Monday, February 9, 2015
Cross-posted from Bill of Health
Given the increasing numbers of health data breaches, including this week’s announcement from Anthem (potentially exposing 80m records, mine included) a brief review of the subject may be appropriate.
At the federal level both the Security Rule and the Breach Notification Rule are in play. In large part the Security Rule requires covered entities and their business associates to base their security precautions on risk assessment. Required precautions include administrative, physical, and technical safeguards. Many of these are required, for example unique user identities for access and tracking. Some precautions, however, are only “addressable.”
This latter is the case with data encryption, defined in the Security Rule as “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key.” In practical terms data may need to be encrypted end-to-end (during transmittal) or while stored (at rest). Being only ‘addressable,’ the question whether to encrypt stored data depends on the data custodian’s assessment whether that technology “is a reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting electronic protected health information.” If the risk assessment goes against encryption that decision must be documented and a reasonable and appropriate alternative safeguard implemented.
Saturday, February 7, 2015
In a much-awaited decision, the Canadian Supreme Court on Friday held that Canada's statutes criminalizing aiding suicide violated the Canadian Charter. The decision in Carter v. Canada is being widely hailed by advocates of the legal permissibility of the practice and decried by disability advocates. I'm writing this post to call people's attention to some noteworthy aspects of the decision--I am most emphatically not taking sides in this blog post (although I do have a view).
The decision in Carter was under Sect. 7 of the Canadian Charter, which reads: "Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice." Briefly, the Court thought that the violation of the right to life is that that criminalization might force people to take their lives earlier than they wish to in order to avoid suffering. The violation of liberty is that people have a right to make decisions concerning their bodily integrity. And leaving people to intolerable suffering violates the security of the person.
Importantly, the decision is not limited to cases of terminal illness. It extends its reasoning to anyone in "intolerable suffering as the result of illness, disease, or disability." But the Court also said that Canada has an interest in protecting the vulnerable that could justify statutory limits on aid in dying. The difficulty with the existing statutes was that they are a complete ban, and thus in the view of the Court not proportional to the state's legitimate goal. Here, the Court cited evidence from other jurisdictions that statutes permitting aid in dying, with appropriate safeguards, have not resulted in evidence of abuse.
In one respect, the decision is a narrow one, because it simply holds that the criminal statutes (prohibiting aiding and abetting a suicide and prohibiting self-consent to the taking of one's life) violate the Charter. The Court left the current prohibitions in place for one year, to allow Parliament to construct a statute that would pass constitutional muster. It will be fascinating to see what Parliament does in response to the decision, especially with respect to crafting safeguards that are appropriately proportional to the goal of protecting people from abuse.
Friday, February 6, 2015
Jamie R. Abrams, The Illusion of Autonomy in Women's Medical Decision-Making, 42 Fla. St. U. L. Rev. (2015).
Andra le Roux-Kemp, Elsie Burger, Shaken Baby Syndrome: A South African Medico-Legal Perspective, 17 Potchefstroom Electronic L. J. 1287 (2014).
Paddy Rawlinson, Vijay Kumar Yadavendu, Foreign Bodies: The New Victims of Unethical Experimentation, 54 The Howard J. of Crim. Just. 8 (2015).
Hannah Alsgaard, Rural Incentive Programs for Legal and Medical Professionals: A Comparative Analysis, 59 S.D. L. Rev. 585 (2014).
Wednesday, February 4, 2015
Guest Blogger Professor Lawrence O. Gostin - Science, Choice, and Parental Rights in Conflict: The Vaccination Debates
The values of public health, personal choice, and parental rights have collided in an intense debate over mandatory vaccinations. Senator Rand Paul argued that parents have the right to choose: “The state doesn’t own your children. Parents own the children.” The overwhelming weight of science supports the safety and effectiveness of immunizations. Parental choice also does not extend to decisions that impose risks on the community. While libertarian values stress autonomy to make self-regarding decisions, it does not give license to place harm others. But if an individual’s right ends at the point that its exercise jeopardizes the safety of others, then why do states allow parents to opt out of vaccinations? The reason boils down to overbroad exemptions granted by many states. The Constitution doesn’t require states to grant exemptions, but lobbying by a minority of parents has resulted in a tragedy of the commons.
First some background. Vaccine preventable diseases are on the rise—diphtheria, pertussis, tetanus, measles, mumps, and rubella. Parents are delaying or selectively administering vital immunizations for their children, often opting out entirely. The CDC declared measles eliminated in 2000. But in 2014, the United States recorded a record number of cases—644 cases from 27 states, more than three-fold higher than any previous year. In January, a measles outbreak started at Disneyland, diffusing to 14 states, re-igniting the immunization debates.
HealthLawProf Blog is very pleased to welcome our first guest blogger for the month of February, University Professor Lawrence O. Gostin. The following is his bio:
Lawrence O. Gostin is University Professor, Georgetown University’s highest academic rank conferred by the University President. Prof. Gostin directs the O’Neill Institute for National and Global Health Law and is the Founding O’Neill Chair in Global Health Law. He served as Associate Dean for Research at Georgetown Law from 2004 to 2008. He is Professor of Medicine at Georgetown University, Professor of Public Health at the Johns Hopkins University, and Director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities.
Prof. Gostin holds a number of international academic professorial appointments: Visiting Professor (Faculty of Medical Sciences) and Research Fellow (Centre for Socio-Legal Studies) at the University of Oxford, United Kingdom; the Claude Leon Foundation Distinguished Scholar and Visiting Professor at the University of Witwatersrand, Johannesburg, South Africa; and the Miegunyah Distinguished Visiting Fellow and Founding Fellow of the Centre for Advanced Studies (Trinity College), University of Melbourne. Prof. Gostin serves as Secretary and a member of the Governing Board of Directors of the Consortium of Universities for Global Health.
Wayne Renke, Researcher Privilege Recognized (This Time): A Comment on Parent and Bruckert v. the Queen, 3 Health L. Rev. (2014).
Antina de Jong, Idit Maya, Jan M.M. van Lith, Prenatal Screening: Current Practice, New Developments, Ethical Challenges, 29 Bioethics 1 (2015).
Monday, February 2, 2015
Stacey Rae Simcox, Lightening the VA's Rucksack: A Proposal for Higher Education Medical-Legal Partnerships to Assist the VA in Efficiently and Accurately Granting Veterans Disability Compensation, SSRN.
Stephen Wilkinson, Prenatal Screening, Reproductive Choice, and Public Health, 29 Bioethics 26 (2015).
Antina de Jong, Guido M.W.R. de Wert, Prenatal Screening: An Ethical Agenda for the Near Future, 29 Bioethics 46 (2015).
Friday, January 30, 2015
Darren S. Tucker, Gregory F. Wells, Emerging Competition Issues Involving Follow-On Biologics, 29 Antitrust Mag. 100 (2014).
Paul F. Rothstein, Ambiguous-Purpose Statements of Children and Other Victims of Abuse under the Confrontation Clause, 44 Sw. U. L. Rev. (Forthcoming 2015).
Anita Stuhmcke, Tick Tock Goes the Clock: Rethinking Policy and Embryo Storage Limits, Feminist Legal Studies, (2014).
Lisa Chiyemi Ikemoto, Can Human Embryonic Stem Cell Research Escape its Troubled History?, 44 Hastings Center Report (2014).
Wednesday, January 28, 2015
In announcing the federal government’s approval of Indiana’s Medicaid expansion, Governor Mike Pence invoked common sense in defending his insistence that beneficiaries shoulder a share of their health care premiums. According to Pence, “It’s just common sense that when people take greater ownership of their health care, they make better choices.”
But relying on common sense is not a good way to make health policy. Common sense leads people to incorrectly believe that they are more likely to catch a cold by going out in cold weather or to take megadoses of vitamins that provide no additional health benefit and can be toxic. Common sense also leads physicians down the wrong path. Because lowering blood sugar has been good for the health of diabetics, medical experts recommended tight control of blood sugar levels. But that resulted in an increased risk of death for many patients.
It turns out that our intuitions often lead us astray, making it important that we rely on data from scientific studies to distinguish between good and bad policies. And we know from the data to date that when the poor are required to pay for their health care, they may choose to forgo it, not only when care is not needed but also when it is needed.
Kudos to Governor Pence for bringing the Medicaid expansion to Indiana and for worrying about health care costs. It may turn out that Indiana's cost-sharing is low enough to avoid problems, but rather than trying to contain costs by discouraging patients from seeking too much care, we should try to discourage physicians from providing too much care. Physicians are better able than patients to distinguish between necessary care and unnecessary care.
[cross-posted at Bill of Health]
Friday, January 23, 2015
Cross-Posted from Bill of Health
Today, the Washington Post ran an interview with Laurence Tribe about the King v. Burwell subsidy litigation (recall that oral arguments are scheduled for March 4). Tribe speculated that Chief Justice Roberts will once again be the swing vote, as he was in Nat’l Fed. of Independent Bus. v. Sebelius. Tribe seems to predict another pragmatic Roberts opinion (and one that might bring Justice Kennedy along), finding the subsidy provisions are at worse ambiguous and that the executive is owed deference as argued by the eminently reasonable Nick Bagley.
Even though Tribe wouldn’t label Roberts as a consequentialist, he does believe that the pragmatic Roberts would be influenced by the impact on the States, the disruption of insurance markets, and the consequences for the newly insured. If the Chief wants more data on those issues he could do no better than to consult two excellent reports from the Urban Institute. The first estimates that a declaration that the subsidies are invalid “would increase the number of uninsured in 34 states by 8.2 million people… and eliminate $28.8 billion in tax credits and cost-sharing reductions in 2016 ($340 billion over 10 years) for 9.3 million people.” Perhaps as important, the Urban Institute’s model also predicts general turmoil in private, non-group insurance markets as the young and healthy would disproportionately drop coverage, causing a predicted 35% increases in premiums.
The second and most recent brief from the Urban Institute begins to put faces on those who will suffer: “Over 60 percent of those who would become uninsured are white, non-Hispanic and over 60 percent would reside in the South. More than half of adults have a high school education or less, and 80 percent are working.”
The executive shouldn’t need such help given the ACA’s clear intent as to how the federal and state exchanges were meant to function. But, if a dose of pragmatism is required to secure a majority of the Court, the stakes couldn’t be any clearer.
Tuesday, January 20, 2015
In 2012, the Supreme Court heard two important Medicaid cases, one in January of 2012 pertaining to payment rates (Douglas v. ILC), and the other in March 2012 pertaining to the ACA's Medicaid expansion (NFIB v. Sebelius). In Douglas, the Court's majority deferred to HHS, allowing the agency to exercise primary jurisdiction over California's Medicaid payment rates and punting the question regarding Supremacy Clause actions by Medicaid providers against noncompliant states. And, in NFIB, the Court decided that Medicaid's modification under the ACA was not Medicaid enough for purposes of Spending Clause doctrine but was Medicaid enough for purposes of the remedy, which was to limit HHS's authority to terminate Medicaid funding for states that refused to expand Medicaid eligibility under the terms of the ACA. Confused yet? So is the Court, and that's a potential problem.
Fast forward to 2014, and the Court is once again hearing a Medicaid reimbursement rate case and an ACA case, in the same time frame as 2012, both of which could be very disruptive. The Medicaid rate case is Armstrong v. Exceptional Child Center, and the weirdly confused oral arguments occurred today. The question the Court granted from the petition for certiorari was whether private parties can enforce the Medicaid Act's equal access provision ("30(a)") against a noncompliant state when HHS has not demanded compliance from the state through payment of adequate reimbursement rates. Armstrong may have far-reaching implications for the Medicaid program, for implied rights of action, and for federal courts' jurisdiction over Supremacy Clause actions, to name a few possible dimensions. Steve Vladeck, author of a very important amicus brief on behalf of former HHS officials, has posted about some of these issues. Rather than re-hash his fine commentary, or Will Baude's pithy overview for SCOTUSblog this morning, I will quickly share some impressions of today's oral arguments.
First, the justices had no idea how Medicaid works, which matters quite a lot when it may be the vehicle for constitutional change. Justice Breyer, for example, did not appear to understand the difference between the state describing how it would set payment rates and the state actually setting the amount of money it would pay to reimburse health care providers for their services. Here, Idaho created a methodology for rate setting that was approved by HHS, but then its legislature decided to use a different rate setting methodology tied to the state's budget. Breyer kept using the example of a doctor submitting a bill for $80 when all he could receive was $60, but the example was inapposite. Another minor example is that the prohibition against balance billing was news to the justices. Another example is Justice Alito's hypothetical about states that allow for medical marijuana being sued because feeral law does not permit possession of marijuana, which had no apparent relevance for the Medicaid preemption questions at hand.
James Piotrowski, on behalf of Exceptional Child Center tried to limit the conversation to whether the state actually followed the plan that CMS approved (which it appears Idaho did not). He also tried to explain why a broad-based Supremacy Clause/Spending Clause decision would be both unnecessary and dangerous, and he advocated for a limited ruling that would allow this set of plaintiffs to seek an injunction to force the state to abide by the reimbursement plan that HHS approved.
The trouble is that the Solicitor General, as he did in 2012, promoted the view that no private rights of action should be permitted. Justices Sotomayor and Kagan quickly called out Mr. Kneedler on HHS’ deep disagreement with this position. Kneedler asserted that HHS does not want these private actions, even though HHS pointedly did not sign the SG's brief, and even though the amicus brief here and in Douglas on behalf of former HHS officials (of all political stripes) clearly explained that HHS both expects and needs private actions to occur. In both cases, the former HHS officials explained that the agency is so woefully understaffed and underfunded that it could never police all of the states' reimbursement rates on a claim by claim basis.
The four dissenters from Douglas were relatively quiet during oral arguments today. In 2012, the Chief Justice authored a dissent that would have denied private rights of action under 30(a) to force states to pay adequate payment rates for equal access to health care providers. I suspect that Roberts, Scalia, Alito, and Thomas remain in the same positions, unless they were convinced that Idaho should have just stuck to the plan and their legislature drove off the rails after CMS approved their rate setting methodology. The real question will be if Kennedy sees this action as some kind of affront to state sovereignty given his affinity for federalism resolutions. If so, then Supremacy Clause actions will be lost for 30(a) litigants, and states will run over Medicaid providers who cannot enforce the adequate payment language in the Medicaid Act. In the very moment that more and more states are negotiating Medicaid expansion under the power given to them by the Court in NFIB, this would be a dangerous precedent both theoretically and on the ground. More to come.
January 20, 2015 in Affordable Care Act, Constitutional, Health Care Costs, Health Care Reform, Health Law, Health Reform, HHS, Medicaid, Policy, State Initiatives, States | Permalink | Comments (0) | TrackBack (0)
Saturday, January 17, 2015
In a pair of recent decisions, the U.S. District Court for the District of Columbia has struck down Department of Labor (DOL) regulations designed to provide wage protections for home care workers. Challenging the regulations were the Home Care Association of America and the National Association for Home Care & Hospice. The first decision, issued December 22, 2014, rejected the DOL’s decision to remove an exemption for third-party employers of home care workers from Fair Labor Standards Act (FLSA) minimum wage and overtime requirements. Removal of the exemption would have required home care agencies to pay minimum wages to employees who provide domestic companionship services to seniors and individuals with disabilities and to pay overtime wages to live-in domestic service employees. Home Care Association of America v. Weil, 2014 WL 7272406 (D.D.C. 2014). The second decision rejected the DOL’s narrowing of the definition of “companionship services.” Home Care Association of America v. Weil, 2015 WL 181712 (D.D.C. 2015)
The FLSA exemption in question had been in effect for over 40 years. The plaintiffs argued that the changes are inconsistent with the statutory language of the FLSA and with Congress’s intent. The FLSA provisions in question date from the 1974 amendments extending minimum wage and overtime protection to domestic service employees. The extension included exemptions for specified types of domestic service work, including “any employee employed in domestic service employment to provide companionship services for individuals who (because of age or infirmity) are unable to care for themselves (as such terms are defined and delimited by regulations of the Secretary).” 29 U.S.C. § 213(a)(15). The 1974 amendment to the FLSA also included an exemption from overtime pay requirements for “any employee who is employed in domestic service in a household and who resides in such household.” 29 U.S.C. § 213(b)(21) The original regulations had extended the companionship services exemption to third-party employers of these workers, such as home health agencies. It had also defined companionship services broadly. Notably, this implementing regulation actually made the situation worse for companionship services workers employed by large home health agencies: these workers had been covered by a different section of the FLSA before the 1974 amendment bringing domestic service workers within the scope of the statute.
Thursday, January 8, 2015
With Harvard professors protesting their increased responsibility for health care costs, we are seeing just the most visible aspect of the recurring cycle described in “Tragic Choices.” As Guido Calabresi and Philip Bobbitt observed in that book, society tries to defuse societal conflict by hiding its rationing choices through implicit forms of rationing. Thus, for example, health care insurers relied on managed care organizations in the 1990’s to contain health care costs with the premise that managed care would preserve health care access and quality while squeezing the fat out of the health care system.
But after a time, the public realizes what’s going on and rebels against the implicit rationing policy. Hence, managed care’s effective cost containment strategies, such as limited networks of physicians or primary care gatekeeping, were dumped, and health care costs began to climb again.
What did health care insurers turn to after abandoning serious managed care? Shifting more of the costs of health care to patients through higher deductibles and higher copayments. Insurers didn’t need to identify limits on their coverage because individuals would respond to their higher out-of-pocket costs by hesitating to seek care. Costs would be contained by “market forces” rather than rationing. But the Harvard professors and other Americans are now rebelling against the shifting-of-costs policy, just as Calabresi and Bobbitt predicted in 1978. (Indeed, they even included the shifting of costs as an example of an implicit rationing strategy.)
Of course, cost shifting raises a number of concerns, including the fact that patients often do not distinguish well between necessary and unnecessary care when cutting back their doctor visits in response to cost shifting.
Where do we go from here? The Affordable Care Act includes many provisions designed to reward high quality care, and maybe we’ll see some meaningful cost containment out of them. But more likely, health care insurers will need to find another form of implicit rationing that will work for a while until the public rejects it.
For more discussion of the "Tragic Choices" cycle and the change from rationing through managed care to rationing through cost shifting, see here. For more discussion of the barriers to explicit rationing, see here.
[cross-posted at Bill of Health.]
Tuesday, January 6, 2015
Cross-posted from Bill of Health
Health reform may have signaled the shift from hospital-based “sick” care to primary care and “wellness” but the ACA failed to provide a detailed roadmap. All we know for sure is that primary care (PC) will be hugely important. Increasingly it also seems that it will look quite different. “Old” PC is being battered; Medicaid primary care physicians (PCP) saw their the two-year ACA bonuses expire in December, the OIG just reported that way too many Medicaid-listed doctors are not taking new patients, and the coverage-doesn’t-equal-access mantra is born out by persistent reports of PCP shortages. If PC as we have known it is not going to step up to the plate, what is the “new” model and who will end up owning it?
The ACA gave hospitals both good (fewer uninsureds in ERs, Medicaid expansion) and bad news (fewer profitably occupied beds because of HAC and readmission penalties). Not surprisingly there was a sharp increase in hospitals buying PCP practices. In part this was just hospitals following the money as usual, looking to roll these practices into their new ACOs. But, longer term strategies also persisted, such as strengthening networks, intercepting patients before they turn up in ERs, and creating local or regional dominant positions. Smaller PCP practices have also been more willing to sell as they faced financial regulatory disincentives (such as meaningful use penalties) if they continued as independents.
However, we are seeing hospitals doing more than increasing the number of hospital-based clinics. Many are also opening their own free-standing urgent care clinics, the “new” PC. There are several models, including full ownership as with the Intermountain Healthcare group or, perhaps for those late to the game, strategic partnerships with urgent care specialists like Premier Health or MedSpring.
Urgent clinics also are proliferating in traditional retail stores such as Wal-Mart, Target, CVS and Walgreens. Although originally designed to capture additional revenue for the stores’ pharmacies or, in the case of Walmart, to provide care for employees, these clinics increasingly are owned by their retail hosts and are viewed as important and growing sources of revenue. Of this cohort CVS may be worthy of particular attention; reportedlythey already have 800 walk-in MinuteClinics with plans to double that number by 2017.
Joining hospitals and traditional retailers in this booming urgent care space are health insurers. For example, in 2010 Humana purchased Concentra, the largest urgent care provider, while CareFirst BlueCross BlueShield is a major regional player. There has also been speculation that WellPoint will enter the space.
It is a fair assumption that “new” PC will be quantitively and qualitatively different from the old, and much maligned, “Doc in a Box” model. But, who will win the urgent care PC war? A good bet would be on the players with the highest level of cost-controlling vertical integration, suggesting the health insurers may be early favorites, with larger networks not far behind. However, as always seems to be the case with healthcare, it is likely that IT prowess, deal making nimbleness, and local variables will throw up many different winners (and losers). Remember, also, that we’ve seen major PCP acquisition activity before, and the last cycle ended badly.
Beyond any scorecard, “new” PC suggests an array of policy and legal issues. Will urgent care centers be in or out of traditional MCO networks? How many will accept Medicaid or treat the uninsured (and should they be required to)? Might “urgent care” nomenclature confuse patients seeking emergency care (on which see this new Illinois statute)? Will conventional healthcare providers harness state laws (everything from the corporate practice to telemedicine licensure, and physician-extender scope of practice) to slow down some or all of these disruptive forces? Will a promise of increased access be accompanied by reduced cost (some studies suggest urgent care clinics cost 20 to 40 percent less per visit)? Or, true to the familiar integration-consolidation narrative, will costs edge up? And, on that note, will current healthcare antitrust litigation alter the landscape of practice acquisitions? The next year or two should answer at least some of these questions.
If you have comments please post to @nicolasterry on Twitter.
Tuesday, December 23, 2014
Research participants don’t always do what they are supposed to do. When their personal interests conflict with the demands of study participation, some participants surreptitiously break the rules. Rule-breaking participants don’t normally intend to compromise the study process; they simply see their own interests as more important than study rules aimed at generating good data.
Some participants have written about their rule-breaking and others have disclosed it to reporters and scholars writing about human trials. Researchers also report discovering various forms of rule-breaking that participants tried to hide. But because not many studies use techniques that can uncover rule-breaking, much of the behavior isn’t detected.
Monday, December 22, 2014
Cross-Posted from Bill of Health
The “Cromnibus” spending bill signed by the President on December 16 rightly upset Senator Warren and not just for providing luxury cars to a feckless Congress. However, in general the bill ignored healthcare. There was no new money for those ACA “villains” CMS and IRS and only a little more for NIH (resulting in net reductions all around given inflation). Of course constituencies have to be pandered to, so there was a symbolic $10 million cut from the moribund IPAB. Meanwhile, the CDC did well, HRSA picked up a few telemedicine dollars, but ONC didn’t get everything it wanted. However, look closer and it seems that during the convoluted legislative process someone threw a meaty wrench into the gears of an already flailing meaningful use program.
As I have discussed at length here and here the meaningful use subsidy program for EHRs may have delivered hundreds of thousands of mediocre electronic health records systems into provider offices but has failed to deliver effective data sharing. ONC knows this is an issue, is aware of and discussed the JASON report, has its own “10-year vision” and emphasizes interoperability in its recently released Health IT Strategic Plan (Disclosure: I serve on the HIT Committee Consumer Workgroup, but these views are mine alone). But, some kind of showdown has been brewing for a while. Have the HITECH billions been wasted? Was the regulatory problem in meaningful use or in certification? Are the HIT developers to blame or health care providers? (Answer: Yes). And, the AMA being “appalled” aside, what happens now that the meaningful use carrots have begun morphing into sticks?
Sunday, December 21, 2014
It's been almost a year since the publication of the HIPAAA Omnibus Rule. Since then then the regulatory mavens have been quiet. And that's not surprising. Solutions for our contemporary health privacy challenges such as big data and information collected by mobile apps generally lie outside the scope of HIPAA. In the interim some state courts have been showing surprising vitality in filling HIPAA’s remedial gap, the absence of a private right of action.
In Walgreen Co. v. Hinchy, 2014 WL 6130795 (Ind. Ct. App.), Withers, the defendant's employee-pharmacist, viewed the prescription records of the plaintiff-customer. Withers then divulged the information she learned from those records (including that the plaintiff had failed to fill her oral contraception prescription) to her husband, the customer’s ex-boyfriend and the father of the plaintiff’s child. Plaintiff brought breach of privacy claims agains the pharmacist and alleged both vicarious liability and direct negligence against the employer pharmacy chain. The jury returned a verdict for $1.8 million.
Thursday, December 18, 2014
Marshall B. Kapp, Getting Physicians and Patients to Choose Wisely: Does the Law Help or Hurt?, 46 U. Tol. L. Rev. (Forthcoming 2015).
Michael Ashley Stein, Christopher P. Guzelian, Kristina M Guzelian, Expert Testimony in Nineteenth Century Malapraxis Actions, 55 Am. J. Legal Hist. 284 (2015).
Daniel James Sheffner, Fatal Medical Negligence and Missouri's Perverse Incentive, 7 St. Louis U. J. Health L. & Pol'y 147 (2013).
Wednesday, December 17, 2014
Not so long ago, medical researchers had a habit of using themselves as guinea pigs. Many scientists saw self-experimentation as the most ethical way to try out their ideas. By going first, researchers could test their hypotheses and see how novel interventions affected human beings. In his book Who Goes First? Lawrence Altman reports that my own institution, Washington University, was nicknamed the “Kamikaze School of Medicine” because of its self-experimentation tradition.
Today we rely on a more systematic process to decide when to begin human testing, with experts and ethicists evaluating when a trial is justified. But a modified version of self-experimentation still makes sense.
Friday, December 12, 2014