First, when electronic stuff directly impacts health, the folks at White Oak get interested. It’s really that simple. They take the public health very seriously, and any IT people new to the health industry need to appreciate that.
Second, when confronted by a situation such as this, FDA’s natural reaction is to interpret the scope of their authority very broadly, and then propose a tiered approach based on risk. So they want everything in the tent, but once in the tent they’re willing to make distinctions. A lot of people back in 2008 thought FDA’s proposed regulation on Medical Device Data Systems was expansive, but Dr. Shuren’s declaration that HIT software is a medical device is orders of magnitude broader in scope.
Third, FDA is not deterred simply because a regulatory task is complex or the technology is important to the point where speedy innovation is desirable. If that were the case, FDA would’ve abandoned regulating pacemakers long ago. Actually, high complexity and high public-health importance are archetypal circumstances for FDA to get involved.
Fourth, prior to yesterday, our orientation was to think about traditional medical devices as the stuff that touches the patient, and then to believe that the software and hardware that moves farther and farther away from that patient contact is less likely to be regulated. But the conclusion that FDA can even regulate the electronic health record (in many cases the point farthest from the patient) means that we now need to rethink the agency’s view on all the stuff that connects those two points. We must think about the various hardware and software tools used for the communication between those elements.
Fifth, from there, it is a short hop to looking at the hardware and software that typifies mHealth applications. If the sensor that collects the data from the patient is a medical device, which we always knew if the use was medical, and if the EHR that is the ultimate repository of that information might also be a regulated medical device, we need to seriously think about whether FDA intends to regulate cell phones that are anything other than generic communication instruments. In my first article, I described how FDA might indeed regulate cell phones based on the claims made about them. That was theory, which now seems more likely to materialize as reality. As I did in that article, I would argue that a phone for which the seller makes no special medical claims is not a medical device in the hands of that seller. But any move toward suggesting that the phone is a specialized tool useful for medical communication apparently means FDA might get interested.
Sixth, frankly I interpret Dr. Shuren’s comments as the beginning of a conversation. I did not hear him dogmatically say what the future will look like. Quite the opposite, I heard him reaching out to stakeholders for input. While he was fairly emphatic on the point that these software products are within their legal authority, he was expressly inviting comments on the degree of regulation required. I did hear him put a stake in the ground on the issue that something should be done, and I think industry needs to respond. The FDA public meeting on interoperability held during the last week of January similarly showed a willingness by FDA to collaboratively discuss the best approach.
And seventh, however the HIT and mHealth industries respond, as with anyone who participates in the health industry, the approach will need to meet one critical criterion. As a wise, old food and drug attorney once told me (please don’t tell my Dad I called him “old”), it all starts and ends with concern for the patient. Whatever approach emerges, whether it’s FDA regulation or a voluntary industry code that allows for self-regulation, it needs to have as its essence a focus on protecting the patient.
In my last article in this series, I will offer some views on specifically where I think the regulatory environment is going for mHealth. But before I get there, my next article will focus on FDA’s relationship with hospitals and other users of the technology. I’ll be examining what discretion users have to modify the stuff they buy. Hopefully you’ll find it useful.
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