The 21st Century Cures Act was legislation passed in December 2016 to help improve the healthcare of many Americans. The purpose of the Cures Act is to support the accelerated development of medical solutions. The Cures Act also seeks to improve the use of patient data while protecting patient access and privacy. As a far-reaching law, some of the accomplishments of the Cures Act include enhanced use of real-world evidence in clinical trials and better inclusion of patient perspectives in the development of new products, devices, and medications.
With the goal of improving the research and development of medical innovations, the Cures Act implemented a number of new guidelines and programs aimed at supporting research professionals.
These programs include the Breakthrough Devices program, which is intended to expedite the review of innovative medical devices in certain categories and, in turn, give the patients who need them the most accelerated access. Meanwhile, the Regenerative Medicine Advanced Therapy (RMAT) program offers a similar streamlined approval process for some biologics innovations.
The Cures Act also aims to guide the Food and Drug Administration (FDA) to create at least one new institute to ensure better coordination among the developers of medications and medical devices for major focus areas (e.g., cancer).
What Is The Final Rule?
While the majority of the Cures Act focuses on researchers in the scientific and technological fields, The Final Rule applies directly to hospitals and ambulatory clinicians. It has to do with requests for patient data and aims to improve the implementation of modern technology (such as EHR adoption) to improve accessibility, interoperability, and reduce cost.
Additionally, it lays out guidelines for implementing patient data systems and prohibits any actions that stand in the way of a patient's access to their own data. This is the most complex part of the Final Rule, as it requires a balance between patient health, safety, and accessibility, along with protecting the intellectual property rights (IPR) of private health devices and solutions providers.
Lastly, The Final Rule protects the ability of hospitals, clinicians, and other healthcare providers to choose from a growing marketplace of apps rather than being required to use a specific solution.
How TempDev Can Help You Comply with The Cures Act
TempDev’s team of experienced consultants, developers, and trainers is here to support enhanced accessibility and customized features and templates. This enables you and your patients to have more control over data with improved transparency.
As part of our streamlining process, we help you implement the Patient Portal, API, and other tools to better support safety, patient engagement, and security. TempDev offers the comprehensive resources and tools you need to ensure compliance from dashboards to automation and workflow redesign.
Contact us here or by calling us at 888.TEMP.DEV to assist in complying with the complexities that The Cures Act introduced.
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