Operations and Implementation
As health care providers continue to increasingly depend on telemedicine to deliver care to a broader population and to reduce the overall cost of its delivery, legal and regulatory questions remain. Devices and mobile medical applications that enable the delivery of telemedicine services are subject to a complex web of regulations by multiple federal agencies, including the Food and Drug Administration (FDA), the Federal Communications Commission (FCC), and the Federal Trade Commission (FTC). Of all of these agencies, the FDA has been particularly active in its promulgation of policies for this slice of the industry - most recently issuing draft guidance in August 2016 on device modification policy. But the challenge for manufacturers of mobile medical apps and devices remains -- understanding how to navigate the process of categorizing your device and state its "intended use" to the agency. This session will help attendees understand how to approach this process, the remaining questions/gaps in the FDA guidance and how to manage them, and importance of recognizing the FDA as a partner throughout the lifecycle of the devices it regulates.
Bethany Hills is a Member and the Chair of the firm's FDA practice. She leverages deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help international and domestic health technology companies enter and navigate the US health care market. Bethany has represented the full breadth of health care provider businesses — hospitals, physicians, accountable care organizations, developmental disability specialists, and others — in a broad range of regulatory, reimbursement, and US and international compliance matters. Through that extensive representation, she has developed an understanding of compliance issues and of the US health care reimbursement system that far surpasses that of most FDA lawyers. She uses her strengths in these areas to provide clients with insight on how regulatory policy, reimbursement issues, and pricing shape innovation, and to help them use that knowledge to develop viable value propositions. Clients rely on Bethany’s practical guidance to help them invest and collaborate strategically, by identifying technologies that are likely to complement the health care delivery system, clear FDA regulatory hurdles, and provide a healthy return on investment.
Bethany also helps companies manage the full range of FDA regulation issues, from inspections and investigations through complex regulatory challenges affecting everything from product approvals and product labeling to collaborative research, supply, and distribution agreements. She advises clients on laws applying to referral relationships, clinical trial compliance, licensure, and security and privacy issues as well as on the ins and outs of government and third-party reimbursement.
Tuesday, April 25
10:45 AM – 11:14 AM