PATIENT IMPLICATIONS OF GLOBAL REGULATORY CHALLENGES IN NEW-AGE TECHNOLOGY BASED MEDICAL DEVICES: A SCOPING REVIEW
Author(s)
Harshada B. Pawar, M.S. Pharm1, Shailee Dewan, M. Pharm1, Elstin Anbu Raj, M. Pharm2, Pradeep Manohar Muragundi, PhD1.
1Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India, 2Center for Evidence-Informed Decision Making, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.
1Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India, 2Center for Evidence-Informed Decision Making, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.
OBJECTIVES: New-age technology based medical devices are revolutionizing patient care, with still inadequate harmonization in the legislative context to address patient safety. This is a scoping review that explores global legislative challenges in patient care.
METHODS: This scoping review was conducted according to the PRISMA-ScR guidelines. An extensive search of four electronic databases, namely Scopus, PubMed, Embase, and Web of Science, was conducted for articles published between 2015 & 2025. The search aimed to identify the regulatory challenges involving new-age technologies in medical devices. A total of 5,390 records were retrieved & imported into the Rayyan. After the exclusion of 1,869 duplicates, 4,225 articles were independently screened for titles & summaries, and full article screening was performed independently by two reviewers. All conflicts were resolved through discussion. 24 full articles were screened for inclusion, of which 17 fulfilled the inclusion criteria. Articles identified and grouped based on the type of mainstream technologies involved, namely AI/ML-based medical devices (n = 11), 3D printed medical devices (n = 5), and IoMT devices (n = 1).
RESULTS: All studies uniformly identified patient risks with direct implications for regulation. For AI based medical devices, black-box algorithms, biases in training datasets, lack of real-world clinical testing, & unclear liability. For 3D-printed medical devices, variability in materials, lack of consistency in manufacturing, & timeliness concerns for patient access. For IoMT devices, patient risks primarily entail cybersecurity threats, such as patient treatment information disclosure, device failures, and loss of service. Across all device platforms, static & non-harmonized regulations impede patient access to beneficial innovations & inaccurately mitigate newly emerging patient safety and security issues.
CONCLUSIONS: New technologies bring many advancements in healthcare, but these also bring complexity in patient safety & trust. Patient-centric, global harmonized regulations with practical, real-world monitoring are required for these new age technology based medical devices.
METHODS: This scoping review was conducted according to the PRISMA-ScR guidelines. An extensive search of four electronic databases, namely Scopus, PubMed, Embase, and Web of Science, was conducted for articles published between 2015 & 2025. The search aimed to identify the regulatory challenges involving new-age technologies in medical devices. A total of 5,390 records were retrieved & imported into the Rayyan. After the exclusion of 1,869 duplicates, 4,225 articles were independently screened for titles & summaries, and full article screening was performed independently by two reviewers. All conflicts were resolved through discussion. 24 full articles were screened for inclusion, of which 17 fulfilled the inclusion criteria. Articles identified and grouped based on the type of mainstream technologies involved, namely AI/ML-based medical devices (n = 11), 3D printed medical devices (n = 5), and IoMT devices (n = 1).
RESULTS: All studies uniformly identified patient risks with direct implications for regulation. For AI based medical devices, black-box algorithms, biases in training datasets, lack of real-world clinical testing, & unclear liability. For 3D-printed medical devices, variability in materials, lack of consistency in manufacturing, & timeliness concerns for patient access. For IoMT devices, patient risks primarily entail cybersecurity threats, such as patient treatment information disclosure, device failures, and loss of service. Across all device platforms, static & non-harmonized regulations impede patient access to beneficial innovations & inaccurately mitigate newly emerging patient safety and security issues.
CONCLUSIONS: New technologies bring many advancements in healthcare, but these also bring complexity in patient safety & trust. Patient-centric, global harmonized regulations with practical, real-world monitoring are required for these new age technology based medical devices.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR24
Topic
Health Policy & Regulatory
Disease
No Additional Disease & Conditions/Specialized Treatment Areas