Information For All: Interview With Taha Kass-Hout
The FDA’s first Chief Health Informatics Officer brought about the information revolution with openFDA, and is now diving deeper into healthcare.
If you’re involved in genomics in the USA, then chances are that you have heard of openFDA and precisionFDA. What you may not be quite so familiar with is the man behind the two platforms that were referenced in the 2015 White House updated Strategy for American Innovation. Taha Kass-Hout, was the FDA’s first Chief Health Informatics Officer. Why isn’t he still at the FDA? Because he’s accomplished what he set out to do, and now he’s helping to make his vision a reality. You can find out even more at the Festival of Genomics San Diego.
FLG: How did you get involved with the FDA?
TKH: I was the first Chief Health Informatics Officer at the FDA, and they created that role in an era of big data and internet to understand how we can take advantage of these new methods and new ways of looking at the information that we have to achieve our mission of protecting consumers and making sure that products in the market place are safe and effective. The agency was really moving towards an evidence-based, consumer-first organisation, and realised the importance of data and informatics. So they created my role and I stayed there for about three and a half years.
OpenFDA was the first initiative I started. The reason I created it was because it was really hard for consumers and clinicians to get the benefits of this information. The FDA had these really awesome sources of information but there was a huge gap between meeting their needs in an easy to access way and where you have a scalable, sustainable ecosystem that can rely on this information and deliver it. So that was the whole essence of how I created openFDA.
FLG: How can we fit ‘patient power’ it into a new healthcare paradigm that makes patients feel like partners instead of people just getting told what to do?
TKH: If you look at the current healthcare system in America, it’s formally structured around episodic care. It’s like driving a car. When it breaks down, you take it to the mechanic to fix it; the ‘fix me’ model. There are always going to be patients that cost the healthcare system a lot; but if you move to a more consumer centred approach, and think about the wider population, there are needs that can be met continuously. These days you don’t have to check your blood pressure once a year; there are ways you can check it regularly so you can monitor how certain behaviours affect it and ultimately affect the outcome.
To achieve a better outcome for the people, you need to engage and empower consumers in a way that won’t overwhelm them. So there’s a responsibility within this situational awareness model : can the consumer be aware of the things that matter most to them at that particular point in time? And how can they figure out what they want to do and what choices they have, in order to better take care of themselves? It’s from prevention all the way to treatment.
The FDA are asking themselves how they can empower the researchers and software developers who can advance the science, figure out evidence and insights, but also develop apps or sites for consumers. They’re a lot closer to consumers and they understand their needs better, so they can provide consistent experience and knowledge to close that last mile.
FLG: How do you go about making all of this information less overwhelming?
TKH: In my experience with openFDA, we were trying to reach the ultimate audience of the general public. To do that, we started with an immediate audience of researchers and software developers that were developing consumer applications, and talked about the FDA.
These consumer safety agencies around the world have troves of relevant information, but not in a way that’s easily or consistently accessible. Unless you’re very familiar with the topic in question or the data system, you can’t access it. That made it very hard for software developers. When you build an app like Uber or Lyft, you depend on Google Maps to be consistent and reliable all the time so that you can deliver that product.
We tried to take a similar approach and said, ‘Let’s develop application programming interfaces (APIs) to make this data available, build a community of these developers, and really start listening to their needs.’ It was a bidirectional approach, listening to the developers’ needs, and building a platform to meet those needs. Then it was really about creating a scalable infrastructure to allow for growth as these apps get developed.
We had several of these sessions, working in a very agile way to consistently improve the software. We didn’t want to wait forever to put something out, so within six months we launched our first API endpoint around drug interactions and within a year we’d launched a dozen additional APIs around medical devices, food, cosmetics, supplements, and other things. Every time we were really listening to the needs of the community and FDA experts in these domains. We put the entire thing in open source for transparency.
We also have a big forum where anyone from the public can challenge some of the work, ask questions, suggest new features, and report bugs. There is also a good social media presence to highlight some of the work and the importance of it and for the community to highlight their work using openFDA data. After just two years, we have over 80 peer reviewed publications out there as well.
At first, the agency was worried about putting data out there and having people misinterpret it. Our hypothesis has been that if you focus on building an ecosystem and open source the entire thing, you’ll have a lot more confidence in the system and in the program. We’re almost like Wikipedia; if you go and edit Wikipedia in the wrong way, you can see how quickly it’s corrected. That’s really stood the test of time. Misinterpretation did happen and it was amazing to see the reaction from the community joining together to correct and help them.
Some industries are already using the information we’re presenting. We’re trying to harmonise it across the board so any additional data sources outside of the FDA, such as electronic medical records, social media, clinical trials data, etc. can link up to it. We’re packaging it all in a way that’s easy to understand and interact with across multiple APIs.
The system has really flourished. Within the space of two years we’ve counted over 6oo different apps and websites using the data, and tens of really awesome peer reviewed publications.
FLG: What made you decide to move away from the FDA?
TKH: When I was first working in the government, seven and a half or eight years ago, it was really in stints to help educate the government around the H1N1 pandemic with the CDC. I was already in the industry working with InSTEDD, which was a start up from Google, and we were looking at emerging infections in SE Asia and flu trends and identifying diseases early just by looking at publically available data.
At the CDC I was in charge of setting up a system that got us to about 90% coverage of the US population after the first wave of H1N1 hit. I came in for six weeks and ended up staying for seven and a half years.
I spent the following two years upgrading the nation’s electronic disease surveillance system which we launched in Nov 2011, It was the first cloud-based disease surveillance program for the whole United States, following all sorts of public healthcare interactions, connecting directly with consumers at every public health department in the country, looking at emergency room visits, outpatients, even getting social media involved. I got discovered by the FDA along the way and they asked me to help bring the FDA into the 21st century and that’s really how my role came about.
I left in June of last year. I felt that after the surveillance efforts, digitising this country-wide system, and creating openFDA, amongst other things, it was time to move on. Over the last year I’ve freelanced, primarily consulting with healthcare and life sciences, with the same goal of taking advantage of technology to empower consumers.
FLG: How do you see the healthcare paradigm changing over the next ten years as we start to move towards precision medicine?
TKH: It comes back to moving away from this ‘fix me’ model of episodic care, and looking towards continuous care outside the bricks and mortar of hospitals and clinics. Focus on healthier living, focus on social health. Today, 40% of Americans cannot afford a $100 medical bill and a lot of that has nothing to do with DNA, it has to do with ZNA – the zipcode they live in. How can we ensure that the public healthcare system is accountable for making sure that these individuals have access to healthy living, healthy lifestyle, healthy food, and empower them in ways such that they can make those choices and make it affordable?
This is really what some of the most impressive healthcare systems in America are doing. Look at Kaiser Permanente, Partners Healthcare, Thomas Jefferson, Intermountain Healthcare… they’re all really focusing on that new model of value-based care. The essence of that is around people-centred design. You see a lot of the life sciences focus on genomics and foundation medicine, but honestly, in time it will be there in the healthcare system. And it will be there beyond just cancer treatments and have better predictions.
There’s definitely an appetite right now within the healthcare system to figure that out. The problem is, of course, how can you reimburse them for that? Are genomics tests accurate and reliable and address the false positive challenge (do no harm)? The more clinical evidence that we build, the more we can think about how we can transfer it into the clinic.
Patients are already asking doctors about sequencing. You turn on the TV and you see commercials for 23andMe for $100. People are doing these things, but there’s a gap when you go see your doctor and try to understand the ways the healthcare system look at them.
I’m consulting for CEOs around the country in healthcare right now. They’re definitely paying attention to all of this. To them, it’s like another form of healthcare transformation from episodic care to value-based care and then to precision medicine. It’s maybe a decade away from being realised universally. What does this mean for our patients? And what does it mean for us to build that business model around it so that we can afford it and make it affordable for our patients?
FLG: Healthcare isn’t known for being too accepting of change. How do you think that transformation will work?
TKH: If you look at value-based care, huge investments had to be made. Care managers had to be hired, as well as case managers, and even clinicians to provide home-based care. Now imagine the cost of all that multiplied by 100 – genetic counsellors, educating clinicians on genomics…
Think about Tesla. They wanted to create a consumer experience for drivers and the first car was almost $100,000. Not everyone could afford it, and now they are rolling out cars for $33,000. It took them almost 10 years to get here through persistence and cost regulations.
That’s how I feel about precision medicine – eventually it will be there and there will be a few cheerleaders and pioneers that will help us get there but it’s going to happen over time. Consumers are going to drive this shift. Healthcare, like any large organisation, is slow to move but that doesn’t mean they don’t see the value in precision medicine. They just don’t understand what that means from an operational standpoint and from a clinical-based standpoint which requires solid and reliable evidence.
FLG: You’re one of the headliners presenting at the Festival of Genomics San Diego. Could you give us a brief overview of what your presentation at the Festival is going to be on?
TKH: I want to talk about my experience, particularly with the FDA and federal government, creating a sustainable data ecosystem to really empower consumers and how a federal agency was able to do this purely through a collaborative approach with entire industries. I want to explain how that model set the tone for new initiatives at the FDA, but also across the board. The White House mentioned openFDA in 2015 as one innovative initiative for the US in the same sentence as smart cities, and driverless vehicles. It was really amazing to see how in such a short time, we’d set the stage for how we should focus on these data-driven, evidence-building ecosystems because ultimately, that’s what can empower consumers in ways that improve efficacy, safety, and other things. That’s the way it should be when we’re thinking about consumers in any sector.
FLG: What are you hoping people come away with from the talk?
TKH: The one thing I want to emphasise is that it’s not a zero-sum game. I truly believe that if you share something, then the benefit will be for everybody. The challenge right now around precision medicine, is that people hesitate to share data, including de-identified data. Look at pharma, look at industry, look at academia – everyone is holding onto their data. If we can change that incentive model, we can show people that sharing data is a way that you can get ahead. Most patients will participate in clinical trials and will say that they want their data shared, but they want it to be shared responsibly and understand how it is being shared. I want to be involved in that conversation. If we just change that mind-set a little bit, and look at what we’ve done with openFDA in such a short period of time, then it could be great.
I’ve talked about the data that we made available from the FDA in a consistent way, but there was tons of other data being made available by others who harmonised the data further, whether for private or public purposes, and further advanced it. Their apps are looking at less costly and less adverse events for the consumer. They saved consumers just over a billion dollars last year, just by looking at those options.
At the end of the day, everybody will flourish and benefit just by sharing a little bit.
I hope people don’t challenge this kind of idea. It’s a very different mantra on how to go about doing business. There are always going to be challenges, and the closer you get to your goal, the more people are going to push back. People are going to be worried about misinterpreting information and all those different things, and I’m happy to provide a counter-argument in any way possible. What I’ve seen in my experience is that people are less interested in challenging your results and more interested in generating new and original research.
This June, Taha will be presenting at the Festival of Genomics San Diego on ‘Returning the power to patients in a data and consumer-driven era’, and moderating the discussion panel ‘How much power should patients hold?’