Faculty Director Marchant Presents to the Federal Court Clerks Association on New Emerging Technologies

Faculty Director Gary Marchant gave a 90 minute plenary talk to the Federal Court Clerks Association in Florida last month. He explained the impact of new emerging technologies to over 550 clerks and clerk officers from the federal courts across the country.

Marchant spoke on the changing processes of the legal system due to emerging technologies such as genetics, artificial intelligence, blockchain and neuroscience and how they are also changing the substance of the legal system as well as the processes.

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LSI Alum Heather Boysel Becomes First Female Managing Partner of Gammage & Burnham

The Center would like to congratulate Heather Boysel, one of our illustrious alumni, on being named managing partner of the Arizona law firm of Gammage & Burnham. Boysel worked closely with the Center during her time as a student at ASU Law and earned her J.D. in 2007. 

She began at Gammage & Burnham as a summer associate and will be succeeding Tim Martens, who is now retiring. Her practice focuses on commercial litigation, especially in the healthcare field. Please join us in congratulating Heather and in wishing her the best in her new role!

Read more about Heather’s success in a recent ASU Now article here.

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A Look at GETS 2019

GETS 2019 has just wrapped up, we are so excited to be able to host and meet wonderful speakers, panelists and attendees discussing the future in technology and governance.

There is no way we can fit all of the amazing panels and presentations we have seen in the past few days in just one blog post, but here is a little information on the conference in case you missed it:

Our first keynote speaker, Shelia Hayman, a documentary film maker, discussed her work on her recent film “Smart: Why Artificial Intelligence Isn’t Intelligent” and discussed that AI is not intricately in tune to the human emotions, as well as other factors that come into play. She opened up an interesting discussion and created many thought-provoking points for the audience. To see more of Hayman’s work check out her website here

Our second keynote speaker, Rachel K. Mushahwar, the vice president of Sale and Marketing Group at Intel, discussed the constant change in technology and the need for businesses to catch up. “Do you think taxi’s predicted Uber,” she said in her speech, “Do you think hotels predicted AirbNb?” She pointed out new technology and how we adapt our lives around devices, because of that, businesses need to think one step ahead to work around any new advances that could shake their consumers away from them.

Other topics discussed included an interesting panel on Virtual and Augmented Reality with panelists from the Universal Film entertainment, Loyola Law School and Loeb& Loeb LLC discussing how VR and AR are great ways to connect with audiences. VR and AR discussions didn’t end there though, with many great solo speakers discussing the future of VR and AR technology and governance.

Other interesting topics up for discussion during the week included gene editing and the implications behind altering embryos, gene doping in sports, life extension therapy, climate engineering, cybersecurity, property rights and policymaking for the human body, and much, much more. Overall this conference covered a vast amount of topics pertinent to the new technology we are seeing introduced in today’s world.

 Sad you missed this year’s conference? Stay tuned for the report series we will be doing on the panels, speakers and events from GETS 2019! 

 Make sure to follow the LSI Center on Twitter, Instagram and Facebook to get updated on when registration is for next summer’s event and to keep up with the Center’s other events! 

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Bowman Releases Article in ‘Social Science & Medicine’

Diana Bowman recently released an article discussing the expectations of cancer screening and the politics that lurk behind this new technology.

The article, in ‘Social Science & Medicine,’ focuses on Australia’s breast and cervical screening programs and “the implications for those who are the targets of screening.”

Many countries have national screening programs in place in an effort to catch potential cancer diagnoses early and start treatment as soon as possible. Australia specifically has screening programs for numerous types of cancer, such as breast, bowl and cervical cancers. Bowman’s article focuses on the two longest running screening programs Australia offers, breast and cervical cancer screenings.

These programs are well-established and report high participation rates, but the effectiveness is what is controversial and the debate about its benefits is still ongoing. In this article, Bowman and her co-authors explored how the screening- relation information assumes the status of scientific ‘facts’ and that the presenting information is neutral and objective which therefore obscures the political choices involved in its generation. Another factor pointed out is the claims in the policy documents is the emphasis of documents and the minimization of the risks and harms that populations-based screening could bring forth.

Bowman and her co-authors suggest that the current national policies could be contributing to sustaining expectations of screening that are higher than warranted. Higher expectations could bring societal and economic costs to the public, and the deep socio-cultural meanings of cancer could also shape the public expectations of the protective value of the screening, which is something that could cause current screening approaches to become resistant to challenge.

Check out Bowman’s great article here.

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Recap: SmartCities Report

The ABA Smart Cities Conference featured several panels discussing current issues and future considerations in developing smart cities. Industry experts, academics, and attorneys came together to discuss what the future of smart cities holds.

Bill Gates opened the conference with the keynote Maricopa County’s Applications of Smart City Technology. Gates servers a chairman of the Maricopa County Board of Supervisors. Gates discussed examples of how big data has been put to use in Maricopa County, the rollout and impact of 5G networks, and other instances of Maricopa County’s drive to become a smart region.

The conference featured other panels discussing exciting smart city topics such as smart transportation, smart stadiums and campuses, AI, and data privacy and cybersecurity in smart cities.

Check it out below:

Smart Cities Report

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Marchant Quoted in Science Magazine on Gene Testing

Faculty Director Gary Marchant was recently quoted in “Science Magazine” discussing the gene testing surges and lawsuits that are trailing behind. Marchant is part of a 3-year project called LawSeq, which aims to help build legal guidelines to support genomic medicine. Those in healthcare are already facing lawsuits that are new territory legally, and are at the risk of being held liable for how they handle genetic testing.

For a long time, the legal and medical standard of care coincided to simultaneously care for the patients while also protecting the doctors from lawsuits. But the new genomic technology is changing at a rapid pace, creating unclear medical standards. Doctors are seeing this issue happen a lot with variant assessments and how these variants play into determining if a patient has an increased risk for heart disease or breast cancer.

One notable case came up after the death of a 16-year-old in Pennsylvania in 2010. The teenager died of a hypertrophic cardiomyopathy 2 years after his father had had an electrocardiogram during a medical check-up. In the lawsuit, the family of the boy contended that the EKG results should have raised alarms and doctors should have done genetic testing on the father which would have led to testing on his son. Despite not having treated the teenager, the family suggested that the doctor had a legal duty to the teenager. In 2015, a judge agreed and the family won the lawsuit. Marchant believes that this case can now be used as a reference point in future cases, and shows the expansion on a physician’s responsibility.

With the growing understanding of genes, another issue has come to light, what happens when the understanding of a variant changes after the initial testing? A DNA change written off as an unknown significance can later be found to raise the risk of ovarian cancer. But finding the person with that variant could pose a challenge.

Check out the article here.

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LSI Center Scholar Walter Johnson publishes article in the Journal of Food Law and Policy

LSI Center Scholar and 3L Walter Johnson has an upcoming article in the Journal of Food Law and Policy. The article, “Blockchain Meets Genomics: Governance Considerations for Promoting Food Safety and Public Health,” considers the promise and challenges of two emerging technologies coming together to improve food safety.

Foodborne illnesses remain a significant public health issue in the U.S. and globally. To better respond to outbreaks, government agencies like the Food and Drug Administration and Centers for Disease Control and Prevention have begun exploring new technical tools. Whole genomic sequencing (WGS) is one such tool, which reveals the DNA of the pathogen responsible for contaminating foods. Scientists can then use the DNA to infer where contamination began and work with food distributors who may have received products from those areas. Meanwhile, blockchain has gained notoriety as more than just a platform for Bitcoin. Large companies including IBM and Walmart have partnered to use blockchain to track food products through global supply chains. Distributors can use this system to work backwards to find each site in the
supply chain that may have harbored contaminated food.

Combining the two technologies may not be a silver bullet for foodborne illness, but blockchain and genomics each have promising benefits and can cover some of the other’s weaknesses.

Despite the promise, bringing together WGS and blockchain systems may create regulatory challenges and conflicts. Government WGS programs and private-driven blockchain systems will require data to flow across the public-private barrier and could raise issues of data integrity, competition between private firms, and system interoperability. Whether the blockchain platforms are public or private, permissioned or permissionless, and which entities control the platforms take on new significance in this context.

The article examines how the design of these technologies and who operates them will create different regulatory hurdles, arguing for early efforts including technical standards and voluntary public-private collaborations to facilitate positive public health outcomes.

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Scientists Add Names to Global Moratorium on Embryo Editing

Leaders of the American Society of Gene and Cell Therapy sent a letter to the Secretary of Health and Human Services, adding their names to the list of scientists who have called for a global moratorium on experiments that could alter the genes of future generations, NPR reports.
This comes after the controversial experiment in China last year that reportedly produced children with edited genomes.

Scientists now are speaking out against the idea of engineering embryos until an “international framework” can be built to proceed responsibly. They wish to continue studies to determine if DNA in human embryos can be edited safely and effectively, as well as ethically. The appropriate uses for this process also need to be determined, such as preventing genetic disorders.
It has been stressed that this moratorium is not permanent, but temporary until the pros and cons of genetically editing embryos are evaluated.

Interested in learning more about genetic editing? Come checkout our panel at the 2019 GETS conference later this month.

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Marchant Speaks at LawSeq Symposium on DNA Sequencing

Faculty Directory Gary Marchant recently spoke at a LawSeq symposium discussing DNA sequencing and the legal aspects that come into play when introduced to the public as a direct-to-consumer option.

Marchant and his LawSeq colleagues met at the University of Minnesota to examine ways the legal world can keep up with the ever changing scientific landscape.  LawSeq is an innovative project that gathers experts to analyze the current US federal and state laws and regulations on translational genomics so they can generate a consensus outline on what the law should be.  

With DNA based tests becoming more available to the public, the concern for legal liability is on the rise. New problems are coming to light as these tests are being used, such as: the healthcare providers disconnect between the tests results and their level of care to provide, and the advancements of technology in the future finding new variants that were deemed meaningless years ago, but now have been proven to be harmful. With the level of care issue that health providers are facing, the typical fallback for most providers would be a rigorous standard of care, which is something that could act as a shield, legally speaking, against malpractice claims. Now this is becoming hazy considering that a patient’s results come from a testing company as opposed to a doctor’s office, which would mean that the doctor has all of the information needed to see what course of action to take. With that, a patient could take a test now, have the results come back with no malicious abnormalities and a certain genetic variant could be deemed meaningless. With new advancements it may come to light, possibly years later, the lab may contact a doctor and notify them that the genetic variant the patient was told to not worry about, is now known to be harmful and the patient is nowhere to be found. Now who can be held liable is up in the air, as the doctors didn’t have the results to notify the patient and the testing company may not have regularly reviewed scientific literature to track the understanding of the gene variants it tests for. Just last year, the South Carolina Supreme Court declared that a testing lab qualifies as a health care provider, therefore holding them liable under medical malpractice.  The case that determined this decision was the death of a boy whose mother contends that the testing lab failed to classify the genetic mutation he carried as pathogenic, leading to inappropriate treatment.

Marchant also discussed at the symposium the various liability claims he anticipates as genomics starts in the clinical care world. Some of these claims could be: failing to test, over testing, and failing to warn family about a variant the patient carries that they might have as well. LawSeq is creating an outline of recommendations to help labs, health care providers, and others to protect them from the legal risks that could come up. This outline will be released in a forthcoming paper and LawSeq’s participants will write up their recommendations.

 

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Marchant and Tournas Publish Anti-Aging Article

Faculty Director Gary Marchant and Lucille Tournas recently published an article in the Food and Drug Law Journal about the regulatory challenges and health span assisting interventions.

The article, “The Fountain of Youth Revisited: Regulatory Challenges and Pathways for Health span Promoting Interventions,” covers the progress that has been made in the scientific understanding of the aging process. This process comes from a new paradigm call the “geroscience” hypothesis and recognizes that aging is the number one risk factor in all chronic diseases. This means that there could be some intrinsic aging factors that can be specifically targeted with interventions, instead of attempting to extend healthy life by treating one chronic disease at a time. By utilizing genetic and other data showing that the aging process is malleable and can be slowed, scientists have identified key aging processes that underlie most chronic diseases and the symptoms of aging (ex. Fragility and cognitive decline.) Next, the potential interventions that can affect the aging process needs to be identified. Currently there are a number of “geroprotectors” have been identified, mainly in animal studies but a few cases in humans as well. This progress has been achieved in the past decade and has advanced a numerous interventions to the point where they are now ready to begin human clinical trials, regulatory approval and commercialization.

There has been a roadblock in this process, though, just as the scientific advancements made health span extension a possibility, regulatory and legal impediments have popped up to slow down the further advancement of these interventions. Mainly because the that the Food and Drug Administration drug approval process is based on prevention and the treatment of diseases, aging is not considered to be a disease and there is no straightforward regulatory approval pathway for therapeutics that may slow aging and extend lifespans.

Marchant and Tournas’ article explores this dilemma, identifies alternative regulatory and commercialization pathways for health span extending interventions, and argues that the FDA should take a more proactive role in speeding these clinical trials and regulatory period for these agents. 

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