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AMIA’s Latest Public Comment Letter Submissions
ONC Notice of Proposed Rulemaking
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)
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.
AMIA commented on the proposed timeframe of implementation, establishing USCDI V3 as the baseline data set, and decision-support interventions to name a few. View AMIA's Comment Letter to ONC.
HIPAA Privacy Rule to Support Reproductive Health Care Privacy
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.
In AMIA’s comment letter, the association’s comments centered around security and privacy of protected health information and emphasizing the protection of the patient-provider relationship. Read AMIA's Comment Letter to HHS.
NAM Launches Artificial Intelligence Code of Conduct
The National Academy of Medicine (NAM) launched the Artificial Intelligence Code of Conduct (AICC), a three-year initiative aimed to form protections and best practices surrounding AI work. Additionally, NAM announced members of their steering committee, which includes four current AMIA members:
- Peter Embi, MD, MS, FACP, FACMI, FAMIA, FIAHSI
- Kevin Johnson, MD, MS, FAAP, FACMI, FAMIA, FIAHSI, FAIMBE
- Philip R.O. Payne, PhD, FACMI, FAMIA
- Kenneth D. Mandl, MD, MPH
See how the NAM Leadership Consortium is collaborating to develop code of conduct.
Regulatory
FTC Health Breach Notification Rule
The Federal Breach Trade Commission (FTC) is proposing changes to the current Health Breach Notification Rule (HBNR) addressing the 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. Public comment period ends August 8. See proposed amendment.
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. AMIA made several successful recommendations to the FTC, which the FTC is addressing in the proposed HBNR, including expanding on the concept of “unauthorized access” under the definition of “breach of security,” to be presumed when a personal health record or PHR-related entity fails to adequately disclose to individuals how user data is accessed, processed, used, reused, and disclosed. Read AMIA's 2020 Comment Letter to the FTC.
HHS-OIG Information Blocking Final Rule
The Department of Health and Human Services Office of Inspector General (HHS-OIG) has established the statutory penalties of up to $1 million per violation if an individual or entity has committed information blocking. This final rule does not create any new information blocking requirements. HHS-OIG has posted information on the ruling, investigation process, and enforcement priorities. Learn more about information blocking.
Previously, AMIA responded during the proposed rulemaking process and highlighted the need for individuals to have an opportunity for education on the final rule before enforcement begins and a database of enforcement actions, as well as instances where potential penalties were found exceptions under the information blocking rule. Read AMIA’s Public Comment Letter responding to HHS-OIG from June 22, 2020.
FDA CDRH Public Comment Opportunity: Increase Patient Access to At-home Use Medical Devices
The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is looking to find ways to assure individuals have access to medical technologies. This commitment involves facilitating access to medical devices designed to be safe and effective when used in the home or outside of the traditional clinical setting. The CDRH seeks comments on several specific questions including:
- How can the FDA support the development of medical technologies, including digital health technologies and diagnostics, for use in non-clinical care settings, such as at home?
- What design attributes and user needs would facilitate the use of medical technologies, including diagnostic and therapeutic devices, for use in a non-clinical setting, for example home use?
- What potential methods and strategies for evidence generation and data analysis could facilitate the regulatory review of medical technologies intended to be used in non-clinical settings, for example home use or school/work use?
Public comments must be submitted by August 30. Find out more about the request for comment.
Legislation and Politics
Legislators Pushing for Edits to CMS Proposal on Prior Authorization
An effort led by Rep. Suzan DelBene (D-Wash.) and Sen. John Thune (R-SD), Congress sent a letter to the Centers for Medicare & Medicaid Services (CMS) calling the agency to add provisions that include quicker turnaround for prior authorization requests and more detailed transparency metrics. This is a response to the proposed rule from CMS back in December 2022. The letter had 233 House of Representatives and 61 Senators cosign. Read the press release.
This initiative builds upon recommendations from legislation last session, Improving Seniors’ Timely Access to Care Act, that AMIA supported alongside the Regulatory Relief Coalition (RRC). Check out the RRC's one-page summary.
Around the Web
- A Resource Guide for Using Medicare's Enrollment Race and Ethnicity Data; HHS
- Transforming Medicare Coverage: A New Medicare Coverage Pathway for Emerging Technologies and Revamped Evidence Development Framework; CMS
- Updated Insights on Hospital Leaders’ Perceptions of Information Blocking; HealthITBuzz
- HHS Marks 24th Anniversary of the Olmstead Decision; HHS
- Former North Carolina health official is picked to be new CDC director; AP News
- ClinicalTrials.gov Gets a Modernized Look for an Improved User Experience; NIH
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.