It might come as a surprise to many in the United States that they may have no Fourth Amendment reasonable expectation of privacy in their physicians’ records when their physicians transfer these records to state agencies under state public health laws. Yet on July 27, the federal district court for the state of Utah said exactly this for records of controlled substance prescriptions—and perhaps for medical records more generally. (United States Department of Justice, Drug Enforcement Administration v. Utah Department of Commerce, 2017 WL 3189868 (D. Utah July 27)). Patients should know that their physicians are required by law to make reports of these prescriptions to state health departments, the court said. Because patients should know about these reports, they have no expectation of privacy in them as far as the Fourth Amendment is concerned. And, so, warrantless searches by the Drug Enforcement Administration (DEA) are constitutionally permissible at least so far as the district of Utah is concerned. Physicians are by law required to make many kinds of reports to state agencies: abuse, various infectious diseases, possible instances of bioterrorism, tumors, abortions, birth defects—and, in most states, controlled substance prescriptions. The Utah court’s reasoning potentially throws into question the extent to which any of these reports may receive Fourth Amendment protection.
Persistent differences in participation in clinical trials by race and ethnicity are well known; for example, the 2015 Report of the Working Group on Precision Medicine (PMI) relies on statistics that only 5% of clinical trial participants are African-American and only 1% are Hispanic. A recently-launched website of the FDA, “Drug Trials Snapshots,” confirms this dismal picture.
Designed to “make demographic data more available and transparent,” and to “highlight whether there were any differences in the benefits and side effects among sex, race and age groups,” the website reveals instead an impressive lack of information. Reported on the website are 70 new drug approvals for 78 different indications. These data report only evidence about differences by the census categories for race (White, Black or African-American, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and Unknown). In nine of the reported trials data were considered sufficient to report detected differences in efficacy or side-effects in all racial categories, in two data were considered sufficient to report these differences for African-Americans and Asians, in seven data were considered sufficient to report these differences for Asians, and in two data were considered sufficient to report these differences only for African-Americans. No data are reported about ethnicity, socioeconomic status, disability, or other categories that might be important to the PMI and the benefits data about the planned cohort might bring. Read More
Surrogacy is legal in many states. Some, like California, directly enforce gestational carrier contracts. Others, like Texas, Illinois, and Virginia, enforce only those contracts that are entered into by a married couple who need a surrogate for medical reasons which a judge approves before embryo transfer occurs. A Pennsylvania court has now shown why gestational surrogacy contract should be directly enforced in the absence of legislation. Its well-reasoned opinion suggests that more states may be open to this approach to surrogacy.
The Pennsylvania case, In re Baby S., arose out of a gestational surrogacy agreement involving embryos created with donor eggs and husband sperm. The written agreement was indisputably clear that that the intended parents would be the legal rearing parents, their names would appear on the birth certificate, and the carrier would have no rearing rights or duties. Unlike previous cases questioning the validity of a surrogacy contract, the challenge here came not from the carrier who now wished to assert rearing rights (see In re Baby M and Calvert v. Johnson) but from the wife (the intended rearing mother). She had praised the carrier’s willingness to help her have a child, which she repeated both at the embryo transfer and at a 20 week ultrasound at 20 weeks of pregnancy, which both intended parents attended. A month later she informed the parties that “irreconcilable marital difficulties” would make it difficult for her to co-parent the child with the intended father. She also refused to complete the paperwork for her name to appear on the birth certificate as the mother.
On July 30, the White House announced the updated 2020 HIV/AIDS strategy. The admirable vision of the strategy is that “The United States will become a place where new HIV infections are rare, and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance, will have unfettered access to high quality, life-extending care, free from stigma and discrimination.”
This said, the strategy reflects continuing concerns about the numbers of people who do not know their HIV status, who do not have access to effective treatment, and who do not take advantage of preventive strategies. Demographic groups especially at risk include men having sex with men, African American men and women, Latino men and women, people who inject drugs, youth age 13-24, people in the Southern United States, and transgender women. The strategy emphasizes care coordination, coordination between health care and other social services such as housing, treatment as prevention, and pre-exposure prophylaxis. Notable initiatives since the 2010 HIV/AIDS strategy include interagency efforts to address the intersection of HIV and violence against women, a DOJ and CDC collaboration to publish a comprehensive examination and best practices guide on the intersection between HIV and criminal laws, and demonstration projects funded through the HHS Minority AIDS Initiative Fund. Read More
[Cross-posted at HealthLawProfs blog.]
Under HIPAA, patients’ spouses and other family members have certain rights to access health information. In an important guidance document in the wake of United States v. Windsor, the Office for Civil Rights (OCR) at HHS has clarified that “spouse” under HIPAA refers to legally married same-sex spouses, even if the individual is receiving services in a jurisdiction not recognizing same-sex marriage. Read More
Like the recent Supreme Court decision in Hobby Lobby, the D.C. Circuit’s ruling earlier this week in Halbig v. Burwell is being hailed by conservatives and bemoaned by liberals as a death knell for Obamacare. Unlike the decision in Hobby Lobby, however the D.C. Circuit’s ruling is not the end of the matter, and many liberals are finding hope in the ruling of the 4th Circuit the same day, the probability of an en banc hearing in the D.C. Circuit, and the ultimate possibility of a favorable Supreme Court decision. In an earlier post in HealthLawProf, I decided to take seriously the possibility of damage control from a limited reading of Hobby Lobby. It is pretty much universally agreed—and I believe correctly—that it is not possible to do similar damage control by giving a limited reading to Halbig v. Burwell. If the ruling stands, that tax subsidies are not available to people purchasing coverage through the exchanges in the states that are letting the federal government do the work, many important other provisions of the ACA will be untenable, including the penalties for large employers not offering insurance whose employees receive subsidies and likely the individual mandate itself. But I think it is possible to undermine Halbig in a way not generally recognized by the liberal critics who argue (correctly) that the statutory provision at issue is ambiguous: argue that the jurisprudence of the majority opinion in Halbig is internally inconsistent. Here’s how. Read More
Cross-post from HealthLawProf Blog
The President’s Council of Advisors on Science and Technology (PCAST) has issued a report intended to be a technological complement to the recent White House report on big data. This PCAST report, however, is far more than a technological analysis—although as a description of technological developments it is wonderfully accessible, clear and informative. It also contains policy recommendations of sweeping significance about how technology should be used and developed. PCAST’s recommendations carry the imprimatur of scientific expertise—and lawyers interested in health policy should be alert to the normative approach of PCAST to big data.
Here, in PCAST’s own words, is the basic approach: “In light of the continuing proliferation of ways to collect and use information about people, PCAST recommends that policy focus primarily on whether specific uses of information about people affect privacy adversely. It also recommends that policy focus on outcomes, on the “what” rather than the “how,” to avoid becoming obsolete as technology advances. The policy framework should accelerate the development and commercialization of technologies that can help to contain adverse impacts on privacy, including research into new technological options. By using technology more effectively, the Nation can lead internationally in making the most of big data’s benefits while limiting the concerns it poses for privacy. Finally, PCAST calls for efforts to assure that there is enough talent available with the expertise needed to develop and use big data in a privacy-sensitive way.” In other words: assume the importance of continuing to collect and analyze big data, identify potential harms and fixes on a case-by-case basis possibly after the fact, and enlist the help of the commercial sector to develop profitable privacy technologies. Read More
At last year’s Petrie-Flom conference on the FDA in the 21st Century, I had an experience that I’ve never really had before in my academic career. I gave a paper (co-authored, actually) that was met with genuine ire. The paper dealt with labeling GMO foods. Several in the audience—including friends—heard me as going over to the dark side of anti-science, irrational skepticism, and downright immoral ignorance of important nutritional and commercial advantages. I wasn’t buying into such bad science, however. The written paper (concededly it’s always possible that a lengthy legal argument doesn’t come across in a nuanced way in a short presentation) argued three points: (1) the FDA has not acted to the full extent of its statutory labeling authority; (2) the present processes for granting market clearance for particular GMO products is highly deferential to industry submissions with respect to safety (the safety of a particular GMO product is a different question from the general question of GMO safety—the FDA’s own example is the unknown allergenic effects of adding peanut genes to other agricultural products); and (3) in a context in which scrutiny of safety is so industry-dependent, there is a case to be made for labeling so that consumers can make their own choices.
In a nutshell, the current FDA process for allowing a particular GMO product to be marketed is a variant of the process for allowing marketing of additives Generally Recognized as Safe (GRAS). Under the GRAS process, anyone can petition for a determination that an additive is GRAS; industry can also make its own GRAS determinations. The procedure for clearing GMO foods is a consultative process that is also voluntary and entirely reliant on information from industry. Unlike the GRAS process, however, it does not even require publication of the information relied on for consultations.
In an article published this week in JAMA Internal Medicine, Neitner et al. demonstrate the extent to which GRAS determinations are riddled with conflicts of interest. The authors conclude, “The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.” Given the parallels between the GRAS process and the process applied to GMO foods, one might hypothesize that conflicts of interest are similarly present in the latter. The FDA should address these concerns, too. This is not anti-science; it is respect for good science.[Leslie Francis]
At the University of Utah, our Center on Law and Biomedical Sciences was fortunate to be able to hold a recent symposium on the future of gene patenting. Our speakers included Ken Chahine and Amelia Rinehart, both faculty at the College of Law, presenting accounts of the science and patent law; Brian Dawson, co-director of the molecular genetics lab at the Mayo Clinic, and Elaine Lyon, co-director of pharmacogenomics at ARUP and incoming president of the Association of Molecular Pathologists, speaking from the perspectives of laboratory directors and the Association of Molecular Pathologists; John Meija, legal director of the ACLU of Utah, speaking on patients’ rights; Wendy Kohlmann, manager of genetic counseling at the Huntsman Cancer Center, considering the ethical dilemmas for genetic counselors confronted by intellectual property restrictions; and Benjamin Jackson, senior director of legal affairs at Myriad Genetics, speaking from the perspective of Myriad. A recording of the symposium can be found here.
For those wishing to follow ongoing developments in gene patenting, we have prepared a libguide with resources on the Myriad decision and ongoing gene patenting cases.
[This is a cross-post from the HealthLawProf blog.]
Cross-posted from the HealthLawProfs blog.
Challenges designed to spur innovative uses of data are springing up frequently. These are contests, sponsored by a mix of government agencies, industry, foundations, a variety of not-for-profit groups, or even individuals. They offer prize money or other incentives for people or teams to come up with solutions to a wide range of problems. In addition to grand prizes, they often offer many smaller prizes or networking opportunities. The latest such challenge to come to my attention was announced August 19 by the Knight Foundation: $2 million for answers to the question “how can we harnass data and information for the health of communities?” Companion prizes, of up to $200,000, are also being offered by the Robert Wood Johnson Foundation and the California Healthcare Foundation.
Such challenges are also a favorite of the Obama administration. From promoting Obamacare among younger Americans (over 100 prizes of up to $30,000)–now entered by Karl Rove’s Crossroads group–to arms control and identification of sewer overflows, the federal government has gone in for challenges big time. Check out challenge.gov to see the impressive list. Use of information and technological innovation feature prominently in the challenges, but there is also a challenge for “innovative communications strategies to target individuals who experience high levels of involuntary breaks (“churn”) in health insurance coverage” (from SAMHSA), a challenge to design posters to educate kids about concussions (from CDC), a challenge to develop a robot that can retrieve samples (from NASA), and a challenge to use technology for atrocity prevention (from USAID and Humanity United). All in all, some 285 challenges sponsored by the federal government are currently active, although for some the submission period has closed. Read More