Free EMR Newsletter Want to receive the latest news on EMR, Meaningful Use, ARRA and Healthcare IT sent straight to your email? Join thousands of healthcare pros who subscribe to EMR and HIPAA for FREE!!

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.

Patient Recruitment & EHR

Posted on April 25, 2012 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.

For some reason I’ve been recently talking and reading more and more about patient recruitment. I’ve been fascinated by the creative ways that those doing the clinical studies use to be able to recruit patients that fit the very specific needs of most clinical studies. Plus, I’ve been amazed at how much money is required to be able to recruit patients for these studies.

There’s so many interesting quirks involved in the whole patient recruitment business. In most cases, it’s very large companies trying to recruit individual patients. Many of the chronic patients want to know about and be involved in the clinical study. In many cases, it can lead to a great mutually beneficial outcome for both the company that’s doing the clinical study and the patient who receives care that they wouldn’t have otherwise received. Of course, there are A LOT more intricacies involved in patient recruitment, but those are a few of them.

The biggest challenge with patient recruitment is usually finding the right patients for the clinical study. I think we’re on the brink of technology largely solving this problem for clinical researchers.

EHR Software for Patient Recruitment
When you think about the volume of data that’s going into an EHR system, you can see how valuable the granular EHR data could be in identifying which patients are eligible for a certain clinical study. Certainly there are plenty of nuances to when and how you can use this information. I won’t get into those in this post, but I think it’s quite clear that EHR software will be essential to patient recruitment in clinical studies.

I’m sure that some won’t like to hear this. My first response is that this doesn’t have to be a bad thing. In fact, if done right it can be a great thing. We just need to be involved in the discussion so that patient recruitment with EHR software is done the right way. My second response is that this is going to happen whether people like it or not. Instead of trying to stop it, we should focus on how to make it work well for everyone.

CCHIT Certification Thoughts

Posted on February 2, 2009 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.

I just came upon a blog post on the TempDev blog that talks about the expansion of CCHIT certification into a number of new specialty categories. It’s really interesting to look at the list of new categories:

  • Behavioral Health
  • Clinical Research
  • Dermatology
  • Oncology
  • Advanced Interoperability
  • Advanced Quality (in reference to Quality Measures)
  • Advanced Clinical Decision Support
  • Long Term Care
  • OB/GYN

As noted by Ben, these are in addition to the HIE and PHR categories added for 2009. Well, I never back away from a discussion about CCHIT. I just wonder why the Senate hasn’t called me up to a hearing to talk about CCHIT certification. Of course, my friend Al Borges would do much better than I, but I digress.

After reading through Ben’s post about the expansion of CCHIT I had to leave a few of my thoughts on the subject in the comments. I thought most of my readers would find it interesting and so here’s some off the cuff thoughts on CCHIT certification that I left in the comments:

You are dead on when you say that CCHIT is a powerful driver in the EHR marketplace. It’s a really tough decision for EMR companies to decide whether to spend money on CCHIT certification or not. Not because CCHIT certification will make their product any better. The biggest advantage CCHIT certification offers is in your ability to market/sale your EMR system. That fact can’t be argued. It’s just unfortunate that the public isn’t better informed about the meaning of CCHIT certification.

I do think that over time CCHIT certifications will be so old that EMR companies are going to have to avoid the discussion of with CCHIT certification year they have or something like that. This will lead to consumers being unhappy with the process and lead to more troubles in the future.

The problem is that CCHIT hasn’t create a sustainable certification model for most EHR companies. I even hear that CCHIT might not have a sustainable certification model themselves despite their incredibly high rates for certification. At least that was what I read when I heard that CCHIT was going back to the government for more funding.

I still think the biggest problem is that most people see certification as a strong indicator of whether the EMR is usable or not, but CCHIT doesn’t test that at all. I’m considering some options to measure that and even possibly pursuing a PhD in health informatics where I’d like to study the subject. We’ll see.

It will be interesting to see how many specialties actually certify in these categories. My guess is that it will be the same Jabba the Hut EMRs (my term) that did the original CCHIT certification.

I guess you know where I stand on this issue.

Watch for more discussion about CCHIT, because I think it’s important to share my views on the subject considering it could be a major part of what I call the Obama EMR stimulus package.