News of Farzad Mostashari's decision to resign as head of the Office of the National Coordinator (ONC) for Health Information Technology has created concern among some mHealth advocates who believe his departure will create transition issues in the ONC that may affect its participation in the Food and Drug Administration Safety Innovation Act (FDASIA) study of a risk-based regulatory framework that will govern health IT, including mobile medical applications.
"A leadership change at ONC will come at an awkward time for the timely completion of the FDASIA 618 committee work and sorting out the confusion over the regulation of mobile health and clinical decision support software," said Robert McCray, president and CEO of the San Diego-based Wireless Life Sciences Alliance. "For the sake of consumers and patients we urge (Health and Human Services Secretary Kathleen Sebelius) to quickly identify a knowledgeable replacement with consensus-building skills and a desire to unleash the power of technology in healthcare, including self care." Article