By Laurent Saugrin
The broad scope of digital health includes categories such as health information technology or wearable devices. Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. Digital tools offer real opportunities to improve medical outcomes and enhance efficiency, and give providers a more holistic view of patient health through access to data.
Within the field of digital health, Artificial Intelligence and Machine Learning (AI/ML) tools and technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated. However, AI/ML presents the challenge of maintaining overall quality and regulatory compliance of IT systems, applications, and solutions in the the life sciences industry.
GAMP5 Edition 2 introduced the new Appendix D11 – Artificial Intelligence and Machine Learning (AI/ML), which provides guidance on how to ensure compliant integration and fitness for use in a validated environment. Learn more about Artificial Intelligence, Machine Learning, and the new AI/ML Appendix D11.