The thought that the government will be assignment individuals a number that will be linked to all of their health information has drawn a significant amount of criticism and inspired some irrational fears. There certainly are some legitimate concerns associated with the National Patient Identifier (“NPI”). With the growth of electronic medicine comes a risk to privacy. [1] However, many concerns begin to look irrational. As one writer for the College of American Pathologists reports, “In some federal government offices, all one has to do to stop a conversation cold is mention a national patient identifier. That’s how adamantly Congress, in a 1998 bill, outlawed any plans for, considerations of, and even research on a national system of assigning patient ID numbers. ’I talk to federal bureaucrats who are very smart, very savvy people in every other respect,’ … ‘But when I start on national patient identifiers, they kind of cross themselves and say, ‘We can’t talk.” [2] Further, “critics fear a system in which someone armed with a patient’s ID number could learn that person’s medical history – including everything from abortions to Viagra prescriptions – at the touch of a button.” [3] Amusingly, some groups even fear that government identification numbers are the “Number of the Beast” spoken of in Revelations. [4] However, as will be discussed more fully in the next blog post, a NPI is actually less of a privacy risk than the Social Security Number or algorithmic matching methods currently used to identify patients, and in fact the NPI provides some unique advantages as well.
The next post in this series will discuss how use of Social Security Numbers and algorithmic matching to identify patients presents a greater privacy risk than the NPI.
[1] See Keith A. Bauer, Symposium: Ethics of Health Care Law Reform: Privacy & Confidentiality in the Age of E-Medicine, 12 J. Health Care L. & Pol’y, 47, 47 (2009).
[2] Anne Paxton, National patient ID: could a voluntary system fill the gap?, College of American Pathologist Today 2009 Archive, November 2009.
[3] Abdon M. Pallasch & Cornelia Grumman, Privacy Advocates Hit Patient-ID Plan: U.S. Health Care Number Safeguards Questioned, Chi. Trib., July 21, 1998, at 5.
The National Patient Identifier (“NPI”) is not a new concept, but is one that has not been realized due in part to concerns about the privacy of medical information. The Health Insurance Portability and Accountability Act (“HIPAA”) mandated the Secretary of Health and Human Services to “adopt standards providing for a standard unique health identifier for each individual, employer, health plan, and health care provider for use in the system.” (1) It has been noted that “the aim [of the NPI] was to provide better infrastructure support for linking of an individual’s medical records across health care, organizations and jurisdictions.” (2) However, citing privacy concerns, “On July 31, 1998, Vice President Gore announced that the administration would delay ‘implementing the unique patient identifier until Congress passed comprehensive privacy legislation.’” (3) In 1999, “Congress prohibited Health and Human Services from expending appropriations to finalize a standard for such an identifier. (4) The Appropriations Act specifically stated that “None of the funds made available in this Act may be used to promulgate or adopt any final standard under section 1173(b) of the Social Security Act providing for, or providing for the assignment of, a unique health identifier for an individual (except in an individual’s capacity as an employer or a health care provider), until legislation is enacted specifically approving the standard.” (5) ”This prohibition has been carried over in every appropriations bill since 1999, providing that the prohibition shall hold until legislation is enacted specifically approving such a final standard.” (6) Thus, concerns about ensuring the safety of the records associated with the NPI have existed since it was first proposed.
The NPI has emerged as a viable option because of a belief that its use will decrease medical errors and medical expenses. ”Today, a single patient is likely to have multiple healthcare identifiers – one for each insurer, and a different patient number for each physician or hospital where he or she receives care, and possible multiple identifiers if that care is delivered in a large healthcare organization that uses a variety of health IT applications. These multiple identifiers lead to fragmented medical records, duplicate tests, increased costs, delayed treatment, and poor outcomes.” By centralizing information, a NPI would reduce these problems in several important ways. First, “[i]f patient identification is more accurate and clinicians have access to electronic medical records across provider organizations, then contraindicated medications or procedures and redundant, unnecessary testing can be avoided.” Further, “[e]liminating the need for a patient to provide the same demographic information to every provider, perhaps at every encounter, not only improves patient satisfaction and staff productivity, but also minimizes the opportunity for medical identity theft.” And finally, “Establishing a consistent method for patient identification enables the creation, over time, of a comprehensive patient record as well as the accurate exchange of clinical data because up-front identification errors are avoided.” (7)
The next post of this series will address several of the fears associated with the NPI.
(1) 42 U.S.C. § 1302d-2(b)(1).
(2) Michael D. Greenberg & M. Susan Ridgely, Patient Identifiers and the National Health Information Network: Debunking a False Front in the Privacy Wars, 4 Journal of Health & Biomedical Law 31, 31-32 (2008).
(3) Susan E. Volkert, Telemedicine: Rx for the Future of Health Care, 6 Mich. Telecomm. & Tech. L. Rev. 147, 219 n.313 (2000).
(4) National Committee on Vital Health and Statistics Tenth Report to Congress on the Implementation of the Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act of 1996 [hereinafter NCVHS Report].
Suppose it were possible through the use of technology to reduce medical costs and medical errors, which at the same time increasing the security and privacy of patient medical information. A National Patient Identifier (“NPI”), wherein each American would have a unique, federally issued patient identifier is such a system. At the same time, the use of the NPI naturally raises concerns, some logical and some irrational, about the privacy and security of medical information. These concerns appear to be a primary obstacle standing in the way of actual adoption and use of the NPI. This series of blog posts advocates in favor of the NPI by identifying, analyzing, and responding to concerns about privacy raised by its use. Presumably, quelling fears about privacy will pave the way to use of the NPI.
The Affordable Care Act (“ACA”) had been hailed as signature legislation of the Obama administration and vilified as “Obamacare.” The United States Supreme Court has scheduled a virtually unprecedented three days of oral argument on the constitutionality of ACA, to take place in April. The Court will hear arguments on the “individual mandate” to maintain minimum coverage, on the requirement for states to expand Medicaid, on whether the federal Anti-Injunction Act bars challenges to the individual mandate, and on whether parts of the law may survive even if others fall.
On February 6, 2012 at 12:15 p.m., the 28th Annual Fordham Debate will preview expected arguments before the court. The event is free and open to the public. Defending the constitutionality of ACA will be David Orentlicher. Criticizing the constitutionality of the law will be Jonathan Adler.
Leslie Francis, Professor of Law at the University of Utah S.J. Quinney College of Law, will moderate. She said, “The debate will challenge everyone’s preconceptions about what the Court might do, and leave everyone more engaged in this tangled issue for the social safety net in the United States.”
Jonathan H. Adler is the inaugural Johan Verheij Memorial Professor of Law and Director of the Center for Business Law & Regulation at the Case Western Reserve University School of Law, where he teaches courses in environmental, administrative, and constitutional law. A graduate of Yale University and the George Mason University School of Law, Adler is the author or editor of four books and his articles have appeared in numerous publications. In 2004, Adler received the Paul M. Bator Award, given annually by the Federalist Society for Law and Policy Studies to an academic under 40 for excellence in teaching, scholarship, and commitment to students, and in 2007, the Case Western Reserve University Law Alumni Association awarded Professor Adler their annual “Distinguished Teacher Award.”
David Orentlicher, M.D., J.D., is Samuel R. Rosen Professor and co-director of the Center for Law and Health at the Indiana University Robert H. McKinney School of Law. He also serves as an adjunct professor of medicine at Indiana University School of Medicine. A graduate of Harvard Law School and Harvard Medical School, Dr. Orentlicher previously served as director of the Division of Medical Ethics at the American Medical Association. While there, he led the drafting of the AMA’s first patients’ bill of rights. Dr. Orentlicher published Matters of Life and Death with Princeton University Press, and he is co-author of the law school textbook Health Care Law and Ethics, now in its 7th edition. He also has written widely in leading legal and medical journals on critical issues in law and medicine.
The Fordham Debate is named in honor of Professor Jefferson B. Fordham, an outstanding legal scholar and defender of individual and civil rights who joined the University of Utah College of Law faculty in 1972. The annual debate addresses relevant contemporary public policy and legal issues.
The 28th Annual Fordham Debate will be held on Monday, February 6, 2012 at 12:15 p.m. in the Sutherland Moot Courtroom. It is free and open to the public. A light lunch will be provided to attendees. One hour CLE (applied for). Parking is available in the Rice-Eccles Stadium lot. For more information, call 801-585-3479.
The problem with the discourse related to abortion is that we seem to have taken nuanced legal holdings and converted them into binary competitions between the “right to abortion” and the “right to fetal life”. In its broadest strokes, as first articulated in Roe v. Wade, women never enjoyed an unqualified right to an abortion. Rather, the Supreme Court narrowly held that up until the moment of gestational viability (legally determined to be the third trimester) the state’s interest in the fetus was not compelling enough to counter a woman’s right to choose for herself whether to terminate her pregnancy. Subsequent precedent in this area has upheld 24- hour waiting periods and parental and spousal notification requirements, as these conditions were not deemed an “undue burden” on a woman’s decision to terminate her pregnancy. The case that made these restrictions constitutional was Planned Parenthood v. Casey.
Even though the Court in Casey found the trimester framework in Roe to not be binding authority, it still relied upon it to affirm that, pre-viability, women are able to terminate their pregnancies without undue interference by the state. Pro-choice advocates were appropriately concerned that Casey chiseled the right envisioned byRoe down to a mere liberty interest. Casey also rattled the cages of pro-choice advocates by stating that the government has legitimate interests from the “outset” of pregnancy (i.e., after fertilization) to protect the health of the woman and the life of the fetus/potential child.
In 2000, the Supreme Court heard Stenberg v. Carhart, a case which challenged a Nebraska statute that banned abortion by dilation and extraction (D&E, or so called “partial birth abortions”). In finding this statute unconstitutional, Justice Breyer signaled that a future statute may be upheld if it met two conditions: a) it provided for an exception to safeguard the life of the mother and b) rested on legislative findings supported by medical evidence that clarified the difference between intact and other types of dilation and extraction abortions.
Taking Breyer’s message from Stenberg seriously, in 2003 Congress passed the federal “Partial Birth Abortion Act.” This statute made factual findings that the method of abortion at issue, dilation and extraction, was “a gruesome and inhumane procedure that is never medically necessary and should be prohibited.” It also clarified that the prohibition was on intact D&E, not on other types. Finally, the preface stated that this particular type of procedure was never needed to save the woman’s life, as there were other methods available that were at least as effective and less risky. Thus, when the Court decided Gonzales v. Carhart (Carhart II), it held that the D&E method could be banned as Congress had made findings of fact.
Despite the movement toward recognizing greater state interests in the “unborn child,” absolute bans on abortion pre-viability have never been upheld as constitutional. In each Supreme Court case challenging Roe v. Wade, the Court has upheld the right of the woman to have an abortion pre-viability, while simultaneously acknowledging that the state interests exist pre-viability. Depending on your perspective, this trend counts as either a frightening slippery slope, or a predictable stare-decisis starecase. Either way, given this slow erosion of the right articulated in Roe, it is less surprising that states have sought more aggressive restrictions on a woman’s right to an abortion during the first two trimesters. One such way states have asserted a stronger state interest pre-viability is to rely on scientific data on the ability of fetuses to feel pain. The data they rely upon are mixed at best, raising the question of what types of scientific authority ought to be required before legislatures make findings of fact that are so deferentially reviewed.
Despite the movement toward recognizing greater state interests in the “unborn child,” absolute bans on abortion pre-viability have never been upheld as constitutional. In each Supreme Court case challenging Roe v. Wade, the Court has upheld the right of the woman to have an abortion pre-viability, while simultaneously acknowledging that the state interests exist pre-viability. Depending on your perspective, this trend counts as either a frightening slippery slope, or a predictable stare-decisis starecase. Either way, given this slow erosion of the right articulated in Roe, it is less surprising that states have sought more aggressive restrictions on a woman’s right to an abortion during the first two trimesters. One such way states have asserted a stronger state interest pre-viability is to rely on scientific data on the ability of fetuses to feel pain. The data they rely upon are mixed at best, raising the question of what types of scientific authority ought to be required before legislatures make findings of fact that are so deferentially reviewed. [1]
Glenn Cohen and Sadath Sayeed carefully reviewed the scientific literature as of 2010 related to this “factual finding.” They ultimately deem it misleading as it relies on inferences about subjective suffering from metabolic changes, hormonal spikes, and motor reflexes to pain stimuli that “can be elicited without nociception or even consciousness.” [2] While imaging maturing brain pathways does provide evidence for what may be the minimum anatomical requirement to feel pain, it does not follow that this data demonstrates that fetuses do or do not feel pain. To begin, researchers have not achieved anywhere near consensus on how to reliably and accurately infer the experience of pain in legally competent adults. How then, can they accurately infer this in a fetus? At this stage, scientists are still discovering how subcortical structures can support pain sensations, and how to infer a subjective feeling of suffering based on a fetus’s withdrawal from a potentially painful stimulus.
The sharp shift away from the trimester framework to the nebulous “pain framework” (here determined to be 20 weeks post-fertilization) is, while not completely arbitrary, not supported by substantial medical data as the sponsors claim. A good number of researchers maintain that pain cannot be reliably and accurately deduced until immediately before birth (~38th week) and others hold that the brain architecture is there by 24 weeks (though as mentioned above, the feeling of pain does not immediately follow from having the necessary brain structures). While completely predictable following Carhart II, it is immensely troubling that the factual findings by these states can be based on such loose interpretations of what counts as “substantial medical authority.”
Of course, this analysis hinges on how we define pain. If my toes are pinched and my chest cut open while I am in a coma, is this the same qualitative experience as someone doing this to me while I am alert? Is pain the same when I have no relation with the object or source of the pain? For a fetus, the entire experience of pain is likely grounded in the presentation of a stimulus that poses a threat to tissue. As one researcher put it, “the entire experience is completely bounded by the limits of the sensory system and the relationship between the system and the stimulus.” [3] If this very low threshold definition of pain is the type of pain for which the state can assert its interest to the point of restricting a woman’s right to an abortion, then the delicate balance between the state, the fetus, and the woman becomes horribly skewed toward the former. [4] Under this framework, states could justify regulations requiring the woman to sleep on her back at night, so that the fetus does not experience any discomfort. However, this interpretation misses the point. Where is the adult woman’s concrete and complex feelings of pain in this equation? If we extend the same broad interpretation of pain to the woman carrying the fetus, then the “pain framework” could be absolutely turned on its head. States would be hard pressed to explain why they have a greater interest in protecting the fetus, rather than the adult woman, from pain, without referencing other aspects of personhood that are not currently being addressed. Before we get there though, we need a more refined concept of pain in order to operationalize it in this legal way. Even if we could reliably and accurately demonstrate that the fetus experiences some threshold of subjective pain, how does this decide the Constitutional matter for us either under Roe, or Carhart?
Without delving into the complicated issue of determining binary consciousness – present or not; we can decide this matter based purely on the non-controversial assertion that the fetus is not the only entity in this equation in which the state has an interest. The woman carrying the baby can also experience pain. She can experience pain of contractions. She can feel emotional anguish over the diagnosis of a birth defect in the 24th week, a diagnosis that would lead the fetus to experience much pain if it were to be born. There is often heartbreak and suffering, and a strong connection with the fetus she is carrying.
While Nebraska, Indiana, Oklahoma, Kansas and Alabama obviously had a pro-life agenda in their sights, the incredibly vague and unsupported findings of fact related to fetal pain may ultimately backfire. Because the Supreme Court has never framed the right in terms of a binary “right to abortion” or “right to life” the balancing act between the women, fetuses, and states will necessarily have to include a discussion of the pain and suffering of the woman carrying the child. Failure to perform this balancing between the entities would signal a radical and delegitimizing watershed moment in Fourteenth Amendment substantive due process jurisprudence. Saying the fetus can experience pain does not convert a balancing test into a black and white issue, where the state now has a compelling state interest to do whatever it wants.
Finally, while abortion and fetal pain may be discussed without reference to personhood, this philosophical, moral, and legally loaded term obviously lies just beneath the surface. To be sure, in the philosophical or moral context, we may just be using labels for various traits we already associate with being a person, to justify inclusion or exclusion. Put another way, including the perception of pain as a relevant criteria for personhood is philosophically questionable, as it starts from the presumption that part of what makes us persons is that we feel pain.
Legal definitions of personhood, while informed by philosophy and morals, are not bound by the same strictures. We can draw on theories of what counts as a conscious person, but under Constitutional analysis, we must answer a separate question: is this a legal person, endowed with relevant legal (as opposed to philosophical or metaphysical) capacities? The legal rights attached to various persons should necessarily change based upon the context, regardless of their moral or philosophical status as persons. To borrow from Peter Singer, “potential prime ministers obviously do not have the rights of actual prime ministers, so that ‘potential persons’ …can hardly be considered in the same moral category as actual persons, or ‘us.’” [5]
Rather than being a binary construct that applies in all legal settings, legal personhood ought to depend on the legal context and the nature of the right that is at stake. Rather than putting forward an exhaustive list of criteria, (with “ability to feel pain” being a necessary and sufficient condition for all aspects of legal personhood), perhaps we should borrow from the bundle of sticks metaphor from property law analysis. Depending on the legal right that is at stake, you may have “enough” of the sticks in the bundle to be a legal person for this particular context. But we should be very careful not to put forward one stick in the bundle (i.e., ability to feel pain) and use it to argue that this entity is a legal person endowed withgreater rights, with associated greater state protection, than the rest of us. The logical extensions of such an approach are far too sweeping to contemplate.
[1] Nebraska Revised Statutes 28-3, 104 (2010)
[2] I. Glenn Cohen & Sadath Sayeed, Fetal Pain, Abortion, Viability, and the Constitution, 39 The Journal of Law, Medicine & Ethics, 235 (2011)
[3] Stuart Derbyshire, Foetal Pain? Best Practice & Research Clinical Obstetrics and Gynaecology 1, 7 (2010)
[4] The laws have other serious Constitutional problems. Namely, they allow the judge to decide sua sponte whether to protect the confidentiality of the woman, and they only provide an incredibly narrow exception for the woman’s life. Specifically, rather than focus on the health interests of the woman, the abortion can only be performed before the 20th week would “avert her death or for which a delay will create a serious risk of substantial and irreversible physical impairment of a major bodily function.”
[5] Chappell, On the Very Idea of Criteria for Personhood, 49 The Southern J. of Philo.1, 4-5 (2011)
In case you’ve been living under a rock, the Supreme Court decided to grant cert to rule on the constitutionality of the Patient Protection and Affordable Care Act. Oral arguments are scheduled to last 5.5 hours. On November 8, 2011, the D.C. Circuit upheld the Act. The entire opinion may be found here. And the Wall Street Journal Law Blog describes “nearly everything you need to know about the health care decision.”
Wake Forest University Director for Bioethics Ana S. Iltis describes how the U.S. health care system is dysfunctional. She describes a need to “connect cost and value,” and the need to ask more often “is it worth it.” Specifically, she discusses the drug Avastin, briefly mentioned on this blog here, which is covered by Medicare despite having been shown to not only not help breast cancer patients, but to actually harm them. Although she stated she does not know how to fix the market, an important first step is acknowledging that it is broken.
A recent poll suggests that doctors support a policy once referred to as ”death panels,” and finds that “Seventy-nine percent of the doctors surveyed said the U.S. ‘spends far too much trying to extend lives,’ compared with just 37 percent of the general public. But the public agreed with the doctors that quality of life is more important than extending life as long as possible, by almost the same margin.”
By Margaret P. Battin – Leslie P. Francis – Jay A. Jacobson, MD – Charles B. Smith, MD
Contagion, the extraordinary film portraying the outbreak of lethal virus that spreads rapidly around the world, may seem eerily familiar: from the medieval plague to the Spanish flu of 1918-19 to more recent fears of avian influenza, SARS, and H1N1 “swine flu”, contagions have long characterized the human condition.
The film captures almost perfectly what a contemporary worst-case scenario might look like, and is eerily familiar because it trades on realistic fears. Contagion, the transmission of communicable infectious disease from one person to another (either by direct contact, as in this film — sneezing or coughing or touching one’s nose or mouth, then a surface like a tabletop or doorknob that someone else then touches — or transmission through an intermediate vector like the mosquito or the rabid bat) is among the oldest fears of humankind, and yet also among the most contemporary as our world has become so much more interconnected by air travel. The scenario depicted in this terrifying film is entirely realistic.
Furthermore, “Contagion” is impressively accurate in portraying its doomsday scenario. The epidemiology, including the source, the index patient, and the possibility of natural immunity are all spot-on. The modes of transmission of an airborne virus are deftly portrayed. Various scenarios of pandemic planning, including quarantine and isolation, mandatory social distancing, vaccine research, and prioritization for access to treatment and prevention are all accurately depicted. And so, chillingly, is the human potential for fear and self-interest. We see misinformation, deception, crime in the pursuit of self-protection, and the governments of countries trying to evade economically devastating publicity by hiding the facts. But we also see what looks like heroism: the scientist who works desperately towards the development of a vaccine in defiance of explicit orders to leave an unsafe lab; nuns who treat patients when nurses are on strike; and the person of greatest privilege and authority who gives his own dose of vaccine, when it is eventually developed, to the son of the janitor in his building, an act of selfless justice in trying to distribute the vaccine in an equitable way.
How, ethically, should we think about issues raised in the movie? Those issues include: whether to tell loved ones information that others don’t know; to what to do about profiteers from pseudoscience (like the promoter of the herbal remedy forsythia); to whether leaving an unsafe lab is putting other lab members or the general public at risk or, instead a genuinely heroic act (or both); to whether to distribute scarce vaccines based on randomized dates of birth. The movie poses all of these questions and more, and leaves us to wonder whether there are fundamental ethical principles that we can use to analyze such horrific circumstances.
These are not just questions dreamed up by a thriller movie. The ethical problems associated with a global epidemic like that portrayed by the movie also arise with many more familiar cases of transmissible infectious disease, from seasonal influenza (actually a real killer, especially of vulnerable people) to sexually transmitted diseases, including HIV/AIDS, a global killer already tragically familiar in the real world. Ethical problems associated with infectious disease are everywhere, even those of smaller scale — problems that may be just as interesting but possibly more amenable to solutions. Contagion depicts a worst-case scenario, but that does not mean we should not pay attention to less dramatic but still challenging real-life scenarios involving any disease that passes from one human being to another.
At bottom, we are all in this together. We are victims of contagious disease; at one and the same time, we are also vectors of contagious disease, threatened by others but also threats to others. Thus we must recognize ethically that we cannot go it alone. We cannot develop policies that seek to protect only ourselves, or assume that we know whether we will be in privileged positions to help ourselves, if a global outbreak of the terrifying contagiousness and lethality portrayed in Contagion ever does occur.
In what has been referred to as “an unbelievable setback for bio-medical research in the area of stem cells,” the European Union’s top court has banned embryonic stem cell patents.
A federal advisory committee has recommended routine HPV vaccination for boys ages 11 and 12.
The New York Times reports venture capitalists put money on easing medical device rules.
One bioethicist argues that we are morally obligated to participate in research.
So called “personhood amendments” seek to declare a fertilized human egg to be a legal person, thereby making abortion and some forms of birth control murder. As proposed in Mississippi, such an amendment would “ban virtually all abortions, including those resulting from rape or incest. It would bar some birth control methods, including IUDs and ‘morning-after pills,’ which prevent fertilized eggs from implanting in the uterus. It would also outlaw the destruction of embryos created in laboratories.”
This post serves as the last of the series addressing the Advanced Notice of Proposed Rulemaking for proposed changes to the Common Rule. For those of you just catching up, it may be helpful to read the past posts. I had the opportunity to interview John Stillman, Director of the Institutional Review Board for the University of Utah, to gain some insight on what the proposed changes mean.
Another major shift in the ANPRM seems to be creating more categories of research that would be exempt or excused from IRB oversight. I asked John what he thought of this proposed change. He was very straightforward that he didn’t like it. It appears extremely problematic to excuse a broad swath of research that today is reviewed by IRB, subjecting it only to audits to determine if the research was done appropriately. It seems obviously silly to try to develop a system where somebody comes to audit excused studies AFTER they’ve been conducted because what is to be done if you find rampart errors (or more likely, the data has simply been destroyed)?
John told me there certainly should be steps taken to reduce the burden for doing minimal risk research, but this proposal goes too far. Perhaps a solution is to have exemptions approved by IRB with the understanding that the IRB can be reasonable, by approving minimal risk studies in a shorter period of time, for example. John thinks it is better to harmonize and make clear to IRBs what is and is not minimal risk, so that they can better make efficient determinations, rather than bypass the IRB process altogether.
Thank you John for allowing me to interview you, and for the interesting insight you provided to the ANPRM for proposed changes to the Common Rule. Remember, if you have anything to say about these proposed changes, the comment period closes on October 26, 2011.