that country, Mexico, has committed to universal health coverage for all its citizens as a matter of right.  With amendments of 2003, the Mexican constitution recognizes a constitutional right to health and health care.  Further, Mexico has adopted many of the international and regional human rights treaties that recognize an international human right to health (U. Minn).

 

 

The Mexican Constitution of 1917 (as amended to 2003) has two provisions regarding health and health care in its con­stitution. Constitución Política de los Estados Unidos Mexicanos [Constitution], as amended, Diario Oficial de la Federación [D.O], art. 4, 5 de Febrero de 1917 (Mex.).  One provision establishes a “right to health protec­tion” and sets forth what subordinate federal statutory law will authorize: 

Every person has the right to health protection. The law will describe the basis and means for access to health care services and will establish the concurrence of the Fed­eration and the federative entities in matters of public health. Boys and girls have the right to satisfy their nutrition, health, and education needs and for healthy recreation for their total development.

Figure 1 Relevant Statistical Indicators for the United States, Canada and Mexico
	Per capita GDP 2010*		Per Capita Health Expenditures, 2007**
	$s	Rank	$s	% of GDP	Rank
Mexico	15,224	47th	823	5.9	29th
United States	47,084	6th	7,290	16.0	1st
Canada	39,699	10th	3,895	10.1	5th
Sources:   *World Bank Group, 2010 **Organization for Economic Cooperation and Development, 2007

As discussed in my last blog entry, the Mexican Congress amended the Ley General de Salud to establish the System for the Social Protection in Health (SPSS) to establish the Seguros Popular for Mexico’s uninsured.  Ley General de Salud [The General Law of Health], as amended, art. 18, Diario Oficial de la Federación [D.O.], 7 de Febrero de 1984 (Mex).  The Seguros Popular initiative includes a universal health insurance scheme called the System for Social Protection in Health (SSPS). The health insurance scheme is financed jointly by the federal government, the states and higher income enrollees.

SSPS covers an essential package of personal health services for low risk, high probability illnesses and injuries. The services include ambulatory primary care and hospitalization for secondary care. The package of essential services is covered by funds at the state level. For the most part, services are provided through a network of providers who work for the state and federal public health sectors. The package of catastrophic interventions includes low-probability, high cost illnesses and injuries including cancers, cardiovascular disease, stroke, severe injuy and HIV-AIDS. Covered services include long-term rehabilitation, neo-natal intensive-care, organ transplantation, and dialysis. These tertiary care services are more limited and funded at the federal level.    (See F. Knaul and H. Arreola 2006).

With implementation starting in January 2004, the a seven year transition period during which SP will be offered on a progressive and voluntary basis to all Mexicans who are not already enrolled one of Mexico’s social insurance institutions. The aim was to have universal coverage in Mexico by 2012. There has been much progress in achieving this goal.  This progress and other aspects of the SSPS and SP are detailed on the website of the Comisión Nacional de Protección Social en Salud and the commission’s annual reports.  (See Comisión Nacional de Protección Social en Salud, Informe de Resultado del Segundo Semestre de 2009 (2009).

Before the Seguros Popular, more than 50 percent of Mexico’s population was uninsured (Knaul et. al., 2003).  Half of the Mexican population was at risk for catastrophic out of pocket medical costs and very limited access to health care services. The express purpose of Seguro Popular was to address this access problem for the poorest members of Mexican society. 

The big question for Seguros Popular generally and SSPS in particular is whether Mexico will be able to carry them off over the long term. The goal of extending coverage seems to be quite achievable. The real question will be if these coverage expansions can be absorbed by the Mexican health care sector and, in particular, the public provider network that serves the informal worker sector?  Also, can they be absorbed without unduly raising the cost of health care services in Mexico?  Finally, with the care provided under the initiative be of high quality? Fortunately, the Comisión Nacional de Protección Social en Salud is well aware of these issues and have been careful to evaluate coverage expansions and other aspects of the initiative.  

It is most interesting compare Mexico to its Northern neighbors, the United States and Canada. Clearly Mexico is more attuned to Canada with its guarantee of health coverage as a matter of right. Seemingly absent from the Mexican experience is the discussion of “government takeovers” of health care and concerns that government sponsored health bill bankrupt the country. One gets the sense that the Mexican government and the people of Mexico believe that health coverage for all people is important a country’s development and are willing to put universal coverage as a national priority.  

Hasta la Vista! 

 Eleanor D. Kinney

 

Electricty Rate Hikes Weighed Against Disease Prevention

The Environmental Protection Agency is finalizing two Clean Air Act regulations.  The Cross-State Air Pollution Rule requires 27 states to improve air quality by reducing power plant emissions that contribute to ozone and/or fine particle pollution. The Power Plant Mercury and Air Toxics Rule will limit mercury, acidic gases and other toxic pollution emanating from power plants, keeping 91 percent of the mercury in coal from being released to the air. Currently, there are no national limits on the amount of mercury and other toxic air pollution released from power plant smokestacks.

 Many operators of older power plants are lobbying for exemptions to the rules, as reported in yesterday’s Environment and Energy Daily newsletter. Out in front of this effort is the National Association of Regulatory Utility Commissioners (NARUC), who is meeting next week to consider passing a resolution (available here on Page 20) that would call on Congress for more flexibility in implementing the rules.

The American Lung Association, American Public Health Association, Asthma and Allergy Foundation of America and Physicians for Social Responsibility Trust for America’s Health is urging NARUC in a letter sent last week to reject taking this stance, claiming the rules will prevent asthma, heart attacks and premature deaths.

As suggested some of my previous postings, Congress has been very sympathetic to industry’s claims about the economic burdens of pollution regulations, with several proposals on the table to weaken or delay them. It is a values discussion couched in cost benefit calculations: how much does the prevention of premature deaths or asthma benefit society in dollars, so that it can be compared to the monetary costs of higher electricity rates in areas served by older plants? If Congress steps in to delay the rules, it would be helpful if the proponents explicitly discussed those trade-offs, but they rarely do.

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Attempted Suicide Is Not a Crime--Unless You're Pregnant

I've written before about a murder prosecution in Indianapolis against a woman who swallowed rat poison in a suicide attempt while she was 33 weeks pregnant. If convicted, she would receive a minimum sentence of 45 years in prison, with the possibility of capital punishment. The trial court judge refused to dismiss the charges, and the court of appeals will consider the motion to dismiss next month. Nada Stotland and I wrote about the case in today's Indianapolis Star.

In about two weeks, I'll be filing an amicus brief on behalf of the American College of Obstetricians and Gynecologists, other medical groups, and individuals in support of the motion to dismiss charges. Many professors of medicine, bioethics and law have agreed to participate.  Others interested in doing so should contact me at [email protected]

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Auditing Studies of Anti-Depressants

Marcia Angell has kicked off another set of controversies for the pharmaceutical sector intwo recent review essays in the New York Review of Books. She favorably reviews meta-research that calls into question the effectiveness of many antidepressant drugs:

Kirsch and his colleagues used the Freedom of Information Act to obtain FDA reviews of all placebo-controlled clinical trials, whether positive or negative, submitted for the initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. . . .Altogether, there were forty-two trials of the six drugs. Most of them were negative. Overall, placebos were 82 percent as effective as the drugs, as measured by the Hamilton Depression Scale (HAM-D), a widely used score of symptoms of depression. The average difference between drug and placebo was only 1.8 points on the HAM-D, a difference that, while statistically significant, was clinically meaningless. The results were much the same for all six drugs: they were all equally unimpressive. Yet because the positive studies were extensively publicized, while the negative ones were hidden, the public and the medical profession came to believe that these drugs were highly effective antidepressants.

Angell discusses other research that indicates that placebos can often be nearly as effective as drugs for conditions like depression. Psychiatrist Peter Kramer, a long-time advocate of anti-depressant therapy, responded to her last Sunday. He admits that “placebo responses . . . have been steadily on the rise” in FDA data; “in some studies, 40 percent of subjects not receiving medication get better.” But he believes that is only because the studies focus on the mildly depressed:

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The "July Effect" Confirmed

It has long been suspected that July is not a good time to seek medical care at a teaching hospital as new trainees join the care teams. Dr. John Young and colleagues writing in the Annals of Internal Medicine, here, demonstrate this is no myth. Such "cohort turnover" does indeed lead to the chillingly labelled "August killing season." Concentrating on what the researchers viewed to be high-quality studies they found considerable correlation between cohort turnover and increased mortality. A similar negative picture emerged with regard to increased hospital stays, hospital bills and other efficiency metrics. How do we fix this? The researchers suggest looking at workload burdens during the turnover and also staggering the way the cohorts move in and out of the system. So, there's another one to add to the process reform list. [NPT]

 

Guest Blogger Eleanor D. Kinney: Greetings from Puerto Vallarta!!

 El 10 de Julio

Greetings from Puerto Vallarta!! 

 

I am your guest blogger for July. I will be blogging from South of the Border – precisely from Puerto Vallarta, Jalisco, Mexico. My major topic in my guest blog will be health care in Mexico. There is much to learn from colleagues south of the border.

Mexico has a relatively advanced health care sector with morbidity and mortality patterns of modern industrialized countries. While there is still poverty in Mexico, with persistence of diarrheal and other infectious disease indicative of third world countries, there is greatly increasing morbidity and mortality from coronary artery disease, diabetes and other chronic diseases that plague more developed countries. See World Health Organization, Country Cooperation Strategy:  Mexico (2006). Indeed, Mexico is now experiencing a tremendous epidemic of diabetes. Elizabeth Barclay, In Mexico, Diabetes Strains Lives and Budgets, New York Times, June 12, 2007.   

Mexico's social security system provides direct health care services to about 50 percent of the population who work or have a family member who work in the formal economic sector. The Mexican Institute of Social Security (Instituto Mexicano de Seguro Social (IMSS)) covers approximately 80 percent of these private sector beneficiaries. The Institute of Security and Social Services for State Workers (Instituto de Seguridad y Servicios Sociales para los Trabajadores del Estado (ISSSTE)) covers government workers and accounts for 17 percent of the beneficiaries. There are separate systems that provide health coverage and care sponsored by the Secretariat of National Defense (Secretaría de Defensa Nacional), the Secretariat of the Navy (Secretaría de Marina), and Mexican Petroleum (Petróleos Mexicanos (Pemex)).   These programs are financed with contributions from employees, employers, and/or government. See Tim L. Merrill and Ramón Miró (ed.), Mexico: A Country Study. Washington: GPO for the Library of Congress (1996).  

In 2003, the Mexican Congress amended the Ley General de Salud to establish the System for the Social Protection in Health (SPSS) for the uninsured population who were not otherwise eligible for coverage under IMSS or ISSSTE. Ley General de Salud [The General Law of Health], as amended, art. 18, Diario Oficial de la Federación [D.O.], 7 de Febrero de 1984 (Mex). The reform includes the Seguro Popular (SP), which is a health insurance scheme financed jointly by the federal government and the states. SP will expand health care coverage to the entire population of Mexico by 2012, starting with the poorest families. Specifically, the reform includes five actions: (1) legislation establishing entitlement to coverage for eligible families; (2) creation of explicit benefits packages; (3) funds to state ministries of health in proportion, calculated on the basis of eligible families within the state; (4) division of federal resources flowing to states into separate funds for personal and non-personal health services; and, (5) creation of a fund to protect families against catastrophic health expenditures.

In 2009, Mexico had an uninvited opportunity to showcase its public health and health care delivery capabilities in the H1N1 flu pandemic of 2009. That spring, Mexico experienced outbreaks of influenza-like illness (ILI). On April 12, 2009, Mexico confirmed an outbreak of ILI occurred in La Gloria in the state of Veracruz and reported this outbreak to the World Health Organization (WHO). Later in April, outbreaks of severe pneumonia in Distrito Federal (Mexico City) and San Luis Potosi precipitated increased surveillance throughout the country. The high fatality rate of the novel influenza A (H1N1) infection among younger, previously healthy people was particularly disturbing.

The WHO announced that this outbreak of influenza A (H1N1) virus in Mexico and the United States marked the beginning of a worldwide pandemic. Mexico reacted quickly and aggressively in its surveillance and social distancing measures. The Mexican government cooperated immediately with international health organizations and neighboring countries to address the flu outbreak. By mid- April, the Mexican government issued a national epidemiologic alert to all influenza-monitoring units and hospitals asking that they test and report all cases of severe respiratory illness. On April 24, the government ordered that all schools and large public gatherings, such as soccer games in Mexico City and surrounding areas, be closed or suspended for about ten days. By May, Mexican authorities reported that the outbreak had likely peaked in late April. WHO publically acknowledged that Mexico had been cooperative and forthright in addressing the influenza A (H1N1) outbreak.  World Health Organization, “Influenza-Like Illness in the United States and Mexico,” April 24, 2009. Mexico’s decisive actions did much to mitigate the spread of the H1N1 flu pandemic throughout the world. 

In my next blog entry, I am going to talk more about Mexico’s efforts to extend universal coverage for all its citizens being with the poorest. The third blog entry will address portability of health insurance across the borders and will focus on making Medicare fully portable. The final blog entry will assess the impact of the North American Free Trade Agreement (NAFTA) on the Mexican health care sector.  

 I look forward to comments and discussion.  

 Hasta la Vista! 

-Guest Blogger Eleanor Kinney

  

Introducing Guest Blogger Eleanor D. Kinney

We are very pleased to welcome our Guest Blogger for July, Eleanor D. Kinney. Here is her bio:

Eleanor D. Kinney is the the Hall Render Professor of Law Emeritus and founding director of the William S. and Christine S. Hall Center for Law and Health at Indiana University School of Law – Indianapolis.  She is also an adjunct professor in the Schools of Medicine and Public and Environmental Affairs.  A widely published author and respected lecturer on the subjects of America’s health care system, medical malpractice, health coverage for the poor, and issues in administrative law, Professor Kinney is author or co-author of numerous law review articles, peer-reviewed health policy articles, book chapters and book reviews. She recently published Protecting American Health Care Consumers (Duke University Press 2002) and edited the Guide to Medicare Coverage Decision-Making and Appeals (ABA Publishing 2002).

Professor Kinney received her J.D. and B.A. (with distinction in history) from Duke University.  She also has a masters degree in public health from the University of North Carolina – Chapel Hill and a masters degree in European history from the University of Chicago.  After graduating from law school, she practiced law for four years at Squire, Sanders & Dempsey in Cleveland, Ohio and then worked as an estate planning officer for Duke University Medical Center. After earning her master’s degree in public health, she served as program analyst for the U.S. Department of Health and Human Services in Washington, D.C.  She received an award from the DHHS Office for Civil Rights for Distinguished Performance on the New York City Health and Hospitals Corporation Investigation for 1979‑1980.  Before joining the IU faculty in 1984, she was Assistant General Counsel of the American Hospital Association.

Professor Kinney has served as a consultant to the Administrative Conference of the United States, President Clinton’s Task Force for Health Care Reform, and the Indiana Commission on Health Care for the Working Poor. She has been appointed by the governor of Indiana to the Executive Board of the Indiana State Department of Health and to other task forces and advisory boards.  During 1999-2000, Professor Kinney was a Fulbright Fellow at the National University of La Plata in La Plata, Argentina.  In 2005-2006, Professor Kinney served as Chair of the American Bar Association's Section on Administrative Law and Regulatory Practice and was inducted as a fellow of the Section in 2007. 

In 2010, she received the Jay Healey Award for Excellence in Teaching, Health Law Professor’s Section of the American Society for Law, Medicine and Ethics. In 2022, she received the IUPUI Senior Woman’s Leadership Award. In 2000, she received Distinguished Alumna Award for Lifetime Achievement from her alma mater, Emma Willard School. In 1986, she was awarded the Best New Professor Award by the Student Bar Association of Indiana University School of Law – Indianapolis.  Professor Kinney is a member of the American Law Institute. 

Professor Kinney’s current research interests focus on the realization of the international human right to health, free trade policy and health care, improved administrative law and procedures for a reformed health law system and an improved system for the resolution of medical malpractice claims.

Your Health Insurance Exchanges Primer

A few months ago predicting the actual date for the announcement of the ACO proposed rule, here, was (almost) as exciting as awaiting a new product announcement from Apple. Well, just as Apple spoiled "Christmas" the other month by pre-announcing the contents of a Steve Jobs product presentation, so Secretary Sibelius, here, has told us that the Exchanges rule is being published today with a summary that somewhat desperately tries to make them appear more user-friendly than the frankly geeky mechanisms they truly are. There are some good resources for the Exchanges newbie, including Julie Appleby's March primer in the Washington Post, here and Sarah Kliff writing for Politico, here. For more detail I recommend Jon Kingsdale and John Bertko writing in Health Affairs, here and, of course, the masterful Tim Jost writing for the Commonwealth Fund, here. Update, HHS site now has Exchanges overview plus links to NPRMs, here. [NPT]

 

Worth Reading This Week

Dwight Golann, Dropped Medical Malpractice Claims: Their Surprising Frequency, Apparent Causes, And Potential Remedies, Health Affairs (Health Aff July 2011 vol. 30 no. 7 1343-1350 Subscription)

Marc A. Pfeffer & Marianne B. Bowler, Access to Safety Data — Stockholders versus Prescribers, NEJM

Tine Hansen-Turton, Jamie Ware, and Frank McClellan, Nurse Practitioners in Primary Care, SSRN/Temple L.Rev.

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Poor Man's Privacy Law May Have Teeth

I am not a big fan of data breach statutes whether legislated by the states (usefully collected here) or the federal government, for example Sec. 13402 HITECH and regulations made thereunder (outlined here). Practically, they seem to embrace a "horse bolted after we left the barn door unlocked" approach to data protection. And,from a policy perspective, they strike me as a lazy post hoc (and sometimes sectoral) legislative responses to a problem that deserves a more comprehensive and integrated regulatory model.

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Beyond Innovation and Competition, Health IT Edition

Last year I published a piece called “Beyond Innovation and Competition,” questioning the dominance of those values. Economists celebrate innovation and competition as the main source of future growth. Innovation has become the central focus of Internet law and policy. While leading commentators sharply divide on the best way to promote innovation, they routinely elevate its importance. Business writers have celebrated search engines, social networks, and tech startups as model corporations, bringing creative destruction and “disruptive innovation” in their wake. Maximum innovation is the goal, and competition is billed as the best way of achieving it. Players in the vast and dynamic tech marketplace are supposed to constantly strive to innovate in order to attract consumers away from rivals.

In the piece, I explain how both competition and innovation can be as destructive as they are constructive. There are many social values (including privacy, transparency, predictability, and stability), and companies can compete for profits in ways that erode those values. In an era of inequality and hall-of-mirrors stock market valuations, innovations of marginal or negative impact on society at large can be vastly overvalued by a stampede of fickle investors.

The shortcomings of the innovation and competition story also play out in health information technology. Stimulus legislation in 2009 provided many carrots and sticks for doctors to digitize their recordkeeping systems, ranging from bonuses now to reimbursement haircuts later this decade if they fail to implement the technology. Congress structured the incentives to encourage a competitive and innovative marketplace in health information technology. But many doctors are shying away from implementation, in part because they fear that the fast and loose ethics of the market can’t mesh with a medical culture of constant commitment to quality care.

Susan Jaffe’s article for the Center for Public Integrity examines doctors’ fears about adopting any given software suite. According to Jaffe, “570 different electronic health systems certified by private organizations for non-hospital settings may be used to qualify for the” stimulus funds. The long-term consequences of the choice make the jam-shopping examples in Barry Schwartz’s book The Paradox of Choice seem quaint:

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Electronic Medical Records Overhyped?

Many policy experts and public officials have touted electronic medical records for their promise in promoting safer, higher quality, and lower cost health care.  At the same time, critics have challenged the claims that have been made on behalf of e-records.  A new study demonstrates that computerizing prescriptions will not reduce medication errors as easily as has been thought.  

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Worth Reading This Week

Barry Furrow, Health Reform and Ted Kennedy: The Art of Politics...and Persistence, SSRN/New York University Journal of Legislation and Public Policy

Brietta Clark, Using Law to Fight a Silent Epidemic: The Role of Health Literacy in Health Care Access, Quality, and Cost, SSRN/Annals of Health Law 

Bradley Areheart, Disability Trouble, SSRN/Yale Law & Policy Review

Art Caplan, Book Review, Vaccination: Facts Alone Do Not Policy Make, Health Affairs (subscription)

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