Event Overview

As many mobile apps pertain to health, the FDA is focused on the subset of mobile medical apps that are subject to oversight by the FDA to promote innovation and to protect patient safety. The FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad applicability of mobile apps, the FDA has issued its guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority. This virtual briefing will give you insight into the importance of this guidance and what you need to know to apply it for your organization’s journey to mHealth.

Learning Objectives:
• Explore what the new implications from this guidance mean to the healthcare industry
• Discuss how the guidance will this impact manufacturers and distributors of apps
• Explain how this guidance will simultaneously have a positive effect on innovation and patient safety
• Study the risk based approach to mobile medical app and medical device oversight


Program:

Time Session
11AM-11:30AM CT The FDA’s Mobile Medical Application Guidance: 101 Overview and Industry Implications
  Abstract: This guidance explains the FDA’s intentions to focus its oversight on a subset of mobile apps. Mobile medical apps as defined include only those mobile apps that meet the statutory definition of a device and either are intended to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device. This session will explore the evolution of the draft guidance and the significant updates provided in the final guidance.

Learning Objectives:
  • FDA regulations and its treatment of software including mobile medical apps
  • How the final guidance may modernize how mobile medical applications are regulated.

Speakers:
Robert Jarrin, JD
Member
mHIMSS Advisory Council
11:45AM-12:15PM CT Examining the Impact of Mobile Medical Applications Risk Awareness for Health IT Professionals
  Abstract: For mobile medical apps, manufacturers must meet the requirements associated with the applicable device classification. If the mobile medical app, on its own, falls within a medical device classification, its manufacturer is subject to the requirements associated with that classification. A mobile medical app, like other devices, may be classified as class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval). This session will discuss the three types of apps that the final FDA intends to regulate, what apps are not subject to regulation, and what apps are up to FDA’s enforcement discretion.

Learning Objectives:
  • Examine the risks and uncertainty related to use of mobile apps and devices
  • Explore what actually defines an app and a medical device
  • Examine what provider organizations need to understand about mobile app and medical device regulation and how to comply

Speaker:
Mark Dahlby, JD
Attorney
Hall, Render, Killian, Heath & Lyman P.C.
12:30PM-1PM CT Medical Mobile Applications Usage: Patient Safety Implications
  Abstract: Care coordination is critical to achieving patient safety, and real time access to healthcare information is greatly enhanced through mHealth. This discussion will review how the FDA guidance and FDASIA framework recommendations will impact the use of medical mobile applications.

Learning Objectives:
  • Discuss patient safety enhancements related to use of mobile medical applications
  • Examine how the integration of apps to legacy health IT systems will impact data sharing and patient safety
  • Discuss how mobile medical application usage will impact care coordination

Speaker:
Morgan Reed
Executive Director and mHIMSS Legal/Policy Task Force Chair
Association for Competitive Technology
1:15PM-1:45PM CT Redefining Mobility in Tomorrow’s Hospital…Today
  Abstract: Health IT often ranges in complexity from devices that can take years to master to everyday solutions found in many current households. When it comes to putting mobile devices to use in ways that help to improve patient outcomes and overall satisfaction, ease of use and overall convenience are key. Follow one community hospital that has taken a proactive approach to this challenge by utilizing smart phone technology to enable secure secondary patient result notifications, voice and text communications, and other alerting functions all in a form factor that many can already use without any formal training.

Learning Objectives:
  • Understand the advantages and technical challenges associated with using technology originally designed for consumer use in a healthcare environment.
  • Learn about the power of integration as part of a mobility strategy that ensures value is added to the patient care experience.
  • Explore cost reduciton and care quality improvement through the use of mobile automation workflows, integrated applications, and other device connectivity as part of an overall healthcare technology strategy.

Speakers:
John Britton
VP, Information Services
Fisher-Titus Medical Center

Robert Jarrin, JD

Member
mHIMSS Advisory Council

Robert Jarrin is Sr. Director of Government Affairs for Qualcomm Incorporated and is based in Washington, DC. Jarrin represents Qualcomm on US domestic regulatory matters relating to wireless health and life sciences. His areas of responsibility include health policy, FDA regulatory oversight, CMS reimbursement and the regulation of health information security and privacy as they relate to wireless technology. Jarrin also serves as Co-Chair of the US Policy Working Group for the Continua Health Alliance. Prior to joining Qualcomm, Jarrin worked as a Manager of Strategic Partnerships for Ericsson Wireless Communications, served as a Law Clerk in the White House Office of Counsel to President Clinton and also served as a Law Clerk and subsequent Consultant in the US Department of Justice to Attorney General Janet Reno. Jarrin holds a Bachelor of Arts degree in Government and Politics from the University of Maryland at College Park and a Juris Doctorate from Northeastern University School of Law.

Mark Dahlby, JD

Attorney
Hall, Render, Killian, Heath & Lyman P.C.

Mark Dahlby is an attorney with the law firm Hall Render Killian Heath & Lyman. His practice focuses on the development of new products and business opportunities for a wide range of health care industry clients, including information technology vendors, health care providers, pharmacies, clinical laboratories, medical device and other life sciences companies. He counsels clients on global medical device matters as diverse as regulatory approvals/clearances, clinical trials, supply chain risk management, import/export, advertising and labeling, and post-approval requirements. Previously, Mark worked for GE Healthcare, where he created a compliance department dedicated to global medical device regulatory enterprise risk management, and served in the United States Marine Corps. Mark received his law degree from the University of Wisconsin.

Morgan Reed

Executive Director and mHIMSS Legal/Policy Task Force Chair
Association for Competitive Technology

Morgan Reed is a widely known and respected expert on the government impact on technology innovation. As ACT’s Executive Director, Morgan specializes in issues involving application development relating to privacy, intellectual property, competition, and small business innovation. His expertise and knowledge has been sought by the House and Senate in multiple hearings while his commentary and insight is a major draw for news networks including Fox Business News, MSNBC, CNBC, CNN, and ABC Radio. He is consistently quoted in the trade and popular press, ranging from the Wall Street Journal and the Washington Post to Ars Technica and Slashdot. His recent work has focused on outreach to app developers to help them recognize and respond to concerns about privacy in the mobile marketplace.

John Britton

VP, Information Services
Fisher-Titus Medical Center

John Britton has 17 years of experience in healthcare IT and has worked with organizations ranging in size from a critical access hospital to a large Integrated Delivery Network. In his current role as vice president of information services at Fisher-Titus Medical Center, Britton has assisted in a clinical transformation implementing information technology solutions that have revolutionized the way the organizations treat patients. Key concepts to Britton’s latest project include patient safety, information accessibility and ease of use. Using industry standard best practices as well as innovative clinical workflow designs, each organization has redefined “ease of use” under his leadership. Britton currently holds a bachelor’s degree in sociology from the University of Bowling Green.

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mHIMSS is the globally-focused mobile initiative of HIMSS entirely focused on the use of mobile technologies to improve quality, accessibility, safety, and cost-effectiveness of care. mHIMSS builds on existing strengths of HIMSS: Convening stakeholders, Sharing knowledge, Providing world-class education, Public policy, and Research.


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