Individual-Level Health Data Ownership, Data Sharing, and Data Governance | BMC Medical Ethics

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There are two main ethical arguments in favor of the PP: the first uses the utilitarian calculation of possible benefits, while the other refers to the principle of autonomy. However, both are doubtful, and the whole model faces more challenges, as demonstrated in the coming sections.

The first public good and utilitarian computing argument is that data privatization creates incentives for efficient data use. Proponents of this option offer a ready-made solution [6,7,8,9]. If individuals, as rational, economic creatures, and private companies driven by profit-making have the opportunity to make money from data, they will. In this case, the invisible hand of the market would contribute to the development of science and public health: individuals and companies will aim to generate profits and the creation of scientific knowledge will be a by-product. Ownership of private data is then a key consideration, because when no one can benefit from the data, it goes unused. Health data comes from an encounter between an individual patient or research participant and a health care provider or researcher [6]. Both have interests in the data obtained from this encounter. An intermediary, for example an independent data bank responsible for collecting individual data, ensuring informed consent and confidentiality rules, can make the data work for the patient and for the greater good. [6]. Such an institution would profit from the sale of access to the data and would share the benefits between the three parties concerned: the patient, the health researcher/institution and itself. It would also help control access to health information at the individual level in the long term. [6,7,8,9].

The second argument is that ownership is an effective tool for exercising autonomy and protecting privacy. This means that an individual can only sell or give their data to a party of their choice. The individual also has the right not to sell or give away their data at all. However, there are a few issues with the PP which are discussed in the following sections.

Justice and privatization

The PP does not provide a reliable instrument for balancing individual and public health interests. Proponents of the PP argue that the privatization of health data at the individual level will create a circle of supply and demand for data, and thus the invisible hand of the market will do the rest: researchers will get the data, and individuals and means – men will get their money. The problem is that market demands are not always in line with public health needs and the demands of justice. The invisible hand of the market cannot be the only instrument to solve these problems. For example, vulnerable populations might be underrepresented in private databases, due to medical illiteracy or lack of contact with health services. Additionally, some rare conditions would require the pooling of data from different parts of the world without the promise of sufficient revenue for private companies. [15].

Furthermore, data privatization would create additional financial barriers to data sharing, instead of creating incentives. Secondary data users such as research institutes would have to pay additional fees to access the data. Meanwhile, it can be argued that sharing data for the development of science and health care could be seen as contributing to the public good. [16]. In rich states, which allow their citizens access to health care, everyone benefits from advances in the health sciences and it is almost impossible to exclude anyone from the benefit of this good. Industrialized countries build scientific infrastructure and society as a whole invests in health sciences. Even private companies use public funds and public infrastructure to conduct their studies. The principle of justice requires solidarity and reciprocity. This implies that while one enjoys the result of scientific progress, one is also obliged to show reciprocity and solidarity with those whom science has not yet benefited. One way to reciprocate the benefits of progress is to contribute to the development of science by making health data at the individual level available for research. Therefore, we can justify the provision of anonymized health data at the individual level with reference to justice, and the privatization of data would violate the principle of justice in this sense. However, it can be said that the arguments referring to reciprocity and justice do not question private property as such, but rather emphasize the moral obligation to make one’s data accessible. As discussed in Sec. 4.4, relying on volunteers in data research is not sufficient to collect representative data.

Autonomy and privatization

Barbara Evans points out that those claiming their proprietary rights to data seem to expect those rights to have absolute status and that in any circumstance they can refuse to provide access to their property. [2]. This is not true, as in many jurisdictions a state has the power to access private property or even take it away. Given that governments have appropriation power guided by social interests, there is no reason to assume that an existing legal framework protects privacy less than a future property law would. [2]. In a hypothetical situation where the data belongs to individuals who do not wish to share it for research conducted in the public interest, that data, in theory, can be legally taken by a government or its agencies. The rationale and extent of this data collection would resemble a situation that may occur under applicable regulations. However, Evan’s argument only refers to a situation where a government is interested in health data at the individual level, and it does not involve a case.

Additionally, if a patient or participant needs complete control over their data, the private property The model requires an intermediary datastore that only leases access to its data. Otherwise, when the data is sold, she has no control over it once sold, the data can be resold to other parties. It therefore seems that despite private property individual control is not absolute vis-à-vis government ownership and requires robust third-party databases in order to maintain control over one’s data.

Risk and privatization

The private property poses problems for embedded research. We have defined “integrated research” as research that acquires data in the process of healthcare delivery, for example by capturing data from patient EHRs, and then analyzes the data with the aim of improving future care. This closed cycle of data collection, analysis and improvement of care is the essence of the LHS [17]. An important feature of LHS is to identify top performers and copy their best practices [17]. To do this, all the health data at the individual level of all the institutions of the health system are necessary.

The main objective of the private property model is to give the right to control data to individuals, not to institutions. This means that a person has the right to give or sell their data to their own health care provider or to third parties, for example other institutions or data banks. Without a comprehensive data set, integrated research cannot be conducted appropriately and the wrong conclusions can be drawn about a vendor’s performance. Additionally, these erroneous conclusions, if negative, can lead to reputational risks and loss of patient trust in their health care provider.

Therefore, a more flexible approach is needed. A data governance model can prevent this problem and provides reasonable ways to prevent reputational risks for institutional healthcare providers.

Practical, conceptual and privatization issues

There are other questions about what private property model would look like in practice. If the private property actually limits access to health data at the individual level in a health system, so from a scientific and methodological point of view, epidemiological and public health research, for which informed consent is generally suppressed, could be blocked, because it would not allow researchers to collect representative samples of participants and their research would lack statistical relevance. Opt-in studies have been proven to be unrepresentative and create biased samples [18].

Moreover, there is an economic problem, although we recognize that we have no empirical data, hence the arguments on both sides are speculative. Proponents of the PP argue that private ownership of data does not preclude research based on health data at the individual level. On the contrary, they argue that private ownership will boost research and the economy [6,7,8,9]. The plan is simple: individuals can sell the rights to use their data to an intermediary, a private health information bank, which will then sell the data to researchers. And yet, is it a viable solution from an economic point of view? The argument is that this solution does not necessarily generate sufficient economic gain to cover all the costs. It presents itself as economically self-sufficient, which does not need the government financial incentives that usually accompany government paternalism. Evans argues that investing in data infrastructure and data retention can be economically unsustainable [2]. We can assume that even if this solution is feasible from an economic point of view, the ramifications seem to include increased fees for researchers, which should cover data preparation costs, infrastructure maintenance and revenue. intermediaries and data owners, and therefore higher research costs for society as a whole.

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