Dr. Marlowe Schaeffer-Polk, attorney, physician and founder of Medlawguard, and Mr. John Steinbach, Chief Technical Officer and co-founder of Medlawguard, a healthcare risk mitigation firm, discuss the recent Draft Guidance on Mobile Medical Applications.
Marlowe and John:
- Examine the scope of the guidance, and highlight what are/are not regulated by FDA
- Distinguish between Medical Devices and Mobile Medical Applications
- Clarify the three categories of Mobile Medical Applications
- Share some potential risks they pose to patients and providers
This interview was conducted by Dr. Jack Varga, Physician Informaticist, Veterans Health Administration.