Dr. Groves

Governments and regulatory bodies worldwide want safe, secure and trustworthy software and artificial intelligence. The European Union (EU) and the United States (US) have recently taken a strong interest in artificial intelligence and machine learning. We’ll review recent updates from the European Union Artificial Intelligence Act, President Biden’s Executive Order on artificial intelligence, and new guidance from the US Food and Drug Administration (FDA).
The FDA’s guidance for artificial intelligence, machine learning, software algorithms, and cybersecurity may have major impact to medical device manufacturers. For example, the draft guidance for artificial intelligence/machine learning-enabled devices moves past “locked” medical algorithms through predetermined change control panels, opening the door for products that allow artificial intelligence/machine learning systems to improve with access to additional data.

Biography:

Dr. Groves is a computational physicist with over 15 years of experience in custom software development and data science. She advises clients on software development, data collection, and artificial intelligence/machine learning applications, particularly for emerging technologies such as artificial intelligence with rapidly evolving regulatory requirements. She has served on multiple panels discussing artificial intelligence and ethics, contributed to the B11.TR10-2020 technical report “Functional Safety of Artificial Intelligence for Machinery Applications,” and has published book chapters on the Food and Drug Administration’s approach to regulating artificial intelligence-based software.

Address:United States

Dr. Sharma

Governments and regulatory bodies worldwide want safe, secure and trustworthy software and artificial intelligence. The European Union (EU) and the United States (US) have recently taken a strong interest in artificial intelligence and machine learning. We’ll review recent updates from the European Union Artificial Intelligence Act, President Biden’s Executive Order on artificial intelligence, and new guidance from the US Food and Drug Administration (FDA).
The FDA’s guidance for artificial intelligence, machine learning, software algorithms, and cybersecurity may have major impact to medical device manufacturers. For example, the draft guidance for artificial intelligence/machine learning-enabled devices moves past “locked” medical algorithms through predetermined change control panels, opening the door for products that allow artificial intelligence/machine learning systems to improve with access to additional data.

Biography:

Dr. Sharma has a more than a decade of experience in the domain of electrical engineering and computer science. He has developed wearables, machine learning algorithms, defect inspection systems, embedded systems, and web applications, in collaboration with data scientists, software engineers, human factors researchers, clinicians and nutritionists. He assists developers entering regulated and safety critical domains (such as medical device software) in complying with federal rules and regulations. Dr. Sharma has published papers in the domain of wearables and the challenge of metrics as machine learning developers transition from small data to big data and real-world data. He also serves as a peer-reviewer for journals in machine learning, healthcare and artificial intelligence.