[Contribution] Challenges in legal and ethical aspects of AI and IoT-based medical devices
Contributors and Pharmacy Newspaper 「We planned a series related to medical devices.. In this contribution AI and IoT Ethics of basic medical devices, Let’s take a look at regulatory challenges. 1. A new paradigm for medical devicesChatGPTrepresented by AI While the craze is spreading across society,, Artificial intelligence in the medical field(AI)and Internet of Things(IoT) Technology is being adopted quickly. Learned video data AI software is cancer∙Early detection of major diseases such as cardiovascular disease, IoT Patient's electrocardiogram via wearable device, blood sugar, sleep patterns 24The sight of time monitoring is no longer unfamiliar..However, these innovative changes are also accompanied by legal and ethical challenges.. "AIWho is responsible if the diagnosis made by?", "IoT How safe is the patient data collected through the device??" Questions such as these have now become an unavoidable reality.. 2. AI·IoT Characteristics of medical devices – Products that are difficult to regulate under the existing regulatory systemAI Algorithm's learning ability: Once an existing medical device receives approval, its structure and performance are fixed.. however AI·IoT The devices have fundamentally different characteristics. in other words AI The performance of the algorithm is updated as the learning data increases., Sometimes the forecasting method itself can change. frequent updates: Software patching through the above learning, Dataset replacement, Cloud updates, etc. are made and accordingly, AI Medical devices change frequently. For existing medical devices, there are almost no changes to the approval requirements after approval., Existing medical device laws are enacted to suit these characteristics.. however AI Medical devices can be difficult to regulate under existing approval systems due to frequent updates.. IoT The ambivalence of connectivity: Remote monitoring and cloud linkage are possible through continuous network connection, and the resulting convenience is considerable., As a reaction, security risks also increase.. existing medical laws-Existence of areas that are difficult to regulate through the medical device law system: With existing medical devices, the doctor is the subject of the final diagnosis, so the doctor has ultimate responsibility.. However, you can make your own judgment based on the learning data. AI For software, As medical devices can even perform diagnostics, it may become unclear who holds ultimate legal responsibility..These characteristics are AI·IoT These are factors that make regulating medical devices difficult., Accordingly, various legal, There are ethical issues involved. 3. ethical challenge – Issues of patient rights and responsibilities. Lack of transparency in the decision-making processAIThe decision-making process of 'black box'close to. In fact, research is still ongoing. ChatGPTIt is said that it is difficult for humans to explain the thought process of. in other words, AIThis means that it is difficult for us to fully understand the way of thinking of.patients and medical staff AII received a diagnosis from, It is difficult to know how the results were derived.. As a result, the patient's right to self-determination is violated or, Problems may arise where legal responsibility becomes unclear.. me. Unclear responsibilityAI The following entities are involved in diagnostic activities using medical devices:, The distribution of responsibilities between them is still unclear.• medical staff: The doctor who made the final diagnosis and treatment decision• manufacturing company: Medical device company that designed the algorithm• hospital: The organization that introduced the device and used it on the patient. Privacy and Security RisksIoT The risk of hacking inevitably follows the process of real-time data transmission through devices.. patient's electrocardiogram, When sensitive health information such as blood sugar records is leaked to the outside world, The patient's personal rights can be seriously violated..In addition, by using patients’ health information, AI Training diagnostic software, As far as the contributor understands, consent for the use of personal information has not yet been properly obtained. 'AI learning'I know that there are many cases where. Although it has not been an issue yet, In this regard, the issue of personal information infringement may also arise.. 4. Regulatory challengesIn the case of Korea 「Medical Device Act」and recently enacted 「Digital Medical Products Act」via software medical devices(SaMD)It regulates, The regulatory sandbox system is used to provide temporary permission and verification of new technologies.. but, AI algorithmic 'continuous learning'Specific regulations or previously mentioned responsibilities, Specific regulations on personal information protection issues are lacking..USA(FDA)silver AI/ML SaMD Related guidelines, etc. are disclosed on the website.. European Union(EU)The main feature of regulation is the dual regulatory approach.. European Medicines Agency(European Medicines Agency, EMA)This medical device regulation(Medical Device Regulation, MDR) and Artificial Intelligence Act(Artificial Intelligence Act, AIA)according to AI Manage basic medical devices.MDRsilver AI Design of medical devices, including basic medical devices, development, sets out requirements for clinical evaluation and post-marketing surveillance;, AIAis a risk-based classification, transparency, Defines human supervision requirements, etc..medical treatmentAI The company is USA, When entering the European market, you must meet strict standards to enter the market, so you need to prepare for this.. Additionally, domestic regulations are still being established., It seems necessary to prepare in advance for regulations that will become stricter.. 5. conclusionAI·IoT Based medical devices are already revolutionizing the lives of patients., It is clear that this trend will accelerate further.. However, the problem is that there is still a large gap between the speed of technological development and the speed of development of legal and ethical systems.. especially, The ethics discussed earlier, The reality is that no one can clearly explain how to deal with legal problems.. Medical device innovation is sustainable only when patient safety and rights are guaranteed, so ethical practices that ensure this are possible., Regulatory discussions are urgently needed.. Therefore, regulators, industry, medical staff, The contributor believes that a forum for discussion in which the legal community participates is needed..one side, big flow AI·IoT It is clear that government regulations related to medical devices will be strengthened.. Some regulations may require considerable technical difficulty., I think there is a need for related industries to prepare proactively for this.. Contributor: Attorney Lee Il-hyung(ilhyunglee@naver.com)lawyer/chemist/patent attorney/american accountant(Maine)pass the exam(前)Attorney at Celltrion Domestic Legal Team(現)law firm(finite) Daeryun Medical Pharmaceutical Group/Director of Pharmaceutical Bio Healthcare Center [View full article]
[Contribution] Challenges in legal and ethical aspects of AI and IoT-based medical devices