Jakub Jirsk - Fotolia
On November 30, 2016, the House of Representatives approved the 21st Century Cures Act, a bipartisan bill that provides billions of dollars to medical research and precision medicine, and implements changes to the FDA's approval process for new drugs and medical devices. The Senate voted to approve the bill the following week, and President Obama signed it into law on December 13.
The legislation received strong support from both sides in the Senate and the House of Representatives. This highlights the big push to reduce bottlenecks in the FDA's approval process and the fact that more progress is needed in precision medicine and cancer research. The bill's approval also shows that politicians recognize that very little progress can be made without funding.
Since the introduction of President Obama's Precision Medicine Initiative (PMI) as part of his national focus on healthcare research, the idea to move toward delivering new therapeutic treatments that target specific and unique genomic signatures in those with serious illnesses has given hope to many patients.
However, although the new bill provides funding to the PMI, it ignores some of the precision medicine challenges many physicians face with their current EHR systems. There is a significant technology and innovation gap around EHR systems supporting the new genomics data requirements. Many current EHR systems lack the abilities to capture and manage biomarkers from patients. Any potential progress because of the bill will face the difficult reality of lack of systems to support clinicians in its adoption.
Another challenge is that most of the tools deployed in medical organizations and hospitals do not have the adequate analytics capabilities to deliver clinical decisions based on the genomics data collected. Only a handful of EHR vendors are rolling out support for genomics; the rest are still in limbo as to how they can deliver meaningful functionality in their systems for this area of medicine.
Despite the above precision medicine challenges, more drugs will be developed as the cost of patient DNA sequencing decreases and funding for precision medicine initiatives increases. Healthcare providers will demand their EHR vendors support genetic data to help them better process relevant information from the results of genetic testing to ensure the right prevention approach or treatment is taken.
Editor's Note: The 21st Century Cures Act received a 392-26 vote in the House of Representatives, and a 94-5 vote in the Senate.
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