REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

TODAY, 10/30 at 5 PM: Health Law Workshop with Aziza Ahmed

October 30, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “‘Dead But Not Disabled’: A Feminist Legal Struggle for Recognition”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Aziza Ahmed is Professor of Law at the Northeastern University School of Law. She is an internationally renowned expert in health law, criminal law and human rights. Her scholarship examines the role of science and activism in shaping global and national law and policy with a focus on criminal laws that impact health. She teaches Property Law, Reproductive and Sexual Health and Rights, and International Health Law: Governance, Development and Rights. Professor Ahmed has been selected as a fellow with the Program in Law and Public Affairs (LAPA) at Princeton University. She will be combining her sabbatical and her fellowship to spend the 2017-2018 academic year developing her work on law, feminism and science into a book with particular emphasis on legal and policy responses to HIV.

Ahmed’s scholarship has appeared in the University of Miami Law ReviewAmerican Journal of Law and MedicineUniversity of Denver Law ReviewHarvard Journal of Law and GenderBoston University Law Review (online), and the American Journal of International Law (online), among other journals.

Prior to joining the School of Law, Ahmed was a research associate at the Harvard School of Public Health Program on International Health and Human Rights. She came to that position after a Women’s Law and Public Policy Fellowship with the International Community of Women Living with HIV/AIDS (ICW). Ahmed has also consulted with various United Nations agencies and international and domestic non-governmental organizations.

Ahmed was a member of the Technical Advisory Group on HIV and the Law convened by the United Nations Development Programme (UNDP) and has been an expert for many institutions, including the American Bar Association and UNDP. In 2016, she was appointed to serve a three-year term on the advisory board of the Northeastern University Humanities Center.

In addition to her BA and JD, Ahmed holds an MS in population and international health from the Harvard School of Public Health.

What are Our Duties and Moral Responsibilities Toward Humans when Constructing AI?

Much of what we fear about artificial intelligence comes down to our underlying values and perception about life itself, as well as the place of the human in that life. The New Yorker cover last week was a telling example of the kind of dystopic societies we claim we wish to avoid.

I say “claim” not accidently, for in some respects the nascent stages of such a society do already exist; and perhaps they have existed for longer than we realize or care to admit. Regimes of power, what Michel Foucault called biopolitics, are embedded in our social institutions and in the mechanisms, technologies, and strategies by which human life is managed in the modern world. Accordingly, this arrangement could be positive, neutral, or nefarious—for it all depends on whether or not these institutions are used to subjugate (e.g. racism) or liberate (e.g. rights) the human being; whether they infringe upon the sovereignty of the individual or uphold the sovereignty of the state and the rule of law; in short, biopower is the impact of political power on all domains of human life. This is all the more pronounced today in the extent to which technological advances have enabled biopower to stretch beyond the political to almost all facets of daily life in the modern world. Continue reading

Book Launch: Specimen Science: Ethics and Policy Implications

Book Launch: Specimen Science: Ethics and Policy Implications
November 9, 2017 12:00 PM
Countway Library, Lahey Room
Harvard Medical School, Boston, MA

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera. This edited volume stems from a conference in 2015 that brought together leading experts to address key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The conference was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center  for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center.  It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.

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Amanda Pustilnik on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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First off, an urgent appeal: please consider donating to chef José Andrés, who is feeding tens of thousands of victims of Hurricane Maria in Puerto Rico. Donation link is here.

We have a particularly brainy episode this week, as we host Amanda Pustilnik, a Professor of Law at the University of Maryland whose research includes work on models of mind in criminal law, evidentiary issues presented by neuroscientific work on memory, and the role of pain in different legal domains. Amanda has also served as a Senior Fellow in Law & Neuroscience of the Center for Law, Brain & Behavior at Massachusetts General Hospital. She recently co-authored the Nature article “Brain imaging tests for chronic pain: medical, legal and ethical issues and recommendations.” She also organized a 2015 symposium here on Bill of Health, titled “Pain on the Brain.” Amanda is a recognized leader in the emerging area of Neuroscience and the Law. Our conversation includes a primer on the area and a discussion of criminal responsibility and the measurement of chronic pain.

Our lightning round concentrates on the current proposals and counter proposals surrounding the workings of the insurance exchanges and we take a close look at Iowa’s challenging individual insurance market. We also covered other health news. Links include: 1) an ongoing public health disaster in Puerto Rico, 2) the imploding Iowa ACA exchanges (and Iowa’s withdrawal of a waiver proposal that would have gutted the ACA there), 3) are AHPs the Trump University of health insurance?, and 4) sequelae of the opioid epidemic: HIV and hepatitis C.

Listen here, and be sure to rate the show on iTunes! 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.

TODAY, 10/23 at 5 PM: Health Law Workshop with Belinda Bennett

October 23, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Law, Transformative Technologies and the Automation Age: Lessons from the Past for a High-Tech Future” 

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Belinda Bennett is a Visiting Scholar at the Petrie-Flom Center in fall 2017. She is Professor of Health Law and New Technologies in the School of Law at Queensland University of Technology (QUT) in Brisbane, Australia. She leads the Governance and Regulation of Health Care program within the Australian Centre for Health Law Research at QUT. Her current research addresses health law and globalisation, global public health law, and the legal and ethical challenges associated with regulation of new technologies in health care. Her publications include: M Freeman, S Hawkes and B Bennett (eds) Law and Global Health: Current Legal Issues Vol 16 (OUP, 2014); B Bennett, Health Law’s Kaleidoscope: Health Law Rights in a Global Age (Ashgate, 2008); and B Bennett, T Carney and I Karpin (eds) Brave New World of Health(Federation Press, 2008).

Patient Safety at the Crossroads

By John Tingle

The NHS (National Health Service) in the UK is 70 next year: it was founded on 5th July 1948 and celebrations are being planned. Clearly a lot has changed since it was founded. Our concept of wellness has changed, we go to the doctor for reasons that would never have been considered appropriate in 1948. Health today is not just about the absence of physical diseases.

What is clear is that ever since 1948 the NHS has been shortage of resources in the face of a seemingly insatiable demand for its services. Balancing finite resources against near infinite demands is no easy task. Seventy years on, it is most concerning that a vast amount of money in the NHS is now being spent on clinical negligence claims. In their latest annual report and accounts, NHS Resolution estimates the total amount for clinical negligence claims it owes is £65 Billion. Damages paid to patients rose significantly from £950.4 million to £1,083.0 million, an increase of 14%. The high cost of clinical negligence is not sustainable and something must be urgently done to reduce the number of claims against the NHS. The issues were recently considered by the National Audit Office (NAO), which found:

  • The cost of clinical negligence claims is rising at a faster rate year-on-year, than NHS funding.
  • Even if successful, NHS Resolution and the Department’s current actions are unlikely to stop the growth in the cost of clinical negligence claims.
  • The government lacks a coherent cross-government strategy, underpinned by policy, to support measures to tackle the rising cost of clinical negligence.

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Errors in Patent Grants: More Common in Medical Patents

By James Love

Recently I have become interested in the frequency of a “certificate of correction” on a granted patent, after two efforts to establish federal rights in patents granted.

The first case involved the University of Pennsylvania.  We had identified five patents on CAR T technologies granted to five inventors from the University of Pennsylvania where there was no disclosure of federal funding on the patents when they were granted by the USPTO, as is required by law.  All five patents had been filed in 2014.    We had reason to believe the five patents should have disclosed NIH funding in the invention, and we were right. But the error had been corrected by Penn, and five “certificate of correction” documents were granted by the USPTO in May 2016, something we had overlooked, in part because the corrections to patents are published as image files, and were not text searchable.

The second case involved the Cold Spring Harbor Laboratory.  KEI had identified two patents listed in the FDA Orange Book for the drug Spinraza,  which were assigned to Cold Spring Harbor, and which had not disclosed federal funding.  KEI was interested in pursuing a march-in case for Spinraza, on the grounds of excessive pricing.  The cost of Spinraza in the first year was $750,000, and the maintenance doses were priced at $375,000 per year.  Researchers listed on the two patents had received funding from the NIH to work on the subject of the two patents. Continue reading

Instagram and the Regulation of Eating Disorder Communities

By Clíodhna Ní Chéileachair

I’m sure not how much time the average health law enthusiast spends on Instagram, but as a rare opportunity to see health regulation in real-time, I’d encourage logging onto the site, which curates content based on user profiles and by tags, and searching for the following tags; #thinspo, #thighgap, and #eatingdisorder. The site will either return no results, or will present the searcher with a warning message that “Posts with words or tags you’re searching for often encourage behavior that can cause harm and even lead to death” and encouraging the user to reach out for help, though the flagged content is still accessible if the user clicks-through. #thinspo (short for another neologism, ‘thinspiration’) is exactly what it sounds like – images designed to inspire an individual to restrict their diet, and exercise to attain what will generally be an underweight physique. Many social media sites have enacted similar bans on content as a reaction to the role that online communities can play in promoting eating disorders.

As a suite of illnesses, eating disorders have severe, and sometimes life-threatening medical complications. Anorexia nervosa has the highest death rate of all psychiatric illnesses; bulimia carries severe medical complications associated with starvation and purging including bone disease, heart complications, digestive tract distress, and even infertility, and EDNOS (eating disorder not otherwise specified) while carrying subclinical status in DMS-IV, carries similar levels of eating pathology and general psychopathology to anorexia nervosa and binge eating disorder, and a similar degree of danger to physical health to anorexia. Instagram had been criticised for its inaction in the face of an explosion of pro-eating disorder community activity on its site after Tumblr and Pinterest enacted bans on ‘thinspiration’ content, at which point many users migrated to Instagram’s platform. Five years on from the initial ban, some terms, like #starve and #purge will display the above warning message; other obvious tags for the pro-eating disorder community, like #skinnyinspiration and #thinspire attract no warning message and display images of emaciated women, romanticizations of eating disorders, images of individuals destroying food, and in line with clinical understandings of how eating disorders manifest themselves, images of self harm.

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TODAY, 10/16 at 5 PM: Health Law Workshop with I. Glenn Cohen

October 16, 2017 5:00 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Cops, Docs, and Code: A Dialogue Between Big Data in Health Care and Predictive Policing” by I. Glenn Cohen & Harry S. Graver

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich at law.harvard.edu.

I. Glenn Cohen is Professor of Law and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Glenn’s current research projects relate to health information technologies, mobile health, reproduction/reproductive technology, research ethics, rationing in law and medicine, health policy, FDA law and to medical tourism – the travel of patients who are residents of one country, the “home country,” to another country, the “destination country,” for medical treatment. His past work has included projects on end of life decision-making, FDA regulation and commodification.

 

Michelle Mello on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week’s guest is Michelle M. Mello, Professor of Law and of Health Research & Policy at Stanford University. She is the author of more than 150 articles and book chapters on the medical malpractice system, medical errors and patient safety, research ethics, regulation of pharmaceuticals, legal interventions to combat obesity and noncommunicable disease, and other topics.

Our conversation focused on her recent work on medical apologiescommunication-and-resolution programsoverlapping surgery (which refers to operations performed by the same primary surgeon such that the start of one surgery overlaps with the end of another), reconciliation after medical injury, and the influence of the malpractice environment on care patterns.

The lightning round featured a tour of the many facets of synthetic ACA repeal: CHIP delay, health budget slashing, zombie reconciliation, marketing budget cuts, inexplicable “maintenance” efforts that bring down HealthCare.gov for 12 hours a day at peak sign up periods, the Trump EO on association health plans, and the suspension of CSR payments. As Nancy LeTourneau reports, “synthetic repeal won’t be scored by CBO and has tossed aside any attempt to replace the law. That means that the results could be even more disastrous for the American people.”

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.

Religion, Health, and Medicine: the Dialectic of Embedded Social Systems

The philosopher in me understands that there are universal principles in logic, mathematics, and in basic scientific tenets such as the law of gravity. Be that as it may, the historian in me recognizes that we inherit epistemologies and ways of thinking from those before us, and from our own historical and cultural contexts. Certain ideas dominate the world; and, while some are indeed universal, especially those based on science, the fact remains that a number of other concepts are only seemingly universal. The concepts of personhood, divinity, self, and even society as we tend to understand them today are largely inherited from a Western, Christian worldview. As these ideas have wrestled with philosophical inquiry throughout history, they have either been decoupled from their origins in religious thought, or they have been secularized and rationalized a la Kantian categorical imperatives or the like—and then disseminated in universities, institutions, cultures, and literatures.

On one level, to speak of the Western world as “secular” is, as the philosopher Charles Taylor notes, to say that “belief in God, or in the transcendent in any form, is contested; it is an option among many; it is therefore fragile; for some people in some milieus, it is very difficult, even ‘weird’” (Taylor: 2011, 49). But on another and much deeper level, this very possibility was only ever tenable on account of two major factors: “First, there had to develop a culture that marks a clear division between the ‘natural’ and the ‘supernatural,’ and second, it had to come to seem possible to live entirely within the natural” (Taylor, 50). This was only possible because of a unique philosophical climate that actively sought to dislodge the old form of moral order and social “embeddedness” in an attempt to establish a “purely immanent order.” Taylor’s groundbreaking work, A Secular Age argues that secularism is part of a grand narrative in the West and shows that its historical and cultural foundations are in fact thoroughly Christian and European. He pushes back against Max Weber’s secularization thesis that religion diminishes in the modern world and in the wake of increasing developments in science and technology—and instead gives a different account of what secularism might mean: one that has deep implications for morality, politics, and philosophy.

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“Siri, Should Robots Give Care?”

By Gali Katznelson

Having finally watched the movie Her, I may very well be committing the “Hollywood Scenarios” deadly sin by embarking on this post. This is one of the seven deadly sins of people who sensationalize artificial intelligence (AI), proposed by Rodney Brooks, former director of the Computer Science and Artificial Intelligence Laboratory at MIT. Alas, without spoiling the movie Her (you should watch it), it’s easy for me to conceptualize a world in which machines can be trained to mimic a caring relationship and provide emotional support. This is because, in some ways, it’s already happening.

There are the familiar voice assistants, such as Apple’s Siri, to which people may be turning for health support. A study published in JAMA Internal Medicine in 2016 found that that the responses of smartphone assistants such as Apple’s Siri or Samsung’s S Voice to mental and physical health concerns were often inadequate. Telling Siri about sexual abuse elicited the response, “I don’t know what you mean by ‘I was raped.’” Telling Samsung’s S Voice you wanted to commit suicide led to the perhaps not-so-sensitive response, “Don’t you dare hurt yourself.” This technology proved far from perfect in providing salient guidance. However, since this study came out over a year ago, programmers behind Siri and S Voice have remedied these issues by providing more appropriate responses, such as counseling hotline information.

An AI specifically trained to provide helpful responses to mental health issues is Tess, “a psychological AI that administers highly personalized psychotherapy, psycho-education, and health-related reminders, on-demand, when and where the mental health professional isn’t.” X2AI, the company behind Tess, is in the process of finalizing an official Board of Ethics, and for good reason. The ethical considerations of an artificially intelligent therapist are rampant, from privacy and security issues to the potential for delivering misguided information that could cost lives. Continue reading

Emergent Medical Data

By Mason Marks

In this brief essay, I describe a new type of medical information that is not protected by existing privacy laws. I call it Emergent Medical Data (EMD) because at first glance, it has no relationship to your health. Companies can derive EMD from your seemingly benign Facebook posts, a list of videos you watched on YouTube, a credit card purchase, or the contents of your e-mail. A person reading the raw data would be unaware that it conveys any health information. Machine learning algorithms must first massage the data before its health-related properties emerge.

Unlike medical information obtained by healthcare providers, which is protected by the Health Information Portability and Accountability Act (HIPAA), EMD receives little to no legal protection. A common rationale for maintaining health data privacy is that it promotes full transparency between patients and physicians. HIPAA assures patients that the sensitive conversations they have with their doctors will remain confidential. The penalties for breaching confidentiality can be steep. In 2016, the Department of Health and Human Services recorded over $20 million in fines resulting from HIPAA violations. When companies mine for EMD, they are not bound by HIPAA or subject to these penalties.

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Introducing New Blogger Mason Marks 

Mason Marks is joining Bill of Health as a regular contributor.

Mason is a Visiting Fellow at Yale Law School’s Information Society Project. His research focuses on the application of artificial intelligence to clinical decision making in healthcare. He is particularly interested in the regulation of machine learning and obstacles to its adoption by the medical community. His secondary interests include data privacy and the regulation of emerging technologies such as 3D-bioprinting, surgical robotics, and genome editing.

Mason received his J.D. from Vanderbilt Law School. He is a member of the California Bar and practices intellectual property law in the San Francisco Bay Area. He has represented clients in the biotechnology, pharmaceutical, and medical device industries. Prior to law school, he received his M.D. from Tufts University and his B.A. in biology from Amherst College.

Representative Publications:  Continue reading

Opportunity: Faculty Fellow in Health Law and Intellectual Property

The Jaharis Health Law Institute is now accepting applications for a Faculty Fellow in Health Law and Intellectual Property!

Established in 1984 and supported by the Mary and Michael Jaharis Health Law Institute (JHLI), DePaul’s health law program has consistently ranked among the top in the nation. JHLI offers students coursework that reflects the diversity of health law from community health to high-tech health care, making DePaul a leader in the education of future generations of health law partners, policy makers and critical thinkers.

About the Fellowship:
An endowment at the DePaul University College of Law funds a faculty fellowship program for scholars to create and disseminate scholarship and teach courses where two dynamic legal fields are increasingly intersecting—intellectual property and health law. The fellowship is designed to encourage scholars interested in entering a career in legal academia in these fields. The Jaharis Faculty Fellow will work with and be mentored by faculty from DePaul’s nationally-ranked Mary and Michael Jaharis Health Law Institute (JHLI) and Center for Intellectual Property Law & Information Technology (CIPLIT®). Continue reading

Call For Abstracts, Due 10/15! Beyond Disadvantage: Disability, Law, and Bioethics – PFC’s 2018 Annual Conference

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

disability-law-bioethics_slideHistorically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading

An Analysis of Five Years of Cerebral Palsy Claims in the UK

By John Tingle

NHS Resolution, an arm’s length body of the Department of Health that manages clinical negligence and other claims brought against the NHS in England, have just published a report on cerebral palsy legal claims. These claims are complex and result in large awards of compensation. In 2016-17, whilst the obstetrics specialty accounted for only 10% of the 10,686 claims received, they represented 50% of the £4,370 Million value of claims received.

Once case may cost £20 Million or more for one child. The report shows that the same errors are often being repeated and that key patient safety lessons go unlearned. The report analyses the data held by NHS Resolution on its claims management system on compensation claims for cerebral palsy that occurred between 2012-2016.There were 50 claims between this period that were suitable for review with a potential financial liability greater than £390 Million. This figure excludes the costs of defending the claim and the wider cost impact on the NHS as a whole. The results of the report are split into two parts. Part one looks at the quality of the serious incident (SI) investigation reports and part two looks at arising clinical themes. Continue reading