Event: Ethical and Legal Ramifications of Stem Cell Research

For our first Speaker Series event of the 2017-2018 academic year we are excited to present a stimulating disuccsion on the legal and ethical ramifications of stem cell research. This event will present diverse perspectives on research involving the development, use and destruction of human embryos, as well as its many potential benefits and its complexities and regulations.

Speakers include:

Dr. William Stanford, Ottawa Research Institute:
Dr. Stanford is a leading stem cell researcher focusing on understanding and manipulating human embryonic stem cells for development of novel therapeutics for many human diseases including cancer.

Me. William Brock:
A partner at Davies who is also a leukemia survivor that underwent stem cell treatment. Me. Brock will give us his legal and personal perspective on the technology.

Dr. Michel L. Tremblay:
Dr. Tremblay is a leading researcher in the Biochemistry Department at McGill University. Dr. Tremblay will discuss techniques for modifying stem cells using CRSPR-Technology in the lab as well as the current use of stem cells in the clinic. Dr. Tremblay will also discuss pertinent ethical issues such as who owns stem cells, stem cell “tourism”, and the future of stem cells including drug development, use of stem cells for tissue/organ replacement and stem cells versus robotics-cybog.

The event will take place at the Thompson House Restaurant (3650 Mc Tavish, Montreal) on November 1st 2017 from 4:45 PM until 6:00 PM. No tickets required. Please arrive 10 minutes in advance to secure a seat.

Artificial Intelligence in Health Care: Are the Legal Algorithms Ready for the Future?

Posted By Dr. Anastasia Greenberg

Big data has become a buzz word, a catch-all term representing a digital reality that is already changing the world and replacing oil as the newest lucrative commodity. But, it is often overlooked that big data alone is literally useless – much like unrefined oil. If big data is the question, artificial intelligence (AI) is the answer. The marriage between big data and AI has been called the fourth industrial revolution. AI has been defined as “the development of computers to engage in human-like thought processes such as learning, reasoning and self-correction”. Machine learning is a field of AI that is concerned with pattern extraction from complex, multidimensional [big] data. Although when we think of AI we tend to think of robots, machine learning algorithms – software, not hardware – are the game changer as they can sort through massive amounts of information that would take a human centuries to do.

7562831366_66f986c3ea_oMachine learning software can harness the usefull information hidden in big data for health care applications || (Source: Flickr // Merrill College of Journalism Press Releases)

While machine learning is already used in fields like finance and economics, the health care industry is the next frontier. In both Canada and the United States, about three-quarters of physicians have now switched to Electronic Health Records, where medical records are digitized as big data. The ability to use such data for medical purposes comes with a host of legal and policy implications. The Canadian Federal Budget 2017 includes $125 million in funding for a Pan-Canadian AI strategy, part of which is meant to “develop global thought leadership on the economic, ethical, policy and legal implications of advances in artificial intelligence.”

How Does a Machine “Learn”?

Machine learning essentially trains a program to predict unknown and/or future values of variables in a similar way to how humans learn. Imagine that you are visiting a friend’s house and you see a furry creature run past you. Automatically, you identify this creature as a cat, not a small dog, even though both are furry animals, and despite never having come across this specific cat before. Your past learning experiences with other cats allowed you to make an inference and classify a novel creature into the “cat” category. This is exactly the kind of task that used to be impossible for computers to perform but has become a reality with machine learning. A computer program is first fed massive amounts of data – for instance, images of biopsies that are pre-classified into categories such as “tumour” and “no tumour” (this procedure is called “supervised” training). The computer then learns to recognize complex patterns within the data, enabling it to classify novel images as either tumour or no tumour.

html php java source codeA machine can be trained to classify health care data for various purposes such as the detection of tumours in biopsy images. || (Source: Flickr // Markus Spiske)

Artificial Intelligence in Health care

Machine learning in the health care context holds a lot of promise for diagnosis, disease onset prediction, and prognosis. Since misdiagnoses are the leading cause of malpractice claims in both Canada and the United States, machine learning could greatly diminish health care and legal costs by improving diagnostic accuracy. With these promises in mind, the research literature on AI applications for health care has taken off in the last few years. Machine learning has been shown to successfully diagnose Parkinson’s Disease using Magnetic Resonance Imaging (MRI) data, predict ischemic stroke, predict lung cancer prognosis better than pathologists, and predict colorectal cancer patient prognosis better than colorectal surgeons. Perhaps most evocative, machine learning algorithms trained using Electronic Health Record data can predict suicide up to two years in advance with 80 percent accuracy.

In the private sector, IBM’s Watson, famous for its performance on Jeopardy, has been reinvented into Watson Health. Watson Health has “read” millions of medical journal articles and understands natural language to answer a host of medical questions. Although it is in its primitive stages, IBM hopes that Watson will soon be able to harness data on patients’ laboratory tests, symptoms, and genetic information. Together, this information processed with Watson’s medical knowledge could be used to effectively diagnose and suggest treatment options.

Legal and Ethical Implications of AI in Health care

In light of the ethical and legal implications, these advances should be both celebrated and received with caution. To understand the presenting issues, it is important to comprehend how these algorithms work. Machine learning is able to take in complex data made up of billions of data points; the more complex the input data that the machine is trained on, the more information it has available for making accurate predictions, but the higher the risk of overfitting. Overfitting occurs when algorithms become very good at modelling the current dataset but cannot successfully generalize to a new dataset – the dataset used to make decisions pertaining to new patients.

Perhaps most evocative, machine learning algorithms trained using Electronic Health Record data can predict suicide up to two years in advance with 80 percent accuracy.

A further complication is that because the machine is learning somewhat autonomously about the data patterns, the process is a black box. It is difficult to understand which features within the data are most important and what kinds of complex nonlinear relationships the machine is modeling to make its predictions. That’s why diligent machine learning researchers test their algorithms on new datasets to figure out how reliable and generalizable they are. In any case, a high level of expertise is required and some level of error is inevitable.

The Current Legal Algorithms

So, what happens when a patient is misdiagnosed using AI? How would the current legal structure deal with such a scenario? One possibility is that such a situation would fall under the default fault-based regime (or “algorithm”) under the Civil Code of Quebec (CCQ, art. 1457), analogous to the tort of negligence in common law Canada. This would imply that the physician using AI technology may be liable for its misdiagnosis. However, AI does not seem well suited for such a regime. As discussed above, the algorithm is going to be more accurate on average than a physician. Thus, once AI in health care becomes commonplace, it would be difficult to find the physician negligent, especially when the physician is not the one writing the code. Given that the accuracy would be an improvement over physician knowledge alone, the physician “expert standard” (where a physician’s actions are compared to her peers) may shift to require the use of such technology.

35338054331_37ea4257a2_oA physician may soon be able to use AI for diagnosing patients and suggesting treatment options || (Source: Flickr // Hamza Butt)

Another option would be to fit AI within the realm of product liability, which, under the CCQ (art. 1468, 1469) is a form of strict liability, meaning that the evidentiary burden would be placed on the defendant, in this case the manufacturer of the AI software, not the patient. This means that the patient has a “leg up” in such a litigation scenario. In line with this idea, in 2017 the Committee on Legal Affairs of the European Union submitted a motion to the European parliament calling for law reform on the issue of robotics (included under the AI umbrella), to implement a strict liability regime. Under the CCQ, the rule governing the autonomous act of a thing (art. 1465), which is close to strict liability (presumption), is another potential possibility, since AI learns semi (or even fully) autonomously. This would again implicate the physician as the guardian of the AI.

The issue with a strict liability regime for AI is that unlike a traditional defective “product”, a human (the physician) and AI are going to work together in the decision making process, making it difficult to point the finger at the manufacturer, software developer or the physician alone. For example, a recent study showed that when presented with images of lymph node biopsies for detecting metastatic cancer, AI was better at finding those hard-to-detect cases while the human physician was better at rejecting false positives (correctly rejecting a cancer diagnosis). When the human and AI skills were combined, correct metastatic cancer detection was at 99.5% accuracy. Another issue comes from the classic economic argument that strict liability can hamper innovation.

AI does not easily fit into any existing private law regimes for compensating patients who will inevitably suffer harm from the however small amount of errors. Another possibility would be to remove AI from the private law system and create compensation schemes. Like AI, vaccines are the utilitarian choice due to their low complication rates and because they do not easily fit into negligence-based regimes. For this reason, the United States has a National Vaccine Injury Compensation Program and Quebec has a similar provincial Program.

AI, along with personalized big data, is projected to be the next disruptive technology that will transform medicine by allowing physicians to see into the future. With great computing power comes great responsibility to develop the right legal and regulatory “scripts” for the implementation of AI in health care.

Anastasia Greenberg is a second-year student in the B.C.L/LL.B. program at McGill University’s Faculty of Law and is the Executive Online Editor of the McGill Journal of Law and Health. Anastasia holds a PhD in Neuroscience from the University of Alberta.

Recruitment 2017-2018

We have officially opened recruitment for all boards on the MJLH. We invite students from all years of the McGill Faculty of Law to send your applications to any of our four executive boards: Editorial, Online, Management and Strategic Planning & Solicitations.

Notez bien que le comité de rédaction est bilingue et les rédacteurs / rédactrices travaillent avec les articles en anglais ainsi que le français. Vous avez donc l’option de soumettre une application pour le comité anglais ainsi que le comité français.

Applications for all Boards will remain open until Monday, September 11th at 11:59PM (exceptionally for the Editorial Board the deadline is September 15th at 11:59 PM). Executives for each board will hold interviews thereafter. Application instructions can be found below.

Brochure1

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Editorial Board:

Please download and complete the following Application Form and Assignment Instructions, along with either an English or French article that you will use to complete the assignment. Please send your completed Application Form, assignment, CV, and cover letter to: editor.mjlh[AT]mail.mcgill.ca (English) or redacteur.rdsm[AT]mail.mcgill.ca (Français). Exceptionally, applications for the Editorial Board will remain open until Friday, September 15th at 11:59 p.m.

Online Board: 

Please send your CV and a cover letter to: web.mjlh[AT]mail.mcgill.ca.

Note: Please keep in mind that you do not need to be on the Online Board to submit online articles. We solicit content for the Online blog from all law students and professors in the legal community at McGill and beyond.

Management Board:

Please download and complete the following Application Form and send the completed form along with your CV and a cover letter to manager.mjlh[AT]mail.mcgill.ca.

SPAS Board:

Please download and complete the following Application Form and send the completed form along with your CV and a cover letter to info.mjlh[AT]mcgill.ca.

Applications for all Boards (except Editorial) will remain open until Monday, September 11th at 11:59PM.

Vous pouvez soumettre votre application en français.

Estate Planning: Ten Practical Steps to Improve Written Advance Directives in Powers of Attorney for Healthcare

Posted By Dr. Laura Hawryluck

Introduction

Advance care planning was originally devised as a process to ensure that a person’s wishes and values are respected in some of the most important decisions of his or her life when that voice is silenced due to incapacity. Such wishes could be expressed, verbally or in writing, to those who would subsequently ensure that these wishes and values were factored into any decisions regarding healthcare and treatment choices. The importance of having one’s voice heard quickly translated into the creation of powers of attorney documents for personal or health care as a legal document with the aim to express one’s directives or appoint someone to make substitute decisions. These documents are now almost always generated at the same time as other, more traditional aspects of estate planning.

The underlying idea holds great promise despite the often flawed execution due to a range of common assumptions made by the parties to a power of attorney document. While people often wish to avoid life-sustaining treatments at the end of life, they rarely understand the realities of the life-sustaining treatments and resuscitation their directives most commonly speak to, the contextin which such treatments may be required or their implications for quality of life. Nor do they seek to deepen their knowledge by systematically consulting their physicians or healthcare teams prior to completing these legal documents, even if their lawyer encourages them to do so.

s_129841.jpg     (Source: Fairview)

Further, most people appointed as substitute decision-makers or falling under the statutorily defined hierarchy of substitute decision-makers have never discussed such personal wishes and values with those they are designated to represent. As a result, many end up substituting their own values for those of the now incapable person and often consent to or request treatments that are more aggressive than the person actually wanted to undergoespecially as the end of life nears. Adding to these issues, decisions with respect to life support and resuscitation often need to be made quickly, which only adds to the tension and stress experienced by SDMs and healthcare teams.

These problems, if unaddressed, are only going to cause increasing challenges in medical and legal practice: as people live longer; as families become smaller; as friendships fade or evolve; as more people choose to stay single and not have children, more people may find themselves alone and may, therefore, seek to express their wishes and values through written advance directives rather than solely appointing a substitute decision-maker. However, the text and content of advance directives are often ambiguous, do not speak to the situation, and are frequently overly standardized in legal practice in ways that prohibit the expression of unique personal wishes and instead promote conformity. While the actual wording and systematic inclusion of “no heroic” clauses in power of attorney documents has not been altered for years, such clauses as currently written are not particularly helpful in clinical practice. For advance directives to speak clearly, truly respect autonomy and provide meaningful guidance, the text of legal documents must improve—the time for them to do so is now.

This series therefore aims to set out an intensivist’s perspectives on the top ten ways estate lawyers can improve the content and scope of advance directives, the wording of any “standardized” no heroics clauses, the process to ensure these wishes and values are respected and, as a result, improve the advice they provide to their clients and the quality of end of care they ultimately receive.

Go to Step 1


The author wishes to encourage and engage in discussion regarding the directives she proposes here. Please take a moment to express your thoughts and critical commentary in the comments section below.

About the Author

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LAURA HAWRYLUCK received her MD in 1992 from the University of Western Ontario where she also served her Internal Medicine residency. She completed a Fellowship in Critical Care at the University of Manitoba in 1997 and received her MSc in Bioethics in 1999 from the Joint Centre for Bioethics and the Institute of Medical Science at the University of Toronto. From 1999-2001 she was Assistant Professor of Critical Care/Internal Medicine, Queen’s University, Kingston, Ontario. In March 2000 she was appointed Physician Leader of the national Ian Anderson Continuing Education Program in End-of-Life Care at the University of Toronto and is currently Associate Professor of Critical Care Medicine at the University of Toronto. In 2002, she was awarded the Queen’s Golden Jubilee Medal for contributions to Canada in recognition of her work in creating the Anderson Program and improving end of life care for Canadians. Dr. Hawryluck is co-author and editor of “Law of Acute Care in Canada” to be published shortly by Carswell, a division of Thomson Reuters.

Dr. Hawryluck is deeply involved in international humanitarian projects. She has worked with critical care and burn units in Indore India and Cote d’Ivoire on a variety of quality improvement and educational initiatives. She was co-creator and co-Director for RCCI of the first Doctorate in Medicine Program in Critical Care in the entire country of Nepal. She worked with the Nepal Medical Council as an international consultant to enact a Code of Ethics and Professionalism for all physicians in Nepal.

The All Families are Equal Act: Does it Fulfill its Potential?

Posted By Colleen Morawetz 

In November 2016, the Ontario Legislature passed the All Families Are Equal Act, which the Liberal government claims will “ensure equal treatment for all parents and children in the province”. This legislation marks an important shift for the province, whose former statutory regime – not having been updated since 1978 – did not explicitly address conception through assisted reproductive technologies or third-party arrangements. The new legislation’s purpose is commendable: to ensure that all types of parents are treated equally, regardless of their sexual orientation, reproductive capacity, or the number of parental figures in a child’s life. However, the statute has faced criticism from multiple angles.

The Good

The All Families Are Equal Act proposes an entirely new scheme for determinations of parentage when a child is conceived through surrogacy—whether the child is genetically related to both intended parents (gestational surrogacy, where an embryo is implanted into a surrogate mother’s uterus through in-vitro fertilization) or not (either gestational surrogacy with a donated egg and/or sperm, or traditional surrogacy where the surrogate mother’s own ovum is artificially inseminated).

Previously, opposite-sex intended parents would have to make a declaration of parentage in court in order to override presumptions that the surrogate mother and her own partner, if applicable, were the parents of the child. Furthermore, same-sex partners (two gay men, or the female partner of a woman who gave birth) could only establish parentage through adoption. The legislation now provides a streamlined, out-of-court process for intended parents. Rather than requiring a judicial application, intended parents will be able to use a mail-in application to register themselves as the legal parents of their child.

According to the Ontario government, this shift will provide greater clarity and certainty during the surrogacy process, while offering greater legal security to parents in the event of a medical emergency. Indeed, the Bill was first introduced as Cy and Ruby’s law. Named for the children of Jennifer Mathers McHenry and her wife Kristi, the Act sought to rectify situations such as theirs: if Jennifer, the genetic mother and carrier of the child, had died during her difficult childbirth, Kristi would have been in a legally precarious situation and may not have been able to take their baby home.

Cheri DiNovoOntario New Democrat MPP Cheri DiNovo introduced the Bill that, in two short months, passed into law as the All Families are Equal Act. || (Source: Christopher Kastarov // Huffington Post)

The All Families Are Equal Act explicitly recognizes that ovum and sperm donors are not the parents of a child; however, the legal status (or lack thereof) of intended parents and donors requires corroboration through a written pre-conception agreement. The legislation also allows for up to four people to be registered on a child’s birth certificate—a codification of the Ontario Court of Appeal’s 2007 decision in AA v BB.

This legislation, as proclaimed by its title, aims to provide equal legal treatment for parents with non-“traditional” family structures or family building processes. Its elimination of gendered legal terms such as “mother” and “father” in favour of “parent” is an important semantic shift towards normative inclusion of non-heterosexual parental setups. Moreover, fertility law experts such as Sara Cohen applaud the act for requiring surrogate mothers to have independent legal counsel in the negotiation of the pre-conception agreement, which may help guard against the exploitation of vulnerable women.

The Bad

However, certain aspects of this new legal regime may have unintended consequences or even run counter to the Act’s stated goals. First, the statute renders all surrogacy contracts unenforceable, whether they concern gestational or traditional surrogacy. Unlike in Quebec, where all surrogacy agreements are absolutely null as per article 541 of the Civil Code, Ontario courts had previously been willing to enforce gestational surrogacy contracts.

As healthcare lawyer Lisa Feldstein notes, surrogacy contracts are sophisticated legal instruments that contain numerous provisions relating to contingencies beyond parentage. For example, provisions may stipulate who will be allowed in the delivery room, who the surrogate should give the child to in the event of the intended parents’ divorce or death, how many embryos will be transferred to the surrogate’s womb, and obligations for support of the surrogate that the intended parents will assume should she require pre- or post-birth bedrest.

Feldstein fears that without the judicial oversight that accompanies the possibility of enforcement, the rights and interests of all parties will not be sufficiently protected. Given how the demand for surrogate mothers dwarfs supply in Canada, where surrogate mothers cannot be paid beyond reimbursement for reasonable expenses, Feldstein argues that rendering all agreements unenforceable will erect additional barriers to family-building by creating a chilling effect. Further, such barriers can only increase socioeconomic inequality in access to reproductive services, as wealthier would-be parents turn to more permissive jurisdictions abroad.

Healthcare professionals should not have to (and are not equipped to) interpret legal surrogacy agreements, particularly in the context of emergency medical situations.

Moreover, the All Families Are Equal Act provides that until the child is seven days old, the surrogate mother must be consulted as a substitute-decision maker in the event that medical treatment is necessary—unless the intended parents and the surrogate have stipulated otherwise in their (purportedly unenforceable) pre-conception agreement. Both Cohen and Feldstein note that healthcare professionals should not have to (and are not equipped to) interpret legal surrogacy agreements, particularly in the context of emergency medical situations. Feldstein argues that this provision undermines the equality thrust of the Bill, as it treats parents who use a surrogate differently from other parents by giving legal weight to the surrogate’s post-birth medical opinions.

Cohen notes further that the “predictability” of the new, streamlined parentage process comes at the price of increased potential for fraud, duress, and undue influence. Without judges scrutinizing pre-conception agreements before declaring parentage, Cohen fears that marginalized women may be coerced into surrogacy. Further, the adoption process may be short-circuited by would-be parents who find an already pregnant woman and subsequently back-date a pre-conception agreement for “traditional surrogacy”. Cohen argues that judicial checks are necessary to determine whether independent legal advice has indeed been provided to all parties and whether the child was conceived through a process that corresponds to the written arrangement.

Given Cohen’s concerns and the underlying rationale for Canada’s criminalization of commercial surrogacy (preventing the bodily exploitation of women), perhaps there are compelling reasons for maintaining a judicial declaration system for establishing parentage. Cohen argues that an administrative scheme like that in Illinois may provide a middle ground between judicial processes and the “mail-in” system, while Feldstein holds that legitimacy could be enhanced by requiring consent to be recorded on a prescribed legal form.

8642605447_f84e663fa6_zWhile the All Families are Equal Act improves access by streamlining the process, experts warn that the lack of enforceability or judicial review puts women in vulnerable situations at risk of undue influence, fraud, and exploitation. || (Source: Jan Truter // Flickr)

Cohen outlines two final concerns about the legislation: first, that the scheme doesn’t allow children born through surrogacy to have the same privacy in court processes as do adoptees (further undermining the statute’s equality rationales), and second, that the Act permits sperm donation through sexual intercourse. Cohen argues that this legal development, coupled with the recognition that donors are not parents, may allow biological fathers who simply may not want to be legal fathers to “opt-out” of parentage through a pre-conception agreement. Cohen fears, in particular, coercion that may result in a woman signing such an agreement, given the lack of judicial oversight.

Further, this provision creates serious inequality between men and women. Though ovum donors are not legally recognized as mothers, a woman cannot, when a child is conceived through sexual intercourse, simply contract out of parentage by creating a pre-conception agreement that designates her a traditional surrogate. Such a development would be dangerous, as it could leave children with no legal parent!

A simple remedy to this potential coercion and actual gender inequality would be not to recognize sperm donation through sex. At-home, “artisanal” artificial insemination is easy enough to do if both biological parents are serious about “non-traditional” family building, and it is unclear how much true, premediated “sperm donation” occurs via sexual intercourse.

Though ovum donors are not legally recognized as mothers, a woman cannot, when a child is conceived through sexual intercourse, simply contract out of parentage by creating a pre-conception agreement that designates her a traditional surrogate. Such a development would be dangerous, as it could leave children with no legal parent!

The Ugly

As expected, there have also been no shortage of reactionary, irrational critiques of the All Families Are Equal Act. Conservative activist organizations such as REAL Women of Canada and the ARPA fear the end of the heteronormative “traditional family”. They argue, respectively, that multiple parents simply “will not be able to agree” on parenting decisions (irrelevant to the legal status of parentage), and that the statute tears at the legitimacy of traditional families by recognizing “non-families” (a blatantly homophobic statement). The ARPA, further, argues that the Act is full of semantic mistakes; for example, the Act references the unimpeachably male fluid of sperm in the provision rendering donors non-parents, while generally avoiding the gendered term of “father”. Clearly, the ARPA’s legal counsel, in its thinly veiled homophobia, has ignored the fact that legal parentage has always been distinct from biological realities.

slide_480772_6580790_compressedSame-sex couples, whom have had the right to marry in Canada since 2005, often make use of donors and surrogacy to have a child of their own. The All Families are Equal Act grants greater access to these services and helps solidify a legal parental relationship between same-sex partners and their children. || (Source: Huffington Post)

The Potential

Despite its hysteria, REAL Women correctly notes the rapidity of the Bill’s life-cycle: NDP MPP Cheri DiNovo introduced the private member’s Bill a mere two months before it was passed. While legislative efficiency is to be admired at times, perhaps this lightning-quick process allowed lawmakers to skate over some of the critiques raised by experts such as Cohen and Feldstein. In fact, Feldstein presented certain concerns about the statute to the Standing Committee on Social Policy in October, but her suggestions were ultimately not incorporated into the final Bill.

Hopefully, the normative value of the All Families Are Equal Act, in addressing many forms of legal discrimination based on family status, will not overshadow the reasoned critiques raised above. This legislation is a step in the right direction for Ontario’s parentage regime. However, it should be amended to allow for, at the very least, enforceability of certain contractual arrangements and a medical decision-making model that maps onto both the legal reality of parentage and the equality goals of the Act itself.