<div>I’ve been quiet on the Portable Legal Consent front for a bit, but
there’s enough going on that it feels like time to make a public update
on where we’ve been, where we are, and where we’re going.</div>


<div>First, the study we’ve been running at Sage
Bionetworks - the Self-Contributed Cohort - has yielded a lot of data.
I’ve got a chapter in the
Privacy, Big Data, and the Public
Good book coming out later this year that goes into some detail, and
we’ll be preparing a paper for peer-review later in the year as well.
The short version is:</div>


<ul>
<li> 

Deploying interaction design is incredibly effective at increasing
informedness in an e-consent context. We can get levels of
informedness, even on complex concepts, that can outstrip traditional
methods of consent. That’s the good news.
</li>
<li> 

Most people do not yet have enough data about themselves, or good
enough data, to feed computational modeling processes that generate
insights. Despite all the advances of patient-centered research,
direct-to-consumer genomics, electronic medical records, and more, the
data simply aren’t yet rich and clean enough to make the big data
analytics tools really sing in a citizen-contributed cohort. That’s
the bad news.
</li>
<li> 

If we want the kind of prediction engines in use by Amazon or
Facebook or Google, which we use to figure out
why drugs work in
arthritis,
generate insights
for personalized cancer therapy,
predict
Alzheimers progression, and more…we need the kind of rich,
clean data that comes out of structured study.
</li>
<li> 

Clinical studies are the best structured place at the
moment to get rich, clean data about individuals to feed
computational reuse.
</li>
</ul>\tightlist


<div>Given these results, we have turned the revision of PLC towards the
study itself. We have been working in partnership with the
Electronic Data
Methods (EDM) Forum as a
Collaborative
Methods Project. The EDM Forum is funded by the
Alliance for Healthcare Research and
Quality and is a multi-year project to build capacity for networks of
actors working in health care.</div>


<div>We conducted a series of interviews under the EDM’s guidance earlier
this year as part of an in-depth interaction design process. We talked
to giant clinical systems, hospital surgical centers, patient-powered
networks, clinical data networks, patient advocates, and more. And to
get to the million patients I’ve always wanted under PLC
and make their data actionable for computation , we need
to infuse PLC into clinical studies. This creates a requirement for
decentralized approaches, which fits nicely with most of my underlying
beliefs about networks (they are either dominated by a dictator at the
center, or they’re built at the edges by lots of people using
standardized tools - take a guess with my preference!).</div>


<div>Clinical studies happen locally, and their protocols and consent forms
are approved locally. Think of it as thousands of little pieces of
software - legal code - that don’t interoperate. Thus, PLC 2.0 is not
“one consent form to rule them all.” It is instead designed to make it
easy for those writing the thousands of little pieces of legal code to
add on functionality: getting the data from the study into the cloud for
secondary reuse, and empowering patients to receive and transmit a copy
of the data about them to other parties. It’s akin to a software
developer’s kit, but for legal code.</div>


<div>The beta of PLC 2.0 (which we’re calling the PLC toolkit) will be
released in the fall of  2014. The toolkit isn’t going to contain any
technology in this release. It’s instead a set of text documents
containing consent language for various classes of data, wireframes for
those classes of data, implementation guidelines for investigators
running studies, and educational materials for institutional review
boards. Supported data modules include mobile devices, wearable sensors,
electronic medical records, labs data, and genetic sequences. All the
files will be available under the
CC-BY 4.0 license,
so they’ll be infinitely reusable by all parties for all uses as long as
we get attribution.</div>


<div>I expect to see a few mobile applications using the toolkit as part of
Sage’s BRIDGE project and partnerships coming out this fall. And we are
conducting private alpha testing now and welcome anyone who wants to get
involved and review - email
me for details.</div>


<div>In the interim, here’s a teaser that I
showed
publicly at the last EDM forum meeting. It’s the dashboard that sits
inside mobile applications and manages a participant’s ongoing consent
inside a clinical study. This is the kind of wireframe we’re designing.</div>