Aidan Petrie of Ximedica said it bluntly. In acknowledging that it is often tough for designers to break into health care institutions and play a significant role, Petrie, an industrial designer, gives this advice to designers: "remember, it’s not about putting lipstick on a pig – it’s about the pig." Exactly. In that stark phrase Petrie captured much of my thinking as I sat through the day-and-a-half long “symposium on art, design and the future of health care” at the Rhode Island School of Design (RISD), sponsored by RWJF’s Pioneer Portfolio. The intersection of art, design and health should not be about prettying up a lousy system—it should be about designing a better system to begin with.

The symposium was the brainchild of RISD president John Maeda, who wanted to connect the talents of RISD students and faculty with the urgent problems of health and health care. And there were many references to the strange bedfellows nature of the gathering. This awkwardness was most pronounced among the participants who came from the health care and public health side of the aisle. The artists and designers who spoke generally seemed quite comfortable with the notion that health does not exist independent of a broader life but is deeply intertwined, and as such, it is a natural subject for art and design.

So we saw Damon Rich apply a designer’s approach to understanding how to boost public participation in the decision-making processes that affect public spaces; the wonderful artist Mel Chin bring his passion and vision to the tragedy of lead poisoning in inner cities; and Amale Andraos’ brilliant visions of greener, healthier urban landscapes and buildings. But, by and large (there were exceptions), participants from the health sector looked at this question of how art and design could intersect with health with a slight puzzlement before defaulting to… communication. As one put it, we need great designers to help us communicate the complexity of health care in ways that people will understand. With all due respect to health communication, which is a vital field, health in the United States has even more fundamental challenges that demand the talents and skills of the design and artistic communities. Let’s get them to focus on the pig.

Within a couple of generations we have managed to engineer movement out of our work days, cooking out of our homes and play out of our children’s lives. We have designed communities and pioneered lifestyles whose only logical consequence is poor health. We have designed a health care system that has brought us the 7-minute office visit, the dreaded emergency room wait, the explanation of benefits statement, 50 million people without coverage and – oh yeah – a crushing federal deficit. I won’t be naïve and say that a few designers will turn this all around – these are deep-rooted problems – but I do believe strongly that we need the creativity and the perspective that they bring. We need people who look at these problems differently. Who are, as John Maeda put it, naturally curious. Whose views are not so deeply ingrained that they cannot ask “why not?” Who, like the delightfully unexpected Kelly Dobson, ask questions that stop us in our tracks, make us uncomfortable and make us remember that we’re human.

After several much-ballyhooed analyses projected an impending boom in the mobile health industry, it seems this once-geeky topic is being talked about everywhere lately. For those of us whom have been long-time advocates (and supporters) of the disruptive potential of mHealth technologies, we are thankful that this conversation is taking place.  We’re in an era where the technology enablers are moving into place and getting better every day, the business models are starting to develop and the policy environment is – well – unsettled at best.  At issue are the questions of whether and how much the FDA will regulate medical apps and how rules and regulations around privacy and security will circumscribe the kinds of products and services developers can offer.  This uncertainty in the policy environment raises the risks for developer/entrepreneurs and the investors that would back them.

FDA regulation is a thorny issue and is especially challenging when a “medical device” consists of a phone carried around by tens of millions of Americans and software that could have been written in a weekend.  The sheer volume of review that would have to take place is overwhelming in an era where agency budgets are going down not up.  An account of the recent FDA approval of the mobile radiology app Mobile MIM gives one a sense of the difficulty here.  And the lack of clarity has a chilling effect.

But aside from the question of how the technologies will be regulated, another fundamental concern needs to be addressed. That being, how will the data contained in an individual’s personal health record (PHR) – the “fuel” that powers the mHealth machine –be protected and secured? And what regulations will be put in place to do so? Until policy makers step in and provide guidance, the chilling effect on innovation will continue, furthering our reliance on an antiquated model of care that does little to empower patients to be active participants in their own health decisions.

But before providing the legal and regulatory framework app developers need to move forward, policy makers must recognize that PHRs are rapidly evolving.  This evolution is something I recently discussed as part of the Office of the National Coordinator for Health Information Technology’s public roundtable “Personal Health Records: Understanding the Evolving Landscape,” where I laid out three themes that have emerged from several Robert Wood Johnson Foundation Pioneer Portfolio-funded projects I’ve helped coordinate. These themes include: separating the apps from the data, expansion of the definition of health information, and the increasingly social nature of health care, all of which I explain in more detail below. It is my hope that policy makers take all three into consideration when crafting policies that will inevitably shape the industry.

Separating the Apps from the Data

When examining the first theme, we must take a look back in history and recognize that PHRs were designed to house – and give and individual access to –medical records, along with a few features that helped display and interpret the information.  Whoever maintained the data also provided the services that displayed, interpreted or otherwise helped you use the data.  Increasingly, however, we’re seeing a movement towards separating these functions:  the function of storing, maintaining, and providing access to the data serves as a platform while additional features and functions can be offered by third parties as apps.  By now we all recognize this as the way the computer industry works – operating systems, like Windows and the MacOS (and now iOS and Android) serve as platforms and third-party developers offer hundreds of thousands of programs or apps that run on those platforms. When it comes to PHRs, this model enables a patient to choose features and functions based upon their own individual preferences and circumstances, instead of being limited to the options of what a single PHR vendor builds into service.  The implication of this trend toward separating the apps from the data is that it makes it hard to regulate a “PHR service” or “PHR vendor,” unless one adopts a very narrow definition that focuses only on the storage, maintenance and control of access to the data.

Expansion of the Definition of Health Information

Individuals are increasingly becoming aware of the fact that health is not just what happens when you go to the doctor. Health happens where you live, work, learn and play.  It happens 24 hours a day, 365 days a year. It is based on the behavioral decisions you make every day, and it is based on the circumstances in which you live.  Apps that help people manage their health often draw from data one finds in a medical record (e.g. medications) and also data from people’s day-to-day experience that contribute to (or detract from) their health.   In our national program Project HealthDesign, which is supporting research on this topic, we refer to this latter set of data as Observations of Daily Living (ODLs), which can include how much exercise you got on a given day, what your text messages say about your mood, or the duration and intensity of headaches to name a few. You can even include in this category relevant environmental data on ambient temperature or the level of particulates in the air.  Regulations around the privacy of health information tend to focus on health information as information retained by health care service providers, but when you take a broader view of health and when app developers mix ODLs with traditional health data, it becomes very hard to draw a line between “health” information and other forms of personal information.  Any future regulations will have to wrestle with the meaning of an expanded definition of health information.  Perhaps the distinction between health information and any other information someone would like to keep private is no longer tenable.

The Increasingly Social Nature of Healthcare

Finally, policy makers must realize that individuals are increasingly sharing their data and health-related decisions with friends, family members, and an increasingly sophisticated care network. Health care is becoming more social in nature. And it’s not just social media or human to human interaction I’m talking about – many emergent mHealth technologies need to share data freely with software or other devices. A wireless blood pressure cuff talks to an app that then requests to deposit the data in a physician’s electronic health record (EHR).   A smartphone app for medication reminders sends a query to an EHR to get up-to-date prescription information.  Whether it’s person to person, device to device or app to app, sharing can add real value and regulations need to find a balance between helping people guard their privacy while also enabling the secure sharing of information.

Separating the apps from the data, expansion of the definition of health information, and the increasingly social nature of health care – all can potentially change how we view PHRs, and how we perceive health care at its very core. However, while mHealth shows tremendous promise, regulations could have a significant effect on how much of that promise is realized.  Policymakers will need to walk a fine line between providing enough clarity to encourage developers to act while offering enough flexibility to accommodate a rapidly evolving shift in how health information is understood and used.

Based upon their extensive experience in the field, several team members from Project HealthDesign submitted public comments to the ONC following the PHR Roundtable at which I spoke. These comments do an excellent job of laying out Project HealthDesign’s vision for the future of PHRs and related privacy and security concerns, providing relevant examples from their work where innovation could be impeded by impractical policy. For example, if data-encryption requirements are so stringent that a device cannot share data with a software program or another device, then we’d lose out on the benefits of technology that uses trackers to automatically monitor a whole slew of ODLs for patients (read Anind K. Dey’s public comment for a wonderful explanation). Or, if privacy/reporting requirements for mHealth devices are created with yesterday’s definition of health information in mind, a wide-range of health apps could be adversely affected (see Katherine Kim’s and Gillian Hayes’ comments). These very concerns are currently being echoed by developers throughout the mHealth industry.

Wading through all of these thorny issues promises to be difficult for policy makers and regulators, but the ultimate solution may be as simple as providing individuals with the ability to control and share their own data as they see fit. The new reality of health care rests on that very notion; that patients should be at the center of their care. Tomorrow’s mHealth policies need to be created with that philosophy in mind.  

I’ve just finished three days at AMIA’s Annual Symposium – the geekfest gathering of informaticians (or informaticists, if you prefer).  It’s a big conference, with many themes and tracks, so it’s hard to draw general conclusions as any observations are largely functions of which sessions one chooses to attend.  So I’ll try not to generalize (too much) but offer a few thoughts on what I saw and heard.

Meaningful Use policy is a really delicate business.  As provider organizations are starting to translate Meaningful Use requirements into operational plans, the details are getting really tricky.  I saw a panel representing some real EHR pioneers (e.g. Intermountain Health Care, Marshfield Clinic) that showed how even for them, who’ve been using EHRs rather meaningfully for years, they will have to make substantial changes to their systems in order to qualify for the subsidies.  Meaningful Use is a great concept because it uses large scale EHR implementation as a vehicle to shift practice in the direction of better quality (good) and more prevention (good again), but doing so without being over-prescriptive is much harder than it looks.  Finding that balance of rewarding the principles while maintaining a fair degree of flexibility on the implementation details seems to be the key (and, to be fair, easier said than done).

Health IT raises interesting questions about roles.  Dan Masys, in his perennially fascinating review of the past year’s research findings and key developments, pointed out that now study after study about clinical decision support shows the same finding:  that decision alerts always have more impact if they are sent to anyone on the care team but the physician.  He also noted that the teachable moment of an order entry system is at the moment of entry (when, for example, a drug-drug interaction or contraindication alert is triggered) and that physicians don’t learn from these opportunities if they delegate the order entry task, as is common.  Dryly, he observed that studies also show that decision support is most effective when it’s not ignored.  On a serious note, he commented that if the trend of these findings continues, disintermediation of physicians will become inevitable.  Ouch.

Rapid Learning is really starting to happen.  I attended a terrific presentation by Nirav Shah, a researcher based at NYU and Geisinger.  He’s been mining Geisinger’s EHR data, which goes back many years now, and doing just the kind of studies one would hope to see when we can start to tap large clinical datasets.  After a preliminary rundown of the pros and cons of mining EHR data vs. running prospective clinical trials, he showed how he was able to compare the effectiveness (not a sanitized clinical trial of efficacy, but actual effectiveness in terms of real-world experience) of a next-generation brand-name drug against a generic (no difference except in cost).  He also showed that he could predict, in 50 percent of cases, which patients would develop congestive heart failure six to 24 months ahead of time.  Wow.  While it would be great to see the 50 percent number climb, that kind of result opens the door for preventive interventions that could save many lives.

Power to the Patients!  One panel brought together some of the true pioneers of patient engagement.  (Okay, I’m a bit biased as RWJF/Pioneer funds two of them currently) Warner Slack, who’s a great-grandmentor of some of the students in the audience (he trained the students that trained the current generation of faculty), gave a hilarious talk about just how strange his colleagues thought him when he was advocating for greater patient participation in clinical decisions 40 years ago.  Tom Delbanco discussed the OpenNotes project , and Patti Brennan discussed Project HealthDesign and the value of tracking observations of daily living (“ODLs,” also a frequent topic on this blog).  Patti gave a very clear explanation of the value of each: OpenNotes, she said, gives a window into what the clinician is thinking; ODLs give the clinician a window into the day-to-day life that a patient is living.  Both, she said, are necessary to improving care.  Charlie Safran made some important observations about the need to drop often stereotypic assumptions about how groups of patients will behave and e-Patient Dave was both passionate and entertaining as he spoke about the value of engaging patients in reviewing their records (not only will they be better informed, they will inevitably fins mistakes – some serious). Dave’s comments raised for me a key point, which is that clinicians should make sure that patients know what’s in their records – not for any moral or philosophical reasons – but for the simple practical reason that it can improve care and safety. 

Those were a few things I noticed.  You can check out the Twitter stream for many perspectives.   I’d love to hear from others who were there and get their take.  And for those who weren’t, are these observations consistent with what you’re seeing?

This article appeared originally in the Huffington Post on 10/19/2010.

This morning my colleague, Dr. Carol Diamond of the Markle Foundation, appeared on the Today Show to talk about an initiative called “blue button.” 

As many have experienced, getting a copy of your medical records is rarely as simple as it sounds.  The process often involves making multiple phone calls, having to fax in requests, paying photocopying charges and waiting – often as much as a few weeks.  And at the end of the process all you have is a stack of paper – good for reading and for filing away, but not much else.  But today, as more and more hospitals, pharmacies, and physician offices are adopting electronic medical records, the process should get better.  Health care institutions in the vanguard of information technology and customer service are making it possible for their patients to review their records online.  But not necessarily take them with them.  That’s where the blue button idea comes in.  It’s a simple practice:  when a patient logs in to her account, provide a highly visible, clickable button to download her records in digital form.  As Dr. Diamond noted, the federal government has taken a leadership role in modeling this practice.   The Department of Veterans Affairs started providing blue button downloads to all patients of the VA system back in August and the Center for Medicare and Medicaid Services has launched a similar blue button service for all Medicare beneficiaries.  And their efforts have not gone unnoticed – more than 60,000 veterans have downloaded their medical data since the launch.  The Markle Foundation has also worked with experts from consumer and patient groups, health care provider, privacy advocates and technology companies to develop a set of recommended blue button practices that ensure high levels of security and privacy. 

So why does it matter?  For starters, reviewing your medical records is a step towards better engagement in your health.  You can learn more about your conditions, your lab results and the treatments you might be undergoing.  You can use the records as a springboard to conversations with your doctor.  But you can do that paper records.  Why does digital matter?  Two reasons:  sharing and apps.  Of course, when you get your paper records, you can always photocopy them and send them on to someone you’d like to review them.  But we all know that it’s so much easier to share digital information online.  So when you want your uncle the doctor to help you interpret a result, or when you and your sibling want to discuss Dad’s condition, it’s easily done. 

But the real power lies in the apps.  We now live in a world where there really is an app for just about everything.  There are 6,000 apps for the iPhone that focus on health and fitness.  They help  with day-to-day health-related tasks, like managing your diet, tracking your exercise, understanding your meds, or checking out your symptoms.  But these apps are, by and large, ignorant of the details of your health that could make them smarter and offer you more value.  Many of them, and many that will soon be invented, could be even better if they could draw upon the information contained in your medical records – to spot trends in your lab values and warn you when a trend is of concern; to correlate your moodiness with a new medication you’re taking; or to remind you it’s time order that prescription refill, to name a few.  And we’ve already seen that the data made available through blue button downloads will lead to new apps.  Earlier this month, the Markle Foundation and the Robert Wood Johnson Foundation announced the results of the blue button Challenge, held as part of the Health 2.0 Developer Challenge.  With only a modest prize, the challenge drew nine entries, including the winner, from Adobe Systems, which was a slick front-end for the VA’s data, making it easy for people to read, share and discuss the information.  It also included a set of tools and reminders related to medications.  Another significant entry came from Microsoft, which built a way for blue button downloads to go straight into its HealthVault personal health record service, which provides access to more than 50 different apps.  And this all happened over the course of a month.  As blue button becomes much more widespread, we can expect to see more and more apps designed to take the data you can download and turn it into useful information and valuable tools you can use to manage your health.

The federal government has taken a strong step forward to give people access to their medical records.  Now it’s time for more in the private sector to do the same.  I know I want a blue button on my doctor’s Website.  If you think this is a good idea – if you believe that people should be able to download their medical records, or if you would like your physician’s office to make yours available, or if you have a totally different take on this question, please join the conversation on Twitter – send a tweet with your opinion and be sure to use the hashtag #bluebutton.

As I mentioned back in August, RWJF joined the Health 2.0 Developer Challenge by offering small prizes for three different challenges:  1) building apps that leveraged the Blue Button initiative; 2) apps that bring the data from County Health Rankings into everyday decisions; and 3) bringing Project HealthDesign designs to life by building apps that work on commercial PHR systems.  At the time I said that we wouldn’t know what to expect – that we might not get anything useful at all from this exercise.  WRONG!

The response was terrific.  I won’t say overwhelming, but given the modest amount of prize money (okay, Markle scored coffee with Clay Shirky, which is no small deal) and the relative short amount of time to respond (barely a month), I’d say pretty darn good.  And definitely useful.

I’m a big fan of the Blue Button initiative for two reasons:  1) it gets the data out of the health care system and into the hands of users, where a marketplace of translators, interpreters and other tools can grow around making data useful to people; and 2) it’s beautifully simple.  The response highlighted the potential of this market:  we had large companies like Adobe and Microsoft build really valuable utilities – to translate a largely unreadable ASCII text files into very nicely designed PDF documents and to import Blue Button data into HealthVault, respectively.  But we also saw smaller organizations (seven in all) like MedCommons and RememberItNow showcase more narrowly focused apps that deal with important tasks – like getting a second opinion on a radiology image or remembering to take your meds.  Adobe came out on top in the end – and deservedly so as they built a really nice app – but the key takeaway is that they’re just the tip of the iceberg of what could come.  Hats off to the Markle Foundation, CMS and the VA for bringing Blue Button so far along so quickly.

The County Health Rankings challenge drew a number of interesting submissions.  Where we live, work, learn and play dramatically affects our health.  So when you’re choosing a place to live, wouldn’t you want to look up health indicators the way parents look up data on the quality of the schools?  That’s what the challenge winner, Acsys Interactive, makes possible.  They embedded the county health rankings data into their mobile real estate app.  So now when you want to get the scoop on the house for sale you’re driving by, you point your phone at it and get both real estate data and easy access to county health data.  The challenge drew four other submissions, which also included a utility to have the data texted to your phone when you text in a zip code and a tool to help understand asthma risks in a given county.

The Project HealthDesign Developer Challenge was won by Ringful Health, which produced a really slick app for managing chronic pain.  With it, you can use your iPhone to jot down your pain levels and triggers, get feedback on frequent triggers and how effective your medications have been at controlling your pain, and generate reports that you can share with your doctor.  Ringful had been working on this app, but, inspired by the design from Roger Luckmann’s team at UMass, added several new features and then built back end integration with the HealthVault, Google Health and Dossia personal health record services.  Another competitor, CureTogether, extended their site, which helps people track their observations of daily living (ODLs) like sleep, exercise, and food intake, to include lab test data.  A third, and very intriguing, submission came from Fred Trotter, who built an open source utility to track ODLs and store them on Twitter (in a protected account) and then use Grafitter to analyze the data and display patterns.  Fred’s solution is especially interesting because he’s leveraging existing infrastructure and by building an open source tool, he’s inviting others to take it further.

So all in all, I’m quite pleased with how the challenges went.  And it makes me wonder what challenges we should put out next.  Any ideas?