There’s a medical app for that – or not: Regulatory threats to mobile health information technologies
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About This Event

Event Summary
Mobile technologies are revolutionizing health care, but outdated federal regulation may discourage their development.  At an AEI event Wednesday morning, Joel White of Health IT Now and Jon Potter of Application Developers Alliance joined AEI's J.D. Kleinke to discuss the shortcomings of federal regulation of mobile health information technologies.

Kleinke explained that health information technology has long benefited from bipartisan support, evidenced by former president George W. Bush's establishment of a health information technologies certification program and its later expansion under President Obama.

However, despite their bipartisan appeal, medical apps and other mobile health information technologies are subject to ill-suited federal regulation, most recently under the U.S. Federal Drug Administration (FDA) user fee bill. As White explained, this regulatory structure — developed in 1976 to oversee medical devices — is outdated, vague and unable to keep pace with rapidly developing technologies. The uncertainty of this regulation discourages potential investors and inventors from developing technologies that may be subsequently rendered unprofitable by the FDA's decisions.
As the FDA begins to regulate these technologies, the speakers urged Congress to step in and create new legislation that is as simple and innovative as the technology it regulates.
-- Catherine Griffin

Event Description
With their potential to dramatically lower costs and enable better quality of care, mobile apps are and will continue to be among the most innovative of health information technologies.  But these products face inconsistent and uncertain regulation from numerous U.S. federal agencies.

In order to promote both patient safety and a robust and innovative market for these crucial technologies, there must be a simple and clear regulatory framework to foster this continuously evolving industry. This media briefing will detail the challenges federal regulation currently poses to innovation and possible solutions for promoting consumer safety and innovation.

Full video will be posted within 24 hours.

Agenda

8:45 AM
Registration

9:00 AM
Panelists:
Jon Potter, Appication Developers Alliance
Joel White
, Health IT Now
 
Moderator:
J.D. Kleinke, AEI

10:30 AM
Adjournment

Event Contact Information

For more information, please contact Catherine Griffin at [email protected], 202.862.5920.

Media Contact Information

For media inquiries, please contact Véronique Rodman at [email protected], 202.862.4871.

Speaker Biographies

J. D. Kleinke is an expert on health care business strategy and entrepreneurship and was instrumental in the creation of four health care information organizations. He has also advised established and start-up companies on health care business, product and technology strategy. Kleinke writes on the business of health care, health insurance and benefits as well as about doctors and the culture of medicine. His books include “Bleeding Edge: The Business of Health Care in the New Century” (Jones & Bartlett Learning, 1998), “Oxymorons: The Myth of a U.S. Health Care System” (Jossey-Bass, 2001) and “Catching Babies” (Fourth Chapter Books, 2011). At AEI, he is studying the interplay between health policy, health care market dynamics and health venture formation; the influence of information technology and medical technology on the overall health economy; and the impact of medical culture on health care organizations, markets and public health.

Jon Potter
is president of Application Developers Alliance. Potter founded the Application Developers Alliance after 12 years as the executive director of the Digital Media Association, which represented pioneering digital media companies such as Apple, Pandora and Amazon.com. He brings to the position more than 30 years of experience in building and managing coalitions, policy advocacy, political consulting, strategic planning and legal issues. Before his career in industry associations, Potter was a senior vice president at the government relations consulting and investment advisory firm Columbus Newport LLC. Before that, he was an associate attorney at the Washington, D.C., law firm Weil, Gotshal & Manges, where he specialized in policy and government relations work on issues such as digital copyright. Potter launched his advocacy career while a law student at New York University, managing political and non-profit fundraising from his dorm room.

Joel White
joined the Health IT Now Coalition — a diverse group of 63 organizations representing patients, health care providers, payers, employers and unions that foster technology and information in health care to improve care and lower costs — in 2007 as its executive director. White is on the boards of directors of America’s Health and the Newborn Foundation.  He is a member of Bloomberg BNA’s Health IT Law and Industry Report Advisory Council and is the chair of the Health Advisory Committee of Broadband for America.  Before joining Health IT Now, White spent 12 years on Capitol Hill where he helped enact 9 laws, including the 2002 Trade Act that created health care tax credits, the 2003 law that established the Medicare prescription drug benefit and Health Savings Accounts, the 2005 Deficit Reduction Act and the 2006 Tax Reform and Health Care Act, which reformed Medicare payment policies. 

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