The Assistant Secretary for Technology Policy Annual Meeting was held on December 4-5, 2024.  Stay tuned for the plenary recordings and slides from the breakout sessions to post in the coming weeks. 

Join ASTP for an overview of USCDI+ respiratory illness, providing you with the latest insights and an opportunity to share your feedback.  During the session, we will give an overview of USCDI+ Respiratory Illness and the acute respiratory distress (ARDS) draft data elements and their role in enhancing clinical trials, and leave time for your questions and comments.  Please come prepared to bring your questions and feedback to help us enhance ARDS clinical trials.We look forward to your valuable participation in shaping the future of data interoperability in respiratory illness research. If you have any questions, please contact us at USCDI.plus@hhs.gov. Presentation Slides [PDF - 2.1 MB] 

Join ASTP and the National Cancer Institute for a listening session on the USCDI+ Cancer Clinical Trials Matching (CTM) and immune-related Adverse Events (irAE) draft datasets.USCDI+ Cancer Clinical Trials Matching (CTM)The USCDI+ Cancer CTM dataset aims to establish a standardized set of data elements reported in a consistent format. By focusing on key screening data, this dataset will support generating a list of potential trials for which a patient may be eligible. This will streamline the matching process, making trial matching more equitable and accessible for all patients, and enabling patients, healthcare providers, and researchers to engage more effectively in cancer treatment decisions and care planning.USCDI+ Cancer immune-related Adverse Events (irAE)The immune-related Adverse Events (irAEs) use case within the USCDI+ Cancer initiative aims to significantly enhance the accuracy and reliability of detecting signals for immune-related adverse events using real-world data. This effort focuses on defining and refining standardized structured data elements that are crucial for identifying signals associated with common immune-related checkpoints for participants in clinical trials.

Got questions about information sharing under ASTP’s information blocking regulations? Join ASTP’s experts for our virtual office hours to ask us about the information blocking regulations.NEW DATE – This session has been rescheduled from October 3 to October 24.  If you had previously registered, your registration will automatically updated. 

Join the ONC Health IT Certification Program for the upcoming quarterly ONC Health IT Certification Program Developer Roundtable. These public meetings are open to all health IT developers, regardless of their participation in the ONC Health IT Certification Program. During these meetings, ONC leads discussions tailored for the health IT developer community on topics such as Certification Program updates, upcoming certification deadlines, and developer requirements.Agenda:

§170.315(b)(11) Decision Support Interventions Certification Companion Guide

API Condition and Maintenance of Certification 

Presentation Slides [PDF - 1.5 MB]

Join ASTP to learn and ask questions about the 2024-2030 Federal Health IT Strategic Plan.Download slides [PDF - 5.7 MB]

ASTP/ONC is holding another installment of the Decision Support Interventions (DSI) Roadshow for Health IT Developers: Advancing your Understanding of ONC Health IT Certification Program Requirements for 45 CFR 170.315(b)(11). During this session, ASTP/ONC will review Certification Program requirements and guidance for health IT developers working to certify Health IT Modules to § 170.315(b)(11), enhancing your understanding of the certification process and requirements.Presentation Slides [PDF - 952 KB]

Join the Assistant Secretary for Financial Resources (ASFR) and the Assistant Secretary for Technology Policy for an overview of ASFR’s proposed rule, the HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology.

Register for an introductory webinar on the free Security Risk Assessment Tool (SRA Tool) hosted by Altarum with the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Assistant Secretary for Technology Policy (ASTP). The webinar will also feature changes in SRA Tool version 3.5, available in September 2024.What is the Security Risk Assessment Tool (SRA Tool)? ASTP, in collaboration with OCR, offers a free, downloadable Security Risk Assessment (SRA) Tool to help guide small and medium-sized provider practices and organizations in their efforts to assess security risks. The tool is designed to help organizations conduct a security risk assessment as required by the HIPAA Security Rule.During this webinar, attendees will receive:

An introduction to security risk assessment

Instructions on how to download, install, and use the SRA Tool

An overview of changes in the new SRA Tool 3.5 Release

An opportunity for Q&A

Presenters will include:

Ryan Callahan, Altarum

Dawn Bishop, Altarum

Nick Heesters, OCR

 

ASTP and NCI invite you to participate in an upcoming listening session focused on the Cancer Registry use case and USCDI+ Cancer Registry data element list published on July 23rd. This session will provide an opportunity to discuss the importance and ease of collection of the data elements, the potential burden of sharing them electronically, and the impact on the future flow of data as we gather feedback from stakeholders like you.If you have any questions, please contact us at USCDI.Plus@hhs.gov.  

Join colleagues from the Vulcan HL7® FHIR® Accelerator, Food and Drug Administration, and ASTP/ONC for a kickoff informational webinar for the Vulcan Interoperability Bridge Event. This webinar is designed to share information on how we will convene clinical research sponsors, including pharmaceutical companies and academic medical centers, EHR providers, clinical research sites and technology solutions providers to work together to demonstrate the future of connected clinical research and clinical care through HL7 FHIR. Learn how you can engage to forge a path forward for clinical research infrastructure. Why You Should Attend:

Discover Key Insights: Learn about the enhancements you can make to advance your clinical research environment through better data exchange.

Learn what is possible: Understand how the Vulcan HL7 FHIR Accelerator is working to improve clinical care and research interoperability.

Explore Engagement Opportunities: Find support through this community of implementers, demonstrate your leadership, and drive research forward by participating in the Vulcan Interoperability Bridge Event.

Spread the word! Please feel free to share this invitation with colleagues or friends who are interested in making a significant impact on clinical research infrastructure by participating in the Vulcan Interoperability Bridge Event.Questions? Contact vib@HL7Vulcan.orgPresentation Slides [PDF - 2.4 MB]

ONC's HTI-2 proposed rule implements provisions of the 21st Century Cures Act and reflects ASPT/ONC’s focused efforts to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities. Each session will be recorded and posted to the HTI-2 webpage.Wednesday, July 17th: Overview SessionTuesday, July 30th: Public HealthThursday, August 8th: Information BlockingThursday, August 15th: Patient, Payer, Provider API

Join ONC at the DSI Roadshow for Health IT Developers: Advancing your Understanding of ASTP/ONC Health IT Certification Program Requirements for 45 CFR 170.315(b)(11). During this session, we will review Certification Program requirements and guidance for health IT developers working to certify Health IT Modules to § 170.315(b)(11), enhancing your understanding of the certification process and requirements.Presentation Slides [PDF - 1030 KB]

ASTP/ONC has launched a search to fill the permanent positions of Chief Technology Officer, Chief AI Officer, and Chief Data Officer to build dedicated talent for this vital team. Attend this webinar to learn about these key executive roles and how to apply.Webinar Slides [PDF- 609 KB]  

Join colleagues from ONC and the National Cancer Institute for a follow-up webinar to the recent Cancer Research Data Exchange Summit. This webinar is designed to provide updates on our use case development activities and share pivotal findings that emerged from the summit discussions, including the Cancer Registry data element list.

On June 24, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule establishing a set of disincentives in CMS programs for certain health care providers that have been found to have committed information blocking by the HHS Office of Inspector General (OIG). The final rule, which reflects contributions from throughout the department, implements the HHS Secretary’s authority under section 4004 of the 21st Century Cures Act (Cures Act).ONC and CMS hosted an information session about the final rule on Wednesday June 26 at 2:00 – 3:00 PM ET. 

Join the ONC Health IT Certification Program for the upcoming quarterly ONC Health IT Certification Program Developer Roundtable. These public meetings are open to all health IT developers, regardless of their participation in the ONC Health IT Certification Program. During these meetings, ONC leads discussions tailored for the health IT developer community on topics such as Certification Program updates, upcoming certification deadlines, and developer requirements.Agenda:

Standards Version Advancement Process (SVAP)

Requirements for Decision Support Interventions and Predictive Models

Presentation Slides [PDF - 1 MB]Q&A: Certification Program Developer Roundtable [PDF - 233 KB]

The Office of the National Coordinator for Health Information Technology (ONC) and the National Institutes of Health’s (NIH) National Cancer Institute (NCI) are excited to announce the upcoming United States Core Data for Interoperability Plus (USCDI+) Cancer Data Exchange Summit, May 8-9th. This two-day, in person meeting will bring together clinical, scientific and technical communities for information sharing as we identify strengths, weaknesses, and gaps in existing data standards and availability of data needed to implement the USCDI+ Cancer Moonshot Use Cases.In person registration for the USCDI+ Cancer Data Exchange Summit is limited due to logistical constraints and physical capacity. For those unable to attend in person, we are pleased to offer a virtual participation option. While active participation in break-out groups won’t be possible, you can still gain valuable insights by tuning in remotely to plenary sessions, keynote addresses, and updates on the USCDI+ Cancer use cases. Details on accessing the virtual platform will be provided closer to the event date. 

Join the ONC Health IT Certification Program for the upcoming quarterly ONC Health IT Certification Program Developer Roundtable. These public meetings are open to all health IT developers, regardless of their participation in the ONC Health IT Certification Program. During these meetings, ONC leads discussions tailored for the health IT developer community on topics such as Certification Program updates, upcoming certification deadlines, and developer requirements.Presentation Slides [PDF - 2.1 MB]

Now that 2023 Real World Testing is complete, Health IT Developers must submit a Real World Testing results report to their ONC-Authorized Certification Body (ONC-ACB). Results reports for Real World Testing conducted in 2023 must be made publicly available on the Certified Health IT Product List (CHPL) no later than March 15, 2024. At this webinar, ONC will assist Health IT Developers in developing their Real World Testing results report and in meeting all Real World Testing requirements.Presentation Slides [947 KB]

ONC will host information sessions to explain the final rule. Each session will be one hour, except for the Insights Condition session which will be one hour and 15 minutes. The sessions will be recorded. 

Information Session #1: Thursday, January 4, 2024 at 1pm ET 

Decision Support Interventions Information Session: Wednesday, January 17, 2024 at 1pm ET 

Information Blocking Information Session: Thursday, January 25, 2024 at 1pm ET 

Overview with Question & Answer Information Session #2: Thursday, February 1, 2024 at 1pm ET 

Insights Condition Information Session: Thursday, February 8, 2024 at 3-4:15pm ET