The digital health space refers to the integration of technology and health care services to improve the overall quality of health care delivery. It encompasses a wide range of innovative and emerging technologies such as wearables, telehealth, artificial intelligence, mobile health, and electronic health records (EHRs). The digital health space offers numerous benefits such as improved patient outcomes, increased access to health care, reduced costs, and improved communication and collaboration between patients and health care providers. For example, patients can now monitor their vital signs such as blood pressure and glucose levels from home using wearable devices and share the data with their doctors in real-time. Telehealth technology allows patients to consult with their health care providers remotely without having to travel to the hospital, making health care more accessible, particularly in remote or rural areas. Artificial intelligence can be used to analyze vast amounts of patient data to identify patterns, predict outcomes, and provide personalized treatment recommendations. Overall, the digital health space is rapidly evolving, and the integration of technology in health

Monday, June 17, 2024

The FDA has recently released a new batch of approvals for AI algorithms in healthcare, and the exponential growth continues!

 

The FDA has recently released a new batch of approvals for AI algorithms in healthcare, and the exponential growth continues!

Software designed for medical use bears the burden of safety and accuracy
. The vetting process will be long.



           AI/ML-Enabled Medical Devices

This list contains publicly available information on AI/ML-enabled devices.

Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles

The FDA approval process is an arduous task and adds considerable cost to obtaining FDA approval. Even after approval, the FDA requires updates regarding medical device failure.  The failure rate for ML or AI has yet to be determined.  

Aberrant answers and hallucinations will be assessed carefully.  The FDA will have to assign failure results. Inaccurate results that lead to death or serious injury as a result of AI. ML errors will need to be reported to the FDA much like the FDA reports used for drugs.





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