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.

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"

20181213 12/13/2018 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.

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

20181129 11/29/2018 Health IT, HHS, ONC, Reports
fa fa-2x fa-binoculars Sec. 4002. Transparent reporting on usability, security, and functionality. 12/13/2017: requires ONC promulgation of a rule updating the health IT certification program to include new requirements for interoperability.
12/13/2017: requires HHS awarding of grants, contracts, or agreements to independent entities on a competitive basis to support the convening of stakeholders as described in subsection (a)(2), collect the information required to be reported in accordance with the criteria established as described subsection (a)(3), and develop and implement a process in accordance with paragraph (5) and report such information to the Secretary.

8/24/2018: ONC requests public input regarding the EHR Reporting Program to help inform subsequent discussions among stakeholders and future work toward the development of reporting criteria. ONC provided background on the topic here.

1/12/2018: HHS announced forthcoming rule Health Information Technology: Interoperability and Certification Enhancements (RIN: 0955-AA01) which would, "update the Health IT Certification Program to support voluntary attestation to the adoption of the Trusted Exchange Framework and Common Agreement (TEFCA)

8/16/2017: ONC hosted a two-day technical interoperability forum with standards and technology industry stakeholders reduce information blocking, and enhancing the usability, accessibility, and privacy and security of health IT. ONC provided meeting materials for public consumption

20180824 08/24/2018 Health IT, Interoperability, ONC, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 4003. Interoperability. 6/13/2017: requires ONC to convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks.
6/13/2018: requires ONC publication of health IT trusted exchange framework and common agreement.
6/13/2019: requires ONC publication of health IT networks that have adopted the trusted exchange framework common agreement. To be updated annually thereafter.
6/13/2019: requires HHS, directly or through a partnership with a private entity, to establish a provider digital contact information index to provide digital contact information for health professionals and health facilities.
The section established the Health IT Advisory Committee (HITAC). Requires the committee no later than 30 days after the date on which first meets to establish and publish a schedule for assessing relevant health IT issues. The schedule will be updated annually. (HITAC consolidates the pre-existing HIT Policy Committee and the HIT Standards Committee.)

2/1/2019: ONC released the 2019 Health Information Technology Advisory Committee public meeting dates.

3/8/2018: HITAC published its schedule for the assessment of policy recommendations.

1/5/2018: ONC released the draft Trusted Exchange Framework for public comment.

12/22/2017: ONC provided the 2018 meeting dates for the Health Information Technology Advisory Committee (HITAC). 

12/1/2017: As part of the ONC Annual Meeting the agency convened the third and final meeting in the trusted exchange series

9/29/2017: ONC hosted a webinar as the second meeting in the series on trusted exchange framework and common agreement. 

7/24/2017: ONC convened the first in a series of meetings to support work on the trusted exchange framework and common agreement provisions.
7/24/2017: HHS announced it is seeking applications for two members of the HITAC; one of whom shall be appointed to be a public health official representative. A third representative will be appointed by the Secretary to represent HHS. To submit an application.
3/8/2017: The Government and Accountability Office (GAO) is accepting nominations for the HITAC. GAO is responsible for 14 of the 25 seats
The remaining 8 members will be appointed by Congressional leaders with the majority and minority leaders of the Senate, and the speaker and minority leader of the House of Representatives each appointing 2 members respectively.

20190201 02/01/2019 Health IT, Interoperability, ONC
fa fa-2x fa-binoculars Sec. 4004. Information blocking. HHS is directed, through rule-making, to determine activities that do not constitute information blocking, and therefore are not subject to penalties established by this section. (No date provided in law.)

12/11/2018: The Subcommittee on Health held a hearing entitled "Implementing the 21st Century Cures Act: An Update from the Office of the National Coordinator" which included a discussion on information blocking.

7/31/2018: The Centers for Medicare and Medicaid Services posed a question pertaining to the reduction of information blocking if CMS were to propose a new CoP/CfC/RfP standard to require electronic exchange of medically necessary information.

4/8/2018: POLITICO speculated at a summer release of information blocking rule by HHS

10/31/2017: James A. Cannatti III Senior Counselor for Health Information Technology provided testimony on HHS activities before the United States Senate Committee on Health, Education, Labor, and Pensions. 

20181211 12/11/2018 Health IT, HHS, Interoperability, ONC, Regulatory Affairs
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. 4006. Empowering patients and improving patient access to their electronic health information. Requires HHS issuance of guidance to health information exchanges on best practices to ensure that patient data is private, secure, accurate, and able to be shared when appropriate.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Guidances, Health IT, HHS, Interoperability, ONC
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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 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
fa fa-2x fa-check Sec. 4010. Medicare pharmaceutical and technology ombudsman. 12/13/2017: requires HHS to establish a pharmaceutical and technology ombudsman.

2/12/2018: CMS announced James Bailey is currently serving as the new Medicare Pharmaceutical and Technology Ombudsman. 

20180212 02/12/2018 CMS, Health IT
fa fa-2x fa-check Sec. 4012. Telehealth services in Medicare. 12/13/2017: requires CMS to provide information to Congress on use of telehealth services by Medicare.

2/15/2018: Medicare published updated Medicare Learning Network (MLN) Booklet on Telehealth Services

2/9/2018: Congress passes the Bipartisan Budget Act including landmark support for telemedicine in Medicare. Specific sections on the topic: Sec. 50323. Increasing convenience for Medicare Advantage enrollees through telehealth.Sec. 50324. Providing accountable care organizations the ability to expand the use of telehealth., and; Sec. 50325. Expanding the use of telehealth for individuals with stroke.

11/15/2017: The Congressional Research Service published a report, "Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet"

6/15/2017: MedPac issued the June 2017 Report to the Congress: Medicare and the Health Care Delivery System. It includes some reference to telehealth.

Other resources relating to CMS telehealth services include:

20180215 02/15/2018 CMS, Health IT


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