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FDA Regulation of Digital Health: Recent Actions by FDA and Congress

  • Dell Medical School - Health Discovery Building Room 1.204 1701 Trinity Street - Room 1.208 Austin, TX 78712 USA (map)

Join the Texas Health CoLab for their monthly learning series on the last Thursday of the month.

Digital health is one of the most explosive areas of innovation with software products aimed at wellness and medical applications. Depending on the intended application, software may meet the FDA’s definition of a medical device and be subject to an extensive set of FDA regulatory requirements. Therefore, Developer Beware! It is critical for innovators to know early in the development cycle whether their software is or is not a medical device and, if so, what regulatory requirements apply so they can accurately plan the time and cost to market. Recent actions by the FDA and Congress in the last two years have dramatically changed the regulatory landscape for digital health products.

In her talk, Carol Pratt, PhD JD, will provide a tutorial on FDA regulation of medical devices and discuss how software can meet the definition of a medical device either as standalone software or as a component or accessory. Dr. Pratt will then cover how the FDA currently is regulating different categories of health/medical software and will discuss the impact of the 21st Century Cures Act on the FDA’s current regulatory framework for digital health products. The scope of digital health products that Carol will cover includes wearables, mobile medical apps, clinical and patient decision support software and AI. She also will discuss how the regulatory position of digital health products can affect business and payment models.


About the Speaker
Carol Pratt is an experienced regulatory attorney and partner at Lee & Hayes whose practice focuses on regulatory issues associated with the research, development and FDA requirements that apply to bio-medical and health products. She provides practical, strategic advice to early stage and established life sciences clients on regulatory issues across the product lifecycle, from pre-clinical and clinical research, FDA pre-market requirements, labeling, promotion and advertising, post-market surveillance and enforcement. Carol advises industry clients on a diverse spectrum of medical and health products, including medical devices (hardware and software), wearables, drugs, stem cells, HCT/Ps, dietary supplements, medical foods and cosmetics.

A distinctive aspect of Carol’s legal practice is her emphasis on coordinating regulatory and IP strategies to determine the most appropriate regulatory pathway and to optimize cost effective product development. In 2016, Carol left a multi-purpose international law firm to join the life sciences group at Lee & Hayes, a predominantly IP law firm.  Lee & Hayes’ is unique in offering both IP and FDA services to its life science clients.

Before obtaining her law degree, Carol obtained her Ph.D. in neuroscience and conducted research on the spinal control of movement for 16 years at the NIH, Purdue University and the Neurological Sciences Institute in Portland, OR. Prior to her career in neuroscience, Carol coached at the college

Earlier Event: July 21
Your Health, Your Medical School
Later Event: August 8
The Population Health Conference