Apollo Hospitals on Tuesday announced that it has received the ISO 13485:2016 BSI registration from the British Standards Institution (BSI) for AI-based software applications providing clinical decision support

In a press statement, the healthcare major said the coveted BSI Quality certification has been awarded for its artificial intelligence (AI) based clinical applications to predict an individual’s risk of diseases such as coronary artery disease, prediabetes and diabetes, COPD and asthma, liver fibrosis and clinical decision support for empirical antibiotic recommendation.

“The receipt of this international standard is an important milestone in our development of AI and ML based integrated healthcare delivery models and recognises our industry leadership in this emerging healthtech sector. It reflects our unwavering commitment to world-class safety, quality and reliability for the highest levels of performance throughout our organisation,” Prathap C. Reddy, Chairman, Apollo Hospitals Group, was quoted in the release.

Stamp of safety

ISO 13485:2016 is an internationally recognised quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes. 

For certification, the medical devices and related services produced must consistently meet customer and regulatory requirements. Apollo Hospitals’ Clinical AI Algorithms fall under Software as a Medical Device Scope, the healthcare major, said.

Sangita Reddy, Joint Managing Director, Apollo Hospitals Group, said, “The certification also attests to the quality, safety, and security of the patient data effectively in this new age of digital healthcare, while also recognising our efforts in developing and deploying user-friendly technological solutions for the benefit of our doctors and patients.”

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