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INNOSC Theranostics and
Pharmacological Sciences AI in medical device safety

development, approval, and oversight of AI technologies through advanced data collection, real-time monitoring,
and medical devices in the European Union. 58 and proactive risk detection. However, the implementation
Nowadays, AI is increasingly being incorporated into of AI in health care comes with significant challenges,
medical devices. In Japan, the “Improvement Design within including ethical concerns, regulatory requirements, and
Approval for Timely Evaluation and Notice” (IDATEN) technological limitations. Addressing these challenges
system was introduced in September 2020 to streamline necessitates a comprehensive approach, guided by
the approval process for medical devices, particularly collaborative efforts among technologists, medical
Software as a Medical Device (SaMD) that utilizes AI. professionals, regulators, and ethicists. To maximize AI’s
Conventionally, any modifications to approved medical benefits, the health-care industry must prioritize ongoing
devices require a comprehensive review, which could be research, robust regulations, professional training, and
time-consuming. The IDATEN system allows for partial a human-centered approach that complements clinical
modifications to be approved more swiftly, facilitating expertise. This coordinated strategy will ensure that
continuous improvements throughout a product’s lifecycle. AI-driven materiovigilance enhances, rather than replaces,
This feature is particularly advantageous for AI-based human judgment, ultimately advancing health-care safety
SaMD, which may require frequent updates to enhance and efficacy.
performance. 59
Acknowledgments
The full potential of AI in health-care requires
addressing four key ethical issues: algorithmic biases and None.
fairness, safety and transparency, consent to use data Funding
55
with patient information, and data privacy. One major
concern with AI-enabled materiovigilance systems is legal None.
accountability. As these systems become more autonomous,
the question of who is responsible for errors or regulatory Conflict of interest
violations becomes more complex. The challenges AI poses The authors declare they have no competing interests.
in monitoring medical devices may require modifications
to current legal frameworks, including data protection laws Author contributions
and liability statutes. In addition, materiovigilance must Conceptualization: Shubhima Grover
60
adhere to ethical guidelines that prioritize transparency, Visualization: Hara Prasad Mishra, Shubhima Grover
fairness, and the protection of patient privacy when Writing–original draft: Kevil Loriya, Nupur Shah, Hara
utilizing AI. 61,62
Prasad Mishra
A comprehensive strategy is essential for addressing Writing–review & editing: All authors
these complex issues effectively. This strategy should
involve the development of explicit regulatory guidelines, Ethics approval and consent to participate
the enhancement of transparency programs, and the Not applicable.
establishment of accountability frameworks. 27,58 To
ensure responsible AI application in materiovigilance, Consent for publication
ethicists, policymakers, technology developers, and legal
professionals must collaborate closely. Furthermore, Not applicable.
63
ongoing research and open dialog are essential for Availability of data
staying up to date with emerging ethical concerns
and ensuring the ethical use of AI technologies in Not applicable.
materiovigilance. 54,64 By fostering a balanced framework
that prioritizes patient safety, privacy rights, and ethical AI References
development, stakeholders can maximize the benefits of 1. Meher BR. Materiovigilance: An Indian perspective. Perspect
AI in materiovigilance while reducing potential risks and Clin Res. 2018;9(4):175-178.
maintaining public trust in the health-care system. 61,62,65 doi: 10.4103/picr.PICR_26_18

6. Conclusion: The future of AI in health- 2. Raju N, Deivigarajan S, Santhakumar S, Balamurugan S.
care vigilance Knowledge, attitude and practice of materiovigilance among
nurses and healthcare technicians in a tertiary care hospital:
AI has the potential to revolutionize health care, particularly A questionnaire-based survey. Open Access Res J Biol Pharm.
materiovigilance, by improving patient safety and outcomes 2023;9(1):38-44.

Volume 8 Issue 3 (2025) 8 doi: 10.36922/itps.6204