Preserving Human Potential as Freedom: A Framework for Regulating Epigenetic Harms

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development and in disease causation. In a sense, epigenetics blurs the distinction between “nature” and “nurture” as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents’ generation might affect our health now, even if we have not experienced the same exposures. In the same vein, current exposures could affect the health of not only individuals currently living but also future generations. Given the relative novelty of epigenetics research and the multifactorial nature of human development and disease causation, it is unlikely that conclusive proof can be established showing that particular exposures lead to epigenetic risks that manifest into specific conditions. Using the Capabilities Approach (“CA”) developed by Amartya Sen and Martha Nussbaum, this article argues that epigenetic risk is not merely a medical issue, but that it more generally implicates the underlying fairness and justice of our social contract. For instance, how we develop mentally or physically has a tremendous impact upon our inherent capabilities and our set of life options. The CA prompts us to ask questions such as: (1) what impact do particular epigenetic risks have on our ability to exercise free choices; (2) are these risks avoidable; and (3) how are these risks distributed across society? Due to the complex nature of epigenetic risk, tort law is predictably incapable of addressing this harm. Further, while regulatory agencies possess the statutory authority to begin addressing epigenetic harms, currently these agencies are not attuned to measure or to respond to this type of harm. This article argues that it is imperative to initiate a regulatory framework to address epigenetic risk from specific substances even if conclusive proof of disease causation cannot be established. Shifting the burden of generating epigenetic risk data to producers of suspected harmful substances serves as a start. As information concerning epigenetic risks accrues, the regulatory response should evolve concurrently. As part of a dynamic policy-making approach our goals need to encompass the following: (i) promotion of knowledge in the scientific, legal, and public domains; (ii) assessment and modification of current regulations to address preventable risk; and (iii) an overarching commitment to protect human capabilities in an equitable manner

Towards Achieving Lasting Healthcare Reform: Rethinking the American Social Contract

The famous preamble to the United States Declaration of Independence reflects a concise and eloquent understanding of the Lockean social contract theory that underpinned the foundation of the original American government: that free people will naturally find it in their self-interest to leave the state of nature (and the tyranny of foreign rule) and join a society where a legitimate sovereign power and the rule of law protect the citizens\u27 fundamental rights. As of the writing of this essay, a new decade approaches and both the U.S. Senate and House have passed historic healthcare reform bills. The two legislative bodies, however, have not yet reconciled the differences between the two bills nor realized the scope of political compromise necessary to get the final bill signed into law. My goal in this essay is not to predict what the final healthcare reform bill will look like. Rather, I will posit as a theoretical matter that, whatever the merits of the final 2010 healthcare reform bill to improve the access, cost, and quality of American healthcare, this effort will necessarily be deficient and need significant reformulation as it has been formed outside of a political context in which basic healthcare is an intrinsic part of the American social contract. In other words, to achieve lasting, rational, and comprehensive healthcare reform there must be a political consensus in the U.S. that healthcare is a basic fundamental right, not merely an important legislative concern subject to compromise among various interests. To illustrate this point, I will briefly examine the historical view of healthcare in the U.S., how other developed countries have viewed healthcare, and how the U.S. has recently dealt with non-healthcare crises that have seemingly imperiled the American social contract

Promoting Ethical Standards in Globalized Drug Trials through Market Exclusion

With the increasing accessibility of cheap internet communication, human research subjects and concerned citizens in developing nations can be empowered to effectuate much of the surveillance and monitoring activities of clinical drug trials. For instance, WHO could maintain a multilingual website for the reporting of alleged ethical violations. A credible report could then prompt WHO officials to obtain a sworn statement from the reporter, which would then trigger an investigation into the alleged ethical abuses. Verified reports of ethical abuses can then be taken into account by drug regulatory agencies when determining whether a drug should obtain market approval

The \u27Uberization\u27 of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology\u27s Impact on the Medical Profession

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined physicians as the primary decision-makers and economic earners within the healthcare industry. In the near term, mobile health represents a potential redistribution of medical authority and financial power to technology companies and lesser-trained medical providers (nurses, physician assistants, etc.) at the expense of physicians. In the long-term, mobile health threatens to transform healthcare into a primarily “providerless” service, in the same fashion mobile taxi app company Uber envisions “driverless” taxis. Therefore, I conclude that while mobile health holds out tantalizing potential to improve upon the cost and accessibility of healthcare, there will be significant resistance to licensing and scope of practice reforms until broader political economy questions concerning the long-term viability of the medical profession are answered

The “Uberization” of Healthcare: The Forthcoming Legal Storm over Mobile Health Technology’s Impact on the Medical Profession

The article examines the potential of mobile health to transform the delivery of healthcare through allowing non-physicians providing care independent of physicians and outside of traditional clinics and hospitals in the United States. It discusses licensing and scope of practice laws from large information technology (IT) corporations

Remembrance of Lives Past: The Challenge of Addressing Epigenetic Risk in Society

Do our ancestors’ experiences from several generations ago play a role in our current health? Could a famine or a period of food abundance experienced by our grandfathers affect whether we are currently obese or likely to develop diabetes? Can being the grandchildren of those who suffered through genocide or intense racial discrimination affect levels of certain chemicals in our brains even if we are not exposed to the same social stresses? In other words, do we biologically inherit the “memories” of past generations independent of changes to our ancestors’ genetic code or DNA? Assistant Professor Fazal Khan explores how certain environmental exposures experienced by our ancestors can affect our health a couple of generations later, independent of our genetic sequence, and some implications for future tort laws

The \u27Uberization\u27 of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology\u27s Impact on the Medical Profession

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined physicians as the primary decision-makers and economic earners within the healthcare industry. In the near term, mobile health represents a potential redistribution of medical authority and financial power to technology companies and lesser-trained medical providers (nurses, physician assistants, etc.) at the expense of physicians. In the long-term, mobile health threatens to transform healthcare into a primarily “providerless” service, in the same fashion mobile taxi app company Uber envisions “driverless” taxis. Therefore, I conclude that while mobile health holds out tantalizing potential to improve upon the cost and accessibility of healthcare, there will be significant resistance to licensing and scope of practice reforms until broader political economy questions concerning the long-term viability of the medical profession are answered

The “Uberization” of Healthcare: The Forthcoming Legal Storm over Mobile Health Technology’s Impact on the Medical Profession

The article examines the potential of mobile health to transform the delivery of healthcare through allowing non-physicians providing care independent of physicians and outside of traditional clinics and hospitals in the United States. It discusses licensing and scope of practice laws from large information technology (IT) corporations