Donald Rucker, the National Coordinator for Health IT, provided a testimony before the House Committee on Energy & Commerce detailing the progress made so far by the Office he is in charge of (Office of the National Coordinator for Heath, ONC), responsible for laying the groundwork for the objectives outlined in the Cures Act.
Designed to help accelerate medical device development and bring innovations to patients who need them more rapidly and efficiently, the 21st Century Cures Act (Cures Act) was enacted on December 13, 2016. The Cures Act was meant to build on FDA’s ongoing work by incorporating the perspectives of patients into the development of drugs, biological products, and Medical Devices in FDA’s decision-making process.
According to his testimony, the progress made so far by the ONC can be summarized as follows:
- The Health IT Advisory Committee (HITAC) was established by ONC the in January 2018 to support the flow of information and provide recommendations to the National Coordinator related to the three priority areas set forth in the Cures Act:
- achieving interoperability,
- the promotion and protection of privacy and security of health information, and
- facilitating secure access by individuals and their caregivers to their electronic health information.
- The Trusted Exchange Framework and Common Agreement (TEFCA) was established by the ONC to expand health information exchange nationwide and ensure that stakeholders can access real-time health information. The first draft of TEFCA, released in January 2018, gathered more than 200 public comments from stakeholders. An updated document is to be released in the upcoming months.
- The implementation of the Electronic Health Record (EHR) Reporting Program as required by Section § 4002(c) of the Cures Act. EHRs are digital versions of a patient’s chart, created and managed by authorized users, meant to be shared instantly and securely with all the clinicians involved in a patient’s care. 77 public comments were received on the program’s components and on the development of reporting criteria and processes, from all major stakeholders’ segments.