Representative Mike Honda (D) of California’s 15th District has introduced the Health Care Innovation and Marketplace Technologies Act of 2012 (H.R. 6626) to introduce some order and promote the world of mHealth.
The bill aims to accomplish two basic goals: to make funding more easily available for the development of mobile healthcare solutions and to create an Office of Wireless Health in the FDA to regulate mobile health.
The bill specifically excludes regulation of electronic health records as this is addressed elsewhere in US law.
Mobile technology is a rapidly growing area that is integral to the future of medicine. Providing funding for development in the field is certainly advantageous to keep the US competitive in the market. It’s difficult to imagine any viable argument against this kind of funding.
The second goal of the bill requires more attention. As is true for all forms of regulation, there is a trade off. Regulation slows the process of development which impedes the development and deployment of technology. On the other hand, regulation aims to protect the people (in this case, patients).
There are two areas in mHealth that have different regulatory concerns: technology designed for patient use and technology designed for use by healthcare providers.
Technology designed for patient use is currently not evaluated for accuracy or efficacy by any regulatory organization. They are directly made available to patients without the requirement of consultation by a healthcare provider. The benefits to patients are pretty clear in the creation of a regulatory body that ensures that patients are not being misled.
Technology designed for the use of healthcare providers, on the other hand, does not have such a problem. In the US, there are already plenty of regulations regarding who can practice as a healthcare provider; therefore, it seems unnecessary and counterproductive to impede the process of development in a field where the users can be trusted to properly evaluate the usage of mobile technology. Healthcare providers in the US are fully accustomed to evaluating and new tools and procedures that are introduced to their practice.
What is your opinion on the possibility of the FDA regulating mHealth technology?
Sources: H.R. 6626