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Open Recommendations

National Institutes of Health: Assessing Efforts to Improve Animal Research Could Lead to Greater Human Health Benefits [Reissued with revisions on Jan. 29, 2026]
GAO-25-107140
Jan 29, 2026
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2 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The Director of NIH should define short-term goals with measurable targets and time frames related to enhancing reproducibility and translatability in animal research that the agency conducts and supports. For example, some initial goals could include targets for the number of NIH-funded publications that report certain factors that affect reproducibility and translatability, such as randomization and appropriate sample sizes. (Recommendation 1)
Open
The agency agreed with this recommendation. We will update the status of the recommendation when we receive additional information.
National Institutes of Health The Director of NIH should collect evidence needed to assess NIH's efforts to enhance reproducibility and translatability in animal research. This could include steps such as (1) analyzing attempts to reproduce NIH-funded studies or (2) collecting information from projects that attempt to reproduce significant lines of research. (Recommendation 2)
Open
The agency agreed with this recommendation. We will update the status of the recommendation when we receive additional information.

Organ Transplantation: HHS Action Needed to Improve Lifesaving Program
GAO-26-107434
Jan 22, 2026
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3 Open Recommendations
Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should ensure the Administrator of HRSA develops detailed plans for the next phase of its OPTN Modernization Initiative, including how it will make reforms to the OPTN to address its identified weaknesses. The plans should take into consideration GAO's key principles for agency reforms. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should ensure the Administrator of HRSA assesses the risks associated with current and future OPTN contractors' provision of supplementary services and the associated fee and makes changes as appropriate. (Recommendation 2)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should ensure the Administrators of HRSA and CMS take action to ensure that OTAG's (the agencies' organ transplantation system coordination group) action plan includes specific, actionable steps with milestone completion dates and markers for measuring success of actions taken, as directed by the OTAG charter. (Recommendation 3)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Health Care Accessibility: Further Efforts Needed to Address Barriers for People with Disabilities
GAO-26-107120
Dec 19, 2025
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5 Open Recommendations
Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of HHS should establish detailed plans—that contain clear steps and timelines—to develop and pilot the collection of national-level data from people with disabilities on the accessibility of health care. The plans should be developed in consultation with stakeholders. (Recommendation 1)
Open
HHS neither agreed nor disagreed with this recommendation. HHS stated that while improving disability data infrastructure was a priority, the agency was unable to execute planning activities for such data collection at this time without dedicated and sufficient funding. The agency also noted the need to be cognizant of respondent burden relative to the value of the information collected. We continue to believe that agency planning would not require a high resource investment. Further, such planning, including establishing clear goals, would allow HHS to determine the scope and resource requirements of such a data collection effort, potentially saving resources over time. We also believe that engaging stakeholders in the development of the plan could help HHS assess data needs and respondent burden.
Department of Health and Human Services The Secretary of HHS should ensure the consistent collection of data on disability status using its Data Standard for Disability Status (currently the ACS-6) in the following population health surveys: Health and Retirement Study, Health Information National Trends Survey, National Health and Aging Trends Study, National Health and Nutrition Examination Survey, National Health Interview Survey Sample Adult Questionnaire, National Survey of Family Growth, and National Survey on Drug Use and Health. (Recommendation 2)
Open
HHS neither agreed nor disagreed with this recommendation. HHS stated that the agency was unable to execute planning or data collection activities without dedicated and sufficient funding. The agency also noted that the HHS Implementation Guidance on Data Collection Standards had minimum data standards and agencies were permitted to include additional questions. HHS cited two efforts underway related to the collection of the ACS-6. Regarding the funding issue, the Guidance notes that incorporating the disability data standard can occur at the next major revision of the survey and in accordance with normal agency planning, budgeting and data collection cycles. We acknowledged the flexibility included in the Guidance. However, the Guidance states that additional questions can be added as long as the minimum data standard is included. We identified seven surveys that did not include the minimum data standard for disability status, the ACS-6. We are encouraged that HHS is taking steps to align data collection on disability status with agency guidance. Increasing the number of surveys that collect disability data in accordance with HHS's data standard will help to increase consistency of data collection in this area.
Department of Health and Human Services The Secretary of HHS should establish plans for achieving its priorities related to accessible health care provided by health care organizations, through the survey and certification process or some other mechanism, to help ensure accessibility for people with disabilities and compliance with the recent Section 504 regulations. Such plans for achieving priorities should be developed in consultation with relevant stakeholders and should include sound planning practices, such as developing activities and timelines and assigning responsible parties. (Recommendation 3)
Open
HHS stated that the agency was continuing to review this recommendation. We will monitor the agency's efforts to address it.
Department of Health and Human Services The Secretary of HHS should ensure that OCR develop a mechanism to compile and publicly share on an annual basis summary data on resolved complaints and compliance reviews, to inform OCR and other efforts to enhance accessibility for people with disabilities. This mechanism could include additional functionality of the OCR case management system to automate the preparation of summary data, to the extent possible. (Recommendation 4)
Open
HHS neither agreed nor disagreed with this recommendation and identified potential challenges in implementing it. First, HHS noted there could be privacy and confidentiality concerns if it were to publicly share complaint and compliance review documents. Our recommendation refers to summary data rather than summary information. We believe that summary data would help to identify common challenges and areas for improving accessibility. Second, HHS noted that it already shares voluntary resolution agreements and settlement agreements resulting from resolved complaints via its website. We acknowledge these efforts and believe that the substance of individual agreements may provide helpful examples of noncompliance and how it may be addressed. OCR is taking steps to modernize its case management system. Completing these efforts could help the agency more efficiently summarize and share data. HHS's ongoing efforts, when combined with sharing summary data, would benefit health care organizations, providers, and the public.
Department of Health and Human Services The Secretary of HHS should ensure that OCR provides additional guidance to health care organizations regarding their responsibilities under Section 504, and make all guidance readily available to health care organizations. (Recommendation 5)
Open
HHS neither agreed nor disagreed with this recommendation. The agency noted that it had already provided guidance on the updated Section 504 regulations, including fact sheets on specific topics such as requirements for web content, mobile apps, and kiosks. However, we believe that while these fact sheets are helpful in addressing certain topics, additional guidance covering all health care organizations' responsibilities under Section 504 regulations is needed to help health care organizations address the new requirements in a timely manner and ensure quality health care for people with disabilities. For example, the fact sheets do not cover the prohibition on limiting medical treatment based on bias about disability. In addition, this guidance should be readily available to providers. We will monitor the agency's activity in these areas.

Medical Device Recalls: HHS and FDA Should Address Limitations in Oversight of Recall Process
GAO-26-107619
Dec 12, 2025
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2 Open Recommendations
Agency Affected Recommendation Status
Department of Health and Human Services As HHS undergoes its restructuring efforts, the Secretary should work with FDA to conduct strategic workforce planning to determine the staffing resources, skills, and capacity that FDA needs to effectively process and oversee medical device recalls—including being able to conduct recall audit checks and terminate recalls within agency goals—and develop strategies for addressing any identified workforce gaps. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services As a part of its restructuring efforts, HHS should work with FDA to assess if the agency would benefit from having additional legislative authority that would allow it to require manufacturers to implement agency recommendations for manufacturer-initiated recall strategies. HHS should seek additional authority, if needed. (Recommendation 2)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
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