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-check Sec. 2012. Privacy protection for human research subjects. Directs HHS to issue certificates of confidentiality to protect personal information of research participants from unauthorized disclosure.
6/11/2017: Updated policies go into effect.

9/7/2017: NIH provided a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality. The changes will be effective 10/1/2017. Further discussion can be found in this NIH blog entitled, "NIH’s Certificates of Confidentiality Policy Enhances Confidentiality of Participants Enrolled in Clinical Research Studies."

20170907 09/07/2017 HHS, Privacy, Research
fa fa-2x fa-binoculars Sec. 2013. Protection of identifiable and sensitive information. Enables HHS to exempt from disclosure, certain information that is or may be identifiable.

FasterCures will periodically assess this item as appropriate. 

20161213 12/13/2016 HHS, Privacy, Research
fa fa-2x fa-long-arrow-right Sec. 2034. Reducing administrative burden for researchers. 12/13/2017: directs OMB to establish of the Research Policy Board.
12/13/2018: requires HHS review and revision of regulations and policies to reduce the administrative burden on researchers.
12/13/2018: requires HHS and USDA review and revision of regulations and policies for the care and use of laboratory animals to reduce administrative burden on researchers.
12/13/2018: requires submission of a Research Policy Board report to the White House and Congress containing formal recommendations on harmonization of policies to reduce administrative burden on researchers.
12/13/2020: requires publication of GAO report on the Research Policy Board's activities.

3/14/2018: NIH posted a guide notice and an accompanying Federal Register Notice requesting input from the grantee community to reduce administrative burden regarding regulations related to the care and use of laboratory animals.  Dr. Lauer also posted a blog

4/26/2017: The Association of American Universities issued an open letter to OMB Director Mick Mulvaney urging the swift implementation and creation of the Research Policy Board.

2/28/2017: The Congressional Research Service issued a brief reiterating 21st Century Cures legislative mandate to OMB to create the Research Policy Board.

20180314 03/14/2018 FDA, GAO, HHS, NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2062. Tick-borne diseases. Requires HHS to establish the "Tick-Borne Disease Working Group." (And subsequent sun-setting of the working group 6 years after enactment of the act.)
12/13/2018 (and every 2 years thereafter): delivery of a summary of tick-born disease research, treatment, and epidemiological studies.

2/12/2018: The Working Group held a public meeting on February 12, 2018

12/13/2017: The Working Group held a public meeting on December 11 & 12, 2017

7/17/2017: HHS announced the establishment the Tick-Borne Disease Working Group and launched the group's website.

20180212 02/12/2018 CDC, FDA, HHS, NIH, Reports, 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

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CDC, Data Sharing, FDA, Guidances, HHS, NIH, Regulatory Affairs, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 3023. Protection of human research subjects. 12/13/2018: requires HHS to submit a report to Congress describing progress being made to harmonize differences between the human subject regulations under the Common Rule and the Federal Food Drug and Cosmetic Act.

12/13/2019: requires harmonization of these rules is to be completed.

2/21/2018: FDA announced it is amending its regulations on acceptance of data from clinical investigations for medical devices. FDA recognized its 21st Century Cures obligation to harmonize the differences between the HHS human subject regulations and FDA's human subject regulations. FDA will be working with others at HHS in carrying out this statutory directive, including with respect to de-identified human specimens.

9/25/2017: FDA issued guidance entitled, "Minutes of Institutional Review Board (IRB) Meetings - Guidance for Institutions and IRBs" consistent with the goal of rule harmonization set forth in this section of 21st Century Cures. Further context for this guidance was laid out in the Federal Register Notice

20180221 02/21/2018 Clinical Trials, FDA, Health Citizenship, HHS, NIH, Research


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