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Infrastructure Vote Delayed Again, as White House Releases Updated ‘Build Back Better’ Framework

Last Thursday, the House of Representatives once again delayed the vote on the Senate-passed Infrastructure Investment and Jobs Act as House progressives continued their pledge to vote it down if it is not accompanied by a vote on the massive reconciliation bill, now termed the Build Back Better (BBB) Act. President Biden made a visit to Capitol Hill to personally cajole House members into supporting an updated $1.75 trillion framework, which he believes can pass the Senate. Formal legislative text was released later that day. Among the many social spending and climate change provisions, the BBB Act additionally includes:

  • $7 billion for the Centers for Disease Control and Prevention (CDC) to issue grants to support core public health infrastructure activities to strengthen of state, territorial, local, or Tribal health departments.
  • $500 million for the Federal Trade Commission (FTC) to create and operate a bureau to accomplish its consumer protection work relating to privacy, data security, identity theft, data abuses, and related matters.
  • $1.4 billion in funding to support renovation, improvement, expansion, and modernization of state and local public health laboratory infrastructure; enhance the capacity of the laboratories at CDC; and enhance the ability of CDC to monitor and exercise oversight over the biosafety and biosecurity of state and local public health laboratories.

Notably, the updated framework and bill text excludes the establishment of the Advanced Research Projects Agency for Health (ARPA-H), which had been in the House’s original, much larger framework for the BBB Act. The proposed new agency is now reportedly being included in the 21st Century Cures Act 2.0, which may come to the House floor when it reconvenes this week. With legislative text of the BBB Act now available, keep an eye out for potential votes on both pieces of the major legislation this week.


FDA to Prioritize CDS Guidance in FY2022

Last week, the Food and Drug Administration (FDA) published its A and B lists of guidance documents it will prioritize in fiscal year 2022, including finalizing a clinical decision support (CDS) software guidance that’s been four years in the making. The FDA divides its planned guidelines into an A-list featuring prioritized documents and a B-list of texts it intends to publish.

AMIA commented on the original draft guidance that was released at the end of 2017, writing that the draft guidance may leave “lingering confusion” about the regulatory status of CDS software. Publishing the A and B lists indicates that FDA is now close to finalizing the guidance, which will clarify when CDS meets the definition of a medical device and set out a risk-based framework for the software functions. Earlier this year, AMIA also released a position paper on informatics-led policy recommendations for safe, effective use of adaptive CDS.

VA’s New AI Strategy Focuses on Ethics, Trust

The Department of Veterans Affairs (VA) released and implemented a strategy around ethical use of artificial intelligence (AI) for enhanced veteran care. Implemented in September 2021, the plan centers on four distinct objectives:

  • Use existing AI capacities to better deliver health care and benefits to veterans
  • Develop these existing AI capacities
  • Increase veteran and stakeholder trust in AI
  • Build upon partnerships with industry and other government agencies.

The plan represents the agency’s first formally published AI strategy since the founding of the National Artificial Intelligence Institute (NAII) in June 2019, which is directed by AMIA member Gil Alterovitz, PhD, FACMI, FAMIA. The VA established the institute with support from the February 2019 American AI Initiative executive order, which increased funding for federal AI research, while establishing new AI institutions across government. While the VA has rapidly developed its AI capabilities since 2019, agency leadership has expressed particular attention to ensuring these capacities are developed as “trustworthy AI” that abides by NIST principles, while expanding these to cover the specificities of the VA’s AI program. The agency’s new strategy can be found here.

Legislation & Politics

Lawmakers Continue to Express Concern Over VA EHR Implementation

At an October 21 House of Representatives hearing, Military Construction, Veterans Affairs, and Related Agencies Subcommittee members noted a lack of clarity in the VA’s responses to questions regarding the agency’s ongoing EHR implementation. Chairwoman Debbie Wasserman Schultz (D-FL) asked VA deputy secretary Donald Remy what specific steps the agency has taken to address EHR implementation-related patient safety concerns, recently highlighted in a VA report this past July. Remy answered that as the agency hears patient safety concerns, it catalogs the information into one of nine domains, then “examine[s] the root cause, and make[s] sure that [the problems] don’t recur.”

Members of the subcommittee also questioned Remy about health IT infrastructure issues related to the implementation. A recent VA strategic review of the project revealed that the agency estimates that it will require an additional $6 billion in funds for infrastructure-related costs. The committee sought clarity on how the VA misjudged the cost of infrastructure upgrades, which Remy said was a result of “both physical and technological” issue. This past summer, Rep. Frank Mrvan (D-IN) introduced the VA EHR Transparency Act of 2021, which would require the agency to deliver cost reporting to Congress every 90 days. At another hearing in early October, the VA said the agency supports the measure, but wants flexibility on reporting times and clarification on other reporting requirements.

AMIA News and Notes

Are You at the Annual Symposium? Join Us for the Public Policy Update!

Date: Tuesday, November 2; 8:30 a.m. PDT
Location: Aqua Salon AB, Hilton San Diego Bayfront

Are you in San Diego? Get caught up on what happened across the Executive Branch and Congress in 2021 and see what AMIA Public Policy leaders have been up to over the past year. Join us in person, featuring AMIA Board Member Susie Hull, for the Annual Symposium installment of “Informatics Inside the Beltway.” We’ll consider the year that was, what’s new with AMIA Public Policy, and what we foresee for Health Informatics Policy in the coming year.

TEFCA Must Augment Existing Exchange Work, AMIA Stresses

In comments submitted to ONC's (Office of the National Coordinator for Health Information Technology) Recognized Coordinating Entity (RCE) for the Trusted Exchange Framework and Common Agreement (TEFCA), AMIA stressed that participants and subparticipants must be confident that participation in TEFCA will be a net benefit to their current exchange activities. AMIA further recommended that ONC scenarios to clarify how TEFCA will facilitate the various exchange purposes and how the participants and subparticipants will fit in.

Upcoming Webinar: Advanced AI Applications for Socially Responsible Biomedical Research

Wednesday, November 17; 11:00 a.m. EST
Friends of the National Library of Medicine

This virtual workshop from the Friends of the National Library of Medicine will examine the opportunities and risks of AI applications in health sciences. The purpose is to accelerate research by exploring, explaining and discussing a variety of AI solutions for biomedical research. The workshop will also look into the question of what can go wrong when experimenting with new AI technologies. Click here to learn more and register.

Around the Web

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.