{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T22:13:35Z","timestamp":1781907215961,"version":"3.54.5"},"reference-count":90,"publisher":"Association for Computing Machinery (ACM)","issue":"2","content-domain":{"domain":["dl.acm.org"],"crossmark-restriction":true},"short-container-title":["ACM Trans. Comput. Healthcare"],"published-print":{"date-parts":[[2026,4,30]]},"abstract":"<jats:p>Navigating the regulatory frameworks that ensure the safety and efficacy of medical devices can be challenging, especially across different regions. These frameworks often require redundant testing, slowing down the process of getting innovations to patients. This study leverages Natural Language Processing (NLP) to analyze 664 regulations and guidelines from the USA, EU, and China over the past decade, covering over 200 million tokens (individual words and sub-word units processed by Bidirectional Encoder Representations from Transformers\u2019s (BERT) tokenizer). We categorize regulations into key phases\u2014such as animal studies, clinical trials, and other testing stages\u2014and use BERT to perform Named Entity Recognition (NER), identifying key regulatory terms and entities. By converting these texts into numerical representations and segmenting them by phase, country, and year, we compare jurisdictional requirements and assess their alignment. Additionally, we apply Latent Dirichlet Allocation (LDA) for theme analysis to observe changes in regulatory focus over time, reflecting evolving priorities and challenges. Our analysis reveals notable semantic similarities and differences between countries and phases. For instance, the closest alignment in animal study regulations is between China and the USA, with a mean cosine distance of 0.33. These findings highlight the computational potential in regulatory science, offering valuable insights for researchers, policymakers, and industry professionals.<\/jats:p>","DOI":"10.1145\/3793533","type":"journal-article","created":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T11:25:28Z","timestamp":1769253928000},"page":"1-34","update-policy":"https:\/\/doi.org\/10.1145\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Transforming Medical Regulations into Numbers: Vectorizing a Decade of Medical Device Regulatory Shifts in the USA, EU, and China"],"prefix":"10.1145","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0527-636X","authenticated-orcid":false,"given":"Yu","family":"Han","sequence":"first","affiliation":[{"name":"Department of Engineering Science, University of Oxford, Oxford, United Kingdom of Great Britain and Northern Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7306-2630","authenticated-orcid":false,"given":"Jeroen H. M.","family":"Bergmann","sequence":"additional","affiliation":[{"name":"Department of Engineering Science, University of Oxford, Oxford, United Kingdom of Great Britain and Northern Ireland and University of Southern Denmark, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"320","published-online":{"date-parts":[[2026,3,17]]},"reference":[{"issue":"5","key":"e_1_3_2_2_2","doi-asserted-by":"crossref","first-page":"420","DOI":"10.1001\/jama.2021.11171","article-title":"FDA regulation and approval of medical devices: 1976\u20132020","volume":"326","author":"Darrow J. J.","year":"2021","unstructured":"J. J. Darrow, J. Avorn, and A. S. Kesselheim. 2021. FDA regulation and approval of medical devices: 1976\u20132020. JAMA 326, 5 (2021), 420\u2013432.","journal-title":"JAMA"},{"key":"e_1_3_2_3_2","unstructured":"Fractyl. 2023. Fractyl Announces FDA Breakthrough Device Designation for Revita DMR in Insulin-Treated Type 2 Diabetes. Businesswire. Retrieved from https:\/\/www.businesswire.com\/news\/home\/20210427005263\/en\/Fractyl-Announces-FDA-Breakthrough-Device-Designation-for-Revita-DMR-in-Insulin-Treated-Type-2-Diabetes"},{"key":"e_1_3_2_4_2","first-page":"e7090","article-title":"How a fake hip showed up failings in European device regulation","volume":"345","author":"Cohen D.","year":"2012","unstructured":"D. Cohen. 2012. How a fake hip showed up failings in European device regulation. BMJ (Clinical Research ed.) 345 (2012), e7090.","journal-title":"BMJ (Clinical Research ed.)"},{"issue":"7","key":"e_1_3_2_5_2","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1080\/17434440.2018.1492376","article-title":"Regulatory convergence of medical devices: A case study using ISO and IEC standards","volume":"15","author":"Imagawa K.","year":"2018","unstructured":"K. Imagawa, Y. Mizukami, and S. Miyazaki. 2018. Regulatory convergence of medical devices: A case study using ISO and IEC standards. Expert Review of Medical Devices 15, 7 (2018), 497\u2013504.","journal-title":"Expert Review of Medical Devices"},{"key":"e_1_3_2_6_2","doi-asserted-by":"crossref","first-page":"1415319","DOI":"10.3389\/fmed.2024.1415319","article-title":"More than red tape: Exploring complexity in medical device regulatory affairs","volume":"11","author":"Han Y.","year":"2024","unstructured":"Y. Han, A. Ceross, and J. Bergmann. 2024. More than red tape: Exploring complexity in medical device regulatory affairs. Frontiers in Medicine 11 (2024), 1415319.","journal-title":"Frontiers in Medicine"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12328-014-0478-2"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.4067\/S0718-27242015000300010"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.18653\/v1\/P19-1424"},{"key":"e_1_3_2_10_2","doi-asserted-by":"crossref","first-page":"6974","DOI":"10.18653\/v1\/2021.emnlp-main.559","volume-title":"Proceedings of the 2021 Conference on Empirical Methods in Natural Language Processing","author":"Chalkidis I.","year":"2021","unstructured":"I. Chalkidis, M. Fergadiotis, P. Malakasiotis, N. Aletras, and I. Androutsopoulos. 2021. Multieurlex\u2014A multi-lingual and multi-label legal document classification dataset for zero-shot cross-lingual transfer. In Proceedings of the 2021 Conference on Empirical Methods in Natural Language Processing, 6974\u20136988."},{"issue":"21","key":"e_1_3_2_11_2","first-page":"11","article-title":"Towards classification of legal pharmaceutical text using GAN-BERT","volume":"12","author":"Auti A.","year":"2022","unstructured":"A. Auti, R. Shanmugam, S. Rajasekaran, and K. Dhingra. 2022. Towards classification of legal pharmaceutical text using GAN-BERT. Applied Sciences 12, 21 (2022), 11\u201383.","journal-title":"Applied Sciences"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1145\/3494193.3494232"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.0307752101"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.5555\/1857999.1858011"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-024-01337-9"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1080\/17434440.2024.2402027"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hfh.2022.100016"},{"key":"e_1_3_2_18_2","first-page":"240","volume-title":"Proceedings of the 1st Workshop on Patient-Oriented Language Processing (CL4Health)@ LREC-COLING 2024","author":"Wunnava S.","year":"2024","unstructured":"S. Wunnava, D. A. Harris, F. T. Bourgeois, and T. A. Miller. 2024. Development of a benchmark corpus for medical device adverse event detection. In Proceedings of the 1st Workshop on Patient-Oriented Language Processing (CL4Health)@ LREC-COLING 2024, 240\u2013245."},{"key":"e_1_3_2_19_2","unstructured":"Y. Han A. Ceross and J. H. Bergmann. 2025. AI for regulatory affairs: Balancing accuracy interpretability and computational cost in medical device classification. arXiv:2505.18695. Retrieved from https:\/\/arxiv.org\/abs\/2505.18695"},{"key":"e_1_3_2_20_2","unstructured":"Y. Han A. Ceross and J. H. Bergmann. 2025. Standard applicability judgment and cross-jurisdictional reasoning: A rag-based framework for medical device compliance. arXiv:2506.18511. Retrieved from https:\/\/arxiv.org\/abs\/2506.18511"},{"key":"e_1_3_2_21_2","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1016\/j.drudis.2023.103700","article-title":"Artificial intelligence in pharmaceutical regulatory affairs","volume":"28","author":"Patil R. S.","year":"2023","unstructured":"R. S. Patil, S. B. Kulkarni, and V. L. Gaikwad. 2023. Artificial intelligence in pharmaceutical regulatory affairs. Drug Discovery Today 28, 103\u2013700.","journal-title":"Drug Discovery Today"},{"key":"e_1_3_2_22_2","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1016\/j.injury.2023.110908","article-title":"Comparison of the international regulations for medical devices\u2013USA versus Europe","volume":"54","author":"Fink M.","year":"2023","unstructured":"M. Fink and B. Akra. 2023. Comparison of the international regulations for medical devices\u2013USA versus Europe. Injury 54 (2023), 110\u2013908.","journal-title":"Injury"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.4103\/picr.PICR_222_20"},{"issue":"4","key":"e_1_3_2_24_2","first-page":"9","article-title":"Requirements for introducing medical devices in India and US market\u2014A comparative study of regulations","volume":"6","author":"Ratna J. V.","year":"2018","unstructured":"J. V. Ratna, M. Parimalambica, and K. V. R. Murthy. 2018. Requirements for introducing medical devices in India and US market\u2014A comparative study of regulations. International Journal of Drug Regulatory Affairs 6, 4 (2018), 9\u201320.","journal-title":"International Journal of Drug Regulatory Affairs"},{"issue":"5","key":"e_1_3_2_25_2","doi-asserted-by":"crossref","first-page":"581","DOI":"10.1177\/2168479013492735","article-title":"Regulations of medical devices in regulated countries: A comparative review","volume":"47","author":"Jyothi G.","year":"2013","unstructured":"G. Jyothi, M. Venkatesh, and T. Pramod Kumar. 2013. Regulations of medical devices in regulated countries: A comparative review. Therapeutic Innovation & Regulatory Science 47, 5 (2013), 581\u2013592.","journal-title":"Therapeutic Innovation & Regulatory Science"},{"key":"e_1_3_2_26_2","doi-asserted-by":"crossref","first-page":"41","DOI":"10.4324\/9781003074984-3","volume-title":"The Ethical Challenges of Emerging Medical Technologies","author":"Kramer D. B.","year":"2020","unstructured":"D. B. Kramer, S. Xu, and A. S. Kesselheim. 2020. Regulation of medical devices in the United States and European Union, The Ethical Challenges of Emerging Medical Technologies. Bert-Jaap Koops, Ibo van de Poel, and Martijn J. van den Hoven (Eds.), Routledge, 41\u201348."},{"key":"e_1_3_2_27_2","author":"Parker D.","year":"2012","unstructured":"D. Parker and C. Kirkpatrick. 2012. Measuring Regulatory Performance: The Economic Impact of Regulatory Policy. Edward Elgar Publishing.","journal-title":"Measuring Regulatory Performance: The Economic Impact of Regulatory Policy"},{"issue":"2","key":"e_1_3_2_28_2","doi-asserted-by":"crossref","first-page":"6","DOI":"10.22271\/tpi.2021.v10.i2a.5657","article-title":"Comparative analysis of evolution of regulatory environment in USA, Europe and Japan","volume":"10","author":"Dhiman S.","year":"2021","unstructured":"S. Dhiman and H. Dureja. 2021. Comparative analysis of evolution of regulatory environment in USA, Europe and Japan. The Pharma Innovation 10, 2 (2021), 6\u201314.","journal-title":"The Pharma Innovation"},{"issue":"1","key":"e_1_3_2_29_2","doi-asserted-by":"crossref","first-page":"62","DOI":"10.1177\/2168479017716712","article-title":"A comparative study of medical device regulations: US, Europe, Canada, and Taiwan","volume":"52","author":"Chen Y.-J.","year":"2018","unstructured":"Y.-J. Chen, C.-M. Chiou, Y.-W. Huang, P.-W. Tu, Y.-C. Lee, and C.-H. Chien. 2018. A comparative study of medical device regulations: US, Europe, Canada, and Taiwan. Therapeutic Innovation & Regulatory Science 52, 1 (2018), 62\u201369.","journal-title":"Therapeutic Innovation & Regulatory Science"},{"issue":"2","key":"e_1_3_2_30_2","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1016\/j.clae.2018.11.001","article-title":"A review of international medical device regulations: Contact lenses and lens care solutions","volume":"42","author":"Zaki M.","year":"2019","unstructured":"M. Zaki, J. Pardo, and G. Carracedo. 2019. A review of international medical device regulations: Contact lenses and lens care solutions. Contact Lens & Anterior Eye: The Journal of the British Contact Lens Association 42, 2 (2019), 136\u2013146.","journal-title":"Contact Lens & Anterior Eye: The Journal of the British Contact Lens Association"},{"key":"e_1_3_2_31_2","volume-title":"Medical Devices: Regulations, Standards and Practices","author":"Ramakrishna S.","year":"2015","unstructured":"S. Ramakrishna, L. Tian, C. Wang, S. Liao, and W. E. Teo. 2015. Medical Devices: Regulations, Standards and Practices. Woodhead Publishing."},{"key":"e_1_3_2_32_2","doi-asserted-by":"publisher","DOI":"10.2196\/46871"},{"issue":"6","key":"e_1_3_2_33_2","doi-asserted-by":"crossref","first-page":"1315","DOI":"10.3233\/THC-220284","article-title":"Post-market surveillance of medical devices: A review","volume":"30","author":"Badnjevi\u0107 A.","year":"2022","unstructured":"A. Badnjevi\u0107, L. G. Pokvi\u0107, A. Deumi\u0107, and L. S. Be\u0107irovi\u0107. 2022. Post-market surveillance of medical devices: A review. Technology and Health Care: Official Journal of the European Society for Engineering and Medicine 30, 6 (2022), 1315\u20131329.","journal-title":"Technology and Health Care: Official Journal of the European Society for Engineering and Medicine"},{"key":"e_1_3_2_34_2","unstructured":"International Medical Device Regulators Forum. 2022. Clinical Evaluation. Tech. Rep. IMDRF\/PMD WG\/N56. Retrieved from https:\/\/www.imdrf.org\/documents\/clinical-evaluation"},{"key":"e_1_3_2_35_2","unstructured":"International Medical Device Regulators Forum. 2023. Post-Market Adverse Event Reporting Criteria. Tech. Rep. IMDRF\/NCAR WG\/N14. Retrieved from https:\/\/www.imdrf.org\/sites\/default\/files\/2023-04\/IMDRF%20NCAR%20WG%20N14Final%202023_edition4.pdf"},{"key":"e_1_3_2_36_2","doi-asserted-by":"publisher","DOI":"10.1080\/13511610.2012.723328"},{"key":"e_1_3_2_37_2","doi-asserted-by":"publisher","DOI":"10.2139\/ssrn.3438276"},{"issue":"8","key":"e_1_3_2_38_2","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1177\/0361198120919399","article-title":"Dynamic origin\u2013destination matrix prediction with line graph neural networks and Kalman filter","volume":"2674","author":"Xiong X.","year":"2020","unstructured":"X. Xiong, K. Ozbay, L. Jin, and C. Feng. 2020. Dynamic origin\u2013destination matrix prediction with line graph neural networks and Kalman filter. Transportation Research Record: Journal of the Transportation Research Board 2674, 8 (2020), 491\u2013503.","journal-title":"Transportation Research Record: Journal of the Transportation Research Board"},{"issue":"4","key":"e_1_3_2_39_2","doi-asserted-by":"crossref","first-page":"519","DOI":"10.1061\/(ASCE)LA.1943-4170.0000308","article-title":"Application of natural language processing and text mining to identify patterns in construction-defect litigation cases","volume":"11","author":"Jallan Y.","year":"2019","unstructured":"Y. Jallan, E. Brogan, B. Ashuri, and C. M. Clevenger. 2019. Application of natural language processing and text mining to identify patterns in construction-defect litigation cases. Journal of Legal Affairs and Dispute Resolution in Engineering and Construction 11, 4 (2019), 519.","journal-title":"Journal of Legal Affairs and Dispute Resolution in Engineering and Construction"},{"key":"e_1_3_2_40_2","doi-asserted-by":"publisher","DOI":"10.1186\/s41231-019-0050-7"},{"key":"e_1_3_2_41_2","unstructured":"Y. Zou L. Jin and X. Xiong. 2024. Dyna-style learning with a macroscopic model for vehicle platooning in mixed-autonomy traffic. arXiv:2405.02062. Retrieved from https:\/\/arxiv.org\/abs\/2405.02062"},{"key":"e_1_3_2_42_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0294560"},{"key":"e_1_3_2_43_2","doi-asserted-by":"publisher","DOI":"10.5555\/944919.944937"},{"key":"e_1_3_2_44_2","doi-asserted-by":"publisher","DOI":"10.1186\/2041-1480-3-15"},{"key":"e_1_3_2_45_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2016.0213"},{"key":"e_1_3_2_46_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2020.06.014"},{"key":"e_1_3_2_47_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-020-2669-y"},{"key":"e_1_3_2_48_2","doi-asserted-by":"crossref","first-page":"3170","DOI":"10.1109\/CDC40024.2019.9029179","volume-title":"Proceedings of the 2019 IEEE 58th Conference on Decision and Control (CDC \u201919)","author":"Xiong X.","year":"2019","unstructured":"X. Xiong, E. Xiao, and L. Jin. 2019. Analysis of a stochastic model for coordinated platooning of heavy-duty vehicles. In Proceedings of the 2019 IEEE 58th Conference on Decision and Control (CDC \u201919), IEEE, 3170\u20133175."},{"issue":"1","key":"e_1_3_2_49_2","first-page":"1","article-title":"Ensuring medical device effectiveness and safety: A cross-national comparison of approaches to regulation","volume":"69","author":"Kramer D. B.","year":"2014","unstructured":"D. B. Kramer, Y. T. Tan, C. Sato, and A. S. Kesselheim. 2014. Ensuring medical device effectiveness and safety: A cross-national comparison of approaches to regulation. Food and Drug Law Journal 69, 1 (2014), 1.","journal-title":"Food and Drug Law Journal"},{"issue":"3","key":"e_1_3_2_50_2","first-page":"101","article-title":"Monolingual and multilingual topic analysis using LDA and BERT embeddings","volume":"14","author":"Xie Q.","year":"2020","unstructured":"Q. Xie, X. Zhang, Y. Ding, and M. Song. 2020. Monolingual and multilingual topic analysis using LDA and BERT embeddings. Journal of Informetrics 14, 3 (2020), 101\u2013055.","journal-title":"Journal of Informetrics"},{"key":"e_1_3_2_51_2","unstructured":"Y. Liu and M. Lapata. 2019. Text summarization with pretrained encoders. arXiv:1908.08345. Retrieved from https:\/\/arxiv.org\/abs\/1908.08345"},{"key":"e_1_3_2_52_2","unstructured":"U.S. Food and Drug Administration. 2024. Guidance Documents (Medical Devices and Radiation-Emitting Products). Retrieved June 24 2024 from https:\/\/www.fda.gov\/medical-devices\/device-advice-comprehensive-regulatory-assistance\/guidance-documents-medical-devices-and-radiation-emitting-products"},{"key":"e_1_3_2_53_2","unstructured":"Medical Device Coordination Group (MDCG). 2024. MDCG Endorsed Documents. Retrieved June 24 2024 from https:\/\/www.medicaldevice-regulation.eu\/mdcg-endorsed-documents\/"},{"key":"e_1_3_2_54_2","unstructured":"National Medical Products Administration (NMPA). 2024. Medical Devices. Retrieved June 24 2024 from https:\/\/english.nmpa.gov.cn\/medicaldevices.html"},{"key":"e_1_3_2_55_2","unstructured":"National Medical Products Administration (NMPA). 2021. Medical Device Supervision Update. Official regulatory update published on May 31 2021. Retrieved June 09 2025 from https:\/\/www.nmpa.gov.cn\/ylqx\/ylqxjgdt\/20210531143615123. html?type=pc&m="},{"key":"e_1_3_2_56_2","unstructured":"European Commission Directorate-General for Health and Food Safety. 2025. Notified Bodies for Medical Devices. EU Medical Devices Topics of Interest page. Retrieved from https:\/\/health.ec.europa.eu\/medical-devices-topics-interest\/notified-bodies-medical-devices_en"},{"key":"e_1_3_2_57_2","unstructured":"U.S. Food and Drug Administration. 2013. Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia Burgdorferi; Guidance for Industry and Food and Drug Administration Staff; Availability. Notice published in the Federal Register (Docket No. FDA-2010-D-0636 78 FR 18988). Retrieved March 28 2013 from https:\/\/www.federalregister.gov\/documents\/2013\/03\/28\/2013-07085\/establishing-the-performance-characteristics-of-in-vitro-diagnostic-devices-for-the-detection-of"},{"key":"e_1_3_2_58_2","unstructured":"U.S. Food and Drug Administration. 2014. Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff. Guidance Document (Docket No. FDA2010-D-0194) issued December. Retrieved from https:\/\/www.fda.gov\/regulatoryinformation\/search-fda-guidance-documents\/infusion-pumps-total-product-life-cycle"},{"key":"#cr-split#-e_1_3_2_59_2.1","unstructured":"U.S. Food and Drug Administration. 2016. Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance"},{"key":"#cr-split#-e_1_3_2_59_2.2","unstructured":"(MR) Environment for Multi-Configuration Passive Medical Devices: Guidance for Industry and Food and Drug Administration Staff. Guidance document issued March 22 2016. Docket No. FDA2015-D-2104. Retrieved from https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/assessment-radiofrequency-induced-heating-magnetic-resonance-mr-environment-multi-configuration"},{"key":"e_1_3_2_60_2","unstructured":"U.S. Food and Drug Administration. 2017. FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions. Guidance document accessed via FDA regulatory guidance database. Retrieved from https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-categorization-investigational-device-exemption-ide-devices-assist-centers-medicare-and-medicaid"},{"key":"e_1_3_2_61_2","unstructured":"U.S. Food and Drug Administration. 2019. Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions. Guidance document; accessed via FDA regulatory guidance database. Retrieved from https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/recommended-content-and-format-non-clinical-benchperformance-testing-information-premarket"},{"key":"e_1_3_2_62_2","unstructured":"U.S. Food and Drug Administration. 2021. Safer Technologies Program for Medical Devices. Guidance document; accessed via FDA regulatory guidance database. Retrieved from https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/safer-technologies-program-medical-devices"},{"key":"e_1_3_2_63_2","unstructured":"U.S. Food and Drug Administration. 2023. Best Practices for Selecting a Predicate Device to Support a Premarket Notification (510(k)) Submission. Guidance document; accessed via FDA regulatory guidance database. Retrieved from https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/best-practices-selecting-predicate-device-support-premarketnotification-510k-submission"},{"key":"e_1_3_2_64_2","unstructured":"U.S. Food and Drug Administration. 2024. Remanufacturing and Servicing of Medical Devices. Regulatory policy page; accessed via FDA website. Retrieved from https:\/\/www.fda.gov\/medical-devices\/quality-and-compliance-medical-devices\/remanufacturing-and-servicing-medical-devices"},{"key":"e_1_3_2_65_2","unstructured":"Allen Institute for AI. 2019. Scispacy: A Python Package for Processing Biomedical Scientific Text. Retrieved from https:\/\/allenai.github.io\/scispacy\/"},{"key":"e_1_3_2_66_2","unstructured":"E. Ai. 2023. Spacy API Documentation. Retrieved from https:\/\/spacy.io\/api\/doc\/"},{"key":"e_1_3_2_67_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bioactmat.2021.09.031"},{"key":"e_1_3_2_68_2","doi-asserted-by":"crossref","unstructured":"A. Petryna. 2009. When experiments travel: Clinical trials and the global search for human subjects.","DOI":"10.1515\/9781400830824"},{"issue":"5","key":"e_1_3_2_69_2","doi-asserted-by":"crossref","first-page":"759","DOI":"10.1515\/cclm-2022-1257","article-title":"Redesigning the surveillance of in vitro diagnostic medical devices and of medical laboratory performance by quality control in the traceability era","volume":"61","author":"Panteghini M.","year":"2023","unstructured":"M. Panteghini. 2023. Redesigning the surveillance of in vitro diagnostic medical devices and of medical laboratory performance by quality control in the traceability era. Clinical Chemistry and Laboratory Medicine 61, 5 (2023), 759\u2013768.","journal-title":"Clinical Chemistry and Laboratory Medicine"},{"issue":"5","key":"e_1_3_2_70_2","doi-asserted-by":"crossref","first-page":"9628","DOI":"10.1609\/aaai.v34i05.6510","article-title":"Semantics-aware BERT for language understanding","volume":"34","author":"Zhang Z.","year":"2020","unstructured":"Z. Zhang, Y. Wu, H. Zhao, Z. Li, S. Zhang, X. Zhou, and X. Zhou. 2020. Semantics-aware BERT for language understanding. Proceedings of the AAAI Conference on Artificial Intelligence 34, 5 (2020), 9628\u20139635.","journal-title":"Proceedings of the AAAI Conference on Artificial Intelligence"},{"key":"e_1_3_2_71_2","first-page":"1","volume-title":"Proceedings of the 2022 11th International Conference of Information and Communication Technology (ICTech \u201922)","author":"Sun J.-W.","year":"2022","unstructured":"J.-W. Sun, J.-Q. Bao, and L.-P. Bu. 2022. Text classification algorithm based on TF-IDF and BERT. In Proceedings of the 2022 11th International Conference of Information and Communication Technology (ICTech \u201922), IEEE, 1\u20134."},{"key":"e_1_3_2_72_2","volume-title":"Pyldavis Documentation","author":"Mabey B.","year":"2018","unstructured":"B. Mabey. 2018. Pyldavis Documentation. GitHub."},{"key":"e_1_3_2_73_2","doi-asserted-by":"crossref","unstructured":"I. Daizadeh. 2021. Historically Stagnate the Number of US FDA Medical Device Guidelines Have Been Growing Quickly since the Mid-2010s: While Partially due to COVID-19 and Digital Health Technologies Is The Upward Trend Now Permanent? Retrieved from Https:\/\/osf.io\/preprints\/osf\/ncmyx_v1","DOI":"10.31219\/osf.io\/ncmyx"},{"issue":"21","key":"e_1_3_2_74_2","first-page":"2696","article-title":"Roadmap for innovation\u2014ACC health policy statement on healthcare transformation in the era of digital health, big data, and precision health: A report of the American college of cardiology task force on health policy statements and systems of care","volume":"70","author":"Bhavnani S. P.","year":"2017","unstructured":"S. P. Bhavnani, K. Parakh, A. Atreja, R. Druz, G. N. Graham, S. S. Hayek, H. M. Krumholz, T. M. Maddox, M. D. Majmudar, J. S. Rumsfeld, et al. 2017. Roadmap for innovation\u2014ACC health policy statement on healthcare transformation in the era of digital health, big data, and precision health: A report of the American college of cardiology task force on health policy statements and systems of care. Journal of the American College of Cardiology 70, 21 (2017), 2696\u20132718.","journal-title":"Journal of the American College of Cardiology"},{"key":"e_1_3_2_75_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-020-00314-2"},{"key":"e_1_3_2_76_2","unstructured":"European Union. 2014. Regulation (EU) No 536\/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001\/20\/EC Text with Relevance. Retrieved from https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32014R0536"},{"issue":"1","key":"e_1_3_2_77_2","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1108\/IJPHM-07-2023-0060","article-title":"A review of the literature on the new European medical device regulations requirements for increased clinical evaluation","volume":"19","author":"McDermott O.","year":"2024","unstructured":"O. McDermott and B. Kearney. 2024. A review of the literature on the new European medical device regulations requirements for increased clinical evaluation. International Journal of Pharmaceutical and Healthcare Marketing 19, 1 (2024), 1\u201321.","journal-title":"International Journal of Pharmaceutical and Healthcare Marketing"},{"key":"e_1_3_2_78_2","unstructured":"Z. Yu. 2024. Regultermanalyzer: A Model for Keyword and Theme Frequency Analysis in Regulatory Texts. GitHub Repository. Retrieved from https:\/\/github.com\/yuzai6666\/RegulTermAnalyzer\/tree\/main"},{"key":"e_1_3_2_79_2","doi-asserted-by":"publisher","DOI":"10.29337\/ijdh.50"},{"key":"e_1_3_2_80_2","unstructured":"International Medical Device Regulators Forum (IMDRF). 2019. Clinical Evaluation. IMDRF MDCE WG\/N56 FINAL. Retrieved from https:\/\/www.imdrf.org\/documents\/clinical-evaluation"},{"key":"e_1_3_2_81_2","unstructured":"International Medical Device Regulators Forum (IMDRF). 2020. Medical Devices Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form. NCAR WG document. Retrieved from https:\/\/www.imdrf.org\/documents\/medical-devices-post-market-surveillance-national-competent-authority-report-exchange-criteria-and-report-form"},{"key":"e_1_3_2_82_2","unstructured":"International Medical Device Regulators Forum (IMDRF). 2017. Software as a Medical Device (SAMD): Clinical Evaluation. IMDRF\/SaMD WG\/N41 FINAL. Retrieved from https:\/\/www.imdrf.org\/documents\/software-medical-device-samd-clinical-evaluation"},{"key":"e_1_3_2_83_2","unstructured":"International Medical Device Regulators Forum (IMDRF). 2020. Medical Device Clinical Evaluation (Working Group Overview). Retrieved from https:\/\/www.imdrf.org\/working-groups\/medical-device-clinical-evaluation"},{"key":"e_1_3_2_84_2","unstructured":"International Medical Device Regulators Forum (IMDRF). 2018. Optimizing Standards for Regulatory Use. IMDRF\/Standards WG\/N51 FINAL. Retrieved from https:\/\/www.imdrf.org\/documents\/optimizing-standards-regulatory-use"},{"key":"e_1_3_2_85_2","unstructured":"International Medical Device Regulators Forum (IMDRF). 2020. Good Regulatory Review Practices (Working Group Overview). GRRP WG working group. Retrieved from https:\/\/www.imdrf.org\/working-groups\/good-regulatory-review-practices"},{"key":"e_1_3_2_86_2","unstructured":"International Medical Device Regulators Forum (IMDRF). 2020. Definitions for Personalized Medical Devices. IMDRF\/PMD WG\/N49. Retrieved from https:\/\/www.imdrf.org\/documents\/definitions-personalized-medical-devices"},{"key":"e_1_3_2_87_2","unstructured":"International Medical Device Regulators Forum (IMDRF). 2019. Clinical Evidence\u2014Key Definitions and Concepts. IMDRF MDCE WG\/N55 FINAL. Retrieved from https:\/\/www.imdrf.org\/documents\/clinical-evidence-key-definitions-and-concepts"},{"key":"e_1_3_2_88_2","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-023-00574-6"},{"key":"e_1_3_2_89_2","doi-asserted-by":"crossref","first-page":"711","DOI":"10.3389\/fphar.2021.711361","article-title":"Comparison of BRICS-TM countries\u2019 biosimilar regulatory frameworks with Australia, Canada and Switzerland: Benchmarking best practices","volume":"12","author":"Rahalkar H.","year":"2021","unstructured":"H. Rahalkar, A. Sheppard, and S. Salek. 2021. Comparison of BRICS-TM countries\u2019 biosimilar regulatory frameworks with Australia, Canada and Switzerland: Benchmarking best practices. Frontiers in Pharmacology 12 (2021), 711\u2013361.","journal-title":"Frontiers in Pharmacology"},{"key":"e_1_3_2_90_2","doi-asserted-by":"crossref","first-page":"272","DOI":"10.1016\/j.pharma.2024.08.007","article-title":"Harmonization of regulatory frameworks for medical devices in BRICS countries: A path to enhanced trade and investment","volume":"83","author":"Pawar H.","year":"2025","unstructured":"H. Pawar and M. Patel. 2025. Harmonization of regulatory frameworks for medical devices in BRICS countries: A path to enhanced trade and investment. Annales Pharmaceutiques Francaises 83 (2025), 272\u2013286.","journal-title":"Annales Pharmaceutiques Francaises"}],"container-title":["ACM Transactions on Computing for Healthcare"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dl.acm.org\/doi\/pdf\/10.1145\/3793533","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T15:11:33Z","timestamp":1773760293000},"score":1,"resource":{"primary":{"URL":"https:\/\/dl.acm.org\/doi\/10.1145\/3793533"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,17]]},"references-count":90,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,4,30]]}},"alternative-id":["10.1145\/3793533"],"URL":"https:\/\/doi.org\/10.1145\/3793533","relation":{},"ISSN":["2691-1957","2637-8051"],"issn-type":[{"value":"2691-1957","type":"print"},{"value":"2637-8051","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,17]]},"assertion":[{"value":"2024-10-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-12","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}