In defending the ever-growing cost of drugs, the pharmaceutical industry can’t roll out a single, intuitive explanation. Rather, their justification breaks down into many independent but interacting parts. We have to tease these apart before examining their validity.
HxRefactored, the conference put on jointly by Health 2.0 & Mad*Pow about technology & design in health care, draws a relatively small crowd–participants numbered in the hundreds, not the tens of thousands found at some health conferences. So I asked a leading health IT expert, Shahid Shah, why he invests so much effort in coming and make presentations to HxRefactored each year. He answered, “This is the only health IT event that covers not just the digital aspects, but the entire healthcare experience, focused on developers and designers who are building solutions. It goes beyond platitudes, cheerleading, and hand waving and gets into actionable advice that engineers need to know to build complex systems that will actually get used.”
And that really shows the key influence provided by design, broadly defined. You can get as “meta” as you want and stay within the field of design:
Worried whether your staff will adapt to and use a new IT system? Success with that is a design goal.
Determined not to let an IT system “get in the way,” but to ensure it enhances relationship-building with patients? Definitely a matter of design.
Eager to make innovation a standard kind of thinking throughout your institution? Designers with the proper combination of support and independence can get you there.
Reflecting the sweep of design itself, sessions at HxRefactored varied from chronicling the path to successful designs, to describing the contributions technologies make, to recommending strategies for getting designs adopted.
Design as a way of Life
A hoary shibboleth of design is that practitioners must seek out users and collaborate tightly with them. A more pointed statement of that principle is to turn all users into designers. This means not flying in to do a design, collecting your pay, and taking off again. Instead, designers hang out in the hallways to meet people, cajole users into joining creativity workshops, and–with teeth gritted–attend committee meetings.
Comprehensive engagement came up from the start of the conference, as when Adam Connor in his keynote pointed out that isolated researcher can’t transfer their insights automatically to others in the organization–everyone in the organization must participate in user research. He also pointed out that no system makes sense except when one views the larger environment of which it is a part.
The CTO of HHS, Susannah Fox, in her inspiring keynote, said “Technology is a Trojan Horse for change…We say interoperability and open data, but we mean culture change.” Design, for her, must recognize people without power, which currently includes most patients and their caregivers.
Fox championed Maker-style innovation at the grassroots, such as promoted in the famous work of Eric von Hippel at MIT. Hundreds of people are making custom prosthetics, for instance. She also mentioned that a very useful sleeve to keep an IV firmly in a child’s skin was designed by a parent. Similarly, patients could improve their medical devices, but manufacturers deny patients access to their own device-generated information, and prohibit patients from making changes. Patients who lack access to research labs and academic libraries are finding the information online to improve their experiences. Fox didn’t describe the risks and downsides of these practices, but I found that acceptable because the risks and downsides are cited all too often to throw up barriers to competition and innovation.
The authors of this article like to believe that we can remain humanists while transitioning from a paper-native to a digital-native industry. We even believe you can remain a humanist while following regulations and sticking to industry guidelines. Margalit Gur-Arie doesn’t seem to feel that way. We have read her work over the years and established that she takes a staunchly humanistic approach to health IT. But even though she’s a leader in that space, she appears to doubt the contributions that either technology or regulation make to a humane health system.
Gur-Arie’s most recent posting dismisses all the tools that electronic health records throw in the way of the doctor: clinical decision support (now often called evidence-based medicine–were we Gur-Arie, we’d say it’s because who can argue against evidence?), reminders, pull-down menus to provide a limited range of choices, and more.
One immediate response is to suggest that, instead of blaming the tools, one should blame the requirements imposed on clinicians by payers and governments–the “thousands of meaningless regulatory words” as Gur-Arie writes eloquently. But the real answer is that these requirements (well, the ones that were thought through) enhance the health care system, and that the problem with current EHRs is that they just “pass through” the requirements, intensifying the burden placed on doctors, instead of finding true innovations when implementing those requirements.
The majority of health problems in modern developed countries are self-inflicted, the results of lifestyle choices. These problems don’t respond to a pill–or even to bariatric surgery. Moreover, the medical profession hasn’t found ways to change lifestyle.
Health problems are killing us, and bankrupting us along the way. It’s well known that a tiny percentage of patients generate the most treatment and the highest health care costs, as Atul Gawande pointed out in a famous New Yorker article.
Of course, lifestyle doesn’t lie behind all hot-spotters (for some we can blame birth defects or other debilitating accidents, and for others we can blame over intervention in dying people), but a lot of them just just exhibit exaggerated versions of the common behavior problems most Americans face: bad eating, drug use, lack of exercise, etc.
We know what improves health–but we’re simply years away from having the tools to achieve it. We know that we can reduce the chronic conditions plaguing the world’s populations by a subtle combination of:
Closely monitoring the behavior of individuals
Linking health goals to treatments and behavior changes
Upgrading the problems in communities that contribute to disease
Such activities call for supple and sophisticated ways to link together disparate types and sources of information–the subject of this article. Doing such linking requires a new way of approaching data that is lacking today in our health care system.
The process of developing the new data approach will have to be incremental (no “Health Data Manhattan Project” for us), will involve thousands of contributors in crowd sourced fashion, and will take unanticipated directions based on the insights of the contributors. I am not laying out a framework in this article, but just touching on the themes that the project will likely explore. I’ll also mention a few of the people working in this area, notably the Yosemite Project. I call this idea Phonemic Path, in reference to the extensive research biologists are carrying on to find genomic paths that explain disease.
The Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?
The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.
Sticking regulatory fences into the fertile plains of software development and low-cost devices will arouse its untamed denizens, who are already lobbying Congress to warn the FDA about overreaching. But to abandon the field is to leave patients and regular consumers unprotected. This is the context in which the Food and Drug Administration, the Office of National Coordinator, after consultation with outside stakeholders, released a recent report on Health IT.
I myself was encouraged by the report. It brings together a number of initiatives that have received little attention and, just by publicizing the issues, places us one step closer to a quality program. Particular aspects that pleased me are:
A call for transparent reporting and sharing of errors, including the removal of “disincentives to transparent reporting”–i.e., legal threats by vendors (p. 25). Error reporting is clearly a part of the “environment of learning and continual improvement” I mentioned earlier. A regulation subgroup stated the need most starkly: “It is essential to improve adverse events reporting, and to enable timely and broader public access to safety and performance data.” Vague talk of a Health IT Safety Center (p. 4, pp. 14-15) unfortunately seems to stop with education, lacking enforcement. I distinctly disagree with the assessment of two commentators who compared the Health IT Safety Center to the National Transportation Safety Board and assigned it some potential power. However, I will ask ONC and FDA for clarification.
A recognition that software is part of a larger workflow and social system, that designing it to meet people’s needs is important, and that all stakeholders should have both a say in software development and a responsibility to use it properly.
Thanks to the flood of new data expected to enter the health field from all angles–patient sensors, public health requirements in Meaningful Use, records on providers released by the US government, previously suppressed clinical research to be published by pharmaceutical companies–the health field faces a fork in the road, one direction headed toward chaos and the other toward order.
The road toward chaos is forged by the providers’ and insurers’ appetites for categorizing us, marketing to us, and controlling our use of the health care system, abetted by lax regulation. The alternative road is toward a healthy data order where privacy is protected, records contain more reliable information, and research is supported or even initiated by cooperating patients.
This was my main take-away from a day of meetings and a panel held recently by Patient Privacy Rights, a non-profit for whom I have volunteered during the past three years. The organization itself has evolved greatly during that time, tempering much of the negativity in which it began and producing a stream of productive proposals for improving the collection and reuse of health data. One recent contribution consists of measuring and grading how closely technology systems, websites, and applications meet patients’ expectations to control and understand personal health data flows.
With sponsorship by Microsoft at their Innovation and Policy Center in Washington, DC, PPR offered a public panel on privacy–which was attended by 25 guests, a very good turnout for something publicized very modestly–to capitalize on current public discussions about government data collection, and (without taking a stand on what the NSA does) to alert people to the many “little NSAs” trying to get their hands on our personal health data.
It was a privilege and an eye-opener to be part of Friday’s panel, which was moderated by noted privacy expert Daniel Weitzner and included Dr. Deborah Peel (founder of PPR), Dr. Adrian Gropper (CTO of PPR), Latanya Sweeney of Harvard and MIT, journalist Sydney Brownstone of Fast Company, and me. Although this article incorporates much that I heard from the participants, it consists largely of my own opinions and observations.
Health reform activists and privacy mavens have been at loggerheads for years. Those touting health reform complain that an oversensitivity to privacy risks would hold back progress in treatments. Running in parallel but in the opposite direction, the privacy side argues that current policies are endangering patients and that the current rush to electronic records and health information exchange can make things worse.
It’s time to get past these arguments and find a common ground on which to institute policies that benefit patients. Luckily, the moment is here where we can do so. The common concern these two camps have for giving patients power and control can drive technological and policy solutions.
PPR has also held three Health Privacy Summits in Washington, DC, at the Georgetown Law Center, just a few blocks from the Capitol building. Although Congressional aides haven’t found their way to these conferences as we hoped (I am on the conference’s planning committee), they do draw a wide range of state and federal administrators along with technologists, lawyers, academics, patient advocates, and health care industry analysts. The most recent summit, held on June 5 and 6, found some ways to move forward on the data sharing vs. privacy stand-off in such areas as patient repositories, consent, anonymization, and data segmentation. It also highlighted how difficult these tasks are.
An unfathomably complex entity such as a health system grows over time like a city. Right now, communications and data usage in the US healthcare system is a bit like a medieval town, with new streets and squares popping up in unpredictable places and no clear paths between them. Growth in health information has accelerated tremendously over the past few years with the popularity of big data generally, and we are still erecting structures wherever seems convenient, without building codes.
In some cities, as growth reaches the breaking point, commissioners step in. Neighborhoods are razed, conduits are laid in the ground for electricity and plumbing, and magnificent new palaces take the place of the old slums. But our health infomation system lacks its Baron Haussmann. The only force that could seize that role–the Office ofthe National Coordinator–has been slow to impose order, even as it funds the creation of open standards. Today, however, we celebrate growth and imagine a future of ordered data.
I came here asking two essential questions of people I met: “What data sources do you find most useful now?” and “What data is missing that you wish you had?” The answer to first can be found at a wonderful Health Data All-Stars site maintained by the Health Data Consortium,which is running the palooza.
The choices on this site include a lot of data from the Department of Health and Human Services, also available on their ground-breaking HealthData.gov site, but also a number of data sets from other places. The advantage of the All-Stars site is that it features just a few (fifty) sites that got high marks from a survey conducted among a wide range of data users, including government agencies, research facilities, and health care advocates. Continue reading…
Open publication adds to the flood of information already available to most doctors, placing a burden on them to search and filter it. IBM’s Watson is one famous attempt to approach the ideal where the doctor would be presented right at the point of care with exactly the information he or she needs to make a better decision. Elsewhere, I have reported on a proposal to help experts doctors filter and select the important information and provide it to their peers upon demand–a social networking approach to evidence-based medicine.
Not only published papers, but the data that led to those research results should be published online, to help researchers reproduce the results and build on them to make new discoveries. I report in an earlier article on this site about the work of Sage Bionetworks to get researchers to open their data. Of course, putting up raw data leaves many challenges: one has to be careful to deidentify it according to accepted standards. One has to explain the provenance of the data carefully: how it was collected and massaged (because data sets always require some culling and error-correction) so it can be understood and properly reused. Finally, combining different data sets is always difficult because they are collected under different conditions and with different assumptions.