Abstract
ABSTRACTBackgroundDigital health applications can improve quality and effectiveness of healthcare, by offering a number of tools to patients, professionals, and the healthcare system. Introduction of new technologies is not without risk, and digital health applications are often considered a medical device. Assuring their safe operation requires, amongst others, clinical validation, which needs large datasets to test their application in realistic clinical scenarios. Access to such datasets is challenging, due to concerns about patient privacy. Development of synthetic datasets, which will be sufficiently realistic to test digital applications, is seen as a potential alternative, enabling their deployment.ObjectiveThe aim of work was to develop a method for the generation of realistic synthetic datasets, statistically equivalent to real clinical datasets, and demonstrate that Generative Adversarial Network based approach is fit for purpose.MethodA generative adversarial network was implemented and trained, in a series of six experiments, using numerical and categorical variables from three clinically relevant datasets, including ICD-9 and laboratory codes from the MIMIC III dataset. A number of contextual steps provided the success criteria for the synthetic dataset.ResultsThe approach created a synthetic dataset that exhibits very similar statistical characteristics with the real dataset. Pairwise association of variables is very similar. A high degree of Jaccard similarity and a successful K-S test further support this.ConclusionsThe proof of concept of generating realistic synthetic datasets was successful, with the approach showing promise for further work.
Publisher
Cold Spring Harbor Laboratory
Reference37 articles.
1. MHRA, Guidance: Medical device stand-alone software including apps (including IVDMDs). Available: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/717865/Software_flow_chart_Ed_1-05.pdf (10/10/2019)
2. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and93/42/EEC.
3. FDA, Clinical Decision Support Software Draft Guidance for Industry and Food and Drug Administration Staff. Available: https://www.fda.gov/media/109618/download (10/10/2019).
4. S.M. Bellovin , P.K. Dutta , N. Reitinger , Privacy and Synthetic Datasets, 22 Stan. Tech. L. Rev. 1 (2019).
5. Data-driven approach for creating synthetic electronic medical records;BMC Med Inform Decis Mak,2010
Cited by
3 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献