Comprehensive Surveys on Validating Wearable ECG Devices and Related FDA’s SaMD Regulating Development – International Journal of Law, Ethics, and Technology

-                                        Title
+                                        Comprehensive Surveys on Validating Wearable ECG Devices and Related FDA’s SaMD Regulating Development
-                                        Author
+                                        Xilin Wang
-                                        Affiliation
+                                        Brown University
-                                        Region/Country
+                                        United States
-                                        Pages
+-113
-                                        Download
-                                        Permalink
-                                        DOI
-                                        Keywords
+                                        SaMD; Medical AI; Administrative Law; Wearable Technology; ECG
-                                        Abstract
+                                        Wearable technology is becoming more and more popular because of its convenience and accessibility, especially in connected health. Machine Learning
algorithms are proven to be a practical approach in improving the accuracy of wearable technology. Recently, the FDA has established several goals of regulating AI/MLbased Software as a Medical Device (SaMD) to validate products before applying in a clinical setting thoroughly. This review comprehensively analyzes studies validating different wearable devices and algorithms conforming to the FDA standards and discusses the potential consequences of wearable devices’ usage. We find an acceptable accuracy for the devices and the need for further investigation into this technology.