Our Committees

Regulatory Affairs Working Group

AI/ML technologies require new regulatory frameworks to accommodate domain specific developments for both regulated and discovery products 

The AAIH Regulatory Affairs Working Group works to:

Engage directly with regulatory and policy thought leaders in North America and Europe 

  • FDA’s Digital health Center of Excellence

  • EMA - Digital Health Technology integrated consultation platform

Pursue projects in support of SaMD Action Plan, including:

  • Develop methodology for the evaluation and improvement of machine learning algorithms

  • Define essential principles for Good Machine Learning Practices (GMLP)

  • Develop a proposed label for FDA0cleared/approved algorithms

Identify AI RWE use cases for regulatory use

Data Working Group

Effective application of AI/ML in healthcare relies on access to large volumes of high-quality data
Technical approaches, including federated data sharing and synthetic data offer opportunity to surmount obstacles to data sharing

The AAIH Data Working Group works to:

  • Map sources and types of data across government, industry, and academia to provide a catalogue/clearinghouse for access to quality data

  • Engage US and EU governmental entities to shape policy as well as best practices for data curation, management, dissemination, and use

  • Develop policies and practices around data privacy, including application of other technical approaches to enhance privacy