31 August 2019

Genetic Interpretation

'Who’s on third? Regulation of third-party genetic interpretation services' by Christi J. Guerrini, Jennifer K. Wagner, Sarah C. Nelson , Gail H. Javitt and Amy L. McGuire in (2019) Genetics in Medicine comments
In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services’ Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services—while limited—could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.
'Direct-to-consumer raw genetic data and third-party interpretation services: more burden than bargain?' by Tia Moscarello, Brittney Murray, Chloe M. Reuter and Erin Demo in (2019) 21 Genetics in Medicine 539–541 comments
 The latest response to consumers’ increased demand for accessible genetic health information is the US Food and Drug Administration (FDA)’s recent approval of 23andMe’s direct-to-consumer (DTC) genetic test for the three common BRCA1 and BRCA2 pathogenic variants found in the Ashkenazi Jewish population.1 23andMe and other DTC genetic testing companies officially report out ancestry, trait, and some health information, while also providing consumers with files of their raw genetic data. Up to 62% of consumers use third-party applications to interpret the raw data and health information not included in companies’ reports. Little data exists on the nature and prevalence of clinical follow up of third-party raw genetic data interpretation, nor on the psychosocial impact on the consumer and their families. This information is of timely importance as a recent study suggests that 40% of genetic variations within DTC raw data sent for clinical confirmation are false positives. This raises many questions about the impact of DTC genetic testing and third-party interpretation tools, including the appropriate use of healthcare resources, clinical utility, provider and patient understanding of limitations, and psychological impact on consumers. In this commentary, we present four case vignettes from cardiovascular genetics clinics to bring awareness to possible harms of DTC raw data interpretation. Future studies investigating the breadth and frequency of cases such as these are required to understand the scope of this harm.
The authors offer a 'Call to action', stating
 As the demand for DTC genetic testing grows and the availability of raw data interpretation tools remain available, we anticipate the consumer themes illustrated above are likely to increase. While DTC genetic testing can empower patients to learn about some medically actionable genetic risk, there are also clear limitations of and misconceptions surrounding such testing. xxx The medical utility of DTC genetic testing is low, but even our limited experience demonstrates that it is placing a burden on the healthcare system to (1) clinically confirm these genetic results and (2) confirm that a patient does not have a clinical diagnosis of the disease associated with the reported SNP. The recommendation that all results obtained from the raw genetic data of DTC tests need to be clinically confirmed5 and recent data on false-positive rates indicate that almost half of consumers seeking clinical confirmation of their genetic testing results would be a waste of healthcare dollars. 
There is limited research on what consumers do with the interpretation of their raw genetic data. Recent studies suggest that 20–30% of consumers share DTC genetic testing results, including raw data interpretation with one or more healthcare providers.  However, despite its clear medical importance given the propensity for false positives, it is not known how many consumers seek a clinical evaluation for the conditions associated with the identified SNP(s), or clinical confirmation of the identified variants. It is also unclear how many healthcare providers sustain misconceptions about the validity of these results. To better understand the prevalence and extent of such outcomes, more research is needed to understand the patient experience and possible harms of receiving raw data interpretation results. To inform policy, future studies should investigate the frequency of these outcomes. Both the clinical and consumer genetics communities must collaborate to ensure consumers have access to valid data and correct interpretations of it. Studies exploring the education, support, and medical care surrounding DTC genetic testing and third-party raw data interpretation are needed to minimize harms to patients and reduce unnecessary costs to the healthcare system.

30 August 2019

Privacy

'Privacy's Constitutional Moment' by Neil M. Richards and Woodrow Hartzog comments 
America’s privacy bill has come due. Since the dawn of the Internet, Congress has repeatedly failed to build a robust identity for American privacy law. But now both California and the European Union have forced Congress’s hand by passing the California Consumer Privacy Act (CCPA) and the General Data Protection Regulation (GDPR). These data protection frameworks, structured around principles for Fair Information Processing called the “FIPs,” have industry and privacy advocates alike clamoring for a “U.S. GDPR.” States seemed poised to blanket the country with FIP-based laws if Congress fails to act. The United States is thus in the midst of a “constitutional moment” for privacy, in which intense public deliberation and action may bring about constitutive and structural change. And the European data protection model of the GDPR is ascendant. 
In this article we highlight the risks of U.S. lawmakers embracing a watered-down version of the European model as American privacy law enters its constitutional moment. European-style data protection rules have undeniable virtues, but they won’t be enough. The FIPs assume data processing is always a worthy goal, but even fairly processed data can lead to oppression and abuse. Data protection is also myopic because it ignores how industry’s appetite for data is wrecking our environment, our democracy, our attention spans, and our emotional health. Even if E.U.-style data protection were sufficient, the United States is too different from Europe to implement and enforce such a framework effectively on its European law terms. Any U.S. GDPR would in practice be what we call a “GDPR-Lite.” 
Our argument is simple: In the United States, a data protection model cannot do it all for privacy, though if current trends continue, we will likely entrench it as though it can. Drawing from constitutional theory and the traditions of privacy regulation in the United States, we propose instead a “comprehensive approach” to privacy that is better focused on power asymmetries, corporate structures, and a broader vision of human well-being. Settling for an American GDPR-lite would be a tragic ending to a real opportunity to tackle the critical problems of the information age. In this constitutional moment for privacy, we can and should demand more. This article offers a path forward to do just that.

Casual Legal Realism?

Positivism, Realism, and Sources of Law' by Leslie Green in Mindus and Spaak (eds), The Cambridge Companion to Legal Positivism (Cambridge University Press, 2019) comments 
 This paper explores the relationships between legal positivism and legal realism. Legal positivists hold that all law is positive law, that it is based on social sources. The law is therefore incomplete: there are legal disputes that cannot be determined by law alone. But legal realists seem to presuppose that all law is positive, and they affirm that, at least in appellate cases, judicial decisions are underdetermined by positive law. Are realists therefore legal positivists? In temper and outlook the doctrines are similar. My argument is that, after some conceptual errors are set aside, one difference lies in their respective attitudes to sources of law. Positivists hold that many sources of law are binding, at least on judges. Legal realists hold that many sources are permissive only: even domestic statutes and cases often have little more authority than, e.g. a doctrine of foreign law. That, in addition to the more familiar sources of indeterminacy acknowledged by positivists and realists alike, helps explain why realists think law is so loosely controlling in court, and why it is often defeated by considerations of policy and preference.

Crypto in Canada

'Twisted Into Knots: Canada’s Challenges in Lawful Access to Encrypted Communications' by Leah West and Craig Forcese comments
 In 2016, the Apple vs FBI case animated the “going dark” (communications encryption) debate in the United States. The Court battle between the tech giant and the most powerful law enforcement agency in the world stemmed from a mass shooting in December 2015, that left 14 people dead. Meanwhile, as American agents worked to unlock the shooter’s phone, prosecutors in Canada were seeking to convict seven men linked to the Montreal mafia for the 2011 abduction and murder of Sal "the Ironworker" Montagna, a member of New York’s Bonanno crime family. The evidence of the men’s conspiracy consisted almost entirely of intercepted emails, chats, and encrypted BlackBerry Pin to Pin messages. 
Publicly divulging the key would effectively render every BlackBerry user vulnerable to interception and endanger ongoing police investigations across the country, if not the world. Predictably, the Crown dropped the murder charges and the accused plead guilty to the significantly lesser offence of conspiracy to commit murder. Over the next two years, the Crown would stay charges against dozens of other men rounded up in the same operation targeting Montreal organized crime; the encryption key was never disclosed. In this manner, the Mirarchi case encapsulates a quintessentially Canadian element of the “going dark” debate: the intelligence-to-evidence dilemma, and specifically, the risk that sensitive technical means and methods may be disclosed in open court under Canada’s broad criminal trial disclosure rules. 
This article addresses the Canadian law governing “lawful access” to potentially encrypted data-in-motion; that is, communications done through electronic means. This article begins by outlining the core agencies responsible for counter-terrorism investigations in Canada, and the recent public debate and government consultation on encryption. Next, we identify how older laws designed for a different era may be leveraged to force service and platform providers to assist law enforcement and the Canadian Security Intelligence Service (CSIS) by decrypting communications and data. We will also touch on the legal capacity of these organizations to develop their own “workarounds,” including the role of Canada’s signal’s intelligence agency, the Communications Security Establishment (CSE). Throughout, we will highlight how Canada’s longstanding intelligence to evidence problem effects and, arguably exacerbates, the going dark phenomenon and consequently impairs Canadian counter-terrorism efforts. We predict legal reform resolving the “going dark” issue will be impossible without modernization of Canada’s disclosure regime.

29 August 2019

The Federal Tax Court and an Automation Tax

'The Gatekeeper Court: For the Revenue or for the Taxpayer?' (University of Melbourne Legal Studies Research Paper No. 828, 2019) By Rachel Davies and Miranda Stewart comments
Since its establishment, the Federal Court of Australia (“the Court”) has become the leading tax court in the nation. The Federal Court is the final port of call for most taxpayers and for the Federal Commissioner of Taxation. In the spirit of inquiry into the nature of “income” for tax purposes, this paper does both a “wide survey and an exact scrutiny” of aspects of the Court’s record in taxation matters over the last 40 years. The paper presents statistics about tax cases in the Court since its establishment in 1977 and discusses trends. We then turn to discuss important themes in tax cases before the Court, including the boundaries of ordinary income and allowable deductions; the complexity of the tax statute and of the task of statutory interpretation; and the approach of the Court to tax avoidance. Finally, the paper considers some features of tax litigation in the Court and challenges for the future.
'Taxation of Automation and Artificial Intelligence as a Tool of Labour Policy' (SMU Centre for AI and Data Governance Research Paper No. 2019/01) by Vincent Ooi and Glendon Goh argue
Rapid developments in automation technology pose a risk of mass displacement of human labour, resulting in the need to support and retrain displaced workers (a negative externality). We propose an “automation tax” that would slow the adoption of automation technology in appropriate circumstances, giving workers and social support systems time to adapt. This could be easily implemented through changes to the existing schedular system of depreciation/ capital allowances, reducing the uncertainty of its application and implementation costs. Such a system would be flexible enough to keep up with rapid technological developments. Two main dimensions may be adjusted to produce intended distortionary effects: 1) accelerated depreciation, and 2) bonus depreciation. While the benefits of efficiency gains mean that the automation tax is unlikely to have widespread application, it does provide a useful tool for specific situations where the rate of automation needs to be slowed due to its resultant social costs.
'Navigating the 4th Industrial Revolution: Taxing automation for fiscal sustainability' by Bronwyn McCredie, Kerrie Sadiq and Ellie Chapple comments 
The 4th industrial revolution has arrived. But this industrial revolution is unlike those witnessed in the past that saw advancements through manufacturing and trade accompanied by higher standards of living for many. Equal opportunity and growth have been replaced by the 21st century trend of rising inequality, in which advancement through digitisation and automation brings fortune to the few and threatens to leave the rest behind (Weyer, 2016). As a result, current tax systems are under pressure with displaced workers requiring support, and the fiscal purse, which has historically been funded by income taxes, being eroded due to a decreasing number of workers to tax. Conceivably, it is up to Governments to address this ‘double negative effect’, but how and from what theoretical basis does it do so? 
This paper presents a theoretical basis and three alternate models for taxing automation: a pigouvian tax; a tax on economic rents and an appreciation tax. Each of these models is evaluated alongside a discussion on the shift in global tax policy from taxing income to taxing capital. This paper argues that this shift is necessary to reduce inequality and to ensure even the lowest common denominator is provided for, for we are the 99%.

Deep Fakes

'21st Century-Style Truth Decay: Deep Fakes and the Challenge for Privacy, Free Expression, and National Security' by Robert Chesney and Danielle Keats Citron in (2019) 78(4) Maryland Law Review 882 comments
On February 1, 2019, the Maryland Law Review hosted a spectacular symposium entitled Truth Decay: Deep Fakes and the Implications for Privacy, National Security, and Democracy.  The Law Review brought together scholars and advocates to discuss the deep-fake phenomenon and the looming challenges to privacy, civil liberties, national security, and civic trust. Before we begin our foreword to the symposium papers, we wanted to thank Executive Symposium Editor Meredith Storm, Editor-in-Chief Alexandra Botsaris, and Managing Editor Caroline Covington for their leadership, hard work, and enthusiasm. 
Last spring, after telling them about our work on the topic, Meredith, Alexandra, and Caroline decided to dedicate the symposium to the deep-fake phenomenon. Of all of the cyber law issues grabbing headlines, from the loss of trust in social media companies to the daily drum beat of data breaches, they chose this topic. As the news from the weeks following the symposium showed, these women had foresight. We are grateful to the staff of the Law Review, especially Meredith, Alexandra, and Caroline, for having the vision, smarts, and devotion to bring together scholars with an array of perspectives to discuss the privacy, free expression, intellectual property, and national security 
On the day before the symposium, U.S. Senator Angus King appeared on MSNBC to discuss President Donald J. Trump’s response to recent testi- mony by U.S. intelligence chiefs. Earlier that week, in public congressional testimony, Director of National Intelligence Dan Coats and Director of the Central Intelligence Agency Gina Haspel expressed their disagreement with the President’s policy toward Syria and ISIS. President Trump responded swiftly to the video. Rather than criticizing them, the President simply asserted that neither Coats nor Haspel had disagreed with him. President Trump said, in so many words, that it was all fake news—that the officials said they agreed with his policies. When the TV host asked for a reaction to the President’s response, Senator King remarked,
Well, this reminds me of the old country song, Chris, who you go- ing to believe, me or your own lying eyes? I mean, the testimony is there. I was there. I asked Gina Haspel very directly, is Iran in compliance with the nuclear agreement and she hemmed around a little bit but then she said yes it is. And that’s what their findings are. 
The Senator was telling the hosts to watch the video of the proceedings to gauge the truth for themselves. In other words, videos do not lie. 
Senator King’s response captures the belief in the truth-telling power of audio and video recordings. Even the United States Supreme Court has attested to this power: If a video shows someone driving recklessly, then that person drove recklessly.  Period, the end, no discussion. Video and audio recordings elicit a visceral response. Human beings believe what their eyes and ears are telling them. Video and audio evidence become inscribed as truths about the world around us and stories embed quickly into memory. Although human beings may be able to dismiss gossip and rumors, especially if the gossip and rumors do not accord with their worldview, watching and hearing video and audio recordings make it much more difficult to disregard the content. 
Senator King’s remarks reflect human experience: We ascribe truth-telling powers to video and audio recordings. This response to digital imagery is exactly why deep-fake technologies are so powerful.
'The Upside of Deep Fakes' by Jessica Silbey and Woodrow Hartzog in the same issue comments
It’s bad. We know. The dawn of “deep fakes”—convincing videos and images of people doing things they never did or said—puts us all in jeopardy in several different ways. Professors Bobby Chesney and Danielle Citron have noted that now “false claims—even preposterous ones—can be peddled with unprecedented success today thanks to a combination of social media ubiquity and virality, cognitive biases, filter bubbles, and group polariza- tion.” The scholars identify a host of harms from deep fakes, ranging from people being exploited, extorted, and sabotaged, to societal harms like the erosion of democratic discourse and trust in social institutions, undermining public safety, national security, journalism, and diplomacy, deepening social divisions, and manipulation of elections. But it might not be all bad. Even beyond purported beneficial uses of deep-fake technology for education, art, and science, the looming deep-fake disaster might have a silver lining. Hear us out. We think deep fakes have an upside. xxx Crucial to our argument is the idea that deep fakes don’t create new problems so much as make existing problems worse. Cracks in systems, frameworks, strategies, and institutions that have been leaking for years now threaten to spring open. Journalism, education, individual rights, democratic systems, and voting protocols have long been vulnerable. Deep fakes might just be the straw that breaks them. And therein lies opportunity for repair. 
People have had good ideas about how to repair democratic institutions and frameworks for years. A leading example is the movement to overturn the Supreme Court decision Citizens United v. Federal Election Commission, which allowed corporations and nonprofits to raise and spend unlimited amounts of money to advocate for and against political candidates, giving rise to super PACs and, many say, the profound distortion of election politics. Another suggestion has been revamping education: making K-12 education less about standardized tests and more about cultivating a love of learning and making higher education more affordable without saddling college graduates with life-long debt. Often what’s been missingisthepolitical will to make them happen. Infrastructure isn’t a titillating political goal. Educators are continuously struggling for more funding. Voting reform is often too politically risky or costly to take on. Many of the harms to our basic institutions have been incremental as they seem destined to suffer death by a thousand cuts. 
Perhaps these small incursions into our technologies and civic institutions haven’t been significant enough to foment a meaningful appetite for reform. Or perhaps lawmakers and the public simply can’t get angry about ephemeral and sometimes difficult to describe harms to concepts like due process, data integrity, and collective intelligence that are not felt viscerally. Sometimes we just need a push. And deep fakes make for a memorable bully. 
That’s because deep fakes are lies. And not just lies, but ones that betray sight and sound, two of our most innate and cherished senses. Deep fakes call into question an entire lexicon of deeply held truths and axioms about the trustworthiness of what we see and hear with our own eyes and ears. “I’ll believe it when I see it.” “Out of sight, out of mind.” “A picture is worth a thousand words.” The potential upside of deep fakes is that they might help muster the political will to address the larger, structural problems made worse by the inability to trust what we see and hear. In other words, maybe an effective way to respond to the scourge of deep fakes isn’t to target the creation and use of deep fakes themselves, but rather to focus on strengthening the social and political institutions they disrupt. Now would be a good time to focus on institutional inoculation, fortitude, redundancy, and resiliency. Deep fakes are a symptom of deep problems. Wouldn’t it be ironic if the symptom is scarier than the sickness and finally compels us to solve the underlying problems? 
Below we briefly address some deep problems and how finally addressing them may also neutralize the destructive force of deep fakes. We only describe three cultural institutions – education, journalism, and representative democracy—with deep problems that could be strengthened as a response to deep fakes for greater societal gains. But we encourage readers to think up more. We have a hunch that once we harness the upside of deep fakes, we may unlock creative solutions to other sticky social and political problems.

Speech

'Drawing Trump Naked: Curbing the Right of Publicity to Protect Public Discourse' by Thomas E. Kadri in (2019) 78(4) Maryland Law Review 899 comments
From Donald Trump to Lindsay Lohan to Manuel Noriega, real people who are portrayed in expressive works are increasingly targeting creators of those works for allegedly violating their “right of publicity”—a state-law tort that prohibits the unauthorized use of a person’s name, likeness, and other identifying characteristics. Intuitively, we might feel confident that Mark Zuckerberg should not be able to block his portrayal in The Social Network movie, that Marilyn Monroe could not have stopped Andy Warhol from exhibiting his vibrant paintings, that O.J. Simpson could not have demanded money from FX to air the American Crime Story docudrama. But what supports these intuitions? And should we be so confident? 
This Article provides a new framework to reconcile publicity rights with a robust commitment to free speech under the First Amendment. After describing the current landscape in the courts, this Article scrutinizes the “educative” First Amendment theory that has motivated many of the past decisions confronting the right of publicity—a listener-focused theory that relies on the public’s right to receive information. This Article then reframes the doctrine in a new way: as four distinct educative defenses that have developed to assuage concerns about publicity rights interfering with speech on matters of public concern. These four defenses might seem encouraging to those who worry that publicity rights impair expressive rights. But all too often they have instead complicated and undermined the opposition to publicity rights and, as a result, they pose an unexpected and underestimated threat to free speech. To combat this threat, this Article recalibrates First Amendment theory as it relates to the right of publicity. 
To adequately protect creators and their expressive works, this Article argues that we must abandon educative models of the First Amendment and instead adopt an approach that also protects the speaker as a central part of enabling public discourse. Failure to adopt this speaker-focused theory in publicity doctrine will perpetuate confusion in the courts and state legislatures, an outcome that will have a chilling effect on creators who seek to portray real people in their work. Yet we must also recognize the interests that publicity rights can serve. As we move into an era of new technology and innovation—from “deep fakes” to nonconsensual pornography—this challenge will only intensify. To address it, courts should refer to the constitutional concept of “public discourse” when publicity rights face off against expressive rights—a concept that not only empowers free expression, but also considers the narrow interests that we should all have in preventing certain uses of our images.

28 August 2019

Individualisation

'Administrative National Security' by Elena Chachko in (2019) Georgetown Law Journal comments 
In the past two decades, the United States has applied a growing number of foreign and security measures directly targeting individuals — natural or legal persons. These individualized measures have largely been designed and carried out by administrative agencies. Widespread application of individual economic sanctions; security watchlists and no fly lists; detentions; targeted killings; and action against hackers responsible for cyber attacks have all become significant currencies of U.S. foreign and security policy. While the application of each of these measures in discrete contexts has been studied, they have yet to attract an integrated analysis. 
This article examines this phenomenon with two main aims. First, it documents what I call “administrative national security”: the growing individualization of U.S. foreign and security policy, the administrative mechanisms that have facilitated it, and the judicial response to these mechanisms. Administrative national security encompasses several types of individualized measures that agencies now apply on a routine, indefinite basis through the exercise of considerable discretion within a broad framework established by Congress or the President. It is therefore best understood as an emerging practice of administrative adjudication in the foreign and security space. 
Second, the article considers how administrative national security integrates with the President and the courts. Accounting for administrative national security illuminates the President’s constitutional role as chief executive and commander-in-chief, and his control of key aspects of administrative foreign and security action. It also challenges deep-rooted doctrines underlying foreign relations and national security law, including the portrayal of the President as the “sole organ” in international relations. Administrative national security further informs our understanding of the role of courts in this context. It renders more foreign and security action reviewable in principle under the APA, and provides a justification for the exercise of robust judicial power in this category.

Charitable Sharing of health data

'Governing Commercial Access to Health Data For Public Benefit: Charity Law Solutions' by Jessica L Bell in (2019) Medical Law Review 1–23 comments
There is a growing body of evidence that supports the view that research participants and the public are concerned about commercial access to health data. Evidence also suggests that attitudes are ameliorated when charity organisations are involved and where research promises to deliver ‘public benefit’. To a significant extent, therefore, mechanisms that ensure the public benefit are key to sustaining public and participant support for research access to health data. As a regime founded on the concept of public benefit, charity law provides regulatory and governance mechanisms through which the public benefit of a charity is protected and promoted. This article examines the merits of charity law mechanisms and analyses their significance for governance of commercial access to health data for public benefit, using UK Biobank Ltd, a charitable company limited by guarantee, as an example. The article critically analyses three charity law mechanisms that operate to ensure that an organization providing access to data meets its public benefit requirements: charitable purposes; members’ and directors’ powers and duties; and accountability via the oversight powers of the Charity Commission and charity proceedings in court. The article concludes that there is potential for the charity model to be the benchmark for governing commercial access to health data for public benefit research, but notes the limitations of the model and recommends the appointment of independent data governance committees to further bolster the charity law framework.
Bell argues
The past decade has seen substantial developments in the scale, scope, availability and use of health data for direct healthcare and secondary purposes such as research. Both private and public organisations are collecting, storing, accessing, analysing and releasing health data for profit and not-for-profit objectives. However, empirical studies indicate that the public are concerned about health data being shared with private companies. The most recent studies that have explored different types of commercial access have revealed that attitudes are ameliorated in the context of research uses of health data, where an academic or charitable organisation is involved, and where research promises to deliver ‘public benefit’. To a significant extent, therefore, where commercial organisations are accessing health data, the type of institution and its research objectives will be key to securing public and participant support for the research. There has been considerable scholarly and policy debate about the concerns raised by commercial access to health data, as well as proposals for enhanced involvement of the public and data subjects in the governance of health data as a way of inspiring trust and confidence in health data access. Comparatively little has been written about how different legal structures give rise to regulatory and governance mechanisms that can serve to protect and promote public benefit uses of health data, including by commercial users, which will also be key to maintaining support for research activity. 
This article analyses the significance of charity law for governance of commercial access to health data. Charity law is important for a number of reasons: first, there is current evidence that indicates a high degree of public trust and confidence in charitable organisations in the health research context, which warrants further exploration, investigation and protection; second, charity law is founded on the concept of public benefit, with a corresponding regulatory framework and governance mechanisms that operate to protect and promote the public benefit in charitable organisations. Moreover, examples are available of charitable organisations in this context, which allows for critical analysis of the charity law mechanisms and their application to concerns regarding commercial access to health data. This article will use UK Biobank Ltd, which has been set up as a charitable company limited by guarantee, as an example of a successful research initiative that provides access (including commercial access) to health data for research purposes, to demonstrate the ways in which the charity law framework for England and Wales protects and promotes public benefit research. 
The article is in three parts: first, background is provided on the empirical research on public concerns regarding commercial access to health data and public confidence in charity institutions. Secondly, the charity law mechanisms that may address these concerns and ensure the public benefit are analysed, namely: charitable purposes; powers and responsibilities of charity members and trustees; and accountability via the Charity Commission for England and Wales and charity proceedings. Finally, the article reflects on issues for further consideration, noting the potential shortcomings of the charitable model for addressing concerns regarding commercial access to health data.