HIPAA and the Medical Records of Deceased Nursing Home Patients

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[this is a cross post from HealthLawProf]

Warning: some of this post is HIPAA-wonky. But read on: the punch line is that HIPAA does not protect the living or the dead from blanket release of medical records to their personal representatives—unless state law provides otherwise or patients have thought to specify in advance that they do not want anyone to see the record or parts of it and state law gives them this opportunity. This means that the default position is that personal representatives may see highly sensitive health information, including mental health records or sexual or reproductive histories: veritable skeletons in family medical closets.

In an important recent decision, the 11th Circuit has held that the federal Health Insurance Portability and Accountability Act (HIPAA) preempts a Florida statute that gave spouses and other enumerated parties the right to request the medical records of deceased nursing home residents. Opis Management Resources v. Secretary, Florida Agency for Health Care Administration, 2013 U.S. App. LEXIS 7194 (April 9, 2013). The nursing homes had refused to respond to requests for records made by spouses and attorneys-in-fact, arguing that these requesters were not “personal representatives” under Florida law. The requesters filed complaints with HHS’s Office for Civil Rights, which determined that the refusals were consistent with HIPAA. The Florida Agency for Health Care Administration issued citations against the homes for violating Florida law, and the homes went to court seeking a declaratory judgment that the Florida statute was preempted by HIPAA.

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    Pharmacist Conscience Clauses

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    By Joanna Sax

    Multiple states have statutes that protect a pharmacist from liability for refusing to fill a prescription for an FDA approved medication.  Other states have laws that require pharmacists to fill prescriptions regardless of their personal beliefs.  The debate surrounding conscience clause legislation falls at two opposing spectrums.  Opponents to conscience clauses argue that refusal to fulfill a prescription for a non-medical reason interferes with the doctor-patient relationship and disproportionately effects women because it is often employed with prescriptions for birth control.  Supporters of conscience clause legislation argue that pharmacists have a constitutional right and that their personal beliefs should be respected.

    These two sides will never meet.  They will continue to argue notions of fairness and each side will dig-in their heels.

    I’ve proposed a different approach to analyze whether pharmacist conscience clauses are beneficial to society using welfare economics.  In short, the pharmacist conscience clauses serve as an affirmative defense in an action for professional negligence.  Pharmacist conscience clauses can be analogized to a no-care regime and arguably not maximize the well-being of individuals.  To see more of my argument of analyzing conscience clauses using an economic approach, you can check out my article here.

      Caplan on Cloning Human Embryos

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      Art Caplan has a new column out spurred by the announcement that researchers at Oregon Health Sciences University have successfully cloned human embryos.  Recognizing the possible ethical concerns and calling for immediate bans on human reproductive cloning (not cloning for stem cell research), Caplan hopefully notes: “Through cloning you can take a disabled or sick person’s DNA from one of their body cells, insert it into a human egg from which the DNA has been removed, fuse the cell electrically (the technique used in Oregon) and create an embryo from which cells can be grown that are identical matches to what the sick or disabled person needs.”

      Take a look at the full column here.

        Introducing New Blogger Leslie Francis

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        We’re pleased to introduce Leslie P. Francis as a regular contributor to Bill of Health.

        Professor Francis holds joint appointments at the University of Utah as Alfred C. Emery distinguished professor of law and distinguished professor of philosophy, and adjunct appointments in Family and Preventive Medicine (in the Division of Public Health), Internal Medicine (in the Division of Medical Ethics), and Political Science. Since 2012, she has also served the College of Law as Associate Dean for Faculty Research and Development. Professor Francis received a B.A. from Wellesley College, where she graduated with high honors in philosophy and was a member of Phi Beta Kappa. She received a Ph.D. in philosophy (1974) from the University of Michigan. After joining Utah’s philosophy faculty, she received her J.D. from the University of Utah (1981) and served as a law clerk to Judge Abner Mikva on the United States Court of Appeals for the District of Columbia Circuit. Appointed to the law faculty in 1982, she teaches and writes extensively in the areas of health law, bioethics, and disability. Professor Francis currently serves as a member of the National Committee on Vital and Health Statistics, where she co-chairs the subcommittee on Privacy, Confidentiality, and Security; and as a member of the Executive Committee of the International Association for Philosophy of Law and Social Philosophy (IVR). Professor Francis also has been a member of the Medicare Coverage Advisory Committee and of the American Bar Association’s Commission on Law and Aging.

        Representative Publications:

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          Kudos to This American Life

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          A few weeks ago, I blogged about a recent episode of This American Life, “Dr. Gilmer and Mr. Hyde,” about the quest of one Dr. Gilmer (Benjamin) to understand why another, beloved Dr. Gilmer (Vince), had brutally murdered his own father after hearing voices that compelled him to do so. The episode ends (spoiler alert) with the revelation that Vince suffers from Huntington’s, a rare, neurodegenerative disease that causes progressive physicial, cognitive, and psychological deterioration.

          Listeners, it seemed to me, could naturally conclude from the episode that it was Vince’s Huntington’s that had caused him to murder his father. That might or might not be true in this particular case. Huntington’s can cause behavioral and mood changes, including irritability, aggression and belligerence. It can also cause (less often) psychosis. But even if Huntington’s caused Vince to murder his father, or somehow contributed to the murder, the extreme violence that Vince displayed — strangling his father, then sawing off his father’s fingertips to preclude identification — is in no way typical of the Huntington’s population as a whole. And so what most troubled me about the episode was its failure to note just how rare this kind of extreme violence is among those with Huntington’s, just as it is very rare among human beings generally. And so I wrote to TAL, requesting a clarification.

          I’m happy to report that the TAL producer for the episode, Sarah Koenig — who had not intended to suggest any causal link between Vince’s murder of his father and his Huntington’s, much less between murder and Huntington’s more generally — has issued a clarification on the show’s blog, and promises to make a similar clarification in the episode itself, should they ever re-air it. Kudos to TAL, and many thanks to Sarah for being incredibly gracious in our exchanges.

          One clarification deserves another. In my earlier blog post, I also worried that some listeners might  conclude that Vince’s father was similarly driven to commit horrific acts of sexual abuse on Vince and his sister because he, too, was (presumably) suffering from Huntington’s (an autosomal dominant genetic disease). Although I think that a listener who didn’t know better could reasonably conclude that Huntington’s causes people to become sexual predators almost as easily as they could conclude from the episode that Huntington’s causes people to become murderers, nothing in the episode suggests that Sarah, Benjamin Gilmer, or anyone else at TAL believe that Huntington’s causes sexual abuse, or that they intended for listeners to reach that conclusion. I regret anything in my earlier post that suggested otherwise.

          Again, I’m very grateful to Sarah and everyone else at TAL for hearing me (and other listeners) out and for agreeing to make the clarification — and just in time for HD Awareness Month!

            Introducing New Blogger Nicholson Price

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            W. Nicholson Price II is an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School.  He holds a J.D. from Columbia Law School, a Ph.D. in Biological Sciences from Columbia University, and an A.B. from Harvard College.  After law school, he clerked for Judge Carlos T. Bea of the U.S. Court of Appeals for the Ninth Circuit and was a Visiting Consortium Scholar at the UCSF/UC Hastings Consortium on Law, Science and Health Policy.  His current research interests include innovation in pharmaceutical manufacturing, genetic testing, and personalized medicine.

            Some of Nicholson’s recent publications include:

            Does Whole-Genome Sequencing Circumvent Gene Patents?  Bio-IT World (December 10, 2012).

            Unblocked Future: Why Gene Patents Won’t Hinder Whole-Genome Sequencing and Personalized Medicine. 33 Cardozo L. Rev. 1601 (2012).

            Price, W.N. et al. Large-scale experimental studies show unexpected amino acid effects on protein expression and solubility in vivo in E. coli. 1 Microbial Informatics and Experimentation 6 (2011).

            Neuner, L.K. & Price, W.N. The Deepwater Horizon Oil Spill: Potential Insurance Coverage Implications. Ins. Law Coverage Bulletin (Sep. 2010).

            Am I My Son? Clones and the Modern Family. 11 Colum. Sci. Tech. L. Rev. 118 (2010). Winner, Julius Silver Notes Competition 2009.

            Price, W.N. et al. Understanding the physical properties that control protein crystallization by analysis of large-scale experimental data. 27 Nat. Biotechnol. 51 (2009).

            Patenting Race: The Problems of Ethnic Genetic Testing of Patents.
            8 Colum. Sci. Tech. L. Rev. 119 (2007). Winner, Julius Silver Notes Competition 2006.

              Medical Malpractice, the Affordable Care Act and State Provider Shield Laws: More Myth than Necessity?

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              By Mary Ann Chirba and Alice A. Noble

              Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.

              In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: http://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].

              In April, the governor of Georgia signed H.B. 499 [link: http://www.legis.ga.gov/legislation/en-US/display/20132014/HB/499] into law, becoming the first state to pass legislation based on the AMA model act.

              This came on the heels of a Medical Association of Georgia Advocacy Brief [link: http://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]

              It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.

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                Online Symposium on the Law, Ethics & Science of Re-identification Demonstrations

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                Over the course of the last fifteen or so years, the belief that “de-identification” of personally identifiable information preserves the anonymity of those individuals has been repeatedly called up short by scholars and journalists. It would be difficult to overstate the importance, for privacy law and policy, of the early work of “re-identification scholars,” as I’ll call them. In the mid-1990s, the Massachusetts Group Insurance Commission (GIC) released data on individual hospital visits by state employees in order to aid important research. As Massachusetts Governor Bill Weld assured employees, their data had been “anonymized,” with all obvious identifiers, such as name, address, and Social Security number, removed. But Latanya Sweeney, then an MIT graduate student, wasn’t buying it. When, in 1996, Weld collapsed at a local event and was admitted to the hospital, she set out to show that she could re-identify his GIC entry. For twenty dollars, she purchased the full roll of Cambridge voter-registration records, and by linking the two data sets, which individually were innocuous enough, she was able to re-identify his GIC entry. As privacy law scholar Paul Ohm put it, “In a theatrical flourish, Dr. Sweeney sent the Governor’s health records (which included diagnoses and prescriptions) to his office.”

                Sweeney’s demonstration led to important changes in privacy law, especially under HIPAA. But that demonstration was just the beginning. In 2006, the New York Times was able to re-identify one individual (and only one individual)  in a publicly available research dataset of the three-month AOL search history of over 600,000 users. The Times demonstration led to a class-action lawsuit (which settled out of court), an FTC complaint, and soul-searching in Congress. That same year, Netflix began a three-year contest, offering a $1 million prize to whomever could most improve the algorithm by which the company predicts how much a particular user will enjoy a particular movie. To enable the contest, Netflix made publicly available a dataset of the movie ratings of 500,000 of its customers, whose names it replaced with numerical identifiers. In a 2008 paper, Arvind Narayanan, then a graduate student at UT-Austin, along with his advisor, showed that by linking the “anonymized” Netflix prize dataset to the Internet Movie Database (IMDb), in which viewers review movies, often under their own names, many Netflix users could be re-identified, revealing information that was suggestive of their political preferences and other potentially sensitive information. (Remarkably, notwithstanding the re-identification demonstration, after awarding the prize in 2009 to a team from AT&T, in 2010, Netflix announced plans for a second contest, which it cancelled only after tussling with a class-action lawsuit (again, settled out of court) and the FTC.) Earlier this year, Yaniv Erlich and colleagues, using a novel technique involving surnames and the Y chromosome, re-identified five men who had participated in the 1000 Genomes Project — an international consortium to place, in an open online database, the sequenced genomes of (as it turns out, 2500) “unidentified” people — who had also participated in a study of Mormon families in Utah.

                Most recently, Sweeney and colleagues re-identified participants in Harvard’s Personal Genome Project (PGP), who are warned of this risk, using the same technique she used to re-identify Weld in 1997. As a scholar of research ethics and regulation — and also a PGP participant — this latest demonstration piqued my interest. Although much has been said about the appropriate legal and policy responses to these demonstrations (my own thoughts are here), there has been very little discussion about the legal and ethical aspects of the demonstrations themselves. As a modest step in filling that gap, I’m pleased to announce an online symposium, to take place here at the Bill of Health the week of May 20th, that will address both the scientific and policy value of these demonstrations and the legal and ethical issues they raise. Participants fill diverse stakeholder roles (data holder, data provider — i.e., research participant, re-identification researcher, privacy scholar, research ethicist) and will, I expect, have a range of perspectives on these questions:

                Misha Angrist
                Madeleine Ball
                Daniel Barth-Jones
                Yaniv Erlich
                Beau Gunderson
                Stephen Wilson
                Michelle Meyer
                Arvind Narayanan
                Paul Ohm
                Latanya Sweeney
                Jennifer Wagner

                I hope readers will join us on May 20.

                  Petrie-Flom Student Fellowship Applications Due in One Week!

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                  [Note: This Student Fellowship program is different from the Petrie-Flom Center Academic Fellowship, applications for which will open again in the Fall.]

                  The Center and Student Fellowship.  The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas.  For more information on our current fellows and their work, see our website. 

                  Eligibility. The student fellowship program is open to Harvard Law School students and students in other Harvard graduate programs who are committed to undertaking a significant research project during the year of their fellowship. 

                  Keep reading for additional information on fellowship requirements and applications…

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                    Tough Advice to Swallow from the NYT Ethicist

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                    Take a look at the answer this physician received about breaking his promise of confidentiality to a patient.  The New York Times’ Ethicist describes this as a modern problem, but it seems to me this is age-old.  And although the confession was not medical, the nature of the doctor-patient relationship and the historical trust it has cultivated can’t be ignored.  The Ethicist says he expects vehement disagreement, and that’s one thing he’s right about for sure.

                      Petrie-Flom Interns’ Weekly Round-Up: 5/4-5/10

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                      [Ed. Note: This will be the last intern round-up of the academic year, to resume in the Fall.  Thanks, Hyeongsu and Kathy!]

                      By Hyeongsu Park and Kathy Wang

                        Too Young for Sex, But Old Enough for the Sex Offender Registry, Part I

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                        This post is the first in a three part series on the use of criminal law to police teen sex.

                        A recent study by Human Rights Watch suggests that statutory rape law is a poor tool for reducing teen sexuality.  Their study and my forthcoming article, Law’s Limits: Regulating Statutory Rape Law, published by the Wisconsin Law Review concur on this point.  Consider an unfortunate case that underscores the importance of revisiting statutory rape law prosecutions in the United States.  In 2011, J.L. was adjudicated a delinquent, charged with first‑degree rape, and convicted under the South Dakota statutory rape statute. According to the South Dakota Supreme Court, J.L., a fourteen-year-old, “engaged in consensual sexual intercourse with his girlfriend, who was twelve” and only fifteen months his junior.  Despite both adolescents consenting to sex in this case, in the state of South Dakota, J.L.’s conviction will result in legal and extralegal penalties far more severe than that of an adult rapist who commits a sexually violent act against a college peer, a random woman, or during the commission of another crime.  This is because J.L.’s “victim” was under the age of thirteen.

                        In a provocative commentary, buried in a footnote, the South Dakota Supreme Court references the harsh penalties J.L. and other minors who engage in consensual sex with minors will encounter. The court explains, “[i]t appears that J.L. will be required to register as a sex offender for life.” In other words, J.L.’s “mark” as a sexual predator burdens him with the same potent and socially stigmatic punishment as that of a convicted, middle-aged pedophile who rapes a minor.  This prosecution and others similar point to the absurd results in many statutory rape cases involving teens who have consensual sex with teens.

                        As I note in the forthcoming article, had J.L.’s girlfriend been an adult and a nonconsensual sexual act occurred, he could qualify for release from the sex offender registry list after only ten years, rather than the life-term that now serves as his punishment.  In South Dakota, consensual sex between minors may result in a more severe punishment than nonconsensual sexual encounters either between adults or between a teenage male and an adult woman.   But, are such outcomes just?  Do they reflect broad social consensus?  Or do such prosecutions lead to absurd, untenable results?

                        In the coming week, my blog posts will address these and other relevant questions.

                          Privacy and Progress and the Deidentification of Whole Genome Sequence Data

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                          [Posted on behalf of Elizabeth Pike and Kayte Spector-Bagdady from the Presidential Commission for the Study of Bioethical Issues - and cross-posted here.]

                          In the most recent issue of the Hastings Center Report, Drs. Amy Gutmann and James Wagner of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), contributed to the lively debate surrounding the identifiability of genetic data. In Found Your DNA on the Web: Reconciling Privacy and Progress, Gutmann and Wagner, Chair and Vice-chair respectively, argue that the paradigm of identifiability has become less relevant to individual privacy protections than restrictions on access and use.

                          In their commentary, Gutmann and Wagner continue the public deliberation of the Bioethics Commission’s report, Privacy and Progress in Whole Genome Sequencing, in which the Bioethics Commission took a forward-looking approach to the privacy concerns raised by whole genome sequencing—issues that have come to the forefront of this important science.

                          Under current law, health information that is deidentified—information for which there is “no reasonable basis” to believe it can identify an individual or that has been stripped of traditional identifiers—is afforded different legal protections than identifiable health information. However, whole genome sequence data are unique to only one person, making them more vulnerable to reidentification.

                          Recent articles have cast doubt on the extent to which whole genome sequence data can be deidentified. For example, in Identifying Personal Genomes by Surname Inference, published in Science in January, Melissa Gymrek, et. al. successfully uncovered full identities of 50 individuals.

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                            PFC Student Intern Applications Due Soon!

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                            The Petrie-Flom Center for Health Law Policy,
                            Biotechnology, and Bioethics at Harvard Law School
                             
                            Call for Applications
                            Student Internship Program

                             

                            The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the upcoming academic year beginning in September 2013.   Full-year availability is preferred, but single-term internships will be considered on an individual basis; please indicate your preference in your application materials. We are not currently accepting applications for Summer 2013, but may consider extension through Summer 2014 if there is mutual interest.

                            Who is eligible?

                            Harvard undergraduate and graduate students with an interest in the Center’s work are eligible to apply. More information about the Center is available here. The internship is open to students in all disciplines, but we particularly welcome applications from students studying health policy, philosophy, bioethics, law, medicine, business economics, and the sciences.  We are also interested in receiving applications from students interested in technology and communications, as we plan to substantially update and expand our Internet presence and social media strategy.

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                              Hair, Stress, and the Law

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                              A new study has found a relationship between cortisol levels in our hair and prevalence of metabolic syndrome (a cluster of abnormalities that increase the likelihood of developing diabetes and heart disease). Here’s how the New York Times describes the study:

                              High levels of cortisol — the so-called stress hormone — have been associated with cardiovascular disease in some studies, but not in others. This may be because measuring cortisol in blood or saliva at one point in time may pick up acute stress, but it fails to account for long-term stress. . . . Now Dutch researchers have assessed cortisol levels over several months by analyzing scalp hair samples. . . . The researchers measured the cortisol content in hair samples corresponding to roughly three months of growth from 283 older men and women, average age 75. They also gathered self-reported data about coronary heart disease, stroke, peripheral artery disease, Type 2 diabetes, lung disease, cancer and osteoporosis. . . . Compared with those in the lowest quarter for cortisol, those in the highest quarter had about three times the risk for cardiovascular disease and diabetes.

                              In the actual paper, the researchers say little or nothing about “stress,” and if I recall correctly, the relationship between cortisol and stress can be complicated. But the research raises the possibility that we will someday identify reliable measurements of chronic stress over time. Of course, we may need more than just your hair. But in what I call the experiential future, such evidence—combined perhaps with other physiological, neurological, and psychiatric data—may enable us to make better assessments of chronic stress levels than we can now.

                              Better measurements of chronic stress could transform the way we measure damages in tort cases and measure punishment severity in criminal cases. Billions of dollars change hands every year based on difficult-to-verify assertions about pain and stress. Similarly, we adjust the severity of incarceration by changing the duration of sentences and pay almost no attention to the very different ways in which prisoners experience confinement. Measurements of stress levels could also help determine when an interrogation tactic constitutes torture.

                              Of course, forensic techniques encourage people to use countermeasures. In the cortisol-hair study, for example, one measurement was apparently affected by rates of shampooing while another was not. So I’m not suggesting there will be a silver bullet that solves all measurement problems. When evaluating the scientific research, however, it is important to remember just how bad we are at measuring stress levels now, despite the fact that we make such assessments every day. The technology need hardly be perfect to represent an improvement.

                                Financial Conflicts of Interest

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                                By Joanna Sax

                                A recent article in the Journal of Law, Medicine & Ethics (Vol. 41:1, pp. 315-22) nicely describes the contours of Physician Payment Sunshine Act (PPSA) on pharmaceutical marketing.  Similar to other policies addressing financial conflicts of interest, the lion’s share of the PPSA focuses on disclosure.  That is, pharmaceutical companies will be required to disclose how much money they are “giving” to physicians.  A financial conflict of interest can arise when the gifts of money unduly influence a physician’s prescribing habits.

                                I’ve previously argued here, here and here that the system of disclosure is inadequate to properly address financial conflicts of interest.  Disclosure does only that; it discloses.  So now people know about it – that’s it.  Instead of a system that increases disclosure, I’ve proposed changes to the underlying environment to decrease or eliminate the possibility of a conflict of interest arising.

                                My research on financial conflicts of interest focuses on scientists at academic medical centers.  I’ve suggested that if academic scientists are in stressful situations, such as worrying about funding, they might be more likely to enter into a situation in which a conflict of interest might arise.  For this reason, if we change the underlying environment of our academic scientists such they are not living in a state of chronic stress, then they might make different decisions, which in turn should lead to fewer situations in which a conflict of interest might arise.

                                Private physicians operate in a different world than scientists at academic medical centers.  I’m curious if readers have suggestions to change the environment of private physicians such that they will be less likely to enter into situations in which a conflict of interest might arise.