Hospital Developed Technologies: Key FDA Regulatory Issues

As technological advancements allow for new and innovative ways to improve healthcare delivery, hospitals are increasingly investing in the development of in-house technologies such as laboratory developed tests (LDTs), telemedicine systems, and clinical decision support software. The functionality of these technologies may render them subject to regulation by the US Food and Drug Administration (FDA). Hospitals will need to understand whether and how FDA policies apply to their products.

Topics will include:

• FDA’s evolving policies for LDTs
• FDA’s role in promoting precision medicine and next generation sequencing based tests
• How FDA’s device regulations may affect hospitals’ efforts on big data and data analytics
• The impact of FDA’s digital health policies on telemedicine, health IT, and other digital health technologies

For more information, please contact Talia Baghdoyan at +1.202.739.5283 or talia.baghdoyan@morganlewis.com.