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Monday, June 27 • 10:45am - 12:00pm
#134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy?

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-561-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this session, basic information on regulations of software as a medical device will be provided. Also, the expectation of mobile health devices in terms of quality of life and medical economy and challenges to develop such devices will be discussed.

Learning Objectives

Explain the regulations on software as a medical device including topics discussed in the International Medical Device Regulators Forum Standalone Medical Device Software Harmonization Working Group for the utilization of mobile health for enhancement of quality of life; Discuss the potential of mobile health in terms of reducing medical costs.

Chair

Madoka Murakami, PhD

Speaker

Academic Perspective
Hiroshi Hosoi

Industry Perspective
Nersi Nazari, PhD

FDA Perspective
Bakul Patel



Chair
MM

Madoka Murakami

Unit Chief, Division of Regulatory Cooperation, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)

Speakers
avatar for Hiroshi Hosoi

Hiroshi Hosoi

President, Nara Medical University
Hiroshi Hosoi, M.D., Ph.D. is a president of Nara Medical University in Japan. He is a doctor who specializes in Otorhinolaryngology. In 2004, he found a new sound conduction pathway “cartilage conduction,” which is different from the two previously known sound conduction pathways, i.e., air and bone conductions. This new pathway has been applied to medical equipment, e.g., hearing aids and to non-medical equipment, e.g., cell phones and... Read More →
avatar for Nersi Nazari

Nersi Nazari

Chairman and Chief Executive Officer, Vital Connect, Inc.
Nersi is Chairman & CEO of VitalConnect, a medical device and healthcare solutions company applying advanced biosensor technology and surrounding data management systems to deliver an innovative platform that enables clinical-grade continuous monitoring of vital signs. He is a veteran technology entrepreneur with more than 25 years of experience in technical innovation, corporate management, and venture funding. He has a doctorate in electrical... Read More →
avatar for Bakul Patel

Bakul Patel

Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical device software. He is the FDA liaison between the FCC and the ONC and chairs the International Medical Device Regulators Forum (IMDRF) "software as a medical... Read More →


Monday June 27, 2016 10:45am - 12:00pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA