Team:Pasteur Paris/law ethics
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Ethics
An Ecological device
The World Health Organization (WHO) noted that in 2018, "85% of health care waste is comparable to household waste and is not hazardous. The remaining 15% are considered dangerous and may be infectious, toxic or radioactive." In addition, in 2012, hospitals produced about 700,000 tons of waste per year, or more than one ton per bed and spot [1]. Very conscious and concerned about these facts, we were careful to design our device to be respectful of this ethical and environmental issue. Indeed, its re-usablility would significantly reduce waste production, which is a strong advantage over single-use detection tests. The WHO has also published a valuable document on waste management that could guide waste management in the least equipped environments. (document: Safe management of wastes from health-care activities,[2])
A reliable device
Since our device will accommodate organic samples that may be infectious, we are aware that simple disinfection will not be sufficient. It will therefore have to undergo strict sterilization procedures to ensure that all microorganisms, including spores, will be eliminated. Similarly, sterilization is a necessary step to ensure that a sample doesn’t contaminate the next: improper cleaning of our device could lead to a risk of false positives, and reduce the reliability of the results.
To minimize this risk, we have decided to provide for specific sterilization by :
1. Washing the device with two liquids (concentrated salt water for lysing bacteria and a buffer solution to purge the system and leave the electrodes in a neutral environment that will not degrade them)
2. Use a specific material, Peek, which reduces the risk of bacteria sticking to the walls of the system
A device designed for humans
Equal treatment or the equity principle in access to care is an essential criterion of social justice. Although we are aware that it is impossible to ever achieve full equality, we believe that we can act on the causes and effects of social inequality. In this sense, achieving equality in health is a social choice in principle. Let's note here that the Act of 4 March 2002 on the rights of sick persons and the quality of the health system, known as the "Kouchner Act", reaffirms the right to health protection as a right of constitutional value, recognized by paragraph 11 of the Preamble to the 1946 French Constitution [3]. This right has been enshrined in several decisions of the Constitutional Council (in particular, CC, 23 July 1999, No. 99-416). The right to health protection is also guaranteed by international instruments ratified by France. This right is also directly protected by the Charter of the World Health Organization of 27 July 1946[4]. Finally, Act No. 2002-303 of 4 March 2002 on patients' rights and the quality of the health system incorporates article L. 1110-3 into the Public Health Code, which stipulates that no person may be discriminated against access to prevention or care. [5]
In practice, we have opted for the portability of the device so that it can improve
access to treatment. Thanks to its portable nature, our device could indeed
benefit a more global population in practice since it would allow faster access to
offshore care. We would not be constrained by a hospital surface.
This could be particularly valuable:
1. In a humanitarian context, where there may be problems of cost and time: sick people are sometimes unable to move because they may be too weak or too poor to go to the nearest equipped hospital
2. Regarding interventions in disaster or risk areas: our device could easily be transported by land (ambulance, truck) or by air (helicopter), which would allow us to cover a wider area.
References
[1] https://www.has-sante.fr/upload/docs/application/pdf/2013-07/reduction_dechets_hospi. pdf"
[3] "The Nation shall provide the individual and the family with the conditions necessary for their development. It guarantees health protection, physical safety, rest and recreation for all, including children, mothers and older workers.”
[4] "The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being, regardless of race, religion, political opinion or economic conduct."
[5] https://www.legifrance.gouv.fr/eli/loi/2002/3/4/2002-303/jo/article_3
Law
The technical developments of the 21st century have highlighted several risks for personal data, particularly because of their granularity, exposure and accessibility, combined with the development of new techniques. The rise of digital technology is leading to major changes in the health sector. This raises the question of the protection of personal data in the age of open data and big data in health. Recently, the GDPR has revolutionized the data protection framework, creating a more protective legal framework, imposing a new accountability system and strengthening individual rights and key data protection principles. This protection has increased for sensitive data, particularly health data that tells our history and all that characterizes us.
"Individual and collective empowerment on health data must be achieved in terms of protection, control and mobilization through new uses". [1]
The GDPR tends to become a model for the world on data protection in a context of volatile data and disparate legislation. The conception of privacy and personal data is very different in Europe and the United States. The United States consider personal data as commercial goods. However, they are regularly threatened. According to a study published in 2016 by the Ponemon Institute, criminal attacks have increased by 125% since 2010 and are now the leading cause of security breaches of healthcare data. [2]
Comparison of the European (RGPD) and American (HIPAA) texts on the protection of personal data
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Thus, in response to these developments our society faces today, we have taken an interest in the protection of health data derived from hospital care. For more information you can read our essay on the subject :
References
[1]Rapport, Conseil National du Numérique, « La Santé, bien commun de la société numérique », October 2015
[2] Stéphane Grynwajc – RGPD v. HIPAA : comparatif des approches US et EU en matière de protection des données de santé, 3rd, 2018.