Scholarship

Sometimes I write about health policy and space law.

Filling the Vacuum: Adapting International Space Law to Meet the Pressures Created by Private Space Enterprises, 49:2 Denver J. of Int'l L. & Pol'y 27 (2021) 

• ​This paper argues that if space is to be preserved for the use of future generations, legal duties must attach directly to the private non-state actors that seek to operate in space. Fortunately, the theoretical “head of power” already exists. The Outer Space Treaty, often referred to as the Magna Carta of space,18 declares space
  should be preserved as the ‘province of all [hu]mankind,’ and this principle now has the status of customary international law. Normally, international law applies only to states, but this should be overcome by analogizing private corporations operating in space to new states to hold them accountable to customary international law. This can be justified because 1) there is an existential threat to 2) a global commons established by a principle of customary international law, and 3) private non-state actors will be entering a vacuum of sovereignty in a way that is analogous to the creation of new states.​

Blurred Lines: The Collapse of the Research/Clinical Care Divide and the Need for Context-Based Research Categories in the Revised Common Rule, 74 Food and Drug L. J. 46 (2019)

• Despite its recent update, the Common Rule governing research on human subjects remains fundamentally flawed. Research is still defined primarily in opposition to clinical care so that the Common Rule draws a line dividing the two, a mismatch that fails to appreciate modern developments in healthcare. The historical origins of the Common Rule imbue the regulations with an understanding that research usually involves greater risks than clinical care. This view is perhaps appropriate for old research models like the randomized control trial. However, as modern medicine shifts focus from infectious diseases with common pathways to chronic illness through personalized medicine, research and clinical care draw closer together in ways that defy the assumptions of the Common Rule. New frameworks of precision medicine and learning healthcare are reliant on and work best with data collected through both research and clinical care so useful information that can be used to personalize and improve standards of care is not lost. The same technological advances that enable these changes also make possible more serious abuses of healthcare data than previously imagined. Thus, research models now exist which are both no more risky than clinical care and which are far more dangerous. Conflating different uses of research means that Common Rule simultaneously impedes new frameworks while remaining unable to address new risks. Context-based research categories, each with regulations that appropriately match the set of risks and benefits inherent in each type of research would help to align the Common Rule with reality and better protect research participants.
  
  

Derived Data: A Novel Privacy Concern in the Age of Advanced Biotechnology and Genome Sequencing, Yale L. & Pol'y Rev. Inter Alia, August 2018. 

• Cheap genetic sequencing, big data, and advanced biotechnology have the potential to revolutionize healthcare, but they also raise health data privacy concerns. They permit the emergence of derived data, which is unknown to the individual it describes and obtained through the analysis of existing data, both related and unrelated to healthcare. Derived data implicates the effectiveness of informed consent, the current method to protect patient privacy. Patients, research subjects, and consumers cannot reasonably consent to sharing, analysis, or use of data they do not know exists. To protect privacy rights while enabling progress in healthcare, regulations which now conceptualize data in silos must properly contend with 21st century data processing capabilities to link distant and seemingly unrelated data to form a more compete whole.