FDA releases new Guidelines for Artificial Intelligence Development

The Food and Drug Administration releases new ethical guidelines for the development of artificial intelligence and machine learning technologies for the healthcare industry. FDA, Health Canada, the United Kingdom’s Medicines, and Healthcare products Regulatory Agency (MHRA) have jointly issued a statement mentioning ten guidelines that researchers have to follow while developing artificial intelligence technologies. 

The agencies have meticulously reviewed the newly issued guidelines for the safe and effective use of AI solutions for diagnosis and treatment of patients. In recent years, artificial intelligence has widely impacted the healthcare industry as developers create new solutions to enhance treatment and diagnosis quality for several health conditions like heart sickness, cancer, tumor, and many more. 

The guidelines will also work as international regulation of the development of ethical and safe AI healthcare technologies. FDA mentioned that areas of international collaboration would include research, consumer standards, global homogeneous solution development, and creating educational tools. 

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Below mentioned are the guidelines issued by government organizations. 

1. Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle
2. Good Software Engineering and Security Practices Are Implemented
3. Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population
4. Training Data Sets Are Independent of Test Sets
5. Selected Reference Datasets Are Based Upon Best Available Methods
6. Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device
7. Focus Is Placed on the Performance of the Human-AI Team
8. Testing Demonstrates Device Performance during Clinically Relevant Conditions
9. Users Are Provided Clear, Essential Information
10. Deployed Models Are Monitored for Performance and Re-training Risks are Managed 

FDA and other government bodies have realized that artificial intelligence technologies will drive innovations in the healthcare industry and revolutionize the way patients are treated in the coming years. Hence they decided to lay down the guidelines mentioned above as a precautionary measure to ensure the safety and security of individuals.