Public interest in health data research: laying out the conceptual groundwork

2020 ◽  
Vol 46 (9) ◽  
pp. 610-616 ◽  
Author(s):  
Angela Ballantyne ◽  
G Owen Schaefer
Keyword(s):  
Public Interest ◽  
Health Data ◽  
Social Value ◽  
The Public ◽  
Public Benefit ◽  
For Profit ◽  
Access To Health ◽  
Conceptual Clarity ◽  
Normative Basis ◽  
Demand For Health

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of particular value. However, several different terms are used to refer to this value (including public interest, public benefit, public good and social value), indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided (1) Those projects have social value, broadly defined. (2) Data are de-identified. (3) Data are kept secure. (4) Businesses are not able to access the data for profit.

Governing Commercial Access to Health Data for Public Benefit: Charity Law Solutions

2019 ◽  
Vol 28 (2) ◽  
pp. 247-269
Author(s):  
Jessica L Bell
Keyword(s):  
Health Data ◽  
Independent Data ◽  
Significant Extent ◽  
Data Governance ◽  
The Public ◽  
Public Benefit ◽  
Company Limited ◽  
Access To Health ◽  
Charity Commission ◽  
Access To Data

Abstract 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.

The perils of a broad approach to public interest in health data research: a response to Ballantyne and Schaefer

2020 ◽  
pp. medethics-2020-106729 ◽  
Author(s):  
Norah Grewal ◽  
Ainsley J Newson
Keyword(s):  
Public Interest ◽  
Personal Information ◽  
Information Privacy ◽  
Health Data ◽  
Social Value ◽  
Public Benefit ◽  
Privacy Law ◽  
The Law ◽  
Special Circumstances ◽  
Broad Approach

The law often calls on the concept of public interest for assistance. Privacy law makes use of this concept in several ways, including to justify consent waivers for secondary research on health information. Because the law sees information privacy as a means for individuals to control their personal information, consent can only be set aside in special circumstances. Ballantyne and Schaefer argue that only public interest, and only a broad conception of public interest, can do the special ‘normative justificatory work’ to override consent requirements. Other, similar-sounding concepts, such as public benefit, public good and social value, also provide useful services. But none more so than public interest. In fact, they argue, public interest is the superior concept precisely because it can capture those concepts as well as a range of other interests. Our response focuses on this claim. We argue their strategy is not as promising as it might first seem. Ballantyne and Schaefer construe the important role that public interest plays in this context as their endpoint. They claim that unless the concept is open and content-rich, it will lose some of its importance. But by refusing to place limits around it, their inquiry leads us back to a catch-all concept that lacks clear focus or meaning. In reply, we argue that, for practically minded theorists, a narrow conception of public interest is more useful. Further, the narrowing of public interest in this context can be achieved by first analysing it in its legal, rather than ethical, sense.

Hospitals: N.Y. Appellate Court Denies Move to Privatize Public Hospital

1999 ◽  
Vol 27 (2) ◽  
pp. 202-203
Author(s):  
Robert Chatham
Keyword(s):  
New York ◽  
New York City ◽  
York City ◽  
Public Health System ◽  
Municipal Hospital ◽  
The Public ◽  
Public Benefit ◽  
For Profit ◽  
Benefit Corporation ◽  
The City

The Court of Appeals of New York held, in Council of the City of New York u. Giuliani, slip op. 02634, 1999 WL 179257 (N.Y. Mar. 30, 1999), that New York City may not privatize a public city hospital without state statutory authorization. The court found invalid a sublease of a municipal hospital operated by a public benefit corporation to a private, for-profit entity. The court reasoned that the controlling statute prescribed the operation of a municipal hospital as a government function that must be fulfilled by the public benefit corporation as long as it exists, and nothing short of legislative action could put an end to the corporation's existence.In 1969, the New York State legislature enacted the Health and Hospitals Corporation Act (HHCA), establishing the New York City Health and Hospitals Corporation (HHC) as an attempt to improve the New York City public health system. Thirty years later, on a renewed perception that the public health system was once again lacking, the city administration approved a sublease of Coney Island Hospital from HHC to PHS New York, Inc. (PHS), a private, for-profit entity.

scholarly journals Public Interest, Health Research and Data Protection Law: Establishing a Legitimate Trade-Off between Individual Control and Research Access to Health Data

Laws ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. 6 ◽  
Author(s):  
Mark J. Taylor ◽  
Tess Whitton
Keyword(s):  
Public Interest ◽  
Data Protection ◽  
Health Research ◽  
Health Data ◽  
Personal Health ◽  
Positive Contribution ◽  
Data Governance ◽  
The Public ◽  
Individual Control ◽  
Data Protection Law

The United Kingdom’s Data Protection Act 2018 introduces a new public interest test applicable to the research processing of personal health data. The need for interpretation and application of this new safeguard creates a further opportunity to craft a health data governance landscape deserving of public trust and confidence. At the minimum, to constitute a positive contribution, the new test must be capable of distinguishing between instances of health research that are in the public interest, from those that are not, in a meaningful, predictable and reproducible manner. In this article, we derive from the literature on theories of public interest a concept of public interest capable of supporting such a test. Its application can defend the position under data protection law that allows a legal route through to processing personal health data for research purposes that does not require individual consent. However, its adoption would also entail that the public interest test in the 2018 Act could only be met if all practicable steps are taken to maximise preservation of individual control over the use of personal health data for research purposes. This would require that consent is sought where practicable and objection respected in almost all circumstances. Importantly, we suggest that an advantage of relying upon this concept of the public interest, to ground the test introduced by the 2018 Act, is that it may work to promote the social legitimacy of data protection legislation and the research processing that it authorises without individual consent (and occasionally in the face of explicit objection).

scholarly journals Clarifying how to deploy the public interest criterion in consent waivers for health data and tissue research

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
G. Owen Schaefer ◽  
Graeme Laurie ◽  
Sumytra Menon ◽  
Alastair V. Campbell ◽  
Teck Chuan Voo
Keyword(s):  
Public Interest ◽  
Health Data ◽  
The Public ◽  
Tissue Research

scholarly journals Some changes in the field of civil law

2006 ◽  
Vol 78 (9) ◽  
pp. 395-412
Author(s):  
Dušan Nikolić
Keyword(s):  
Separation Of Powers ◽  
Civil Law ◽  
Social Value ◽  
European Court Of Justice ◽  
The Other ◽  
The European Union ◽  
The Public ◽  
Public Benefit ◽  
Court Of Justice ◽  
European Court

In the first part of the paper, the author has outlined some changes that have happened in the field of civil law during the history, and in the second part of the paper, the author has paid attention to the modern trends, produced by the process of globalization. By analyzing certain sectors, the author has come to the conclusion that ownership title and public office are being slightly shifted from state to non-state authorities. On the other hand, this trend of the global (re)privatization has contributed to the change of attitude toward the title. The owner is expected to ewoy his title both for his own and for the public benefit. One of the most recent judgments of the European Court of Justice speaks in favor of this and it has been mentioned in this paper. This judgment supports the view that the property is not absolute and that it has a social value. The special attention is paid to the so called new institutionalism and need to question the concept of separation of powers within the European Union.

scholarly journals Democratic Information Communities

2018 ◽  
Author(s):  
Peter M. Shane
Keyword(s):  
Problem Solving ◽  
Public Interest ◽  
Local Communities ◽  
Political Liberty ◽  
Media Environment ◽  
The Public ◽  
For Profit ◽  
Organization Analysis ◽  
Media Power ◽  
Flow Of Information

In order that American communities may thrive in a 21st century democratic context, both individuals and organizations across the private, public, and nonprofit sectors must intentionally dedicate themselves to promoting an inclusive flow of information designed to support collective problem-solving, the coordination of community activity, public accountability, and connectedness within the community. Our national commitment to democracy – to ideals of political liberty and equality – means not only that local communities need information adequate for these purposes, but that our practices of information creation, organization, analysis, and transmission be democratic in character. This creates a special community need for good journalism, for a for-profit media environment attentive to issues of access, diversity, relevance, and media power, and for nonprofit institutions that develop and organize information in the public interest that assist communities by actively facilitating democratic conversation for community agenda-setting, problem-solving and conflict resolution. Communities that pursue these aims should be considered “democratic information communities.”

scholarly journals Between consensus and the “tax agreement” provided for in the draft of the Tax Ordinance of June 4, 2019

2019 ◽  
Vol 29 ◽  
pp. 47-62
Author(s):  
Maria Tsima
Keyword(s):  
Public Interest ◽  
Present Author ◽  
Tax Law ◽  
Optimal Dimension ◽  
The Public ◽  
Legal Structure ◽  
Consumer Contracts ◽  
Normative Basis ◽  
The Relationship ◽  
Contractual Agreement

A change in the perception of the relationship between the tax debtor and the tax creditor is necessary. The regulation of non-governing forms of operation of tax authorities is the normative basis that determines the change in the way in which tax matters are dealt with. This article reviews the proposal for consensual resolution of disputes contained in the draft of the Tax Ordinance of March 8, 2019. In this draft, a chapter entitled “Tax agreement” was included, which is devoted entirely to the structure of the tax agreement. However, to what extent does the outlined legal structure of the tax agreement make it possible to create a negotiating space between the taxpayer and the tax authority? The consensuality that the parties strive for should foster the pursuit of the private interest in the optimal dimension and, at the same time, should not affect the public interest. This is possible. In this way, the equality of parties manifests itself in the framework of consumer contracts where the entrepreneur’s party is stronger or on the level of repressive law for example, in criminal law — where, as indicated, the consensual way of settling the matter should not disqualify the aspiration to equalize the position of all participants of this consensus. The position defended by the present author is that obtaining a contractual agreement in tax law based on a consensus assuming the parity of parties does not exclude the possibility of pursuing a fiscal interest.Między konsensusem a „umową podatkową” przewidzianą projektem Ordynacji Podatkowej z dnia 4 czerwca 2019 rokuKonieczna jest zmiana postrzegania relacji dłużnik podatkowy–wierzyciel podatkowy. Regulacja niewładczych form działania organów podatkowych stanowi bowiem podstawę normatywną warunkującą przeprowadzenie zmiany sposobu załatwiania spraw podatkowych. W artykule analizie poddano propozycję konsensualnego rozwiązywania sporów podatkowych zawartą w projekcie Ordynacji podatkowej z 8 marca 2019 roku. W projekcie tym ujęto rozdział poświęcony w całości konstrukcji umowy podatkowej. Na ile jednak zarysowana konstrukcja prawna umowy podatkowej umożliwia zaistnienie przestrzeni negocjacyjnej między podatnikiem a organem podatkowym? Warto, by konsensualność, do której dążyłyby strony takiej umowy, sprzyjała realizacji interesu prywatnego w wymiarze optymalnym i jednocześnie nie godziła w interes publiczny. Jest to możliwe. W taki sposób równość stron przejawia się w ramach umów konsumenckich w których strona przedsiębiorcy jest wyjściowo stroną silniejszą czy na płaszczyźnie prawa represyjnego przykładowo w prawie karnym — gdzie jak się wskazuje, konsensualny sposób załatwienia sprawy nie powinien dyskwalifikować dążenia do zrównywania pozycji wszystkich uczestników tego konsensu. Autorka niniejszego artykułu broni stanowiska, że uzyskanie w podatkach umownego uzgodnienia na podstawie konsensusu zakładającego równorzędność stron nie wyklucza możliwości realizacji interesu fiskalnego.

scholarly journals Digital health and digital information in the context of big data. An ethical insight on interests

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Mirchev ◽  
A Kerekovska
Keyword(s):  
Public Interest ◽  
Digital Health ◽  
Scientific Progress ◽  
Personal Data ◽  
Health Data ◽  
Individual Responsibility ◽  
Digital Information ◽  
The Public ◽  
Rational Argumentation ◽  
The Individual

Abstract Background Health data is the key link between the prospects we face in improving health services and the context of current information reality. In the field of public health, the sheer scale of data collecting, digitalization and use is already raising questions related to the ethical norms among different stakeholders. The fact that it is personal data at stake, confronts at least two views: the individual versus the public interest. The more we ease the process of health data aggregation and use, the more risks of possible harms we face. So, whose interest is a priority? Aim To consider if it is possible to balance the conflicting interests of individuals and society in the digital health era by advocating for mutual compromises and rational argumentation. Methods Ethical, documental and historical research. Results The amount of digital health related personal data transforms both opportunities for improved healthcare and research, and possible uncertainties related to improper use, harms, abuses, injustice. This nourishes individuals' doubts and potentially restricts the public interest by putting limits on future use of data. A balance between the confronting interests is needed. Granting ownership rights over data requires entirely new legal frame, since property rights hardly encompass the unique nature of information. Moreover, data is a valuable artefact, and ownership could provoke further commercialization. On the other hand, it is virtually impossible to put a separating line between commercial and ideal use of health data for care improvements and science. Our focus should be on the ideal use and essentially on insuring individual's privacy and confidentiality, but not at the expense of public benefits and scientific progress. Conclusions Health information is a powerful tool, and its utilization suggests compromises, which are possible if rational argumentation and support is provided to individuals with the aim to overcome the existing discrepancies. Key messages The appearance of digital health fully represents the dynamic information reality in which constructing a balance between different stakeholder’s interests is vital and not impossible to achieve. Healthcare prospects depend on our individual responsibility and willing to share as we have the data and the means to use and secure it, and we have the duty to do it.

scholarly journals Guarding a Cultural Icon: Concurrent Intellectual Property Regimes and the Perpetual Protection of Anne of Green Gables in Canada

2011 ◽  
Vol 56 (4) ◽  
pp. 1011-1055 ◽  
Author(s):  
Andrea Slane
Keyword(s):  
Intellectual Property ◽  
Public Interest ◽  
Public Domain ◽  
The Other ◽  
Property Law ◽  
Cultural Significance ◽  
The Public ◽  
Public Benefit ◽  
Anne Of Green Gables ◽  
Property Regimes

This article uses the various intellectual property protections afforded to the classic children’s novel Anne of Green Gables as a means of illustrating the blurring between copyright, trademark, and official marks regimes in Canada. By not keeping these regimes distinct, the author argues, Canadian intellectual property law seriously threatens the integrity of the public domain, a central means by which an appropriate balance is struck between the interests of authors, other cultural producers, and the public at large. The blurring between regimes is located in three conceptual sites: origin in copyright versus source in trademark; reputation in copyright versus goodwill in trademark; and the weak requirement that a public authority serve a "public benefit" in order to qualify for official marks protection, without any consideration of the public interest served by the limitations on protections built into the other intellectual property regimes. Reinforcing the distinctions between regimes and clarifying the public benefit requirement for official marks would help protect the public domain from unjustified encroachments that potentially deprive us of access to creative works of shared cultural significance.

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