Yes, You Can Reconcile The Wide Sharing Of Personal Medical Research Data With Greater Participant Control

from the this-is-how-to-do-it dept

Although the benefits of sharing big datasets are well-known, so are the privacy issues that can arise as a result. The tension between a desire to share information widely and the need to respect the wishes of those to whom it refers is probably most acute in the medical world. Although the hope is that aggregating health data on a large scale can provide new insights into diseases and their treatments, doing so makes issues of consent even trickier to deal with. A new study of Parkinson's disease from Sage Bionetworks, which describes itself as a "non-profit biomedical research organization," takes a particularly interesting approach. Unusually, it used an iPhone app to gather data directly from the participants:

The mPower app, built by Sage with support from the Robert Wood Johnson Foundation, collects data on capacities affected by Parkinson's disease, including dexterity, balance and gait, memory, and certain vocal characteristics, through tasks that make use of iPhone sensors. For example, to measure dexterity, participants complete a speed tapping exercise on their iPhone’s touchscreen. To evaluate speech, participants use their iPhone's microphone to record themselves pronouncing a vowel -- saying Aaaaah -- for 10 seconds. The app also allows participants to track when each task is completed alongside the time they take their medication, to help determine the effects of that medicine on their symptoms. Participants also complete regular surveys, rating the severity of their symptoms and what they think makes them better or worse.

That's a clever use of smartphone capabilities to allow people to become active participants in the study -- citizen scientists, almost -- but hardly a major breakthrough. What is much more impressive is the way in which the study has handled the issue of how widely the resulting data will be shared, and with whom:

Unlike traditional studies, mPower participants are able to choose who to share their data with. Sharing options include only those researchers associated with mPower, or qualified researchers worldwide. So far, over 75 percent of the more than 12,000 mPower participants chose to share their data broadly with researchers. This cutting-edge consent process, which is the driving force behind the decision to widely release the mPower data set, is outlined in a third paper published today in Nature Biotechnology, and represents a sea of change in participant control over data sharing.

There's a double benefit here. Not only are participants given direct control over how their data will be used, but a broader range of "qualified researchers" can gain access. To be classed as "qualifying," researchers must:

demonstrate their awareness and understanding of the data-sharing framework and applied ethics through a short, 18-question examination;

validate their identity to Sage Bionetworks through a variety of approved methods, such as an academic letter from a signing official, a notarized letter attesting to identity or a copy of a professional license;

make a public statement of intended data use, which we can in turn feed back to participants in the spirit of engagement and transparency;

explicitly agree to a 'contract' of data sharing, including the following: (i) downloading, initialing, signing, scanning and uploading a researcher oath to adhere to a code of behavior; (ii) complying with any data-specific conditions of use.

As you might expect, the researchers at Sage Bionetworks are great believers in openness:

As part of living our philosophy, all of our tools, platforms, and products are open source. Our software is available in Github, and our non-software creative works are licensed under the Creative Commons Attribution 3.0 Unported license except for legacy publications in closed journals.

We now dedicate funds to pay author processing charges for full Open Access on research publications and are actively working to free up our backfile of closed publications.

Open source, open access, open data released with informed consent: this is what open science looks like.

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Filed Under: control, medical info, openness, parkinsons, personal information, privacy, research

Free Speech vs. Medical Privacy Hits The Supreme Court

from the seems-like-a-stretch dept

I'm a big First Amendment advocate, but there are certainly times when people claim First Amendment rights that don't make much sense. Take, for example, the case that the Supreme Court recently decided to hear, Sorrell v. IMS Health, in which pharmaceutical companies are claiming a First Amendment right to use data from pharmacies to market to doctors.

The details involve a Vermont law that forbids data-mining companies and pharmaceutical firms from buying up prescription data, compiled by various pharmacies as required by law, to then go and market certain drugs directly to doctors. As you probably know, pharmaceutical firms spend billions every year trying to convince various doctors to prescribe their brand name drug, over the much cheaper generic equivalents (this "marketing" often involves ethically questionable practices). Thus, the data of what's being prescribed is really useful. The Vermont law said that this data couldn't be sold to data mining firms or drug companies without the doctors' consent. The 2nd Circuit appeals court said the law violated the First Amendment. Similar laws from neighboring New Hampshire and Maine had been upheld as Constitutional in the 1st Circuit, which is probably why the Supreme Court agreed to hear this case now -- to settle the split between the lower courts.

In this case, it seems like the 1st Circuit rulings make more sense. The key issue isn't even really the First Amendment rights of the companies to make use of this data, but that the data is available at all. The reason the marketing firms and pharmaceutical companies have access to that data at all is because the government requires the pharmacies to collect such data. Thus, it seems reasonable for governments to also then restrict how that data is used and/or sold in the interest of medical safety. It's not as if the data is public, and it's only being collected at the behest of the government. So it seems like a stretch to claim that this data, which is only available due to a government requirement, can't then include other restrictions.

Filed Under: first amendment, medical info, medical privacy, privacy
Companies: ims health, sorrell