As the Food and Drug Administration implements provisions of the 21st Century Cures Act, an industry stakeholder organization is urging the agency to ensure that final rules are consistent with congressional intent.
“The passage of the 21st Century Cures Act last year was an acknowledgement that our regulatory processes and statutory structures related to technology and data must be revised to allow innovation to flourish,” wrote Health IT Now, a coalition of patient, provider, employer and payer organizations, in a recent letter to the agency. “Many of these provisions now fall to the FDA to implement in a way that balances the transformative nature of technology with the FDA requirement that products be safe and effective.”
Register or login for access to this item and much more
All Health Data Management content is archived after seven days.
Community members receive:
- All recent and archived articles
- Conference offers and updates
- A full menu of enewsletter options
- Web seminars, white papers, ebooks
Already have an account? Log In
Don't have an account? Register for Free Unlimited Access