Advancing 21st Century Cures

Documenting new ways to find better and faster cures in medicine, the House Energy and Commerce Committee on January 27th, released an initial discussion document outlining some specific proposals related towards building the foundation for 21st Century medicine. The document contains responses obtained from five white papers issued, eight hearings, and from the numerous roundtable discussions held this year.

The Committee seeks feedback on the proposals outlined in the document and will continue on an aggressive schedule to introduce 21st Century legislation and ultimately send the bill to the President for his signature by the end of 2015.

The discussion document includes ideas authored by both political parties that would incorporate patient perspectives into the regulatory process and help address unmet medical needs, streamline clinical trials, accelerate the discovery, development, and delivery cycle process, and support innovation at federal agencies.

The document’s Title II Section, Subtitle E presents ideas on how to help provide regulatory certainty for those developing apps and health information technologies. This provision includes language from the recently released discussion draft based on H.R 3303 or referred to as the SOFTWARE Act.

Under Title II Section, Subtitle F, the establishment of a data sharing framework would be in effect to enable patients and physicians to better identify ongoing clinical trials, enable researchers and developers to use Medicare data to improve the quality of patient care, and develop a process for Congress to address other issues identified by the President’s Council of Advisors on Science and Technology (PCAST).

The document’s Title IV Subtitle I concerns telemedicine. This provision led by Health Subcommittee Chairman Joe Pitts (R-PA), Frank Pallone (D-NJ), Representatives Gregg Harper (R-MS), Doris Matsui (D-CA), Bill Johnson (R-OH), Peter Welch (D-VT), Greg Walden (R-OR) and Bob Latta (R-OH) would like to advance opportunities for telemedicine and new technologies to improve the delivery of quality healthcare services to Medicare beneficiaries.

Other topics in the document include information on not only establishing medical device reforms but also modernizing the regulation for social media, authorizing additional funding for the National Center for Advancing Translational Science (NCATS) at NIH, and establishing the Medical Product Innovation Advisory Committee.

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