Summary: New bill proposed to help regulate mobile health. Let’s talk about the Healthcare Innovation and Marketplace Technologies Act.
Healthcare Innovation and Marketplace Technologies Act
A new bill was proposed on December 3, 2012 by Mike Honda, Representative from California, to provide structure and regulation over the mobile health industry. The proposed bill is entitled The Healthcare Innovation and Marketplace Technologies Act (HIMTA). The premise for the bill is to remove barriers in wireless health such as smartphones, encourage and promote the development of new technologies and create a marketplace for innovation in the mobile health field.
By 2015, it is estimated there will be more than 500 million smartphone users using medical apps. There are so many medical apps emerging, but how do you know the data is valid? It is becoming much like the internet itself. You can find any information for which you are searching, but is there any way to make sure the information is current, valid, and accurate? The bill was created to try to address these type of issues.
There has been buzz about a bill such as this for at least a couple of months. There has been a great amount of speculation as to who would have regulatory authority over mobile health. Some of the proposals have included: FDA’s Center for Devices and Radiologic Health, another office within the FDA or yet a separate entity under the Department of Health and Human Services (HHS).
Mr. Honda’s bill contains the following components:
- Create a separate office under the Federal Drug Administration called the Office of Wireless Health. This office will provide consistent regulation over mobile health and all of the issues associated.
- Create a prize program to incentivize developers to continue in their efforts to create new medical apps. The program would create a challenge-type atmosphere and reward those with the best new medical apps.
- Create a tax incentive/deduction similar to the incentive created for electronic medical records for health information
technology costs not already included as EMR.
- Create a commission of private industry, patient safety/privacy advocates, medical professionals, and government officials to identify and promote 3 up and coming areas of HIT.
- HHS will setup an mhealth developer support program to assist with privacy concerns.
- Create a low-interest loan program available for smaller physician offices to help offset some of the costs.
- Setup 2 grants to help provide training to staff regarding the regulations of mobile health.
There has been a bit of opposition to this bill as well. Developers are concerned medical apps will not be approved in a timely manner and may slow the process of innovation.
Stay tuned to see if this bill does indeed pass. I think it holds a lot of promise. I do think there should be some sort of regulation of medical apps to provide some level of confidence in the information found in medical apps. Those apps that go through the approval process will provide a higher level of credibility.
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