mHealth: Regulation vs. Innovation

In mid-February of this year, I wrote an article on Mobile Health App Regulations: FDA & HIPAA, citing the several regulatory bodies that oversee mobile health apps and medical devices. The debate, and need for a balance between regulation for the safety of public health and the need to allow technological innovation and entrepreneurship to flourish with reasonable time-to-market is still ongoing in the health IT world today.

I still believe we need a cohesive and productive collaboration between every regulatory agency that touches mHealth as a way of streamlining processes and preventing wasted resources and time. Doing away with regulations and compliance standards entirely won’t work for the health industry, as it undermines patient care efforts and allows untested and potentially harmful products to market, and would ultimately do a major disservice to public health.

But the current timeline for FDA (Food & Drug Administration) clearance and exorbitant fees that greet technology innovators is not the right answer either (for example – the medical imaging software company, MIM Software, spent roughly $150,000 and more than two years to achieve FDA clearance).

Tatiana Melnik, health IT attorney for Dickinson Wright and frequent guest speaker during Online Tech’s webinars, forwarded an article from the Washington Post on this very issue, aptly titled Health-care Apps for Smartphones Pit FDA Against Tech Industry. From this article, I learned of a coalition called Health IT Now! The group represents healthcare providers, patient advocates and health insurance companies.

Health IT Now! believes “timely and consensus legislative action is critical, necessary and possible this year to create a basis for future action.” They support not only HIT (Health IT Exchange), but also the improvement of patient care through developing other technology that affects the quality, accuracy and efficiency of care; whether it’s about managing chronic care or identifying and eliminating unneeded care.

Focusing on the real benefits of health IT is key to moving forward and providing transparent, clear expectations for medical mobile devices and app developers. For example, the coalition states that health IT can “reduce administrative costs and eliminate the problem of duplicative or lost test results, which today accounts for approximately 20% of all tests.”

While the transition from paper records to digital by use of electronic medical and health record systems has been incentivized by the government, and HIPAA compliance standards upheld by contracted audits still ongoing, the next hurdle is the regulation of mobile health devices.

But where is federal regulation headed, exactly? According to the Washington Post, Jeffrey E. Shuren, head of the FDA’s Center for Devices and Radiological Health, mentioned that the agency may create a website with generic examples of apps that would be exempt, further clarifying where the bar is set for the industry.

Regulation of the app and mobile device industry is required for safety and security reasons, and regulation of those that use the devices is also required to meet compliance standards for handling sensitive health data in a secure way. According to GovHealthIT.com, the ONC (Office of National Coordinator) will provide mobile security tips in simple steps and plain language to small and medium-sized companies that use mobile devices, as early as Fall 2012. The ONC will also offer case studies of actual security scenarios as well as practical tips that can be easily implemented when it comes to handling remote access, data transmission via email, and BYOD (bring-your-own-device).

While regulation may appear to lag behind technology, it’s a given. Technology will always develop at a faster rate than government entities can write up and pass legislation on, and the same goes for higher educational institutions that try to teach it – by the time a curriculum is drafted, the next generation/trend/development has already arrived.

For more about FDA regulation of medical mobile devices, as well as the criteria to determine whether or not your app qualifies, and what type of premarket clearance it will need, watch this video/view slides of our recent webinar on the FDA Regulation of Mobile Health Devices.

Sign up for our upcoming webinar, Overcoming Cloud-Based Mobility Challenges in Healthcare and submit your questions in advance about mobile healthcare security and HIPAA cloud hosting.

References:
Health-care Apps for Smartphones Pit FDA Against Tech Industry
ONC to Offer Mobile Device Security Tips

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