ONC Notice of Proposed Rulemaking
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)
Comments due June 20.
This proposed rule would implement certain provisions of the 21st Century Cures Act and includes new and updated standards, implementation specifications, and certification criteria. The Office of the National Coordinator for Health Information Technology (ONC) states implementation of the proposed rule’s provisions will advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.
FDA Guidance on Conduct of Clinical Trials
On June 6, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials. The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise. The guidance is open for comment. See more information.
MEDPAC Submits Report to Congress
The Medicare Payment Advisory Commission (MEDPAC) released its June report to Congress entitled “Medicare and the Health Care Delivery System.” View the report.
Newly Released Data Briefs Detail Medicaid/CHIP Enrollee Demographic Characteristics
For the first time, the Center for Medicare and Medicaid Services (CMS) released a series of data briefs detailing various demographic characteristics of Medicaid and Children’s Health Insurance Program (CHIP) enrollees. The four data briefs focus on the race and ethnicity, rural residency, primary language, and disability-related eligibility of the national Medicaid and CHIP populations. Read the series of data briefs.
FDA Issues Final Guidance on Device Software Functions
Recently, the U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. It replaces the FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005. Additionally, this guidance release updates the FDA’s thinking related to the risk-based approach to the documentation the FDA recommends sponsors include for the review of device software functions in premarket submissions. On July 20, the FDA will host a webinar for medical device manufacturers and other stakeholders interested in learning more about the final guidance and the recommendations for documentation sponsors should include in premarket submissions.
Relatedly, the FDA intends to issue minor updates to the guidance Off-The-Shelf Software Use in Medical Devices, as well as to certain device specific guidances, to reflect and ensure consistency with the information conveyed within the final guidance.
Legislation and Politics
60 Senators Focus Legislative Effort on Bolstering Telehealth
The CONNECT for Health Act of 2023 was recently introduced to expand Medicare coverage of telehealth and to make permanent the telehealth flexibilities established during the Covid 19 Public Health Emergency (PHE). See more about the CONNECT for Health Act of 2023.