[author: Antoinette F. Konski]
On December 3, 2012, Representative Mike Honda of California introduced The Healthcare Innovation and Marketplace Technologies Act (HIMTA), to foster more innovation in the health care industry by removing barriers in wireless health. See HR 6626, attached.
Office of Wireless Health
The bill would establish an Office of Wireless Health at the Food and Drug Administration (FDA) to coordinate with other governmental agencies and private industry, and provide recommendations to the FDA Commissioner on how to develop and maintain a consistent, reasonable, and predictable regulatory framework on wireless health issues. The goal of the Office of Wireless Health, according to Representative Honda’s office, is not to expand the mandate or responsibilities of the FDA, but rather to seek to better clarify and simplify existing regulations while providing sorely needed expertise in this important field.
The bill will also establish an mHealth developer support program at the Department of Health and Human Services to help mobile application developers build their devices in line with current privacy regulations. An array of support resources are envisioned, such as a national hotline, an educational website, and a yearly report that will help translate the wide array of privacy guidelines into common English.
Other goals of the bill include creating a marketplace for innovation by creating a low-interest small business loan program to clinics and physician offices for the purchasing of new health information technologies. It also would create a tax incentive program to allow medical providers to deduct costs related to non-electronic health record information technology. A grant program would also be established to assist medical care providers in retraining their employees into new positions that use health information technology.
Implications for Personalized Medicine
Personalized medicine is more than targeted therapeutics, it also involves direct patient involvement in monitoring and selecting therapies. Smart phones and other mobile devices will lead the way, offering a cost-effective truly mobile means to collect and monitor patient care. This bill, if enacted, should foster innovation in this growing trend in health care delivery and facilitate the coming electronic revolution in health data storage and management.