The 21st Century Cures Act
Because the perspective of the patient is so important to the development of new drugs, biological products, and devices, the 21st Century Cures Act was signed into law in December 2016. The Cures Act builds on the continuing work of the FDA to help accelerate medical product development and help bring new advancement and innovation to patients who need them faster and with more efficiency.
By inspiring and modernizing clinical trial designs and processes, the Cures Act is enhancing today’s healthcare through the reporting and documenting of real-world evidence, clinical outcome assessments, and corresponding medical countermeasures. The Act is also designed to improve the healthcare industry’s ability to recruit and retain scientific, technical, and professional experts.
A notable part of this legislation centers on healthcare organizations’ ability to improve data sharing between disparate systems and sidestepping information roadblocks. This interoperability is now a crucial element of modern-day healthcare. And although as a regulatory requirement, interoperability carries considerable weight, as an arbiter of patient outcomes, it is essential.
True interoperability has five key payoffs:
- Improved care coordination and patient experiences
- Greater patient safety
- Stronger patient privacy and security
- Higher productivity and reduced healthcare costs
- More accurate public health data
As more and more companies embrace and ultimately execute interoperability, the intricacies of successful interoperability become more apparent. To best address the needs of the patient, the caregivers must communicate and exchange information with stakeholders across the spectrum: specialists, hospitals, ASCs, EHR vendors, health IT developers, social services providers—and the patients themselves.