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Validic Survey Raises Hopes of Merging Big Data Into Clinical Trials

Posted on September 30, 2016 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site ( and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

Validic has been integrating medical device data with electronic health records, patient portals, remote patient monitoring platforms, wellness challenges, and other health databases for years. On Monday, they highlighted a particularly crucial and interesting segment of their clientele by releasing a short report based on a survey of clinical researchers. And this report, although it doesn’t go into depth about how pharmaceutical companies and other researchers are using devices, reveals great promise in their use. It also opens up discussions of whether researchers could achieve even more by sharing this data.

The survey broadly shows two trends toward the productive use of device data:

  • Devices can report changes in a subject’s condition more quickly and accurately than conventional subject reports (which involve marking observations down by hand or coming into the researcher’s office). Of course, this practice raises questions about the device’s own accuracy. Researchers will probably splurge for professional or “clinical-grade” devices that are more reliable than consumer health wearables.

  • Devices can keep the subject connected to the research for months or even years after the end of the clinical trial. This connection can turn up long-range side effects or other impacts from the treatment.

Together these advances address two of the most vexing problems of clinical trials: their cost (and length) and their tendency to miss subtle effects. The cost and length of trials form the backbone of the current publicity campaign by pharma companies to justify price hikes that have recently brought them public embarrassment and opprobrium. Regardless of the relationship between the cost of trials and the cost of the resulting drugs, everyone would benefit if trials could demonstrate results more quickly. Meanwhile, longitudinal research with massive amounts of data can reveal the kinds of problems that led to the Vioxx scandal–but also new off-label uses for established medications.

So I’m excited to hear that two-thirds of the respondents are using “digital health technologies” (which covers mobile apps, clinical-grade devices, and wearables) in their trials, and that nearly all respondents plan to do so over the next five years. Big data benefits are not the only ones they envision. Some of the benefits have more to do with communication and convenience–and these are certainly commendable as well. For instance, if a subject can transmit data from her home instead of having to come to the office for a test, the subject will be much more likely to participate and provide accurate data.

Another trend hinted at by the survey was a closer connection between researchers and patient communities. Validic announced the report in a press release that is quite informative in its own right.

So over the next few years we may enter the age that health IT reformers have envisioned for some time: a merger of big data and clinical trials in a way to reap the benefits of both. Now we must ask the researchers to multiply the value of the data by a whole new dimension by sharing it. This can be done in two ways: de-identifying results and uploading them to public or industry-maintained databases, or providing identifying information along with the data to organizations approved by the subject who is identified. Although researchers are legally permitted to share de-identified information without subjects’ consent (depending on the agreements they signed when they began the trials), I would urge patient consent for all releases.

Pharma companies are already under intense pressure for hiding the results of trials–but even the new regulations cover only results, not the data that led to those results. Organizations such as Sage Bionetworks, which I have covered many times, are working closely with pharmaceutical companies and researchers to promote both the software tools and the organizational agreements that foster data sharing. Such efforts allow people in different research facilities and even on different continents to work on different aspects of a target and quickly share results. Even better, someone launching a new project can compare her data to a project run five years before by another company. Researchers will have millions of data points to work with instead of hundreds.

One disappointment in the Validic survey was a minority of respondents saw a return on investment in their use of devices. With responsible data sharing, the next Validic survey may raise this response rate considerably.

Restoring Humanity to Health Care – My Experience Part 2

Posted on February 27, 2015 I Written By

John Lynn is the Founder of the blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

It seemed appropriate for me to follow up with part 2 of my experience with a new wellness focused medical practice called Turntable Health, an operating partner of Iora Health. In case you missed part 1 of the journey, you can find it here.

Walking into the clinic, there was a different feel. It felt more like walking into a local coffee shop than going for a doctors appointment. The lobby was so inviting that I wondered if some in the community used it as a place to go and work on occasion. I spend a fair amount of time in the Downtown Las Vegas tech community, so it wasn’t a surprise that I actually knew a few of the people in the lobby. So, I was able to connect with some friends while I waited for my appointment.

The check in process was simple and I was invited back by my health coach. In this case the health coach acted very much like an MA or nurse in a regular medical office, but the feel was more friendly an casual. We both knew we had an hour together so there wasn’t the usual frenetic pace the accompanied a doctors office.

I had a couple paper forms to sign (yes, the signature is still often easier on paper), but no major health history to fill out or anything like that. They had a one question survey that I think was about my current state of wellness. Over the hour the health coach did ask many of the questions that would be on a normal health history form and key them into the Iora EHR system. It was a unique approach since it gave me the opportunity to talk about the things as we went through them and many of the things we talked about (ie. my family health history) came up later in my conversation with the doctor.

The exam room looked quite a bit like any other exam room you might visit. The colors and lighting were nice and they had little touches like this local art work display in the exam room (see picture below). It’s kind of interesting to think about a doctor’s office as a kind of local art gallery.

At one point in the conversation with my health coach, we talked a bit about fitness tracking and she quickly emailed me some fitness apps that she liked. Little did she know that I write about such apps and that industry for a living on Smart Phone Healthcare. It also illustrated how much of a need there is for someone to be a trusted content curator of the 30k+ mobile health apps out there. Especially if we want healthcare providers to make a dent in actual usage of these to improve our wellness.

After completing her assessment, my health coach left the room and came back with the doctor. When he came in he told me that my health coach had talked with him about me and my health (in a normal practice this amounts to “Fever in room 3”) and he wanted to talk to me about a few of the issues I was dealing with. When he did this, the doctor and my health coach came into the room and we all sat around a small table. It was almost as if I’d just sat down for hot chocolate (I don’t drink coffee) with my doctor and my health coach.

There were a few differences though. When my doctor sat down he plugged in a chord to display his computer screen (my record) on a big plasma monitor that we could all see. I’m not sure why my health coach didn’t do that too. I almost moved over next to her to watch her enter the data, but I felt like that was just my inner EHR nerd coming out. Plus, I didn’t want her to necessarily know my background in that regard and that I’d be writing about the experience later. I wanted to see what they usually did for patients.

Because we were all sitting around the proverbial exam room “coffee table” I didn’t feel rushed at all. We talked about a couple sports issues I’ve been dealing with and ways that I could make sure they don’t continue to get worse (since I’m definitely not stopping my sports playing). We also spent some time talking about how to work on some long term wellness tracking around high cholesterol and diabetes.

After the visit, I realize that in many ways it wasn’t any different than a regular doctor visit. I could have gone into any doctor’s office and discussed all of these things and likely gotten similar answers. I think part of this is Turntable Health still working on the evolution of how to really treat a patient from a Wellness perspective. However, while many aspects of the treatment were the same, the experience felt different.

The long appointment time. The health coach. The doctor that wasn’t rushed all contributed to a much different visit than you’d get in most doctors’ offices. You can be certain that had I gone to a doctor for my sports issues, we wouldn’t have talked about things like cholesterol and diabetes. There wouldn’t have been time. Was the care any better or worse? It’s the same care that would have been provided by other professionals, but the care was given room to breathe.

As I left the visit, a part of me did feel a little disappointed. You might wonder why after this glowing review of the unique experience. I think the disappointment came from some improperly placed expectations. I’m not sure I really thought deeply about it, but I wish I’d realized that they’re not going to solve your wellness in one visit.

When I think about my psyche as it relates to doctors, I’ve always approached a doctor as someone you go into and they fix you and then you go home. When applying that same psyche to a wellness based approach to medicine, it leads to inappropriate expectations. Wellness is a process that takes time to understand and address. In fact, it’s a process that’s likely never done. So I think that led to my gut reflex expectation of what I’d experience.

I think one way Turntable Health could help to solve these expectations is to do a better job on the first visit to describe the full model and plan for what they want to accomplish with a patient. Otherwise, you really just feel like you’re going in for another doctor’s appointment. I’m not sure if that’s a cool chart of all their services and how they help me improve my wellness or if it’s a list of ways that they’re working to help improve my wellness.

Basically, I wish they’d over communicated with me how Turntable Health was different and how they were going to deploy a suite of professionals and services to better help my overall wellness. It’s easy for those working at Turntable Health to forget that new patients haven’t seen their evolution and don’t know everything they’ve done to improve the primary care experience.

A few other things I’d have loved to seen. First, I filled out their 20 minute (I think it took me 10-15) survey before the appointment. I didn’t get any feeling that the health coach or the doctor had actually seen the results. In fact, the health coach asked me some of the same questions. Redundancy can be appropriate on occasion, but it could have made the visit more efficient if they already knew the answer to those questions and instead of getting the info they could have spent the time talking about the answers as opposed to getting the answers. Plus, I’m sure my answers would have triggered some other discussions. It all made me partially wonder why I filled out the survey in the first place. Were those just part of some research experiment or were they to help me improve my health?

I was quite interested in their portal and what it offered (obviously, since I’m a techguy). It seemed like the framework as opposed to a fully fleshed out solution. I could see where it could grow to something more powerful, but was disappointing on first login. In one area called measurements it had graphs of my Blood Pressure, Fasting Glucose, and Weight. Unfortunately, after one visit they only had one data point and now way for me to easily upload all my weight measurements from my iHealth scale. Hopefully integrations like that are coming since that data could definitely inform my wellness visits. I guess they need to work on the first time user experience for the portal. At least I can schedule appointments through it.

I imagine some of you are probably looking at this as a pretty major investment in my health. Some might even think an hour long appointment would be more time than they want to spend with the doctor. I get that and I don’t always want my appointment to be that long. In fact, now that I have my baseline, I hope that many visits become an email exchange or other electronic method that saves me going into the doctor at all. However, as I’m getting older, I see this as an important investment in my long term health. Hopefully this investment has a good ROI.

With that in mind, I’ll do what I can to keep you updated on my experience. Since I’m on a journey of wellness, I imagine this is Part 2 of Many. I hope you enjoyed the look into my experience.