medical devices – Duane Morris TechLaw

October 16, 2023 by Duane Morris

Webinar: Let’s Talk About Tech – Wearable Fitness and Health Tech

Duane Morris LLP will hold a webinar, The Data Privacy and Security Landscape: Let’s Talk About Tech ‒ Wearable Fitness and Health Tech on Monday, November 6, 2023, from 12:30 p.m. to 1:30 p.m. Eastern time.

About the Program

Wearable tech is everywhere—on your wrist, in your pocket, on your finger and even at work. With the ubiquity of fitness technology, what are the implications of these pervasive devices? How are companies collecting this data storing and protecting consumer information? What laws and regulations are in place as device use continues to expand? Join our panelists for a discussion on the current state and future of wearable fitness and health tech, including:

- FDA regulation of wearable devices: What is and isn’t a medical device?
- FDA guidance on wireless technology and medical devices
- Biometric laws, including Illinois Biometric Information Privacy Act (BIPA), and the storage and protection of such data
- Implications of HIPAA and wearable tech

Presenters

Frederick R. Ball, Partner

Neville M. Bilimoria, Partner

Sheila Raftery Wiggins, Partner

June 1, 2023September 22, 2023 by Duane Morris

FDA Issues Recommendations on Artificial Intelligence Software Functions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to promote the development of safe and effective medical devices that use a type of artificial intelligence (AI) known as machine learning (ML). The draft guidance further develops FDA’s least burdensome regulatory approach for AI/ML-enabled device software functions (ML-DSFs), which aims to increase the pace of innovation while maintaining safety and effectiveness.

Read the full Alert on the Duane Morris website.