Top News
CDC Director Dr. Rochelle Walensky Resigns
Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention, announced she will resign effective June 30. Learn more.
ONC HTI-1 Proposed Rule Released for Public Comment
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. Comments due June 20. View the Proposed Rule
Regulatory
ONC Policy in Practice Webinar
The ONC will host a webinar on June 5 at 2:00 pm ET to address how the demand for immediate access to test results is changing the care paradigm, and how providers are advancing communications with patients throughout the test ordering and result process. Register now.
COVID Public Health Emergency Ends
The COVID Public Health Emergency ends May 11. This brings the spotlight on many public health challenges and the need to achieve improvements in addressing overall public health needs, including social determinants of health. Healthy People 2030 goals are central to this effort. Learn more.
Relatedly, the National Center for Health Statistics released two video tutorials on how to use the previously published (1) Trend Analysis and (2) Percent Improvement and Minimal Statistical Significance target-setting tools. These tools are available to anyone interested in developing targets or goals for health indicators for states, localities, specific populations, or other groups that are methodologically consistent with those developed for Healthy People 2030.
CMS Blog: Role of Data in Organ Procurement Reforms
As noted in the Washington Download earlier this year, the Health Resources and Services Administration (HRSA) has launched the Organ Procurement and Transplantation Network (OPTN) Modernization Initiative. Recently, the Centers for Medicare and Medicaid Services (CMS) issued a blog post to highlight the importance of data in this effort. Read the blog.
FDA Resources on Cybersecurity and Medical Devices
The Food and Drug Administration (FDA) has developed a new video on cybersecurity and other resources to assist health care delivery organizations with resources on cybersecurity preparedness and planning. See links below for detailed information:
- Medical Device Cybersecurity
- Medical Device Cybersecurity Regional Incident Preparedness and Response, a resource to help health care organizations prepare for cybersecurity incidents. The playbook focuses on preparedness and response for medical device cybersecurity issues that impact device functions.
- Tips for Clinicians - Keeping Your Patients' Connected Medical Devices Safe is aimed to increase clinician comfort as they discuss cybersecurity in connected medical devices with patients.
- Cybersecurity Awareness for Connected Medical Devices offers practical steps patients can take to protect their device and personal information.
FDA Guidance on Decentralized Clinical Trials
The FDA recently issued a new draft guidance that provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials to advance medical product development and research. Comments due by August 1. View the draft.
FDA Data and Technology Strategic Plan
The FDA has extended the comment period until June 12, for responses to the RFI on the FDA’s Data and Technology Strategic Plan. See the details.
CMS Issues IPPS Proposed Rule
Recently, CMS issued the FY 2024 hospital inpatient prospective payment system (IPPS) proposed rule. For acute care, hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting program and are meaningful electronic health record users, proposed increase in operating payment rates for FY 2024 is projected to be 2.8%. Other items of interest include CMS’ proposal to add 15 new health equity hospital categorizations for the FY 2024 IPPS payment impacts. View the CMS Fact Sheet.
HIPAA and Reproductive Health Care
The Department of Health and Human Services (HHS) recently issued a proposed rule to strengthen Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule protections by prohibiting the use or disclosure of protected health information (PHI) to investigate, or prosecute patients, providers, and others involved in the provision of legal reproductive health care, including abortion care. See the details.
Legislation and Politics
Electronic Health Record Modernization
House Committee on Veterans’ Affairs Chairman Mike Bost (R-IL) and Ranking Member Mark Takano (D-CA) introduced legislation to address the VA’s electronic health record modernization effort. Read the summary of H.R. 2809, the Electronic Health Record Program Restructure, Enhance, Strengthen, and Empower Technology Act of 2023.
Senate Finance Hearing on Ghost Networks
The Senate Finance Committee recently held a hearing on “Barriers to Mental Health Care: Improving Provider Directory Accuracy to Reduce the Prevalence of Ghost Networks.” The hearing focused on provider directories maintained by insurance companies that are often inaccurate and unusable. Senate Finance Chairman Ron Wyden (D-OR) is committed to ensuring accountability in provider networks, outlining the need for more audits, greater transparency, and stronger consequences for insurance companies that don’t keep their directories up to date. He noted a planned focus this year on ghost Medicare networks. Get the details.
Around the Web
- VA’s new EHR hits another outage, as agency reconsiders FY 2024 request for project; Federal News Network
- Electronic health information exchange lags among rural hospitals, GAO finds; Beckers Hospital Review
- FTC Chair Khan and Officials from DOJ, CFPB and EEOC Release Joint Statement on AI; Federal Trade Commission
AMIA’s Washington Download is your source for health informatics policy news and information from around the Beltway, covering action from the Hill, the Administration, and important AMIA collaborators.