NPRM Symposium: Privacy and Promises, Promises, Promises

Part Two of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The first blog post in this series probably provided a few surprises, but the surprises are just beginning. Can the NPRM to amend the Common Rule keep its promises?

The NPRM promises that patients will be able to consent to use of their clinical data in research, which is actually two promises, not one. The first is that the consent will be given effect. The second is that the refusal will be given effect.  As to refusal, the NPRM absolutely does not keep its promise.

The NPRM is filled with page after page of exceptions where your consent is not required. These include examples like trailing you and spying on you in public, some tests done on how to affect children’s behavior, and more. Continue reading

Looking Towards 2030 in Patient Safety

There is a clear need for those charged with patient safety policy making to prepare for the future and to take account of emerging trends. This would be so in any commercial or professional organisation. These issues were addressed in the context of patient safety at the recent,Patient Safety Global Action Summit held in March 2016 in London. The conference was designed to mirror the discussions contained in the report  by NIHR (National Institute for Health Research), Patient Safety Translational Research Centre at Imperial College London and The Imperial College NHS Trust on the priorities and direction that the patient safety movement should follow going towards 2030.

There is a lot that is excellent in this report  which is very rich in analysis and detail. Lots of deep thinking about patient safety issues with interesting and novel ideas expressed on nearly every page.

Emerging threats to patient safety

In the report, in chapter one, it is acknowledged that there are many existing issues at the root of patient harm that have yet to be solved. Also that unfortunately trends in healthcare are likely to increase the risks to safety. The report focuses on four emerging trends: Continue reading

REGISTER NOW! 2016 Annual Conference: Big Data, Health Law, and Bioethics

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2016 Annual Conference:
Big Data, Health Law, and Bioethics
May 6, 2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).

Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers.  And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records. Continue reading

LGBT Backlash Legislation and the Politics of Biology

By Maayan Sudai

Of the many responses to the monumental victory of the gay marriage movement in Obergefell v. Hodges in 2015, one was a backlash of legislative proposals submitted by conservative groups. A popular target was the regulation of sex-segregated public spaces like bathrooms, schools, etc. – also called “bathroom bills” – in TexasFloridaKentucky, and other states. The anti-LGBT bills are meant to either block the extension of anti-discrimination protections that could accommodate free use of sex-segregated public spaces, or strictly ban Transgender people from entering public bathrooms that fit their self-identified gender.

In South Dakota, failed bill HB1008 would have made it illegal for schools to provide accommodations for Transgender students and would have required every public bathroom, shower, or locker room be “designated for and used only by students of the same biological sex.” The bill did not pass, as Governor Dennis Daugaard vetoed it last March, affirming the authority of local municipalities to determine their own standards. Nevertheless, a few weeks later a similar bill was passed in North Carolina. The new law, also known as HB2 or the “Charlotte Bill” (more formally: “Public Facilities Privacy and Security Act”) came as a response to a local non-discrimination ordinance issued by the Charlotte City Council which provided protections and accommodation to the LGBT community in public bathrooms. HB2 affectively repealed the Charlotte ordinance, and restricted the ability of other cities in the state to expand equality measures beyond the standard determined by HB2.[1] Rich Schragger said that HB2 is “thus an anti-LGBT law masked as an anti-discrimination provision.”

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Leo Beletsky on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we interviewed Leo Beletsky, Associate Professor of Law and Health Sciences at Northeastern University. Leo utilizes empirical and theoretical approaches to analyze how legal mechanisms can help curb substance abuse, prevent the spread of HIV and other infectious diseases and improve patient care. By highlighting discrepancies between black letter law and its real-world implementation, he also examines the relationship between police practices, public health outcomes and human rights of vulnerable groups.

We had plenty of opportunity to apply Leo’s expertise to the topic we focused on this week: opioid addiction. Recent studies have demonstrated a rapidly rising rate of opioid abuse, with troubling consequences for individuals and communities. This drug use has also attracted a host of legal responses, which Leo has expertly dissected in past work (including some recent studies here).

Our lightning round featured discussions of recent research on income and life expectancy, the emerging natural experiment in Kentucky on Medicaid rollback, and insurer mergers.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

Continue reading

The Petrie-Flom Center & Coalition to Transform Advanced Care Launch “The Project on Advanced Care and Health Policy”

The Project on Advanced Care and Health Policy will foster development of improved models of care for individuals with serious advanced illness nearing end-of-life, through interdisciplinary analysis of important health law and policy issues.

March 28, 2016 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Coalition to Transform Advanced Care (C-TAC) today announced a new collaboration, The Project on Advanced Care and Health Policy.

This initiative is prompted by the fact that current health law policy and regulation, developed largely in a fee-for service environment with siloed providers, creates barriers that may impede widespread adoption of improved models of care for those with advanced illness. The Project will seek to address this problem through policy and research projects that will identify and analyze these barriers, and propose policy solutions that promote development and growth of successful programs. This may entail developing proposed regulatory approaches for the advanced care delivery model that could be adopted by policymakers at the state and federal levels, as well as exploration of potential payment methodologies for this model of care.  Continue reading

Sex Markers in Official Documentation – Between Biology and Self-Identification

A recent civil action filed by LAMBDA Legal highlights a debate ongoing for the past several years on the issue of “sex-markers” in official documentation to the U.S courts. In different instances, plaintiffs and interest groups have sought to challenge the state’s sex-binary classification system when issuing official identification documents such as passports, birth certificates, driver’s licenses and more. Litigation and advocacy around sex-markers in official documentation may be roughly distinguished between groups advocating for easier access to the existing Male /Female categories (“M/F”), mostly by and for the trans community, and to groups asking to break the M/F distinction altogether in favor of an unspecified category: ”X”/”MF”/Unknown/Unspecified. This group is not seeking better access to the existing M/F categories, but is rather pursuing the goal of creating an all-inclusive new category for those who do not identify as males or females, sometimes also referred to as “third sex” or “third gender”.

These challenges were sometimes fruitful in generating administrative adjustments. For example, in 2011 it became possible to mark “X” instead of M/F on passports in Australia. In 2013 Germany approved a change in legislation that allows leaving the “sex” checkbox in birth certificates empty. These developments were presented very positively in the media with headlines like: “Germany got it right by offering a third gender option on birth certificates” in the Guardian, or: “Germany allows ‘indeterminate’ gender at birth” in the BBC, that portrayed them as victories for intersex and LGBT activists. Although the wish to open up sex categories in official documentation seems to be in line with progressive politics, some Intersex advocacy organizations have had misgivings about this line of advocacy. One argument is that being an Intersex or a Trans person does not necessarily dictate a non-specified gender identity and so conjoining intersexuality and transgenderism with non-specified gender identity is incorrect to say the least.

Continue reading

NPRM Symposium: Consent and Consistency in the NPRM

By Luke Gelinas, Guest Blogger

  1.  Interpreting the proposed consent requirement

One of the most discussed and controversial aspects of the Department of Health and Human Services’ recent notice of proposed rule-making (NPRM), which stands to change the federal regulations governing research with human beings, is a new consent requirement for secondary research on bio-specimens.  ‘Secondary research’ involves leftover blood or tissue samples that are re-purposed for research after their original use as clinical samples or in prior research studies has been served.  Whereas the current regulations permit re-purposed samples to be used in research without consent so long as the samples are anonymized or de-identified, the new rule would require individuals to be notified that their samples will be used in research, and to give broad permission or consent for such use, before research using them is permitted.

One possible justification for the new consent requirement is what I will call the ‘rights-violation’ interpretation.  The rights-violation approach maintains that consent for research with biospecimens is ethically required to avoid a rights-violation—which is what, the view claims, using someone’s samples without their consent amounts to.

Defenders of this view face the challenge of saying precisely which right is violated by research with re-purposed specimens.  One idea is that the samples still count as part of the individual’s body, even if they are no longer spatially continuous with it, so that using them without consent infringes a bodily right.  A second possibility is that, even if donated specimens are not part of one’s body in the relevant sense, we yet have ownership interests in and claims to our biological materials, so that  something closer to a property right at stake.  A third view focuses on the personal health information that can be garnered from certain sorts of research with bio-specimens (e.g., research involving whole genome sequencing), claiming that privacy rights stand to be infringed when specimens are used without consent.  Each of these views raises complex ethical (and indeed in some cases metaphysical) issues that defenders of the rights-violation interpretation must work out.  Continue reading

TOMORROW, 3/25 in NYC! Book Talk & Panel: FDA in the 21st Century – The Challenges of Regulating Drugs and New Technologies

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FDA in the 21st Century:
The Challenges of Regulating Drugs and New Technologies

March 25, 2016 12:00 PM

92nd Street Y
1395 Lexington Ave. (at 92nd St.), New York, NY

Join co-editors Holly Fernandez Lynch (Petrie-Flom Executive Director) and I. Glenn Cohen (Petrie-Flom Faculty Director) and contributor Lewis Grossman (American University) for a discussion of FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015). This volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This is a ticketed event. To learn more, visit the 92nd Street Y’s website!

Sponsored by the 92nd Street Young Men’s and Young Women’s Hebrew Association (New York, New York) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

PANEL (4/5): The National Security Implications of the Genetics Revolution

 

Technology Concept

The National Security Implications of the Genetics Revolution
April 5, 2016 12:00 PM
Pound Hall, Room 101
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

 

Panelists:

  • Jamie Metzl, JD ’97, Senior Fellow for Technology and National Security of the Atlantic Council. He has served on the U.S. National Security Council, State Department, and Senate Foreign Relations Committee, as Executive Vice President of the Asia Society and with the United Nations in Cambodia. A globally syndicated columnist and regular guest on national and international media, he is the author of a history of the Cambodian genocide and the novels The Depths of the Sea and Genesis Code.

Topic: The National Security Implications of the Genetics Revolution

  • George J. Annas, JD, MPH, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law

Topic: Post-9/11 Uses of Public Health and Medicine by National Security Agencies 

  • Jonathan D. Moreno, PhD, David and Lyn Silfen University Professor of Ethics, Perelman School of Medicine, University of Pennsylvania

Topic: National Security and Biology

This event is free and open to the public. Lunch will be provided.

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the Harvard National Security & Law Association, the Harvard National Security Journal, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Uterus Transplants: Challenges and Potential

[Cross posted at the OUPBlog]

By John A. Robertson

The birth of a healthy child in Sweden in October, 2014 after a uterus transplant from a living donor marked the advent of a new technique to help women with absent or non-functional uteruses to bear genetic offspring. The Cleveland Clinic has now led American doctors into this space, performing the first US uterine transplant in February, 2016 as part of an Institutional Review Board (IRB)-approved series of ten transplants using cadaveric donors. Dallas and Boston medical centers have also been approved for this program, as will other programs as progress continues. An estimate of 50,000 American women are potential clients.

The path to womb transplants, however, will not be easy. On 7 March, the Cleveland Clinic celebrated its transplant with a media announcement full of joy and celebration. Two days later in a decidedly different key, the Clinic informed the world that the organ was surgically removed because the recipient had “suddenly developed a serious complication.” One can only imagine the disappointment of the patient and medical team, who had smiled so happily in media coverage. Of course, early failure is not surprising with innovative surgery, and no doubt the Cleveland clinic will proceed with other patients. The case is a reminder that the road to success is long, and initial steps should be closely monitored by IRBs, as is occurring in Cleveland, Sweden, and elsewhere. Continue reading

The EEOC’s Role In Reshaping Wellness Programs

This new post by Kristin Madison appears on the Health Affairs Blog concludes the blog series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Wellness programs remain a popular feature of the employer landscape, but the legal environment surrounding them has long been uncertain. In April 2015, the Equal Employment Opportunity Commission took a significant step toward resolving this uncertainty by formally proposing a ruleclarifying the applicability Americans with Disabilities Act of 1990 (ADA) to wellness programs.

In doing so, it staked out middle ground between an approach that would have sharply limited the use of incentives in wellness programs, and a more permissive approach consistent with regulations already in place under the Affordable Care Act (ACA). The proposed rule has the potential to shape, or reshape, future wellness programs. The extent to which it will do so, however, remains uncertain. […]

Read the full post here.

New Federal Employee Drug Screening Guidelines to Include Opioid Testing

By Jonathan K. Larsen, JD, MPP

There is no denying that the United States is experiencing an opioid overdose epidemic. Drug overdose deaths generally in the United States have been associated, at least in part, with increasing mortality rates among white non-Hispanics, which is counter to trends in other wealthy nations. The Urban Institute’s Laudan Aron recently posted about the underlying causes of our current epidemic, paying special attention to aggressive marketing of painkillers, the related spike in opioid prescriptions, and the closely correlated increase in opioid abuse. The issue has even made it into the current Presidential campaign, however briefly. President Obama has sought increased funding to address the issue, as well as a focused private, state, and local effort to tackle prescription drug abuse. While opioid abuse has been on the rise, it is not typically part of employee drug testing, when employers choose or are required to test. This may be changing.

The Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency responsible for drug testing standards for federal agencies, is poised to release drug screening guidelines (see page 4 (28104 in the Federal Register) that would expand drug screening for opioid abuse to federal employees, and could influence employee drug testing policies across the nation. The US Department of Defense has been testing for hydrocodone and benzodiazepines (used to treat anxiety and seizures among other things) since May 1, 2012. SAMHSA cites sobering statistics about opioid-related deaths now outnumbering deaths from illicit drugs, as it prepares to test for oxycodone, oxymorphone, hydrocodone, and hydromorphone, all classified as Schedule II drugs, or drugs with high risk of abuse, by the United States Food and Drug Administration (FDA). The proposed guidelines were released May 15, 2015, so the final rules should be coming soon. Continue reading