Dec. 20, 2024: National Advocacy Update

Over the past week, the Department of Health and Human Services’ (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) finalized two regulations relating to the access, exchange and use of individuals’ medical records: the Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (HTI-2) Final Rule and the Health Data, Technology, and Interoperability: Protecting Care Access (HTI-3) Final Rule.   

For the past several years, the AMA has been urging ASTP/ONC to enhance protections for individuals’ health information and clarify when physicians, electronic health record (EHR) vendors, and other actors who withhold access, exchange, or use of medical records to protect patients will not be considered information blockers. HTI-3 finalizes the Protecting Care Access Exception to information blocking and addresses physicians’ concerns about implicating the information blocking definition if they choose not to share reproductive health information when a physician believes in good faith there is a risk of exposing a patient or physician to legal action. Following the Dobbs v. Jackson Women’s Health Organization decision, physicians and other actors have been asking for clear guidance that using exceptions to prevent the disclosure of specific health records will not be considered information blocking. Physicians and other actors can take advantage of the Protecting Care Access Information Blocking Exception immediately.   

Physicians and other actors should now have the confidence to delay the release of reproductive health information when, for example, they are aware that a court order requiring the release is being contested. The HTI-3 rule also now clarifies that physicians, EHR vendors and other actors may, when honoring a patient's request, withhold test results and lab reports without being considered an information blocker. This allows physicians and EHRs to delay results until a physician has a chance to review or withhold information from the patient's portal or app to prevent patients from experiencing anxiety or harm from receiving life-changing information without physician context. 

In addition, HTI-3 includes changes to policies where physicians or EHR vendors cannot segment requested information from the patient’s complete medical record. The “segmentation condition” provides physicians, EHR vendors and other actors the clarity and certainty to confidently withhold portions of health records, e.g., medications or test results related to reproductive health, without fear of incurring an information blocking claim.   

HHS’ Office of Civil Rights (OCR) recently released new guidance (PDF) for physicians and other health care professionals regarding the use of language assistance services for patients with limited English proficiency (LEP). Included in the “Dear Colleague” letter is guidance to health care professionals regarding the use of AI-enabled language assistance services. The guidance follows the finalization of the Section 1557 Non-Discrimination Rule, which implements, among other policies, a new prohibition on discrimination by clinical algorithms (including those utilizing augmented intelligence (AI)) and creates new burdens on health care professionals to make reasonable efforts to ensure clinical algorithms they may use do not result in discriminatory harms. The rule also creates new requirements to ensure meaningful access to care for patients whose primary language for communication is not English and who have a limited ability to read, write, speak or understand English. 

The new guidance requires entities that use “machine translation” for critical documents to ensure that those documents are reviewed by a qualified human reviewer. Documents that will require this human review include documents where “accuracy is essential,” “when the source documents or materials contain complex, nonliteral or technical language,” or “when the underlying text is critical to the rights, benefits, or meaningful access” of individuals with LEP.  

The guidance also notes some exceptions. Situations where a patient must receive urgent or emergent care will not require review by a qualified human reviewer. Human review will also not be required where the risk of translation errors to the patient is low, although in these cases, the guidance notes the patient should be warned that the translation in question may contain errors.  

The OCR guidance is one of the first guidance documents to require the human review of AI-enabled outputs in a health care setting. The AMA is closely monitoring the implementation of new regulations impacting the use of AI in clinical practice. The AMA strongly supports prohibitions on discrimination by AI but is working to ensure physician liability for AI output errors is limited. 

The AMA recently submitted a letter (PDF) to the U.S. Food and Drug Administration (FDA) providing feedback on draft industry guidance (PDF) for updated Phase II voluntary sodium reduction targets. The guidance builds on the FDA’s voluntary Phase I sodium reduction targets which set target average sodium consumption at 3,000 milligrams (mg)/day, a reduction of 400 mg or around 12% from the current average intake of 3,400 mg/day for Americans older than one year to be achieved over a two-and-a-half-year period from October 2021 to April 2024. Phase II voluntary targets would support reducing average individual sodium intake to 2,750 mg per day over three additional years, which aligns with the Healthy People 2030 goal.  

In the letter, the AMA reiterated the link between increased sodium intake and higher risk for hypertension, high blood pressure and poor cardiovascular health and expressed overall support for voluntary sodium reduction targets. The AMA also called for additional transparency into how the FDA arrived at the recommended draft reduction targets and asked for potential consideration of slightly more ambitious short-and long-term voluntary targets. The AMA also suggested additional strategies to further enhance the voluntary targets, including reiterated that voluntary targets should be one component of a larger multi-pronged strategy and further strengthening the voluntary targets through enhanced transparency and enforcement, such as shedding additional transparency into which individual companies are hitting the targets versus those that are not. 

The 2025 AMA National Advocacy Conference is quickly approaching—Feb. 10-12 at the Grand Hyatt in Washington, D.C. The room block closes on Jan. 13, so make sure to book your hotel room and register now. 

This year, opportunities to meet with your members of Congress will also feature a special event hosted by the AMA on Capitol Hill to bring even more attention to the Medicare physician payment crisis. Join fellow physicians during the afternoon of Feb. 11 at the historic U.S. House Cannon Caucus Room and hear directly from lawmakers working toward Medicare payment solutions. There is power in numbers: we need you at this year’s National Advocacy Conference more than ever. Register now. 

Featured speakers at the conference will include: 

• Michael J. Sorrell, Ed.D., visionary leader, institutional change agent, and president of Paul Quinn College 

• Anna Palmer, co-founder and CEO of Punchbowl News, former co-author of POLITICO Playbook 

• Jake Sherman, co-founder of Punchbowl News, former co-author of POLITICO Playbook 

View the preliminary agenda (PDF) for more information. We are once again working with Soapbox to book Hill visits for all attendees (until 5:00 p.m. on Wednesday, Feb. 12), so please plan your travels accordingly. 

Please contact [email protected] with any questions.

• Dec. 20, 2024: Advocacy Update spotlight on scope of practice advocacy
• Dec. 20, 2024: Medicare Payment Reform Advocacy Update
• Dec. 20, 2024: State Advocacy Update