FDA-Approved AI Software for Reliable Medical Information Tech companies are putting artificial intelligence (AI) into their

Tech companies are putting artificial intelligence (AI) into their products such as consumer-grade medical devices and wearables like smartwatch to improve the ability of these devices to pick up and analyse data to give us information about our health. Some companies even went as far as getting US FDA (Food and Drug Administration) clearance or approval for specific functionality of their AI software running on these devices.

But can we use these devices to get reliable medical information? In this article we will explore that.

Apple Watch Built-in AI

Apple is one of the first few tech companies to incorporate AI software in their products such as Apple Watch. One use case is for heart rate tracking and detection of atrial fibrillation. The heart rate tracking capabilities has been demonstrated to be the more accurate during walking or low-intensity exercises, but not as accurate when there is more intense activities like jogging and running.

In addition, Apple received FDA clearance for the Apple Watch’s feature of detecting atrial fibrillation (AFib). However, the AI software on the Apple Watch only performs AFib check intermittently, and it does not detect other heart conditions such as heart attack or heart failure.

Wearable health monitoring

Researchers have studied the effectiveness of wearable health monitoring for heart problems and found FDA-cleared AI software has better accuracy to detect abnormal heart rhythm, although it not 100% reliable when compared to traditional cardiac monitoring devices.

They also noted the devices may not provide accurate detection for more active individuals during physical activities, and these devices did not significantly increase the number of people found to have heart conditions such as AFib.

Tips to identify if healthcare AI software is accurate and valid for clinical use in human

• FDA-cleared vs FDA-approved: FDA-cleared usually means the software or functionality is almost the same as another legally marketed product. On the other hand, the stricter process of FDA-approval means the software has undergone proper and vigorous clinical testing to be used on real human patients.
  
  
• Usage by medical doctors or in hospitals: If doctors or hospitals are using specific wearables or devices that have AI software, it demonstrates the software’s effectiveness and reliability in real patients.
  
  
• Certifications beyond the FDA: Check if an AI software running on a device or wearable also receives other certification such as CE-mark in Europe, ISO (International Organization for Standardization) certifications for medical devices, or US HIPAA (Health Insurance Portability and Accounting Act) compliance for proper data security with sensitive personal confidential information. These certifications may not guarantee accuracy but can indicate it is a professional-grade software.
  
  
• Clinical Trials or Peer-Reviewed Studies: Look for clinical trials or peer-reviewed studies conducted on the AI software. An example is the potential use of Therabot to manage mental health issues with the use of generative AI chatbot therapy published in the prestigious medical journal New England Journal of Medicine. These trials or studies can serve as an independent audit and check on the AI software for its accuracy, safety, and reliability.

In conclusion, AI software running on our wearable devices should not be treated as an actual diagnostic tool, but rather a tool to improve our wellness. Any information coming from AI software should be used only as a conversation starter with your actual health care professional to see if there is a need for a proper diagnostic.

This article was produced solely for the purpose of healthcare and medical knowledge. Not all innovations are available or approved for clinical use. AsiaMD may receive financial or non-financial sponsorship from the companies or institutions involved in these innovations. However, AsiaMD does not endorse any specific product or services in the article, in addition to the Terms and Conditions for the use of our AsiaMD.com website. Please consult your healthcare professional if you need more information.