COVID

'Australia’s ‘COVIDSafe App’: An Experiment in Surveillance, Trust and Law (2020) University of New South Wales Law Research Series 999) by Graham Greenleaf and Katharine Kemp comments 

The joint Australian governments’ coronavirus contact tracing app, marketed as ‘COVIDSafe’, was released on 26 April 2020 for public download by the federal government, together with an emergency Determination under the Biosecurity Act to govern its operation, a Privacy Impact Assessment (PIA) with the Health Department’s response to that PIA, and (not least) the App itself and its privacy policy. 

It is a package intended to create sufficient public confidence to result in downloads of the app by a sufficient percentage of the Australian mobile-phone-owning population, for it to have a significant effect on the tracing of persons infected with the COVID19 virus. In the first few days since its launch nearly 3 million Australian’s have downloaded the app. 

When Parliament resumes, probably on May 12, it is expected that the government will introduce legislation to replace the non-disallowable Determination. This article analyses the steps that Australian governments need to take if public trust is to be justified, and aims to make a constructive contribution to the development of better legislation and greater transparency. 

We conclude that the conditions necessary to justify sufficient public trust in government for the Australian public to opt in voluntarily to the installation and use of the COVIDSafe app, and to not opt out, are lacking. Many of the main deficiencies we identify in this article are remediable: five deficiencies in transparency; and nine categories of improvements to the current Determination by the proposed COVIDSafe Act. However, the question of whether an individual Australian would be well advised to install and run the app remains a decision which depends on individual circumstances.

'Covid-19 and the Global Legal Disorder' by Simon Chesterman comments

When the world restarts and the masks are put away, will the global legal order look the same? Should it? A crisis is a terrible time to make predictions about the future. But it’s a great time to rethink dubious assumptions of the past, and address tensions revealed in the present. Just within the field of international law, Covid-19 has encouraged all three. Pundits predict the death of globalization — or its rebirth. Others assert that they always knew the global public health infrastructure was fundamentally flawed, or that it was the one thing saving us from apocalypse. And, of course, there are those eagerly seeking someone, somewhere, against whom they might bring a lawsuit. So it might be helpful to sort some of the wheat from the chaff and map out what we know, what we don’t know, and where we might go from here.

Panics, Crises and Health Research Ethics

'Against pandemic research exceptionalism' by Alex John London and Jonathan Kimmelman in (2020) Science warns

Regulatory agencies and public health authorities should play a leading role in identifying studies that meet these standards and fostering collaboration among a sufficient number of centers to ensure adequate recruitment and timely results. They should also avoid making public recommendations or granting emergency use authorization for interventions whose clinical merits remain to be established and, instead, present clinical trials as a mechanism for addressing uncertainty without compromising patient interests. At public briefings, health authorities can point stakeholders to trials being pursued within their catchment and report recruitment milestones to elevate the profile and progress of high-quality studies. 

The authors argue

 The global outbreak of coronavirus disease 2019 (COVID-19) has seen a deluge of clinical studies, with hundreds registered on clinicaltrials.gov. But a palpable sense of urgency and a lingering concern that “in critical situations, large randomized controlled trials are not always feasible or ethical” perpetuate the perception that, when it comes to the rigors of science, crisis situations demand exceptions to high standards for quality. Early phase studies have been launched before completion of investigations that would normally be required to warrant further development of the intervention, and treatment trials have used research strategies that are easy to implement but unlikely to yield unbiased effect estimates. Numerous trials investigating similar hypotheses risk duplication of effort, and droves of research papers have been rushed to preprint servers, essentially outsourcing peer review to practicing physicians and journalists. Although crises present major logistical and practical challenges, the moral mission of research remains the same: to reduce uncertainty and enable caregivers, health systems, and policy-makers to better address individual and public health. Rather than generating permission to carry out low-quality investigations, the urgency and scarcity of pandemics heighten the responsibility of key actors in the research enterprise to coordinate their activities to uphold the standards necessary to advance this mission. 

Rigorous research practices can’t eliminate all uncertainty from medicine, but they represent the most efficient way to clarify the causal relationships clinicians hope to exploit in decisions with momentous consequences for patients and health systems. Nevertheless, fastidious research standards may seem a luxury that pandemics can ill accommodate. Commenting on a study using suboptimal design, one group of scientists stated, “Given the urgency of the situation, some limitations…may be acceptable, including the small sample size, use of an unvalidated surrogate end point, and lack of randomization or blinding”. The perception that core methodological components of high-quality research are dispensable is underpinned by three problematic assumptions. The first is that some evidence now, even if flawed, seems preferable to expending greater resources on more-demanding studies whose benefits only materialize later. Because the window for learning in pandemics is often short, the need to “balance scientific rigor against speed” seems inevitable. 

The problem with this view is that challenges that rigorous methods address do not disappear in the face of urgent need. Small studies that build on basic science and preclinical research in early phases of drug development routinely generate signals of promise that are not confirmed in subsequent trials. Even when new drugs are established to be safe and effective, rarely are their benefits so massive that they can be detected in small, open-label, nonrandomized trials. The proliferation of small studies that are not part of an orchestrated trajectory of development is a recipe for generating false leads that threaten to divert already scarce resources toward ineffective practices, slow the uptake of effective interventions because of an inability to reliably detect smaller but clinically meaningful benefits, and engender treatment preferences that make patients and clinicians reluctant to participate in randomized trials. These problems are amplified by published reports of compassionate use, which was designed as an alternative pathway to access interventions outside of research, not to support systematic evaluation.  

The second underpinning of research exceptionalism is the view that key features of rigorous research, like randomization or placebo comparators, conflict with clinicians’ care obligations. However, when studies begin in, and are designed to disturb a state of, clinical equipoise (meaning that it’s uncertain whether a particular treatment is better than the alternatives), they ensure that no study participant receives a standard of care known to be inferior to any available alternative. Under this condition, randomized trials with appropriate comparators configure medical practice in a way that allows patients to access investigational interventions under conditions designed to eliminate ineffective strategies and exploit effective alternatives. 

The third underpinning of research exceptionalism derives from the expectation that researchers and sponsors are generally free to exercise broad discretion over the organization and design of research. However, that discretion never operates in a vacuum. Even under normal conditions, the goal of research ethics and policy is to use regulations, reporting guidelines, and other social controls to align research conduct with the public interest. Crucially, the information that research produces is a public good on which caregivers, health systems, and policy-makers rely to efficiently discharge important moral responsibilities. As recent international guidelines for ethical research emphasize, the justification for research is its social and scientific value, understood as its ability to produce the information that multiple actors need to make decisions that implicate health, welfare, and the use of scarce resources.

They go on to identify five conditions of informativeness and social value to enable stakeholders to fulfill their social responsibilities -

• importance.
• rigorous design. 
• analytical integrity. 
• trials should be reported completely, promptly, and consistently with prespecified analyses
• feasibility

Further

 Individual clinicians should avoid off-label use of unvalidated interventions that might interfere with trial recruitment and resist the urge to carry out uncontrolled, open-label studies. They should instead seek out opportunities to join larger, carefully orchestrated protocols to increase the prospect that high-quality studies will be completed quickly and generate the information needed to advance individual and public health. Academic medical centers can facilitate such coordination by surveying the landscape of ongoing studies and establishing mechanisms for “prioritization review” to triage studies. The goal would be to incentivize participation in efforts that uphold the criteria outlined here and to foster robust participation in multicenter studies so that data can be generated from different institutions before their capacity to meet fastidious research requirements is overwhelmed by surging medical demand.

COVID Cyborgs

'The COVID Cyborg and Protecting the Unaugmented Human' by Kate Galloway in (2020) Alternative Law Journal comments

This article examines the increasing tendency towards governance of people through their representation via data. In its most contemporary iteration, the COVID-19 pandemic has raised the prospect of contact tracing apps. While public discourse about the apps has focused principally on the important issue of data privacy, there are other possible effects whereby participation in such schemes might become a pre- requisite to accessing services or basic rights—either from government or from corporations. The pathway to acceptability of applying our data in this way is already paved, through fitness monitors and other technologies by which we represent ourselves. This article sets out the foundation of such technologies and their application, before outlining their effect on the recognised boundaries of governance and the conception of the holder of rights and the substance of those rights. 

Galloway argues

In 2018, biohacker Meow-Ludo Disco Gamma Meow-Meow was found guilty of travelling on Sydney buses without a valid ticket. Rather than carrying Sydney transport’s Opal Card with him, he had instead implanted its chip into his hand. He had indeed tapped on when entering the bus—so had paid for his trip. However, Sydney transport authorities were not satisfied with this, alleging that he had breached the card’s terms of use. 

Meow-Meow claimed that his case was based on the principle of ‘cyborg rights’. The modification of his body through embedding technology-capable hardware is a feature of a posthuman evolution, a ‘leaky distinction between animal-human and machine’. As an activist pushing the boundaries of the definition of human, Meow-Meow was simultaneously pushing the boundaries of the rights held by an altered human before the law. 

The science fiction-like nature of body modification is occurring in more prosaic ways. A pacemaker, for example, might transmit data about its human operating system in the same way that Meow-Meow’s Opal card chip transmitted data concerning payment of a bus fare. Whether therapeutic interventions properly constitute a ‘cyborg’ remains an open question, however to the extent that they might, the pacemaker example certainly poses less of a challenge to our general conceptions of humanity than does a more extreme bodily modification, possibly undertaken by oneself. 

Machines and other hardware (and software) may be implanted within us, but more readily we are enhancing our physical capabilities by carrying them on our person. Smartphones are ubiquitous, and as they extend our intellectual capacity, ability to communicate, and even provide biophysical feedback for lifegiving treatments, and share myriad personal data with government and corporations alike. Fitness trackers worn on the wrist measure our physiological signs not only re-presenting them to their wearer as a variety of metrics by way of graphs and icons, but also sharing with other users and their corporate creators. Our devices also call for biometric data to unlock their features. We readily submit to fingerprints and facial recognition, granting global corporates the most intimate of insights into ourselves. 

At the same time as we have willingly released aspects of ourselves, through our data, in the private sphere our government has constructed a surveillance architecture affording security services wide scope for access to our telecommunications data and our biometric data. Although governments have pushed through the suite of legislation for over a decade, this has not come without a cost. The uptake of My Health Record, a putative personal database of one’s medical information, has been poor. And now, in the thrall of a pandemic, government is proposing a contact tracing app whereby a user’s proximity to another person (within 1.5m for more than 15 minutes) would be identified through Bluetooth technology, encrypted, and recorded in the app. If a contact is diagnosed with COVID-19, then all contacts would be notified of that. 

Critique of the app—at the time of writing not yet released—has generally been concerned with data privacy per se. This is, of course, important. However, independently of data privacy is a question the opposite to that encountered by Meow-Meow. For the foreseeable future, and in particular while we are in a declared public health emergency, our infection status regarding COVID-19 is central to our freedom, and indeed, to wider societal freedom. In that sense, a tracing app —a nd its data — effectively function as an extension of ourselves. They are a means of reassurance not only to public health officials running the program, but to wider society, that we, collectively, are safe. Meow-Meow exercised his freedom to extend the functioning of his body by inserting the Opal card chip. But will we be free from extending our corporeal body through the incorporeal data contained in a contact tracing app? Without making the app mandatory, there are multiple ways that it might entrench itself within society to create classes of people. Those whose provenance is known (via the app) and those whose provenance is not. 

This article suggests that the COVID-19 pandemic will test the boundaries of our personhood in a new way. Despite the existing state/corporate data infrastructure whereby others are able to construct a picture of our most intimate lives, there is not yet a universally compelling basis for production of personal data as a threshold for acceptance into places or institutions. Contact tracing may present one. And if our data is to be carried with us as an integral and qualifying part of our interface with the world around us, it may be considered as part of our person. To the extent that our data engagement differentiates us from other humans, the question arises of the protections available at law. In particular, with an ‘extended’ human, the question arises about where recognised boundaries of governance lie, whether the extended human is the bearer of rights, and if so, what is the substance of those rights. 

Part II outlines the basis on which our data is effectively an extension of ourselves, and as such constitutes the extended human as a species of ‘cyborg’ following Haraway’s interpretation. Part III then hypothesises about a variety of social contexts that might prefer or demand, what I call here a ‘COVID cyborg’—a person enhanced by their COVID tracing data—to the exclusion of those not so enhanced. It envisages our society comprising two classes of people: the COVID cyborg, and the unaugmented human. Unlike the experience of Meow-Meow, the COVID cyborg has the potential to be embraced, effectively affording them rights superior to those of the unaugmented human. If this is to be the case, the law needs to comprehend both cyborg and unaugmented status as equal subjects of protection.