Central Drugs Standard Control Organisation (CDSCO) released a notification that AI software that engages in cancer diagnonsis and detection will be categorised and regulated as Class C medical devices.
This classification is reserved for moderate to high risk products. This implies that AI products being used in medical facilities such as hospitals and diagnostic centres for cancer research will require screening and monitoring before use.
These AI tools would be subject to official approval, safety validation, and continuous monitoring before extensive use in clinics. Developers will also be beholden to uphold standards of quality, and flag and report issues connected to patient safety.
This risk classification list will be reviewed periodically by the CDMO as more AI startups start offering such services.
Experts cited by reports stated that this regulation was crucial as it ensures that such emerging technologies are utilised ethically. They noted that AI is promising when it comes to the detection of cervical, lung and breast cancers.
The issue still remains that Indian datasets are limited are not adequate to fuel regular clinical use of AI tools for cancer screening.
This step would ensure that quickly evolving tech such as AI will be brought under legal scrutiny before wider adoption. It may also set a precedent for the regulation of other AI tools in the field of medical technology.
AI cancer research is rapidly developing, with reports of Indraprastha Institute of Information Technology Delhi researchers discovering a way to test for cancer at its early stage via a blood test undertaken using AI tools.
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