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. 3060. Clarifying medical software regulation. 12/13/2018 (and every two years thereafter): requires HHS issuance of a report on the current state of health-related software and the regulation of those products.

9/27/2019: FDA announced the availability of a final guidance entitled "Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act." Comments on the guidance may be submitted electronically indefinitely.

12/13/2018: FDA released a report entitled "Report on Non-Device Software Functions: Impact to Health and Best Practices," fulfilling their requirement to issue a report on the current state of health-related software and their regulations.

12/8/2017: FDA announced the release of a draft guidance entitled "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act"; Submit either electronic or written comments on the draft guidance by February 6, 2018.

12/30/2016: FDA communicated its interpretation of this policy through final guidance titled "Medical Device Accessories--Describing Accessories and Classification Pathway for New Accessory Types"

20190927 09/27/2019 FDA, Health IT, Regulatory Affairs, Reports
fa fa-2x fa-binoculars Sec. 4001. Assisting doctors and hospitals in improving quality of care for patients. 6/13/2017: requires ONC issuance of a report on the Medicare and Medicaid EHR Meaningful Use Incentive program.
6/13/2017: requires the Secretary of HHS to submit to the HIT Advisory Committee of the Office of the National Coordinator for Health Information Technology, a report concerning attestation statistics for the Medicare and Medicaid Meaningful Use Incentive Program.
6/13/2018: requires ONC issuance of recommendation for a voluntary certification program for health IT use in pediatric settings.
12/13/2018: requires ONC adoption of certification criteria for a voluntary certification program for health IT use in pediatric settings.
12/13/2018: requires HHS issuance of a strategy and recommendations for improving patient care and reducing the administrative burden of electronic health record use by medical professionals.

8/14/2019: CMS requests information on the provider to patient exchange initiative specific to the Cures Act’s proposed rule for new proposals that focus on how certified health IT can use APIs to allow health information to be accessed, exchanged, and used without special effort through the use of APIs or successor technology or standards, as provided for under applicable law.

8/8/2019: HHS requested healthcare providers review the proposed rules, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” and “Interoperability and Patient Access,” and provide feedback on they might affect prospective payment rates for inpatient rehab facilities (IRFs). CMS announced the feedback here.

8/7/2019: HHS requested healthcare providers review the proposed rules, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” and “Interoperability and Patient Access,” and provide feedback on they might affect prospective payment systems for skilled nursing facilities (SNFs). CMS announced the feedback here.

2/11/2019: HHS proposed a new rule to improve the interoperability, access, and exchange of electronic health information, impacting sections 4001, 4002, 4003, 4004, and 4006 of the Cures Act. Comments are requested for the proposed rule, and may be submitted electronically until 5/3/2019.

11/28/2018: HHS released a draft "Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs." Comments are requested and may be submitted electronically until 1/28/2019.

5/10/2018: No ONC report on the Medicare and Medicaid EHR Meaningful Use Incentive program could be found on the ONC website.

ONC provides information on its website related to Meaningful Use and MACRA. 

ONC provides information on pediatric health IT through the Health IT Playbook: 11.2 Find resources for pediatric health IT

20190815 08/15/2019 Health IT, HHS, ONC, Reports
fa fa-2x fa-long-arrow-right Sec. 4005. Leveraging electronic health records to improve patient care. 12/13/2020: requires HHS submission to Congress, a report concerning best practices of patient safety organizations to improve the integration of health information technology into clinical practice.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Health IT, ONC, Reports
fa fa-2x fa-long-arrow-right Sec. 4007. GAO study on patient matching. 12/13/2017: requires GAO issue a study on matching patient identities to their health information - and protection of their privacy - by electronic health records and other health IT products.

1/15/2019: GAO shared a report entitled "Approaches and Challenges to Electronically Matching Patients' Records across Providers," identifying that additional efforts need to be implemented to improve patient matching.

20190131 01/31/2019 GAO, Health IT, ONC, Reports
fa fa-2x fa-check Sec. 4008. GAO study on patient access to health information. 6/13/2018: requires GAO submission of a report to Congress on the findings of the study conducted 

5/15/2018: GAO published GAO-18-386: Report to Congressional Committees. Full report available here

20180515 05/15/2018 GAO, Health IT, Reports

 

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