Applications Due TODAY, 8/11! 2017-2018 Petrie-Flom Student Fellowship

PFC_Logo_300x300The 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 closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website and check out profiles of some of our past Fellows in the PFC Spotlight.

Eligibility

The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs to wait until after their first year to apply. Continue reading

Sharing Data for 21st Century Cures – Two Steps Forward…

By Mary A. Majumder, Christi J. Guerrini, Juli M. Bollinger, Robert Cook-Deegan, and Amy L. McGuire

The 21st Century Cures Act was passed with support from both sides of the aisle (imagine that!) and signed into law by then-President Obama late last year. This ambitious legislation drives action in areas as diverse as drug and device regulation and response to the opioid epidemic. It also tackles the issue of how to make data more broadly available for research use and clinical purposes. In our recently published GIM article, “Sharing data under the 21st Century Cures Act,” we examine the Act’s potential to facilitate data-sharing, in line with a recent position statement of the American College of Medical Genetics and Genomics. We highlight a number of provisions of the Act that either explicitly advance data-sharing or promote policy developments that have the potential to advance it. For example, Section 2014 of the Act authorizes the Director of National Institutes of Health to require award recipients to share data, and Section 4006 requires the Secretary of Health and Human Services to promote policies ensuring that patients have access to their electronic health information and are supported in sharing this information with others.

Just as relevant, the Act takes steps to reduce some major barriers to data sharing. An important feature of the Act, which has not been extensively publicized, is its incorporation of provisions from legislation originally proposed by Senators Elizabeth Warren and Mike Enzi to protect the identifiable, sensitive information of research subjects. Senator Warren, in particular, has been a vocal advocate of data sharing. Arguably, one of the biggest barriers to sharing is public concern about privacy. The relevant provisions address this concern chiefly via Certificates of Confidentiality. Among other things, the Act makes issuance of Certificates automatic for federally-funded research in which identifiable, sensitive information is collected and prohibits disclosure of identifiable, sensitive information by covered researchers, with only a few exceptions such as disclosure for purposes of other research. These protections became effective June 11, 2017. While NIH has signaled its awareness of the Act, it has not yet updated its Certificates of Confidentiality webpage. Continue reading

Copenhagen Conference: Legal Perspectives on Synthetic Biology and Gene Editing

Join us at the Centre for Information and Innovation Law (CIIR) Faculty of Law, University of Copenhagen on 20 November, 2017 to discuss Legal Perspectives on Synthetic Biology and Gene Editing.

CALL FOR PAPERS

Emerging technologies in Synthetic Biology and Gene Editing offer incredible opportunities and promising solutions to some of the most urgent challenges faced by humanity, such as climate change, environmental protection, growing population, renewable energy and improved health care. But the emerging applications also raise exceptional ethical, legal and social questions.

This conference marks the final phase of the participation of the Copenhagen Biotech and Pharma Forum (CBPF) Research Group at the Centre for Information and Innovation Law (CIIR) in the cross-faculty research project BioSYNergy. In accordance with the goals of this large cross-faculty project on Synthetic Biology, the event explores legal perspectives on synthetic biology, systems biology and gene editing. Dealing with the legal responses to ethical and scientific challenges raised by emerging life science technology. Continue reading

How should we organize consent to research biobanking in the hospital?

By Alena Buyx, MD PhD

Ever wondered what happens to the biological material you leave behind when you check out of the hospital? Nothing much, is the usual answer. However, the little bits of blood, tissue, and urine are potentially valuable for medical research; miniscule amounts of it may already allow sophisticated analyses, including genetic ones. Thus, in an approach termed ‘healthcare-embedded biobanking’, healthcare providers have started collections of leftover patient materials to create resources for future research.

However, unlike traditional research, healthcare-embedded biobanking is not done with a clear research question in mind. The materials are simply left-overs from diagnosis or treatment and, at the time of collection, the scientific projects for which they may be used eventually are entirely unclear.

This approach leads to an ethical conundrum. Established research ethics frameworks found here and here require that patients be asked for their consent and that they are given  all the information they need to make an informed decision about whether to donate their material (and its associated data) or not.  This includes, in particular, the research goals as well as the potential benefits and risks. However, this provision of information is not possible in healthcare-embedded biobanking: the risks and benefits can only be described in very broad terms, and the goals and timing of future research are usually unknown. Indeed, the materials may even not be used at all. Continue reading

Webinar, 6/28: Procedural Aspects of Compulsory Licensing under TRIPS

I am very happy to host yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below:

Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Wednesday 28. June 2017
4-6 p.m (CEST)
Sign-up & questions: Jakob.blak.wested@jur.ku.dk

This webinar on “TRIPS and the life sciences” will approach the question of compulsory licensing by looking at the technical and procedural requirements applied by courts when evaluating a petition for a compulsory license.  

The balancing of the instrumental application of patent rights as a stimulator of innovation and the public interest in having access to these innovations form a controversial trajectory of discourse, which is as old as patent law. Compulsory licenses are one of the means that have been applied throughout the history of patent law, to condition this complex intersection of interests. The TRIPS agreement is no exception and art 31 contains the provision for member states to grant CL. In 2013, the Indian authorities granted a compulsory license to NATCO Pharmaceuticals for Bayers patented pharmaceutical product Carboxy Substituted Diphenyl Ureas, useful for the treatment of liver and kidney cancer. This decision raised several issues regarding the procedures and requirements to be met in order to grant a compulsory license. Furthermore, in January 2017 an amendment to TRIPS agreement entered into force allowing compulsory licensors to export their generic pharmaceuticals to least developed countries, further recalibrating the intersection of the monopoly power of the patent and public interest. Continue reading

The 100th ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

twihl 5x5

This week, we celebrate Episode 100! Like Episode 1 from 2015, it’s just the two of us–revisiting topics from the first show, commenting on the current health policy landscape, and exploring past and present projects in health information law, privacy, data protection, and AI. Nic’s SSRN page is here, and Frank’s is here.

And we leave you with two of our recent public lectures: Nic Terry’s Rome Lecture (Appification to AI and Healthcare’s New Iron Triangle), and Frank Pasquale’s reflections on the political economy of health automation (inter alia).  Enjoy!

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

New Blog Symposium: Between Complacency and Panic – Legal, Ethical and Policy Responses to Emerging Infectious Diseases

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Wendy E. Parmet and Jennifer L. Huer

Public health is often invisible. In contrast to health services, public health interventions usually operate behind the scenes, reducing risks to broad populations. No one can say who was saved, what deaths were prevented.

For public health, this invisibility presents political and budgetary challenges. Without clear beneficiaries, public health has lacked the political support and dollars allocated to health services. This challenge may be even more formidable today as the Trump Administration seeks enormous cuts to public health programs, while questioning settled public health science.

In the face of such challenges, it may be tempting for public health advocates to emphasize the dangers of emerging infectious diseases. Over the last forty years, a multitude of new or previously tamed infectious diseases such as HIV/AIDS, SARS, Ebola, and Zika have emerged, wrecking morbidity and mortality, and causing panic around the globe. During these outbreaks, public health’s importance becomes, at least briefly, all-too-apparent. Continue reading

The First Human Body Transplant – Ethical and Legal Considerations

By Ana S. Iltis, PhD

brain_glowingprofileTo what lengths should we go to preserve human life? This is a question many are asking after hearing that three men plan to make medical history by conducting the first human head transplant. Or, rather, whole body transplant. Italian neurosurgeon Dr. Sergio Canavero and Chinese surgeon Dr. Xiaoping Ren plan to provide a Russian volunteer, Valery Spiridonov, a new body. During the procedure, Spiridonov’s body and head would be detached and, with the help of a crane, surgeons would move the head and attach it to the donor body.  But is this ethical? What role might law and regulation play in monitoring them or in assessing their conduct after the fact?

Critics call the plan crazy, unethical, and sure to fail. The likelihood of success is very low and the risk of Spiridinov dying is high. Spiridonov says that as soon as animal studies confirm the possibility of survival, the risks will be worth taking. He has Werdnig-Hoffmann Disease, a genetic disorder that destroys muscle and nerve cells. He is confined to a wheelchair and has lived longer than expected. Body transplantation offers him the best chance at a life worth living. Continue reading

Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GiM article Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Continue reading

Genomes on-line and the Health of Privacy

By Effy Vayena and Alessandro Blasimme

Technology Concept

In January 1999, Scott McNealy, CEO of Sun Microsystems (now part of Oracle Corporation), announced that we should no longer be concerned with privacy, since consumers ‘have zero privacy anyway’ and should just ‘get over it.’ His argument, that in the era of information technology we have become unable to protect precisely what such technology relies on and delivers (information) has met the full spectrum of imaginable reactions – from outrage to enthusiastic endorsement. Many different cures have been proposed to treat at least the symptoms of the disease caused by the loss of privacy. Yet there is little disagreement concerning the diagnosis itself: privacy does not enjoy an enviable state of health. Recent emphasis on big data and their inescapable presence have only made the prognosis dimmer for the once cherished ‘right to be let alone’ – as Samuel D. Warren and justice Louis D. Brandeis famously defined privacy back in 1890.

Such a deteriorating outlook should sound especially alarming in the fields of healthcare and medical research. In such domains, professional norms of medical confidentiality have long ensured sufficient levels of privacy protection, accountability, and trust. Yet we are told that this may no longer be the case: sensitive, personal, health-related information – just like any other type of information – now comes in electronic formats, which makes it much more reachable than before, and increasingly difficult to protect. Imagine the consequences this may have in the case of genomic data – arguably one of the most sensitive forms of personal information. Should such information fall into the wrong hands, we may face harsh consequences ranging from discrimination to stigmatization, loss of insurance, and worse. To enjoy the right to genomic privacy, one has to be able to exercise some meaningful amount of control over who gets access to her genetic data, be adequately shielded from harms of the sort just mentioned, and yet retain the possibility of deciphering what’s written in her DNA for a variety of purposes – including, but not limited to, health-related ones. All this is undoubtedly demanding. All the more so now that we know how even apparently innocent and socially desirable uses, like genomic research employing anonymized DNA, are not immune from the threat of malicious re-identification.

In light of such considerations, one might be led to think that health privacy protection is a lost cause. In fact, one may go even further and argue that, all things considered, we shouldn’t worry too much about the decline of privacy. Having our sensitive data in a state of highly restricted accessibility, so the argument goes, prevents us from extracting medically valuable insight from those data and hinders medical discovery from which we may all benefit. Continue reading

Quantified Self as Personal (Citizen) Science

This post is part of Bill of Health’s symposium on Critical Studies of Citizen Science in Biomedical Research. Here, drawing upon interviews with self-trackers, Nils Heyen analyzes the different types of activities that self-trackers engage in and reflects on what kind of knowledge they produce. Background on the symposium is here. You can call up all of the symposium contributions published by clicking here.

By Nils B. Heyen

Quantified Self (QS) is the name of a growing international movement of people united by mainly one thing: an interest in collecting data about their own bodies and lives in order to obtain insights into their everyday health or performance. “Self knowledge through numbers” is the movement’s slogan, and indeed QS can be seen as an emerging field of knowledge production. Less obvious is, however, what type of knowledge is actually being produced here, how this knowledge production is to be characterized and how it relates to both science and citizen science. Based on interviews with self-trackers and participant observations of QS meetups and conferences in the context of an explorative empirical study, my post briefly deals with these questions (see this book chapter for more extensive considerations). Accordingly, my intention here is not to give a comprehensive classification or interpretation of the QS movement as a cultural phenomenon, but simply to shed some light on the aspect of knowledge production and on the relationship of self-tracking and citizen science. Continue reading

Petrie-Flom Center Welcomes New Executive Director!

PFC Logo-New-Horizontal_slide

shachar_peopleWe are thrilled to announce that Carmel Shachar, JD, MPH (HLS ’10, HSPH ’10) will join the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School as our next Executive Director. In this role, Carmel will be responsible for oversight of the Center’s sponsored research portfolio, event programming, fellowships, student engagement, development, and a range of other projects and collaborations.

“We are delighted that Carmel will be joining the Center,” said I. Glenn Cohen, Professor of Law and Faculty Director of the Petrie-Flom Center. “Throughout her career, Carmel has focused on designing, developing, and executing large health law and policy projects. This expertise and leadership will be a strong resource for the Center as it implements the vision for its second decade.”  Continue reading

Citizen Science where there are no citizens: participation and exclusion in Antarctic science

This post is part of Bill of Health’s symposium on Critical Studies of Citizen Science in Biomedical Research. Challenging the lay-professional divide in portrayals of citizen science, Vanessa Heggie examines a case study of an expedition to the Antarctic in the 1950s, where participants were at once researchers, research subjects, experts, and technicians. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Vanessa Heggie

The Antarctic environment poses plenty of challenges for scientists, but for those who need human participants there’s the additional problem of finding and recruiting ‘citizen scientists’.  With no indigenous residents, the residents of the Antarctic are a carefully selected population, most of whom are already doing some form of scientific work and juggling multiple identities and roles.  Radio operators take readings for meteorologists, geologists volunteer as guinea pigs for physiologists, and botanists collect rocks. There isn’t a clear divide between ‘scientist’ and ‘lay participant’; often human subjects, whether they’re collecting data or acting as human guinea-pigs, understand the principles of experimental design, and are able to give feedback about the experiment itself, not just the data generated.  At what point do citizen scientists become experimental collaborators? And who gets left out of these relationships? Continue reading

Do–It–Yourself Biology as Citizen Science: Taking Participation a Step Further

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Taking a closer look at the role of public participation in science, Rosen Bogdanov and Eduard Aibar argue that participation in DIY-biology is best understood as a collaborative experiment in technoscientific practices. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Rosen Bogdanov and Eduard Aibar

We begin our small blog contribution from the very proposition suggested by our subtitle – “taking participation a step further”. What do we mean by “a step further” and is participation inherently linear such that we can take it to another level?

Contrary to many accounts of public participation in science (especially those that aim to increase it), we don’t assume that scientific innovation will somehow speed up, or become more accountable, with more public input. Rather, recalling Michael Gibbons and Helga Nowotny’s work (2001), we argue that the production of scientific knowledge can be made more “socially robust” by including other perspectives. This, however, presents a dilemma when thinking about the case of “citizen science” as the current flagship field for public participation in science. Often, citizen science projects are presented as data-driven ventures whereby citizens are invited to participate in a specific stage, or stages, of this process, or they are framed from the start as the non-expert “public” that participates in collecting or analyzing data. Continue reading

More than Data Collectors: Valuing Data Expertise Beyond Professional Science

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Responding to controversies over the validity of patient and patient groups’ contributions to biomedical research, in this post, Sabina Leonelli turns to the environmental sciences in order to examine the construction of expertise in participatory research. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Sabina Leonelli

In the context of biomedical research, particularly following the emergence of evidence-based medicine, extensive debate surrounds the choice and evaluation of appropriate sources of evidence. Contributions from patients and patients’ groups generate substantial scientific, ethical and methodological controversies, and clinicians often regard with suspicion any dataset that is gathered by non-professionals outside controlled conditions. At the same time, the collection of health data through social media is becoming increasingly visible as a potential source of information, with defenders of precision medicine going as far as to value those strategies of data collection over traditional clinical trials. To shed some light on this situation and its potential pitfalls, it is useful to consider the experience of fields such as botany, ethology, oceanography, environmental science and ornithology, which have long relied extensively on contributions by non-professionals. With the recent emergence of “citizen science” projects, these contributions are often construed in the form of data offerings, with citizens volunteering to collect data that can be fed into scientific projects – as in the well-known cases of eBird and eOceans. Just as often, researchers conceptualise these offerings as an opportunity to get hold of data that would otherwise remain beyond their reach. Due to their location, occupation or hobbies, citizens may be able to document circumstances and events of interest to researchers, but which researchers themselves do not have the resources and personnel to identify and witness in person. Thus, citizens are positioned as precious data collectors, whose engagement with science consists in the provision of potential sources of evidence. At the same time, a line is drawn between such data collectors and professional scientists as the veritable data experts, who can direct and situate citizens’ efforts to procure the raw materials for scientific investigation. In this configuration, key questions such as what the evidence will be useful for, and whether the data will be of good enough quality to play that role, are left to the scientists in charge; and data collectors remain peripheral to the formulation and development of research projects and related knowledge claims. Continue reading

Call for Abstracts: Wiet Life Sciences Law Scholars Conference

Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for its inaugural Wiet Life Science Law Scholars Conference on Friday, October 13, 2017.

The conference is designed to provide a new intellectual venue for life science professors, scholars, and practitioners to convene and discuss current research and scholarship. The phrase “life science law” aims to capture research and disciplines spanning food and drug law, health law, intellectual property (IP), biotechnology, environmental, administrative, antitrust, and other realms that involve the life sciences in some meaningful respect. Our goal is to foster recognition of life science law as a cohesive, dynamic, area of legal study and strengthen connections among national life science law scholars.

Loyola is currently soliciting 750-1,000 word abstracts reflecting early or mid-stage ideas for the purpose of workshopping with other conference scholars. Modeled after successful events for law professors and scholars in other areas, participants will be organized in topical panels of three to five authors with approximately 15-20 minutes allotted to each abstract presentation, followed by discussions with scholar attendees. Abstracts from the authors will be distributed one week prior to the conference; authors may also submit draft articles for distribution to conference attendees.

SUBMISSION AND REVIEW TIMELINE: The deadline for 750-1,000 word abstracts, including author contact information is June 15. Submit via email to health-law@luc.edu with subject line Wiet Life Science Law.

Authors will be notified of speaker selections by email on or before July 15.

Continue reading

Self-reporting and participatory health platforms: Empowerment through sharing information about oneself online?

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Here, Dana Mahr examines claims of empowerment in participatory health platforms and the implications of this for participants and biomedical research more broadly. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Dana Mahr

A new social contract for health?

Since the beginning of the 21st Century, self-reported experiential knowledge of patients (alongside other data) has often been communicated and promoted as an untapped treasure for both medical research and patient empowerment (Goetz 2008). Although this portrayal lacks historical and sociological accuracy (the sharing of experience has always been part of medical practice; e.g. the process of anamnesis) it informs a prominent discourse on so-called “P4-medicine”: “prediction”, “prevention”, “participation” and “personalization” (Hood 2013). Within this coordinate system of concepts, practices of participatory self-reporting (via fitness tracking, information sharing in social health networks, etc.) are seen as steps towards a “New Social Contract for Medical Innovation” (Horne et al. 2015).

Advocates of this social contract claim that it “tackle[s] the rising tide of chronic diseases and transform[s] healthcare from a disease-oriented provision to a true health maintenance service” (Horne et al. 2015). The core element of this new social contract is the collection and use of large amounts of participatory generated data for the democratization of biomedical research. The growing variety of online participatory medicine platforms can be interpreted as part of this trend. Other relevant aspects, however, are market interests, bio-governmentality, and people’s curiosity for self-exploration, self-presentation, and the urge to compare oneself with others. This is most evident in direct-to-consumer (DTC) genetic testing. The slogan of the DTC company 23andMe is telling in this respect: “Welcome to you”. Continue reading

What is Citizen Science anyway? Introduction to the new blog symposium “Citizen Science”

We are pleased to present this symposium featuring commentary from participants in the “Critical Studies of Citizen Science in Biomedical Research” conference held on the March 2, 2017, at King’s College London. Organized by different projects concerned with citizen science in Kiel (A. Buyx) & London (B. Prainsack), Exeter (S. Leonelli), and Geneva (B. Strasser),  the event took a critical look at the role of citizen science in biomedical research in the 21st Century. Presenters from the event give us a peek into their work in the forthcoming posts, which will appear daily. 

By Barbara Prainsack, Alena Buyx, and Amelia Fiske

As many of our teachers have told us, and as we have repeated told to our students: if you have to insist that you are engaging in a “critical” analysis, then something is wrong. We should be able to assume that as social scientists, ethicists, or scholars more generally we always take a critical distance to our materials. So why did we call a meeting on citizen science in biomedicine “critical studies of”?

The reason was one of emphasis: we wanted to bring together people who were not merely cheerleaders for citizen science, offering analyses that remove friction points in the name of making citizen science even better (whatever ‘better’ might mean in this respect). Instead, we were looking for work that challenges the very assumptions portraying citizen science as novel and noteworthy, or as something particularly problematic and in need of ethical attention. We did so not because we necessarily disagree with these portrayals, but because we felt that we should pay as much attention to continuities as to discontinuities; to old practices as well as to new ones; and to offline as well as online collaboration in scientific knowledge creation. We felt that only if we explored the values and goals underpinning practices and initiatives that use the label “citizen science” can we approach the questions that matter most to us: How do these practices change the distribution of power between different actors? Who is (dis)empowered by them? Who or what gains visibility, and who or what is obscured? What new patterns of inclusion or exclusion emerge as a result? We have long been interested in the concept of solidarity and its role in biomedicine (see our new book with Cambridge University Press), and we wanted to know if some of the citizen science initiatives could be seen as emerging forms of solidaristic practice. Continue reading

Medical Records and the NFL Combine

This post is part of our Blog Symposium “Applying the Americans with Disabilities Act and Genetic Information Nondiscrimination Act to the NFL Workplace.” Background on the symposium and links to other blog posts are here

By Jessica L. Roberts

In our recent law review article, published by the University of Pennsylvania Law Review, my co-authors and I explore exactly what kinds of player health data the NFL and its Clubs can lawfully obtain from NFL hopefuls, as well as from current players.  While the Clubs and the NFL have strong interests in accessing all kinds of information about players, current federal employment laws—mainly the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act—limit the collection of employee health data.  Significantly, these statutes not only restrict how an employer can use its employees’ health data.  They also restrict the ability of the employer to even ask.  Among the major takeaways of our paper was that, via National Football Scouting, the NFL and its Clubs may be violating these laws with the interviews and medical examinations that take place during the National Scouting Combine.  Our article focused primarily on evaluative technologies: things like physicals, athletic drills, wearables, ingestibles, and genetic tests.  But what about when the source of the player health data is not a technique or technology but rather simply a medical record?  In this blog post, I take a closer look at how the ADA and GINA apply to requests for medical records.

Medical Waivers at the Combine

As explored in-depth in a recent installment of this blog symposium, prospective players are particularly vulnerable because they are not yet members of the NFL Players Association (NFLPA), and thus cannot reap the benefits of the collective bargaining agreements it negotiates.  The inferior bargaining position of aspiring players is particularly apparent considering the medical waivers they sign to even participate in the Combine.  One waiver authorizes a mind-bogglingly long list of parties—including health care providers, physicians, mental health professionals, hospitals, schools, student health services, and former trainers and teams, even at the amateur level—to release and to discuss the players’ medical records with an equally long list of potential recipients—including National Football Scouting, the NFL and all its Clubs, their representatives, agents, medical staff, team physicians, and trainers, in addition to third-party physicians.  The player consents to share: Continue reading

Patenting Bioprinting Technologies in the US and Europe – The Fifth Element in the Third Dimension

By Timo Minssen

I am happy to announce the publication of our new working paper on  “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has  been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions are currently being patented. Based on our findings we then discuss what types of future innovations we can expect from the technological development and how far these would and/or should be protectable under European and US patent laws.

The paper is forthcoming in: RM Ballardini, M Norrgård & J Partanen (red), 3D printing, Intellectual Property and Innovation – Insights from Law and Technology. Wolters Kluwer, but the working paper is already available on SSRN. Continue reading