Speed of Digital Health: Opportunities and Challenges in Software as a Medical Device (SaMD)

Digital health has the potential to make the delivery of healthcare more accessible, convenient and cost-effective. Software as a Medical Device (SaMD), a type of digital health software technology, has the potential to offer tremendous benefits to the healthcare system such as assisting in diagnosis, screening, monitoring and prediction of a disease enabling a professional to take preventive measures at the right time. It also presents new challenges and unfamiliar territory in regulating software that can have frequent updates.

Software, when used as a medical device, has several challenges, including cybersecurity, clinical evaluation, scientific validity and clinical validation. The FDA is currently piloting a Software Pre-Certification Program to help the development of a future regulatory model for digital health technology such as SaMD.

Join us to learn:

• History of Software as Medical Device (SaMD)
• Recent developments and opportunities for SaMD
• FDA’s Artificial Intelligence / Machine-based learning based SaMD Action Plan
• FDA’s Digital Health Center of Excellence and pilot Software Pre-Certification Program
• Concerns, recommendations, and Next Steps