Tag: OpenFDA

How Digital Health Can Solve Healthcare’s Data Portability Challenges

Screen Shot 2014-09-22 at 5.24.59 PMA recent Pew Research study revealed that 7 in 10 U.S. adults track their health data (a growing number use digital health apps and devices), yet only 1 in 10 share that data with a clinician. This begs the question: in a world where consumers are compelled to share everything from thoughts on celebrity gossip to well-orchestrated videos of themselves being doused with buckets of ice water, do we have a sharing problem? Clearly not. We have a data access problem.

Patients don’t have a simple mechanism and compelling reason for sharing their digital health data with healthcare professionals. Likewise, healthcare professionals don’t have a systematic way of accessing actionable patient generated health data. This disconnect inhibits clinicians from providing preventative care, making more informed patient decisions, uncovering medical breakthroughs, and gaining valuable insights into high-risk patients’ day-to-day activities.

As an emerging and powerful market force, the personalized health movement presents an occasion to construct a revised healthcare system free of silos. We as an industry must consider this opportunity and concentrate efforts on bridging the digital health divide in the near term to avoid exacerbating, and potentially eliminate, health data portability challenges. So, how do we accomplish this?

The Case for Open Data

Recent open data initiatives such as the Open FDA, the efforts of the Health Data Consortium, and standards organizations such as Open mHealth have resulted in collaboration around how digital health data can be utilized in the provision of care. Open data programs like these are key to the future success and financial viability of the healthcare system by providing entrepreneurs, researchers, and clinicians access to large datasets and standard workflows to perform population analysis, aspiring to leading to discovery of otherwise opaque trends and causal relationships.

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OpenFDA – the Good, the Bad, and the Ugly

Screen Shot 2014-07-21 at 5.59.57 PM

Adverse Event Reports Since 2004. Source: OpenFDA

On June 3rd, the FDA launched OpenFDA, in an attempt to take large internal datasets and make them more accessible and usable by the developer and business community.

OpenFDA is delivered in a search-based API that should enable software developers to more easily build applications based on adverse event data from the FDA Adverse Event Reporting System (FAERS) dataset for the period 1/1/2004 to 6/30/3013. The FDA has announced plans to add device and food adverse events data to the framework, along with structured product labeling and recall data (update: drug and device recall data was added on July 16).

The launch was heralded with the sort of buzz and hoopla usually reserved for a major product launch from a Silicon Valley startup. We have held off on any analysis and opinion until now to give our team the needed time to look through the system thoroughly.

Now, I readily admit, I am biased. As a data geek with 15+ years working on Big Data problems, I really want to love OpenFDA.  It is, after all, a major step forward both in terms of technology, but more importantly, philosophy from an agency that hasn’t exactly been a shining example of either in recent years.

In an ideal world, OpenFDA could usher in a world of new and improved tools and products that would improve patient safety and adherence, increase physician awareness of drug safety dangers, assist healthcare decision makers who are driving prescribing behavior with better decision support, and lower the overall cost of care by reducing avoidable side effects.

But we don’t live in an ideal world.

So, here are my thoughts on the Good, Bad, and Ugly of OpenFDA:

The Good:

OpenFDA is a seal of approval over the use of FAERS data in multiple settings. This is the first time that FDA has confirmed what we have believed all along – that these data are valuable and should be used in multiple venues to improve patient safety. It has long seemed ridiculous that the FDA spends millions of dollars to collect these data, uses it for their own internal safety signaling and review processes, but then deters others in the healthcare community from deploying these same data in new and innovative ways.

OpenFDA gives the long awaited ‘all-clear’ to harness the power of these data to improve care throughout the healthcare system.   We’re excited to see how this evolves in the product space – especially at the patient level – in the months and years ahead.

The Bad:

As with any new launch, once the excitement dies down, the true capabilities and limitations of the system are revealed. After careful review we’ve discovered several major concerns, two of the big ones are detailed below:

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