FDA and mHealth: Upcoming FDASIA report implications

In watching what is going on with the FDA and mHealth, I’ve become a bit more nervous on the topics that are lying “in between the lines” of what the FDA is working with the ONC and FCC to determine where government fits in to the oversight and regulation of the apps. Most of the articles I read keep mentioning the apps that are medically oriented – which there are thousands – and then they slide in the software just once in a while. It’s the software that I am concerned with.

In an article from mobihealth news  March 3rd, Bradley Merrill Thompson talks about current events with the Food and Drug Administration Safety and Innovation Act (FDASIA) and the PROTECT Act. Congress gave specific direction to convene a working group which included the FDA (Food & Drug Administration) , ONC (Office of the National Coordinator for health information technology), and FCC (Federal Communications Commission) to make recommendations for the regulation or lack of regulation for HIT. The report from the group is due at the end of this month and frankly, based on my research, we don’t have a really good idea of what they are going to come out with. I talked about some of the questions that Congress recently sent to the FDA in a letter in this blog.

In the article from Mr. Thompson, he gives us a quick review of the Power Point that the FDA presented (Here and then click on the FDASIA Recommendations) and picks out some very good items that the FDA report needs to answer. He refers to slide 35 and notes that the FDA should be very concise about what software is regulated and what is not. This is one of those points that I cringe at. When you say software to me I am thinking electronic medical records but the overarching “software” really can refer to mobile apps or software that is privately produced by either individuals, organizations, or companies to assist with connecting the patient to medical/disease information, patient information collection or even interaction with clinical providers, among many others. It also specifically calls to software that is directly related to or interacts with a medical device. This is truly the first door that the FDA could reasonably step thru to have more oversight and regulation of medical software – specifically electronic medical records.

The second slide he refers to, 36, speaks to defining requirements. These requirements are from development to deployment and then the post deployment updates for the apps. We, in the industry of healthcare IT, need to know the requirements before we start building these apps. Otherwise, the development is severely impacted financially. You can imagine that you spend, for example, 100 hours creating the app and for each of the hours you paid the developer $60. Then you find out after you’ve finished the app and are ready to deploy it to the public that you don’t meet the FDA requirements. That is a lot of money for any business to absorb. Additionally, if you have already deployed the app and are doing updates then you have the same concerns. And next Mr. Thompson notes that slide 37 truly drives home the fact that these regulations need to be entrepreneur friendly. Again, the regulations and requirements for the software need to be known or communicated as well as reasonable.

Generally, the FDA, ONC and FCC should be looking at which software or apps directly touch the patient and medical devices, create clear, concise and communicated regulations so that the entrepreneurs, established companies and organizations can adhere to the regulations at the very beginning. They should also consider for those apps or software already established what the reasonable regulations and timeline for any changes required should be. The industry is very far along and has complex software that could be adversely affected and the economic impact could be significant.


Any thoughts on the upcoming report and it’s potential impact on mHealth?



About Tisha Clinkenbeard

Born and raised in a rural Texas town, went off to college in the big city and now I'm living in a rural town and working in the big city. I have a loving, supportive husband, fellow adventurer and love of my life as well as 4 kiddos and 2 dogs. We love traveling, adventures and spending time together. My goal is to share what I find Round & About through the lens of my camera, in the news of healthcare and out in the world, with YOU! View all posts by Tisha Clinkenbeard

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