Feedback on the passing of the 21st Century Cures Act in early December 2016 has generally been encouraging, with many industry experts weighing in on the positive impacts of the act and the need to continually advance new healthcare technologies.
The law introduces several important regulatory changes for medical devices, particularly in digital healthcare. For example, the act includes a “breakthrough devices” program, which requires the U.S. Food and Drug Administration to provide opportunities for medical device makers to help them expedite bringing devices to the market.
Building upon existing programs, such as the Expedited Access Pathway Program, we should see new devices come to market for medical conditions where technologies are unavailable or limited. The FDA has also been directed to review class I (lowest risk) and class II (slightly higher risk) devices to identify possible exemptions to 501(k) (pre-market submission to FDA), as well as strengthening expertise on classification panels reviewing medical device clearance.
The Cures Act also clarifies the FDA’s role in regulating medical software. While continuing to oversee the regulation of image analysis software, the FDA will not regulate clinical decision support software that uses large data sets or big data. Ultimately, providing faster turnaround in the classification, review, and clearance of digital medical devices should have wide-ranging impacts on the development and release of new technologies, as well as the implementation of digital healthcare across the industry. But it also means organizations must be ready to support the development and release of new medical devices.
What can organizations do to ready themselves for the Cures Act?
Ensure policies, infrastructures, technologies, and security methods are in place to manage data medical devices will create. Organizations can’t rely on their traditional IT methods and processes to capture, analyze, and store information considering these regulatory changes, which absolutely streamline the classification, review, and approvals of new devices. Speed is of the essence.
Long lead times to obtain software and implement infrastructures will be a thing of the past in this new environment. The breakthrough advances digital medical devices introduce will continue to improve the quality and efficiency of healthcare. In addition, it will also increase the maturity and effectiveness of digital-based healthcare, particularly the importance of information and the secure exchange of that information. Overall, the 21st Century Cures Act advances digital healthcare and promotes its positive benefits for the industry, as well as for healthcare consumers.
How will you (and your organization) use digital technologies to think outside the box and transform the way you do business? Answering those questions, and identifying some simple yet important steps are the basis for my e-book: Preparing for Digital Healthcare, now available for download on the HighPoint Solutions website.