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Hear the AMIA Public Policy team review the AMIA public comment process and public policy updates. During this on-demand webinar, you will learn more about the typical federal government public commenting process and timeline, how AMIA fits within the government’s constraints, and how you can get involved.
Regulatory
NLM Funding Opportunity: Personal Health Informatics for Delivering Actionable Insights to Individuals
The National Library of Medicine’s (NLM) Division of Extramural Programs is seeking proposals for a funding opportunity to advance the field of personal health informatics. NLM is requesting research that provides meaningful and actionable insights to individuals through personal health data collection, integration, and analysis, as well as personalized risk assessments and interpretation. Approved applications will receive up to $250,000 annually. Applications open September 5.
Learn more about the funding announcement.
AMIA Submits Public Comment Letter to FTC Health Breach Notification Rule
The Federal Trade Commission (FTC) is proposing changes to the current Health Breach Notification Rule (HBNR) addressing applicability to health applications and other direct-to-consumer health technology. Essentially, the FTC is looking to modernize and improve HBNR to fit the current landscape of healthcare.
In 2020, AMIA submitted a public comment to the FTC’s regular 10-year review of the HBNR and made near- and long-term recommendations. FTC is addressing AMIA's recommendations in their proposed HBNR, including to expand on the concept of “unauthorized access” under the definition of “breach of security”.
In AMIA’s Public Comment Letter, AMIA encourages the FTC to ensure that HBNR and HIPAA are aligned such that there are no gaps in regulation over the covered entities and other non-covered entities that work with PHRs; to align definitions with other agencies, including the definition of PHR; and to provide clarity around whether a non-health data source is being used in a health context and qualifies for coverage under the HBNR. AMIA also strongly encourages interagency coordination on such issues, particularly regarding standardizing definitions of terms and processes of addressing breaches. Some recommendations included clarification of entities covered, clarification regarding types of breaches subject to the rule and revised scope of PHR related entities.
ICYMI: In Case You Missed It
ONC 2023 Interoperability Standards Advisory
On August 8, ONC opened the comment period for the 10th Annual ISA Reference Edition. The Interoperability Standards Advisory (ISA) is the model ONC uses to coordinate the identification, assessment, and public awareness of interoperability standards and implementation specifications that can be used by the healthcare industry to address specific interoperability needs including, but not limited to, interoperability for clinical, public health, and research purposes.
Comment period ends October 6. Learn more about ISA and get the latest updates.
Time to submit USCDI v5 Draft Submissions
On July 20, the United States Core Data for Interoperability (USCDI) Version 4 was released. The Office of the National Coordinator for Health Information Technology (ONC) added one new data class and 20 new data elements. Under the Laboratory data class, the data element Result Reference Range was added. This addition came after AMIA’s recommendation! Check out the latest updates to USCDI v4 in the ONC Health IT Standards Bulletin Issue 2023-2.
Based on the USCDI v4, the ONC has opened the comment period for updates and recommendations to USCDI v5 draft. The deadline for new submissions is September 20. Submit now.
CMS Proposed Rules to Expand Behavioral Health Access and Increase Hospital Price Transparency
The Centers for Medicare & Medicaid Services (CMS) is proposing to expand access to behavioral health services through coverage of intensive outpatient services. CMS is seeking comments on potential payment adjustments to hospitals for the additional costs of establishing and maintaining a buffer stock of essential medicines in hopes to support practices curtail shortages of essential medicines.
Additionally, CMS is proposing new policies to improve and streamline its enforcement capabilities, including certification by hospital officials as to the accuracy and completeness of data; requiring hospital acknowledgement of warning notices; reserving the right for CMS to communicate directly with health system leadership about all of its hospitals, not just one hospital at a time; and publishing other enforcement activities, in addition to civil monetary penalties, on a CMS website. In this proposed rule, CMS is also promoting equity and taking actions to support Indian Health Service and tribal facilities.
Comments for both proposed rules due September 11:
- View the CMS Expand Behavioral Health Access proposed rule.
- View the CMS Increase Hospital Price Transparency and Enforcement proposed rule.
Health and Human Services (HHS) Proposed Rule to Advance Non-discrimination in HHS Programs for LGBTQI+ Community
The proposed rule would protect LGBTQI+ people from discrimination in important health and human services programs with HHS’ interpretation of the prohibition of discrimination on the basis of sex to include (1) discrimination on the basis of sexual orientation and (2) discrimination on the basis of gender identity, consistent with the Supreme Court's decision in Bostock v. Clayton County (2020).
Comments for the proposed rule due September 11. See full proposed rule text.
- Review of Physician and Advanced Practitioner Recruiting Incentives; AMN Healthcare
- CMS is Taking Action to Address Benefit Integrity Issues Related to Hospice Care; CMS.gov
- ONC Tech Forum: Clinical Decision Support Series; healthit.gov
- Next Session: The Future of Clinical Decision Support – Wednesday, September 27, 11:00 am – 4:00 pm ET
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.