JAMA Health Forum最新文献

{"title":"Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices.","authors":"Maryam Mooghali, Faaizah Arshad, Vinay K Rathi, Kushal T Kadakia, Alexander O Everhart, Joseph S Ross, Sanket S Dhruva","doi":"10.1001/jamahealthforum.2026.2626","DOIUrl":"10.1001/jamahealthforum.2026.2626","url":null,"abstract":"<p><strong>Importance: </strong>High-risk medical devices approved through the US Food and Drug Administration (FDA) premarket approval (PMA) pathway may be supported by limited premarket clinical evidence, leaving uncertainties about safety. Whether device, premarket clinical evidence, or regulatory characteristics are associated with subsequent device recalls is unknown.</p><p><strong>Objective: </strong>To examine the association between device, premarket clinical evidence, and regulatory characteristics and serious recalls among high-risk therapeutic devices.</p><p><strong>Design and setting: </strong>This cross-sectional study reviewed 193 high-risk therapeutic medical devices approved through the FDA's PMA pathway between January 1, 2014, and December 31, 2023. Data were analyzed between August 2025 and December 2025.</p><p><strong>Exposures: </strong>Device characteristics, premarket pivotal clinical study characteristics, and regulatory characteristics.</p><p><strong>Main outcome and measure: </strong>The main outcome was occurrence of serious recall (Class I or II) and Class I (highest severity) recall.</p><p><strong>Results: </strong>From 2014 to 2023, the FDA approved 193 original high-risk therapeutic medical devices through the PMA pathway. As of July 31, 2025, a total of 68 (35.2%) were subject to at least 1 serious recall, with a median (IQR) of 2.6 (1.5-4.6) years from approval to first recall; 20 (10.4%) devices were subject to at least 1 Class I recall. Life-supporting or life-sustaining devices more often had serious recalls (28 of 60 [46.7%] vs 40 of 133 [30.1%]; P = .02) and Class I recalls (14 of 60 [23.3%] vs 6 of 133 [4.5%]; P < .001) than non-life-supporting and life-sustaining devices. Cardiovascular devices more often had Class I recalls than noncardiovascular devices (16 of 99 [16.2%] vs 4 of 94 [4.3%]; P = .004). Class I recalls differed by pivotal study design: single-arm with no controls, 3 of 9 (33.3%); single-arm with nonconcurrent controls, 11 of 89 (12.4%); and multiple-arm with concurrent controls, 6 of 95 (6.3%) (P = .03). Devices with required postapproval studies had more serious recalls (56 of 140 [40.0%] vs 12 of 53 [22.6%]; P = .04) than those without. Other characteristics were not associated with recall likelihood.</p><p><strong>Conclusions and relevance: </strong>In this cross-sectional study, more than one-third of high-risk therapeutic medical devices were subject to serious recalls. Because device, premarket clinical evidence, and regulatory characteristics were not consistently associated with serious recalls, robust postmarket surveillance is needed to ensure patient safety.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 8","pages":"e262626"},"PeriodicalIF":12.5,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13451980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148686547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ebola and the Catastrophic Cost of Public Health Infrastructure Disinvestment.","authors":"Lawrence O Gostin","doi":"10.1001/jamahealthforum.2026.3633","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2026.3633","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 8","pages":"e263633"},"PeriodicalIF":12.5,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148680945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medicare Advantage Beneficiary Enrollment Decisions Following New Complex Conditions.","authors":"Mark K Meiselbach, Jianhui Xu, Teneil Brown, Daniel Polsky","doi":"10.1001/jamahealthforum.2026.2843","DOIUrl":"10.1001/jamahealthforum.2026.2843","url":null,"abstract":"<p><strong>Importance: </strong>Prior research has demonstrated higher rates of disenrollment from Medicare Advantage (MA) among people with greater health care needs. Yet, less is known about how disenrollment responds to changes in medical complexity, whether disenrollment varies by the degree of complexity, and how these patterns differ by state Medigap protections and MA plan characteristics.</p><p><strong>Objective: </strong>To examine changes in MA plan disenrollment following the development of new complex medical conditions and assess heterogeneity by number of conditions, state Medigap policy, and plan characteristics.</p><p><strong>Design, setting, and participants: </strong>This cohort study used Medicare enrollment and claims data from 2016 to 2021. The study population included beneficiaries continuously enrolled in MA in 2016 without complex medical conditions from 2016 through 2018. A treatment group developed a new complex condition in 2019; a comparison group did not develop a complex condition through 2021. Data were analyzed from December 1, 2025, to March 1, 2026.</p><p><strong>Exposure: </strong>Development of 1 or more new complex medical conditions in 2019, including acute myocardial infarction, Alzheimer disease and related dementia, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease, depression, congestive heart failure, or stroke.</p><p><strong>Main outcomes and measures: </strong>Annual disenrollment from the prior year MA plan, which included disenrollment to traditional Medicare (TM) or switching to another plan within MA. Difference-in-differences models with beneficiary and year fixed effects were estimated and converted to differences in percentage points.</p><p><strong>Results: </strong>The analytic sample included 1 054 926 beneficiaries, including 219 942 (mean [SD] age, 75.3 [6.3] years; 54.6% female) who developed new complex conditions in 2019 and 834 984 (mean [SD] age, 73.8 [5.6] years; 56.7% female) who did not develop a new complex condition in 2019. Developing any new complex condition was associated with an increase of 3.3 (95% CI, 3.1-3.5) percentage points (pp) in MA disenrollment, including an increase of 2.8 (95% CI, 2.7-2.9) pp in disenrollment to TM. The number of new complex conditions was associated with increased disenrollment, from 1.4 (95% CI, 1.3-1.6) pp for 1 condition to 12.8 (95% CI, 11.6-13.9) pp for 4 or more conditions. Disenrollment to TM was 1.5 (95% CI, 0.9-2.1) pp higher among beneficiaries residing in states with Medigap guaranteed issue and community rating protections.</p><p><strong>Conclusions and relevance: </strong>In this study, development of new complex medical conditions was associated with higher MA disenrollment, particularly to TM and in states with Medigap protections, and the magnitude increased with medical complexity. These findings highlight how changes in health status and state policy may shape Medicare coverage decisions.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 8","pages":"e262843"},"PeriodicalIF":12.5,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13499002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148801477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Closing the Health Policy Implementation Gap With Artificial Intelligence.","authors":"Emma E McGinty, Yongkang Zhang, Fei Wang, John Z Ayanian, William L Schpero","doi":"10.1001/jamahealthforum.2026.2515","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2026.2515","url":null,"abstract":"<p><strong>Importance: </strong>Health care policies often fail to achieve their goals due to implementation challenges attributable to workforce constraints, fragmented health information systems, and administrative complexity. This Special Communication proposes a framework for how artificial intelligence (AI) tools could support effective health care policy implementation, using the implementation of Medicaid work requirements under the Budget Reconciliation Act of 2025 as an example.</p><p><strong>Observations: </strong>Opportunities for AI-augmented health care policy implementation include executing key policy processes, such as generating eligibility screening tools, reviewing documentation, and linking and analyzing data for indicators of policy compliance; identifying individuals at risk of adverse consequences from implementation failure who should receive proactive support; enhancing policy communication to diverse audiences; facilitating implementation monitoring; and learning from and adapting implementation across all of these domains. To realize the potential of AI augmentation, the field needs to overcome challenges related to data availability, as well as the limitations of AI tools themselves, such as hallucinated false information.</p><p><strong>Conclusions and relevance: </strong>AI-augmented health care policy implementation has the potential to meaningfully limit unintended consequences from implementation of Medicaid work requirements. Rigorous evaluation of state-led innovations in AI-augmented implementation of Medicaid work requirements is key to advancing effective approaches and mitigating the potential for harm. The federal government should support state efforts with AI expertise, data infrastructure, and partnerships with preferred vendors who demonstrate that their AI-augmented digital assistants and other AI tools effectively facilitate Medicaid enrollment among eligible individuals.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 8","pages":"e262515"},"PeriodicalIF":12.5,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148686543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Removing Synthetic Food Dyes from the Food Supply-Contextualizing the Efforts of the US Food and Drug Administration.","authors":"Nolan R Fox, Diana R H Winters, Yuxuan Bo, Joseph T Kannarkat","doi":"10.1001/jamahealthforum.2026.2345","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2026.2345","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 8","pages":"e262345"},"PeriodicalIF":12.5,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148686695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dental Care as a Test Case for Rural Health Reform.","authors":"Hawazin W Elani, Ichiro Kawachi","doi":"10.1001/jamahealthforum.2026.2402","DOIUrl":"10.1001/jamahealthforum.2026.2402","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 8","pages":"e262402"},"PeriodicalIF":12.5,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148763266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alternative Payment Models in Inpatient Psychiatry-Moving Beyond Per Diem Toward Value.","authors":"Jack J Huang, Alisa B Busch, Curtis W Wittmann, Andrew D Carlo","doi":"10.1001/jamahealthforum.2026.1929","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2026.1929","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 7","pages":"e261929"},"PeriodicalIF":12.5,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148474136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Drug Launches in Most-Favored-Nation Countries and Medicare Pricing Benchmarks.","authors":"Mengyuan Fu, Rohini Ghosh, Erfan Taherifard, Reshma Ramachandran, Joseph S Ross","doi":"10.1001/jamahealthforum.2026.2340","DOIUrl":"10.1001/jamahealthforum.2026.2340","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 7","pages":"e262340"},"PeriodicalIF":12.5,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13428281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148632825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Errors in Citations and Tables 1 and 4.","authors":"","doi":"10.1001/jamahealthforum.2026.2551","DOIUrl":"10.1001/jamahealthforum.2026.2551","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 7","pages":"e262551"},"PeriodicalIF":12.5,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13355140/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148426446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bulk Prescription Transfers and Access After Chain Pharmacy Closures.","authors":"Sai Veeramachaneni, Sujith Ramachandran, Marie Barnard","doi":"10.1001/jamahealthforum.2026.2070","DOIUrl":"10.1001/jamahealthforum.2026.2070","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"7 7","pages":"e262070"},"PeriodicalIF":12.5,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148377958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}