House Committee's 393-page draft proposal includes health IT, telemedicine provisions
House of Representatives Committee on Energy and Commerce has released a 393-page draft document, called the 21st Century Cures Act, which contains a wide array of provisions that seek to advance medicine—including those directly related to health IT.
The draft document culminates from discussions with patients, innovators, regulators and researchers, according to the committee. “[I]t is clear that Congress must take bold action to accelerate the discovery, development and delivery of promising new treatments and cures for patients and maintain our nation’s standing as the biomedical innovation capital of the world,” according to the committee’s document outlining the proposal.
The document includes numerous provisions that would:
- Incorporate patient perspectives into the regulatory process and help address their unmet needs
- Build the foundation for 21st century medicine
- Streamline clinical trials
- Accelerate the discovery, development and delivery cycle and support continued innovation at our federal public health agencies
- Modernize medical product regulation
In the area of health IT, the proposal seeks to provide regulatory certainty for those developing apps and health information technologies, as based on the SOFTWARE Act. Another provision directly relates to interoperability, and while the provision is under development, it supports the goal of the national interoperability infrastructure.
The proposal also addresses the accessing, sharing and using of health data for research purposes. One provision pushes for the unlocking of data siloed in healthcare facilities that have research potential. Also included is a provision related to telemedicine, which would advance its use in delivering care to Medicare beneficiaries.
In other areas, one provision would require the FDA to establish a structured framework for the meaningful incorporation of patient experience data into the regulatory decision-making process.
Other provisions include approval of breakthrough therapies when early stage clinical data show sufficient evidence that they are effective, with consideration of the risks. A similar provision would allow accelerated approval for breakthrough devices. The proposal also seeks to reward companies for pursuing treatments and cures for complex diseases, like Alzheimer’s.
Read an outline of the draft proposal.