When your phone is also your doctor
March 13, 2015 7:04 PM   Subscribe

The early days of Apple's ResearchKit software seem set to revolutionize clinical research recruitment, with one Parkinson's study enrolling thousands of people in just a few hours. Apple's new ResearchKit: 'Ethics quagmire' or medical research aid?, from The Verge, discusses some of the ethical quandaries surrounding recruitment for medical studies via mobile app. A follow-up article discusses some changes already made to the developer guidelines to address some of these concerns about informed consent and data sharing. Ars Technica covers the Food and Drug Administration's regulatory requirements for medical devices and how they may apply to mobile apps, including those using ResearchKit.
posted by Stacey (31 comments total) 24 users marked this as a favorite
 
This is going to be an increasingly important and increasingly complicated issue. It bypasses a lot of the traditional research safety nets like institutional review boards that have been inplemented to protect human research subjects, and as such oversight is going to be so so so important.
posted by ghostpony at 7:23 PM on March 13, 2015 [1 favorite]


That's not to say IRB approval is any guarantee of ethical research.
posted by ghostpony at 7:24 PM on March 13, 2015 [1 favorite]


It bypasses a lot of the traditional research safety nets like institutional review boards

Hang on, does it, though? Won't any studies done with these apps have to go through IRB approval?
posted by BungaDunga at 7:25 PM on March 13, 2015 [5 favorites]


I think the IRB is involved at the "create the app and push it out to users" stage, isn't it? This is just a simple extension of "keep a log of your {x,y,z} at times {1,2,3}", except it can nag you repeatedly and you can't lie to yourself as easily.

Yes, there are serious issues with the demographics who can/will participate in ResearchKit. On the other hand, right now all drugs are tested only on poor college kids, so...
posted by RedOrGreen at 7:28 PM on March 13, 2015


and as such oversight is going to be so so so important.

The new Apple iPhone 10 is just injected directly into your blood and lets the appropriate people know if you have problems with drug use, influenza, or throat spiders.

5 fascinating colors and so, so, slim.
posted by the uncomplicated soups of my childhood at 7:30 PM on March 13, 2015 [11 favorites]


The FDA piece is particularly interesting to me as a research compliance professional. We're starting to see people who have no idea they're creating an app that will fall under medical device regulations, so they're not doing the regulatory stuff they should be doing in the early stages of developing a medical device. Which can mean that the data they're collecting won't be acceptable to the FDA and they may have to backtrack majorly and redo studies if they want FDA approval once they figure out they need it, wasting time and (taxpayer) funds and human participants' time and goodwill.

The regs are lightyears behind what researchers actually are doing, and researchers have no idea the regs apply to them. Medical apps are a hot mess in research ethics and research compliance.

But an interesting hot mess, at least to me.
posted by Stacey at 7:40 PM on March 13, 2015 [14 favorites]


Or they'll just roll out the app like Uber and hope that the IPO will get them FU money before the government notices.
posted by sammyo at 7:47 PM on March 13, 2015 [2 favorites]


Didn't Google Health try to tackle this back in the day? I don't remember if they explained why they failed.
posted by RobotVoodooPower at 7:47 PM on March 13, 2015


Gah, throat spiders?? Fuck. Dude, some of us read this site at night. In bed. Ugh. I can't even storm off in a huff.
posted by nevercalm at 7:52 PM on March 13, 2015 [7 favorites]


One time I called my doctor and got through the nurse phone maze and I asked her, "If I promise to never use google again, will you reassure me that I don't have tetanus of the eyeball?" After she laughed in excess of 120 seconds, she said, "Well, it'd be tetanus of the central nervous system and you'd die, but don't worry, you're fine."
posted by Eyebrows McGee at 8:09 PM on March 13, 2015 [19 favorites]


Ricky Bloomfield is a hospitalist and Director of Mobile Health Technology Strategy and Duke University. He's pretty excited about ResearchKit.

ResearchKit and the future of healthcare

ResearchKit: More Details

There is a huge amount of work being done now to create a Learning Healthcare System, a system in which clinical data is systematically brought back into the research community to provide orders of magnitude more data than researchers have now. There are big issues to overcome -- driven largely by issues of interoperability and privacy -- but the potential is so huge that those issues will eventually be overcome.

ResearchKit comes at this from a different angle: it's not about bringing in existing medical data but creating a new patient-driven stream of data. It could be another important step towards creating a healthcare system that is much more dynamic and data driven than what we have now. Apple's reach and the ubiquity of the iPhone have the potential of really accelerating this process and making it real much sooner than it would have otherwise. Tim Cook is clearly very excited about it, too. He gave it a very high profile launch --- a big chunk of time during the Apple Watch event.
posted by alms at 8:11 PM on March 13, 2015 [4 favorites]


Didn't Google Health try to tackle this back in the day?

No, it was a personal health record service which was supposed to be a central repository that your health care providers could consult.
posted by Johnny Wallflower at 8:17 PM on March 13, 2015 [1 favorite]


I'd just like Google Translate to work with my insurance forms and documents.
posted by srboisvert at 8:23 PM on March 13, 2015 [2 favorites]


Apple's new ResearchKit: 'Ethics quagmire' or medical research aid?, from The Verge, discusses some of the ethical quandaries

It's too bad Verge only got one ethicist to comment on the subject, and he didn't seem all that informed about it, either. Seemed more like opinions than a discussion of facts, and thus a bit of a missed opportunity. This is pretty revolutionary stuff, and it would have been good to go into the actual ethical and legal questions from well-known people in the field who would know something about the technology and the actual issues at hand (Kaplan, etc.).
posted by a lungful of dragon at 9:54 PM on March 13, 2015 [1 favorite]


On the upside in terms of medical-device compliance issues, less than 5% of the world's population has to listen to anything the FDA says or wants. The majority of Apple's users aren't based in the United States either.

If compliance issues become problematic, there are plenty of other nations that would welcome this method of collecting/using medical data.
posted by The Zeroth Law at 9:54 PM on March 13, 2015 [4 favorites]


My new App is "Mango WormWatch".
posted by benzenedream at 10:30 PM on March 13, 2015 [1 favorite]


Is there research into using neural net learning / AI to identify cancerous cells?
posted by anadem at 10:34 PM on March 13, 2015


There is at least 20 years of using machine learning techniques to try and classify cancerous cells. There are probably 30+ companies based on this.
posted by benzenedream at 10:52 PM on March 13, 2015 [4 favorites]


How do I begin to get more info on companies using machine learning re cancer?
posted by anadem at 11:08 PM on March 13, 2015


Gah, throat spiders?? Fuck. Dude, some of us read this site at night. In bed. Ugh. I can't even storm off in a huff.

Well, yah, there might be spiders on the floor. Ugh. In bed. Dude, some of us read this site at night. Fuck. Gah, it feels like I'm crawling with them.
posted by five fresh fish at 11:24 PM on March 13, 2015


That iPhone 10 scenario is absolutely insane.

An  flagship line will never offer more than three colors.
posted by Apocryphon at 12:45 AM on March 14, 2015 [5 favorites]


It could be another important step towards creating a healthcare system that is much more dynamic and data driven than what we have now. Apple's reach and the ubiquity of the iPhone have the potential of really accelerating this process and making it real much sooner than it would have otherwise.

The parts I worry about are the ones based off this kind of misconception. The iPhone is not ubiquitous. It just seems that way to people in the Apple walled-garden. The iPhone is ubiquitous in the same way that non-white people are minorities.
posted by srboisvert at 4:06 AM on March 14, 2015 [4 favorites]


The iPhone is not ubiquitous. It just seems that way to people in the Apple walled-garden. The iPhone is ubiquitous in the same way that non-white people are minorities.

I'm really confused as to what exactly you mean with this. Is it a classism thing? I have a bunch of thoughts on both this and the general researchkit thing... but i keep running in to this sort of attitude all over the place.

Is it some kind of "the ubiquity of the iphone is socially constructed and exaggerated" thing?
posted by emptythought at 4:38 AM on March 14, 2015 [1 favorite]


They mentioned having sold their 700 millionth iPhone at the thing, so

I mean, yes, that's only about 10% as many iPhones sold as there are people in the world, so obviously that isn't literal ubiquity, but it does seem like they're at least enjoying moderate success with overall market penetration
posted by DoctorFedora at 5:54 AM on March 14, 2015


[A few comments deleted; let's maybe drop the continued derail about "ubiquity" and snark about affluenza.]
posted by taz (staff) at 6:50 AM on March 14, 2015


The thing is, as the article mentions, there are already some pretty huge sampling biases in medical research. It's possible, and even likely, that iPhone users are an unrepresentative sample and yet are still more representative than the samples that medical researchers currently get.

I don't know how I feel about this. On the one hand, the potential seems sort of amazing. On the other hand, I am very uneasy about a huge corporation becoming so central to medical research, although maybe that's naive and that ship has already sailed.
posted by ArbitraryAndCapricious at 7:18 AM on March 14, 2015


It's also worth noting that it's being open-sourced, so it would probably be prudent to rephrase any potential concerns with the word "smartphone" instead of "iPhone"
posted by DoctorFedora at 7:30 AM on March 14, 2015 [4 favorites]


On the other hand, right now all drugs are tested only on poor college kids, so...

Phase I trials, maybe. Phase II and III trials use patients with the target disease state, and those demographics tend to swing older.

Apps can still be a powerful tool even if the recruitment and informed consent process takes place in person. A lot of medical studies use retrospective self-report or periodic phone interviews to gather data, and frankly those methods suck. Passive data collection or even push notification surveys would work better.
posted by dephlogisticated at 7:44 AM on March 14, 2015


No reason ResearchKit can't be implemented in non-smart devices. Fitbits, or swallowed capsules, or whatever.
posted by five fresh fish at 8:25 AM on March 14, 2015 [1 favorite]


Right, exactly. Most of the "controversy," such as it exists, seems to be Apple Grar or Apple-Related Headline Clickbait.

Which often kind of amuses me, because I grew up in the '90s, when Apple was fundamentally a hopeless brand. It still feels like seeing people making "I don't drive a Volvo" an active part of their identity.

Something tells me that this whole thing is going to be an improvement for effective data collection for medical research, especially since what came before was so limited in so many ways.
posted by DoctorFedora at 4:37 PM on March 14, 2015 [1 favorite]


So, this is the timeline that gets Halo in the 2010s. Not good. :-\
posted by MikeKD at 11:58 PM on March 14, 2015


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