With Apple, Google and just about everyone else jumping on the health and fitness bandwagon the FTC isn’t so sure it’s a good idea.
Federal Trade Commissioner Julie Brill has some serious reservations about the collection of health data by consumer apps, particularly in light of the way that large corporations are increasingly making use of powerful big data analytics to sort through (and draw conclusions from) the growing mountains of information being sucked up every day.
At The Hill’s Tech in Policy event in Washington DC Wednesday morning Commissioner Brill made it clear that she considers collection and use of data to be one and the same — and she thinks there should be heavy restrictions on apps gathering health data. Obviously this would have a major impact on the future of mobile health.
Brill talked about a case where Target was able to predict pregnancies of its female customers using big data techniques and inadvertently let the cat (or baby in this case) out of the bag before one woman had a chance to tell her family.
Brill said she fears that the vastness of big data, particularly in health, might pose a serious compliance challenge for twentieth century laws.
Commissioner Brill is leading the FTC’s efforts to review consumer privacy and security in healthcare and technology. While the FTC typically is not involved with the enforcement of healthcare data it could get involved if health app developers are not being clear with consumers about what kinds of data they’re collecting and how it’s being used.
Morgan Reed, executive director at the Association for Competitive Technology (ACT) who moderated the round-table discussion where Brill raised her concerns added, “There have been incredible developments in mobile technology that help students learn and improve health outcomes. We need a regulatory environment that encourages innovation while protecting consumers in areas that make a real difference in our lives.”
It seems to me that the FTC aren’t the only ones who should be looking into this issue. One government agency that should have the loudest voice is the FDA – they are, after all, supposed to be the ones who regulate all things health related. Another voice that should be heard is the office of the Surgeon General.
As we mentioned in an article published last month Could Apple’s HealthKit initiative come under FDA scrutiny?
Last December Apple met with the FDA to get some clarification about what types of health apps and devices would or would not fall under FDA rules and regulations. It’s an interesting question that a lot of device makers are going to have to consider as more and more health-oriented wearables come to market.
When it comes to medical devices the FDA has a slew of rules and regulations. There are all sorts of things that are required to go through rigid clinical tests and trials, reports have to be filed and the FDA has the power to regulate, accept or reject medicines and medical devices.
And as Satish Misra, MD and Iltifat Husain, MD pointed out:
In the example Apple gave in their keynote address — they explained how Healthkit would be able to get a blood pressure reading from a peripheral device, send it the native Health app, and if the reading was high, the patient’s doctor would be notified. In this example, if its third-party software that is generating the “high” alert and Health/HealthKit are just transmitting that message, then Apple would most likely avoid FDA oversight. If, on the other hand, Apple’s software is just getting the number and recognizing it is high, then it would most likely fall into the category of clinical decision support where FDA oversight is just starting to be defined.
It’s going to be an interesting regulatory mess, but I guess that’s the cost of technological progress these days. Here’s hoping the regulators get it right.