21st Century Cures

The 21st Century Cures Act (P.L. 114-255) is landmark, bipartisan legislation that was signed into law on Dec. 13, 2016, and touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. Read what FasterCures has said about 21st Century Cures over the years.

FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation’s journey to the president’s desk. In February 2017, we debuted the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. (Other divisions of the law pertain to mental health and Medicare; since those are not areas of focus for FasterCures, we will not be actively tracking them here.) Learn more about how to use the tracker with our FAQs page.

A few examples of the issues we will be tracking include the impact of changes to the National Institutes of Health’s administrative requirements for grantees, how the Food and Drug Administration implements new changes designed to enhance patient engagement and how the Department of Health and Human Services is using its new authorities to promote health information technology interoperability.

Many external factors will affect the progress of these initiatives, including policies related to hiring freezes and uncertain funding levels. This tracker is not meant to be a pass/fail report card, but rather a snapshot in time that can help explain impact and identify where progress is needed.

Please keep coming back, as we will be updating the information regularly. Use the button below to send us feedback on the value of the information we are presenting, and the usability of this new resource.

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FasterCures' 21st Century Cures Act Tracker (P.L. 114-255)

Status Section Tracked Deadlines and Requirements Update Date of Update Tags
fa fa-2x fa-long-arrow-right Sec. 2011. Precision Medicine Initiative. 12/13/2017: requires HHS submission of a report on the relevant data access policies and procedures to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. The report should include steps the HHS has taken to consult with experts or other heads of departments or agencies of the Federal Government in the development of such policies.

5/6/2018: NIH launched the All of Us Research Program, a study aimed to advance the science of precision medicine by involving 1 million participants living in the United States.

20180508 05/08/2018 Data Sharing, Reports
fa fa-2x fa-long-arrow-right Sec. 2014. Data sharing. Requires NIH grant recipients to share the data generated from NIH funded research.

10/10/2018: The National Institutes of Health (NIH) issued a Request for Information (RFI) on proposed key provisions to inform future NIH policies for data management and sharing. Comments may be submitted here until December 10, 2018.

NIH is addressing Data Sharing as instructed in this section through: RFIs: NOT-OD-16-133 and NOT-OD-17-015,  NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources, and NIH Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research.

20181011 10/11/2018 Data Sharing, NIH, Research
fa fa-2x fa-check Sec. 2053. Updates to policies to improve data. Updates policies to ensure reporting of data from valid analyses for certain clinical trials. Revised policies go into effect for all grant awards received 1 year after enactment.

11/28/2017: a Guide Notice (NOT-OD-18-014) was released notifying the research community that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analysis are submitted to Clinicaltrials.gov.

20171128 11/28/2017 Clinical Trials, Data Sharing, NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2054. Consultation. 3/13/2017 (90 days): requires HHS to consult with relevant Federal agencies, including the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the National Institutes of Health, as well as other stakeholders (including patients, researchers, physicians, industry representatives, and developers of health information technology) to receive recommendations with respect to enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including with respect to usability, functionality, and search capability.

6/1/2017: NLM rolled out the first in a series of changes to ClinicalTrials.gov
3/16/2017: in a letter responding to several organizations who expressed interest in ensuring the requirements of this provision be fulfilled, the Director of the NIH highlighted a new partnership between NIH and technical experts at 18F to make enhancements to ClinicalTrials.gov.
2/28/2017: the Secretary of HHS delegated the authority to fulfill the requirements of this Section to the NIH.
2/1/2017: a new beta version of ClinicalTrials.gov was released and is available here."

20170601 06/01/2017 Clinical Trials, Data Sharing, FDA, NIH, ONC, Research
fa fa-2x fa-long-arrow-right Sec. 2063. Accessing, sharing, and using health data for research purposes. 12/13/2017: requires HHS issuance of guidance clarifying that remote access of health data by researchers (under appropriate circumstances) is not forbidden by regulation.
12/13/2017: requires HHS issuance of guidance clarifying requirements for the authorized disclosure of protected health information for research.
12/13/2017: requires HHS establishment of a "Working Group on Protected Health Information for Research" to study and, within 1 year of establishment, report on whether the uses and disclosures of protected health information for research purposes should be modified.
12/13/2017: requires submission of a report to the HHS Secretary

12/13/2017: HHS issued a guidance entitled "21st Century Cures Act Guidance: Remote Access to PHI for activities Preparatory to Research." The issuance of this guidance signifies the completion of two of the requirements of this section.

20180105 01/05/2018 CDC, Data Sharing, FDA, Guidances, HHS, NIH, Regulatory Affairs, Reports, Research


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