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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.


Madoka Murakami, PhD


Academic Perspective
Hiroshi Hosoi

Industry Perspective
Nersi Nazari, PhD

FDA Perspective
Bakul Patel


Madoka Murakami

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

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... 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... Read More →
avatar for Bakul Patel

Bakul Patel

Director, Digital Health Center of Excellence (DHCoE), CDRH, FDA, United States
BAKUL PATEL is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate... Read More →

Monday June 27, 2016 10:45am - 12:00pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices/InVitro/CombProd, Session