Apollo Hospitals receives ISO 13485:2016 BSI certification for AI-based software applications providing Clinical Decision Support

Apollo Hospitals, one of Asia’s largest integrated healthcare providers, has received the ISO 13485:2016 BSI Registration from the British Standards Institution (BSI). 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 ISO 13485: 2016 Quality Management System certification is a requirement for regulatory purposes and showcases the regulatory compliance and systems in place for effectiveness, quality and safety.

Dr Prathap C. Reddy, Chairman, Apollo Hospitals Group said, “We are proud to receive the BSI Quality certification that outlines the requirements for a quality management system specific to the medical devices industry. The receipt of this international standard is an important milestone in our development of AI and ML based integrated healthcare delivery models and recognizes our industry leadership in this emerging health tech sector. It reflects our unwavering commitment to world-class safety, quality and reliability for the highest levels of performance throughout our organization.”

ISO 13485:2016 is an internationally recognized 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.

Ms Sangita Reddy, Joint Managing Director, Apollo Hospitals Group said, “The ISO 13485:2016 Medical Device certification demonstrates that Apollo Hospitals has adopted best practices in quality management in the design, development and deployment of its Clinical AI API programs. It also attests to the quality, safety, and security of the patient data effectively in this new age of digital healthcare, while recognizing our efforts in developing and deploying user-friendly technological solutions for the benefit of our doctors and patients.”

The current Clinical AI APIs that have been launched include the AICVD Cardiac Risk Score, a novel artificial intelligence based risk score system that provides the individual’s risk of having Coronary Artery Disease related events in the next 10 Years; the Prediabetes Scanner, a novel artificial intelligence based risk score system that provides the individual’s risk of having Prediabetes / Diabetes in previously undiagnosed individuals; the AI COPD Acute Exacerbation of COPD & Asthma Risk Score, a novel artificial intelligence based risk score system that provides the individual’s risk of having Acute Exacerbation of COPD or related events in the next 3 months; and the AI LF – Non-alcoholic fatty liver disease (NAFLD) Clinical AI API to identify and distinguish advanced fibrosis and accurately predict onset of liver fibrosis in NAFLD. Clinical AI APIs are available as a part of Apollo Hospital’s ProHealth Platform and as standalone APIs for EMR integration. This will be soon available on Apollo 247.

Apollo Hospitals also has clinical AI algorithms in the pipeline for other diseases including breast cancer, osteoarthritis, acute liver failure, pre-anesthesia, stroke, heart failure and sepsis. The use of AI in these clinical areas will enable Apollo Hospitals to take their clinical expertise and technology to the last mile, serving the people with unmet needs.