Shift in data ownership

The involvement of many stakeholders – patients, medical professionals, pharmaceutical companies and regulators – has led to the collection of health data becoming a complex process. To enable a transparent system that does not undermine patient safety, we must investigate the legal issues that come with it. 

Potential legal issues arise with the use of health data by patients themselves

According to the principle of “market-inalienability of the human body”, the body – except for hair and nails – is subject to restrictions on transferability, ownership, or use. For instance, blood and organ donation cannot give rise to any remuneration, direct or indirect, in France or in Singapore. Underlying this principle, there is a fear of the possible dangers of instrumentalisation and exploitation of persons and their bodies. It is a protection mechanism that places the body outside the realm of objects and property entitlement. 

Even if the notion of health data has mostly been addressed through the data privacy angle, it may also be considered as an emanation of the personality and, therefore, protected by the principle of “market-inalienability of the human body”. However, contrary to the body, health data is usually not vital, nor material and a unique regime applicable to both the human body and health data might be subject to debates. Furthermore, health data is already being used by industries and various stakeholders to create value without the patients themselves taking any advantage of this value. There is a fundamental ethical and legal question around the option for patients to value their own health data and benefit from it. 

Having acknowledged the value of health data, various jurisdictions may take different views on how to regulate its value. In a global economy, there is a clear need to define and determine how such data should be regulated and valued. An international convention on health data could be a great instrument to provide a common legal framework empowering individual and to create a patient-centric model to share health data. 

The use of new technologies and the creation of new economic and legal models

Two platforms, Ocean Protocol and Embleema have already created a new collaborative model for data sharing which gives patients control over their data and rewards them for sharing it – in a transparent, secure and controlled environment – with pharmaceutical companies and researchers. Available data on the marketplace can be used as training sets to train AI algorithms and improve the performance of clinical trials. More individual patients may be able to store and control access to their medical data and make it visible to trial recruiters using AI and blockchain. 

This new economic model raises the question of the right to use the data: how is everyone involved in the value chain compensated for their contribution to the clinical trials data, and what is the basis of their reward? Various legal models could be envisaged: 

  • Joint ownership. This concept was created in the context of intellectual property and corresponds to the situation where various persons participated in the creation of a joint work have rights to the work. The persons shall contribute to common creative work. 
  • Composite work. This concept was also created to grant intellectual property rights on a new work which is incorporated into a pre-existing work. It is characterised by the lack of participation of the first author to the new work. 
  • Collective work. This apprehends the right to a work created by several persons but merged on the whole, without being able to attribute to each of them a separate right to the ensemble. 
  • Fractional ownership. A key manifestation of this notion is the tenancy-in-common in common-law countries, where each owner has percentage ownership in an asset. 
  • License. A license agreement is an agreement giving someone permission to use something. The licensor gives permission to use their right over an asset to the licensee. In exchange, the licensee pays royalties to the licensor for the right to sell the product or use the right. 

Various actors are involved in clinical research via new technologies: 

  • Raw health data. To conduct clinical trials, raw health data from individuals is obviously necessary. Without the patients’ data, clinical research cannot be performed. The paternity of the data should, therefore, be rewarded. 
  • Data selection. In itself, raw health data is not practicable and involves selection and transformation via AI and/or software, therefore the party who created the algorithm to analyse the data should also benefit from his/her work. 
  • Data interpretation. Researchers are subsequently interpreting and using the data to allow pharma companies to create their products. 

Each actor should be incentivised for getting involved in the research The new economic model can be characterized as truly collaborative via projects such as Ocean Protocol where all the actors of the value chain (i.e., the patients, the searchers, the doctors, the pharma companies, the coders) can be rewarded. Patients’ participation is mandatory to allow the research to be conducted by providing access to raw health data, that might be categorised as the patients’ asset. 

In the light of the various legal concepts analysed, the most accurate notion to translate this new economic model might be a license agreement whereby the patient gives access to his/her health data in exchange for a royalty. The value of participation should be set in the original license agreement and could amount to a fixed fee or a variable fee, depending on the usefulness of the end results. This flexible tool can also allow the patient to manage the confidentiality of the data as well as his/her consent, and the revocability of the latter, by providing dedicated clauses in the licence agreement. 


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