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Risk areas associated with the use of new technologies to which children are exposed during medical procedures


The effects of the 19th-century Industrial Revolution impacted everyone. According to N. Davies: “As never before, 19th-century Europe pulsed with power - technical, economic, cultural, intercontinental”. At the same time, Davies continues: “Among the losers and victims (of the Industrial Revolution – ZW) were all individuals and all nations that either could not adapt or were unable to compete - peasants, artisans/weavers, the urban poor; peoples living in the colonies; the Irish, Sicilians, and Poles (…)[1]”.

Now, we find ourselves at the very epicenter of yet another revolution, this time a technological one. Every day we hear about new opportunities brought by progress, including those related to the development of artificial intelligence (AI) algorithms. In 2024, the Nobel Prize in Physics was awarded jointly to American John J. Hopfield (Princeton University) and British-Canadian scientist Geoffrey E. Hinton (University of Toronto) for “fundamental discoveries and inventions enabling machine learning through artificial neural networks”, thus contributing to the advancement of AI.

But, just like in the 19th century, will this new revolution, also affecting everyone, once again create winners and losers? This question is justified, although we are theoretically capable of preventing such an outcome, being equipped with the lessons of the past. In practice, however, it would require a global consensus among key powers, and unfortunately, that seems unlikely. Legal regulations concerning AI are developing inconsistently across the globe. Although Europe is not a leader in terms of the number of AI-supported inventions, it undoubtedly holds the leading position when it comes to legal regulations surrounding artificial intelligence. It is even difficult to pinpoint whether the Council of Europe or the European Union is more advanced in the process of creating a legal framework for AI.

Listing all the benefits that technological development brings is likely impossible within the constraints of a limited-length paper. The same could be said about the risks that AI entails. Nonetheless, there are areas of our daily lives that can significantly benefit users of new technologies. One such area is undoubtedly the broad field of healthcare, which includes not only the creation of new medicinal products and medical devices but also the healthcare system itself. Users of the healthcare system are referred to as patients, and although Polish law defines a patient in the Act on Patients' Rights and the Ombudsman for Patients' Rights in Article 3(1)(4) as a person seeking or receiving healthcare services from an entity providing such services or from a medical professional, it is clear that this definition refers exclusively to a specific segment of healthcare - namely, healthcare services.

Furthermore, when defining a patient, the legislator does not distinguish between groups of patients, who may require special support. However, the Constitution of the Republic of Poland does make such distinctions. According to Article 68(1), “Everyone has the right to health protection”. Moreover, under paragraph 3 of the same article, “Public authorities are obliged to ensure special healthcare for children, pregnant women, persons with disabilities, and the elderly”. One must agree with A. Malarewicz-Jakubów that “A child is a human being who demands appropriate conditions for their full development. A child is a being with particular needs and therefore requires treatment from adults that meets these needs[2]”.

A similar expression of concern, at least on a verbal declaration level, can be found in the latest European Union legal act on AI, known as the AI Act[3]. In the third sentence of recital 48 of the preamble, it is stated that: “It should be underlined that children enjoy specific rights as enshrined in Article 24 of the Charter and in the UN Convention on the Rights of the Child, further elaborated in General Comment No. 25 on children's rights in the digital environment, contained in the UN Convention on the Rights of the Child, which require the consideration of children's specific vulnerability and the provision of such protection and care as is necessary for their well-being”.

Unfortunately, the level of declarations does not always match actual actions, with a clear example being the EU regulations on medical devices. The system for medicinal products used in pediatrics is regulated by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for pediatric use (...)[4]. However, there are no similar regulations that specifically address medical devices used in pediatrics. Unfortunately, there are very few medical devices available on the market, that are specifically designed for children[5]. Instead, devices intended for adults are often adapted and used off-label in pediatric care[6].

Pediatricians and pediatric surgeons, acting in the best interests of children, take risks by modifying devices for adult patients in a way that meets children's needs. Unfortunately, medical devices intended for adults and used in children often lack confirmation that they are safe for the youngest patients[7]. Additionally, medical devices that require active participation from the patient may be beyond the capabilities of younger children. It must be emphasized that there is no separate certification system for medical devices intended for children within the European Union. However, children differ from adults in many ways, including physiological, neurodevelopmental, and epidemiological aspects. Their disease processes, even if nominally the same as in adults, often manifest differently and may require distinct diagnostic and treatment approaches. Designers and manufacturers of medical devices must take into account various factors, such as the unstoppable or unrelenting developmental progress of pediatric patients, which can significantly affect the size, function, and structure of a given device[8].

Europe ranks second after the United States in the global pediatric healthcare market. Despite the fact that this market was valued at approximately USD 11.881 billion in 2018 and is projected to generate around USD 15.984 billion by 2025[9], the medical device sector has been dominated by the development of products for adults[10]. The most commonly cited reasons for the lower interest of manufacturers in pediatric medical devices include: engineering challenges (smaller size requires greater precision), identical regulations for medical devices for both children and adults (the difficulty of conducting trials on a small number of patients from a heterogeneous population), and the lack of financial incentives from payers (pediatric care does not involve potential voters).

In conclusion, it should be reiterated that under current EU regulations, medical devices intended for children, including AI-assisted devices, must meet the same requirements as those intended for adults. In contrast to EU regulations, the U.S. Food and Drug Administration (FDA) has issued many guidelines in recent years concerning the pediatric evaluation of medical devices[11]. While support for pediatric medical devices takes place at the national project level in many countries[12], it would be beneficial for this to become a pan-European initiative. Using medical devices, including AI-assisted devices designed for adults but used on children, can pose a risk of harm. A priority should be to initiate legislative work on regulations concerning pediatric medical devices, similar to those governing pediatric medicinal products. Regulatory (shortened market approval processes, extended protection periods for patent-protected products) and financial incentives are necessary, especially when the devices are intended for pediatric patients suffering from rare diseases.

 


[1] N. Davies, Europa, Kraków 2002, p. 807.

[2] A. Malarewicz-Jakubów, Dziecko jako pacjent (in:) Wybrane prawne i medyczne problemy ginekologii dziecięcej, ed. E. M. Guzik-Makaruk, V. Skrzypulec-Plinta, J. Szamatowicz, Białystok 2015, p. 61.

[3] Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 on laying down harmonized rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144, and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act).

[4] Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC, and Regulation (EC) No 726/2004.

[5] In 2018, the FDA informed Congress that new medical devices intended for children represented only one-quarter of all medical devices designed, evaluated, and approved (J. Espinoza, P. Shah, G. Nagendra, Y. Bar-Cohen, F. Richmond, Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities, “Pediatrics” (2022) 149 (5), https://doi.org/10.1542/peds.2021-053390)

[6] Ibidem.

[8] J. Espinoza, P. Shah, G. Nagendra, Y. Bar-Cohen, F. Richmond, op.cit.

[9] J. Espinoza, P. Shah, G. Nagendra, Y. Bar-Cohen, F. Richmond, op.cit.

[10] P. Dimitri et. al., Medical Device Development for Children and Young People-Reviewing the Challenges and Opportunities, “Pharmaceutics”, 2021 Dec 17;13(12):217, doi: 10.3390/pharmaceutics13122178.

[12] Few examples: Small Patients, big need—medical-technical solutions for a healthcare appropriate for children (Germany), Technology Innovation Transforming Child Health (UK), Children and Young People MedTech Cooperative (UK), National Clinical Trials Network and the Pediatric Medical Devices Public-Private Partnership (USA), Pediatric Device Consortia (USA).

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