Climbing the Summit

 
Climbing the Summit

When surveying the current landscape, I see a host of reasons to be excited about where our little collective of clinicians, researchers, academics, standards geeks, and industry partners sit at the close of 2016. Those who dabble in health informatics and health IT can look back over the last five to eight years and see a real transformation in how care is delivered, and we are on the cusp of doing the same to the clinical research enterprise.

Advances in the coming years

Public policy, with the aid of congressional support and impressive scientific advancement, has laid the groundwork for what promises to be an exciting next few years:

• EHRs are no longer the play toys of academic medical centers, with more than 98% of hospitals and 51% of office-based physicians using EHRs to deliver care;
• Congressional support for efforts like the Precision Medicine and Cancer Moonshot initiatives has reached a fever pitch, which fundamentally shifts conversations from “what is ideal,” to “what can be operationalized”;
• Data storage prices have fallen through the floor and computational speeds have gone through the clouds, with more organizations are leveraging SaaS-based platforms;
• Advances in genetic sequencing and gene-editing technology have changed how we understand and treat disease for generations to come; and
• A cultural shift that integrates patients, families and participants into care and research decision-making.

Reaching summits only to discover more

Now, the experience of wiring our healthcare system has taught us that once we reach the summit of one challenge, we are likely to see the summits of other, more daunting challenges.  This is a natural consequence of progress, which I measure by the complexity of our problems, not a list of our accomplishments. These complex challenges include:

• Continuing the march towards interoperability among different and disparate health IT;
• Identifying clinical utility of ‘omics’ data;
• Integrating useful omics data with routine clinical data; and
• Developing sustainable funding models, supported by data sharing and privacy-related public policies.

We need to prioritize our actions to move interoperability forward

These challenges are formidable, but they’re not insurmountable.  There are, however, some key actions that warrant prioritization in Washington, DC over the near-term.  First, Congress must make good on its promise to fully fund NIH and FDA efforts. This can happen through a package of legislation, like H.R. 6, or it can occur through other avenues, such as appropriations bills and User Fee Agreement legislation expected in 2017. Without funding, all expectations must be reexamined. Second, regulatory – or legislative – changes to policy must enable more non-interventional research. This can happen through finalizing proposed changes to the Common Rule, or by enacting section 1124 of H.R. 6.

We must remove the current red tape, or we will struggle to find clinical utility in the sea of digital data being created on a daily basis. Third, standards must be developed and/or anointed to determine which metadata elements are crucial to allow for reinterpretation and reanalysis of genomic and other high-volume data. Finally, with great allowances come great expectations. If funding levels increase, so too will expectations that research is impactful and conducted with transparency.

Excitement ahead

As we look to 2017, the new Administration and the 115^th Congress, we have reason to be excited about the work the lies ahead. We also have good reason to believe that the tallest challenge, once bested, will provide a great viewing point for more important work to be done.

Join me at HL7's Clinical Genomics Conference October 26-27 in Washington, DC as we discuss key policy issues in cancer, genomics and interoperability.